Key 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
Agenda September 23, 2026: Main Conference Day One - ET (Eastern Time, GMT-05:00)
Agenda September 23, 2026: Main Conference Day One
- ET (Eastern Time, GMT-05:00)
8:00am - 9:00am60 mins
Registration Break
Registration and Morning Coffee
9:00am - 9:30am30 mins
Cell Line Development & Engineering
Engineering Targeted Integration (TI) CLD platforms with multiple landing pads: lessons learned from landing pad configurations, vector design, and selection strategies
- Natalia Cherepanova - Senior Scientist II, Abbvie
9:00am - 9:30am30 mins
Cell Culture & Upstream Processing
Building Robust Chemically Defined Media Processes: A QbD Framework for Critical Material Attribute Risk Management
- Hesam Mahjoubi - Senior Principal Scientist, Amgen
- Wade Nudson - Strategic Implementation Manager, MilliporeSigma
9:00am - 9:30am30 mins
Downstream Processing
KEYNOTE: Process Intensification Leveraging Integrated Continuous Purification and Pionic - From Vision to Reality
- Kevin Brower - Global Head of Purification Development, Sanofi
9:00am - 9:30am30 mins
Digital Biomanufacturing and Data Driven Operations
KEYNOTE: Transforming Biologics Manufacturing: Leveraging Predictive Analytics and Advanced Process Control for Next-Generation Operations
- Veera Padmanabhan - Head of Manufacturing Sciences & Technology, AstraZeneca
9:00am - 9:30am30 mins
CMC Strategy & Manufacturing Performance
KEYNOTE: The Molecule Looked Perfect - Why did CMC Pay The Price?
9:00am - 10:30am90 mins
Workshop 1: Potency Masterclass
Potency Masterclass
- Christopher Bravery - Consulting Regulatory Scientist, Advbiols
9:00am - 10:30am90 mins
Workshop 2: Mastering CDMO Partnerships & External Tech Transfers for Cell & Gene Therapies
Mastering CDMO Partnerships & External Tech Transfers for Cell & Gene Therapies
- James Blackwell - President and Principal Consultant, The Windshire Group, LLC
9:30am - 10:00am30 mins
Cell Line Development & Engineering
Engineering Vector-Cell Line Development Workflows to Accelerate Biopharma Development
- Dylan Frabutt - Research Scientist, Elanco
9:30am - 10:00am30 mins
Cell Culture & Upstream Processing
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, BioProcess Development, Alexion Pharmaceuticals
9:30am - 10:00am30 mins
Downstream Processing
Rapid Polishing Chromatography Optimization for Challenging Bispecific Antibodies Using Automated High Throughput Screening
- Lei Wang - Principal Scientist, Gilead Sciences
9:30am - 10:00am30 mins
Digital Biomanufacturing and Data Driven Operations
Advancing At-Line Analytics Through a Structured PAT Roadmap: An Industrial Case Study
- Yuxiang (Henry) Zhao - Senior Scientist, Bristol-Myers Squibb
9:30am - 10:00am30 mins
CMC Strategy & Manufacturing Performance
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 - 10:30am30 mins
Cell Line Development & Engineering
Sponsored Presentation
10:00am - 10:30am30 mins
Cell Culture & Upstream Processing
Comparative Study of Gamma and X-ray Irradiation on CHO Cell Culture Growth: Risk Analysis and Performance Evaluation
10:00am - 10:30am30 mins
Downstream Processing
Sponsored Presentation
10:00am - 10:30am30 mins
Digital Biomanufacturing and Data Driven Operations
Sponsored Presentation
10:00am - 10:30am30 mins
CMC Strategy & Manufacturing Performance
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
10:30am - 11:00am30 mins
Break
Morning Break
11:00am - 11:15am15 mins
Cell Line Development & Engineering
Morning Break
11:00am - 11:15am15 mins
Cell Culture & Upstream Processing
Morning Break
11:00am - 11:15am15 mins
Downstream Processing
Morning Break
11:00am - 11:15am15 mins
Digital Biomanufacturing and Data Driven Operations
Morning Break
11:00am - 11:15am15 mins
CMC Strategy & Manufacturing Performance
Morning Break
11:00am - 12:45pm105 mins
Workshop 1: Potency Masterclass
Potency Masterclass
- Christopher Bravery - Consulting Regulatory Scientist, Advbiols
11:00am - 12:45pm105 mins
Workshop 2: Mastering CDMO Partnerships & External Tech Transfers for Cell & Gene Therapies
Mastering CDMO Partnerships & External Tech Transfers for Cell & Gene Therapies
- James Blackwell - President and Principal Consultant, The Windshire Group, LLC
11:00am - 12:45pm105 mins
CGT: C-Level Forum
CGT: C-Level Forum - Invite Only
11:15am - 11:45am30 mins
Cell Line Development & Engineering
A high-fidelity, dual site-specific integration system in CHO cells by a Bxb1 recombinase
- Yifeng Xu - Principal Scientist, Pfizer
11:15am - 11:45am30 mins
Cell Culture & Upstream Processing
Data Automation and Model Predicted Control for Cell Culture
- Yi Li - Principal Scientist, Amgen, Inc.
11:15am - 11:45am30 mins
Downstream Processing
Scientific, Sustainability and Product Quality Assessment to Reduce Buffer Consumption on Platform Chromatography Steps
- Sarah Scully - Scientist, Purification Process Development, Pfizer
11:15am - 11:45am30 mins
Digital Biomanufacturing and Data Driven Operations
Advancing Raman chemometric models: A path to scalable and reliable bioprocess real-time monitoring and control
- Bingyu Kuan - Scientist II, Abbvie
11:15am - 11:45am30 mins
CMC Strategy & Manufacturing Performance
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 - 12:15pm30 mins
Cell Line Development & Engineering
Optimizing the clone screening process within cell line development for biologics
- Tania Chakraborty Kelly - Senior Scientist, Merck
11:45am - 12:15pm30 mins
Cell Culture & Upstream Processing
Achieving product quality targets while maintaining high titer in CHO cell culture processes
- Aditya Walvekar - Scientist, Genentech
11:45am - 12:15pm30 mins
Downstream Processing
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.
11:45am - 12:15pm30 mins
Digital Biomanufacturing and Data Driven Operations
Transforming Biomanufacturing: Why Architecture Must Precede Analytics
- Martin Kockx - Principal Manufacturing Systems Engineer, Vertex Pharmaceuticals
11:45am - 12:15pm30 mins
CMC Strategy & Manufacturing Performance
Advancing dual-payload bispecific ADCs: Strategies to overcome process and quality challenges
- Yang Li Ph.D. - Vice President, CMC Development, Altruist Biologics
12:15pm - 12:45pm30 mins
Cell Line Development & Engineering
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
12:15pm - 12:45pm30 mins
Cell Culture & Upstream Processing
Boosting Productivity with Intensified N 1 Perfusion and High-Seed HILVOP Operation
- Alaina Anand - Scientist, Upstream Process Development, Bioprocess R & D, Pfizer
12:15pm - 12:45pm30 mins
Downstream Processing
Digital Twin-Enabled Control of Ion Exchange Chromatography for Robust mAb Purification
- Ran Chen - Associate Director of Process Development Downstream, Henlius Bioscience
12:15pm - 12:45pm30 mins
Digital Biomanufacturing and Data Driven Operations
Qualification of mechanistic models in biopharmaceutical process development
- Till Briskot - Senior Scientist, Boehringer Ingelheim
12:15pm - 12:45pm30 mins
CMC Strategy & Manufacturing Performance
Optimizing Downstream Processes for Non-Platform Molecules
- Wei Lu - Senior Staff Engineer, Takeda Pharmaceuticals
12:45pm - 1:00pm15 mins
Break
Transition To Lunch Presentations
1:00pm - 1:45pm45 mins
Scientific Lunch Presentation 1
Lunch Slot 1
1:00pm - 1:45pm45 mins
Scientific Lunch Presentation 2
Lunch Slot 2
1:00pm - 1:45pm45 mins
Scientific Lunch Presentation 3
Biologic Stability Enhancement: Formulation Strategies and Excipients
- Jinghan Li - Applications Scientist, Croda Inc.
1:00pm - 1:45pm45 mins
Scientific Lunch Presentation 4
From Complexity to Confidence: De-risking Bispecific Antibody Development
- Daniel Buckley - Senior Director, Process Development, Samsung Biologics
1:00pm - 1:45pm45 mins
Scientific Lunch Presentation 5
Lunch Slot 5
1:00pm - 1:20pm20 mins
Scientific Lunch Presentation 6
CLD Scalable Automation in Protein Therapies
- Alicia Barker - Cell Line Development- Scientist I, Just-Evotec
1:00pm - 1:45pm45 mins
Scientific Lunch Presentation 7
Lunch Slot 7
1:20pm - 1:45pm25 mins
Scientific Lunch Presentation 6
Osmolality as a Critical Quality Attribute: Evidence from a Multi Site Study
- Benjamin Duckless - Field Application Scientist, Nova Biomedical
1:45pm - 2:00pm15 mins
Break
Lunch Networking
2:00pm - 2:30pm30 mins
Cell Line Development & Engineering
Reimagining Vaccine Production: Automated Cell-Free Biomanufacturing for Distributed Rapid Response
- Jonathan Jones - Manager, Microbial-Upstream, CPI
2:00pm - 2:30pm30 mins
Cell Culture & Upstream Processing
How gassing strategies and specifically pCO2 impact production CHO cell culture
- Jesse Fisher - Senior Associate Scientist, Gilead
2:00pm - 2:30pm30 mins
Downstream Processing
PANEL DISCUSSION: Scaling Downstream Processes: From Lab to GMP Manufacturing
- Alpana Naresh, Ph.D. - Chief Manufacturing Officer, Hinge Bio, Inc.
- Jin Yu - Senior Scientist, Process Development Downstream, Amgen
2:00pm - 2:30pm30 mins
Digital Biomanufacturing and Data Driven Operations
Development of a Mechanistic Model for Predicting Dissolved pCO2 in Mammalian Cell Culture Processes
- Alex Vaca - Senior Engineer II, Biogen
2:00pm - 2:30pm30 mins
CMC Strategy & Manufacturing Performance
Stability of protein-based therapeutics (i.e. mAbs, ADCs, AOCs, LNPs, peptides, etc.) during freeze-thaw studies
2:00pm - 2:40pm40 mins
Cell & Gene Keynote Plenary
Keynote Panel Discussion- Big Pharma’s Cell and Gene Therapies Wish List: Investment Priorities and Emerging Opportunities
- Todd McDevitt - Vice President, Cell Therapy, Genentech
- Kevin Cognetti - Head of Corporate Strategy, Kite Pharma
- Angela Moore - VP, US GM, CAR-T Immunology and Oncology, Novartis
2:30pm - 3:00pm30 mins
Cell Line Development & Engineering
Optimizing cell line development technologies for high-speed and efficient cell line engineering
- Thomas Jostock, PhD - Associate Director, Novartis
2:30pm - 3:00pm30 mins
Cell Culture & Upstream Processing
PANEL DISCUSSION: Sensors for Robust Upstream Processes - When Sensors Help and When To Stop
- Alex Williams - Scientist, Biologics Development, Bristol-Myers Squibb
- Jacob Crowe, PhD - Associate Director of Technical Services, Hamilton Company
2:30pm - 3:00pm30 mins
Downstream Processing
Evaluation of a High-Throughput Convective Chromatography Technology for Developing mRNA Affinity Purification
- Daniel Yur - Senior Scientist, Merck
2:30pm - 3:00pm30 mins
Digital Biomanufacturing and Data Driven Operations
KEYNOTE: Accelerating Biologics Development Through Advanced Analytics and Digital Transformation
- Christian Airiau, Ph.D - Global Head, Data Sciences, Sanofi
2:30pm - 3:00pm30 mins
CMC Strategy & Manufacturing Performance
CMC challenges associated with highly potent and difficult-to-manufacture bispecific antibodies
- Arvind Srivastava, Ph.D. - Senior Vice President, ThirdArcBio
2:40pm - 3:20pm40 mins
Cell & Gene Keynote Plenary
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
- Khandan Baradaran - Principal, Mill Creek Consulting LLC
3:00pm - 3:30pm30 mins
Cell Line Development & Engineering
AI-Enabled Multivariate Clone Selection for Enhanced Cell Line Development
- Brian R. Berquist, PhD - Chief Scientific Officer, Wheeler Bio
3:00pm - 3:30pm30 mins
Cell Culture & Upstream Processing
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
3:00pm - 3:30pm30 mins
Downstream Processing
Sponsored Presentation
3:00pm - 3:30pm30 mins
Digital Biomanufacturing and Data Driven Operations
Bridging the Gap Between Upstream and Downstream Process Automation by Integrating an Autosampling Solution and the Connected Lab
- Joseph Hunziker - Process Characterization and Technology Scientist, Regeneron
- David Hansen - Principal Engineer, MilliporeSigma
3:00pm - 3:30pm30 mins
CMC Strategy & Manufacturing Performance
A Toolbox for Success: Processing and Formulating High Concentration Monoclonal Antibodies
- Christopher Marlein - Senior Principal Scientist, Process Development, FUJIFILM Biotechnologies
3:20pm - 4:00pm40 mins
Cell & Gene Keynote Plenary
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.
3:30pm - 4:00pm30 mins
Cell Line Development & Engineering
Afternoon Break and Grand Opening of the Exhibit Hall
3:30pm - 4:00pm30 mins
Cell Culture & Upstream Processing
Afternoon Break and Grand Opening of the Exhibit Hall
3:30pm - 4:00pm30 mins
Downstream Processing
Afternoon Break and Grand Opening of the Exhibit Hall
3:30pm - 4:00pm30 mins
Digital Biomanufacturing and Data Driven Operations
Afternoon Break and Grand Opening of the Exhibit Hall
3:30pm - 4:00pm30 mins
CMC Strategy & Manufacturing Performance
Afternoon Break and Grand Opening of the Exhibit Hall
Afternoon Break
4:00pm - 4:50pm50 mins
Break
Afternoon Break and Grand Opening of the Exhibit Hall
4:50pm - 5:00pm10 mins
BPI Plenary Keynote
Welcome to BWB Day 1/ Chairperson’s Opening Remarks
4:50pm - 5:00pm10 mins
Exhibit Hall Roundtable Sessions
Afternoon Break
4:50pm - 5:00pm10 mins
CGT Live Labs Tour in Exhibit Hall
Afternoon Break
5:00pm - 5:45pm45 mins
BPI Plenary Keynote
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
5:00pm - 5:30pm30 mins
Exhibit Hall Roundtable Sessions
CGT Exhibit Hall Roundtable Discussions
- Thorsten Gorba - VP, Process & Analytical Development, Aspen Neuroscience, Inc.
- Scott Jeffers - Chief Technology Officer, GenSight Biologics
5:00pm - 5:30pm30 mins
CGT Live Labs Tour in Exhibit Hall
CGT Live Labs Tour in Exhibit Hall
5:45pm - 7:15pm90 mins
Break
Networking Drinks
7:15pm - 7:20pm5 mins
Break
Close of Day One
* 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。