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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Showing 1 of 1 Streams
Fun Run
6:45am - 7:45am
Biotech Week Boston 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, The 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
Panel Discussion: Scale-Up Strategies: Navigating the Road Ahead for In Vivo CAR-T
- Christopher Bravery - Consulting Regulatory Scientist, Advbiols
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
- 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
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
- Laura Greenfield - Bioprocessing Expert, .
11:30am - 12:00pm
Metabolic Engineering of CHO Cells Towards Cysteine Prototrophy and Systems Analysis of The Ensuing Phenotype
- Mariah Brantley - Senior Scientist in Upstream Process Development within Bioprocess R&D, 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
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
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
11:25am - 11:30am
Chairperson Remarks
- Madiha Khurshid - Senior Scientist, Amgen
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
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, Bora Biologics
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
11:45am - 12:30pm
Designing for the Unknown: How Do You Plan CGT Manufacturing Facilities When the Patient Count is a Moving Target?
- Samir Gondalia - Director, Business Development and Marketing, Hart Companies
- Kristi Ballard - Senior Director, Cell Therapy Manufacturing, Bristol Myers Squibb
- Adam Bartley - Chief Operating Officer, Chrysalis
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
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
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
- Zach Stanley - Executive Director, Bioversity
- Steve Favaloro - Board of Advisors, Life Science Cares Boston
Showing 3 of 3 Streams
Break
Innovation and Community Stage (Exhibit Hall)
Live Labs in Exhibit Hall
Live Lab 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 Solution Consulting, 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
Development of Emerging Cell & Gene Therapies
Cell Therapy Manufacturing & Analytics
Gene Therapy Manufacturing & Analytics
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
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
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
2:10pm - 2:15pm
Chairperson's Remarks
- Madiha Khurshid - Senior Scientist, Amgen
2:15pm - 2:45pm
Predict, Prevent, Perfect: The New Era of Intelligent Biologics Manufacturing
2:45pm - 3:15pm
FEATURED PRESENTATION: Optimizing Upstream Processes Through Digital Approaches
- Michael Betenbaugh - Professor, Department of Chemical & Biomolecular Engineering, Johns Hopkins University
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
Establishment of Limit of In Vitro Cell Age (LIVCA) for Biologics Manufacturing Process
- Sharyn Farnsworth - Director of Upstream Process Development, FUJIFILM Diosynth Biotechnologies
2:40pm - 2:45pm
Chairperson’s Opening Remarks: Development of Emerging Cell & Gene Therapies
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
Practical Applications of AI and Machine Learning in GMP Manufacturing
- Jainish Kothari - Cell Therapy GMP Specialist, Bayer Pharmaceuticals
3:15pm - 3:45pm
Case Study: Harnessing AI & Digitalization for Cell Therapy Manufacturing and Development
- Rashed Harun - Scientist, Genentech
2:10pm - 2:15pm
Chairperson’s Opening Remarks: Gene Therapy Manufacturing & Analytics
2:15pm - 2:45pm
High Throughput Process Development for Anion Exchange Chromatography of AAV
- Lukas Maloney - Process Development Engineer I, Regeneron
2:45pm - 3:15pm
Effective Tech Transfer of Manufacturing Processes to CDMO Partners
- Hunter Reese - Senior Scientist, AskBio
2:10pm - 2:20pm
From Lab to Launch: The Right Systems That Scale with Every Stage
- Amy Vasquez - Systems Architect, Strategic Information Group
2:20pm - 3:00pm
PANEL: The Value-Alignment Era: Building Durable Careers in a Shifting Policy Landscape
- Joanne Kamens - CEO, Women In Bio
- Lisa Stanek - Senior Vice President, R&D, Life Biosciences and EWIB Volunteer
- Cissy Young - Managing Director, Life Sciences & Venture Capital,, True Search
- Nicola Ambler - Co-Founder, The CGT Circle
3:00pm - 3:20pm
Single Use Support
- Dominic Lobgesang - Senior Expert Product Management Equipment, Single Use Support
3:20pm - 3:25pm
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
- Andrew Rodriguez - Interim CEO & C-suite Advisor, AJS Consulting Company LLC
- Salvador Diaz-Bazan - Co-founder, CFO, Bonds Biosystems
- Kristina Fontanez - Founder, CEO, Adept Scientific
- Maria Artunduaga - Founder, CEO, Samay
Showing 8 of 8 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
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
5:00pm - 5:30pm
An Integrated In Vitro Assessment of Biologic Formulations for Subcutaneous Administration
- 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
Defining Digital Twins in a Biomanufacturing Environment
- Kim Wilson - Business Value Consultant Expert, Life Sciences & Healthcare Industry, Dassault Systèmes' Life Sciences & Healthcare
- Vicki Pearson - Global Life Science Segment Director, Schneider Electric
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
- Allen Horton - Head of External Manufacturing, 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
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
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 - 6:00pm
Coaches to Networking Party
6:00pm - 9:30pm
Biotech Week Boston Festival Party @ The Museum of Science
Join us for our exclusive evening reception at the iconic Boston Museum of Science! Sip on refreshing beverages and savor a selection of delicious light bites while reconnecting with fellow Biotech Week Boston attendees, all set to the backdrop of live music that'll keep the energy flowing.
But that's just the beginning! Explore the museum after hours and immerse yourself in world-class exhibits, including a jaw-dropping life-sized T. Rex skeleton that'll transport you back millions of years. And don't miss the electrifying lightning show featuring the world's largest Van de Graaff Generator—a spectacular display that's guaranteed to leave you buzzing!
This is more than just networking—it's an evening of discovery, connection, and pure excitement.
Roundtrip transportation is provided from the Hynes Convention Center, as the Museum is about 2 miles away. Badges are required for entry.
9:30pm - 9:35pm
Close of Day Two
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