September 22-25, 2026 as part of Biotech Week Boston
Hynes Convention CenterBoston, USAKey Sessions
Jon Coffman
PLENARY KEYNOTE: Integrated and Continuous Bioprocessing: what’s holding us back, and where do we go from here?
Astra Zeneca
Veera Padmanabhan
KEYNOTE: Transforming Biologics Manufacturing: Leveraging Predictive Analytics and Advanced Process Control for Next-Generation Operations
AstraZeneca
Christian Airiau, Ph.D
KEYNOTE: Accelerating Biologics Development Through Advanced Analytics and Digital Transformation
Sanofi
Todd McDevitt
Keynote Panel Discussion- Big Pharma’s Cell and Gene Therapies Wish List: Investment Priorities and Emerging Opportunities
Genentech
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Agenda September 23, 2026: Main Conference Day One - ET (Eastern Time, GMT-05:00)
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Agenda September 23, 2026: Main Conference Day One - ET (Eastern Time, GMT-05:00)
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Showing 1 of 1 Streams
Registration Break
8:00am - 9:00am
Registration and Morning Coffee
Showing 7 of 7 Streams
Cell Line Development & Engineering
Cell Culture & Upstream Processing
Downstream Processing
Digital Biomanufacturing and Data Driven Operations
CMC Strategy & Manufacturing Performance
Workshop 1: Potency Masterclass
Workshop 2: Mastering CDMO Partnerships & External Tech Transfers for Cell & Gene Therapies
9:00am - 9:30am
KEYNOTE: The State of CLD – Where We Are and Why It Still Takes Too Long
9:30am - 10:00am
Gene to FIH CLD: How to cut months without downstream chaos
- Dylan Frabutt - Research Scientist, Elanco
10:00am - 10:30am
Sponsored Presentation
9:00am - 9:30am
KEYNOTE: Where Upstream Value is Shifting: From Titre-Chasing To QbD in the Bioreactor
9:30am - 10:00am
Seed Train Process Intensification Using Ultra-High Cell Density (UHCD) Banking to Enable Direct Inoculation and Reduce Seed Train Complexity
- Rajlaxmi Deshpande - Associate Scientist II, Alexion Pharmaceuticals
10:00am - 10:30am
Comparative Study of Gamma and X-ray Irradiation on CHO Cell Culture Growth: Risk Analysis and Performance Evaluation
9:00am - 9:30am
KEYNOTE: Process Intensification Leveraging Integrated Continuous Purification and Pionic – From Vision to Reality
- Kevin Brower - Global Head of Purification Development, Sanofi
9:30am - 10:00am
Rapid Polishing Chromatography Optimization for Challenging Bispecific Antibodies Using Automated High Throughput Screening
- Lei Wang - Principal Scientist, Gilead Sciences
10:00am - 10:30am
Sponsored Presentation
9:00am - 9:30am
KEYNOTE: Transforming Biologics Manufacturing: Leveraging Predictive Analytics and Advanced Process Control for Next-Generation Operations
- Veera Padmanabhan - Head of Manufacturing Sciences & Technology, AstraZeneca
9:30am - 10:00am
PAT and product quality toolbox study
- Bingyu Kuan - Scientist II, Abbvie
10:00am - 10:30am
Sponsored Presentation
9:00am - 9:30am
KEYNOTE: The Molecule Looked Perfect – Why did CMC Pay The Price?
- Matthew Rittler - Strategic Innovative Leader in Biologics Manufacturing Operations, AstraZeneca
9:30am - 10:00am
From Bench to Bioprocess: Overcoming Challenges in the Evolving Landscape of Plasmid Manufacturing for Cell and Gene Therapy
- Alois Jungbauer - Professor, Dept. of Biotechnology, BOKU University (BOKU)
10:00am - 10:30am
Sponsored Presentation
9:00am - 10:30am
Potency Masterclass
This interactive workshop will run from 9am – 12:45pm.
Through a series of presentations, case studies, interactive discussion and exercises this workshop will delve deeply into the underlying science of developing potency assays.
Some of the topics to be discussed include:
- Overview of what potency is, and what it is not
- Considerations when qualifying and validating bioassays
- From initial ideas, through characterisation to the final potency method
- Clinical correlation
- Regulator objections and why
- Examples of potency assays for approved products
- Examples of a cell and gene therapy potency assays for various product types
- Christopher Bravery - Consulting Regulatory Scientist, Advbiols
9:00am - 10:30am
Mastering CDMO Partnerships & External Tech Transfers for Cell & Gene Therapies
This interactive workshop will run from 9am – 12:45pm.
Through a series of presentations, case studies and interactive discussions and exercises this course will focus on CDMO oversight- selection, negotiation, tech transfer and life cycle management specifically for cell and gene therapy products.
Some of the topics to be discussed include:
- CDMO Selection: Models and Process
- Contract and Quality Agreement Negotiation
- Tech Transfer: Best practices and risk management for external tech transfers
- Knowledge Management and Digital Transformation in Tech Transfer
- Quality Assurance and Quality Control
- Life Cycle & Relationship Management
- James Blackwell - President and Principal Consultant, The Windshire Group, LLC
Showing 1 of 1 Streams
Break
10:30am - 11:00am
Morning Break
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
Workshop 1: Potency Masterclass
Workshop 2: Mastering CDMO Partnerships & External Tech Transfers for Cell & Gene Therapies
CGT: C-Level Forum
11:00am - 11:15am
Morning Break
11:15am - 11:45am
A high-fidelity, dual site-specific integration system in CHO cells by a Bxb1 recombinase
- Yifeng Xu - Principal Scientist, Pfizer
11:45am - 12:15pm
Optimizing the clone screening process within cell line development for biologics
- Tania Chakraborty Kelly - Senior Scientist, Merck
12:15pm - 12:45pm
Establishment and Application of a Novel CHO Cell Line (CHO-MK) in Antibody Manufacturing Processes
- Tomohiro Makino - Senior Director, Head of Cell Line Development at Bioprocess Technology Research Laboratory II, Daiichi Sankyo
11:00am - 11:15am
Morning Break
11:15am - 11:45am
Data Automation and Model Predicted Control for Cell Culture
- Yi Li - Principal Scientist, Amgen, Inc.
11:45am - 12:15pm
Achieving product quality targets while maintaining high titer in CHO cell culture processes
- Aditya Walveka - Scientist, Genentech
12:15pm - 12:45pm
Boosting Productivity with Intensified N 1 Perfusion and High-Seed HILVOP Operation
- Alaina Anand - Scientist, Upstream Process Development, Bioprocess R & D, Pfizer
11:00am - 11:15am
Morning Break
11:15am - 11:45am
Scientific, Sustainability and Product Quality Assessment to Reduce Buffer Consumption on Platform Chromatography Steps
- Sarah Scully - Scientist, Purification Process Development, Pfizer
11:45am - 12:15pm
Process Development to GMP Implementation of Raman Spectroscopy as a PAT Tool for the Purification of Protein Based Therapeutics
- Christina Passno - Senior Staff Engineer, Regeneron Pharmaceuticals, Inc.
12:15pm - 12:45pm
Digital Twin–Enabled Control of Ion Exchange Chromatography for Robust mAb Purification
- Ran Chen - Associate Director of Process Development Downstream, Henlius Bioscience
11:00am - 11:15am
Morning Break
11:15am - 11:45am
Advancing At-Line Analytics Through a Structured PAT Roadmap: An Industrial Case Study
- Yuxiang (Henry) Zhao - Senior Scientist, Bristol-Myers Squibb
11:45am - 12:15pm
Transforming Biomanufacturing: Why Architecture Must Precede Analytics
- Martin Kockx - Principal Manufacturing Systems Engineer, Vertex Pharmaceuticals
12:15pm - 12:45pm
Qualification of mechanistic models in biopharmaceutical process development
- Till Briskot - Senior Scientist, Boehringer Ingelheim
11:00am - 11:15am
Morning Break
11:15am - 11:45am
Fireside Chat: If We’d Known Then What We Know Now: Hard Lessons from Novel Modalities in CMC
- Alpana Naresh, Ph.D. - Chief Manufacturing Officer, Hinge Bio, Inc.
- Siddhartha (Sidd) Shrivastava, PhD - SVP, Head of CMC and Global Technical Operations, Cue Biopharma
11:45am - 12:15pm
Advancing dual-payload bispecific ADCs: Strategies to overcome process and quality challenges
- Yang Li Ph.D. - Vice President, CMC Development, Altruist Biologics
12:15pm - 12:45pm
Optimizing Downstream Processes for Non-Platform Molecules
- Wei Lu - Senior Staff Engineer, Takeda Pharmaceuticals
11:00am - 12:45pm
Potency Masterclass
- Christopher Bravery - Consulting Regulatory Scientist, Advbiols
11:00am - 12:45pm
Mastering CDMO Partnerships & External Tech Transfers for Cell & Gene Therapies
- James Blackwell - President and Principal Consultant, The Windshire Group, LLC
11:00am - 12:45pm
CGT: C-Level Forum - Invite Only
The CGT C-Level Forum provides a unique, powerful and valuable space for candidly sharing ideas and experiences between executives of ~20 CGT therapeutic development companies. The forum is designed to foster new ideas and create new relationships between attendees so that they can leave with tangible outcomes and that will drive their businesses and the sector forward.
An exclusive invite-only session, in a closed room setting, the forum will include 2-3 case studies discussing the right approach to engage and partner with pharma and industry. It will also include general discussion focussed on brainstorming solutions to the most pressing and current challenges of CEO/CSO/CBO/CMOs in the CGT sector.
Showing 1 of 1 Streams
Break
12:45pm - 1:00pm
Transition To Lunch Presentations
Showing 7 of 7 Streams
Scientific Lunch Presentation 1
Scientific Lunch Presentation 2
Scientific Lunch Presentation 3
Scientific Lunch Presentation 4
Scientific Lunch Presentation 5
Scientific Lunch Presentation 6
Scientific Lunch Presentation 7
1:00pm - 1:45pm
Lunch Slot 1
1:00pm - 1:45pm
Lunch Slot 2
1:00pm - 1:45pm
Lunch Slot 3
1:00pm - 1:45pm
Lunch Slot 4
1:00pm - 1:45pm
Lunch Slot 5
1:00pm - 1:45pm
Lunch Slot 6
1:00pm - 1:45pm
Lunch Slot 7
Showing 1 of 1 Streams
Break
1:45pm - 2:00pm
Lunch Networking
Showing 6 of 6 Streams
Cell Line Development & Engineering
Cell Culture & Upstream Processing
Downstream Processing
Digital Biomanufacturing and Data Driven Operations
CMC Strategy & Manufacturing Performance
Cell & Gene Keynote Plenary
2:00pm - 2:30pm
Reimagining Vaccine Production: Automated Cell-Free Biomanufacturing for Distributed Rapid Response
- Jonathan Jones - Manager, Microbial-Upstream, CPI
2:30pm - 3:00pm
Faster Growing Hosts: Speed versus Product Quality Trade Offs
- Thomas Jostock, PhD - Associate Director, Novartis
3:00pm - 3:30pm
Trace Element Prediction - Data-Driven Understanding and Control of Impurities in Cell Culture Media
- Scott Wilson - Director of Raw Material & Manufacturing Innovation R&D, MilliporeSigma
3:30pm - 4:00pm
Afternoon Break and Grand Opening of the Exhibit Hall
2:00pm - 2:30pm
How gassing strategies and specifically pCO2 impact production CHO cell culture
- Jesse Fisher - Senior Associate Scientist, Gilead
2:30pm - 3:00pm
PANEL DISCUSSION: Sensors for Robust Upstream Processes – When Sensors Help and When To Stop
- Alex Williams - Senior Associate Scientist, Biologics Development, Bristol-Myers Squibb
3:00pm - 3:30pm
Simplifying custom media from development to GMP with an end-to-end approach
- Duncan Omune - Senior Director of MSAT, Lonza
- Sanjay Kumar - Senior Subject Matter Expert, Lonza Bioscience, USA
3:30pm - 4:00pm
Afternoon Break and Grand Opening of the Exhibit Hall
2:30pm - 3:00pm
Evaluation of a High-Throughput Convective Chromatography Technology for Developing mRNA Affinity Purification
- Daniel Yur - Senior Scientist, Merck
3:00pm - 3:30pm
Sponsored Presentation
3:30pm - 4:00pm
Afternoon Break and Grand Opening of the Exhibit Hall
2:00pm - 2:30pm
Development of a Mechanistic Model for Predicting Dissolved pCO2 in Mammalian Cell Culture Processes
- Alex Vaca - Senior Engineer II, Biogen
2:30pm - 3:00pm
KEYNOTE: Accelerating Biologics Development Through Advanced Analytics and Digital Transformation
- Christian Airiau, Ph.D - Global Head, Data Sciences, Sanofi
3:00pm - 3:30pm
Sponsored Presentation
3:30pm - 4:00pm
Afternoon Break and Grand Opening of the Exhibit Hall
2:00pm - 2:30pm
Stability of protein-based therapeutics (i.e. mAbs, ADCs, AOCs, LNPs, peptides, etc.) during freeze-thaw studies
- Mike Lucas (pending final confirmation) - Senior Scientist, AbbVie
2:30pm - 3:00pm
CMC challenges associated with highly potent and difficult-to-manufacture bispecific antibodies
- Arvind Srivastava, Ph.D. - Senior Vice President, ThirdArcBio
3:00pm - 3:30pm
A Toolbox for Success: Processing and Formulating High Concentration Monoclonal Antibodies
3:30pm - 4:00pm
Afternoon Break and Grand Opening of the Exhibit Hall
2:00pm - 2:40pm
Keynote Panel Discussion- Big Pharma’s Cell and Gene Therapies Wish List: Investment Priorities and Emerging Opportunities
- Todd McDevitt - Vice President, Cell Therapy, Genentech
- Tyler Koop - Vice President, Global Commercial, Cell Therapy, Bristol Myers Squibb
2:40pm - 3:20pm
Investor Panel Discussion: Funding the Future- Investment Trends and Opportunities for Cell and Gene Therapies and Enabling Technologies
- Daniel Friedman - Managing Director, BroadOak Capital
- Laura Stoppel - Partner, RA Capital Management
- Christian Uhrich - Executive Investment Director, M Ventures
- Sebastien Latapie - Partner, AVANT BIO
3:20pm - 4:00pm
Keynote Presentation: Bridging Science and Regulation - Lessons Learnt from Developing the World’s First iPSC-derived Cardiomyocyte Patches
- Tadayuki Tanimura - Executive Vice President, Cuorips Inc.
Afternoon Break
Showing 1 of 1 Streams
Break
4:00pm - 4:50pm
Afternoon Break and Grand Opening of the Exhibit Hall
Showing 3 of 3 Streams
BPI Plenary Keynote
Exhibit Hall Roundtable Sessions
CGT Live Labs Tour in Exhibit Hall
4:50pm - 5:00pm
Welcome to BWB Day 1/ Chairperson’s Opening Remarks
5:00pm - 5:45pm
PLENARY KEYNOTE: Integrated and Continuous Bioprocessing: what’s holding us back, and where do we go from here?
- Jon Coffman - Executive Director of Bioprocess Technology and Engineering, Astra Zeneca
4:50pm - 5:00pm
Afternoon Break
5:00pm - 5:30pm
CGT Exhibit Hall Roundtable Discussions
- Roundtable 1: AI Revolution in CGT Manufacturing – Beyond the Hype: Where is it Having an Impact?
Leader: Thorsten Gorba, Vice President of Process Development at Aspen Neuroscience
- Roundtable 2: Navigating IITs in China
- Roundtable 3: Supply Chain Mastery: Architecting Success from Bench to Market
- Thorsten Gorba - VP, Process & Analytical Development, Aspen Neuroscience, Inc.
4:50pm - 5:00pm
Afternoon Break
5:00pm - 5:30pm
CGT Live Labs Tour in Exhibit Hall
Gain an insight into some of the most cutting- edge technology and services hitting today’s Cell & Gene Therapies market through a series of 10-minute product demos live at the exhibit booths.
If you are interested in presenting your technology or service as part of the live lab tour please contact Roshni Shah – Roshni.shah@informa.com for more information.
Showing 1 of 1 Streams
Break
5:45pm - 7:15pm
Networking Drinks
7:15pm - 7:20pm
Close of Day One
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