Key Sessions
Andrea Little
KEYNOTE: Engineering ADC Success from the Start: The Critical Role of Cell Culture
Pfizer
Jared Auclair, PhD
KEYNOTE: Biopharmaceutical Characterization in the Age of Artificial Intelligence: From Data to Decision
Northeastern University
Nelly Viseux
Keynote: Journey from R&D to Clinical Manufacturing
Regeneron
Robert Hofmeister
Keynote: Programming Immunity In Vivo: Targeted RNA–LNP Platforms for Precision CAR Engineering
CREATE Medicines
Agenda September 25, 2026: Main Conference Day Three - ET (Eastern Time, GMT-05:00)
Agenda September 25, 2026: Main Conference Day Three
- ET (Eastern Time, GMT-05:00)
8:00am - 8:50am50 mins
Registration Break
Registration and Morning Coffee
8:50am - 9:00am10 mins
Cell Line Development & Engineering
Chairperson
8:50am - 9:00am10 mins
Cell Culture & Upstream Processing
Chair
8:50am - 9:00am10 mins
Downstream Processing
Chair
8:50am - 9:00am10 mins
Digital Biomanufacturing and Data Driven Operations
Chair
8:50am - 9:00am10 mins
CMC Strategy & Manufacturing Performance
Chair
8:50am - 9:00am10 mins
Development of Emerging Cell & Gene Therapies
Chairperson’s Opening Remarks: Development of Emerging Cell & Gene Therapies
8:50am - 9:00am10 mins
Cell Therapy Manufacturing & Analytics
Chairperson’s Opening Remarks: Cell Therapy Manufacturing & Analytics
8:50am - 9:00am10 mins
Gene Therapy Manufacturing & Analytics
Chairperson’s Opening Remarks: Gene Therapy Manufacturing & Analytics
8:50am - 9:00am10 mins
CDMO Partnering & External Manufacturing
Registration Break
9:00am - 9:30am30 mins
Cell Line Development & Engineering
Fireside Chat: New Modalities, Old Playbook: Are Multispecifics and Gene Therapy Cell Lines Stuck in mAb Thinking?
- Yifeng Xu - Principal Scientist, Pfizer
9:00am - 9:30am30 mins
Cell Culture & Upstream Processing
The Age of Automation: Successful Design, Development, and Deployment of a Fully Automated, Bench-Scale Bioreactor Platform
- Brandon Veres - Staff Engineer, Regeneron
9:00am - 9:30am30 mins
Downstream Processing
Split, Switch, and Stitch: Generating multispecific antibodies using column based redox reactions
- Verzhiniya Aho - Senior Scientist, Pfizer
9:00am - 9:30am30 mins
Digital Biomanufacturing and Data Driven Operations
KEYNOTE: Biopharmaceutical Characterization in the Age of Artificial Intelligence: From Data to Decision
- Jared Auclair, PhD - Dean Northeastern University College of Professional Studies, Director of Bioinnovation, Northeastern University
9:00am - 9:30am30 mins
CMC Strategy & Manufacturing Performance
Critical Quality Attributes in Modern Biopharmaceutical Development: From Established mAbs to Emerging Modalities
- Elisabeth Krug - Executive Director, Eli Lilly & Company
9:00am - 9:30am30 mins
Development of Emerging Cell & Gene Therapies
Keynote: Journey from R&D to Clinical Manufacturing
- Nelly Viseux - Vice President, Cell Therapies Development, Manufacturing, Supply & Quality, Regeneron
9:00am - 9:30am30 mins
Cell Therapy Manufacturing & Analytics
Panel Discussion: Decentralized Manufacturing in Cell Therapy: Overcoming Implementation Challenges and Enhancing Patient-Centric Solutions
- Therese Choquette - Chief Technical Officer, Tigen Pharma SA
- Thorsten Gorba - VP, Process & Analytical Development, Aspen Neuroscience, Inc.
- Tatyana Matveeva - Director of cGMP Operations, Regenerative Cell Therapy, Massachusetts General Hospital and Harvard Medical School
9:00am - 9:30am30 mins
Gene Therapy Manufacturing & Analytics
Keynote Panel Discussion: Navigating BLA Success - Strategies for Streamlined Gene Therapy Approval Success
- Tiffany D Rau, PhD - Principal Consultant BioPharma Technical Consulting and Rau Consulting, Adjunct Professor Biochemistry and Cell Biology, University College Cork, Ireland
9:00am - 9:30am30 mins
CDMO Partnering & External Manufacturing
Shaping the Future of Pharma Outsourcing: Regulatory, Legislative, and Business Strategies for Success
- Gil Roth - Founder & President, Pharma & Biopharma Outsourcing Association
9:30am - 10:00am30 mins
Cell Line Development & Engineering
Rational Vector Design and Screening Strategies for Bispecific Cell Line Development via Random Integration
- Paul Rousseau - Sr. Engineer II, Cell Line Development, Biogen
9:30am - 10:00am30 mins
Cell Culture & Upstream Processing
KEYNOTE: Engineering ADC Success from the Start: The Critical Role of Cell Culture
- Andrea Little - Associate Research Fellow - Cell Culture, Pfizer
9:30am - 10:00am30 mins
Downstream Processing
ADC Purification and The Platform Gap
- Mark Shannon, Ph.D. - Associate Director of Operations, Abbvie
9:30am - 10:00am30 mins
Digital Biomanufacturing and Data Driven Operations
Accelerating Biologics Process Analytics through End-to-End Sample Testing Automation
- Pernesso Geffrard - Scientist, Bristol-Myers Squibb
9:30am - 10:00am30 mins
CMC Strategy & Manufacturing Performance
Forced degradation studies, understanding molecule liabilities and de-risking manufacturing during early-stage development
- Gregory Zarbis-Papastoitsis, Ph.D - Chief Process and Manufacturing Officer, Ankyra
9:30am - 10:00am30 mins
Development of Emerging Cell & Gene Therapies
Keynote: Programming Immunity In Vivo: Targeted RNA-LNP Platforms for Precision CAR Engineering
- Robert Hofmeister - Chief Scientific Officer, CREATE Medicines
9:30am - 10:00am30 mins
Cell Therapy Manufacturing & Analytics
Enabling sgRNA Release and Stability Testing with a ddPCR-Based Potency Assay
- Hugh Gannon - Associate Director, KSQ Therapeutics
9:30am - 10:00am30 mins
Gene Therapy Manufacturing & Analytics
From Vial to Brain: Demonstrating AAV Gene Therapy Stability During Convection-Enhanced Delivery
- Nathalie Clement - VP Vector Development for Translational Gene Therapies, Siren Biotechnology
9:30am - 10:00am30 mins
CDMO Partnering & External Manufacturing
Strategies for harmonizing vendor operational models and improving efficiency between internal R&D organizations and external partners
- May Zhu - Director, Takeda Pharmaceuticals
10:00am - 10:30am30 mins
Cell Line Development & Engineering
Sponsored Presentation
10:00am - 10:30am30 mins
Cell Culture & Upstream Processing
Sponsored Scientific Presentation
10:00am - 10:30am30 mins
Downstream Processing
Reducing Protein A Capture Costs in Commercial mAb Manufacturing: Two Technical Pathways
- Aaron Moulin - Field Applications Specialist, Ecolab Life Sciences
10:00am - 10:30am30 mins
Digital Biomanufacturing and Data Driven Operations
Sponsored Presentation
10:00am - 10:30am30 mins
CMC Strategy & Manufacturing Performance
Sponsored Presentation
10:00am - 10:30am30 mins
Development of Emerging Cell & Gene Therapies
Moving Gene Editing Beyond the Liver
- Devyn M. Smith - Chief Executive Officer, Arbor Biotechnologies
10:00am - 10:30am30 mins
Cell Therapy Manufacturing & Analytics
Sponsored Scientific Track Presentation: Application and Validation of Rapid Cell Analytical Technologies for Product Release at Scale
10:00am - 10:30am30 mins
Gene Therapy Manufacturing & Analytics
Sponsored Scientific Track Presentation
10:00am - 10:30am30 mins
CDMO Partnering & External Manufacturing
Sponsored Presentation
10:30am - 11:15am45 mins
Break
Morning Break
11:15am - 11:45am30 mins
Cell Line Development & Engineering
Right-First-Time Cell Line Development: Speed, Productivity, and Quality by Design
- Yizhou Zhou - Director, Cell Line Development & Engineering, Bristol-Myers Squibb
11:15am - 11:45am30 mins
Cell Culture & Upstream Processing
Upstream Matters for ADCs: Locking High-Performance Upstream to Simplify Downstream
- Xiaolin Zhang - Associate Principal Scientist, Merck & Co
11:15am - 11:45am30 mins
Downstream Processing
End-to-end high throughput platform leveraging resin tip technology to accelerate AAV purification process development
- Qingxuan Li - Principal Scientist, Sanofi
11:15am - 11:45am30 mins
Digital Biomanufacturing and Data Driven Operations
Artificial Intelligence Applications in the Modeling and Analysis of Biopharmaceutical Factory Digital Twins
- Joseph Pekny - Professor, Chemical Engineering, Purdue University
- Jonathan Forstrom - Director, Manufacturing Science and Technology, Sanofi
11:15am - 11:45am30 mins
CMC Strategy & Manufacturing Performance
A Practical Workflow for Assessing Glass Vial Performance in Drug Product Development
- Manasi Nawathe - Scientist I, Macrogenics
11:15am - 11:30am15 mins
Development of Emerging Cell & Gene Therapies
Development of Next Generation Cell Therapies for Autoimmune Disease
- Mayo Pujols - CTO, Kyverna
11:15am - 11:45am30 mins
Cell Therapy Manufacturing & Analytics
Culture and Non-Culture-Based Approaches to Cell Therapy Potency
- Ronnie Lum - Director Analytical Development, Analytical and Quality Control, BlueRock Therapeutics
11:15am - 11:45am30 mins
Gene Therapy Manufacturing & Analytics
Characterizing Adeno-associated viruses (AAV) by Micro-Electrophoresis
- Rishi Kothari - Process Development Engineer, Regeneron Pharmaceuticals
11:15am - 11:45am30 mins
CDMO Partnering & External Manufacturing
Tech Transfer Strategies for DS PPQ delivery at CMO Partners
- Kelly Wei - Associate Director, AstraZeneca
11:30am - 11:45am15 mins
Development of Emerging Cell & Gene Therapies
The Siren Experience: Advancing SRN-101 for High Grade Gliomas
- Lauren Kelly - Director of Translational Research, Siren Biotechnology
11:45am - 12:15pm30 mins
Cell Line Development & Engineering
Rebuilding CLD Without Legacy Constraints: A Strategy- and Data-Driven Case Study
- Sowmya Balasubramanian - Associate Director, Cell Line Development, Gilead Sciences
11:45am - 12:15pm30 mins
Cell Culture & Upstream Processing
A Solubility-Enabled Tyrosine Delivery Strategy for Robust Biologics Manufacturing
- Utsavi Sevak - Senior Associate Scientist, Bioprocess Development, Bristol-Myers Squibb
11:45am - 12:15pm30 mins
Downstream Processing
Reducing COG in Downstream Biologics Production
- Eashwar Rajaraman - Principal Scientist I, Novartis
11:45am - 12:15pm30 mins
Digital Biomanufacturing and Data Driven Operations
Fireside Chat: From Pilot to Plant: What It Really Takes To Scale Digital Biomanufacturing
- Tiffany D Rau, PhD - Principal Consultant BioPharma Technical Consulting and Rau Consulting, Adjunct Professor Biochemistry and Cell Biology, University College Cork, Ireland
11:45am - 12:15pm30 mins
CMC Strategy & Manufacturing Performance
Process Validation in Practice: Approaches, Acceleration Strategies, and Lessons Learned
- Jian Ren, Ph.D. - Principal Scientist, AbbVie
11:45am - 12:00pm15 mins
Development of Emerging Cell & Gene Therapies
Gene Therapy for Immune Reprogramming and the Treatment of Inflammatory Diseases
- Shahrooz Rabizadeh - CEO & Co-Founder, Sagittarius Bio, Inc
11:45am - 12:15pm30 mins
Cell Therapy Manufacturing & Analytics
Progress toward Standards and Reference Materials for Cell Viability
- Laura Pierce - Biomedical Engineer, NIST
11:45am - 12:15pm30 mins
Gene Therapy Manufacturing & Analytics
Machine Learning and Mechanistic Modeling Approaches Within Upstream Process Development to Improve AAV Product Quality
- Neil Templeton - Director, Upstream Process Development, Solid Biosciences
11:45am - 12:15pm30 mins
CDMO Partnering & External Manufacturing
Fireside Chat: Overcoming Supply Chain Disruptions: Insights from the Pandemic
12:00pm - 12:15pm15 mins
Development of Emerging Cell & Gene Therapies
Case Studies: Development of Next-Gen Cell & Gene Therapies - Overcoming Challenges and Breakthroughs
12:15pm - 12:45pm30 mins
Cell Line Development & Engineering
Sponsored Presentation
12:15pm - 12:45pm30 mins
Cell Culture & Upstream Processing
Sponsored Scientific Presentation
12:15pm - 12:45pm30 mins
Downstream Processing
Sponsored Presentation
12:15pm - 12:45pm30 mins
Digital Biomanufacturing and Data Driven Operations
Sponsored Presentation:
12:15pm - 12:45pm30 mins
CMC Strategy & Manufacturing Performance
Sponsored Presentation
12:15pm - 12:45pm30 mins
Development of Emerging Cell & Gene Therapies
Sponsored Scientific Track Presentation
12:15pm - 12:45pm30 mins
Cell Therapy Manufacturing & Analytics
Sponsored Scientific Track Presentation: Latest Advances in Cryopreservation Techniques and Maintaining Cell Viability at Scale
12:15pm - 12:35pm20 mins
Gene Therapy Manufacturing & Analytics
Predictive Modeling and Process Interdependency: A Strategic Approach to Late-Stage AAV Purification Development
- Chen Wang - Principal Scientist GMU CMC Purification Process Development, Sanofi
12:15pm - 12:45pm30 mins
CDMO Partnering & External Manufacturing
Sponsored Presentation
12:45pm - 2:00pm75 mins
Break
Lunch
2:00pm - 2:30pm30 mins
Cell Line Development & Engineering
Causal intelligence through multiplex cell line engineering
- Stefan Schmidt - Advisor, Optigenomics Ltd
2:00pm - 2:30pm30 mins
Cell Culture & Upstream Processing
How targeted process optimization can improve efficiency and robustness and improve overall protein yield through controlled bioprocessing conditions
- Ramona Cheriaparambil - PhD Student, University of Massachusetts Amherst
2:00pm - 2:30pm30 mins
Downstream Processing
A Case Study
- Stefano Menegatti - Professor, Chemical and Biomolecular Engineering, NC State University, North Carolina State University
2:00pm - 2:30pm30 mins
Digital Biomanufacturing and Data Driven Operations
From Copilots to Agents: A GMP-Ready Framework for AI Adoption across CMC and Bioprocessing
- Alexa Kopf - Consultant, BioProcess Technology Group (BDO) and Founder, LabScale AI
2:00pm - 2:30pm30 mins
CMC Strategy & Manufacturing Performance
Unlocking the Regenerative Potential of Exosomes: From Bioprocess Development to Advanced Drug Delivery Platform
- Lior Shaltiel - CEO, NurExone Biologic
2:00pm - 2:05pm5 mins
Cell & Gene Keynote Plenary
Chairperson’s Opening Remarks
2:00pm - 2:30pm30 mins
CDMO Partnering & External Manufacturing
Cost of Goods (COG) Optimization: Strategies for External Manufacturing
2:05pm - 2:45pm40 mins
Cell & Gene Keynote Plenary
Keynote Patient Fire Side Chat: Amplifying Patient Voices- Patient Centric CGT Innovation
2:30pm - 3:30pm60 mins
Cell Line Development & Engineering
PANEL DISCUSSION: Precision Cell Line Engineering for Biologics: Focused Innovations and Applications
- Stefan Schmidt - Advisor, Optigenomics Ltd
- Yifeng Xu - Principal Scientist, Pfizer
2:30pm - 3:00pm30 mins
Cell Culture & Upstream Processing
Cell Culture Control of Thiol Cap-State for Consistent DAR in Engineered-Cysteine ADCs
- Jin Xu - Senior Scientist, AstraZeneca
2:30pm - 3:00pm30 mins
Downstream Processing
Novel Approaches in Affinity Chromatography & Process Design
- Gavin Wild - Associate Director, UCB
2:30pm - 3:30pm60 mins
Digital Biomanufacturing and Data Driven Operations
PANEL DISCUSSION: The Future of Facilities: Enabling Autonomous Bioprocessing
- Udayanath Aich, Ph.D. - Associate Director, Bristol Myers Squibb
2:30pm - 3:30pm60 mins
CMC Strategy & Manufacturing Performance
PANEL DISCUSSION: Strategies to Future-Proof Manufacturing Processes for Large-Scale Production
- Bharat Dixit - Chief Technology Officer, ClearB Therapeutics
- Tiffany D Rau, PhD - Principal Consultant BioPharma Technical Consulting and Rau Consulting, Adjunct Professor Biochemistry and Cell Biology, University College Cork, Ireland
- Deniz Temel, PhD - Director, CMC & Analytical Development, Third Arc Bio
2:30pm - 3:00pm30 mins
CDMO Partnering & External Manufacturing
Navigating Regulatory Complexities in External Manufacturing: A Case Study
- Bharat Dixit - Chief Technology Officer, ClearB Therapeutics
2:45pm - 3:30pm45 mins
Cell & Gene Keynote Plenary
Keynote Presentation: Lessons Learnt of the Path to Commercialisation
- Silviu Itescu - CEO, Mesoblast
3:00pm - 3:30pm30 mins
Cell Culture & Upstream Processing
PANEL DISCUSSION: Shared Pain Points Between Upstream and Downstream Processes
- Ken Lee - Director, AstraZeneca
- Yi Wang - Senior Scientist, Merck
- Renée Hart - President & Chief Business Officer, LumaCyte
3:00pm - 3:30pm30 mins
Downstream Processing
Guiding Robocolumn Use in Process Development: FAQs, Limitations, and Fit-for-Purpose Scope
- Skaison Kim - Sr. Staff Engineer, Process Development, Takeda
3:00pm - 3:30pm30 mins
CDMO Partnering & External Manufacturing
PANEL DISCUSSION: Building Resilient CDMO Partnerships: Lessons from Industry Leaders
3:30pm - 3:35pm5 mins
Break
Close of Conference
* 活动内容有可能不事先告知作更动及调整。