Key Sessions
Sarfaraz Niazi, PhD
PLENARY KEYNOTE: Biosimilars: From Therapeutic Proteins to Gene Therapies--a Novel Perspective for Affordable Medicines
UIC College of Pharmacy
Jack Prior
PLENARY KEYNOTE: Are We Here Yet? A Digital Maturity Model for Enabling Process Monitoring and Artificial Intelligence in Biologics Manufacturing
Sanofi
Sarwat Khattak
KEYNOTE: AI/ML in Upstream PD: “Show Me The Run” Case Studies
Biogen
Phillip Ramsey
Keynote Panel Discussion: Strategies for Scaling Up, Accelerating and Commercializing Gene Therapy Manufacturing
Sangamo Therapeutics
Thursday 24th September - Main Conference Day Two - ET (Eastern Time, GMT-05:00)
Thursday 24th September - Main Conference Day Two
- ET (Eastern Time, GMT-05:00)
7:30am - 8:50am80 mins
Registration Break
Registration and Morning Coffee
8:50am - 9:00am10 mins
BPI Plenary Keynote
Welcome to BWB Day 2 / Chairperson’s Opening Remarks
8:50am - 9:00am10 mins
Development of Emerging Cell & Gene Therapies
Chairperson’s Opening Remarks: Development of Emerging Cell & Gene Therapies
8:50am - 9:00am10 mins
Cell Therapy Manufacturing & Analytics
Chairperson’s Opening Remarks: Cell Therapy Manufacturing & Analytics
- Amy Shaw - Head of Process and Product Development, Takeda
8:50am - 9:00am10 mins
Gene Therapy Manufacturing & Analytics
Chairperson’s Opening Remarks: Gene Therapy Manufacturing & Analytics
9:00am - 9:45am45 mins
BPI Plenary Keynote
PLENARY KEYNOTE: Biosimilars: From Therapeutic Proteins to Gene Therapies--a Novel Perspective for Affordable Medicines
- Sarfaraz Niazi, PhD - Adjunct Professor, Department of Biopharmaceutical Sciences, UIC College of Pharmacy
9:00am - 9:30am30 mins
Development of Emerging Cell & Gene Therapies
Keynote: In Vivo CAR-T Therapies Product Development and Clinical Advances
- Hari Pujar, PhD - Chief Operating Officer, Tessera Therapeutics
9:00am - 10:00am60 mins
Cell Therapy Manufacturing & Analytics
Keynote Panel Discussion: Scaling Cell Therapies- Lessons from Pioneers for Smarter, Faster, and More Affordable Ex Vivo Cell Therapy Manufacturing
- Arvind Natarajan - Senior Vice President, Technical Development, Iovance Biotherapeutics
9:00am - 10:00am60 mins
Gene Therapy Manufacturing & Analytics
Keynote Panel Discussion: Strategies for Scaling Up, Accelerating and Commercializing Gene Therapy Manufacturing
- Phillip Ramsey - CTO, SVP Technical Operations, Sangamo Therapeutics
- Kumar Dhanasekharan, PhD - President and CEO, Gokyo Biosciences Inc.
- Craig Malzahn - EVP, Product Development and Chief Technology Officer, Regenxbio
- Jared Simons - VP, Manufacturing, Solid Biosciences Inc.
- Keenan Bashour - VP, Manufacturing & Process Development, 4D Molecular Therapeutics
9:30am - 10:00am30 mins
Development of Emerging Cell & Gene Therapies
Revolutionizing In Vivo Delivery: Overcoming Challenges and Advancing Therapeutic Impact
9:45am - 10:30am45 mins
BPI Plenary Keynote
PLENARY KEYNOTE: Are We Here Yet? A Digital Maturity Model for Enabling Process Monitoring and Artificial Intelligence in Biologics Manufacturing
- Jack Prior - Head of Process Monitoring & Data Science/AI Strategy, Sanofi
10:00am - 10:30am30 mins
Development of Emerging Cell & Gene Therapies
Panel Discussion: Scale-Up Strategies: Navigating the Road Ahead for In Vivo CAR-T
- Christopher Bravery - Consulting Regulatory Scientist, Advbiols
10:00am - 10:30am30 mins
Cell Therapy Manufacturing & Analytics
Building Toward Commercial Readiness: How Comparability and Process Improvements Enable Scalable and Robust TCR-T Manufacturing?
- Elisaveta Todorova - Associate Director, Process Development and Technology Innovation, TScan Therapeutics
10:00am - 10:30am30 mins
Gene Therapy Manufacturing & Analytics
Building an AAV Production Strategy Utilizing Stable Producer Cell Lines for Scalable, Gene Therapy Manufacturing
- Ryan Schweller - Associate Director, Process Development, AskBio Inc.
10:30am - 11:30am60 mins
Break
Morning Break in Exhibit Hall
11:30am - 12:00pm30 mins
Cell Line Development & Engineering
Metabolic engineering of CHO cells towards cysteine prototrophy and systems analysis of the ensuing phenotype
- Laura Greenfield - Senior Scientist, Pfizer
11:30am - 12:00pm30 mins
Cell Culture & Upstream Processing
KEYNOTE: AI/ML in Upstream PD: “Show Me The Run” Case Studies
- Sarwat Khattak - Head of Cell Culture & Cell Line Development, Biogen
11:30am - 12:00pm30 mins
Downstream Processing
Tech Transfer Challenges in Downstream Biologics Manufacturing: Ensuring Process Robustness
- Laura Orella - Director of R & D, Sunflower Therapeutics
11:30am - 12:00pm30 mins
Digital Biomanufacturing and Data Driven Operations
Leveraging AI/ML For GMP Processes
- Alexa Kopf - Manager, BDO USA
11:30am - 12:00pm30 mins
CMC Strategy & Manufacturing Performance
From Fed-Batch to Continuous: Unlocking Efficiency and Scalability in Biomanufacturing
11:30am - 12:00pm30 mins
Development of Emerging Cell & Gene Therapies
Optimizing LNP Delivery and Non-Viral Vector Manufacturing as Scalable, Redosable Alternatives to Viral Vectors
- Ratnesh Joshi - Associate Director, Downstream Process Development, Editas Medicine
11:30am - 12:00pm30 mins
Cell Therapy Manufacturing & Analytics
Process Development to Commercial Scale: Overcoming Manufacturing Bottlenecks in Next-Generation Allogenic Cell Therapies
- Nafees Rahman - Senior Director, Process Development, Nkarta, Inc.
11:30am - 12:00pm30 mins
Gene Therapy Manufacturing & Analytics
Cell Culture Advances in Recombinant AAV Manufacturing for Gene Therapy Leveraging Systems Biology and Modelling
- Madhuresh Sumit - Associate Director, Genomic Medicine CMC, Sanofi
12:00pm - 12:30pm30 mins
Cell Line Development & Engineering
KEYNOTE: AI-Driven Cell Line Development Beyond Conception: Digitalization, Prediction & Data-Enabled Decisions
- Nathan Lewis - Professor, Co-Founder, University of Georgia, NeuImmune
12:00pm - 12:30pm30 mins
Cell Culture & Upstream Processing
Modelling diversion strategies with integrated dynamic continuous processes
- Ken Lee - Director, AstraZeneca
12:00pm - 12:30pm30 mins
Downstream Processing
Accelerating IND & BLA Timelines with Downstream Strategies
- Valerie Cusick - Director, Regeneron
12:00pm - 12:30pm30 mins
Digital Biomanufacturing and Data Driven Operations
Digital Twins in Action: De-Risking Scale-Up, Accelerating CMC, and Enabling Smarter Biomanufacturing
- Mark Duerkop - Chief Executive Officer, Novasign
- Matthias Müllner - CEO, bespark*bio
12:00pm - 12:30pm30 mins
CMC Strategy & Manufacturing Performance
Complexity and Strategies of Developing Bispecific Antibody Products - from Design to Clinics
- Yun Bai - Executive Vice President of CMC, Santa Ana Bio
12:00pm - 12:30pm30 mins
Development of Emerging Cell & Gene Therapies
Novel Delivery Approaches: Beyond the Liver
12:00pm - 12:30pm30 mins
Cell Therapy Manufacturing & Analytics
Modular Process Development of HSC-derived CAR-NK Cell Therapies
- Rui Tostoes - CTO, ImmuneBridge
12:00pm - 12:30pm30 mins
Gene Therapy Manufacturing & Analytics
Expanding the Upstream Toolbox: Enabling High Productivity, Robust, and Scalable AAV Production
- Sha Sha - Senior Scientist, Ultragenyx
12:30pm - 1:00pm30 mins
Cell Line Development & Engineering
Sponsored Presentation
12:30pm - 1:00pm30 mins
Cell Culture & Upstream Processing
Sponsored Scientific Presentation
12:30pm - 1:00pm30 mins
Downstream Processing
Sponsored Presentation
12:30pm - 1:00pm30 mins
Digital Biomanufacturing and Data Driven Operations
Sponsored Presentation:
12:30pm - 1:00pm30 mins
CMC Strategy & Manufacturing Performance
Sponsored Presentation
12:30pm - 1:00pm30 mins
Development of Emerging Cell & Gene Therapies
Sponsored Scientific Track Presentation: Revolutionizing Targeted Delivery: Emerging Technologies to Enhance Precision & Minimize Off-Target Effects
12:30pm - 1:00pm30 mins
Cell Therapy Manufacturing & Analytics
Sponsored Scientific Track Presentation
12:30pm - 1:00pm30 mins
Gene Therapy Manufacturing & Analytics
Sponsored Scientific Track Presentation
1:00pm - 2:10pm70 mins
Break
Lunch Networking
2:10pm - 2:15pm5 mins
Cell Line Development & Engineering
Chairperson's Remarks
2:10pm - 2:15pm5 mins
Cell Culture & Upstream Processing
Chairperson's Remarks
2:10pm - 2:15pm5 mins
Downstream Processing
Chairperson's Remarks
2:10pm - 2:15pm5 mins
Digital Biomanufacturing and Data Driven Operations
Chairperson's Remarks
2:10pm - 2:15pm5 mins
CMC Strategy & Manufacturing Performance
Chairperson's Remarks
2:10pm - 2:15pm5 mins
Emerging Therapies
Chairperson’s Opening Remarks: Development of Emerging Cell & Gene Therapies
2:10pm - 2:15pm5 mins
Cell Therapy
Chairperson’s Opening Remarks: Cell Therapy Manufacturing & Analytics
2:10pm - 2:15pm5 mins
Gene Therapy
Chairperson’s Opening Remarks: Gene Therapy Manufacturing & Analytics
2:15pm - 2:45pm30 mins
Cell Line Development & Engineering
Expression System & Integration Technology Choices
- Dong Seong Cho - Technical Development Associate Scientist, Genentech
2:15pm - 2:45pm30 mins
Cell Culture & Upstream Processing
Enabling Sample-Free Bioreactor Operation Through Raman-Based pH Monitoring
- Alyssa Melville - Engineer, Cell Culture Development, Biogen (USA)
2:15pm - 2:45pm30 mins
Downstream Processing
Current Insights and Future Directions for Host Cell Protein Challenges in Antibody Manufacturing
- Younghoon Oh - Senior Scientist, J&J Innovative Medicine
2:15pm - 2:45pm30 mins
Digital Biomanufacturing and Data Driven Operations
The Reality of Real-Time Release: What’s Achievable Today
- Preeya Boppana - Director Manufacturing Science & Technology, AstraZeneca
2:15pm - 2:45pm30 mins
CMC Strategy & Manufacturing Performance
Biomanufacturing Initiative - CMC Strategy & Manufacturing Performance
- Laura Pierce - Biomedical Engineer, NIST
2:15pm - 2:45pm30 mins
Emerging Therapies
Moving Gene Editing Beyond the Liver
- Devyn M. Smith - Chief Executive Officer, Arbor Biotechnologies
2:15pm - 2:45pm30 mins
Cell Therapy
Closing the Loop: Practical Steps for Implementing Closed Systems
2:15pm - 2:45pm30 mins
Gene Therapy
Process Intensification for Affinity Capture of AAV Gene Therapies
- Lukas Maloney - Process Development Engineer I, Regeneron
2:45pm - 3:15pm30 mins
Cell Line Development & Engineering
Leveraging Transposase-Based Expression Systems for Complex Biologics Quality
- Mark Blenner - Professor, University of Delaware
2:45pm - 3:15pm30 mins
Cell Culture & Upstream Processing
Raman Case Studies (Not Theory): What Worked, What Failed and What Got Filed
- Gayatri Dhara - Principal Scientist, Pfizer
2:45pm - 3:15pm30 mins
Downstream Processing
Project Lexy: A Context-Driven Data Mapping Framework for Downstream Process Development
- Benjamin Borow - Associate Scientist, Bristol-Myers Squibb
2:45pm - 3:15pm30 mins
Digital Biomanufacturing and Data Driven Operations
Digital Twins for Biologics: Where Are We Actually Seeing Impact?
- Christoph Herwig - Senior Scientific Advisor, Körber Pharma Austria GmbH, Austria
2:45pm - 3:15pm30 mins
CMC Strategy & Manufacturing Performance
KEYNOTE: CMC Strategies for Regulatory Success and Platform Optimization
- Rashmi Korke-Kshirsager - Bioprocessing Expert, .
2:45pm - 3:15pm30 mins
Emerging Therapies
Harnessing AI and Machine Learning for the Future of Cell & Gene Therapy Development
2:45pm - 3:15pm30 mins
Cell Therapy
Automated Closed-System Expansion of Pluripotent Stem Cells: Enhancing Process Consistency and Reproducibility for Cell Therapy Manufacturing
- Sheila Sharifzad - Process Development Scientist - Cell Therapy, Bayer
2:45pm - 3:15pm30 mins
Gene Therapy
Development of Membrane Processes for Continuous Purification of Adeno-associated Virus for Gene Therapies
- Andrew Zydney, Ph.D. - Bayard D. Kunkle Chair, Chemical Engineering, Penn State University
3:15pm - 3:45pm30 mins
Cell Line Development & Engineering
Sponsored Presentation
3:15pm - 3:45pm30 mins
Cell Culture & Upstream Processing
Sponsored Scientific Presentation
3:15pm - 3:45pm30 mins
Downstream Processing
Sponsored Presentation
3:15pm - 3:45pm30 mins
Digital Biomanufacturing and Data Driven Operations
Sponsored Presentation
3:15pm - 3:45pm30 mins
CMC Strategy & Manufacturing Performance
Sponsored Presentation
3:15pm - 3:45pm30 mins
Emerging Therapies
Sponsored Scientific Track Presentation
3:15pm - 3:45pm30 mins
Cell Therapy
Sponsored Scientific Track Presentation
3:15pm - 3:45pm30 mins
Gene Therapy
Sponsored Scientific Track Presentation
3:45pm - 4:30pm45 mins
Break
Afternoon Break
4:30pm - 5:00pm30 mins
Cell Line Development & Engineering
Fast Tracking CHO Cell Line Development Using Integrated Engineering Strategies
- Jacqualyn Schulman, Ph.D. - Principal Scientist, Cell Line Development & ‘Omics Biologics Development, Bristol-Myers Squibb
4:30pm - 5:00pm30 mins
Cell Culture & Upstream Processing
AI-assisted foam control in benchtop bioreactors
- Allison Tang - Senior Scientist, Merck
4:30pm - 5:00pm30 mins
Downstream Processing
Fireside Chat: Innovative Approaches to Impurity Removal in Complex Biologics
4:30pm - 5:00pm30 mins
Digital Biomanufacturing and Data Driven Operations
AI in Action: Accelerating Upstream Development with Predictive Insights
- Lenora Dieyi - Modeling & Simulation Engineer - Investigator, Drug Product Development, GSK
4:30pm - 5:00pm30 mins
CMC Strategy & Manufacturing Performance
Impact of freezing process parameters on crystallization of Poloxamer 188 in a lyophilized drug product formulation
- Xiaofeng Lu - Principal Scientist, AbbVie
4:30pm - 5:30pm60 mins
Development of Emerging Cell & Gene Therapies
Panel Discussion: Starting with the End in Mind: Designing Smart and Phase Appropriate Manufacturing for Successful Cell and Gene Therapy Development
- Khandan Baradaran - Principal, Mill Creek Consulting LLC
- Guillaume Cornelis - Senior Director, AD and Global Head of AS&T, Cellectis
- Bo Yan, PhD - Senior Director, Analytical Development, Beam Therapeutics
- Shankar Swaminathan, PhD - Team Lead, Drug Product Development, CMC-Tech Ops, Astellas Institute for Regenerative Medicine
- Amy Shaw - Head of Process and Product Development, Takeda
4:30pm - 5:00pm30 mins
Cell Therapy Manufacturing & Analytics
An Integrated Analytical Control Strategy - Execution Roadmap to Support Automation for Cell Therapies
- Stephan Krause - Executive Director, Analytical Strategy, Cell Therapies Global Quality, Bristol Myers Squibb
4:30pm - 5:00pm30 mins
Gene Therapy Manufacturing & Analytics
Effective Tech Transfer of Manufacturing Processes to CDMO Partners
- Hunter Reese - Senior Scientist, AskBio
5:00pm - 5:30pm30 mins
Cell Line Development & Engineering
Glycoengineered CHO cell production and secretion of a hepatitis C virus envelope-based vaccine candidate improves biochemical properties and immunogenicity
- Thomas Fuerst - "Professor, Department of Cell Biology and Molecular Genetics Director, Center for Glycosylation of Advanced Biologics", University of Maryland
5:00pm - 5:30pm30 mins
Cell Culture & Upstream Processing
Fireside Chat: What Actually Changed Upstream in the Last 5 Years?
- Henry Lin - Global Head of Cell Culture Process Development, Sanofi
- A Representative - ., ATCC
5:00pm - 5:30pm30 mins
Downstream Processing
Predicting formulation computability in the subcutaneous space
- Lalitha Ramasubramanian - Scientist, Gilead Sciences
5:00pm - 5:30pm30 mins
Digital Biomanufacturing and Data Driven Operations
From Fragmented Risk Registers to AI-Enabled, Proactive Tech Transfer: Building an Integrated Risk Tracking & Scenario Simulation Platform
- Yu Yuan - Senior Data Scientist, Amgen
5:00pm - 5:30pm30 mins
CMC Strategy & Manufacturing Performance
CMC Strategy For Viral Vectors
- Rishi Kothari - Process Development Engineer, Regeneron Pharmaceuticals
5:00pm - 5:30pm30 mins
Cell Therapy Manufacturing & Analytics
Case Study: Harnessing AI & Digitalization for Cell Therapy Manufacturing Optimization and Process Control
5:00pm - 5:30pm30 mins
Gene Therapy Manufacturing & Analytics
Analytical Control Strategy for Successful Method Transfer to Commercial Testing Lab
- Rajeev Boregowda - Associate Director, Bioassay & Molecular Analytical Development, Genomic Medicine CMC, Sanofi
5:30pm - 7:30pm120 mins
Break
Networking Party at the Museum of Science
7:30pm - 7:35pm5 mins
Break
Close of Day Two
* 不測の事態により、事前の予告なしにプログラムが変更される場合があります。