講演者

I am skilled scientist with a Master of Science in Bioinformatics from Northeastern University and a Bachelor of Science in Biology with a minor in Computer Science from Frostburg State University. I have extensive experience in the biological science field, having worked as a Principle Research Associate/Engineer at Vedere Bio, a Gene Therapy company in Cambridge, MA. At Vedere Bio, I led the downstream process development, improving yields and impurities removal, and evaluating the binding capacity of different AAV constructs. Prior to joining Vedere Bio, I was a Senior Associate Scientist at Solid Bioscience, another Gene Therapy company in Cambridge, MA. At Solid Bioscience, I was responsible for the optimization of UF/DF, ultracentrifuge, clarification, and chromatography processes, as well as the development of scalable processes for AAV and enveloped virus purification.

• Advances in Purification & Recovery
• Gene Therapy Manufacturing

Maral is a computational scientist in drug product development at Johnson & Johnson. In this role, she leads modeling and simulation efforts to support formulation for new biotherapeutics. Before joining Johnson & Johnson, Maral worked as a post-doctoral fellow at Sanofi where she developed in silico workflows to examine product/HCP interactions in protein purification process department. Maral earned her bachelor’s degree at Sharif university of technology in physics and received her PhD in computational biophysics from Lehigh university in 2019.

• Formulation and Delivery of High-Concentration Proteins and New Modalities

Shreya is currently a Senior Principal Scientist at Prevail Therapeutics, a wholly owned subsidiary of Eli Lilly and Company. She leads and manages the analytical characterization for gene therapy neurodegenerative disorder product portfolio. Prior to joining Prevail, Shreya was a Senior R&D Scientist with MilliporeSigma. During her 6 year tenure at MilliporeSigma, she contributed to the development of new products and experimental methods. Her expertise focuses on characterization of large molecules including proteins, glycoproteins, and antibody analysis using mass spectrometry principles and applications. Shreya holds a Masters in Biotechnology from Indiana University with a Certificate of Business Life Sciences from Kelley School of Business. During her graduate studies, she interned at Dow Agrosciences in the Advanced Technology Development department. Shreya is passionate about advancing minority causes and actively volunteers her time towards community development to raise the standard of living for the underserved and disadvantaged. In her free time Shreya loves to play tennis, drink coffee, and explore new restaurants.

• Gene Therapy CMC and Analytics

Christian Airiau is the Global Head of Data Science in Sanofi R&D, Biologics Development, based in the Boston area. He has over 18 years of experience in the pharmaceutical industry, working on Data Science, Process Modeling and Process Analytical Technologies (PAT). His remit is to drive alignment across the global Sanofi network to develop data science, process modeling and control in Biologics development. Christian is also the Advanced Analytics lead in the iCMC-Digital Transformation program in Sanofi. In this role, he is developing and implementing the program strategy to maximize the use of data across the CMC perimeter, as Sanofi implements its digital transformation. Trained as a chemist, he holds a Masters and a Ph.D. in Data Science/Chemometrics from the University of Bristol in the UK.

• Smart Biomanufacturing & Digitalization

Yemi is currently a research analyst within the office of biotechnology products at the FDA, conducting research into downstream biotechnology manufacturing process development. Yemi received his PhD in chemical engineering from University of Maryland Baltimore county and has completed two post-doctoral fellowships within the FDA in both research and regulatory-related fields.

• Advances in Purification & Recovery

Nicholas Alden has worked in biopharmaceutical process development for 8 years. He began his career in Upstream Process Development and has spent much of his career focused on making data readily available and simple to process by building custom data warehouse solutions, and automated data collection and visualization workflows. As a member of the Analytical Development Automation team at Ultragenyx Gene Therapy he is focused on improving data storage practices and improving process efficiency by integrating existing workflows with a LIMS.

• Accelerating Analytical Development

Sakhr Alhuthali is an early career researcher at the Sargent Centre in Imperial College London and an assistant professor in the Chemical Engineering Departement at King Abdulaziz University. He has extensive knowledge about mathematical modelling and bioprocess engineering. He published a range of research papers in chemical engineering journals about monoclonal antibody optimisation from CHO cells. Sakhr is a reviewer for some academic journals such as PLOS One and Plant Biotechnology. He is currently working with Prof. Cleo Kontoravdi to improve the prediction of HCP dynamics in mAb processes.

• Host Cell Proteins

Niamh Alix joined Prime Medicine in June 2022 as Chief Human Resources Officer. Niamh is a passionate human resources leader who brings her experience, of helping to grow teams from small, early-stage organizations to global enterprises, to Prime. She has vast experience across multiple biotech and pharmaceutical organizations, where she led HR and Talent Acquisition teams from a couple of people to over 120 talented individuals. Niamh joins Prime from Orchard Therapeutics, where she was Global Vice President, Talent, and HR Business Partner. She partnered with the leaders across all departments such as Research, Regulatory Affairs, Technical Operations and Commercial. Niamh and her team developed and deployed important people practices like Talent Management, Diversity and Inclusion and Learning and Development to the employees. Prior to that, Ms. Alix held global and regional roles at Lonza, including HR Business Partner for Americas, Mexico, and Canada where she led a large HR team and people strategy for a 5,000+ employee population across corporate and manufacturing clients. Niamh also held the Global Head, HR Business Partner role for the Cell and Gene Technology’s group which spanned three continents and grew rapidly. Prior to that, Niamh was the Ireland Country HR Head for Novartis Pharmaceuticals and Oncology. Before this, she held additional senior roles of increasing responsibility at Novartis and Bristol Myers Squibb across Manufacturing and Commercial organizations.

• W1: Talent Acquisition and Retention Strategies for Biopharma

Geneva received her bachelor’s degree in 2013 from Columbia University while working as a lab technician in Dr. Martin Chalfie’s lab. She earned her PhD in 2020 from the Molecular, Cellular, and Developmental Biology Department at the University of California, Santa Barbara, under the supervision of Dr. Joel Rothman. She started at Amgen in 2021 as a Postdoctoral Fellow in the Cell Line Development group in Process Development, where she is currently working in her new role as Scientist. Geneva’s efforts are focused on Amgen’s pipeline needs as well as genome engineering initiatives.

• Cell Line Development & Cell Culture Optimization

David joined Ampersand in 2010. Previously, David spent six years with Covington Associates, a specialty investment bank focused on middle-market M&A in the healthcare sector. Prior to Covington, he spent five years as a consultant for Boston Healthcare Associates. David's current and past board seats include Vernal Bio, Genezen, Arranta Bio, StageBio, Protogene, BioClinica, Brammer Bio, Cellero, and Vibalogics. David holds a B.Sc. In Immunology from the University of Aberdeen, a Ph.D. in Tumor Immunology from the University of Sheffield and a M.B.A. from Babson College.

• Bioprocessing Tech: Venture, Innovation, and Partnering Conference

Rosalind grew up in Singapore. She went to college in Liverpool, U.K., and then completed Master of Science in National University of Singapore. Rosalind received her PhD from Mount Sinai School of Medicine - New York University, U.S.A.. Her graduate research focused on delineating the mechanism of actions of hallucinogens with the goal to understand cognition (Neuron 2007 and Nature 2008). She completed her post-doctoral training in Precision Immunology Institute, Icahn School of Medicine at Mount Sinai, NYC, U.S.A.. In her post-doctoral training, her research focused on understanding the impact of cellular deaths on immune system and development of diseases (e.g. Cell Death & Disease 2020, JCI Insights 2021 and PNAS 2021). In 2018, she joined Cell Therapy Development Operation, Celgene, as a Scientist. She supported the development of early CAR-T drug candidates and commercialization of drug products. Rosalind then continued her career in MERCK, as an Associate Principal Scientist in Biologics-ARD. Working with a multi-functional team, her primary focus is on analytical strategy and method development (with heavy emphasis on residuals, purity and adventitious virus) and authoring specific BLA/IND sections. She enjoys hiking and traveling.

• Host Cell Proteins

Georgina Armstrong conducted her bachelor’s degree in Pharmacutical Science and Masters in Cancer Immunology at the University of Nottingham. She has been a downstream processing scientist at GSK for four years, specialising in scaled down automation solutions, and is now in her second year as a PhD student in collaboration with the University of Strathclyde, focusing on sequence-engineering to improve the performance of biologics in autoinjector devices. Her interests include downstream bioprocess optimisations, delivery, and formulation of biologics, and in silico predictive approaches to the developability of monoclonal antibodies.

• Formulation and Delivery of High-Concentration Proteins and New Modalities

Dennis works as a scientist and project manager in early drug discovery and his main research interests are protein biophysics and characterization, antibody discovery, and protein stability. Before joining the biophysics department, he worked for four years with characterization of chemical stability of peptide and protein, also at Novo Nordisk. He holds a PhD from Karlstad University, Sweden, within pharmaceutical analysis of small molecules and which was a collaboration with AstraZeneca R&D, Gothenburg.

• Rapid Methods to Assess Stability and Impurities in Biologics

Anthony graduated from Old Dominion University with a Master’s and PhD where he worked in the Center for Bioelectrics focusing on how the cell microenvironment affects cell differentiation and tissue development through electrophysiological responses. He then joined the NIH as a postdoc fellow investigating ubiquitin signaling pathways involved in stem cell fate decisions. Anthony then joined NIST as a Biologist working to develop faster and streamlined imaging pipelines to advance live cell imaging capabilities of stem cells combined with AI-based approaches for single cell tracking of cell dynamics.

• Cell Therapy CMC and Analytics

Fouad Atouf is Vice President, Global Biologics, for USP. He leads all scientific activities related to the development and maintenance of documentary and reference standards for biologics and advanced therapies and oversees the biologics laboratories in USP-U.S. and USP-India. Dr. Atouf has been at USP for over 15 years and served in a variety of scientific leadership roles including being the regional champion for the Middle East and North Africa Region, where he helped facilitate programs designed to enhance the understanding of the role of regulations and standards in the registration of medicinal products. Dr. Atouf has strong background and experience in the development and standardization for cellular and tissue-based products. Prior to joining USP in 2006, his research at the U.S. National Institutes of Health focused on developing methods for the in vitro generation of cell-based therapies for diabetes. Dr. Atouf is the author of numerous publications in peer-reviewed journals and a frequent speaker at national and international scientific conferences. Dr. Atouf earned his master’s degree in Biochemistry and his PhD.in Cell Biology from the Pierre & Marie Curie University, Paris, France

• Cell Therapy CMC and Analytics

Since September 2021: PhD student at the Insitute of Bioprocess Science and Engineering (IBSE) and Junior Researcher at the austrian center of industrial biotechnology (acib) in the field of virus analytics with a focus on vaccine development and cell-based assays 2020: Master Thesis at Department of Nanobiotechnology (BOKU) and Medical University Vienna in the fields of microbiology and immunology: "Cellular responses to an HtrAserine protease from the oral pathogen Tannerella forsythia and to a novel health-associated Tannerella strain”; Recombinant production of HtrA, purification, exposure of cell cultures following immunological analyses and characterisations 2018: Participation ata convention about synthetic biology - iGEM (International Genetically Engineered Machine competition): A project in the field of synthetic biology was developed and caried out in the lab in a group of 10 students from different fields. The practicalpart was followed by a presentation about our developed project Robocrop and took part at the Hynes Convention Center in Boston. Further experiences in the biotech industry as summer staff in the qualification and validation of biotechnoloical plants.

• Vaccine Development and Manufacturing

No bio available.

• Cell Therapy Manufacturing

Dr. Ramin Baghirzade is the Global Head Commercial - Gene Therapy CDMO Services at Charles River Laboratories. With 15+ years of experience in life science and healthcare, Dr Baghirzade previously held roles of increasing responsibility at Roche, Lonza, and AGC Biologics in global business development, strategic marketing and market intelligence functions. He holds a PhD Degree in Medical Sciences, as well as an MBA.

• Bioprocessing Tech: Venture, Innovation, and Partnering Conference

Gagan Bajwa is a senior scientist at CMC Process Development, Immatics, Houston, TX. She has provided scientific lead to several projects related to process development and next generation programs at Immatics. She obtained her doctoral training from UT Southwestern Medical Center at Dallas followed by post-doctoral training in the field of Cell and Gene Therapy from Baylor College of Medicine.

• Cell Therapy Manufacturing

Meisam

• Advances in Purification & Recovery
• Gene Therapy Manufacturing

I am currently working as an Associate Director within the Drug Product Development Organization at Sanofi wherein I primarily lead and provide oversight to all the DP development activities (including formulation and process development) for non-viral and viral gene therapy programs. I obtained my bachelor’s in chemical engineering from Institute of Chemical Technology (India) and PhD from New York University in Chemical Engineering with focus on developing lipid-based drug delivery nanocarriers for cancer therapy. Prior to joining Sanofi, I worked at Shire (Takeda) in the drug product development and device development teams on leading early and late-stage programs.

• mRNA-Based Therapies
• Formulation and Delivery of High-Concentration Proteins and New Modalities

Kyle Barlow is a Senior Scientist at Adimab. He has been part of the San Francisco Bay Area-based computational biology team at Adimab for five years, where he works on the design and characterization of Adimab’s synthetic antibody libraries, the analysis and optimization of sequences from immunizations, and in silico design, including the design of chain pairing mutations to enable bispecifics. Working closely with experimentalists at Adimab, he also works to develop and evaluate machine learning models to predict and improve the developability properties of antibodies throughout the discovery process. Previously, Kyle completed his PhD in Bioinformatics at the University of California, San Francisco. His graduate research included work developing the Rosetta suite of protein modeling and design software, as well as the application of computational methods of protein design, such as in silico design and experimental validation of protein-based biosensors. He also developed and benchmarked the performance of computational methods to predict changes in stability or binding affinity after protein mutagenesis.

• Rapid Methods to Assess Stability and Impurities in Biologics

No bio available.

• Cell Therapy CMC and Analytics

Debashree Basu is a senior scientist in the analytical development group at Ultragenyx. Her work focuses on the functional potency assay development of different AAV gene therapy programs. Before joining Ultragenyx, she worked at Homology Medicines, where she worked on developing different gene editing assays. She was a Research Scientist in University of Minnesota and University of Texas. She received her PhD in Biochemistry from Manipal University, India and was a Postdoctoral Fellow in University of Texas Medical Branch.

• Gene Therapy CMC and Analytics

Dr. Ronald Bates is the Vice President of CMC Process Development and Manufacturing at Immunovant (IMVT). At IMVT, Ron leads the development and manufacturing of novel biological moieties targeting immunotherapies. Prior to IMVT, he led the Manufacturing Science and Technology (MST) group at Bristol-Myers Squibb (BMS) in Syracuse, NY and was responsible for monitoring, validating, transferring, and improving late-stage and commercial manufacturing processes. Before BMS, Ron led the process development and MST group at Allergan (now part of AbbVie) focusing on developing and manufacturing wild-type and recombinant prokaryotic-based systems as well as developing novel technologies including automated, high throughput methods and disposable manufacturing processes. Ron started his career at Pfizer purifying small molecule moieties using chiral, normal phase, and reversed phase chromatography in traditional, flash, and multi-column continuous systems. He received his Ph.D. from the University of Maryland, Baltimore County in Biochemical Engineering under Doug Frey studying mathematical modeling of ion exchange chromatography and his B.S. in Chemical Engineering from Rensselaer Polytechnic Institute. Ron is also active in the biopharma industry sitting on conference planning, conference scientific, and journal editorial boards in addition to chairing and presenting at international conferences and authoring research articles and patents.

• Advances in Purification & Recovery

Mr. Timothy Belski is Branch Chief of the Biopharmaceutical Manufacturing Program (BioMaP), under the Pharmaceutical Countermeasures Infrastructure Division of the Biomedical Advanced Research and Development Authority (BARDA), Department of Health and Human Services. Mr. Belski earned a Master of Science degree in Biotechnology from Johns Hopkins University and is a certified Project Management Professional (PMP) through the Project Management Institute. Before joining BARDA in 2019, Mr. Belski spent 14 years with the Department of Defense's Joint Program Executive Officer for Chemical Biological Radiological and Nuclear Defense in Frederick, MD serving various roles, including the Joint Product Lead for the Advanced Development and Manufacturing Capabilities program.

• Vaccine Development and Manufacturing

Svetlana Bergelson, PhD, Senior Director, Analytical Development, Biogen. At Biogen, Svetlana is leading a team of scientists and analysts located in Cambridge, MA, and RTP, NC. The group provides analytical support for gene therapy and protein modalities at all stages of development, from R-D transition through commercial. Main responsibilities include development, qualification, automation, implementation and transfer of analytical methods to support process development, product characterization, batch release and stability, as well as CMC program support. Svetlana has over 20 years of experience in the biopharmaceutical industry. Prior to joining Biogen in 2005, she worked at two companies focused on anti-viral drug development. Her educational training includes MSc in Biochemistry and Virology from Moscow State University (Russia), a PhD in Molecular Biology from Weizmann Institute of Science (Israel) and a post-doctoral fellowship at Whitehead Institute at MIT (USA).

• Gene Therapy CMC and Analytics

I am a Purification Development Scientist in Sanofi Genomics Medicine Unit since July 2021. Before this I was a Scientist in Sanofi Biologics Purification development for 4.5 years.

• Advances in Purification & Recovery
• Gene Therapy Manufacturing

No bio available.

• Cell Therapy CMC and Analytics

Siddharth Bhoraskar is currently working as a Scientist at Beam Therapeutics with the Analytical Research & Development team based in Cambridge, MA. He has been involved in early-stage LC/LC-MS characterization of lipids, mRNA, sgRNA and lipid nanoparticles and supporting research as well as CMC teams in driving Beam’s molecules from pre-clinical to clinical stage. He received his Ph.D. in Chemistry from University of Massachusetts Lowell, Masters in Pharmaceutical Sciences from Northeastern University and Bachelors in Pharmacy from Devi Ahilya University in Indore, India.

• mRNA-Based Therapies
• Formulation and Delivery of High-Concentration Proteins and New Modalities

Yiling Bi is a scientist in the analytical development department at Sangamo Therapeutics, a genomic medicine company. With focus on characterization of AAV-based gene therapies, Yiling is responsible for LC-MS, CE-MS, and HPLC-CAD method development. She also works with CRO and vendors for routine testing and new technology evaluations on HCP analysis, genome integrity, and empty/full ratio to support gene therapy product development. Yiling obtained her PhD in medicinal chemistry at the University of Utah. She has been involved in analytical development for biologics since 2019, with a broad experience in early/late phase analytical development and CMC.

• Gene Therapy CMC and Analytics

Eric Bishop is the Vice President for Research and Development at Cygnus Technologies. Eric leads the research and development team and is responsible for new product development and custom development services. Eric has 25 years of experience in HCP analytics. Eric joined Cygnus Technologies in 2010, bringing a background in R&D for several biopharmaceutical companies. Prior to joining Cygnus, Eric worked for AstraZeneca, formerly MedImmune, from 2002-2010. During his time there he had multiple roles from HCP assay development and tech transfer to being Analytical Representative on CMC teams guiding projects from IND to BLA submissions as well as Head of New Technology Development group. Prior to AstraZeneca, he was at CropTech Development from 1998-2002, where he was involved in characterization of recombinant proteins produced in plants.

• Host Cell Proteins

Jay is currently the Vice President of People and Culture at Lykan Biosciences an innovative CDMO delivering advanced cell-based therapies that improve and save patient lives. Before joining Lykan, Jay was the Vice President of People and Culture at Spero Therapeutics, a global, multi-asset, clinical-stage biopharmaceutical company developing transformative antibiotics where he was responsible for Human Resources, Facilities, and Administration. Jay also held an executive Human Resource leadership position at InVivo Therapeutics, a research and clinical-stage biomaterials and biotechnology company with a focus on the treatment of spinal cord injuries. In addition, Jay has lived and worked Globally in Human Resources leadership positions at EMC Corporation, Avid Technology, State Street Corporation and Monsanto Chemical Corporation. Jay has a Bachelor of Science in Human Resources Management from the University of Massachusetts and a Master of Science in Management from Lesley University.

• W1: Talent Acquisition and Retention Strategies for Biopharma

Dr. Anthony Blaszczyk is in the Pipeline Development group within USP’s Global Biologics department. At USP, he works with scientific experts and stakeholders to develop new standards to support biopharmaceutical quality assessment and development. Prior to USP, Anthony worked at Catalent Cell and Gene Therapy, where he managed an analytical development team responsible for the development, qualification and transfer of methods. He obtained his Ph.D. in Biochemistry from Penn State University in 2018.

• Gene Therapy CMC and Analytics
• Host Cell Proteins

Andy has over 40 years’ experience as an analytical scientist in the chemical and pharmaceutical industries and a BS in Biological Sciences. Over the past 16 years at Biogen, Andy’s work has focused on development and optimization of chromatographic and electrophoretic methods for characterization of proteins and gene therapy-based products.

• Accelerating Analytical Development

I completed my PhD dissertation at the University of Vermont in 2020 on hormone receptor signaling in cancer cells followed by a postdoctoral fellowship at the University of Colorado Anschutz where I worked on a project to study metabolic signaling and obesity in thyroid cancer. In early 2022 I joined 2seventybio as a scientist in the analytical development team where I have been working on the development of cell based assays.

• Cell Therapy CMC and Analytics

Dr. Bolton is a An Executive Director at Amgen, where he leads late-stage cell culture and purification development. Prior to joining Amgen, he worked with different organizations including Pfizer and Biogen. He also taught the Protein Purification and Cell and Microbe Cultivation courses at Tufts Univeristy. He has served as Division Chair, Conference Chair and Treasurer for the ACS Biochemical Technology Division and is currently the chair of the 8th International Conference on Accelerating Biopharmaceutical Development (AccBio 2023). Dr. Bolton is a Director of Zepteon Corporation and on the Scientific Advisory Board of AcousticaBio. Glen earned his Ph.D. in Biochemical Engineering from the Massachusetts Institute of Technology.

• Rapid Methods to Assess Stability and Impurities in Biologics
• Intensified & Continuous Processing
• Cell Therapy CMC and Analytics
• Gene Therapy CMC and Analytics
• Cell Line Development & Cell Culture Optimization
• Host Cell Proteins
• Vaccine Development and Manufacturing

Jose is a Science and People Lead in the Mass Spectrometry department of Large Molecule Research at Roche Pharma Research and Early Development (pRED). He leads large molecule drug discovery projects, from an initial concept to Phase I, and develops hands-on state of the art MS methods for characterization of therapeutic molecules. He holds a Ph.D. and M.S. in Biology & Life Sciences from the University of Buenos Aires and has been working in Protein Biochemistry and MS-based Proteomics for more than 13 years.

• Accelerating Analytical Development

Rajeev Boregowda is Director of the Analytical Development at Solid Biosciences. Within the CMC, Rajeev’s effort is focused on the analytical method development specifically bioassay development, qualification, tech transfer, validation, and method life cycle management to support process optimization, product development, and commercialization. Rajeev earned PhD in Biochemistry and worked in the academic setting focused on the bioassay and molecular biology methods before moving into biotech industry. In addition to the release methods, he thinks that having additional orthogonal methods are essential for understanding the product quality attributes.

• Gene Therapy CMC and Analytics

Dr. Richard D. Braatz is the Edwin R. Gilliland Professor at the Massachusetts Institute of Technology (MIT). He leads the modeling, control, and systems activities in many biopharmaceutical manufacturing efforts at MIT, including for vaccines, gene therapy, and monoclonal antibodies. Most activities are in automated process development workflows and modeling, design, and control of fully automated modular manufacturing unit operations and end-to-end systems, which are experimentally validated. He has consulted or collaborated with more than 25 companies including Novartis, Pfizer, Merck, Biogen, Sanofi, and Amgen. Honors include the AIChE PD2M Award for Outstanding Contribution to QbD for Drug Substance, the AIChE Separation Division Innovation Award, the AIChE Excellence in Process Development Research Award, the Research Collaboration Award from the Council for Chemical Research, and the IEEE Control Systems Society Transition to Practice Award. He is a member of the National Academy of Engineering.

• Accelerating Analytical Development
• Cell Therapy Manufacturing
• Advances in Purification & Recovery
• Gene Therapy Manufacturing
• mRNA-Based Therapies
• Formulation and Delivery of High-Concentration Proteins and New Modalities
• Smart Biomanufacturing & Digitalization

Dr. Christoph Brandenbusch studied Chemical Engineering at the Department of Biochemical and Chemical Engineering at TU Dortmund, (Germany) 2003-2007. He finished his Ph.D. thesis in the field of downstream processing in biocatalysis in 2011. Since 2012 he works as a group leader and assistant professor at the Laboratory of Thermodynamics, Department of Biochemical and Chemical Engineering, TU Dortmund (Germany). His main research fields include: Novel strategies for protein purifications in pharmaceutical bio-processes as well as the development of liquid and lyophilized biopharmaceutical formulations. The methods used include analytical techniques as well as coarse-grained modeling approaches for predictive formulation screening.

• mRNA-Based Therapies
• Formulation and Delivery of High-Concentration Proteins and New Modalities

Christopher founded Consulting on Advanced Biologicals Ltd at the end of 2009 in order to focus his activities within the Regenerative Medicine sector. Advbiols Ltd provides EU regulatory services to the regenerative medicine industry in addition to business and regulatory research and analysis to identify and focus on the real barriers to commercialisation of regenerative medicine. Christopher has a PhD in xenotranplantation immunology and spent 8 years in biotech (Imutran Ltd, A Novartis Pharma AG Co. and Intercytex) before joining the MHRA as a quality (CMC) assessor (biologicals and biotechnology unit). During this time Christopher was involved with National implementation of the new Advanced Therapies Regulation and also involved through his participation in the CHMP’s cell products working party (CPWP) in implementation at the EMA level including drafting guidelines.

• TS4: Potency Assays and Comparability for Cell and Gene Therapies
• Cell Therapy CMC and Analytics

I completed my PhD in polymer and organic chemistry at the Leibniz Institute of Catalysis in Germany. Following my PhD, I joined Novartis as a Process Expert in Menges, Slovenia. During the initial years, I acquired significant knowledge in bioprocessing, which I continue to utilize as a leader of a group of process experts at the Menges production site.

• Intensified & Continuous Processing

Kevin Brower is the Global Head of Purification Process Development at Sanofi, leading teams in France, United States, and England responsible for process, platform, and technology development, from first-in-human development through commercialization. The organization delivers a modality-diverse pipeline including traditional mAbs, multi-specifics, ADCs, enzymes, and various novel constructs and has technology focus areas in integrated continuous biomanufacturing, high throughput process development, and PAT. Kevin received his BS in Chemical Engineering from Yale University and his MS and PhD in Chemical Engineering from MIT.

• Advances in Purification & Recovery

Adam has 15+ years of medtech/life science leadership experience spanning roles in general management, commercial operations, strategy and corporate development, and investment banking. He has a passion for the cell and gene therapy space and the amazing work being progressed by therapy developers. He currently leads the Personalized Medicines Business Unit at Lonza where his team focuses on automated manufacturing technology development for the cell and gene therapy field. Prior to joining Lonza, Adam led the creation and launch of ScaleReady, a joint venture between Wilson Wolf, Fresenius Kabi, and Bio-techne and served as Vice President of Fresenius Kabi’s Therapeutics and Cell Therapy business. Adam has an MBA from the Kellogg School of Management at Northwestern University with an emphasis in Health Enterprise Management and Entrepreneurship and a BS in Finance from Brigham Young University.

• Bioprocessing Tech: Venture, Innovation, and Partnering Conference

Scott R. Burger, MD, is the Principal of Advanced Cell and Gene Therapy, a consulting firm specializing in cell and gene therapy product development, manufacturing, and regulatory affairs. Dr. Burger has over 25 years of experience developing cell and gene therapy products and has consulted for over 140 companies in North America, Europe, Asia, and Australia. He has directed or consulted on process development, manufacturing, and CMC regulatory aspects of a wide range of cell therapy and gene therapy products, including CAR T-cell, NK, and DC immunotherapies, gene-edited cell therapy products, as well as stem cell- and somatic cell-based regenerative medicine products. Prior to founding Advanced Cell & Gene Therapy in 2002, Dr. Burger was Vice-President for R&D at Merix Bioscience, and director of the University of Minnesota Cell Therapy Clinical Laboratory. His regulatory background includes numerous IND and IDE submissions and productive interactions with FDA-CBER Office of Tissues and Advanced Therapies (OTAT, formerly the Office of Cellular, Tissue and Gene Therapies, OCTGT). Dr. Burger is a member of several scientific advisory boards, and has served on the USP Cell, Gene and Tissue Therapies Expert Committee, the ISCT advisory board and ISCT committees on gene therapy, regulatory affairs, commercialization, and product/process development. A graduate of the University of Pennsylvania School of Medicine, Dr. Burger completed training in clinical pathology and transfusion medicine at Washington University in St. Louis, and is author of over 200 scientific publications and presentations, and recipient of numerous honors and awards.

• Cell Therapy CMC and Analytics
• Cell Therapy Manufacturing

Michael Butler is a Principal Investigator in Cell Technology at the National Institute of Bioprocessing Research & Training (NIBRT), Ireland, Adjunct Full Professor in University College Dublin as well as Distinguished Professor Emeritus of the University of Manitoba, Canada. He holds degrees in Chemistry and Biochemistry from the Universities of Birmingham, London (UK) and Waterloo (Canada). He was the scientific director of MabNet, a Canadian network for Mab production and founder of Biogro Technologies Inc., a spin-off company dedicated to serum-free media development. His research work focuses on the development of bioprocesses using mammalian cells for the production of recombinant proteins, monoclonal antibodies and viral vaccines.

• Accelerating Analytical Development

No bio available.

• W1: Talent Acquisition and Retention Strategies for Biopharma

Huiyi Cao, Ph.D., has been a Senior Scientist from the Manufacturing Intelligence team at Pfizer’s Global Technology & Engineering since 2022. His primary research interests are in the development and implementation of advanced analytics, including mechanistic modeling, machine learning, and advanced process control, to support the manufacturing processes at Pfizer Global Supply. Dr. Cao completed his Ph.D. in mathematical modeling and numerical optimization at McMaster University in 2021. He also holds a M.Sc. in Computer Science from Georgia Institute of Technology with a specialization in machine learning.

• Smart Biomanufacturing & Digitalization

Antonio Gaetano Cardillo, Senior Scientist in Drug Substance Technical Research and Development, GSK Vaccines. Holds a master’s degree and PhD in Chemical engineering. Thesis on: Process intensification at University of Bologna. Started in GSK Vaccines (formerly Novartis Vaccines) in 2015 as scientist, where he held product development positions of increasing professional responsibility until 2019. Lead of the process modelling Centre of excellence (2017 - 2019). Since September 2019, member of the Global Innovation Centre for Drug Substance Technical Research and Development and Automation and Robotics transversal lead. Interest to apply in GSK Pharma 4.0 framework for digital strategies to the unique contexts of pharmaceutical manufacturing.

• Smart Biomanufacturing & Digitalization

No bio available.

• Advances in Purification & Recovery
• Gene Therapy Manufacturing

Ping has a PhD in Biochemistry; she has ten years of experience at CMC analytical development bioassay and 3+ years in the AAV gene therapy field. She worked at Eli Lilly, BMS, and is now focused on gene therapy bioassay in Passage Bio.

• Gene Therapy CMC and Analytics

Dr. Trevor P. Castor is President and CEO, Aphios Corporation, Woburn, MA. He has over 30 years of diversified experience in technology and business development, management, marketing, and finance in the biotechnology industry. He graduated from the University of California, Berkeley, with a PhD in Mechanical Engineering and a MSc in Chemical Engineering, and summa cum laude with a BSc in Chemical Engineering from the University of Toronto, Canada. He studied Business Administration at St. Mary’s College, Brooklyn, NY, and Management, Marketing, and Finance at the Harvard University Extension Program, Cambridge, MA. He is the author of over 100 issued and pending US and international patents on SuperFluids, nanotechnology drug delivery, siRNA, mRNA, and other enabling technology platforms and enhanced therapeutic products. He has collaborated with several pharmaceutical and biotechnology companies including Eli Lilly, BMS, Novartis, Pfizer, and Merck-Millipore-Sigma.

• mRNA-Based Therapies

Senior Director, MockV Products at Cygnus Technologies and the founder and C.E.O. of MockV Solutions, Inc., a company acquired by Cygnus that commercialized a novel series of BSL-1 viral clearance prediction kits. Prior to MockV, David was a purification scientist at Human Genome Sciences specializing in viral clearance and nanofiltration.

• Intensified & Continuous Processing

Dr. Lina Chakrabarti is an Associate Principal Scientist at Biopharmaceutical R&D Development group in AstraZeneca located in Maryland, USA. Dr. Chakrabarti is actively involved in the planning and execution of projects aimed at improving the efficiency, predictability and robustness of the cell line development process. Dr. Chakrabarti has authored and co-authored several peer-reviewed articles in this field.

• Cell Line Development & Cell Culture Optimization

Shanti Chari has a blend of biotech/pharma industry and consulting experience for 20+ years. Currently she heads “Digital Technologies and Innovation” at Landmark Bio. More recently, she worked with Emergent and Amgen and was responsible for digital strategy and deployments in manufacturing, quality and supply chain space. Her major stints in consulting include Deloitte and The Hackett Group.

• Smart Biomanufacturing & Digitalization

Dr. Rachel Chen is an Associate Director of Analytical Development at Biogen. She has broad experience in the analytical method development and characterization of biotherapeutics, with a focused interest in host cell protein analysis. Dr. Rachel Chen earned her PhD in chemistry from Northwestern University and a bachelor's degree from Tsinghua University.

• Host Cell Proteins

Victor Chen is currently working as a principal scientist at Regenxbio. He leads a team of scientists to provide analytical development support for gene therapy programs at all stages of development and manufacturing. Prior to this, he worked at GlaxoSmithKline in a thriving team of biopharma scientists across discovery, development, and manufacturing. He has a broad industrial experience in the development and licensure of various therapeutic biologics including fusion proteins, mAbs, ADCs, and gene & cell therapies. Victor received his PhD in 2008 from Barnett Institute for Chemical & Biological Analysis at Northeastern University.

• Accelerating Analytical Development

Hao Chen obtained his Ph.D. degree from Purdue University in 2005 and he is currently a professor in chemistry at New Jersey Institute of Technology (NJIT). Dr. Chen's research focuses on the combination of electrochemistry (EC) and mass spectrometry (MS) for developing novel methods/devices for bioanalysis. He developed the approach of MS analysis of proteins following online electrochemical reduction of protein disulfide bonds. Recent efforts aims to develop Columetric Mass Spectrometry (CMS) for absolute quantitation of proteins and drug impurities without using standards, as well as ultrafast digestion of antibody in microdroplets in microseconds. He has published 138 papers in peer-reviewed journals (H index 48) and 13 patents.

• Host Cell Proteins

Cylia has over 20 years of experience in the biopharmaceutical industry. Currently, Cylia is the Director of Business Performance and chief of staff to the EVP of Operations at Amgen. In this role Cylia has responsibility for working with the leadership team to set strategies, provide oversight to the decision-making framework and drives several business critical initiatives, including digitization/automation of key performance measures. She has been at Amgen since 2006 and has held various roles in GxP setting in Quality and Process Development. Prior to Amgen, she had experience in consulting with Baxter and Watson on various process validation projects brining online new fill finish manufacturing facilities. She holds a Master of Science degree in Regulatory Sciences and Bachelor of Science in Biomedical Engineering from University of Southern California.

• Smart Biomanufacturing & Digitalization

Ashutosh Chilkoti is the Alan L. Kaganov Professor and of Biomedical Engineering at Duke University. His areas of research include genetically encoded biomaterials and the development of synthetic biomolecular condensates for synthetic biology. He has published ~350 papers, has been cited ~43,000 times, has a Google Scholar H-index of 110, and has 40 patents and 60 patent applications in process. Prof. Chilkoti was awarded the Clemson Award for Contributions to the Literature by the Society for Biomaterials in 2011, the Robert A. Pritzker Distinguished Lecture award by the Biomedical Engineering Society in 2013, was elected to the National Academy of Inventors in 2014, received the Distinguished Alumni award from the Indian Institute of Technology, Delhi in 2015, and the Diamond award from the College of Engineering at the University of Washington in 2017. He is a fellow of the American Association for the Advancement of Science. He is the founder of six start-up companies: (1) PhaseBio Pharmaceuticals, a publicly traded company on NASDAQ (sticker: PHAS) that is taking drug delivery technology that he developed into clinical trials; (2) Sentilus, a clinical diagnostics company that was acquired by Immucor in 2014; (3) BioStealth, a spinoff of Sentilus; (4) GatewayBio, that is commercializing a next-generation PEGylation technology for biologics; (5) Isolere Bio that is developing a non-chromatographic technology for purification of biologics; and (6) inSoma Bio that is developing a recombinant protein matrix for tissue reconstruction.

• Formulation and Delivery of High-Concentration Proteins and New Modalities

Therese Choquette, Head of Analytical Sciences at Tigen Pharma, has a passion for cell therapy, cellular function, and immunology. She holds a PhD in Rheumatology from the Karolinska Institute in Sweden and completed her postdoctoral fellowship at University of Massachusetts Medical School in Worcester, MA, investigating the impact of hyperglycemia in host defense against M.tb. Her career has been focused on cell and gene therapy since 2014 in the space of analytical development, analytical strategy, and quality control.

• Cell Therapy CMC and Analytics

Prior to joining USP Dr. Cipollo founded and led the Vaccine Structure Group at US FDA CBER. His group focused on vaccine antigen structure, pathogen interaction with the host immune system, and development of mass spectrometry based and other analytical methods as well as supporting informatics. He served as a CMC reviewer for a wide range of vaccines for over 15 years. John’s role at USP includes leveraging his experience in vaccine research and review to lead efforts towards identifying and advancing the development of documentary and physical standards to support vaccine development and manufacture. His efforts also include educational outreach to foster greater understanding of the principles of vaccine development, production, and quality as well as their importance in human health.

• Rapid Methods to Assess Stability and Impurities in Biologics
• mRNA-Based Therapies
• Vaccine Development and Manufacturing

Dr. Clarke has over 15 years of experience developing enabling solutions to support cell and gene therapies. He was the Global Head of Cell Therapy at HemaCare, a leading provider of source material for clinical development and commercial manufacturing of cell-based therapies. His previous roles include Global Product Manager for Charter Medical's cell therapy and bioprocessing single-use systems portfolio and Director of Research and Development for BioLife Solutions. Dominic currently serves as the Co-chair for the International Society for Cell and Gene Therapies' Process and Product Development Committee with efforts directed towards translating research and process development from bench to clinic.

• Cell Therapy Manufacturing

Ben Clarke supports USP’s portfolio of documentary and physical reference standards for the Global Biologics group. He specializes in cell and gene therapy, vaccines, and monoclonal antibodies. Before joining USP, Ben developed analytical bioassays at GSK Vaccines for RSV and self-amplifying mRNA vaccines. Before GSK Vaccines, he pioneered the development of mouse models of sphingolipid biology using CRISPR/Cas9 genome editing technology at the National Institute for Health. Before NIH, he optimized upstream PER.C6 cell culture for the production of adenovirus at Janssen. He received his PhD from Cornell University for his work on mammalian membrane biology and lipid remodeling enzymes. He received his BS from Pennsylvania State University for Biochemistry, Molecular, and Cell Biology.

• Cell Therapy CMC and Analytics

Dr. Clement has 25+ years of experience in the field of Gene Therapy, with industry leading expertise in viral vectors, specifically adeno-associated virus (AAV). She led AAV production and process development at research, preclinical and clinical grades during her time at the Powell Gene Therapy Center, University of Florida, Gainesville. SHe oversaw manufacturing, release and stability campaigns of more than eight AAV INDs, including CMC preparation. Her research focused on optimizing large-scale suspension platforms using HSV or transfection systems in suspension to produce clinical rAAV. Dr. Clement then joined Resilience as the head of the Process Development group for Viral Vaccines and Gene Therapy, where she oversaw production at scale up to 200L in suspension format, and in large scale adherent platforms. Currently, Dr. Clement acts as the Vice-President of Vector Development at a new startup company and continue to consult in the field of gene therapy and AAV.

• Cell Therapy Manufacturing
• Gene Therapy Manufacturing

Adriana Coll De Pena is a Dominican Ph.D. Candidate in Tripathi Laboratory (Center for Biomedical Engineering) at Brown University. Prior to joining Brown, she completed a B.S. in Biotechnology and Molecular Bioscience, a B.S. in Biomedical Engineering, and an M.S. in Science, Technology and Public Policy at the Rochester Institute of Technology. Her research currently focuses on the development of miniaturized platforms for the detection and analysis of biomolecules.

• Rapid Methods to Assess Stability and Impurities in Biologics
• Vaccine Development and Manufacturing

Scott has 20+ years' experience in the G&CT field and working in GMP environments. He has been responsible for cleanroom design and build out and commissioning of vector facilities, as well as the oversight of cell therapy, fill finish, and manufacturing support departments. Scott started his career at Merck and Co. working on the development of an adenovirus-based HIV vaccine, before moving on to manage GMP production and testing at the Indiana University (IU) Vector Production Facility and the National Gene Vector Laboratories (NGVL). He then went on to manage GMP viral vector production at Cincinnati Children's Hospital before becoming the Director of Cell Therapy, Fill Finish, and Support Operations at Florida Biologix/Brammer Bio. Prior to joining Dark Horse, Scott was the Vice President of Vector Operations at Orchard Therapeutics.

• TS3: Introduction to Viral Vectors and Gene Therapy

Liz Csaszar is the Senior Director of Manufacturing Sciences at Notch Therapeutics and is responsible for cell-based process development, non-clinical cell manufacturing, and GMP cell banking. Her experience is in preclinical and early clinical process development, optimization, and scale-up/-out of cell and gene therapies, technology transfer, and CMC support. Prior to Notch, Liz worked as a process development manager at CCRM, where she oversaw CCRM’s immunotherapy platform and managed process development teams executing client-based development projects and internal process and product development, in partnership with Cytiva.

• Cell Therapy Manufacturing

Jackie Cullinan is a research analyst in the Bioprocessing lab as part of Center for Drug Evaluation and Research (CDER) at the US FDA. She graduated from Simpson College in 2018 with a B.A. in Forensic Biochemistry, then in 2019 graduated from Georgetown University with a Masters in Biochemistry and Molecular Biology. During Jackie’s time at the FDA she has been working on a research project involving an N-glycan analysis HPLC column.

• Accelerating Analytical Development

Alejandro D’Aquino is a Principal Investigator at GSK with over 8 years of experience in development of pharmaceuticals. Specializing in formulation development, Alejandro combines biophysical characterization of biopharmaceuticals and automation to advance programs into late and commercial phase. Alejandro has applied the principles of thermodynamics that he learned during his doctoral studies in Molecular Biophysics at The Johns Hopkins University to develop novel approaches to monitor formulation stability. Following that, Alejandro acquired knowledge of structural biology during his postdoctoral work at Brandeis University. At GSK, he is responsible for the high concentration development of biopharmaceuticals, where he has has introduced screening techniques and statistical analysis to late phase development. Alejandro is passionate about bringing better medicines to patients and it is this passion that gets him up in the morning.

• Rapid Methods to Assess Stability and Impurities in Biologics

Susan D’Costa, PhD, is the Executive Vice President & Global Head of Technology at Alcyone Therapeutics. She is a molecular virologist with extensive expertise in viral vector analytics, process development, and manufacturing. She has built a considerable amount of this experience in the contract manufacturing industry (Thermo Fisher/Brammer Bio) working with different viral vectors, liaising with diverse biotech clients, and building teams with scientific and operational excellence. In her current role, she oversees both internal and external CMC (chemistry, manufacturing, and Controls), device development, and building out new technologies for both gene therapy and precision delivery. Dr. D’Costa holds a PhD in Biology (specializing in Virology) from Texas Tech University, an MS in Biochemistry from Mumbai University (Grant Medical College), and a BS in Microbiology/Biochemistry also from Mumbai University (St. Xavier’s College).

• Rapid Methods to Assess Stability and Impurities in Biologics
• Intensified & Continuous Processing
• Cell Therapy CMC and Analytics
• Gene Therapy CMC and Analytics
• Cell Line Development & Cell Culture Optimization
• Host Cell Proteins
• Vaccine Development and Manufacturing

Ajit D’Souza is the Sr. Director of Combination Product Development and Manufacturing at Kiniksa Pharmaceuticals where he directs the development of formulations, devices and manufacturing processes. Ajit has earned a PhD in Pharmaceutical Chemistry from the University of Kansas, a Professional Certificate in Systems Engineering at MIT xPRO and an MBA. He has spent majority of his career in functional and program leadership roles, developing drug formulations, medical devices for drug delivery and combination products.

• Formulation and Delivery of High-Concentration Proteins and New Modalities

Armin Delavari has a PhD in chemical engineering and has been working in biopharmaceutical industry for ~5 years. His expertise is in chromatography purification and filtration method developments and he’s currently working at ASO purification development team at Biogen.

• Advances in Purification & Recovery

Kurtis Denny has been working as an engineer in Biogen’s Cell Culture Development department since 2017. Kurtis has a primary focus of continuous manufacturing process development for biologics. Additionally, he leads a team focused on process analytical technology applications in the upstream space, and he is passionate about when PAT and CM come together!

• Smart Biomanufacturing & Digitalization

Mr. Vaibhav Deokar is Principal Scientist at Formulation Development Team of R&D, Lupin Limited (Biotech Division), India. He has pursued M.Tech (Bioprocess Technology) from Institute of Chemical Technology (ICT) (formerly UDCT), Mumbai, and is pursuing PhD under the Lupin’s ASCENT PhD programme. He has authored research articles in peer reviewed journals and is key contributor to 6 formulation patents for biopharmaceuticals. He has 13+ years of experience in developing formulations for complex biopharmaceuticals like peptides, fusion proteins, monoclonal antibodies. He is responsible for fill-finish process development, characterization, and technology transfer within Lupin and other drug product manufacturing facilities. He has faced regulatory agencies for formulation and fill-finish process development related queries. He has special interests in new product development, product differentiation, and enhancement strategies, and has provided new differentiation strategies for a couple of products in pipeline.

• Formulation and Delivery of High-Concentration Proteins and New Modalities

Wenjun Di is a scientist II in Downstream Process Development in PharmDev at Ultragenyx. She is focusing on AAV purification and downstream process development. She did her PhD at Northeastern University in pharmaceutical sciences and joined Ultragenyx ever since. She is passionate about developing and exploring novel ways to improve AAV full capsid percentage and clearance of impurities. She is also interested in helping with scale up challenges with more reliable and robust process. She likes cooking for her three year old and enjoys classical music.

• Gene Therapy Manufacturing

Nicholas holds a degree in chemical engineering from the University of Massachusetts at Amherst. and has over 7 years of experience in the biotech industry developing biologics manufacturing processes. He got his start supporting commercial manufacturing at Sanofi and has since held roles of increasing responsibility in the process development groups at Bristol Myers Squibb and LogicBio therapeutics. He is currently serving as a manager of genomic medicines process development at Alexion pharmaceuticals.

• Gene Therapy Manufacturing

Dr. Yanhuai (Richard) Ding, Director at AnaptysBio, is responsible for Downstream Process Development and Manufacturing Operations. He is one of the key players in the CMC team at AnaptysBio. He had more than 25 years’ experience for cell harvest, clarification, protein purification, PD, technology transfer, MFG support, process characterization, process validation, viral clearance, CMC strategy, regulatory filing, and commercial production support. He has hands-on experience for purifying proteins from mAbs, biosimilars, Fc-fusion proteins, enzymes, collagen IV, vaccines (HIV gp140), viral vector.... He currently manages multiple projects from phase I to III and CDMOs. He presented and/or chaired in many conferences such as PepTalk, BPI West, CBI Bioprocessing, Americas Antibody Congress of Festival of Biologics, Commercializing Continuous Process in Pharma. He published more than 30 scientific papers in academic and industry (18 publications and one book chapter for continuous bioprocessing in the United States and New Zealand). (He also had 15 publications in China.)

• Intensified & Continuous Processing
• Advances in Purification & Recovery

Valerie Dixon is a Managing Director in the Healthcare Investment Banking Group at Morgan Stanley. She joined Morgan Stanley in 2018 and currently leads the franchise’s global client coverage efforts of Life Sciences Tools and Diagnostics companies. For more than 16 years, Ms. Dixon has served as a trusted advisor to C-suite executives and Boards whose experience includes corporate finance and mergers and acquisitions advisory; and equity and debt financings for a variety of healthcare clients and industrial conglomerates. She has executed such transactions as Thermo Fisher’s acquisition of PPD, Inc. for $17.4 billion. Prior to joining Morgan Stanley, Valerie worked in J.P. Morgan’s Healthcare Investment Banking group for four years. She was also at Citigroup for four years, including a stint as a sell-side research analyst covering the emerging medical technology, life sciences tools, and diagnostics sectors. She began her investment banking career as an Associate at Lehman Brothers. Valerie earned an MBA from Yale School of Management and is a graduate of Harvard College. In her free time, Valerie is an avid trekker and alpine climber and has had successful summits of Mt. Kilimanjaro (19,341’), Mt. Shasta (14,179’), Mt. Baker (10,781’), Mt. Rainier (14,411’), and has trekked the 103-mile Tour du Mont Blanc and to Mt. Everest Base Camp.

• Bioprocessing Tech: Venture, Innovation, and Partnering Conference

Terrence has led the Upstream Process Development group for Gene Therapy programs at Biogen since 2016. His group has supported the development of multiple programs, enabled by multiple industry and academic collaborations as well as internal development. Before joining the Gene Therapy Department, he contributed to program and technical initiatives for Biogen Biologics programs including early phase development, mid-phase optimization and late-phase process characterization. Terrence earned B.S. in Chemical Engineering from the University of Notre Dame in 2005 and a Ph.D. in Chemical and Biomolecular Engineering from Johns Hopkins University in 2010 where he focused on characterizing lentiviral adhesion kinetics.

• Gene Therapy Manufacturing

Mike currently works as a Staff Engineer at Takeda, where he specializes in the downstream process development of protein therapeutics. His efforts largely focus on harvest, chromatography, filtration, and UF/DF development of monoclonal antibodies and engineered proteins, spanning from early manufacturability through process performance qualification and commercialization. In addition to his day-to-day responsibilities, Mike is pursuing his PhD in Chemistry & Chemical Biology under the direction of Prof. Sunny Zhou at Northeastern University. Through their industry-academia collaboration, Mike and Sunny are investigating and characterizing host cell protein impurities to better understand their interactions with therapeutic proteins and to develop practical solutions that can aid the industry at large.

• Rapid Methods to Assess Stability and Impurities in Biologics

Mark is currently Director, Head of Talent Acquisition, Executive Recruiting and Sourcing at Kinnate Biopharma and is responsible for building out and leading talent acquisition strategy and function for the company. Mark created a recruiting strategy with more targeted outreach, talent pipelining, and active engagement with candidates for all roles - executive, management, and professional level positions - across all functional areas the company, led the Diversity, Equity & Inclusion (DEI) strategy for talent acquisition and in 2022 successfully filled 40 roles - including 3 Vice Presidents - within 9 months of starting in role and completed 90% of annual hiring target by end of Q2 growing headcount from 52 to 88 FTEs. Prior to Kinnate, Mark was the Associate Director of Executive Recruiting at Bristol Myers Squibb for their R&ED, GDD, and Medical divisions. Mark has also held executive recruiting positions for PTC Therapeutics and Seattle Genetics

• W1: Talent Acquisition and Retention Strategies for Biopharma

Lauren M. Drouin leads the Analytical Development, Genomic Medicine group at Alexion, AstraZeneca Rare Disease, where she supports the development and implementation of analytical methodologies needed to progress LB-001 and other pipeline products from preclinical development into the clinic and beyond. Current research interests include novel AAV capsid characterization and developing a robust understanding of the factors that influence potency of gene therapy products. Previously, Lauren worked at Voyager Therapeutics where she was responsible for analytical method development and overseeing CMC analytics operations for the Parkinson’s Disease clinical program. Lauren received her PhD in Biochemistry and Molecular Biology from the University of Florida where she utilized molecular, biophysical, and structural techniques to characterize the AAV capsid for improved gene delivery.

• Gene Therapy CMC and Analytics

Daryl has 30 years of experience in the research and development of liposomal and lipidic nanoparticle (LNP) based therapeutics and vaccines. Daryl is currently the Founder, Chief Scientific Officer, and Senior Vice President of Akagera Medicines. At Akagera, he is advancing the use of sophisticated lipid-based nanotechnologies to deliver novel and highly potent anti-bacterial agents directly to innate immune cell reservoirs for mycobacterium or gram-positive bacterium and mRNA vaccines, targeting some of the world’s most challenging and neglected infectious diseases. Daryl also joined Tidal Therapeutics in 2019 as an SAB member, and later as the Interim Head of Research and Development, prior to be acquired by Sanofi in April 2021. At Sanofi he oversees the engineering and pharmacology of immune cell-targeted mRNA lipid nanoparticles (LNPs). Through June of 2019, Dr. Drummond served as the Head of Research and Senior Vice President of Discovery for Merrimack Pharmaceuticals, a public biotechnology company headquartered in Cambridge, MA, where he oversaw the discovery efforts for Merrimack’s Nanotherapeutics and Biologics-based therapeutics. Dr. Drummond received a Ph.D. degree in Biochemistry from Indiana University in 1997, with an emphasis on membrane biochemistry and biophysics, and later completed a postdoc under the renowned father of lipid-based drug delivery systems, Demetrios Papahadjopoulos at California Pacific Medical Center in 1999. Dr. Drummond was a principle inventor for a wide range of nanotechnology-based drugs and platform technologies, most notably Onivyde, a highly stabilized liposomal formulation of irinotecan. He joined Merrimack in 2009 following the merger of Merrimack with Hermes Biosciences. Overall, Dr. Drummond has more than 30 years of experience in the research and development of advanced drug delivery systems, including five unique drugs or imaging agents that have been tested in various clinical trials, an NDA and EMA approval for Onivyde, >40 issued patents or patent applications, and more than 75 peer reviewed publications. The focus of his research at Merrimack had been in developing targeted nanotherapeutics for treating a wide range of solid tumors. He successfully developed novel platform technologies for targeting lipidic nanocarriers such as liposomes or lipid nanoparticles (LNPs) using a range of novel ligands, but most notably Fab’ or scFv antibody fragments. He has also developed platform technologies for dramatically improving the in vivo drug retention of difficult to stabilize small molecule drugs, and for systemic delivery of nucleic acids. Three of these nanotherapeutics were studied in clinical trials, including an ErbB2-targeted liposomal doxorubicin which was evaluated in a Phase II study in ErbB2-overexpressing breast cancers and a nanoliposomal formulation of irinotecan which was approved by both the EMA and FDA following promising results in a Phase III trial in gemcitabine-refractory pancreatic cancer. Onivyde is currently being studied in front line pancreatic cancer in combination with oxaliplatin and 5FU and in second line small cell lung cancer by Ipsen Pharmaceuticals. A fourth antibody targeted lipososomal drug (MM-310) was recently evaluated in a Phase I study in multiple EphA2 overexpressing solid tumors. In addition, Dr. Drummond previously oversaw the discovery and development of more traditional biologics, such as a stabilized TRAIL-Fc fusion and a monoclonal antibody against the immuno-oncology target, TNFR2.

• mRNA-Based Therapies

Dr. Zhimei Du is a leader in the fields of Cell/Gene Therapy and Biologics with significant experience in both early and late-stage development. Currently serving as Vice President at Landmark Bio, she leads the Translational Research and Early Development of next-generation cell/gene therapies for various diseases. Prior to joining Landmark Bio, Dr. Du served as Vice President at Atara Biotherapeutics, where she focused on accelerating both early and late-stage cell therapy pipelines. She also worked at Merck & Co. as Executive Director and Global Head of Process Cell Sciences, where she established various new core functions in cell therapy and biologics during early development. Dr. Du has also been actively involved in successful business development activities, including evaluating and building partnerships for CAR-T and CAR-NK programs. Her research contributions include numerous patents and publications in cell and gene therapy, process development, protein engineering, cell engineering, vector engineering, and genetic/epigenetic biomarker development. Dr. Du received her Ph.D. in Immunology from Cornell University Medical College. She then worked as a Postdoctoral Fellow in Robert G. Roeder's laboratory at Rockefeller University, a world-renowned lab known for its groundbreaking work in transcription, in vitro transcription, and epigenetics.

• Cell Therapy CMC and Analytics

Sue Duan (she/her) is an Associate Director of CMC Analytical Development of Astellas Gene Therapy. She has been working in gene therapy field for over 5 years focusing on assay development, validation, transfer, and product characterization. Prior to joining Astellas, Sue has worked in several other companies, including Pfizer, Medivation, Diadexus, Avigen, and Chiron, and has developed assays for diagnostic biomarkers and antibody drugs. Sue obtained a bachelor’s degree in Biochemistry at Sichuan University and a master’s degree in Genetics at Iowa State University.

• Gene Therapy CMC and Analytics

Dr. Mohamed ElSayed is the Chief Technology Officer at RVAC. He is an accomplished leader with over 25 years of experience spanning academic, biotechnology, and pharmaceutical organizations. He has deep expertise in the development of innovative delivery technologies for nucleic acids, biologics, bioconjugates, and small molecules. Prior to RVAC, Dr. ElSayed held positions of increasing responsibilities at Eli Lilly & Company where he established the Oral Peptides Delivery Platform and led the discovery and preclinical development of multiple oral biologics. He is a recognized expert in the development of nucleic acid therapies. Earlier in his career, Dr. ElSayed was a tenured professor at the University of Michigan and served as an advisor for multiple biopharmaceutical companies; he received a Ph.D. in Pharmaceutical Sciences from the University of Maryland in Baltimore.

• mRNA-Based Therapies

Mark A. Emalfarb is the founder of Dyadic. He has been a member of Dyadic’s board of directors since October 2004 and has served as its Chairman as well as President and Chief Executive Officer from October 2004 until April 2007 and from June 2008 until the present. Since founding Dyadic in 1979, Mr. Emalfarb has successfully led and managed the evolution of Dyadic from its origins as a pioneer and leader in providing ingredients used in the stone-washing of blue jeans to the discovery, development, manufacturing and commercialization of specialty enzymes used in various industrial applications and the development of an integrated technology platform based on Dyadic’s patented and proprietary C1 fungal microorganism. Mr. Emalfarb is an inventor of over 25 U.S. and foreign biotechnology patents and patent applications resulting from discoveries related to the Company’s patented and proprietary C1 fungus, and has been the architect behind its formation of several strategic research and development, manufacturing and marketing relationships with U.S. and international partners. Mr. Emalfarb earned his B.A. degree from the University of Iowa in 1977.

• Vaccine Development and Manufacturing

I am a Cell Line Development Scientist with over 11 years of experience in mammalian cell engineering using various platforms including, the CRISPR/Cas9 technology, Zinc finger nucleases (ZFNs) and Transcription Activator-like effector nucleases (TALENs) as well as proficient in cell line cloning. Presently at REGENXBIO, I am utilizing this expertise for the creation of stable cell lines, disease model cell lines and novel engineered cell lines for enhanced production of rAAV vectors and reduction in cost of goods.

• Cell Line Development & Cell Culture Optimization

Heather Erickson serves as Vice President of Supply Chain Management and Business Operations at Sangamo Therapeutics, a publicly traded, clinical-stage company with programs in gene therapy, genome editing, cell therapy, and gene regulation. She joined Sangamo in 2016 as Chief of Staff, a post she held for two years. Previous roles included serving as President and CEO of the Life Sciences Foundation and founding President of MedTech Association. Earlier in her career, she served as Senior Consultant at Edgar Dunn & Company, a boutique strategy consultancy. She currently serves on several industry and community Boards.

• Bioprocessing Tech: Venture, Innovation, and Partnering Conference

Broad experience with stem cells culture at various scales, and how to translate early discovery cell culture with requirements for cell therapy process in which the cells are the product. Current research focus on expansion and differentiation of pluripotent stem cells.

• Cell Therapy Manufacturing

The aging of chromatography columns can significantly impact process efficiency, but it is often not accounted for in traditional fixed protocols. A novel approach that combines model predictive control (MPC) and an extended Kalman filter (EKF) has been developed to address this issue. By constantly monitoring the resin capacity and adjusting the loading volume and velocity gradient, this system is able to maintain high resin utilization and productivity while reducing buffer consumption. This approach also enables automation of the chromatographic unit operation, ensuring a stable, long-term process.

• Intensified & Continuous Processing

Scott Estes is the Head of Cell Line Development at Asimov with 25+ years of biotech industry experience. He has worked at Codiak BioSciences, Biogen, and Genzyme, specializing in cell line development, early process development, and analytics. Scott has contributed to five approved products and multiple INDs. He holds a PhD from the University of Buffalo and completed post-doctoral training at the Koch Institute for Integrative Cancer Research at MIT.

• Cell Line Development & Cell Culture Optimization

Allen is the Founder and Chief Scientific Officer of HebeCell Corp. Prior to HebeCell, Allen was the Director of Cell Biology of Semma Therapeutics (Acquired by Vertex), R&D Head of Stem Cell Bioprocessing Group at EMD Millipore (Merck, KGaA), Director and Senior Scientist at Advanced Cell Technology (Acquired by Astellas), and Senior Scientist at Stemgent, Inc (Now ReproCell). Allen is an inventor of several key patents of hematopoietic lineage-specific differentiation from human pluripotent stem cells (hPSCs), such as the generation of HLA-negative platelets, and a scalable 3D manufacture platform of NK from hPSCs.

• Cell Therapy Manufacturing

Gisela Ferreira received her Ph.D. in Chemical Engineering from the University of Maryland Baltimore County in 2001 and is currently a Director in the Purification Process Sciences at AstraZeneca. Dr. Ferreira has broad biotechnology experience and expertise in areas including process development for large-scale cGMP manufacture of biologics, recombinant biopharmaceutical purification (early and late stage development), Quality by Design concepts, scale-up, technology transfer, CMC project management, virus clearance, and regulatory agency interaction through commercial launch, including Imfinzi, Fasenra and Imjudo.

• Intensified & Continuous Processing

Larry Forman is the Founder and CEO of CHO Plus. Larry started CHO Plus to address the high costs and capacity limitations associated with biomanufacturing by engineering cells to make them more productive for manufacturing therapeutic proteins and other biologics. Larry has a BA in Biology. He began his research career in academia, at the Albert Einstein College of medicine in New York City where he worked on colony-stimulating factors. After that, Larry was an early employee at Genentech where he spent 16 years, mainly involved with aspects of mammalian cell culture process development and process engineering. After Genentech, he worked directly or indirectly for numerous biopharma companies, mainly on process improvement. Throughout his many years in the industry, Larry observed that process improvements came mainly from better clone-screening methods, or better culture media. Larry believed that the next leap forward would come from creating cells that were more productive. He developed cell-engineering technologies that have led to unprecedented increases in productivity per cell for manufacturing antibodies for treating arthritis and cancer, viruses for gene therapy, and other biologics. These cell-engineering technologies were the basis for founding CHO Plus.

• Vaccine Development and Manufacturing

Jason has held leading roles in consulting, healthcare and technology companies for nearly 20 years in the US, UK and Europe. Jason is currently CEO and Executive Director for Ori Biotech, a cell and gene therapy manufacturing technology start-up with offices in London and New Jersey who raised a $30M Series A funding round in August 2021.Jason also serves as a Non-Executive Director of London-based healthtech start-ups gripAble and Credentially, as well as Auxita Pty, an Australian healthcare data platform and hystrix medical AG, a Swiss B2B marketplace for medical products. As the Managing Director of Health Equity Consulting, he has advised PE/VC funds, family offices, accelerators and healthTech start-ups.

• Bioprocessing Tech: Venture, Innovation, and Partnering Conference

Lynne Frick has extensive experience with start-ups and emerging Life Sciences technology and service companies, leading them from inception to sale. In her most recent exit, she was CEO of 4th Dimension Bioprocess, Inc., a CDMO focused on innovation and operational efficiency in Continuous Bioprocessing, which was sold to National Resilience, Inc. in Dec 2020. Most recently, she served as Co-Head of the Biologics Franchise at Resilience. Other exits in the life sciences industry include the sale of Tarpon Biosystems, Inc. and its BioSMB multi-column chromatography technology to Pall Corporation in 2015, joining Pall as Director of Continuous Bioprocessing for the Americas and the sale of the BioFlash LLC, a single use column technology provider, to Repligen Corporation in 2010.Throughout her career, she has managed sales and marketing functions at leading suppliers to the life sciences industry and served as VP of Business Development for CDMOs focused on drug development, aseptic filling and biomanufacturing. She has worked with CEOs and entrepreneurs to gain customer input and develop strategic plans for their emerging technologies and has helped numerous life sciences companies through their product development and technology adoption challenges. She has a track record in commercializing and growing technology companies and strategic positioning toward acquisition.

• Bioprocessing Tech: Venture, Innovation, and Partnering Conference

Erika Friedl is currently working as quality assessor (pharmaceutical quality/CMC) at the Paul-Ehrlich-Institute (PEI) in Langen, Germany. As quality expert in the European authorization process, she is responsible for the evaluation of blood products covering plasma-derived and recombinant proteins. In addition, she is involved as expert in national and international GMP inspections. Erika is a member of the Host Cell Protein Working Party at the EDQM (European Directorate for the Quality of Medicines & HealthCare, Strasbourg, France). Erika received her Ph.D. in biochemistry from the Albert-Ludwig University of Freiburg, Germany. During her career she worked in the fields of virology and transcription factors. As research associate, Erika joined the Department of Biochemistry at the Howard Hughes Medical Institute (UMDNJ, USA).

• Host Cell Proteins

No bio available.

• Gene Therapy CMC and Analytics

I am currently working at Merck, where my responsibilities include supporting all the late-stage programs, including BLA filing. In addition, I also serve as the technical SME for cell banking tech transfer and its related activities.

• Cell Line Development & Cell Culture Optimization

Nitin is a highly experienced and accomplished leader in the gene therapy industry, with over 14 years of progressive responsibility under his belt. He currently holds the position of Senior Director at PTC Therapeutics, where he plays a key role in the development of innovative gene therapy treatments for rare diseases. Nitin holds a Master's degree in Biomedical Engineering, as well as PMP and Black Belt certifications. Prior to joining PTC, he spent several years working at AGTC where he was instrumental in the development of early-stage and late-stage processes.

• Gene Therapy Manufacturing

Dr. Ian Gaudet has been with Miltenyi Biotec since 2016, currently as the Site Head at Miltenyi’s cutting-edge contract development and manufacturing organization (CDMO) in San Jose, CA, leading a team focused on rapid translation of novel cell-based therapies from bench to bedside while enabling long-term commercial feasibility. He studied Bioengineering at the University of California, San Diego, and received his doctorate in Biomedical Engineering jointly from Rutgers University and the University of Medicine and Dentistry of New Jersey. Including his tenure at Miltenyi, Dr. Gaudet has 20 years of experience in biomedical research and development.

• Cell Therapy Manufacturing

Georgeen Gaza-Bulseco is a Senior Principal Research Scientist II in the Analytical Development department at AbbVie Bioresearch Center, Worcester, MA. Georgeen has 26 years of industry experience and has worked on characterization of kinase inhibitors (small molecules), as well as the development, qualification, and execution of analytical methods to provide product and process understanding for biological entities from discovery through commercial processes. Since 2010, Georgeen has led a group in Analytical Development responsible for providing process impurity support, focused on specific and platform HCP methods development and qualification for early and late phase projects.

• Host Cell Proteins

No bio available.

• Rapid Methods to Assess Stability and Impurities in Biologics

Uwe has more than 30 years of experience within the field of bioprocessing and enzyme purification technologies. He was CSO (Chief Scientific Officer) and CTO (Chief Technical Officer) of Lonza Pharma, a world leader in Life Sciences headquartered in Switzerland, from 2014 to 2021, where he focused on downstream bioprocesses. Prior to Lonza, he was successively Vice President in Purification Technologies (2001-2009) and Group Vice President (2009-2014) of Sartorius, a leading international partner of life science research and the biopharmaceutical industry, listed on the German DAX stock market. A German national, Uwe holds a Ph.D in Chemistry from the University of Munster.

• Bioprocessing Tech: Venture, Innovation, and Partnering Conference

Harsha Gunawardena obtained his Ph.D. from Purdue University where his thesis research was carried out in advanced multi-source ion traps to facilitate the manipulation, reactivity (ion parking) of gaseous ions. He was a post-doctoral fellow at the Lineberger comprehensive cancer center, at The University of North Carolina at Chapel Hill, where his research focused on developing and refining quantitative platforms to support investigators in large-scale proteomics studies in the basic sciences to clinical research. He was a co-investigator for the National Cancer Institute’s Clinical Proteomics Tumor Analysis Consortium (CPTAC) and was a member of UNC ENCODE consortium. He has over 100+ research publication and proceedings and 3 patents. His industry career as scientist started at Bayer Health Care providing mass spectrometry and bioanalytical support of plasma-based therapeutics. He later worked at Amgen applying proteomics methods to support biomarker programs in discovery. His current role at Janssen R&D uses mass spectrometry to support discovery and early development programs.

• Rapid Methods to Assess Stability and Impurities in Biologics

Matt oversees the Gamma portfolio and is responsible for identifying and executing investments as well as driving growth, strategic and operational initiatives and business development activities at Gamma’s portfolio companies. Matt was most recently Global Head of Business Development for GE Healthcare, where he was responsible for M&A and strategic alliances across the $19B division of GE. Matt joined GE in 2011 and held a variety of other leadership positions in strategy, business development, venture investing and new business creation during his nearly nine years at the company. Matt began his career as a corporate attorney at Sidley Austin LLP. He holds a J.D. from the University of Michigan and a B.A. in Economics from Georgetown University.

• Bioprocessing Tech: Venture, Innovation, and Partnering Conference

Jia Guo is a principal scientist in Protein Analytical Chemistry at Genentech. She received her Ph.D. from the University of North Texas Health Science Center. Her current primary focus is on utilizing LC-MS for host cell protein characterization and multi-attribute method (MAM) development and validation. Before joining Genentech, Jia served as a scientist in BioAnalytical Sciences at BioMarin Pharmaceutical Inc, where she was responsible for the development of LC-MS-based bioanalysis of protein drugs, biomarkers and small molecules.

• Host Cell Proteins

Ashutosh Gupta is currently Head of Vector Production at Takeda. He has over 15 years of experience in process development and optimization across various modalities. He previously worked at uniQure, Sanofi and Pfizer before joining Takeda in 2020.

• Gene Therapy Manufacturing

Before my time at Roche, I did my post-doctoral research at German Cancer Research Center (DKFZ) together with European Molecular Biology Laboratory (EMBL), in Heidelberg where I was leading a project dedicated towards characterization of iron-regulatory proteins and antibodies. By education, I did my bachelors in biotechnology from India and then moved to the UK for my masters from the University of East Anglia. PhD in biochemistry from University of Wuerzburg, Germany together with National Institute of Health (NIH).

• Host Cell Proteins

Professor Habib is a leading academic hepatobiliary surgeon, Head of Surgery at the Hammersmith Hospital Campus, Imperial College London and Founder, Head of R&D and Chief Medical Officer for MiNA Therapeutics Ltd. His research programme evolved from research in oncogenes to tumour suppressor genes, epigenetic modification, gene therapy, stem cell therapy, RNA, and saRNA and RNA aptamers. Professor Habib is the first to trial a first-in-human and a first-in-class RNA oligonucleotide (MTL-CEBPA) in patients with liver cancer. Among his accomplishments, Professor Habib co-founded several biotech companies, including: EMcision (acquired by Boston Scientific), OmniCyte, MiNA Therapeutics, Apterna Therapeutics, Medeva (acquired by Celltech), and Bioenvision (acquired by Genzyme).

• mRNA-Based Therapies
• Formulation and Delivery of High-Concentration Proteins and New Modalities

BPEC Laboratory Supervisor and Associate Industrial Liaison Officer

• Intensified & Continuous Processing

Dr. Hanley is the Chief and Director of the Cellular Therapy Program and an associate professor of pediatrics at Children’s National Hospital and the George Washington University, respectively. He oversees processing for standard of care stem cell transplantation as well as the development, manufacture, quality, and testing of novel cellular therapies and is responsible for seeking partnerships and commercialization of promising cell and gene therapies. Trained as an Immunologist, Dr. Hanley has an extensive background and interest in cellular therapy and is passionate about improving regulations for cellular therapy, training the next generation of cell therapists, and facilitating the translation of new therapeutics. Over the past 16 years he has helped to translate more than 300 products on over 25 cell therapy protocols - ranging from mesenchymal stromal cells to cord blood virus-specific T cells and tumor-associated antigen specific T cells - into the clinic. Dr. Hanley was elected Vice President, North America of the International Society for Cell and Gene Therapy (ISCT) where he also serves on the board of directors, on the Immuno-Gene Therapy Committee (and former co-chair),and co-founded and served as the inaugural co-chair of the Early Stage Professionals committee which focuses on workforce development and training. He also serves on the board of directors of the Foundation for the Accreditation of Cellular Therapy (FACT) and is an active cellular therapy and cord blood inspector. Dr. Hanley has actively participated in the Cell Therapy Liaison Meeting with the Food and Drug Administration since 2018 and he is the commissioning editor of the journal Cytotherapy. In 2017, along with Drs Catherine Bollard and Russell Cruz, he founded Mana Therapeutics, a biotech company aimed at educating immune cells and eliminating cancer. In his free time he enjoys tweeting with fellow scientists and Bills fans, playing soccer, cycling, cooking, and traveling.

• Cell Therapy CMC and Analytics

Tom Hayes is a Senior Scientist at Sanofi with 15+ years of experience in cell culture development for biologics manufacturing. After completing a B.S.E at Worcester Polytechnic Institute he joined Genzyme and supported cell culture perfusion process development for enzyme replacement therapies. He is currently working at Sanofi developing and scaling-up commercial cell culture processes for multiple modalities, including enzymes, monoclonal antibodies, and bispecific antibodies.

• Cell Line Development & Cell Culture Optimization

Gaofei He is currently work at Pfizer in the Analytical Research & Development department. He got Ph.D from Chemistry Department at Carnegie Mellon University with Professor Danith Ly in the area of Peptide Nucleic Acid research. He did the post-doctoral research study in Polyamide with Professor James Bashkin at University of Missouri-St. Louis. Prior to joining Pfizer, Gaofei had previous worked as Scientist at Thermo Fisher.

• mRNA-Based Therapies

Dr. Hebert earned his Ph.D. in Bioengineering from the Fischell Department of Bioengineering at the University of Maryland and was part of the team that developed the underlying technology used in LumaCyte’s Radiance instrument while at the Naval Research Laboratory. In addition to his contributions to the label-free cell analysis platform developed by LumaCyte, he has authored numerous publications and patents over a diverse range of areas including metabolic engineering using the baculovirus expression system and cell signal engineering. In his role at LumaCyte, Dr. Hebert oversees technical operations including instrument R&D, LumaCyte’s BSL-2 cell culture facilities, designing internal and external biological experiments and managing the design and development of LumaCyte’s analytical platforms.

• Vaccine Development and Manufacturing

Dr. Heidaran joined PAREXEL International as Vice President of Technical in December of 2018. He has close to 9 years prior experience as a Biologist and as a Master Reviewer in OTAT, and as a facility reviewer and inspector in the Division of Manufacturing and Product Quality (DMPQ). During his tenure at OTAT, in addition to his review responsibilities, he also served as Acting Team Lead and Branch Chief briefly and as a DCGT representative to several FDA and CBER wide working groups and outside organizations such as USP. He has also been involved in various standard development activities, cell-based product manufacturing initiatives and various compliance activities. Mo is currently member of USP Bio3 Complex Biologic Expert Committee, ISCT Legal and Regulatory Affairs Committee and contributor to the A-Gene Project sponsored by the Alliance for Regenerative Medicine (ARM). Dr. Heidaran has a multidisciplinary academic and industrial background in basic and applied cell biology and innovative cell therapy and tissue engineering product development. He also has hands-on industrial experience in manufacturing of cell therapy and tissue engineering products for about 15 years in small and large size Biotech companies. His long lasting scientific interest is to understand the molecular control mechanisms that regulate growth and differentiation of stem cells in the three-dimensional microenvironments. He is also founder and first chair of prestigious Gordon Research Conference in “Signal Transduction by Engineered ECMs.” Mo received his formal training at the National Cancer Institute where he served as a Senior Staff Scientist for about 6 years and 3 years as an IRTA fellow studying signal transduction by receptor tyrosine kinases. Dr. Heidaran holds a Ph.D. in biochemistry from the University of South Carolina, and received his formal training at the National Cancer Institute. Prior to FDA, he served as R&D Director at both Celgene and Becton Dickinson. He has been an ad hoc reviewer and member of editorial boards of several peer reviewed publications. He also holds 25 issued patents and 54 pending patents and his work has appeared in more than 50 scientific publications.

• Cell Therapy CMC and Analytics

Christoph Herwig, bioprocess engineer from RWTH Aachen, worked in industry in the design and commissioning of large chemical facilities prior to enter his interdisciplinary PhD studies at EPFL, Switzerland in bioprocess identification. Subsequently he positioned himself at the interface between bioprocess development and facility design in biopharmaceutical industry. Since 2008, he is full professor for biochemical engineering at the Vienna University of Technology. The research area focuses on the development of data science methods for integrated and efficient bioprocess development along PAT and QbD principles for biopharmaceuticals. In 2013 he founded the company Exputec, which is now part of Korber Pharma, pioneering data science software solutions for the biopharma life cycle.

• Intensified & Continuous Processing
• TS2: Integrating AI and Data Science in the Product Life Cycle
• Smart Biomanufacturing & Digitalization

Oliver Hesse is Head of Biotech Data Science & Digitalization at Bayer - Product Supply in Berkeley, Ca. He started his career in small biotech, building up and running high throughput screening systems for large molecules that generated large amounts of data and incorporated automated decision making. Since 2008 he is at Bayer and since 2011 at the Berkeley site. There he has been developing and implementing strategies and directed projects with respect to lab automation, lab informatics and data sciences for the global biological development organization and since March he is in his new role where his focus is on the application of data science and digital technologies to gain better process understanding and the seamless digital integration from process development to commercial manufacturing.

• Smart Biomanufacturing & Digitalization

Matthew Hewitt, PhD, currently serves as Vice President, Technical Officer for CGT and Biologics at Charles River Laboratories (CRL) playing a critical role in driving CGT strategic vision as well as leading multiple operational initiatives across CRL’s CGT sites. Before joining CRL, he was Head of R&D and Clinical Development for Lonza’s Personalized Medicine Business Unit leading Cocoon platform development, a closed, automated, scalable cell therapy manufacturing solution. In addition, he executed numerous collaborations across academia and industry leveraging the Cocoon. Prior to Lonza, Matt led the Tumor Immunology and Microenvironment program at Bellicum Pharmaceuticals, focusing on improving cell therapy efficacy in solid tumors. He also led the Immunology group at the University of Pennsylvania’s Gene Therapy Program, leading and contributing to numerous AAV gene therapy programs. Matt received his PhD in Biophysics and Physiology from the University of Alabama at Birmingham and completed his postdoctoral fellowship at Johns Hopkins University.

• Bioprocessing Tech: Venture, Innovation, and Partnering Conference

Jonathan is a Principal Scientist in the Analytical Development group at Solid Biosciences, an organization focused on developing gene therapies for rare diseases such as Duchenne muscular dystrophy and Friedreich's ataxia. In this role, his main projects have been centered on development, application, and troubleshooting of separation-based and spectroscopic-based methods such as HPLC, CE, cIEF, and DLS. He has also served as the analytical lead for formulation development and screening for multiple gene therapy products. These projects have resulted in an expanded knowledge outside the realm of the chromatography and DLS worlds and into molecular biology and cell-based techniques. Jonathan earned his PhD in Biochemistry from Loyola University Chicago and has spent time working in biologics characterization as well as agricultural science.

• Gene Therapy CMC and Analytics

Moo Sun Hong is an assistant professor at the Seoul National University (SNU). Moo Sun received a B.S. from SNU and an M.S. and Ph.D. from Massachusetts Institute of Technology (MIT). His research is in the mechanistic modeling and model-based design and control of biopharmaceutical processes.

• Smart Biomanufacturing & Digitalization

Dr Huang is currently Senior Director leading the Data Enablement and Analytics function in Preclinical Manufacturing and Process Development at Regeneron. Responsible for advancing digital/data infrastructure and analytics capabilities to support bioprocess development, technology transfer and manufacturing process improvement. Prior to Regeneron, he led a team in Pfizer Global Technology & Engineering, delivering digital, IIoT, AI/ML, analytics and control solutions to improve manufacturing visibility, productivity and quality. He also worked for GSK and PerkinElmer supporting analytics, PAT and QbD efforts. Dr. Huang holds a PhD in chemometrics from the Norwegian University of Science and Technology in Norway, an MBA in Finance and Supply Chain Management from Rutgers University in the USA, an MSc in Thermophysics from Zhejiang University and a BSc in Mechanical Engineering from Huazhong University of Science and Technology.

• Smart Biomanufacturing & Digitalization

Grace Huang is a scientist working on cell line development at IGM biosciences. Before joining IGM biosciences, her research in Biomedical Science from Temple University focused on developing stem cell/exosome-based therapies and investigating genetic mechanisms for the treatment of cardiac ischemia. Grace completed her postdoctoral studies at the Cardiovascular Insitute, Stanford University.

• Cell Line Development & Cell Culture Optimization

Justin Huckaby is an Upstream Process Development Scientist at Shattuck Labs working to develop bi-functional fusion proteins for cancer immunotherapy.

• Intensified & Continuous Processing

Dr. Ruud Hulspas works at the Dana Farber Cancer Institute as Technical Director of Process Development in the Cell Manipulation Core Facility. He is the Founder of Cellular Technologies Bioconsulting, a company dedicated to increase reproducibility and quality of (pre-)clinical research, with a focus on incorporating reliable analytics into cell therapy manufacturing processes. Previously, Dr. Hulspas was Vice President of Scientific Affairs at Cytonome, a company originally created to develop technologies for cell sorting in manufacturing of cell-based products for cell therapies. Prior to joining Cytonome, Dr. Hulspas led the R&D and lean operations of cytometry assays and cell-sorting methods in the stem cell expansion and cord blood storage divisions of ViaCell, Inc. He received his B.S. and M.S. from Leiden University, his Ph.D. in Cell Biology from University of Amsterdam, and his technical training at the TNO Radiobiological Institute in Rijswijk, the Netherlands. As a postdoc at the newly founded Cancer Center at the University of Massachusetts, Dr. Hulspas headed the Cytometry core facility, while his research projects focused on the identification and purification of a wide range of hematopoietic and neural progenitor cell types.

• Cell Therapy CMC and Analytics

Obtained BS from Moscow State University in 2004, with major in Bioorganic Chemistry working on protein interactions in NFkB pathway. Moved to the United States and pursued PhD at Tufts University (nice to be home again) working on providing experimental evidence to one of the protein evolution hypotheses (exon coded polypeptides as primordial enzymes) and upon graduation in 2012, started my industrial journey by joining Abbott/Abbvie as a process development Senior Scientist working on ADCs, and then switching gears to do a postdoc at Washington University partially due to a family move to St. Louis, MO, with scientific focus on RNAseq library preparation from small amounts of blood to identify early diabetes biomarkers. My move back into industrial space began with me joining MilliporeSigma (former Sigma Aldrich) working in the R&D group concentrated on developing products that could support protein research and then finally finding home at Pfizer Gene therapy process development group as a principal scientist in the downstream purification group. I am and always will be fascinated by proteins and the role their biophysical properties play in all things drug manufacturing related.

• Advances in Purification & Recovery
• Gene Therapy Manufacturing

Lauren Jansen has over a decade of experience combining cell biology and materials to engineer solutions for drug development and delivery. She is currently the Senior Director of Process Development at Avenge Bio where she is responsible for IND-enabling CMC studies, process scale up, tech transfer, and MSAT. Previously, she was at Sigilon Therapeutics where she led the cell and engineering teams to perform IND-enabling studies for platform and process development to treat rare disease with a novel cell therapy platform. Lauren has also worked to understand breast cancer cell signaling for drug development using novel biomaterials during her PhD, and did a postdoc focused on automating biological sample preparation for next generation sequencing. Lauren Jansen received her B.S. from Oregon State University and Ph.D. from the University of Massachusetts Amherst, both in Chemical Engineering.

• Cell Therapy Manufacturing

William E. Janssen, Ph.D. has worked for more than 30 years at translating lab bench models into cell and gene therapy products for administration to patients. In the course of these efforts he has developed and refined methodologies for all aspects of cell based therapy from cell collection, through manufacturing and administration. Dr. Janssen has also been responsible for facility design, drug master file creation, development of staff training programs, process engineering, technology transfer, SOP development, process validation, comparison studies and integration of processes, equipment and raw materials. He is particularly interested in and has been both a proponent and implementer of informatics solutions for management of cell and gene therapy development and manufacturing data.

• Cell Therapy Manufacturing

Don Jarvis is a Professor of Molecular Biology at the University of Wyoming and President of GlycoBac, LLC, which was spun-out to translate his group’s progress in basic research on the baculovirus-insect cell system. Since 1987, Don’s research groups have focused on improving the quality of recombinant protein production in this system, with an emphasis on humanizing insect cell protein glycosylation pathways. In addition, GlycoBac's most recent work has addressed the fact that insect cell lines commonly used as hosts in this system are contaminated with adventitious viruses. These efforts have yielded virus-free insect cell lines that are now being assessed as improved hosts for biologics manufacturing and for the detection of adventitious viral contaminants in the baculovirus-insect cell system.

• Cell Line Development & Cell Culture Optimization

Ronald Jenkins, Ph.D. has served as the Senior Director for Process Development at Passage Bio since January 2022. Prior to his role at Passage Bio, Dr. Jenkins served in roles of increasing responsibility at Merck, first as an Associate Director of Technical Operations for the HPV Drug Substance Purification plant at West Point (April 2018 to January 2021), and as a Director of Process Sciences Labs as part of the Global Vaccines Technical Operations group (January 2021 to January 2022). Prior to his roles at Merck, Dr. Jenkins worked in the Manufacturing Sciences and Technology group at AstraZeneca (February 2014 - March 2018). Dr. Jenkins performed a Postdoctoral Fellowship at Johns Hopkins School of Medicine, received his Ph.D. in Medicinal Chemistry from the University of Michigan and received his B.S. in Biochemistry from Temple University.

• Advances in Purification & Recovery
• Gene Therapy Manufacturing

Dr. Li Jing is a Principal Scientist in USP’s Global Biologics Department. Dr. Jing leads a team of liaisons working with the USP Expert Committees and multiple Expert Panels for proteins, peptides, and carbohydrates to develop standards that support biopharmaceutical quality assessment and development. Recently, Dr. Jing worked with USP MAM Expert Panel and developed general chapter <1060> Mass Spectrometry Based Multi-Attribute Method for Therapeutic Proteins

• Accelerating Analytical Development

I graduated in 2015 from the University of Sheffield with a Ph.D. in Chemical & Biological Engineering, followed by a 2-year postdoctoral research at the university, both in collaboration with Biogen, MA. I then continued with a 4-year postdoctoral research at Sheffield working in collaboration with REGENXBIO, MD. I briefly joined Lonza Biologics, Cambridge (2021-2023) as a Lead Scientist, then Associate Principal Scientist, and am currently working as a Principal Bioengineer at SynGenSys, Sheffield - a small, growing start-up company at the interface of cell and molecular biology, informatics and engineering.

• Cell Line Development & Cell Culture Optimization

Thomas is the lead researcher for the UCL-Pall Centre of Excellence, established in 2018. He received his PhD in 2019 and was awarded a three-year UKRI Fellowship in 2021.

• Advances in Purification & Recovery

Professor Alois Jungbauer received his PhD in Food Technology and Biotechnology from the University of Natural Resources and Life Sciences Vienna, Austria 1986. He serves since then as a professor at the Department of Biotechnology. He teaches Protein Technology and Downstream Processing and Bioprocess Engineering. He also acts as area head and Deputy Director of Research in the Austrian Centre of Industrial Biotechnology. He is currently working in the field of bioengineering of proteins, plasmids and viruses with special focus on expression, downstream processing and characterization of large biomolecules. For more than 10 years he is working on continuous manufacturing of biopharmaceuticals. As a proliferate researcher he has more than 340 publications on recombinant protein production and bioseparation, 17 patents and 12 book contributions and recently a monograph entitled “Protein Chromatography , Process Development and Scale Up”. He is executive editor and co-founder of Biotechnology Journal, and member of editorial boards from numerous journals in the area of biochemical engineering. He acts also a the vice president of research of the European Society of Biochemical Engineering Science.

• mRNA-Based Therapies
• Smart Biomanufacturing & Digitalization
• Vaccine Development and Manufacturing

Hemanth Kaligotla is the Director of External Innovation at Lonza Biopharma, where he leads the identification, strategic planning, and implementation of technology initiatives in alignment with the company's overall business strategy. With over 16 years of experience in biomanufacturing and commercial business development in the biopharma industry, Hemanth is a seasoned leader. Previously, he held various positions at Sartorius, including Regional Head of the Chromatography Applications organization, where he oversaw commercial technology implementation, contributed to strategic marketing, and led the launch strategies for regional product releases. Hemanth also successfully commercialized several biologics and led technology transfers at Shire Biopharma.

• Bioprocessing Tech: Venture, Innovation, and Partnering Conference

Reza Kamyar is the director of AI and Advanced Control Solutions from Global Technology & Engineering organization at Pfizer. He leads the development and implementation of Industry 4.0 technologies including soft sensors, advanced process control and AI/ML models to improve pharmaceutical manufacturing process efficiency and product quality across Pfizer's global manufacturing network. He received his PhD in Control systems theory from Arizona State University in 2016, after which joined Pfizer Global Technology & Engineering organization.

• Smart Biomanufacturing & Digitalization

Mark A. Kay MD, PhD is the Dennis Farrey Family Professor of Pediatrics and Genetics at Stanford University and is Head of the Division of Human Gene Therapy in Pediatrics. Dr. Kay has made seminal contributions in the fields of Gene and Genome engineering based therapeutics, RNAi and non-coding RNA biology. His work spans basic research through clinical trials that includes the first systemic delivery of AAV into humans. Dr. Kay was a founding board member of the American Society for Cell and Gene Therapy and served as the President of the Society in 2006. He received the Outstanding Investigator Award in 2013. Dr. Kay served on the Board of Directors of the Oligonucleotide Therapeutics Society for 10 years. He has published >300 peer reviewed papers, and has served and continues to serves as an editor of several journals. He is an inventor on many patents including those related to key gene therapy vectors and the use of RNAi in whole mammals. He has co-founded 4 companies and serves on many biotech/pharmaceutical advisory boards. In 2020, he was elected to the National Academy of Inventors.

• mRNA-Based Therapies

Tim Kelly, Ph.D., joined RoosterBio Inc. as Chief Executive Officer in October 2021. Previously, he served as President of Manufacturing at Asklepios Biopharmaceutical, Inc. (AskBio), which was acquired by Bayer in October 2020 for up to $4 billion. At AskBio, Tim was responsible for the manufacturing strategy and delivery of AAV-based gene therapy products for over eight clinical programs. For 15 years prior, he was with KBI Biopharma, Inc., an industry-leading contract development and manufacturing organization, where he ultimately served as President and Chief Executive Officer. As CEO of KBI Biopharma, Tim led four acquisitions and served as Chairman of Selexis SA while leading the integration of Selexis and KBI Biopharma. He began his corporate experience at Diosynth Biotechnology. Tim has overseen development and manufacturing services for over 325 biologics at all stages of development and commercialization and has supported numerous successful FDA and international regulatory inspections throughout his career. Tim earned his Ph.D. in molecular genetics and biochemistry from Georgia State University and his BA in biology from College of the Holy Cross.

• Bioprocessing Tech: Venture, Innovation, and Partnering Conference

Jessica Kenney is a process engineer at Alexion, AstraZeneca Rare Disease with over 10 years of experience in upstream and downstream process development. She holds a BS in chemical engineering with a minor in biochemical engineering from Northeastern University.

• Cell Line Development & Cell Culture Optimization

I received my Masters degree in Organic chemistry in India. In addition, I obtained PhD degree in chemistry from University of Kentucky in 2010. Then I joined University of Minnesota for Postdoctoral training in the Department of Chemistry until 2012. I joined BioVision Inc where I built a team focused on designing, manufacturing and analytics for metabolic enzymes for commercial use. Then I pivoted to Gene Therapy when I joined Brammer Bio (now a part of Thermofisher Viral Vector Services) as principal scientist and led the team for developing analytical assays for viral vectors. Furthermore, in 2018, I joined Sangamo Therapeutics as a Senior Scientist for helping build analytical team on developing assays for viral vectors. I left Sangamo to join Asklepios Biopharmaceuticals (North Carolina) as the Director of Analytical Development but after a short duration, I rejoined Sangamo Therapeutics as an Associate Director where I am overseeing analytical development for early and late phase viral vectors.

• Gene Therapy CMC and Analytics

No bio available.

• Rapid Methods to Assess Stability and Impurities in Biologics

Marina Kirkitadze, Ph.D, MBA has 19 year experience in Sanofi Pasteur, the vaccine division of Sanofi group. She is Head of Biophysics and PAT Platform, Analytical Sciences Toronto. Marina is focusing on selection and implementation of PAT solutions for in-line monitoring of media components, protein concentration and conformation, process-related residuals, and protein adsorption. Her contributions went towards CMC section in eBLA application for Adacel, approvals for new manufacturing facility and its extension, Pentacel, and to Module 3 CTD of Hexaxim vaccine submission. Marina has published 42 manuscripts.

• Rapid Methods to Assess Stability and Impurities in Biologics
• Vaccine Development and Manufacturing

No bio available.

• Vaccine Development and Manufacturing

Before joining Codiak, Konstantin Konstantinov was responsible for the late-stage bioprocess and technology development at Sanofi’s Boston Hub, including all functions, from cell banking to fill/finish/lyophilization. Prior to Sanofi, Dr. Konstantinov worked for Bayer in Berkeley, California for 14 years, advancing to the position of Head of Process Sciences. He has published 60 peer-reviewed papers and has more than 15 patents and patent applications. During the last 23 years, Dr. Konstantinov has worked on the development and commercialization of various products, including monoclonal antibodies, blood factors and enzymes expressed in mammalian cells. Most recently, he has pioneered the development of an end-to-end integrated continuous biomanufacturing platform, which is becoming a strategic technological trend for the biomanufacturing industry worldwide. Dr. Konstantinov received his PhD in Biochemical Engineering from Osaka University, Japan, which was followed by a post-doctoral assignment at DuPont and the University of Delaware. He is a member of the board of directors for Repligen.

• Accelerating Analytical Development
• Cell Therapy Manufacturing
• Advances in Purification & Recovery
• Gene Therapy Manufacturing
• mRNA-Based Therapies
• Formulation and Delivery of High-Concentration Proteins and New Modalities
• Smart Biomanufacturing & Digitalization

Daniella Kranjac is the Founding Partner at Dynamk Capital LLC. Daniella founded the first venture fund focused entirely on Life Science Industrials based on her experiences as an entrepreneur and business development leader. She is CEO and Founder of Dynamk Consulting, providing capital, strategy and business development consulting to leading life science companies, startups and investment firms. She started her career as an entrepreneur, co-founding Wave Biotech LLC driving the start-up, growth and commercialization of a highly disruptive technology. As Vice President, Daniella established a high growth company with significant brand recognition, and led the group to a successful exit and acquisition by GE Healthcare in 2007 (now Danaher/Cytiva). At GE Healthcare, Daniella held a variety of strategic, M&A and business development roles. One of her most notable achievements is the success in an entrepreneurial group within the broader GE Healthcare, where a focus on integrating the acquired Xcellerex business enabling global commercialization of a several hundred million dollar enterprise solutions business. She holds a B.E. in Chemical Engineering from Stevens Institute of Technology and an Executive MBA from New York University Stern School of Business.

• Bioprocessing Tech: Venture, Innovation, and Partnering Conference

Dr. Kueltzo received her B.S. in Pharmacy from Purdue University. She obtained her Ph.D. in Pharmaceutical Chemistry at University of Kansas in 2002, under Dr. C. Russell Middaugh, followed by post-doctoral experience under Dr. John Carpenter in the Department of Pharmaceutical Sciences, University of Colorado between 2002 and 2005. Her work focused on biophysical characterization, stabilization and process instability of multiple therapeutic proteins and monoclonal antibodies. Following her post-doctoral studies, Dr. Kueltzo led the analytical development efforts at GlobeImmune, Inc. in Louisville, Colorado, focusing on immunotherapy approaches to treatment of cancer and infectious disease targets, prior to joining the National Institutes of Health in 2011. Dr. Kueltzo currently serves the Director of the Formulation Program at the Vaccine Production Program within the National Institutes for Allergy and Infectious Disease at the NIH. The Vaccine Production Program translates vaccine and therapeutic biopics from the research stage to GMP manufacturing for evaluation in clinical and experimental medicine human trials. Her experience includes development of glycosylated trimers, virus-like particles, protein-nanoparticles and protein conjugate vaccine candidates as well as high concentration monoclonal antibodies for both prophylactic and therapeutic applications.

• Vaccine Development and Manufacturing

Robert Kuo is an Associate Principal Scientist in the Sterile & Specialty Products group at Merck & Co. He is responsible for both early and late stage formulation development of biologics drug products. In addition, Robert leads efforts to develop predictive approaches in process engineering to bring about successful manufacturing outcomes. Robert joined Merck after completing his Ph.D. in Chemical Engineering at the University of Michigan.

• Smart Biomanufacturing & Digitalization

Ashton is the Head of Downstream Process Development at BridgeBio Gene Therapy. She has been with BridgeBio for three years, with heavy focus on implementation of strategies and technologies to improve AAV purification processes. She earned her bachelors in Chemical Engineering at Northeastern University, and her masters and Ph.D. in Chemical Engineering at North Carolina State University. She has worked in biomanufacturing for 13 years with academic and industrial experience spanning upstream and downstream process development, technology transfer, and primary cell isolation.

• Advances in Purification & Recovery
• Gene Therapy Manufacturing

Andrew Lee is a Principal at Northpond Ventures focusing on investments in life science tools, biomanufacturing, and synthetic biology. He also leads Northpond’s sponsored academic partnerships, Northpond Labs. Previously, Andrew was a technical advisor at Booz Allen Hamilton working in the Defense Advanced Research Projects Agency (DARPA) Biological Technologies Office, where he worked on developing and managing a high-risk, high-reward research funding portfolio in gene editing and synthetic biology. Earlier, Andrew was a researcher at Sangamo Biosciences (now Sangamo Therapeutics) and the Joint BioEnergy Institute. Andrew earned a Ph.D. in Microbiology and Immunology from Columbia University and received a B.A. with Honors in Molecular and Cell Biology, with an emphasis in Biochemistry and Molecular Biology, at University of California, Berkeley.

• Bioprocessing Tech: Venture, Innovation, and Partnering Conference

Ann Lee is Chief Technical Officer at Prime Medicine, a next generation gene editing company aiming to deliver a new class of one-time curative genetic therapies to patients. For over 30 years, she has built and led industry-leading global technical and operational organizations across multiple biopharma companies including BMS, Celgene, Juno, Genentech, Roche and Merck. Her teams have developed new processes and technologies, designed new facilities, manufactured high quality vaccines, small molecules, biologics, and cell therapies, and built global supply chains and digital systems to deliver these medicines. Ann is an elected member of the National Academy of Engineering, the American Institute of Medical and Biological Engineering, and the American Academy of Arts and Sciences. She serves on the board of directors of Alliance of Regenerative Medicine, American Institute of Chemical Engineering, and two public companies. Over the course of her career, she has contributed to the commercialization of 25 new vaccines and medicines, the most recent being two CAR-T cell therapies.

• Bioprocessing Tech: Venture, Innovation, and Partnering Conference

Ulrike Lemke is the Business Unit President, Sterile Fill & Finish at Recipharm AG. Ulrike has 20 years’ experience from the pharmaceutical sector working mainly within marketing, business intelligence and business strategy for companies such as Sartorius, Lonza and McKinsey. Ulrike holds a Diploma in Biochemistry from the University of Leipzig, 2002 and a Ph.D. in Functional Genomics, German Cancer Research Center, Heidelberg.

• Bioprocessing Tech: Venture, Innovation, and Partnering Conference

Professor Sabrina Leslie studied honours physics and mathematics at the University of British Columbia twenty years ago before moving to UC Berkeley where she obtained her PhD in optical physics in 2008, followed by her Mary Fieser postdoctoral fellowship in biophysics at Harvard University 2009-2011. There she invented a tether-free, high-throughput single-molecule imaging technology called Convex Lens-induced Confinement (CLiC), which established her as a pioneer in single-molecule investigations. In 2012, she became an Assistant Professor at McGill University and founded her research group in the Physics Department. There she developed CLiC into a platform technology and used it for new single-molecule studies of nucleic acids, proteins, polymers, nanomaterials, biologics, and cells. In 2019 she was honored with the Young Investigator Award from the Biophysical Society of Canada, and in 2020 she was elected to the Royal Society of Canada (RSC) College of New Artists Scholars and Scientists. In 2021, she and her team re-located to the Michael Smith Labs at UBC where her Associate Professor appointment is joint with the Department of Physics and Astronomy and affiliated with the School of Biomedical Engineering, Genome Science and Applied Technology and Bioinformatics programs.

• Rapid Methods to Assess Stability and Impurities in Biologics
• Vaccine Development and Manufacturing

Seth Levy, PhD, joined Modalis Therapeutics in 2021 as Director of Bioprocess Development to build and oversee internal process development and analytics efforts, as well as manage external manufacturing. Prior to Modalis, Seth lead teams in Manufacturing Science and Technology and Small-Scale Development for AAV and LV manufacturing at Viral Vectors Services. Seth worked in gene therapy R&D before his time at a CDMO and drove numerous AAV projects including basic biology research, capsid engineering, and translational gene therapy approaches at Sanofi Genzyme and academia.

• Host Cell Proteins

Dr. Xuanwen (Shawn) Li is currently a principal scientist and scientific supervisor in the Analytical R&D, Mass Spectrometry group at Merck. His research focused on mass spectrometry-based biologics and vaccine characterization for CMC development and regulatory submission. Prior to join Merck in 2018, Dr. Li worked as a research scientist at Eli Lilly on protein characterization. Before his industry career, Dr. Li was a director of the mass spectrometry facility at the Institute for Translational Medicine and Therapeutics at the University of Pennsylvania. Dr. Li received a Ph.D. in proteomics at the Hunan Normal University in China and completed his post-doctoral training in clinical pharmacology and bioanalysis at the University of Pennsylvania.

• Accelerating Analytical Development

Xue (Shelly) Li is an Associate Director at Bristol Myers Squibb in New Jersey, where she leads the development and validation of analytical methods for release & stability testing of biologics and gene therapy. Before joining BMS Shelly worked for Novartis Pharmaceuticals and Amgen, leading the analytical development of various protein therapeutics. Shelly received her Ph.D. degree in Bioanalytical Chemistry from Michigan State University and conducted postdoctoral research in the Department of Cell Biology at Harvard Medical School. Her academic training focused on the application of LC-MS in protein characterization.

• Accelerating Analytical Development

Delia Li is a Technical Development Scientist in the Protein Analytical Chemistry (PAC) department within the Pharma Technical Development organization at Genentech, where she has worked for 8 years. As a member of the Mass Spectrometry group within PAC for the past several years, she has worked on developing and implementing a variety of MS methods for the analytical characterization of pipeline therapeutics. Specialized efforts include disulfide peptide mapping, sequence variant analysis, host cell protein analysis, and native mass spectrometry.

• Accelerating Analytical Development

Zhirui Jerry Lian joined Eli Lilly and Company in Indianapolis, Indiana in 2004 and is currently a Senior Director leading the structural characterization team in Bioproducts Research and Development. Jerry and his team support the development of various modalities of biotherapeutics including peptides, oligonucleotides, proteins, antibodies, bispecific antibodies, protein-drug conjugates and gene therapy products using mass spectrometry and other techniques. Jerry’s experiences cover all stages of biotherapeutic development from candidate selection to BLA submission to manufacturing support. Jerry’s major expertise includes protein structural characterization, impact of protein modification on biological activities, CQA risk assessment, comparability assessment, LC-MS based analytical method development, validation and transfer to QC labs, overall biotherapeutic CMC development process and control strategy, and IND/BLA/NDA filings.

• Accelerating Analytical Development

Emmanuel Ligner has deep roots in biopharma, leadership and engineering. He’s driven to bringing transformative health to patients through researchers, hospitals and the pharmaceutical partners of Cytiva. He’s been the President and CEO of Cytiva since July 2017, when it was known as GE Healthcare Life Sciences. He led the company to more than 7% revenue and 13% operating profit growth. In 2021 he was appointed Group Executive of the Danaher Biotechnology Group, consisting of Cytiva and Pall Life Sciences, which is within the Danaher Life Sciences Platform. Emmanuel joined GE Healthcare in April 2008, following its acquisition of Whatman International Plc. His career has spanned many continents and business areas that experienced massive growth under his leadership - from heading up the North America BioProcess business to the Commercial part of Life Sciences across Europe, the Middle East and Africa, and holding the position of General Manager of Core Imaging (now Pharmaceutical Diagnostics) until he was named President. His biopharma journey started in Japan in 1996, when Emmanuel joined Otsuka Pharmaceutical International Ltd as a Medical Representative in Tokyo. He stepped into various roles, and in 1999 became Marketing Director, Diagnostic Division and later Commercial Director, Diabetes Care Division for Abbott Diagnostics. In 2004, Emmanuel moved to the UK to become Vice President, Sales & Marketing Europe for Whatman International. Emmanuel is a French citizen and earned his Master’s Degree in Commercial Engineering at L’Universite Savoie, France.

• Bioprocessing Tech: Venture, Innovation, and Partnering Conference

No bio available.

• Accelerating Analytical Development

Jennifer has 15 years of experience in biotechnology, focusing on formulation and drug product process development for late clinical stage therapeutic proteins and biosimilars. Her areas of specialty include in-use compatibility, high concentration formulation development, and educational outreach. She is a member of the IQ Physiochemical In-Use Stability Testing Working Group. Jennifer received a Ph.D. in Biochemistry from the University of Alberta (Edmonton, Alberta, Canada) in 2003. She works at the Cambridge site of Amgen Inc.

• Formulation and Delivery of High-Concentration Proteins and New Modalities

Dongfang Liu, PhD, Associate Professor, Director of Immunoassay Development Program in the Department of Pathology and Laboratory Medicine and the Center for Immunity and Inflammation in Rutgers University. In 2012, Dr. Liu was recruited to Baylor College of Medicine as a tenure-track Assistant Professor in the Department of Pediatrics and Department of Pathology & Immunology, before joining Houston Methodist Research Institute as an assistant professor in 2015. In 2018, Dr. Liu was promoted to an Associate Professor in Houston Methodist Research Institute. Dr. Liu did his postdoctoral training on natural killer (NK) cells at the National Institute of Allergy and Infectious Diseases (NIAID) in National Institutes of Health (NIH) from 2005 to 2011. After completing the postdoctoral training, he joined Ragon Institute of MGH, MIT and Harvard in 2011 as a senior research scientist, where he worked on HIV-specific CTL dysfunction with a focus on PD-1 in HIV-specific CTL immunological synapse. Dr. Liu’s current research is primarily focused on the immunobiology of chimeric antigen receptor (CAR) T and NK cells, immunoreceptors, CAR immunotherapy, and HIV-specific CTLs in chronic HIV and its related malignancies, with a focus on immunological synapse biology and its clinical applications.

• Cell Therapy Manufacturing

Ping obtained her Ph.D. in Molecular Genetics and Biochemistry at Georgia State University and completed her postdoc training at Johns Hopkins University. She started her first industry job as a staff scientist for process development at Thermo Fisher. She worked as a technical lead for cell line development of antibodies and recombinant proteins in CHO system. After that she took a leadership role at Jecho Laboratories, Inc. where she worked as a process development group leader. Currently she is head of cell line development team in RGENXBIO where she leads efforts of vector design, cell line development and engineering to improve AAV production levels.

• Cell Line Development & Cell Culture Optimization

Dr. Zhiguo Liu is currently a Senior Scientist in Vaccine Process Development at Merck, focusing on Upstream bioprocess development to support drug substance generation for multiple vaccine projects. Prior to Merck, Zhiguo has 5. yrs experience as Fermentation Scientist in the synthetic biotech industry at Amyris and Intrexon, leading scale-down strain screening fermentation model development and supporting scale-up tech transfer process. His expertise covers batch, fed-batch and continuous culture. Dr. Zhiguo Liu conducted his Ph.D. study at Department of Biosystems and Agricultural Engineering, Michigan State University, where he explored systematically various fermentation and cell cultures paths to bring more value-added products to traditional anaerobic digestion plant and improve its sustainability. Beforehand, Zhiguo received his Master and Bachelor degree from Department of Bioengineering and Biotechnology, Jiangnan University, China. His research there highlights building a E.coli host with enhanced secretory capability of recombinant protein production via gene-knockout, chaperone co-expression as well as fermentation process optimization. Zhiguo spends most of his spare time with his two growing boys, on top of some limited hiking and biking outdoor activities.

• Cell Line Development & Cell Culture Optimization

Christopher P. Locher, PhD is CEO and co-founder of Versatope Therapeutics, a preclinical-stage Massachusetts-based company currently focused on the development of technology platform using nano-vesicles. He previously led drug discovery projects for infectious diseases at Vertex Pharmaceuticals in Boston, inflammatory diseases at Opsona Therapeutics in Ireland and malaria and alphaviruses vaccine development programs at Maxygen in California. He completed postdoctoral training at the University of California, San Francisco, was a Fulbright Hayes Research Fellow at the Institute of Tropical Medicine in Antwerp, Belgium and received his PhD in Tropical Medicine and BA in Biological Sciences from the University of Hawaii.

• Vaccine Development and Manufacturing

Ben Locwin is an industry executive and has been working on novel therapies and vaccines for over 2 decades. His expertise has spanned discovery and development, toxicology, epidemiology, and commercialization of biologics, viral vector vaccines, as well as cell therapies and gene therapies. He has taught clinical medicine and healthcare economics, as well as advocating for patient-centricity and equitability of healthcare practice. He has been featured in top-tier media, including The Wall Street Journal, Forbes, The Associated Press, USA Today, Der Spiegel, and many others.

• mRNA-Based Therapies

Martin Loignon holds a Ph.D. in molecular biology from Universite de Montreal and a postdoctorate in oncology from McGill University. He joined the Human Health Therapeutics Research Centre of the National Research Council Canada in 2015 and lead of the Cell Engineering team. In this role, he has led projects related to the production of difficult-to-express recombinant proteins and contributed to the development of a CHO expression platform. Since 2020, he is leading the Cell Culture Scale-Up team, overseeing experts in bioprocess development and scale-up, and engineering viral-based and non-viral tools for gene editing and cell engineering.

• Cell Therapy Manufacturing
• Gene Therapy Manufacturing

Matthew Lotti is a Senior Research Associate II in the the Analytical Development department of Ultragenyx's Gene Therapy Pharmaceutical Development facility, located in Woburn, MA. His background involves assay development for multiple impurity and titer immunoassays.

• Host Cell Proteins

Tom is a seasoned HR professional, with over 12 years of Talent Acquisition and HR roles in the Biotech and Pharma space at company stages ranging from pre-clinical to Global Commercial. Throughout his career, Tom has been successful solving business challenges with a human forward approach to attract, integrate, develop and coach top biotech and pharma talent. Tom’s expertise in TA and HR extends across a wide range of functions, including recruitment, onboarding, employee engagement, and talent development. He has a strong track record of building and leading high-performing teams, fostering a positive and inclusive work culture, and developing innovative solutions to complex HR challenges. Prior to his current role as Sr. Director of Talent Acquisition and People + Culture Programs at Kymera Therapeutics, Tom held a variety of HR and field leadership positions across prominent biotech and Human Capital services firms. In these roles, he gained valuable experience across all aspects of strategic HR in support of business objectives. Tom holds an MBA from Babson College and B.A. in Sociology from Colorado College.

• W1: Talent Acquisition and Retention Strategies for Biopharma

Dr. Xiaohui Lu is the Sr. Director of Analytical Development in Ultragenyx Gene Therapy, overseeing analytical activities for the development of Ultragenyx’s gene therapy products. Before join Ultragenyx, Dr. Lu was a Director of Analytical Development in CRISPR Therapeutics. Dr. Lu spent 8 and a half years in Analytical Development at Biogen from 2009 to 2018, leading bioassay development and process-related impurity assay development for biologics and gene therapy programs. Prior to joining Biogen Idec, he was Senior Research Scientist at Ariad Pharmaceuticals in Cambridge, MA from 2007 to 2009. Dr. Lu received his Ph.D. in Biochemistry from Dartmouth Medical School, and had post-doctoral training at the Whitehead Institute.

• Gene Therapy CMC and Analytics

Dr. Haibin Luo is an Associate Director in Biopharmaceutical Development (BPD) in AstraZeneca. He leads scientists and engineers to develop downstream manufacturing processes for inhaled biologics in AstraZeneca portfolio from early to late stage; he leads a CMC team for a new medicine targeting patients with leukemia; he also leads impurity safety risk assessment for AstraZeneca global biologics. He has 12-year experience in downstream process development for biologics like monoclonal antibody, fragmented antibodies, bispecific/tri-specific/multi-specific antibodies, and fusion proteins. He published multiple papers in downstream processing field and is an active speaker on international conferences. He did postdoc trainings at NIAID and University of Maryland before joining AstraZeneca. He received PhD degree in Drug Design from Chinese Academy of Sciences and bachelor’s degree in Biochemistry from Shandong University.

• Host Cell Proteins

Sri Madabhushi is a Principal Scientist at Merck & Co., Inc. where she leads a cross-functional process development team that is responsible for developing cell culture and downstream purification processes for early and late-stage programs of their biologics portfolio. Over her 10 years of experience in the industry, she has driven multiple innovations that led to significant improvements in the performance of fed-batch and perfusion cell culture processes at Merck & Co., Inc. Sri also leads the Biologics Sustainability efforts at Merck and is passionate about technology development efforts that improve the efficiency and sustainability of the manufacturing processes that deliver lifesaving therapies to patients across the world.

• Intensified & Continuous Processing

Sheila Magil has over 40 years of experience in quality and analytical method development for biologics, peptides and small molecules. Her expertise includes quality assurance, protein and peptide biochemistry and analytical development. She was formerly Senior Manager of Analytical Development and Quality Control at Biomeasure, Inc., and previously held positions at Waratah Pharma, Alkermes, Bion and HHMI at Massachusetts General Hospital. Dr. Magil has implemented quality systems and has managed external analytical and QC activities for multiple biopharmaceutical products. Dr. Magil holds a PhD in Biochemistry from the University of Minnesota.

• TS1: Introduction to Bioprocessing

Behzad Mahdavi, Ph.D., MBA, is senior vice president of biopharma manufacturing and life sciences tools at Ginkgo Bioworks, Inc. In this role, Dr. Mahdavi leads the commercial efforts in the growing areas of bio-reagents, cell and gene therapies and new biopharmaceutical modalities. Dr. Mahdavi brings more than 20 years of experience in developing and leading innovative patient-centric growth strategies in challenging environments in the biopharmaceutical, cell and gene therapy, personalized medicine and life sciences sectors. Dr. Mahdavi most recently served as vice president of global open innovation at Catalent Pharma Solutions, where he created a distinctive portfolio of innovative services and expanded its customer base in new market segments. Prior to his work at Catalent, he held numerous leadership positions during his 13 years at Lonza and served as CEO of SAM Electron Technologies. Throughout his career, Dr. Mahdavi has built expertise in defining and developing optimal growth strategies and actionable business plans across biologics, cell therapy, and viral pharmaceutical modalities. In addition to his company leadership roles, he has also served in multiple Board of Directors and Advisory Board roles. Dr. Mahdavi holds a Doctorate in Chemistry from the University of Sherbrooke, Canada, and also has a Master in Business Administration from the University of Quebec in Montreal.

• Bioprocessing Tech: Venture, Innovation, and Partnering Conference

Muthiah Manoharan, PhD. Dr. Muthiah (Mano) Manoharan serves as a Senior Vice President of Drug Innovation, a Scientific Advisory Board Member, and a Distinguished Research Scientist at Alnylam Pharmaceuticals, Cambridge, Massachusetts, USA. In 2003, he was the first chemist hired at Alnylam. He and his team pioneered the discovery and development of the chemical modifications, GalNAc conjugation chemistry, and LNP delivery platform that make RNA interference-based human therapeutics possible. This work led to the approval of four RNAi therapeutics: ONPATTRO® (patisiran, 2018), GIVLAARI® (givosiran, 2019), OXLUMO® (lumasiran, 2020) and Lequio® (inclisiran, 2020). Dr. Manoharan has had a distinguished career as a world-leading chemist in the field of oligonucleotides. He is an author of more than 225 publications (nearly 50,000 Google Scholar citations with an h-index of 101 and an i10-index of 399) and over 400 abstracts, as well as an inventor of over 250 issued U.S. patents. Prior to Alnylam, Dr. Manoharan worked in the field of antisense oligonucleotide therapeutics at Ionis (formerly Isis) Pharmaceuticals and LifeCodes Corporation (1988-1990) . Dr. Manoharan received his B.Sc. and M.Sc. degrees in chemistry at the American College, Madurai, India. He earned his Ph.D. in chemistry (with Professor Ernest L. Eliel) at the University of North Carolina, Chapel Hill and carried out post-doctoral research (with Professor John A.Gerlt) in the field of oligonucleotide chemistry at Yale University and at the University of Maryland. Dr. Manoharan is the winner of the Lifetime Achievement Award of the Oligonucleotide Therapeutics Society (2019), the M. L. Wolfrom Award from the American Chemical Society (2007) and D. Horton Industrial Carbohydrate Chemistry Award from the American Chemical Society (2021).

• mRNA-Based Therapies
• Formulation and Delivery of High-Concentration Proteins and New Modalities

Athanasios (Sakis) Mantalaris is Professor in the W.H. Coulter Department of Biomedical Engineering at Georgia Tech & Emory since August 2018. Prior to his move to Atlanta, he was Professor of BioSystems Engineering in the Department of Chemical Engineering at Imperial College London. He received his PhD (2000) in Chemical Engineering from the University of Rochester. His expertise is in modelling of biological systems and bioprocesses with a focus on mammalian cell culture systems, stem cell bioprocessing, and tissue engineering. He has published over 170 original manuscripts, co-edited one book, and holds several patents with several more pending. He has received several awards including the Junior Moulton Award for best paper by the Institute of Chemical Engineers (IChemE) in 2004. In 2012, he was elected Fellow of the American Institute for Medical & Biological Engineering and in 2013 he was awarded a European Research Council (ERC) Advanced Award. In 2015, he was awarded the Donald Medal by the Institution of Chemical Engineers (IChemE) for his contributions to biochemical engineering.

• Cell Therapy Manufacturing

R. Kenneth (Ken) Marcus is University Professor of Chemistry, starting his career at Clemson in 1986. Throughout his career, Marcus’ research group focus has been the development of novel chemical instrumentation. His current research program can be broken down to two, diverse fields of chemical analysis. In the first case, ionization sources based on microplasma technologies are being developed to deliver information on the elemental, isotopic, and molecular levels. The incredible versatility of the liquid sampling-atmospheric pressure glow discharge (LS-APGD) source is demonstrated through support of DTRA, NNSA, Oak Ridge National Laboratory, Merck Pharmaceuticals, Advion, the National Institute for Innovation in the Manufacture of Biopharmaceuticals (NIIMBL), and the Advance Mammalian Biomanufacturing Innovation Center (AMBIC). The second, diametrically opposite, focus is the use of capillary-channeled polymer fibers for the chemical separation of proteins. Here again, funding from diverse sources has included the National Science Foundation and Merck. Potentially most impactful has been a year-old collaboration with Dr. Terri Bruce (CLIF) using the fibers for the separation of exosomes; “the next big little thing.” Exosomes are integral components in intercellular communication, and thus the spread of disease, as well as potentially powerful biomarkers for clinical diagnosis and as biotherapeutic drug delivery vehicles. The same platform is also being developed for the purification of viruses which are important as well in clinical diagnosis and in the production of biotherapeutics. Marcus has been recognized through numerous awards at both the University, state, national, and international levels. He is a Fellow of four learned societies, the Royal Society of Chemistry (London), the American Association for the Advancement of Science, the Society for Applied Spectroscopy, and the National Academy of Inventors. He serves on the advisory boards of three international journals.

• Advances in Purification & Recovery

Since 2008, Dr. Marino has served as the leader of the NIST Biomolecular Structure & Function Group and Associate Director of the Institute for Bioscience and Biotechnology Research (IBBR), a joint research institute of the University of Maryland and NIST, in Rockville, Maryland. Dr. Marino joined NIST in 1997 as a Research Chemist and was appointed Adjunct Professor at the University of Maryland. Prior to coming to NIST, Dr. Marino completed a Ph.D. in Chemistry from Yale University in 1995 and an A.B in Chemistry from Princeton University in 1989. After his PhD, he held an Alexander von Humboldt post-doctoral fellowship for two years at the Goethe Universitat in Frankfurt, Germany. Dr. Marino’s research focuses on precision measurement of biomolecular structure and dynamics, with a recent focus on NMR techniques for characterization of the higher-order-structure (HOS) of biotherapeutics.

• Rapid Methods to Assess Stability and Impurities in Biologics

Lukas is a Principal Consultant and project lead in innovative lighthouse projects. He holds an MSc in Biochemical Engineering from the University of Technology, Vienna. Over the last 7 years he was involved in basic engineering, process optimization, and process validation projects. Always running at the exciting interface between data science and process engineering he masters both languages (statistics and process technology) fluently. Currently he has the lead on several process validation projects and helps top-tier pharmaceutical companies on reaching their goal of successful submission.

• TS2: Integrating AI and Data Science in the Product Life Cycle

Daria holds an MEng, MRes and an EngD in Biochemical Engineering form University College London. She has over 10 years of experience in the Bioprocessing space and 8 years of experience in the Cell and Gene Therapy field. She has worked on primary recover strategy development and Cost of Goods modelling for high cell density CHO cell processes in the EngD programme with Lonza Biologics. Later focusing on manufacturing development for early phase autologous processes at the Cell and Gene Therapy Catapult. As a Lead Scientist she supported bioprocessing efforts across Cell and Gene therapy programs as, including efforts in the set-up of a newly built GMP facility. She then moved to set up and manage production and MSAT operations at TCR2 Therapeutics as Associate Director for Manufacturing and MSAT. Now at Cell and Gene Therapy Catapult as Head of Bioprocessing she is responsible for managing process development activities within the Technology and Process Innovation team.

• Cell Therapy Manufacturing

Tony Martignetti is a trusted advisor, leadership coach & facilitator, best-selling author, podcast host, and professional speaker. He brings together over 30 years of business and leadership experience, formal training, and extreme curiosity to elevate leaders and equip them with the tools to navigate through change and unlock their true potential. Before becoming the founder and Chief Inspiration Officer of Inspired Purpose Coaching, he was a finance and strategy executive with experience working with some of the world's leading life sciences companies. Along his journey, he also managed small businesses and ran a financial consulting company. Tony hosts The Virtual Campfire podcast and is the author of "Climbing the Right Mountain: Navigating the Journey to An Inspired Life" and the co-author of "Secrets of Next-Level Entrepreneurs."

• W1: Talent Acquisition and Retention Strategies for Biopharma

My journey has evolved from systems biology to practicing medicine, to co-leading the digital transformation and virtual care initiatives at a large IDN, to healthcare data interoperability, to machine learning analytics, to investing in healthcare technology (diagnostic, therapeutic, value-based care delivery incorporating virtual care and virtual clinical trials). Along this journey, John has acquired a multifaceted lens into the co-evolution of healthcare delivery models, clinical research models, and the role of technology in support of the virtuous cycle of accelerating new discoveries and incorporating them into daily clinical practice.

• Vaccine Development and Manufacturing

Dr. Mukesh Mayani is a Head of Process Development (PD), Gene Therapy Franchise at National Resilience, Waltham, USA. In his current role, Mukesh is responsible for viral vector platform development, and supporting Resilience's gene therapy franchise clients’ programs. Previously, Mukesh worked at Genomic Medicine CMC organization at Sanofi, USA, where he supported development of Lentiviral, AAV and non-viral GT modality platforms. Prior to Sanofi, Mukesh worked at Cytiva, Bristol-Myers Squibb (BMS) and Therapure Biopharma for the development of viral vector, mAbs, RNA-based vaccine and other modalities. Dr. Mayani trained in Chemical Engineering and acquired PhD degree in Chemical Engineering.

• Cell Therapy Manufacturing
• Gene Therapy Manufacturing

Brian is Director, Digital Product Management for Amgen and focused on insights and intelligence for executive leadership. He works at the intersection of knowledge management, advanced analytics, and digital product management to drive innovation and transformation. Brian recently co-authored "Organizational Intelligence and Knowledge Analytics" from Emerald Publishing Ltd.

• Smart Biomanufacturing & Digitalization

Dr. Aisleen McColl-Carboni is a Senior Director of Analytical Development at Oxford Biomedica Solutions and is responsible for bioassay development strategy, analytical characterization, and innovation. Prior to Oxford Biomedica Solutions, Aisleen worked at Biogen, Sanofi, and Homology Medicines in roles of increasing responsibility, where she led teams responsible for analytical method development and qualification. Aisleen holds a BSc in Immunology from the University of Glasgow and a PhD in Immunology from the University of Edinburgh.

• Gene Therapy CMC and Analytics

For over 27 years, Andrew has achieved a significant track record of success within three critical areas of healthcare innovation: overseeing and advancing novel therapeutics and medical technologies from inception to NDA approval; executing complex corporate development transactions including capital formation, alliance management, and acquisitions; and venture finance and initial company creation. Prior to founding Health Innovation Capital, Andrew was a Partner at Excelyrate Capital Fund I, during which time he was responsible for: 1) building a pipeline of potential investment opportunities; 2) expanding and managing syndicate relationships; 3) creating a healthcare centric venture portfolio that yielded significant returns to LPs, established a collection of investments that are either standards of care or best in class within their respective therapeutic areas. During his tenure, he created a proprietary set of integrated search, evaluation, and risk assessment methodologies and tools that have received praise within both the entrepreneur and venture communities. As a Principal investor with Essex Woodlands, the Michigan Economic Development Corp’s Life Science Venture Fund, and Excelyrate Capital, Andrew’s investing experience included the execution of 11 investments with 10 Exits that achieved a track record for providing significant collective net cash on cash returns for investors and exits that included 7 IPOs and 3 acquisitions. Andrew’s tenure as a senior healthcare financial, business development and commercial strategy executive includes multinational experiences in both Large Cap pharma (Baxter) and rapid growth venture backed biotech and medtech companies including SkinAxis (SVP Commercial Operations and Corp. Strategy) and Conceivex, Inc. (Chief Strategy and Business Development Officer). During this tenure, he was responsible for originating and negotiating several multi-million dollar strategic partnerships, co-development/marketing alliances, and inorganic pipeline growth initiatives that yielded significant shareholder value. He was responsible for leading the commercialization of three (3) products, which grew from $0.00 gross revenues to between $85 to $250M respectively after 18 months of his leadership. As a C-Suite executive, Andrew has successfully led three healthcare companies to successful M&A exits at significant multiples to EBIDTA. During his tenure at UBS Warburg, Andrew worked on a number of market leading biotech and medtech transactions, with over $10 BN in IPO, M&A, and Equity/Debt financing transactions executed. Andrew is a key opinion leader in pediatric health innovation and venture capital investment targeting that patient population frequent speaking internationally on such topics as risk management, program and new product planning, early stage capital formation strategies, and healthcare commercial innovation strategy. In addition, Andrew has worked with the National Institute of Health (NIH) and nationally recognized indication specific advocacy groups. Andrew lives in Boston’s Beacon Hill and is actively involved in a number of philanthropies dedicated to improving the lives of children. When not enjoying time with family, Andrew is actively traveling to cross “things” off his ever expanding “Bucket List”.

• Bioprocessing Tech: Venture, Innovation, and Partnering Conference

A father, husband and proud northerner with more than 20 years experience working internationally in commercial leadership, recruitment and human resources. Early career in human resources developed with leading brands in professional services, consumer goods and automotive before moving into specialist talent acquisition. Enjoyed a successful career with two privately owned recruitment groups, developing and delivering high value talent partnerships in support of strategic goals. Internally delivered ambitious growth strategies, delivered major restructure and rebranding in support of long term strategy. Very proud to be leading the Lead Candidate team as we champion people & talent in pharma and biotech outsourcing.

• W1: Talent Acquisition and Retention Strategies for Biopharma

Dr. Meghrous received his M.Sc. and Ph.D. in Biochemistry from the University of Nancy (France) and has more than 20 years of experience in the pharmaceutical industry in process development for recombinant and therapeutic proteins, viral vaccines, and monoclonal antibodies. Dr. Meghrous is Deputy Director Upstream Process Development at Protein Sciences, A Sanofi company, in Meriden, Connecticut, and is currently in charge of developing, optimizing, and implementing cell culture processes for influenza vaccines. He has also held positions as fermentation specialist and Senior Scientist at Protein Sciences Corporation. Prior to joining Protein Sciences Corporation, he worked at DSM biologics and before at the NRC-Biotechnology Research Institute. He worked at NRC-BRI for eight years, first as a post-doctoral fellow then as scientist in the Animal Cell Culture group. The focus of his work was the development of processes to produce viral vaccines and other recombinant proteins using the baculovirus expression system.

• Vaccine Development and Manufacturing

Miriam-Rose Menezes, Ph.D., is a Senior Scientist in the High-throughput Technologies and Operations group at Spark Therapeutics, Philadelphia. She graduated with a Ph.D. in Oncology and Cancer Biology from the University of Nebraska Medical Center, Omaha. She has more than ten years of experience in Molecular and Cell Biology and High-Throughput Screening.

• Accelerating Analytical Development

No bio available.

• Vaccine Development and Manufacturing

Dr. Rahul Misra is a Scientist in the Biophysics and Process Analytical Technology platform at Sanofi Pasteur, Canada. He develops analytical methods for size and structural characterization, antigen content, purity analysis and thermal stability of vaccine candidates. He is also working on providing inline/online PAT solutions to monitor CQA’s in vaccine manufacturing process. Prior to joining Sanofi, he has worked as a Scientist in Eurofins Canada, Keenan Research Centre of St. Michael’s Hospital, and Intas Pharmaceuticals. He was a Fulbright Postdoctoral Research Fellow at Purdue University, USA and received a PhD in Biochemistry at the Indian Institute of Technology, Delhi. He is co-author of 20 research papers and co-inventor of patents in the field of nanomedicine and drug delivery.

• Rapid Methods to Assess Stability and Impurities in Biologics
• Vaccine Development and Manufacturing

Vesselin Mitaksov graduated from Washington University in St. Louis, MO with a Ph.D. in Biochemistry. His doctorate work was focused on understanding and harnessing the structural principles of antigen presentation. In 2006 Vesselin joined Pfizer, Global Research and Development as a bioassay scientist. Currently, Vesselin has been leading analytical support teams for rAAV gene therapy product development and readiness for commercialization, specializing in analytical technology transfers across Pfizer’s global commercial supply network. Vesselin is also the CMC analytical lead responsible for rAAV global licensure applications and regulatory support.

• Gene Therapy CMC and Analytics

Shigeki Miyake-Stoner, PhD is a passionate biotechnologist with 16+ years of experience spanning organic chemistry, synthetic biology, oncology, immunology, virology, and phototrophic organisms. His graduate work at the Salk Institute for Biological Studies (La Jolla, CA) resulted in new oncolytic adenovirus technology enabling preclinical development at IconOVir Bio (San Diego, CA). He went on to pursue development of self-replicating RNA technology R&D at Viridos (previously Synthetic Genomics; La Jolla, CA) and later joined Replicate Bioscience (San Diego, CA), where the development of novel self-replicating RNA vectors and delivery technology is being further accelerated.

• mRNA-Based Therapies

Dr. Morrison is a Professor in the Department of Microbiology and Physiological Systems of the University of Massachusetts Medical School. She is a fellow of the American Association for the Advancement of Sciences (AAAS) and the American Academy for Microbiology. She is an Associate Editor for Science Advances, and a member of the editorial board of the Journal of Virology. She has served as the Program Chair for the American Society for Virology, the Chair of the Microbiology Test Committee for the National Board of Medical Examiners, and the Chair of Division T of the American Society for Microbiology. She has over 100 publications concerning RNA virus entry and assembly as well as vaccine development.

• Vaccine Development and Manufacturing

Ejvind holds a PhD from the University of Southern Denmark in Protein Chemistry & Molecular Biology. He has more than 20 years of experience developing protein analyses and mass spectrometry methods in the research & development of protein biologics; vaccines, monoclonal antibodies, therapeutic proteins, and cell and gene therapies.

• Host Cell Proteins

My name is Paria Moxley and I am currently a scientist at Sanofi in Drug Product Development and Manufacturing department. I obtained a Ph.D. in Chemical Engineering from Northeastern University in 2020 and have been with Sanofi since. In the beginning of my professional career, I started my work with focus on protein therapeutics formulation development and later followed my interest in gene therapy modalities.

• Formulation and Delivery of High-Concentration Proteins and New Modalities

Jill has more than seventeen years of experience motivating and developing individuals to be successful in professional and personal situations and is currently the Director of Human Resources at Genezen. She is passionate about using her strengths of Developer, Winning Others Over, Communication, Positivity, Activator, her values of kindness and curiosity and her altruistic motivation to make a positive impact on the culture. Jill has experience in managing all aspects of hiring and employee retention for organizations experiencing rapid growth. Jill aims to further improve Genezen’s status as a highly desirable place to work and grow as a professional in the state of Indiana. She is proud to be working alongside amazingly smart and talented individuals who are passionate about the work they do and the difference they make. Jill has a bachelor's degree from Purdue University and her MBA from Indiana University Kelley School of Business.

• W1: Talent Acquisition and Retention Strategies for Biopharma

Victor is a skilled molecular biologist with expertise in next-generation sequencing, gene editing (e.g., CRISPR), plasmid design and cloning, and bioinformatic analysis. He joined Resilience in Jan. 2022 as part of the Tmunity Therapeutics acquisition and currently leads the Molecular Biology and Sequencing lab in the Resilience Philadelphia site. His team has successfully developed and implemented sequencing assays for variant detection in plasmids, lentivirus, and integrated cell products. Additionally, he led the development of multi-product sequencing assays for CT product contamination. Prior to joining Resilience/Tmunity, he worked at Spark Therapeutics, where he led the development of in-house analytical assays for product impurity profiling for AAV, including truncated product analysis using NGS methods. Victor enjoys fishing with his two kids as well as playing baseball and tennis.

• Cell Therapy CMC and Analytics

Hirsh Nanda is the Director of Analytical Sciences at The Janssen Pharmaceutical Companies of Johnson & Johnson. Hirsh joined Janssen in 2015 and currently he is leading an analytical sciences group supporting research and development of biologic therapeutics, including cell line engineering and development. His team performs in-depth mass-spec and biophysical characterization across modalities and next-generation therapies. State-of-the-art robotics, along with high-throughput mass-spec data acquisition and analysis, is used to automate and streamline our processes. Prior to joining Janssen, Hirsh was Senior Scientist at NIST, working on the adsorption and aggregation of mAbs at surfaces relevant to pharmaceutical processing.

• Accelerating Analytical Development

No bio available.

• Accelerating Analytical Development

Dr. Niss is Chief Technology Officer at eGenesis, overseeing the organization’s use of cutting-edge technology to redefine the future of organ transplantation. Dr. Niss is a seasoned biotechnology executive and scientist with more than 20 years of experience in molecular biology and the biotechnology industry. Most recently, he served as Chief Technology Officer at Mustang Bio Inc., where he led a team developing and manufacturing cell therapy products, including the build-out of the company’s autologous CAR-T manufacturing platform. Dr. Niss also served as Mustang’s Vice President of Operations, with a focus on the establishment of facilities to support commercial manufacturing. Prior to his tenure at Mustang, Dr. Niss held various scientific and technical leadership roles at the vanguard of innovation in cell and gene therapy. At Biogen, Dr. Niss led the Cell Therapies group, overseeing operations and supporting regulatory filings. Dr. Niss played a pivotal role in the advancement of Kymriah® (tisagenlecleucel), the first chimeric antigen receptor therapy to be approved in the US, establishing critical CMC and manufacturing capabilities and supporting cross-functional development activities. At Pfizer, Dr. Niss led global research teams supporting target identification and validation as well as preclinical, clinical development. Dr. Niss earned a Ph.D. in Molecular Biology from Humboldt University in Berlin, Germany, an M.S. in Biology at Georg-August University in Goettingen, Germany. He completed post-doctoral work at the Children’s Hospital and Dana-Farber Cancer Institute.

• Cell Therapy Manufacturing

Dr. O’Connor is the director of the Division of Product Quality Research in the Office of Testing and Research in the Office of Pharmaceutical Quality and is a member of CDER’s Emerging Technology Team (ETT). His responsibilities include managing research and testing projects that answer and anticipate pharmaceutical quality-related regulatory challenges through scientific approaches. The impact of OTR research and testing is utilized to support regulatory assessment and policy development in areas such advanced manufacturing, drug quality standards, characterization of complex drug substances and drug products, and post market product quality and public health issues. Tom is a co-author of several papers on emerging pharmaceutical technology (such as continuous manufacturing, 3D printing, and the utilization of modeling and simulation for quality assurance). Through the ETT he has contributed to the review of several regulatory applications utilizing novel technologies. He is the co-chair of the OPQ Manufacturing Science and Innovation Center of Excellence and is a member of the advanced manufacturing working groups within the FDA. Tom originally joined the FDA as chemistry reviewer in the Office Generic Drugs and prior to joining the FDA, Tom worked at ExxonMobil Research and Engineering where he held job functions in both process analytical technology and process control. Dr. O’Connor earned a B.S. in chemical engineering from the Cooper Union and a Ph.D. in chemical engineering from Princeton University.

• Smart Biomanufacturing & Digitalization

Sarah O’Reilly is the Senior Director of Human Resources for Andelyn Biosciences. In this role, Sarah leads all essential HR functions including talent acquisition, learning and development, employee relations, and performance management, in addition to safety and internal communications. With over 17 years in the manufacturing industry, Sarah has acquired a broad range of HR knowledge and experiences, in addition to her formal education with a bachelor’s in human resource management and MBA. Prior to her role at Andelyn, she worked at Honda of America Manufacturing, where she focused on HR business plans and strategy, as well as leading the compensation, succession planning, performance management and HR analytics teams. Sarah currently serves on the Workforce Advisory Committee for Central Ohio that partners with local businesses and educational institutes to bridge existing talent gaps between employer needs and workforce skillsets.

• W1: Talent Acquisition and Retention Strategies for Biopharma

Jungmin Oh is a manager of new product development at Avantor. In her current role, Jungmin leads product and process development projects with multiple biopharmaceutical industry partners, including customized product development for cell and gene therapy customers. She holds a MS and Ph.D. in chemical engineering, specializing in the optimization of a continuous chromatography system.

• Advances in Purification & Recovery

Jianfa is a Principal Scientist in the Upstream Process Development group at Bristol Myers Squibb. He works to optimize the cell culture manufacturing process for mAb and AAV production. He holds a PhD of Biomedical Engineering from the University of Alabama. He specializes in late-stage cell culture process development as well as early-stage biopharmaceutics discovery and characterization with 7+ years’ experience.

• Cell Line Development & Cell Culture Optimization

Nisha Palackal is a Director in Protein Biochemistry at Regeneron Pharmaceutical in Tarrytown, NY. She received her Ph.D in Biochemistry from the University of Pennsylvania at Philadelphia. Prior to joining Regeneron, she has held positions of increasing responsibilities at Diversa (now BASF) corporation in San Diego, Cayman Chemical Company in Ann Arbor, MI and Hospira (a Pfizer company) in Lake Forest, Illinois. In her current role at Regeneron Pharmaceutical, she is responsible for overseeing groups involved in extended characterization of reference standards, comparability and BLA support, Host Cell Protein method development as well as the development and life cycle management of Critical Protein Reagents.

• Host Cell Proteins

I am currently working as a Senior Research investigator in the Cell Culture Process Sciences group at Incyte Corporation. in Wilmington, DE. I lead upstream process development, tech transfer and scale-up/down activities for early and late-phase programs. Previously, I have worked in upstream group at Catalent Biologics in Bloomington, IN and Merck in West point, PA.

• Intensified & Continuous Processing

I am currently the Downstream Bioprocessing Practice Director within the FormulatedProducts team at Siemens. My focus is on enabling the application of mechanistic models to downstream unit operations such as chromatography and membrane filtration. Prior to my current role, I was a downstream development scientist at GSK for over 3 years, where I developed purification processes for antibody-based therapeutics. I have completed a Masters in Chemical Engineering at Imperial College London and an Engineering Doctorate in Biochemical Engineering at University College London.

• Intensified & Continuous Processing

Purbasa is a Senior Manager, CMC Formulation & Drug Product Development at NGM Bio. In this role, she supports formulation development and CMC activities related to drug product development, manufacturing & fill finish operations. Purbasa has a Masters in Biotechnology from Northwestern University. Over the last 10+ years, she has worked on developing formulations and analytical assays for various monoclonal antibodies, T-cell engagers, bispecific antibodies and small molecules.

• Formulation and Delivery of High-Concentration Proteins and New Modalities

Will co-founded Culture Biosciences in 2016 and has been the company’s CEO since then. Will’s vision of innovation in bioprocess development is grounded in experiences in various other areas of innovative engineering, including 3D printed microfluidics, Google's drone delivery program, and Google Glass. Will has a Master of Media Arts and Sciences degree from the MIT Media Lab and a Bachelor of Science degree in Mechanical Engineering from Duke University.

• Bioprocessing Tech: Venture, Innovation, and Partnering Conference

Ted has over seven years of experience in the biopharmaceutical industry developing clonal CHO cell lines for the production of therapeutic antibodies. In his current role, Ted is interested in elucidating sources of genetic drift in CHO cells in an effort to identify cell lines that can maintain stable expression. Ted received his PhD at the University of Colorado - Health Sciences Center and continued his training at the Buck Institute for Research on Aging as a postdoctoral scholar.

• Cell Line Development & Cell Culture Optimization

Nikolai Petrovsky is Research Director of Vaxine, an Adelaide-based biotechnology company focused on vaccine development, and Professor of Medicine at Flinders University. He has been awarded over 50 million dollars in grants from the U.S. National Institutes of Health for his vaccine research. He has authored over 200 peer-reviewed research papers and is an inventor on multiple vaccine patents. In 2020, he developed the Covax-19/SpikoGen vaccine against COVID-19 that in October 2021 received emergency use authorization, making it the first recombinant protein COVID-19 vaccine in the world to achieve regulatory approval and the first Australian-developed human vaccine over the last 40 years.

• Vaccine Development and Manufacturing

Poonam leads the delivery of process modelling projects for technical R&D at GSK. She oversees and coordinates process modelling activities on multiple Vaccines R&D projects and platforms. She is an established process modeler, and has expertise in process modelling, process optimization and computational fluid dynamics. She has previously worked at Bristol Myers Squibb, Devens as a process engineer/scientist. She has also worked at Reliance Industries Ltd, India for 5 years where she delivered process modeling projects for process optimization, yield improvements and process safety. She has completed PhD in Chemical Engineering from the University of Massachusetts, Amherst.

• Smart Biomanufacturing & Digitalization

Tarran Pierfelice, PhD, MBA is a stem cell biologist by training who is currently the Business Head of National Resilience’s Gene Therapy Franchise where her team is developing transformative technologies and platforms to improve how gene therapies are manufactured. Dr. Pierfelice has >10 years of gene therapy manufacturing experience spanning business development and commercial operation roles both at CDMOs and cell and gene therapy innovator companies. She was the Director of Business Development at Paragon Bioservices, an industry-leading gene therapy CDMO, where she was heavily involved in developing the company’s commercial strategy to drive organic growth to position the company for its sale to Catalent. After completing her MBA, Dr. Pierfelice worked at Editas Medicine leading its cell therapy pipeline and CMC strategy business development efforts where she worked on several collaborative partnerships to advance the company’s pipeline to clinic. Dr. Pierfelice received a BS in Molecular Biology from Florida Institute of Technology, a PhD in Cellular and Molecular Medicine from Johns Hopkins University School of Medicine, and MBA from Harvard Business School.

• Bioprocessing Tech: Venture, Innovation, and Partnering Conference

Bryan leads the GMP manufacturing team in the GMP facility at St. Jude Children's Research Hospital. While at St. Jude, he has contributed to the development and GMP manufacturing of AAV and lentiviral vector products.

• Gene Therapy Manufacturing

As Operating Partner, Mr. Poltilove leads BroadOak’s investment strategy in Cell and Gene Therapy, Bioproduction, and Cell Biology. Mr. Poltilove joined BroadOak after 12 years with Thermo Fisher Scientific where he served as Vice President and General Manager. Mr. Poltilove led long-range strategy and day-to-day operations for the company’s cell and gene therapy business. Prior to Thermo Fisher, Mr. Poltilove served as Director of Revenue Strategy & Operations at the Corporate Executive Board and also held several commercial strategy roles with Johnson & Johnson. He holds Bachelor’s degrees in Chemical Engineering and Economics from the Massachusetts Institute of Technology as well as an MBA from the J.L. Kellogg School of Management at Northwestern University.

• Bioprocessing Tech: Venture, Innovation, and Partnering Conference

Elizabeth Pontius graduated from Rensselaer Polytechnic Institute (RPI) in biomedical engineering and began work at Bristol Myers Squibb (BMS) in 2019 through the Kick-Start Rotational Program. After working in downstream late-stage process characterization, upstream fed-batch manufacturing operations, and manufacturing automation support, she chose to continue downstream lab work in the areas of filtration and chromatography.

• Advances in Purification & Recovery

Lauren Powers is a Senior Scientist at Merck, based in Keniworth, NJ. She has eight years experience in process development and tech transfers of biologics, five of which have been in the continuous manufacturing space. Her specialty is in continuous capture.

• Intensified & Continuous Processing

Philip is an experienced research scientist familiar with high-throughput process development, design of experiment approaches to process optimisation and process scale up and validation. At CPI Biologics, Philip manages the technical team, working across mammalian, microbial, viral and cell-free projects.

• Intensified & Continuous Processing

Hari is Chief Operating Officer of Tessera, as well as Operating Partner at Flagship Pioneering. At Tessera, his responsibilities span across research, manufacturing, program management and IP. Hari is a global Biopharmaceutical executive with 20+ years of value creation in the biologics and vaccine industry. Before Flagship, Hari served as Chief Technology Officer of Spark Therapeutics, leading the technical operations, process and technology development and quality assurance organizations. At Spark, Hari was responsible for growing and scaling the company’s cutting-edge technology capabilities for an expanding development pipeline. Prior to Spark, Hari was head of Technical Development & Manufacturing at Moderna Therapeutics. At Moderna, he built and led the technology and early manufacturing organizations that delivered on supply for more than a dozen clinical programs in a brand-new technology area.

• Bioprocessing Tech: Venture, Innovation, and Partnering Conference

Charlie has spent a 30-year career in the Biotech industry working across a breadth of companies from Industrial Enzymes, Biopharma (Vx, gene therapy, small molecules development), Informatics, and Life Science and Diagnostic tools. He has spent the last 13 years at Danaher in M&A, Business Development & Strategy, and was a founder of their corporate ventures group. Today he leads the Biotech platform investing activities and serves on six boards with a focus in cell, gene, and genomic medicine companies.

• Bioprocessing Tech: Venture, Innovation, and Partnering Conference

Leon Pybus, Ph. D. is a member of the Bioprocess Strategy & Development team for FUJIFILM Diosynth Biotechnologies, leading development of the company’s next generation CHO expression and upstream processing technologies that improve and assist customers with the manufacture of therapeutic recombinant proteins. Leon holds a PhD from the University of Sheffield and has worked in the field of cell culture biotechnology for over 10 years.

• Cell Line Development & Cell Culture Optimization

No bio available.

• Formulation and Delivery of High-Concentration Proteins and New Modalities

Rachel is the Director of the BARDA Alliance for Johnson & Johnson Innovation, based at Johnson & Johnson Innovation - JLABS (JLABS) in Washington, DC, and the Interim Head of JLABS @ TMC in Houston, Texas. As BARDA Alliance Director, she is responsible for managing BLUE KNIGHT, a joint initiative between JLABS and the Biomedical Advanced Research and Development Authority (BARDA), which aims to stimulate the innovation and incubation of science and technologies that may improve health security and response by supporting companies focused on public health threats and emerging infectious diseases. Rachel leads the strategic direction, alliance management, and oversight of all operational activities related to the collaboration with BARDA, including managing the sourcing and selection of high potential companies for JLABS locations and developing global programming. Before joining JLABS, Rachel was the Chief of Staff for the National Evaluation System for Health Technology Coordinating Center (NESTcc) - an initiative of the Medical Device Innovation Consortium (MDIC) - that was established with funding from the U.S. Food and Drug Administration (FDA) and was recognized in September 2019 as one of the first collaborative communities with participation by the FDA. Prior to joining NESTcc, Rachel worked at PCORI, helping to launch the Patient-Centered Clinical Research Network (PCORnet), a national effort to engage patients and leverage electronic health data to improve the speed and efficiency of clinical research in the United States. Rachel received her MBA from Georgetown University and MPH in global health policy from George Washington University.

• Vaccine Development and Manufacturing

Xiaozhi Ren, PhD, is Director of Plasmid and Cell Line Development at Nvelop Therapeutics. Prior to Nvelop, he was Director of Cell Line and Process Development at Vedere Bio, where he designed and developed a high-quality clonal suspension HEK293 cell line called X-RAP for AAV production. Prior to Vedere, he was Senior Scientist in Upstream Process Development at Casebia Therapeutics. Prior to Casebia, he was Scientist in Cell Line Development at Sanofi, where he led the New CHO host cell line development. Before Sanofi, he worked as Visiting Scientist at Mike Betenbaugh's lab for CHO cell engineering.

• Gene Therapy Manufacturing

Siyuan Ren is working in Biologics Drug Product Development in AbbVie Inc. as Senior Scientist I. His work focus on physicochemical characterization, stability assessment, and drug product development of NBEs, including candidate screening and selection for clinical studies and commercialization of monoclonal antibodies, antibody drug conjugates, bispecifics, and fusion proteins. Prior to joining AbbVie, Siyuan gained his PhD from Chemistry Department of Illinois Institute of Technology in 2020. His PhD research was under supervision of Professor Chong and focused on cell culture, drug screening and targeting, bioconjugation of chelators with cancer cell targeting proteins, and radiolabeling of metal chelators and antibody drug conjugates for application of radioimmunotherapy and positron emission tomography (PET). Siyuan gained his master’s degree in biology from Biology Department of Illinois Institute of Technology in 2016.

• Rapid Methods to Assess Stability and Impurities in Biologics

Wilhad “Hans” Reuter is a Lead Engineer on the Upstream Process Development team for Alkermes’ oncology department, with experience in multiple therapeutic modalities, including lentiviral vectors, AAV gene therapies, and cytokine-based immunotherapies.

• Cell Line Development & Cell Culture Optimization

Lyndi Rice, PhD is the Head of Gene Therapy Analytical Technologies (GTAT) at BioMarin, focusing on analytical strategies from early phase development through commercialization for gene therapy products. GTAT works closely with Technical Development teams, CMC, Regulatory, site QC, QA, and several other departments to streamline method development, optimization, transfers and validations, and to platform methods with a focus on method lifecycle strategies. Previously, she served as Head of QC Viral Vector Analytical at BioMarin and has been with the company for almost four years. Her team focused on routine testing and method life cycle management for gene therapy products, including method transfer, validation, and optimization work. Prior to BioMarin, Lyndi was the Director of Analytics at the Gene Therapy Program (GTP), University of Pennsylvania, where she led multiple teams that conducted analytical development and QC release of toxicology and GMP material. Prior to GTP, she spent nearly a decade working at a biotechnology company where she oversaw a team that worked on oncology and cardiovascular disease therapeutics, spanning target identification/validation through pre-clinical development.

• Gene Therapy CMC and Analytics

Frank J. Riske, PhD, has over 30 years of experience in the biopharmaceutical industry and has been involved in the development, or improvement, of eight commercial protein products. Prior to joining BioProcess Technology Group, Dr. Riske was a Senior Director in the Late Phase Process Development Group at Genzyme, a Sanofi company. At Genzyme, Dr. Riske was responsible for the development of late-stage downstream processes for recombinant enzymes, monoclonal antibodies, adenovirus (gene therapy), and the identification and exploration of new technologies, including continuous processing, to streamline and improve purification. Prior to joining Genzyme, Dr. Riske managed the development, implementation, and manufacture of a peptide bound within a novel sustained-release vehicle and the development of a next-generation process to purify IVIG from plasma (both at Epic Therapeutics). Before Epic, Dr. Riske held positions at Repligen and Hoffmann-LaRoche during which he developed and improved downstream processes for proteins produced in mammalian cell culture, E. coli, and Pichia systems. Dr. Riske was also responsible for the manufacture of mAb fragments at Repligen. Dr. Riske has published over twenty peer-reviewed papers and patents and is active in the scientific community as both a mentor to young scientists and as a conference speaker and organizer. He is also on the Advisory Board for the Biotechnology Journal. Dr. Riske received his BS in Biology from Fairfield University, PhD in Biochemistry and Microbiology from Rutgers University, and completed a post-doctoral position at Hoffmann-LaRoche.

• TS1: Introduction to Bioprocessing

Matt is the Associate Director of AAV Production at BridgeBio Gene Therapy, at which he is focused on designing and implementing new strategies for the production and purification of adeno-associated virus. Matt completed his bachelor’s degree in biological sciences at North Carolina State University and his master’s degree in microbiology and cell science at the University of Florida. Prior to BridgeBio, Matt spent time at Precision BioSciences leading a process development team focused on developing upstream and downstream processes for clinical production of AAV. Prior to Precision, Matt worked at Pfizer on AAV purification and the Biomanufacturing Training and Education Center training industry professionals on downstream bioprocessing operations.

• Gene Therapy Manufacturing

Dr. Rochlin is the Chief Operating Officer at IN8bio. She has over 17 years of extensive expertise in biotechnology and company development, including preclinical scientific research, overseeing strategic & business development and managing company operations including corporate strategy, partnering and team buildout. She directs the clinical-stage cell therapy manufacturing program and all technical operations at IN8bio including process development and translational biosciences. She joined from Curadigm, a Cambridge, MA-based biotechnology company where she served as Chief Business Officer. Crain’s New York Business recognized Kate as one of the top women in tech in 2019. She is a scientific and business advisor to Immunovent, a New York-based biotechnology company she co-founded and previously served as its Chief Scientific Officer. Dr. Rochlin also serves as an executive board member to The Solution Lab, a New York-based non-profit organization. Dr. Rochlin earned a Ph.D. in Molecular Biology and Genetics from Weill Cornell Medical College, conducting research at Sloan Kettering Institute, and a BA in Biology from the University of Pennsylvania.

• Cell Therapy Manufacturing

MS in Biochemistry and Microbiology (UCLA). Currently working as a Senior Scientist in Janssen large molecule Formulation Development with prior experiences in Analytical Development and Quality Control. Significant exposure to projects relating to high concentration formulation development as well as surfactant degradation and particle formation.

• Formulation and Delivery of High-Concentration Proteins and New Modalities

Dr. Sean Ruane is a Senior Data Scientist at CPI’s National Biologics Manufacturing Centre in Darlington, UK. Sean's current focus is leading projects in process modelling and digitalisation, leading CPI's Smart Bioprocessing project which aims to build transferrable, cross-process predictive models. Sean also works in Process Intensification and Process Control, including setting up CPI's continuous processing lab, and in novel techniques for RNA and mAb production and purification.

• Intensified & Continuous Processing

Dr. Rachel Salzman serves as the Global Head of Corporate Strategy at Armatus Bio, a privately held preclinical stage biotech focusing on curative approaches for neuromuscular disorders where toxic gain of function plays a causative role in disease pathology. Prior to joining Armatus, Rachel was Executive Vice President of Portfolio, External Affairs & Development at Alcyone Therapeutics, a precision medicines company advancing therapies in serious neurological disorders by integrating novel delivery technologies with innovative genetic platforms. Rachel co-founded SwanBio Therapeutics in 2017, and served as Chief Executive Officer (CEO) and Director through 2019. She was the company's President and Chief Portfolio & Development Officer until January 2021. She then founded UltraSquared Bio, a not-for-profit organization dedicated to bringing gene therapies to ultra-rare populations where traditional business cases are not tractable, and in this capacity was awarded a prestigious Termeer Foundation Fellowship. Prior to her time at Swan, she was the Chief Science Officer (CSO) of The Stop ALD Foundation since 2001. The Stop ALD Foundation is a non-profit Medical Research Organization dedicated to employing entrepreneurial approaches and innovative methodology towards effective therapies, cures, and prevention of X-linked adrenoleukodystrophy (ALD), an often-fatal neurodegenerative disease. As CSO she made critical contributions in driving forward the world’s first ex vivo lentiviral gene therapy clinical trial conducted in non-HIV infected patients. Dr. Salzman has been an active member of ASGCT (American Society of Gene and Cell Therapy) for over 20 years and has served in a leadership capacity including elected membership to the Board of Directors, along with multiple committees and task forces designed to build and enhance the state of gene and cell therapy in both the US and EU. She currently represents ASGCT at the National Academy of Sciences Forum on Regenerative Medicine.

• Rapid Methods to Assess Stability and Impurities in Biologics
• Intensified & Continuous Processing
• Cell Therapy CMC and Analytics
• Gene Therapy CMC and Analytics
• Cell Line Development & Cell Culture Optimization
• Host Cell Proteins
• Vaccine Development and Manufacturing

Andrew Sandford brings over 20 years of experience in building, operating, and leading life science technology and manufacturing companies and will continue to extend ElevateBio BaseCamp® strategic partnerships in the field of cell and gene therapy. Prior to ElevateBio, Andrew worked in several leadership roles to oversee the successful implementation of strategic business development, marketing, and manufacturing operations. Notably, as Global Vice President of Business Development, Biologics for Catalent Pharma Solutions, Inc., his teams were responsible for driving revenue expansion, enabling the transformation of Catalent to a global biologics services provider. Prior to Catalent, Andrew held various leadership positions at Selexis Inc, Lonza Corporation, and Dow Chemical Company, creating strategic value through global business and licensing opportunities and increasing business unit profitability. Most recently, Andrew was an Executive in Residence for Anzu Partners, Co-founder and Chief Executive Officer of VREX Therapeutics, and Founder, Inventor and Managing Director of Arthropod Biosciences.

• Bioprocessing Tech: Venture, Innovation, and Partnering Conference

Sumona Sarkar is a Biomedical Engineer at the National Institute of Standards and Technology in Gaithersburg MD. She has been at NIST for 8 years with a focus on cell material interactions for tissue engineering and regenerative medicine, and analytical methods for cell and gene therapy. She serves as a subject matter expert and project leader in ISO TC 276: Biotechnology with particular expertise in cell count, viability, and characterization. Prior to joining NIST Sumona received her Ph.D in biomedical engineering from Drexel University, and her M.S. from Boston University.

• Cell Therapy CMC and Analytics

Jay Sarkar is an Aging and Systems Biology Researcher and Entrepreneur. His formal background is in Applied Physics and Electrical Engineering, and he translates many of the principles, analyses, and solutions of these fields to design novel biotechnologies. As an example, he is a founder of the field of Transient/Partial Reprogramming, having published on the concept for his doctoral work at Stanford University. He then spun out this solution into his first company using an mRNA approach to translate its benefits. This technology explores the ability to reset the cellular epigenetic framework by transient expression of key transcription factors, but only to the degree that the epigenetic landscape is normalized and not erased - thus preserving yet improving cell function. In building this technology he further explored the fields of custom mRNA development and lipid carrier design. He now progresses forward to develop the next generation of strategies and solutions for biologicals information manipulation in cells, tissues, and organ systems, in which the medium of mRNA plays a crucial role.

• mRNA-Based Therapies

Nicole Schiavone is a Principal Scientist at Pfizer within Analytical Research & Development. She earned her Ph.D. from the University of Notre Dame where she developed a capillary electrophoresis-mass spectroscopy (CE-MS) workflow for metabolomics. She then completed a postdoctoral fellowship at Merck focused on applying hydrogen-deuterium exchange (HDX)-MS and circular dichroism to study global conformational changes of peptides in solution. At Pfizer, Nicole currently leads mRNA vaccine analytical strategy and method development.

• mRNA-Based Therapies

Dr. Stefan R. Schmidt MBA currently serves as Head of Operations/COO at BioAtrium AG, a joint venture of Lonza and Sanofi in Visp, Switzerland. Previously he held the position as CSO and other senior executive roles at Rentschler Biopharma with overall responsibilities for development and production for more than 5 years. Before that, he was CSO at ERA Biotech in Barcelona, directing the company’s R&D efforts. Prior to that, he worked for 7 years at AstraZeneca in Sweden where he led the unit of Protein Sciences as Associate Director. He started his leadership career at Biotech companies in Munich where he built up protein biochemistry teams for Connex and GPC-Biotech.

• Intensified & Continuous Processing

Saurabh Sen, PhD is a research scientist with a domain expertise in Gene Therapy, Antibody Therapeutics, Proteomics, GPCRs and CNS disorder (Parkinson’s disease). In his current position at Sanofi, he is actively engaged in Cell Line Development (CLD) delivering top class Producer Cell Lines (PCL) for Gene Therapy and stable cell lines for Biologics. Previously, at Boehringer Ingelheim (BI), he was leading antibody discovery projects (from early discovery to final leads for pre-clinical development) towards developing new drugs for unmet medical needs; as well as being the SME for antibody expression (transient and pools).

• Cell Line Development & Cell Culture Optimization

I started my scientific career with my academic training in Biology. Prior to joining Novartis, I worked on hit validation of small molecules at the Broad Institute of MIT and Harvard. I have also worked on proteomics analyses examining antibodies produced in response to the flu vaccine at Vanderbilt University. Presently I am a Research Scientist at the Novartis Institutes for Biomedical Research specializing in mass spectrometry characterization of various therapeutic modalities from antibodies to lentiviruses.

• Cell Therapy CMC and Analytics

Yuefei Shen is a Principal Scientist within the CMC Drug Product Development Organization at Sanofi wherein she leads early Drug Product Development for gene therapy programs. Prior to Sanofi, she worked at Novartis leading research projects. She obtained her PhD in Chemistry from Washington University in St. Louis and Postdoc from the University of Massachusetts Medical School with focus on non-viral RNA therapy and gene therapy.

• mRNA-Based Therapies
• Formulation and Delivery of High-Concentration Proteins and New Modalities

Andrew has over 30 years’ design and operational experience in the biopharmaceutical industry, with direct responsibility for manufacturing, logistics, maintenance and capital programme management. He has developed Biopharm Services into a leading provider of bioprocess modelling and knowledge management tools that support bioprocess innovation. The focus of his work is in the understanding the impact of innovative technologies on biomanufacturing with focus on single use systems and continuous processing. Prior to Biopharm Services, Andrew was Director of Engineering and Logistics at Lonza Biologics and holds an MSc in Biochemical Engineering from UCL. He was a finalist in “The Manufacturing Processing Thought Leader of the Decade” category at the 2012 BioProcess International Awards and in 2014 was appointed a Fellow of the Royal Academy of Engineering in the UK.

• Intensified & Continuous Processing

Chadakarn is currently a manager, process engineer focusing on modeling and simulations in Manufacturing Science and Technology (MS&T) at Bristol Myers Squibb in Devens, Massachusetts. In her role, she develops advanced process models using computational fluid dynamics (CFD) approaches and other modeling tools to support upstream and downstream processes in commercial drug substance manufacturing. She obtained her Ph.D. in Chemical Engineering from New Jersey Institute of Technology (NJIT). Her research interests center on the single and multi-phase mixing phenomenon, with an emphasis on the hydrodynamics in small and large pharmaceutical vessels using experimental and computational approaches.

• Advances in Purification & Recovery

Elena Smith, PhD, is Analytical CMC leader at Sanofi Vaccines and leads the definition and implementation of analytical strategy for vaccines in mRNA platform. Dr Smith joined Sanofi (Protein Sciences) in 2013 and led Quality Control for the commercialization of the new product, world's first recombinant Influenza vaccine Flublok, with several seasons of product scale-up on the market. Elena contributed to analytical strategy, provided CMC IND/BLA and analytical transfer support for various products produced in the recombinant platform products spanning from Phase 1 to Commercial including bringing to the market Flublok Quadrivalent/Supemtek. In her following role in the Sanofi as Quality Analytical Expert, Elena provided her expertise by leading technical CMC discussions with Regulatory authorities and being site Quality lead for product launches of Flublok Quadrivalent/Supemtek in several countries as well as being part of CMC team for the bringing to the market new COVID 19 vaccine booster - VidPrevtin. Dr. Smith obtained her Ph.D. in Molecular Biology on HIV antivirals following completion of postdoctoral training on Molecular Pharmacology at U.S. National Institutes of Health. Dr. Smith focuses her industrial operations interests on analytical strategy for new products, standards, tech transfer, manufacturing process, and microbiological control of manufacturing sites. Dr Smith is a lead of subgroup for early availability of reagents at WHO Pandemic SWITCH Potency Assay Working Group contributing to WHO operation plan for Pandemic Influenza Vaccine Response.

• Accelerating Analytical Development

Cait Sofa is a Principal Scientist in the Biopharmaceutical Drug Product Development group of GlaxoSmithKline (Collegeville, PA). She has over 10 years of industrial experience and has led and contributed significantly to projects ranging from pre-candidate selection through late phase drug product development and commercialization. Cait earned her Bachelors degree from Monmouth University (NJ) and her Masters degree from Villanova University (PA).

• Formulation and Delivery of High-Concentration Proteins and New Modalities

Dr. Michael Sokolov is co-founder and COO of DataHow AG, a spin-off company from ETH Zurich specialized on process data analytics and modeling with a particular focus on the biopharmaceutical and chemical domains. He also holds a lecturer position for statistics for chemical engineers at ETH.

• Smart Biomanufacturing & Digitalization

No bio available.

• Gene Therapy Manufacturing

I hold a PhD in pharmaceutical sciences and have experience in drug product development for vaccines and gene therapy. I have been a part of the gene therapy team at Biogen for nearly 4 years, where the focus of my work has been end-to-end drug product development (formulation to fill-finish) for Adeno Associated Viruses (AAVs) both in early and late stages of clinical development.

• Gene Therapy CMC and Analytics

Patrick is an Associate Scientist at Bristol-Myers Squibb in Biologics Downstream Process Development, where he has operated since January of 2020. He earned his Bachelor of Science degree in chemical engineering from the University of Massachusetts Amherst in 2019. His experience mainly centers around development, optimization, and characterization of biologics purification steps such as various types of column chromatography and membrane filtration, among others. In addition to helping patients through science, Patrick is also passionate about sharing in the joys of simple pleasures like music, video games, and food.

• Advances in Purification & Recovery

Lasse is a Scientific Leader in the Developability team within Biopharm Discovery at GSK. His expertise is in drug discovery, structural biology, protein characterisation, and post-translational modifications. Lasse received his PhD from University College London in 2013, for structural studies in the field of protein kinase signalling. A PostDoc followed at Imperial College London, on structural and mechanistic studies of protein homeostasis. In 2017 Lasse joined GSK, and since 2020 he has been leading the Developability team within Biopharm Discovery. At the interface between discovery and CMC, the team’s focus is the physical and chemical characterisation of protein-based therapeutics to identify developable leads for progression.

• Formulation and Delivery of High-Concentration Proteins and New Modalities

Mara Strandlund is a global Human Resources executive with deep experience in linking people and business strategies, using data to collaborate with leaders on complex talent, scaling, inclusion and cultural challenges in rapidly changing markets including life sciences, cloud computing, ecommerce, healthcare, academia, distribution, gaming, aerospace, oil, and construction. Her experience leading large-scale teams has spanned across 6 continents (missing Antarctica) and extended beyond HR in leading big data research, product development, and customer training teams. Outside of Resilience, she is an active volunteer supporting veterans transitioning back into the workforce and ensuring that the Internet is a positive force for good that improves the lives and well-being of people around the world. She received her undergraduate and MBA degrees from the University of Chicago and is a certified Coach, Compensation Professional and Six Sigma expert.

• W1: Talent Acquisition and Retention Strategies for Biopharma

Shantanu Sule is a Principal Scientist in the Drug Product Technologies group at Amgen. He has extensive experience in drug product formulation and process development covering multiple modalities, combination products, and early- to late-stage programs. Shantanu received his PhD in Chemical Engineering from Rensselaer Polytechnic Institute in 2013, where he developed AC-SINS -- a novel developability assay. He is a recipient of the prestigious W.H. Peterson Award from ACS (BIOT).

• Formulation and Delivery of High-Concentration Proteins and New Modalities

Jessie has nearly 10 years of experience in fermentation and cell culture in the pharmaceutical industry. She joined Ultragenyx in 2019 and has been focusing on HEK platform, as well as late stage development. During her time in Boehringer Ingelheim and GSK, she worked on and led process development for both early stage and late stage projects, such as monoclonal antibody or other therapeutic proteins. She also led GMP clinical supply runs when she was at Boehringer Ingelheim. Jessie has been trying to apply innovative technologies to cell culture/fermentation process, i.e., metabolomics, were applied for scale-up troubleshooting. She also evaluated and integrated PAT tools (such as Raman, holographic microscopic technology) for upstream process, to gain more knowledge between process indicators vs. process productivity. She has a BS in Biological Science from Nankai University in Tianjin, China and a MS in Applied Statistics and a PhD in Biochemistry, with an emphasis in Biochemical Engineering from The Ohio State University, where she also was a postdoctoral researcher for 1 year working on fermentation bioprocess.

• Gene Therapy CMC and Analytics

No bio available.

• Cell Therapy CMC and Analytics

No bio available.

• Intensified & Continuous Processing

Bruce Thompson, PhD is an immunologist by training and spent his formative years at Pfizer learning analytical and CMC development. After leading the CMC team to help develop early allogeneic CART products, he spent several years in early program and product development at Fred Hutchinson Cancer Research Center leading the GMP cell product facility and Lyell Immunopharma building the Process Sciences team. He has depth of knowledge in cell-based immunotherapies and CMC development and strategy. He is currently leading the technical team of the Cell Therapy Franchise at Resilience, Inc.

• Cell Therapy CMC and Analytics

Sam Thompson has a PhD in Computational Biology from Imperial College London and National University of Singapore. He has worked for almost four years as a Data Scientist at Cell and Gene Therapy Catapult, supporting lab-scientists in the research and development of cell and gene therapies. He has experience working across the bio-tech stack, including building tooling for data capture and analysis, bioinformatics and building large-scale data infrastructure.

• Smart Biomanufacturing & Digitalization

Timothy-Neil Tiambeng is a senior scientist at Regeneron Pharmaceuticals, Inc. He received a B.S. in chemistry from the University of California - Irvine. He completed his doctoral degree in chemistry under the supervision of Professor Ying Ge at University of Wisconsin - Madison, where he developed analytical techniques and tools for the analysis of low-abundance proteoforms from clinical samples. At Regeneron, he focuses on developing LC-MS based analytical methods to support development and characterization of biotherapeutic drug candidates.

• Accelerating Analytical Development

Grace is a business-oriented human resources professional with experience in organizational effectiveness, culture building, leadership development and coaching, talent acquisition and employment branding, global mobility, compensation and people operations. Adept at developing and executing people and culture programs that balance strategic business needs with effective, impactful and practical solutions. Credible leader who builds strong relationships across diverse industries, companies, employees and vendor partners. Grace is currently senior director, people and talent acquisition at Celsius Therapeutics. She began her human resources career in life sciences at Feinstein Kean Healthcare (Ogilvy) and has also held human resources leadership roles at Bluefin BioMedicine, Cell Signaling Technology and Pear Therapeutics.

• W1: Talent Acquisition and Retention Strategies for Biopharma

Dr. Jens Traenkle is Head of PAT & Automation at Bayer. Together with his group he supports PAT activities for Bayer’s biopharma initiatives. The mission of the group is to bring lab analytics closer to the process and to integrate the resulting data. Dr. Traenkle has studied biochemistry and specialized on biophysics and protein structure during his PhD thesis at the Max-Planck-Institute for Molecular Physiology in Dortmund. He joined Bayer in 2006 and held previous positions in bioanalytics in Switzerland and in Germany within the company. Since 2012 he is responsible for PAT for Biotechnology at Bayer.

• Smart Biomanufacturing & Digitalization

Alexandria is an engineer in the Cell Culture Development group at Biogen in Cambridge, MA. Her experience includes process development, cell culture, and continuous perfusion. She received a bachelor's degree in both Chemical Engineering and Biochemistry/Molecular Biology from the University of Massachusetts Amherst.

• Intensified & Continuous Processing

Jacob Trotta received his B.S. in Chemistry from Villanova University in 2014. Throughout his time as an undergraduate, Jacob worked as an intern at Alkermes, Inc. during summer and winter breaks, where he studied the crystal form diversity of pharmaceutically relevant small molecules. After completing his undergraduate work, Jacob joined the Fors Research Group in the Cornell University Department of Chemistry and Chemical Biology, where he studied the synthesis and polymerization of renewable polymers derived from itaconic acid. After receiving his PhD in organic and polymer chemistry in 2019, Jacob returned to Alkermes, Inc. full time, where he has worked in the Analytical Development department on method development and validation of analytical methods for both small and large molecules.

• Accelerating Analytical Development

Dr. Undey heads up the Pharmaceutical Technical Development (PTD) Data & Digital organization in Roche/Genentech. He is responsible for strategizing, architecting and delivering major digital and data programs and solutions for both PTD and Pharma Technical Cell & Gene Therapy Development and Manufacturing to accelerate speed to patient and increase productivity during drug development and advancement. Prior to his current role, he led the Operations Digital Strategy and Capabilities Advanced Analytics team at Amgen. His group helped improve end-to-end Operations for Reliability, Efficiency, Agility and Differentiation harnessing the power of digital capabilities including Industry 4.0, machine learning, statistical learning and digital twins. Dr. Undey and his team’s work were externally recognized receiving CIO100 Award in Life Sciences in 2013 for Amgen implementing advanced data analytical solutions. He has co-authored and co-edited two books, published in scientific journals and books in the areas of process systems engineering, PAT, artificial intelligence, process monitoring, control, supervision, biotechnology and bioengineering. He has received his B.Sc., M.Sc. and Ph.D. degrees all in Chemical Engineering from Istanbul University, Turkey. He also holds an Executive MBA degree from the University of California, Los Angeles, Anderson School of Management. Dr. Undey is based in the South San Francisco, CA, USA.

• Smart Biomanufacturing & Digitalization

Sudhakar Voruganti received his doctorate in Biochemistry and Molecular Biology from OSU, Stillwater. Since May 2022 Dr. Voruganti is working as Director of Business Development for US East Coast at Pfanstiehl, the world’s leading manufacturer of low endotoxin and high purity GMP parenteral grade carbohydrate based excipients, providing commercial and technical support to customer base in the territory. Dr. Voruganti has over 15 years of experience in bio-pharmaceutical industry.

• Formulation and Delivery of High-Concentration Proteins and New Modalities

George Van Den Driessche joined Biogen in 2019 as a member of the Strategic Analytics team within the Analytical Development department. Strategic Analytics is implementing solutions to automate laboratory workflows through a combination of robotic and data science platforms. George is leading lab instrument data capture initiatives that leverage a combination of technologies to convert and store raw instrument data into a standardized format leveraging cloud platforms that can be used in downstream analytics and machine learning applications. George received his PhD in chemistry from North Carolina State University in May 2019.

• Accelerating Analytical Development

Phil is responsible for technical due diligence and evaluation of potential investments, as well as guiding operational, R&D and strategic initiatives carried out at portfolio companies. An entrepreneurial and strategic international business leader, Phil joins Gamma from GE Healthcare’s Cell and Gene Therapy business unit where he directed strategy and portfolio growth. Phil received his Ph.D. in Biochemistry and Molecular Biology at Georgetown University Medical Center followed by an IRTA fellowship at the National Cancer Institute in Maryland, and at the Hollings Cancer Center in Charleston, SC. Phil was an instructor for Johns Hopkins University Advanced Academic Programs teaching Biotechnology Marketing in the Masters of Biotechnology / MBA program, and has held leadership positions in a number of life sciences companies including Life Technologies, Becton Dickinson, and Lonza. Phil is a Board Member of CCRM in Toronto Canada and a Board Member of the ARM Foundation.

• Bioprocessing Tech: Venture, Innovation, and Partnering Conference

Murali has a deep passion for transforming Science, Technology and Medicine at scale to impact patient lives. Murali joined Danaher (NYSE: DHR) in 2019, a global Science and Technology leader with $32.5 Billion in revenue and >$200 Billion market cap, operating companies including Beckman Coulter, Leica Micro- and Biosystems, IDT, Sciex, Aldevron, Cytiva and more. As Head of Danaher Ventures, Murali leads Danaher’s strategy and investments across healthcare and is responsible for an active portfolio of over 40 companies valued at >$11 Billion. Murali serves as a Board Director for more than five companies and has joint responsibilities across Mergers & Acquisitions, including the ~$10 Billion acquisition of Aldevron. Prior to joining Danaher, Murali was Director of Business Development at Lam Research (NASDAQ: LRCX), a leader in Semiconductor manufacturing tools and responsible for Lam’s strategy and investments in Life Sciences. Murali had previously spent ~7 years at Illumina (NASDAQ: ILMN) as a Scientist, Inventor and Senior Manager, across Advanced Research, Technology Development and Product Development, leading technology teams that enabled the $1000 and $100 genomes. These products have generated over $4B in revenue for Illumina. Murali holds a Ph.D. in Electrical & Computer Engineering from the University of Illinois at Urbana-Champaign and is a graduate of the Stanford Executive Program. He is an inventor on 20 patents and has published in various scientific journals including Nature Nanotechnology, Nature Scientific Reports, Advanced Materials and Lab on Chip with over 3000 citations. Murali also holds Bachelor of Science and Bachelor of Engineering degrees in Pure Mathematics, Computer Science and Electrical Engineering from University of Western Australia.

• Bioprocessing Tech: Venture, Innovation, and Partnering Conference

Stacey Veysey is a business-oriented Talent Acquisition Leader with 22+ years progressive experience in the Biotechnology, Investment, IT Consulting and Healthcare industries with a track record of driving business and talent objectives. Stacey joined Vertex Pharmaceuticals in May 2020 leading Talent Acquisition for Research; and Cell & Genetic Therapies-which has more than tripled in size since she joined the organization. As Vertex continues to invest over 70% of revenue in R&D, driving scientific innovation to create transformative medicines for people with serious diseases, the Talent Acquisition team within Stacey’s remit is working to build our expertise in the areas of: cell biology and biomanufacturing, cell therapy delivery and device, hemoglobinopathies, AAV, gene therapy vectors and Duchenne muscular dystrophy research- across research sites in Boston, Cambridge and Providence, R.I. Before joining Vertex, Stacey spent the prior 14 years spanning both large and small bio-tech companies. On a personal note, Stacey lives outside of Boston with her husband and three children in a lively household where she enjoys personal time to run, bike and enjoy the beaches and nature in and around New England.

• W1: Talent Acquisition and Retention Strategies for Biopharma

Raj has more than 13 years of experience in drug substance process development, scale-up, tech transfer, and cGMP clinical manufacturing of therapeutic recombinant proteins. He has successfully completed both early and late phase development activities, including scale-down model qualification, viral clearance validation, process characterization, and optimization by applying QbD principles to develop a robust downstream process. He has authored several regulatory sections, enabling successful phase-appropriate regulatory submissions. He is always interested in exploring cutting-edge technologies and implementing them to improve process efficiency and process economics.

• Advances in Purification & Recovery

Peter Walters is a Fellow of Advanced Therapies at CRB with 20 years of experience specializing in pharmaceutical process and facility design. He has a deep technical background designing equipment and processes for multi-process facilities predicated on maximum flexibility, logistics optimization and technologies that reduce costs while allowing for pipeline expandability and higher quality therapeutics. In addition to leading projects, Peter is responsible for CRB’s companywide strategy and growth in the cell and gene therapy market.

• Cell Therapy Manufacturing

Shaoying Wang is a senior scientist in process development department at Passage Bio. He received his Ph.D. in pharmaceutical Science from the University of Kentucky, and has extensive experience in virus packaging, process development and protein engineering. His work has resulted in over 20 peer-reviewed journal articles and more than 10 patents.

• Gene Therapy Manufacturing

Dr. Warren has 28 years of experience in the development, manufacturing, and commercialization of gene therapy viral vectors and live viral vaccines, with applied focus on bioprocess development and CMC Development Strategy. At Ultragenyx, he leads a team of 86 scientists and engineers, responsible for all early- and late-stage Process and Analytical Development of AAV portfolio products as well as Pilot Scale Manufacturing in Woburn, MA. Before coming to Ultragenyx Jim held senior CMC leadership positions at Homology Medicines, bluebird bio, Shire, and Merck & Co., leading process development and manufacturing teams responsible for development of several clinical candidates as well as the licensure of RotaTeq®, Varivax®, ProQuad®, and Zostavax®. Dr. Warren holds BS/MS degrees in Biotechnology from William Paterson University and a PhD in Molecular and Cellular Biology from Lehigh University.

• Gene Therapy Manufacturing

Ron Weiss is Professor in the Department of Biological Engineering and in the Department of Electrical Engineering and Computer Science at the Massachusetts Institute of Technology, and is the Director of the Synthetic Biology Center at MIT. Professor Weiss is one of the pioneers of synthetic biology. He has been engaged in synthetic biology research since 1996 when he was a graduate student at MIT and where he helped set up a wet-lab in the Electrical Engineering and Computer Science Department. After completion of his PhD, Weiss joined the faculty at Princeton University, and then returned to MIT in 2009 to take on a faculty position in the Department of Biological Engineering and the Department of Electrical Engineering and Computer Science. The research pursued by Weiss since those early days has placed him in a position of leadership in the field, as evidenced both by publications from his lab as well as a variety of awards and other forms of recognition. He pursued several aspects of synthetic biology, including synthesis of gene networks engineered to perform in vivo analog and digital logic computation. The Weiss lab also published seminal papers in synthetic biology focused on programming cell aggregates to perform coordinated tasks using engineered cell-cell communication with chemical diffusion mechanisms such as quorum sensing. Several of these manuscripts were featured in a recent Nature special collection of a select number of synthetic biology papers reflecting on the first 10 years of synthetic biology. While work in the Weiss lab began mostly with prokaryotes, during the last 5 years a majority of the research in the lab shifted to mammalian synthetic biology. The lab focuses both on foundational research, e.g., creating general methods to improve our ability to engineering biological systems, as well as pursuing specific health related applications where synthetic biology provides unique capabilities.http://groups.csail.mit.edu/synbio/

• mRNA-Based Therapies

I studied for an integrated Master's (MChem) in Biological Chemistry at the University of Sheffield (2010-2014). Following this, I joined the University of Leeds for my PhD in Molecular Biophysics (2014-2018), supervised by Profs David Brockwell, Nik Kapur, and Alison Ashcroft. I was funded by the EPSRC Centre for Doctoral Training in Innovative Manufacturing in Emergent Macromolecular Therapies. I commenced my postdoctoral research in October 2018, funded by an EPSRC Doctoral Prize Fellowship, together with collaborations with industrial partners in both the UK and the USA. I am currently supervised by Profs David Brockwell, Nik Kapur, and Sheena Radford.

• Rapid Methods to Assess Stability and Impurities in Biologics

No bio available.

• Gene Therapy CMC and Analytics

Cong Wu is a Principal Scientist in the Department of Biochemical and Cellular Pharmacology at Genentech Research and Early Development (gRED). He joined gRED in 2018 and has been working on the development and implementation of various bioanalytical assays to understand the in vivo pharmacology (PK/PD/biotransformation/biodistribution) of novel large molecule modalities in a preclinical setting. He obtained his PhD in Biochemistry from University of Illinois at Urbana-Champaign in 2013 and worked at Dow AgroSciences (now Corteva) and Amgen prior to joining Genentech.

• Rapid Methods to Assess Stability and Impurities in Biologics

Zhijie Wu is a Principal Scientist at Regeneron Pharmaceuticals, Inc. He completed his doctoral degree in chemical biology under the supervision of Professor Ying Ge at University of Wisconsin - Madison, where he developed analytical techniques and software tools for intact protein characterization and quantification. At Regeneron, he focuses on developing LC-MS and CE-MS based analytical methods to support development of monoclonal antibody, bispecific antibody, as well as other new modality biotherapeutic drug candidates such as adeno-associated viruses.

• Rapid Methods to Assess Stability and Impurities in Biologics

Senior Staff Scientist, Regeneron Pharmaceuticals, Inc.

• Host Cell Proteins

Gang Xiao, a senior scientist at Amgen Process Development, who joined Amgen in 2005, and has worked on characterization of the attributes (including HCPs) of biopharmaceuticals, their degradation pathways, process control and impact on efficacy and safety, to support all phases of the product process development from early molecule assessment to product manufacturing and releasing. In this presentation, he describes his work on the optimization of HCP analysis by 1D nano LC-MS.

• Host Cell Proteins

Jimmy Xin is an accomplished scientist with extensive experience in the cell and gene therapy field. Currently, he works as a scientist in vector process development at ElevateBio, where he develops, scales, and transfer processes for the production and purification of viral vectors, with a focus on AAV and LVV vector development. He also played an instrumental role in the development of ElevateBio’s LentiPeak™ platform process for manufacturing of lentiviral vector material. Prior to his role at ElevateBio, Jimmy worked in the downstream process characterization group at bluebird bio, where he compiled and analyzed the data for bluebird bio’s first commercial product, Zynteglo™, as well as supported the development and tech transfer activities for additional commercial products: Abecma™ and Skysona™. Jimmy has demonstrated expertise in the technical aspects of downstream purification, including depth, tangential flow, and nano-filtration, as well as other purification techniques like nuclease treatment, chromatography (Affinity, AEX, CEX, HIC), and final formulation. He is also knowledgeable in late-stage process development and characterization activities for developing a path forward to Process Performance Qualification (PPQ) and filing of commercial processes. He holds a B.S. in chemical engineering from the University of Florida, where he served as both a research assistant and undergraduate assistant in various biophysical laboratories.

• Cell Therapy CMC and Analytics

Wei Xue is Sr. Scientist at Ultragenyx Pharmaceuticals, focusing on early stage modified-batch process development and IND-enabling activities. Before Ultragenyx, he worked at Regeneron Pharmaceuticals as a Sr. Process Scientist for 5 years, leading efforts on process understanding, investigation and raw material identification activities to support Upstream Manufacturing. He earned his Ph.D in Chemical Engineering at the Ohio State University.

• Gene Therapy Manufacturing

Dr. Yan heads Beam Therapeutics' Attribute Sciences team, developing cutting-edge characterization and bioanalytical assays for various molecules. His work supports research, development, and GMP release of ex vivo and in vivo base editing drug substances and drug products. He has 50+ peer-reviewed papers, a Peking University B.S., and a UMass Amherst Ph.D.

• Cell Therapy CMC and Analytics

Shu Yang is a Senior Scientist at Pfizer working on developing AI solutions for smart manufacturing of pharmaceutical and biopharmaceuticals. Prior to joining Pfizer, he was a research intern in IBM Thomas J Watson Research Center studying advanced AI-based decision optimization algorithms. His research focuses on developing hybrid models that combines mechanistic knowledge with AI, as well as developing AI-based decision making models that are robust for smart manufacturing applications. Shu received his Ph.D. degree in Chemical Engineering from Rensselaer Polytechnic Institute in 2022.

• Smart Biomanufacturing & Digitalization

Christopher Yehl is a Process Development Scientist in the Research and Technology group at Spark Therapeutics. His expertise is in tangential flow filtration unit operations. Chris received his PhD in Chemical Engineering in just under three and half years from Pennsylvania State University. He worked in Dr. Andrew Zydney’s group where his focus was on single-use, single-pass downstream processing and innovate strategies for ultrafiltration and buffer exchange of high value biotherapeutics. Some highlights include 6 peer reviewed papers, a pending patent, and an awarding of a graduate fellowship for individuals focused on innovation and entrepreneurship. Chris is interested in exploring innovative downstream unit operations and hopes that the industry will evolve into utilizing a fully continuous dynamic system for downstream purifications in the future.

• Intensified & Continuous Processing

Dr. Bojiao Yin is the Director of Viral Process Development at ElevateBio BaseCamp. She has > 12 years of post-doctoral experience working on process development, at the academic and industry settings. She led multiple platform developments for broad therapeutics, including large molecules, Lenti- and Adeno-associated viral vectors, nucleic acids, as well as vaccine development. With the combined background in both biology and chemical engineering, she helped to build up processes in small to big pharmaceutical companies. Currently, she is focusing on both upstream and downstream development of Lenti and AAV and pursuing innovative technologies for next-generation platforms. Prior to ElevateBio, she worked at Amgen, where she supported a broad range of projects for drug development. Prior to Amgen, Bojiao did her postdoctoral fellowship in Dr. Michael J. Betenbaugh's lab at Johns Hopkins University, where she focused on cell line development, process development, metabolic engineering, and media development.

• Gene Therapy Manufacturing

Helen manages the Synthetic and Mammalian Upstream team at CPI Biologics, that is responsible for delivery of a range of collaborative and commercial projects. These encompass a diverse range of product types including monoclonal antibodies, viral vectors and nucleic acids expressed in mammalian and/or cell-free systems. Helen specialises in development and optimisation of processes, and associated molecular methods, for production of AAV gene therapies. This includes high throughput process development, design of experiment approaches to process optimisation and up to 200L scale production. Prior to joining CPI in 2017, Helen worked as a post-doctoral researcher at the University of Manchester using mammalian cell culture and in vivo models to study the inflammatory microenvironment in tumours. Helen holds a PhD in Molecular Cancer Studies from the University of Manchester.

• Cell Line Development & Cell Culture Optimization

Kevin has over 20 years of broad experience in Biologics CMC, and Strategic and Technical Operations. Prior to joining AnaptysBio, he held various positions in biologics CMC disciplines at Allergan, AstraZeneca, Becton Dickinson, and Catalent Biopharma Solutions. In addition to developing therapeutic biological products in-house, Kevin also had extensive experience working with external contract manufacturing organizations (CMO) and contract research organizations (CRO), including production cell line development, bioprocess development, DS/DP cGMP manufacturing, process characterization, process performance qualification (PPQ), formulation development by DoE, analytical procedure development and method validation, reference standard qualification, extended characterization, and CMC analytical comparability.

• Rapid Methods to Assess Stability and Impurities in Biologics
• TS5: Introduction to CMC for Biotech, Cell & Gene Therapy Products

Dr. Wei Zhang is a molecular biologist specializing in method development using next generation sequencing technology. She has hands-on experience in NGS library prep automation and major NGS platforms such as Oxford Nanopore and Illumina. She received her PhD in biochemistry and molecular biology from China Agricultural University, China. She published scientific articles in reputed international journals like eLife, Am J Trop Med Hyg etc. on using NGS technology for diagnostic testing. Dr. Zhang is currently working on characterization of various biopharmaceutical candidates including viral vectors for gene therapy, and cell lines in the field of genomic medicine using next generation sequencing (NGS) technology at Sanofi US.

• Gene Therapy CMC and Analytics

Dr. Zhang works in Analytical Development to support Biogen’s gene therapy portfolio and has an expertise in mass spectrometry. Prior to joining Biogen, Dr. Zhang spent 8 years at BioAnalytix (now Protagene), where she led the characterization of biologics and gene therapy products using LC-MS. Dr. Zhang received her PhD in Analytical Chemistry from Northeastern University at the Barnett Institute.

• Host Cell Proteins

Major in Pharmaceutical Sciences. Extended experience in spectroscopy, process control, and chemometrics. Currently working on application of process analytical technology for bioprocess.

• Intensified & Continuous Processing

Xi Zhao is a senior scientist from sterile and specialty product group, MRL, Merck & Co. At Merck, her responsibility covers biological combination products development spanning from early phase readiness to commercialization. Other than pipeline development, Xi is interested in fundamental understanding on high concentration formulation development as well as subcutaneous injection technologies to enable high-dose subcutaneous administration.

• Formulation and Delivery of High-Concentration Proteins and New Modalities

Ms. Zheng is a biotechnology industry veteran who brings more than 25 years of experience in biotechnology operations across multiple geographies to Landmark Bio. Ms. Zheng most recently served as Chief Technical Officer at Orchard Therapeutics, a commercial-stage global gene therapy company specializing in HSC based gene therapies. In this role, Ms. Zheng established the technical operations function and manufacturing network, and advanced the company’s product pipeline, including the approval of Libmeldy™ - the first gene therapy product for metachromatic leukodystrophy. Ms. Zheng has also held leadership positions at several major biotechnology companies including Genzyme (now Sanofi) and Amgen. At Amgen, Ms. Zheng played a key role in building differentiating capabilities in manufacturing for clinical supply and commercial product launch to enable speed to clinic and speed to market strategies for Amgen’s innovative products.

• Accelerating Analytical Development
• Bioprocessing Tech: Venture, Innovation, and Partnering Conference
• Cell Therapy Manufacturing
• Advances in Purification & Recovery
• Gene Therapy Manufacturing
• mRNA-Based Therapies
• Formulation and Delivery of High-Concentration Proteins and New Modalities
• Smart Biomanufacturing & Digitalization

Professor Zhou’s laboratory applies protein chemistry, analysis and engineering to biology and medicine. One program is “Hybrid Modality Engineering of Proteins”-a platform to introduce non-canonical chemical moieties and/or scaffolds into peptides and proteins to confer novel functions otherwise unavailable, such as photomedicine. The second is to devise chemo-enzymatic methodologies to characterize protein modifications, such as crosslinking, isoaspartic acid formation (asparagine deamidation) and methylations. In collaboration with biologists and clinicians alike, we also investigate their biological effects, and moreover, as critical attributes in protein pharmaceuticals. Over the past decade, Professor Zhou has been actively collaborating and consulting with biotech and pharm companies on biotherapeutics, enzymes and protein chemistry. These collaborations have led to the elucidation of product and process-related modifications (many of which were previously unknown). He also developed and now teaches a new advanced course entitled “Chemistry and Design of Protein Pharmaceuticals,” as well as workshops on antibody-drug conjugates (ADC), and training courses for scientists from industry, academia, and regulatory agencies in the US, China, and APEC economies.

• Rapid Methods to Assess Stability and Impurities in Biologics

Laura has been a Senior Scientist as part of Pfizer’s Bioprocessing R&D Cell Line Development team since 2021. Since her time at Pfizer, Laura has focused on optimizing Pfizer’s stable CHO cell expression system for the robust production of recombinant protein therapeutics as well as portfolio work in the recombinant protein space. A native of upstate New York, Laura received her BS in Biomolecular Science from Clarkson University in 2013 and completed her PhD in Chemistry at Binghamton University in 2021. Laura enjoys playing volleyball and tennis as well as painting and drawing in her free time.

• Cell Line Development & Cell Culture Optimization

Started my career focused on increasing process robustness and product uniformity at a small tissue engineering company that developed acellular blood vessels to treat cardiovascular disease and trauma patients. Now my career centers on process development and optimization in the cell therapy and immuno-oncology field, working on increasing cell yield and purity to provide quality cancer-fighting iT-cells.

• Advances in Purification & Recovery

Dr. van der Loo has been involved in early phase GMP viral vector manufacturing since 2002. He is the Director of the the Clinical Vector Core at the Children’s Hospital of Philadelphia (CHOP). The Clinical Vector Core has manufactured AAV and lentiviral vectors for 18 years in support of phase 1, 2 and 3 clinical trials in 10 countries. His expertise includes upstream and downstream process development and manufacturing of pre-clinical and clinical grade vectors on several viral vector platforms, including gamma-retrovirus, lentivirus and AAV. Dr. van der Loo is a member of the Editorial Board of Molecular Therapy - Methods & Clinical Development. He is also a member of the 4Bio Ventures Management Advisory Board and serves as consultant in several capacities.

• Gene Therapy Manufacturing