Key Sessions

Niklas Engler

PLENARY KEYNOTE: CMC Development - A Key Differentiator for Biotech

F. Hoffmann-La Roche

James Warren

PLENARY KEYNOTE: Case Study from Ultragenyx On CMC Development for New Products

Ultragenyx

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 TwoWednesday, 17 September 2025 - 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: Ensuring Quality and Access: Advancing Standards for Complex Biologics

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

Mahesh Bule - Associate Director, Kite Pharma a Gilead Company

8:55am - 9:00am5 mins

Cell Therapy Manufacturing & Analytics

Chairperson’s Opening Remarks: Cell Therapy Manufacturing & Analytics

8:55am - 9:00am5 mins

Gene Therapy Manufacturing & Analytics

Chairperson’s Opening Remarks: Gene Therapy Manufacturing & Analytics

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

9:10am - 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: Case Study from Ultragenyx On CMC Development for New Products

James Warren - VP Pharmceutical Development, Ultragenyx

10:00am - 10:30am30 mins

Development of Emerging Cell & Gene Therapies

Revolutionizing Targeted Delivery: Emerging Technologies to Enhance Precision & Minimize Off-Target Effects

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

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

11:30am - 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 - Process Engineer III, 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

Strategies for Success Implementation of Automation at Scale in Cell Therapy Manufacturing

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

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

12:30pm - 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

Sponsored Presentation: Novel Approaches in Affinity Chromatography & Process Design

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

Sponsored Presentation: Multi-Omics for Biologics: Deep Dive into Product Quality and Process Understanding

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

12:30pm - 1:00pm30 mins

Gene Therapy Manufacturing & Analytics

Next-Gen Innovations: Transforming Upstream Process Development in Gene Therapy

1:00pm - 2:10pm70 mins

Break

Lunch Networking in Exhibit Hall

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

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

2:15pm - 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 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

Viral vs. Non-Viral - The Future of In Vivo Delivery Systems

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

Evaluating a high-throughput cell culture system for late-stage process development

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

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

Sponsored Presentation: Managing Shear Stress and Mechanical Forces in Bioreactors For Improved Cell Health and Viability

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

4:30pm - 5:00pm30 mins

Cell Line Development & Engineering

Generating and characterizing a comprehensive panel of CHO cells glycosylation mutants for advancing glycobiology and biotechnology research

Zhiwei Song - Senior Principal Scientist, A*STAR

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

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?

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

5:30pm - 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

* 活动内容有可能不事先告知作更动及调整。

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Keynote Plenary

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