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
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Agenda September 25, 2026: Main Conference Day Three - ET (Eastern Time, GMT-05:00)
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Agenda September 25, 2026: Main Conference Day Three - ET (Eastern Time, GMT-05:00)
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Streams
Showing 1 of 1 Streams
Registration Break
8:20am - 8:50am
Registration and Morning Coffee
Showing 10 of 10 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
CDMO Partnering & External Manufacturing
Innovation and Community Stage (Exhibit Hall)
8:50am - 9:00am
Chairperson Remarks
- Kent Rapp - CEO, Biolinco
9:00am - 10:00am
Fireside Chat: New Modalities, Old Playbook: Are Multispecifics and Gene Therapy Cell Lines Stuck in mAb Thinking?
- Yifeng Xu - Principal Scientist, Pfizer
- Duncan McVey, Ph.D. - Senior Scientific Director, Bristol-Myers Squibb
- Maximilian Hoerner - Head of Optogenetics, Prolific Machines
- Thomas Kelly - Director, Cell Engineering & Analytical Sciences, Johnson & Johnson Innovative Medicine
8:50am - 9:00am
Chairperson's Remarks
- Aravindan Rajendran - Associate Research Fellow - Group Leader, Pfizer
9:00am - 9:30am
The Age of Automation: Successful Design, Development, and Deployment of a Fully Automated, Bench-Scale Bioreactor Platform
- Brandon Veres - Staff Engineer, Regeneron
9:30am - 10:00am
KEYNOTE: Engineering ADC Success from the Start: The Critical Role of Cell Culture
- Andrea Little - Associate Research Fellow – Cell Culture, Pfizer
8:50am - 9:00am
Chair
- Medine Ayhan - Senior Scientist, Downstream Process Development, Amgen
9:00am - 9:30am
Building a Polishing Chromatography Toolbox for AAV Manufacturing
- Garima Thakur - Staff Engineer, Regeneron Pharmaceuticals
9:30am - 10:00am
A Case Study
- Stefano Menegatti - Professor, Chemical and Biomolecular Engineering, NC State University, North Carolina State University
8:50am - 9:00am
Chair
- Michael O'Connor - Principal Scientist, Pilot Plant Network & External Manufacturing, Bristol-Myers Squibb
9:00am - 9:30am
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
9:30am - 10:00am
Accelerating Biologics Process Analytics through End-to-End Sample Testing Automation
- Pernesso Geffrard - Scientist, Bristol-Myers Squibb
8:50am - 9:00am
Chair
- Vanecia Harrison-Sanders - Director of Graduate Co-op, Northeastern University
- Mary McLaughlin - Associate Director of Partnership Development, Northeastern University
9:00am - 9:30am
Critical Quality Attributes in Modern Biopharmaceutical Development: From Established mAbs to Emerging Modalities
- Elisabeth Krug - Executive Director, Eli Lilly & Company
9:30am - 10:00am
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
8:50am - 9:00am
Chairperson’s Opening Remarks: Development of Emerging Cell & Gene Therapies
- Christopher Bravery - Consulting Regulatory Scientist, Advbiols
9:00am - 9:30am
Keynote: Journey from R&D to Clinical Manufacturing
- Nelly Viseux - Vice President, Cell Therapies Development, Manufacturing, Supply & Quality, Regeneron
9:30am - 10:00am
Keynote: Programming Immunity In Vivo: Targeted RNA–LNP Platforms for Precision CAR Engineering
- Robert Hofmeister - Chief Scientific Officer, CREATE Medicines
10:00am - 10:30am
Moving Gene Editing Beyond the Liver
- Devyn M. Smith - Chief Executive Officer, Arbor Biotechnologies
8:50am - 9:00am
Chairperson’s Opening Remarks: Cell Therapy Manufacturing & Analytics
- Mariana Loperfido - Senior Scientist, Analytical Development, Cell & Gene Therapy, Novartis
9:00am - 10:00am
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
- Richard McFarland - Chief Regulatory Officer, Advanced Regenerative Manufacturing Institute (ARMI)
10:00am - 10:30am
Enabling sgRNA Release and Stability Testing with a ddPCR-Based Potency Assay
- Hugh Gannon - Associate Director, KSQ Therapeutics
8:50am - 9:00am
Chairperson’s Opening Remarks: Gene Therapy Manufacturing & Analytics
- Rajeev Boregowda - Associate Director, Bioassay & Molecular Analytical Development, Genomic Medicine CMC, Sanofi
9:00am - 10:00am
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
- Ying Cai - MSAT Executive Director, Ultragenyx Pharmaceutical
- Scott Jeffers - Chief Technology Officer, GenSight Biologics
- Corina McCarthy - Director, Technical Operations, Rocket Pharmaceuticals, Inc.
- Tara Crnkovich - CEO, Texcell
10:00am - 10:30am
From Vial to Brain: Demonstrating AAV Gene Therapy Stability During Convection-Enhanced Delivery
- Nathalie Clement - SVP, Vector Development, Siren Biotechnology
8:50am - 9:00am
Registration Break
9:00am - 9:30am
Shaping the Future of Pharma Outsourcing: Regulatory, Legislative, and Business Strategies for Success
- Gil Roth - Founder & President, Pharma & Biopharma Outsourcing Association
9:30am - 10:00am
Strategies for harmonizing vendor operational models and improving efficiency between internal R&D organizations and external partners
- May Zhu - Director, External Manufacturing and Testing, Takeda Pharmaceuticals
9:00am - 9:10am
Chairperson’s Opening Remarks
- James Boyle - Associate Director of Experiential Partnerships, Northeastern University
10:20am - 10:30am
Chairperson’s Opening Remarks
- James Boyle - Associate Director of Experiential Partnerships, Northeastern University
Showing 3 of 3 Streams
Break
Innovation and Community Stage (Exhibit Hall)
CGT Community Hub (Exhibit Hall)
10:30am - 11:15am
Morning Break in the Exhibit Hall and Poster Viewing
10:40am - 11:15am
10:40 – 11:20 PANEL: What is AI Ready Data?
- James Colley - Senior Phorum Director, BioPhorum IT, Digital and Data, BioPhorum
- Martin Kockx - Principal Manufacturing Systems Engineer, Vertex Pharmaceuticals
- Bharath Sundararaman - Senior Director, Digital Manufacturing, Pfizer
10:45am - 11:15am
CGT Meet the Speakers
Go beyond the podium and engage in meaningful dialogue with the researchers, clinicians, and industry leaders who are advancing the field.
Showing 10 of 10 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
CDMO Partnering & External Manufacturing
Innovation and Community Stage (Exhibit Hall)
11:15am - 11:45am
Right-First-Time Cell Line Development: Speed, Productivity, and Quality by Design
- Duncan McVey, Ph.D. - Senior Scientific Director, Bristol-Myers Squibb
11:45am - 12:15pm
Rebuilding CLD Without Legacy Constraints: A Strategy- and Data-Driven Case Study
- Sowmya Balasubramanian - Associate Director, Cell Line Development, Gilead Sciences
11:15am - 11:45am
Upstream Matters for ADCs: Locking High-Performance Upstream to Simplify Downstream
- Xiaolin Zhang - Associate Principal Scientist, Merck & Co
11:45am - 12:15pm
A Solubility‑Enabled Tyrosine Delivery Strategy for Robust Biologics Manufacturing
- Utsavi Sevak - Senior Associate Scientist, Bioprocess Development, Bristol-Myers Squibb
11:15am - 11:45am
Fireside Chat: Platform vs. Bespoke: How to Design Robust, Scalable Purification Solutions for Standard mAbs and Novel, Complex Therapies
- James Pullen - Senior Director of Downstream Process Development, FUJIFILM Biotechnologies
- Millie Hoe - Life Science Reporter, Bioxconomy, Informa Connect
11:45am - 12:15pm
Bispecific DSP: Double the Trouble or Twice as Nice
- Gavin Wild - Head of Early Process Sciences, UCB
11:15am - 11:45am
Artificial Intelligence Applications in the Modeling and Analysis of Biopharmaceutical Factory Digital Twins
- Joseph Pekny - Professor, Chemical Engineering, Purdue University
- Sumitava De - Bioprocess Modeling Engineer, Sanofi
11:45am - 12:15pm
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
- Jon Stratton - Sales and Business Development Manager, SciY
- Dan Stanton - Trade Media Relations Expert, Sartorius
11:15am - 11:45am
A Practical Workflow for Assessing Glass Vial Performance in Drug Product Development
- Manasi Nawathe - Scientist I, Bora Biologics
11:45am - 12:15pm
Agility and Robustness by Design: Rethinking the Process Validation Lifecycle
- Jian Ren, Ph.D. - Principal Scientist, AbbVie
11:15am - 11:35am
Development of Next Generation Cell Therapies for Autoimmune Disease
- Mayo Pujols - CTO, Kyverna
11:35am - 11:55am
Case Studies: Development of Next-Gen Cell & Gene Therapies – Overcoming Challenges and Breakthroughs
- Daniel Shelly - Chief Business Development Officer, Immuthera/PolTREG
11:55am - 12:15pm
The Siren Experience: Advancing SRN-101 for High Grade Gliomas
- Lauren Kelly - Director of Translational Research, Siren Biotechnology
12:15pm - 12:35pm
Gene Therapy for Immune Reprogramming and the Treatment of Inflammatory Diseases
- Shahrooz Rabizadeh - CEO & Co-Founder, Sagittarius Bio, Inc
11:15am - 11:45am
Culture and Non-Culture-Based Approaches to Cell Therapy Potency
- Ronnie Lum - Director Analytical Development, Analytical and Quality Control, BlueRock Therapeutics
11:45am - 12:15pm
Progress toward Standards and Reference Materials for Cell Viability
- Laura Pierce - Biomedical Engineer, NIST
12:15pm - 12:45pm
Reading the Signal in the Noise: A Quantitative Framework for Understanding VCN–%CAR+ Relationships in CAR-T Manufacturing
- Brian Murphy - formerly VP Cell Process Sciences, Arcellx
11:15am - 11:45am
ddPCR-Based Vector Genome Titer and Integrity Assays for Adeno-associated Virus
- Rishi Kothari - Process Development Engineer, Regeneron Pharmaceuticals
11:45am - 12:15pm
Applying Beta-Dispersion Analysis as a Process Analytical Technology (PAT) to Optimize AAV Product Quality
- Stephanie Klaubert - Scientist II, Solid Biosciences
12:15pm - 12:35pm
Predictive Modeling and Process Interdependency: A Strategic Approach to Late-Stage AAV Purification Development
- Chen Wang - Principal Scientist GMU CMC Purification Process Development, Sanofi
11:15am - 11:45am
Tech Transfer Strategies for DS PPQ delivery at CMO Partners
- Kelly Wei - Associate Director, AstraZeneca
11:45am - 12:15pm
How should we begin to approach fully Digital Tech Transfer
- Kim Wilson - Business Value Consultant Expert, Life Sciences & Healthcare Industry, Dassault Systèmes' Life Sciences & Healthcare
- Tosin Dipeolu - R&D Information Architect and Data Strategy, Merck & Co., Inc., Rahway, NJ, USA
12:15pm - 12:45pm
Win as One: Building a Two-Way CDMO-Sponsor Relationship for Reliable Manufacturing Execution
- Mihir Shukla - Founder & CEO, Biopharma Consulting Solutions
11:15am - 11:20am
10:40 – 11:20 PANEL: What is AI Ready Data?
- James Colley - Senior Phorum Director, BioPhorum IT, Digital and Data, BioPhorum
- Martin Kockx - Principal Manufacturing Systems Engineer, Vertex Pharmaceuticals
- Bharath Sundararaman - Senior Director, Digital Manufacturing, Pfizer
11:20am - 11:30am
High-Efficiency HMW & HCP Clearance in Antibody Purification with VDX MMA ultra
- Liao Jiali - Chief Scientist, VDO Biotech
11:40am - 12:20pm
PANEL: The CDMO Exit Interview: Why suppliers lose opportunities—and what buyers wish they had done differently.
- Alejandro Laplana - CEO, Shokworks
- Joseph Payne - Founder, JEP Consulting Services
- Jeremy Burt - Founder, Cicada Marketing
12:40pm - 12:45pm
12:40 – 13:20 PANEL: Women in Bioprocessing: Leadership, Innovation, and Career Growth in Biotech
- Pamela Klecki - President, Association for Women in Science, Massachusetts (Boston) Chapter
- Amy Shaw - Senior Director, Process Development, Genetix Biotherapeutics
- Deniz Temel, PhD - Director, CMC & Analytical Development, Third Arc Bio
- Melanie Matheu - Co-Founder and CSO, Lyric Bio
- Janet Chung - CMC Project Manager, Rocket Pharmaceuticals
Showing 3 of 3 Streams
Break
Innovation and Community Stage (Exhibit Hall)
Live Labs in Exhibit Hall
Live Lab 12:45pm - 2:00pm
Lunch
12:45pm - 1:20pm
12:40 – 13:20 PANEL: Women in Bioprocessing: Leadership, Innovation, and Career Growth in Biotech (Continued)
- Pamela Klecki - President, Association for Women in Science, Massachusetts (Boston) Chapter
- Amy Shaw - Senior Director, Process Development, Genetix Biotherapeutics
- Deniz Temel, PhD - Director, CMC & Analytical Development, Third Arc Bio
- Janet Chung - CMC Project Manager, Rocket Pharmaceuticals
- Melanie Matheu - Co-Founder and CSO, Lyric Bio
1:20pm - 1:30pm
Sedimentation Velocity Analytical Ultracentrifugation Evaluation of Cellular EV Subpopulations Isolated Using Rate Zonal Density Gradient Ultracentrifugation and characterized on the CytoFLEX nano Flow Cytometer
- Lutz Ehrhardt - Senior Manager Field Marketing Centrifugation, Beckman Coulter Life Sciences
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
Cell & Gene Keynote Plenary
CDMO Partnering & External Manufacturing
2:00pm - 2:30pm
Genetic Characterization in Cell Line Development: What Matters Most in Practice Today
- William Stanney Ph.D. - Senior Scientist, Abbvie
2:30pm - 3:30pm
PANEL DISCUSSION: Precision Cell Line Engineering for Biologics: Focused Innovations and Applications
- Stefan Schmidt - Advisor, Optigenomics Ltd
- Andy Racher, Ph.D. - co-Chief Executive Officer, SynGenSys
- Laura Greenfield - Bioprocessing Expert, Pfizer
- Jacqualyn Schulman, Ph.D. - Principal Scientist, Cell Line Development & ‘Omics Biologics Development, Bristol-Myers Squibb
2:00pm - 2:30pm
From Capping to Conjugation: Cell Culture Levers That Shape Cysteine Availability and ADC DAR
- Jin Xu - Senior Scientist, AstraZeneca
2:30pm - 3:30pm
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
- Smita Shankar - Founder & CEO, CUVIA
- Timothy Keefe - Leading CMC strategy as Independent CMC Consultant, Independent
- Ayman Ismail - Principal Consultant, Ayman Ismail Consulting
2:00pm - 2:30pm
Guiding Robocolumn Use in Process Development: FAQs, Limitations, and Fit-for-Purpose Scope
- Skaison Kim - Sr. Staff Engineer, Process Development, Takeda
2:30pm - 3:30pm
Room 312: 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
- Smita Shankar - Founder & CEO, CUVIA
- Timothy Keefe - Leading CMC strategy as Independent CMC Consultant, Independent
- Ayman Ismail - Principal Consultant, Ayman Ismail Consulting
2:00pm - 2:30pm
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
2:30pm - 3:30pm
PANEL DISCUSSION: The Future of Facilities: Enabling Autonomous Bioprocessing
- Udayanath Aich, Ph.D. - Director, Bristol Myers Squibb
- Mihir Shukla - Founder & CEO, Biopharma Consulting Solutions
- Alexa Kopf - Consultant, BioProcess Technology Group (BDO) and Founder, LabScale AI
- Kat Kozyrytska - AI & Automation Technology Strategy, Advisory
- Gemma McCarthy - Senior Engineer II, MSAT, Takeda
- Jordan Croteau - Head, Intelligent Operations, Stellix
- Jin Kim - Executive Director of Global Business Development, Enzene
2:00pm - 2:30pm
Unlocking the Regenerative Potential of Exosomes: From Bioprocess Development to Advanced Drug Delivery Platform
- Tali Kizhner - RD Director, NurExone Biologic
2:30pm - 3:00pm
Accelerating Site Readiness: Risk-Tiered Facility CQV Strategy for Qualification from Development-to-Commercial Continuum
- Gurinderpal Singh - Director, Quality Operations R & D, GSK
3:00pm - 3:30pm
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
- Linda Klauss, PhD - Senior Field Application Scientist, Gyros Protein Technologies
- Ravi Chari - Associate Director (Analytical Development), Boston Institute of Biotechnology
2:00pm - 2:05pm
Chairperson’s Opening Remarks
- Catherine Simpson - Conference Director - Cell and Gene Therapy Portfolio, Informa Connect LifeSciences
2:05pm - 2:45pm
Keynote Presentation: Lessons Learnt of the Path to Commercialisation
- Silviu Itescu - CEO, Mesoblast
2:00pm - 2:30pm
Navigating regulatory complexities in external manufacturing
- Bharat Dixit - Chief Technology Officer, ClearB Therapeutics
2:30pm - 3:00pm
Securing Funding in the Biotech Space and the Impact on External Manufacturing
- Jeffrey Hausfeld - BioFactura Inc./Capitol Biologics, BioFactura Inc./Capitol Biologics
Showing 1 of 1 Streams
Break
3:30pm - 3:35pm
Close of Conference
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