September 22-25, 2026 as part of Biotech Week Boston
Hynes Convention CenterBoston, USAKey Sessions
Sarfaraz Niazi, PhD
PLENARY KEYNOTE: Biosimilars: From Therapeutic Proteins to Gene Therapies--a Novel Perspective for Affordable Medicines
Washington State University
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: What we have learned and also refined by using AI and ML in Upstream process development
Biogen
Tiffany D Rau, PhD
Keynote Panel Discussion: Strategies for Scaling Up, Accelerating and Commercializing Gene Therapy Manufacturing
University College Cork, Ireland
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Agenda September 24, 2026: Main Conference Day Two - ET (Eastern Time, GMT-05:00)
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Agenda September 24, 2026: Main Conference Day Two - ET (Eastern Time, GMT-05:00)
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Streams
Showing 1 of 1 Streams
Fun Run
6:45am - 7:45am
BPI International 2026 Fun Run
Showing 1 of 1 Streams
Registration Break
8:15am - 8:50am
Registration and Morning Coffee
Showing 5 of 5 Streams
BPI Plenary Keynote
Development of Emerging Cell & Gene Therapies
Cell Therapy Manufacturing & Analytics
Gene Therapy Manufacturing & Analytics
Innovation and Community Stage (Exhibit Hall)
8:50am - 9:00am
Welcome to BWB Day 2 / Chairperson’s Opening Remarks
9:00am - 9:45am
PLENARY KEYNOTE: Biosimilars: From Therapeutic Proteins to Gene Therapies--a Novel Perspective for Affordable Medicines
- Sarfaraz Niazi, PhD - Affiliate Professor, Washington State University
9:45am - 10:30am
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
8:50am - 9:00am
Chairperson’s Opening Remarks: Development of Emerging Cell & Gene Therapies
- Nicola Ambler - Co-Founder, CGT Circle
9:00am - 9:30am
Keynote: In Vivo CAR-T Therapies Product Development and Clinical Advances
- Hari Pujar - Chief Operating Officer, Tessera Therapeutics
9:30am - 10:00am
Revolutionizing In Vivo Delivery: Overcoming Challenges and Advancing Therapeutic Impact
10:00am - 10:30am
Panel Discussion: Scale-Up Strategies: Navigating the Road Ahead for In Vivo CAR-T
- Christopher Bravery - Consulting Regulatory Scientist, Advbiols
- Stephen Kennedy - Head of Technical Operations, CRISPR Therapeutics
8:50am - 9:00am
Chairperson’s Opening Remarks: Cell Therapy Manufacturing & Analytics
- Amy Shaw - Senior Director, Process Development, Genetix Biotherapeutics
9:00am - 10:00am
Keynote Panel Discussion: Scaling Cell Therapies- Lessons from Pioneers for Smarter, Faster, and More Affordable Ex Vivo Cell Therapy Manufacturing
- Shashi Murthy - Vice Provost for Global Innovation and Head, Dublin Innovation Institute, Northeastern University
- Arvind Natarajan - Senior Vice President, Technical Development, Iovance Biotherapeutics
- Mayo Pujols - CTO, Kyverna
- Pooja Sabhachandani - Associate Director, Science and Technology, Cell & Gene Therapy, Novartis Pharmaceuticals
- Marcia Blackmoore - Chief Commercial Officer & Customer Operations, L7 Informatics, Inc.
10:00am - 10:30am
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
8:50am - 9:00am
Chairperson’s Opening Remarks: Gene Therapy Manufacturing & Analytics
9:00am - 10:00am
Keynote Panel Discussion: Strategies for Scaling Up, Accelerating and Commercializing Gene Therapy Manufacturing
- Tiffany D Rau, PhD - Principal Consultant BioPharma Technical Consulting and Rau Consulting, Adjunct Professor Biochemistry and Cell Biology, University College Cork, Ireland
- 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
10:00am - 10:30am
Building an AAV Production Strategy Utilizing Stable Producer Cell Lines for Scalable, Gene Therapy Manufacturing
- Ryan Schweller - Associate Director, Process Development, AskBio Inc.
9:20am - 9:30am
Chairperson’s Opening Remark
- Willis Thomas - HR Business Partner, PQE
9:50am - 10:10am
W. L. Gore & Associates, Inc. - Durable. Resilient. Radiation Compatible: A new advanced material tubing solution for demanding single-use bioprocessing applications
- Keith Fritsky - Product Specialist, W. L. Gore & Associates, Inc.
- Ron Gott - Technical Lead - Product Development, W. L. Gore & Associates, Inc.
10:10am - 10:20am
Cellufine MLP™: Wide Pore Cellulose Base Bead 3D Architecture for Large Biomolecule Chromatography Applications
- Chigusa Mori - Research Scientist, JNC Corporation
10:20am - 10:30am
10:20-10:40 Rewriting Bioprocessing with Synthetic Affinity Ligands
- Alex Shephard - Head of Product, Tozaro
Showing 2 of 2 Streams
Break
Innovation and Community Stage (Exhibit Hall)
10:30am - 11:25am
Morning Break in Exhibit Hall
10:30am - 10:40am
10:20-10:40 Rewriting Bioprocessing with Synthetic Affinity Ligands (Continued)
10:40am - 10:50am
Evotec
10:50am - 11:00am
Revolutionizing Fluid Disconnections and Tear-Down
- Spencer Juola - Product Manager, Connectors, CPC Biotech
11:00am - 11:10am
Enzene
11:10am - 11:20am
From Cell Sourcing to Expansion: The Role of Quality-Driven Human Raw Materials in Cell Therapy
- Alejandra Gutierrez-Guerrero - Product Manager, Cell Therapy, Grifols
11:20am - 11:25am
11:20 – 11:40 Enhancing Suspension Cell Culture Processes with METHONOVA™ Methylcellulose
- Joshua Katz - R&D Director, Roquette Health & Pharma Solutions
Showing 9 of 9 Streams
Cell Line Development & Engineering
Cell Culture & Upstream Processing
Downstream Processing
Digital Biomanufacturing and Data Driven Operations
CMC Strategy & Manufacturing Performance
Development of Emerging Cell & Gene Therapies
Cell Therapy Manufacturing & Analytics
Gene Therapy Manufacturing & Analytics
Innovation and Community Stage (Exhibit Hall)
11:25am - 11:30am
Chairperson Remarks
11:30am - 12:00pm
Metabolic Engineering of CHO Cells Towards Cysteine Prototrophy and Systems Analysis of The Ensuing Phenotype
- Laura Greenfield - Senior Scientist, Pfizer
12:00pm - 12:30pm
KEYNOTE: AI-Driven Cell Line Development Beyond Conception: Digitalization, Prediction & Data-Enabled Decisions
- Nathan Lewis - Professor, Co-Founder, University of Georgia, NeuImmune
12:30pm - 1:00pm
Advancing CHO Cell Line Development: A Dual-Strategy Approach Using Site-Specific and Transposon-Based Integration Platforms
- Dennis Lin - Associate Director, Cell Line and Cell Culture Process Development, Bora Biologics
11:25am - 11:30am
Chairperson Remarks
- Daniela Espinosa Hoyos - Principal Scientist, Sanofi
11:30am - 12:00pm
KEYNOTE: What we have learned and also refined by using AI and ML in Upstream process development
- Sarwat Khattak - Head of Cell Culture and Cell Line Development, Biogen
12:00pm - 12:30pm
Predicting the impact of diversions in a dynamic continuous process
- Ken Lee - Director, AstraZeneca
12:30pm - 1:00pm
Sponsored Scientific Presentation
11:25am - 11:30am
Chairperson Remarks
- Kabir Dhingra - Senior Scientist, Merck
11:30am - 12:00pm
Leveraging Large-scale Manufacturing Experience To Improve Scalability of Resin Lifetime Studies
- Benjamin Ko, Ph.D. - Associate Director, Development Operations Drug Substance, Boehringer Ingelheim
12:00pm - 12:30pm
Accelerating Downstream Technology Transfer Through Innovative GMP Solutions and Phase-Appropriate Work Packages
- Qingxuan Li - Principal Scientist, Sanofi
12:30pm - 1:00pm
Designing process intensification in the mAb capture step for the MSAT handoff—not just PD success
- Henrik Ihre, Ph.D. - Distinguished Fellow, Cytiva
11:25am - 11:30am
Chairperson Remarks
11:30am - 12:00pm
Digital Twins for Biologics: Where Are We Actually Seeing Impact?
- Christoph Herwig - Senior Scientific Advisor, Körber Pharma Austria GmbH, Austria
12:00pm - 12:30pm
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
12:30pm - 1:00pm
Sponsored Presentation:
11:25am - 11:30am
Chairperson Remarks
11:30am - 12:00pm
KEYNOTE: Lessons from Global Leadership in CMC, Technology Transfer, and Manufacturing
- Tom Gervais - Vice President, Manufacturing, Macrogenics
12:00pm - 12:30pm
Complexity and Strategies of Developing Bispecific Antibody Products - from Design to Clinics
- Yun Bai - Executive Vice President of CMC, Santa Ana Bio
12:30pm - 1:00pm
The Rise of Modular Manufacturing: Scalable Solutions to Accelerate Novel Therapy Development
- Bella Neufeld - VP, Operations, Teknova
12:00pm - 12:30pm
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 - 12:00pm
Process Development to Commercial Scale: Overcoming Manufacturing Bottlenecks in Next-Generation Allogenic Cell Therapies
- Nafees Rahman - Senior Director, Process Development, Nkarta, Inc.
12:00pm - 12:30pm
Modular Process Development of HSC-derived CAR-NK Cell Therapies
- Rui Tostoes - CTO, ImmuneBridge
12:30pm - 1:00pm
Sponsored Scientific Track Presentation
11:30am - 12:00pm
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 - 12:30pm
Expanding the Upstream Toolbox: Enabling High Productivity, Robust, and Scalable AAV Production
- Sha Sha - Senior Scientist, Ultragenyx
11:25am - 11:40am
11:20 – 11:40 Enhancing Suspension Cell Culture Processes with METHONOVA™ Methylcellulose (Continued)
- Joshua Katz - R&D Director, Roquette Health & Pharma Solutions
11:40am - 11:50am
The Razor Without a Blade: Why Bioprocess Equipment OEMs Are Leaving Recurring Consumable Revenue on the Table
- Keith Smith - President & CEO, Vonco Products, LLC
11:50am - 12:30pm
PANEL: Mass LifeSciences
12:30pm - 12:40pm
Chairperson’s Opening Remarks
12:40pm - 1:00pm
12:40 – 1:20 PANEL: From Opportunity to Impact: How Community Partnerships Change Lives and Build the Future Biomanufacturing Workforce
- Rosie Cunningham - Executive Director, Life Science Cares Boston
Showing 2 of 2 Streams
Break
Innovation and Community Stage (Exhibit Hall)
1:00pm - 2:10pm
Lunch Networking
1:00pm - 1:20pm
12:40 – 1:20 PANEL: From Opportunity to Impact: How Community Partnerships Change Lives and Build the Future Biomanufacturing Workforce (Continued)
- Rosie Cunningham - Executive Director, Life Science Cares Boston
1:20pm - 1:30pm
Sapio Sciences
- Asa Oudes - Global, Head of Pre-Sales, Sapio Sciences
1:50pm - 2:00pm
SynGenSys - Engineering Transcriptional Control in CHO Cells: Synthetic Promoters for Higher-Productivity Biomanufacturing
- Molly Smith - Head of CHO Expression Technologies, SynGenSys
Showing 9 of 9 Streams
Cell Line Development & Engineering
Cell Culture & Upstream Processing
Downstream Processing
Digital Biomanufacturing and Data Driven Operations
CMC Strategy & Manufacturing Performance
Emerging Therapies
Cell Therapy
Gene Therapy
Innovation and Community Stage (Exhibit Hall)
2:10pm - 2:15pm
Chairperson's Remarks
2:15pm - 2:45pm
Expression System & Integration Technology Choices
- Dong Seong Cho - Technical Development Associate Scientist, Genentech
2:45pm - 3:15pm
Leveraging Transposase-Based Expression Systems for Complex Biologics Quality
- Mark Blenner - Professor, University of Delaware
3:15pm - 3:45pm
Evolving Cell Line Development for next-generation biotherapeutics
- Sigma Mostafa, PhD - Chief Scientific Officer, KBI Biopharma
2:10pm - 2:15pm
Chairperson's Remarks
- Daniela Espinosa Hoyos - Principal Scientist, Sanofi
2:15pm - 2:45pm
Enabling Sample-Free Bioreactor Operation Through Raman-Based pH Monitoring
- Alyssa Melville - Engineer, Cell Culture Development, Biogen (USA)
2:45pm - 3:15pm
From Prediction to Control: Tuning Lactate Metabolism Using Raman Enabled Automated Lactate Control
- Gayatri Dhara - Principal Scientist, Bioprocess Research & Development, Pfizer
3:15pm - 3:45pm
Cell Culture Media Optimization as a Strategic Lever for Biosimilar Productivity and Product Quality
- Jeraldine Mendoza - Sr. Technical Support Scientist, OPM Biosciences
2:10pm - 2:15pm
Chairperson's Remarks
- Kabir Dhingra - Senior Scientist, Merck
2:15pm - 2:45pm
Current Insights and Future Directions for Host Cell Protein Challenges in Antibody Manufacturing
- Younghoon Oh - Principal Scientist, J&J Innovative Medicine
2:45pm - 3:15pm
Project Lexy: A Context-Driven Data Mapping Framework for Downstream Process Development
- Benjamin Borow - Associate Scientist, Bristol-Myers Squibb
3:15pm - 3:45pm
Sponsored Presentation
2:10pm - 2:15pm
Chairperson's Remarks
2:15pm - 2:45pm
Predict, Prevent, Perfect: The New Era of Intelligent Biologics Manufacturing
- Preeya Boppana - Director Manufacturing Science & Technology, AstraZeneca
2:45pm - 3:15pm
FEATURED PRESENTATION: Optimizing Upstream Processes Through Digital Approaches
- Michael Betenbaugh - Professor, Department of Chemical & Biomolecular Engineering, Johns Hopkins University
3:15pm - 3:45pm
Enabling Data-Driven Process Intensification with Multivariate Analytics and PAT
- Gregory Casee - Data Scientist, Sartorius
2:10pm - 2:15pm
Chairperson's Remarks
2:15pm - 2:45pm
Biomanufacturing Initiative – CMC Strategy & Manufacturing Performance
- Laura Pierce - Biomedical Engineer, NIST
2:45pm - 3:15pm
KEYNOTE: CMC Strategies for Regulatory Success and Platform Optimization
- Rashmi Korke-Kshirsager - Bioprocessing Expert, .
3:15pm - 3:45pm
Intensification of protein A capture step using membrane technology
- Anupama Kante, PhD - Scientist Downstream Process Development, Avid Bioservices
2:10pm - 2:15pm
Chairperson’s Opening Remarks: Development of Emerging Cell & Gene Therapies
2:15pm - 2:45pm
Harnessing AI and Machine Learning for the Future of Cell & Gene Therapy Development
2:45pm - 3:15pm
Leveraging Platform-Based, Multi-Attribute LC Assays to Characterize Multi-components Prime Editing (PE) RNA-LNP
- Minjia Wang - Analytical Development Scientist II, Prime Medicine
2:10pm - 2:15pm
Chairperson’s Opening Remarks: Cell Therapy Manufacturing & Analytics
- Rahul Visalakshan - Innovation Lead- Global MSAT, Legend Biotech
2:15pm - 2:45pm
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
2:45pm - 3:15pm
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
3:15pm - 3:45pm
Sponsored Scientific Track Presentation
2:10pm - 2:15pm
Chairperson’s Opening Remarks: Gene Therapy Manufacturing & Analytics
2:15pm - 2:45pm
Process Intensification for Affinity Capture of AAV Gene Therapies
- Lukas Maloney - Process Development Engineer I, Regeneron
2:45pm - 3:15pm
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 - 3:45pm
Sponsored Scientific Track Presentation
2:20pm - 3:00pm
PANEL: The Value-Alignment Era: Building Durable Careers in a Shifting Policy Landscape
- Nicola Ambler - Co-Founder, CGT Circle
3:40pm - 3:45pm
15:40 - 16:00 Turning Integrated Bioprocess Data into Predictive Decisions with Models and AI
- Soichiro Shimoda - Bioprocess Solution Manager, Yokogawa Electric Corporation
Showing 2 of 2 Streams
Break
Innovation and Community Stage (Exhibit Hall)
3:45pm - 4:30pm
Afternoon Break
3:45pm - 4:00pm
15:40 - 16:00 Turning Integrated Bioprocess Data into Predictive Decisions with Models and AI (Continued)
- Soichiro Shimoda - Bioprocess Solution Manager, Yokogawa Electric Corporation
4:20pm - 4:30pm
16:20 – 17:00 PANEL: Latinos in Bio Founder Showcase: Building Innovation Across Life Sciences—From MedTech to Biomanufacturing
Showing 9 of 9 Streams
Cell Line Development & Engineering
Cell Culture & Upstream Processing
Downstream Processing
Digital Biomanufacturing and Data Driven Operations
CMC Strategy & Manufacturing Performance
Development of Emerging Cell & Gene Therapies
Cell Therapy Manufacturing & Analytics
Gene Therapy Manufacturing & Analytics
Innovation and Community Stage (Exhibit Hall)
4:30pm - 5:00pm
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
5:00pm - 5:30pm
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 Glycoengineering of Advanced Biologics, University of Maryland
4:30pm - 5:00pm
Fireside Chat: Innovative Approaches to Impurity Removal in Complex Biologics
- Jin Yu - Senior Scientist, Process Development Downstream, Amgen
- Florian Settele, Ph.D. - Managing Director, Navigo Proteins GmbH
5:00pm - 5:30pm
Predicting formulation computability in the subcutaneous space
- Lalitha Ramasubramanian - Senior Scientist, Gilead Sciences
4:30pm - 5:00pm
AI in Action: Accelerating Upstream Development with Predictive Insights
- Lenora Dieyi - Modeling & Simulation Engineer - Investigator, Drug Product Development, GSK
5:00pm - 5:30pm
Topic TBD
4:30pm - 5:00pm
Developing a Robust Lyophilization Process for Manufacturing a Bispecific Antibody Drug Product
- Xiaofeng Lu, Ph.D., - Principal Research Scientist,, AbbVie
5:00pm - 5:30pm
A Systematic Approach to Responding to Microbial Contamination Events in Biopharmaceutical Manufacturing
- Hilary Chan - Principal QC Scientist, Takeda
4:30pm - 5:30pm
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 - Senior Director, Process Development, Genetix Biotherapeutics
4:30pm - 5:00pm
Case Study: Harnessing AI & Digitalization for Cell Therapy Manufacturing Optimization and Process Control
- Rashed Harun - Scientist, Genentech
5:00pm - 5:30pm
Case Study from Arcellx: Application of MOI Titrations to Evaluate Vector Lots and Aid Process Decisions and Process Control
- Brian Murphy - VP Cell Process Science, Arcellx
4:30pm - 5:00pm
Effective Tech Transfer of Manufacturing Processes to CDMO Partners
- Hunter Reese - Senior Scientist, AskBio
5:00pm - 5:30pm
Analytical Control Strategy for Successful Method Transfer to Commercial Testing Lab
- Rajeev Boregowda - Associate Director, Bioassay & Molecular Analytical Development, Genomic Medicine CMC, Sanofi
4:30pm - 5:00pm
16:20 – 17:00 PANEL: Latinos in Bio Founder Showcase: Building Innovation Across Life Sciences—From MedTech to Biomanufacturing (Continued)
Showing 1 of 1 Streams
Break
5:30pm - 7:30pm
Networking Party at the Museum of Science
7:30pm - 7:35pm
Close of Day Two
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