September 15 -18, 2025
Hynes Convention CenterBoston, USA
Key Sessions
Niklas Engler
PLENARY KEYNOTE: CMC Development - A Key Differentiator for Biotech
F. Hoffmann-La Roche
James Warren, Ph.D.
PLENARY KEYNOTE: Strategic Considerations for the BLA-Enabling CMC Development of AAV Gene Therapy Programs
Ultragenyx Pharmaceutical Inc.
Amy Shaw
Scale-Out Versus Scale-Up Strategies for Maximizing Cellular Therapies
Takeda, USA
Kelvin Lee
KEYNOTE: The Future of Biopharmaceutical Manufacturing: Innovation and Collaboration
NIIMBL
Wednesday 17th September - Main Conference Day Two - ET (Eastern Time, GMT-05:00)
Wednesday 17th September - Main Conference Day Two - ET (Eastern Time, GMT-05:00)
7:30am - 8:20am50 mins
Registration Break
Registration and Morning Coffee
8:20am - 8:30am10 mins
Keynote Plenary
Welcome to BWB Day 2 / Chairperson’s Opening Remarks
8:30am - 9:10am40 mins
Keynote Plenary
PLENARY KEYNOTE: Evolving Pharmacopeial Standards to Shape the Future of Biological Medicines
- Fouad Atouf - Vice President, Science-Global Biologics, US Pharmacopeia
8:55am - 9:00am5 mins
Development of Emerging Cell & Gene Therapies
Chairperson’s Opening Remarks: Development of Emerging Cell & Gene Therapies
8:55am - 9:00am5 mins
Cell Therapy Manufacturing & Analytics
Chairperson’s Opening Remarks: Cell Therapy Manufacturing & Analytics
- Mahesh Bule - Associate Director, Kite Pharma a Gilead Company
8:55am - 9:00am5 mins
Gene Therapy Manufacturing & Analytics
Chairperson’s Opening Remarks: Gene Therapy Manufacturing & Analytics
- Francesca Vitelli, PhD - Former VP Cell Therapy and Viral Vector PD and MSAT, Intellia Therapeutics, Inc
9:00am - 9:30am30 mins
Development of Emerging Cell & Gene Therapies
Harnessing AI and Machine Learning for the Future of Cell & Gene Therapy Development
9:00am - 9:30am30 mins
Cell Therapy Manufacturing & Analytics
Scale-Out Versus Scale-Up Strategies for Maximizing Cellular Therapies
- Amy Shaw - Head of Process and Product Development, Takeda, USA
9:00am - 9:30am30 mins
Gene Therapy Manufacturing & Analytics
Keynote Panel Discussion: Strategies for Scaling Up, Accelerating and Commercializing Gene Therapy Manufacturing
- Ying Cai - MSAT Executive Director, Ultragenyx Pharmaceutical
- Nripen Singh - Head of Process Development, TRD CGT, Novartis
9:00am - 9:30am30 mins
Innovation and Community Stage (Exhibit Hall)
Tech Showcase
9:10am - 9:50am40 mins
Keynote Plenary
PLENARY KEYNOTE: CMC Development - A Key Differentiator for Biotech
- Niklas Engler - Global Head and Vice President, Technical Development Portfolio and Projects, F. Hoffmann-La Roche
9:30am - 10:00am30 mins
Development of Emerging Cell & Gene Therapies
Redosable DNA Delivery Systems Designed by Machine Learning
- Shashi Murthy, PhD - CTO and Co-Founder, Nanite Inc.
9:30am - 10:00am30 mins
Cell Therapy Manufacturing & Analytics
Scaling Out Cell Therapy Manufacturing
- Mark Farmery - Chief Development Officer, Anocca AB
9:30am - 10:00am30 mins
Gene Therapy Manufacturing & Analytics
Case Study on Tech Transfer and Scale Up - How to Translate from Small to Large Scale / GMP
- Phillip Ramsey - Senior Vice President, Technical Operations, Sangamo Therapeutics
9:50am - 10:30am40 mins
Keynote Plenary
PLENARY KEYNOTE: Strategic Considerations for the BLA-Enabling CMC Development of AAV Gene Therapy Programs
- James Warren, Ph.D. - Senior VP, Global CMC Development, Ultragenyx Pharmaceutical Inc.
9:50am - 10:30am40 mins
Innovation and Community Stage (Exhibit Hall)
Tech Showcase
10:00am - 10:30am30 mins
Development of Emerging Cell & Gene Therapies
Efficient and Liver-Detargeted In Vivo Multiplex Gene Editing of Human Hematopoietic Stem and Progenitor Cells
- Pauline Schmit - Senior Scientist, nChroma Bio
10:00am - 10:30am30 mins
Cell Therapy Manufacturing & Analytics
Bringing Cell Therapy to the Patient-Implementing Decentralized Manufacturing
10:00am - 10:30am30 mins
Gene Therapy Manufacturing & Analytics
Tech Transfer Best Practices in Gene Therapy
- Jordan Ball - Sr. Manager, Technology Transfer, Regeneron
10:30am - 11:25am55 mins
Break
Morning Networing Break in Exhibit Hall
10:30am - 10:40am10 mins
Innovation and Community Stage (Exhibit Hall)
Accelerating Bioprocess Innovation through Intelligent Automation and Digital Integration
10:40am - 10:50am10 mins
Innovation and Community Stage (Exhibit Hall)
ProBio DE
10:50am - 11:20am30 mins
Innovation and Community Stage (Exhibit Hall)
Tech Showcase
11:25am - 11:30am5 mins
Cell Line Development & Engineering
Chairperson Remarks: Cell Line Development & Engineering
11:25am - 11:30am5 mins
Cell Culture & Upstream Processing
Chairperson Remarks: Cell Culture & Upstream Processing
11:25am - 11:30am5 mins
Downstream Processing
Chairperson Remarks: Downstream Processing
- Naveen Singh - Principal Scientist II, Process Development, Gilead
11:25am - 11:30am5 mins
Manufacturing Strategy & Digitalization
Chairperson Remarks: Manufacturing Strategy & Digitalization
11:25am - 11:30am5 mins
Analytical, Quality and Characterization
Chairperson Remarks: Analytical, Quality and Characterization
11:25am - 12:00pm35 mins
Innovation and Community Stage (Exhibit Hall)
BPI State of the Industry
11:30am - 12:00pm30 mins
Cell Line Development & Engineering
Removing remaining limitations for plant-based expression of biologicals and unlocking large-scale, commercial-grade cell culture potential
- Andreas Schaaf - CSO & Managing Director, Eleva GmbH
11:30am - 12:00pm30 mins
Cell Culture & Upstream Processing
Next-Gen Upstream Lab: Flexible and Scalable AI Deployment with MLOps
- Shu Yang - Senior Scientist, Pfizer
- Edwin Shen - Principal Scientist, Pfizer
11:30am - 12:00pm30 mins
Downstream Processing
The challenge of impurity clearance in a world of complex modalities and high productivities: a case study in low molecular weight (LMW) removal
- Crystal Thomas - Principal Scientist, Purification Process Development, Sanofi
11:30am - 12:00pm30 mins
Manufacturing Strategy & Digitalization
KEYNOTE: The Future of Biopharmaceutical Manufacturing: Innovation and Collaboration
- Kelvin Lee - Institute Director, NIIMBL
11:30am - 12:00pm30 mins
Analytical, Quality and Characterization
Ensuring Product Comparability & Accelerating Analytical Method Development: Bridging Early and Late-Phase Development
- Elisabeth Krug - Executive Director, BRD Analytical Development, Eli Lilly & Company
11:30am - 12:00pm30 mins
Development of Emerging Cell & Gene Therapies
Leveraging Gene Editing Technologies for Precision and Efficiency in Cell and Gene Therapy Development
- Kristy Wood, PhD - SVP, Technical Operations, Intellia Therapeutics
11:30am - 12:00pm30 mins
Cell Therapy Manufacturing & Analytics
Revolutionizing Cell Therapy with Automated Manufacturing and Testing Solutions
- Shawn (Xueyuan) Wang - Director, Process Development, Kite Pharma
11:30am - 12:00pm30 mins
Gene Therapy Manufacturing & Analytics
Revolutionizing Large Scale Gene Therapy Production: Boosting Cell Density and Cell Specific Productivity with Advanced Producer Cell Lines
12:00pm - 12:30pm30 mins
Cell Line Development & Engineering
Enhancing production cell line development through a next-generation sequencing platform
- Xiaodong Sun - Senior Scientist, Takeda
12:00pm - 12:30pm30 mins
Cell Culture & Upstream Processing
Error Reduction Using Small-Scale Models and Scale-Up Insights
- Prasad Pathange - Senior Manager, Bayer U.S.
12:00pm - 12:30pm30 mins
Downstream Processing
Harvest Development and Optimization using pDADMAC Flocculation
- Kate Zhao - Scientist I, Upstream Process Development, Alexion, AstraZeneca Rare Disease
12:00pm - 12:30pm30 mins
Manufacturing Strategy & Digitalization
AI-Enhanced Smart Workflows: Unlocking Speed and Insight in Process Development and Manufacturing
- Mark Duerkop - Chief Executive Officer, Novasign, Austria
12:00pm - 12:30pm30 mins
Analytical, Quality and Characterization
Defining and Controlling Critical Quality Attributes (CQAs) for Gene and Cell Therapies
- Callum Chapman - Senior Director, Product Quality, AstraZeneca
12:00pm - 12:30pm30 mins
Development of Emerging Cell & Gene Therapies
Next-Gen Gene Editing - Pushing Boundaries for Enhanced Therapeutics
- Devyn M. Smith - Chief Executive Officer, Arbor Biotechnologies
12:00pm - 12:30pm30 mins
Cell Therapy Manufacturing & Analytics
Scalable and Cost-Effective Pluripotent Stem Cell Expansion: Enabling Commercialization
- Wonjong Si - Associate Director, Cell Therapy Platform Process, Bayer
12:00pm - 12:30pm30 mins
Gene Therapy Manufacturing & Analytics
Expanding the Upstream Toolbox: Enabling High-Productivity, Robust, and Scalable AAV Production
- Huize Yan - Process Development Scientist, Spark Therapeutics
12:00pm - 1:00pm60 mins
Innovation and Community Stage (Exhibit Hall)
Tech Showcase
12:30pm - 1:00pm30 mins
Cell Line Development & Engineering
Sponsored Presentation: Establishing a Robust Workflow to Identify High-Performing Clones
12:30pm - 1:00pm30 mins
Cell Culture & Upstream Processing
Sponsored Presentation: Emerging Tools for Real-Time Process Monitoring
12:30pm - 1:00pm30 mins
Downstream Processing
Improve Manufacturing Efficiencies with the Latest Advanced Chromatography Resins
- Aaron Moulin - Field Applications Specialist, Purolite
12:30pm - 1:00pm30 mins
Manufacturing Strategy & Digitalization
Sponsored Presentation: Beyond the Playbook: Operational Efficiency in CMC
12:30pm - 1:00pm30 mins
Analytical, Quality and Characterization
Application of Raman Spectroscopy to Monitor Product Quality in Purification Workflows
- Kévin Grollier - PAT Implementation & Support Engineer, MilliporeSigma
- Innocent Bekard, PhD - Director, Purification Development, CSL Innovation Pty Ltd
12:30pm - 1:00pm30 mins
Development of Emerging Cell & Gene Therapies
Application of Next Generation Editing Technologies
12:30pm - 1:00pm30 mins
Cell Therapy Manufacturing & Analytics
Automating the Future: Enabling Closed-System Cell Therapy Manufacturing
1:00pm - 2:10pm70 mins
Break
Lunch Networking in Exhibit Hall
1:20pm - 1:40pm20 mins
Innovation and Community Stage (Exhibit Hall)
Tech Showcase
2:10pm - 2:15pm5 mins
Cell Line Development & Engineering
Chairperson Remarks: Cell Line Development & Engineering
2:10pm - 2:15pm5 mins
Cell Culture & Upstream Processing
Chairperson Remarks: Cell Culture & Upstream Processing
2:10pm - 2:15pm5 mins
Downstream Processing
Chairperson Remarks: Downstream Processing
- Xuan Han, PhD - Senior Scientist, Amgen
2:10pm - 2:15pm5 mins
Manufacturing Strategy & Digitalization
Chairperson Remarks: Manufacturing Strategy & Digitalization
2:10pm - 2:15pm5 mins
Analytical, Quality and Characterization
Chairperson Remarks: Analytical, Quality and Characterization
2:10pm - 2:15pm5 mins
Development of Emerging Cell & Gene Therapies
Chairperson’s Opening Remarks: Development of Emerging Cell & Gene Therapies
2:10pm - 2:15pm5 mins
Cell Therapy Manufacturing & Analytics
Chairperson’s Opening Remarks: Cell Therapy Manufacturing & Analytics
- Shashi Prajapati - Director, Cell & Gene Therapies Analytical Development, Vertex Pharmaceuticals
2:10pm - 2:15pm5 mins
Gene Therapy Manufacturing & Analytics
Chairperson’s Opening Remarks: Gene Therapy Manufacturing & Analytics
- David Dobnik - Scientific Associate, National Institute of Biology
2:10pm - 2:50pm40 mins
Innovation and Community Stage (Exhibit Hall)
PANEL: Women in Bio and CGT Circle - What Pharma Companies are Doing to Improve Diversity, Equity, and Inclusion and How This Influences Research
2:15pm - 2:45pm30 mins
Cell Line Development & Engineering
13 C Metabolic Flux Analysis (MFA) of CHO cells utilizing various media and feed packages to elucidate metabolic bottlenecks
- Lorena Pena - Scientist, Bristol-Myers Squibb
2:15pm - 2:45pm30 mins
Cell Culture & Upstream Processing
Leveraging Capacitance in Perfusion Bioreactors in the Generation2 Ambr(R) 250 High Throughput
- Lorraine Peters - Associate Scientist, AstraZeneca
2:15pm - 2:45pm30 mins
Downstream Processing
Modernizing the design of convective chromatography tools and processes for high-productivity mAb and Viral Vector purification
- Stefano Menegatti - Associate Professor, North Carolina State University
2:15pm - 2:45pm30 mins
Manufacturing Strategy & Digitalization
CMC in the Age of Personalized Medicine: Meeting the Unique Challenges of Small Batch Manufacturing
- Gregory Zarbis-Papastoitsis, Ph.D - Chief Process and Manufacturing Officer, Ankyra
2:15pm - 2:45pm30 mins
Analytical, Quality and Characterization
Innovative Approaches to Potency & Stability: Overcoming Analytical Drug-Delivery Challenges
- Arvind Srivastava, Ph.D. - Senior Vice President, ThirdArcBio
2:15pm - 2:45pm30 mins
Development of Emerging Cell & Gene Therapies
Case Study from Editas Medicine
- Ratnesh Joshi - Associate Director, Downstream Process Development, Editas Medicine
2:15pm - 2:45pm30 mins
Cell Therapy Manufacturing & Analytics
Advanced Analytical Strategies for Cell Therapy Product Characterization
- Lena Yang - Senior Scientist, Cell Therapy Analytical Development, Takeda
2:15pm - 2:45pm30 mins
Gene Therapy Manufacturing & Analytics
Rapid Development of AAV Purification Process Without Sacrificing Recovery
- Hunter Reese - Scientist II, Asklepios Biopharmaceutical
2:45pm - 3:15pm30 mins
Cell Line Development & Engineering
Optimizing Vector Design to Enhance Expression and Quality of Bispecific Antibodies
- Fernanda Sobreira - Associate Principal Scientist, Merck
2:45pm - 3:15pm30 mins
Cell Culture & Upstream Processing
Scale-Down Model Qualification and Process Characterization Utilizing the Second-Generation Ambr® 250 High Throughput Mini Bioreactor System
- Coral Fung Shek - Process Development Associate Scientist, Amgen
2:45pm - 3:15pm30 mins
Downstream Processing
Case Study and Development Overview of Recovery and Downstream Challenges from Harvest to UF/DF for an Antibody in Accelerated Development
- Chase Herman, Ph.D. - Investigator, GSK
2:45pm - 3:15pm30 mins
Manufacturing Strategy & Digitalization
CMC Regulatory Filings for NCE’s - How to Develop Module 3 for the FDA and the EU/UK without constraining Development Efforts
- Jack Greene - Chief Technical and Manufacturing Officer, JucaBio
2:45pm - 3:15pm30 mins
Analytical, Quality and Characterization
Emerging Technologies & Bioassay Innovations: Bridging the Gap Between Development and Compliance
- Anand Srinivasan - Vice President of Technology and Innovations, and Head of the Center for Innovations and Biodesign, BioBridge Global
2:45pm - 3:15pm30 mins
Development of Emerging Cell & Gene Therapies
Optimizing LNP Delivery and Non-Viral Vector Manufacturing as Scalable, Redosable Alternatives to Viral Vectors
- Weiyi Li - Senior Manager, LNP Formulation, Prime Medicine, Inc.
2:45pm - 3:15pm30 mins
Cell Therapy Manufacturing & Analytics
Best Practices for Developing Robust Potency Assays for Cell Therapies
- Mariska ter Haak - Senior Director Analytical Development, IN8bio
2:45pm - 3:15pm30 mins
Gene Therapy Manufacturing & Analytics
Maximizing Capsid Recovery: Optimizing Downstream Processing for Higher Yields
- Junfen Ma - Head of Genomic Medicine Purification Process Development, Sanofi
2:50pm - 3:40pm50 mins
Innovation and Community Stage (Exhibit Hall)
Tech Showcase
3:15pm - 3:45pm30 mins
Cell Line Development & Engineering
Sponsored Presentation: CLD Strategies Fit For a New Era of Biologic
3:15pm - 3:45pm30 mins
Cell Culture & Upstream Processing
Optimising poloxamer 188 for CHO and HEK suspension cells for reduced batch-to-batch variation
- Kritika Bajaj - Lead Research Scientist, Croda
3:15pm - 3:45pm30 mins
Downstream Processing
Sponsored Presentation: Unlocking Hidden Yields: Maximizing Product Recovery with Purification Technologies
3:15pm - 3:45pm30 mins
Manufacturing Strategy & Digitalization
Sponsored Presentation: Building a Sustainable Future for Biomanufacturing
3:15pm - 3:45pm30 mins
Analytical, Quality and Characterization
Streamlining residual host cell impurity monitoring in biotherapeutic products: Driving efficiency and precision
- Anis Khimani, PhD - Senior Strategy Leader, Revvity Inc
3:15pm - 3:45pm30 mins
Development of Emerging Cell & Gene Therapies
Utilizing Next-Gen Delivery Vehicles
3:15pm - 3:45pm30 mins
Cell Therapy Manufacturing & Analytics
Novel Analytical Technologies to Enhance Cell Therapy Product and Process Characterization
3:15pm - 3:45pm30 mins
Gene Therapy Manufacturing & Analytics
Optimizing AAV and LV Purification and Analytics: Accelerated High-Quality Processes using CIM® Monoliths and PATfix®
- Hana Jug - Product Manager (Enveloped viruses, VLPs and EVs), Sartorisu BIA Separations
3:45pm - 4:30pm45 mins
Break
Afternoon Break
4:00pm - 4:20pm20 mins
Innovation and Community Stage (Exhibit Hall)
Tech Showcase
4:30pm - 5:00pm30 mins
Cell Line Development & Engineering
A Comprehensive CHO Glycosylation Mutant Panel for Advancing Glycobiology and Therapeutic Protein Engineering
- Song Zhiwei - Senior Principal Scientist, Nexa Biologics
4:30pm - 5:00pm30 mins
Cell Culture & Upstream Processing
Identifying upstream levers to improve monomer purity in antibody production
- Yingnan (Michael) Si - Scientist, Sanofi
4:30pm - 5:30pm60 mins
Downstream Processing
PANEL DISCUSSION: Future Trends in Bioprocess Chromatography: Exploring Novel Technologies and Approaches
- Naveen Singh - Principal Scientist II, Process Development, Gilead
- Kabir Dhingra - Senior Scientist, Merck
4:30pm - 5:00pm30 mins
Manufacturing Strategy & Digitalization
Creating a Winning Target Product Profile: A Roadmap for Successful Biopharmaceutical Development
- Regina Au - CEO, New Product Planning/Strategic Planning, BioMarketing Insight
4:30pm - 5:00pm30 mins
Analytical, Quality and Characterization
Streamlining Biologics Testing: Implementing Multi-Attribute Methods from Development to QC
- Hao Zhang - Sr. Principal Scientist, Amgen
4:30pm - 5:30pm60 mins
Development of Emerging Cell & Gene Therapies
Cell and Gene Therapy CDMO Selection and External Manufacturing Best Practices
- Shankar Swaminathan, PhD - Team Lead, Associate Director Drug Product Development, Astellas Institute for Regenerative Medicine
- Jeff Masten - Senior Vice President CMC, Secretome Therapeutics
- Matthew Provencal - Executive Director Gene Therapy BDS Manufacturing, Sarepta
4:30pm - 5:00pm30 mins
Cell Therapy Manufacturing & Analytics
Strategy for Cell Therapy Potency Assurance
- Dong Xu, Ph.D. - Associate Director, Cell Therapy Analytical Development, TScan Therapeutics
4:30pm - 5:00pm30 mins
Gene Therapy Manufacturing & Analytics
Detectability and Propagation of MVM in HEK293 Cells: What it means for your Viral Safety Strategy
- Dana Schreffler - Sr. Manager QC Viral Safety, Regeneron
4:30pm - 5:00pm30 mins
Innovation and Community Stage (Exhibit Hall)
PANEL: Latinos in Bio - Missed Opportunities: The Cost of Ignoring Diversity in Biotech Panel Overview
5:00pm - 5:30pm30 mins
Cell Line Development & Engineering
Accelerating Biopharmaceutical Cell Line Selection with Label-Free Multimodal Nonlinear Optical Microscopy and Machine Learning
- Jindou Shi - PhD Student, GSK Center for Optical Molecular Imaging, UIUC
5:00pm - 5:30pm30 mins
Cell Culture & Upstream Processing
Fireside Chat: How do we go to the next level for Cell Culture and Upstream Development?
- Charles Sardonini - Consultant to the Biotechnology Industry, Sardonini Consulting, LLC
5:00pm - 5:30pm30 mins
Manufacturing Strategy & Digitalization
Mastering ADC Manufacturing: Overcoming Complexities and Optimizing for Success
- Kelvin Lau - Principal Engineer, Abbvie
5:00pm - 5:30pm30 mins
Analytical, Quality and Characterization
AI's Power in the Future of Process Analytical Technology (PAT)
- William Whitford - Founder, Oamaru BioSystems
5:00pm - 5:30pm30 mins
Cell Therapy Manufacturing & Analytics
Robust Process Validation Strategies for Cell Therapies
5:00pm - 5:30pm30 mins
Gene Therapy Manufacturing & Analytics
Mastering hcDNA: A Harmonized CMC Approach in AAV Therapies
- Parag Kumthekar - Gene Therapy Downstream Process Development Lead, UCB Pharma
5:00pm - 5:30pm30 mins
Innovation and Community Stage (Exhibit Hall)
Tech Showcase
5:30pm - 7:30pm120 mins
Break
Innovation After Dark: Networking Party at the Museum of Science, Boston
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。
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