Key Sessions

Kristy Wood

Leveraging Gene Editing Technologies for Precision and Efficiency in Cell and Gene Therapy Development

Intellia Therapeutics

Ying Cai

Keynote Panel Discussion: Strategies for Scaling Up, Accelerating and Commercializing Gene Therapy Manufacturing

Ultragenyx Pharmaceutical

Wednesday, September 17th, 2025 - Main Conference Day OneWednesday, 17 September 2025 - ET (Eastern Time, GMT-05:00)

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Wellness Activites

7:15am - 8:15am

Fun Run & Morning Yoga Session

Join us for an invigorating start to your day with our special wellness combo event!

Fun Run

Lace up your running shoes and hit the trail with colleagues for our energizing Fun Run. Whether you're a seasoned runner or prefer to walk, this inclusive event welcomes participants of all fitness levels. Enjoy the camaraderie, fresh air, and endorphin boost as we move together through scenic surroundings.

Morning Yoga Session

Happening simultaneously, our rejuvenating yoga session offers a peaceful alternative. Our experienced instructor will guide you through gentle poses designed to increase flexibility, reduce stress, and center your mind for the day ahead.

How To Sign Up: Please ask at registration onsite
What to Bring: Comfortable athletic wear, water bottle, sunscreen

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Registration Break

8:15am - 8:50am

Registration & Morning Coffee

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Development of Emerging Cell & Gene Therapies

Cell Therapy Manufacturing & Analytics

Gene Therapy Manufacturing & Analytics

8:50am - 9:00am

Chairperson’s Opening Remarks: Development of Emerging Cell & Gene Therapies

Christopher Bravery, Ph.D. - Consulting Regulatory Scientist, Advbiols

9:00am - 9:30am

Accelerate Manufacturability and Personalize Therapies with Confidential Collaboration

Kat Kozyrytska - Founder, Cell Therapy Manufacturability Program

9:30am - 10:00am

Redosable DNA Delivery Systems Designed by Machine Learning

Shashi Murthy - CTO and Co-Founder, Nanite Inc.

10:00am - 10:30am

Efficient and Liver-Detargeted In Vivo Multiplex Gene Editing of Human Hematopoietic Stem and Progenitor Cells

Pauline Schmit - Senior Scientist, nChroma Bio

8:50am - 9:00am

Chairperson’s Opening Remarks: Cell Therapy Manufacturing & Analytics

Mahesh Bule - Associate Director, Kite Pharma a Gilead Company

9:00am - 9:30am

Scale-Out Versus Scale-up Strategies for Maximizing Cellular Therapies

Amy Shaw - Head of Process and Product Development, Takeda, USA

9:30am - 10:00am

TCR-T: Scaling for Success

Mark Farmery - Chief Development Officer, Anocca AB

10:00am - 10:30am

Panel Discussion: Bringing Cell Therapy to the Patient—Implementing Decentralized Manufacturing

Defining point-of-care manufacturing and decentralized manufacturing
Scaling with consistency: key elements for global standardization
Tech & innovation: cutting-edge solutions for safe, efficient, and cost-effective decentralized manufacturing
Overcoming obstacles to decentralised manufacturing to enable access to approved CGTs
Differences in systems across decentralized cell therapy manufacturing models - how can we harmonize?
Standardization vs a modular approach
Equipment, data, and technologies
Dialogue and collaboration between developer/practitioner to streamline eventual implementation
Improving worldwide access: how can local manufacturers and supplier help?
Real world experience with a decentralized cell therapy manufacturing platforms supporting Phase I/II clinical trials

8:50am - 9:00am

Chairperson’s Opening Remarks: Gene Therapy Manufacturing & Analytics

Francesca Vitelli, PhD - Former, VP Cell Therapy and Viral Vector PD and MSAT, Intellia Therapeutics, Inc

9:00am - 10:00am

Keynote Panel Discussion: Strategies for Scaling Up, Accelerating and Commercializing Gene Therapy Manufacturing

Ying Cai - MSAT Executive Director, Ultragenyx Pharmaceutical
Nripen Singh - Head of Process Development, TRD CGT, Novartis
Vaishali Shukla - Vice President, CGT & API Global Expansion, Eli Lilly and Company
James Warren - Senior VP, Global CMC Development, Ultragenyx Pharmaceutical Inc.

10:00am - 10:30am

Tech Transfer Best Practices in Gene Therapy

Jordan Ball - Sr. Manager, Technology Transfer, Regeneron

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Break

10:30am - 11:30am

Networking Refreshment Break in The Exhibit Hall

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Development of Emerging Cell & Gene Therapies

Cell Therapy Manufacturing & Analytics

Gene Therapy Manufacturing & Analytics

11:30am - 12:00pm

Leveraging Gene Editing Technologies for Precision and Efficiency in Cell and Gene Therapy Development

Kristy Wood - SVP, Technical Operations, Intellia Therapeutics

12:00pm - 12:30pm

Expanding Gene Editing Beyond The Liver

Devyn Smith - CEO, Arbor Biotechnologies

12:30pm - 1:00pm

Scalable Mixing for Small-Volume GMP Applications: Introducing the 10 L LevMixer™ System

Saadia Zakai - Senior Global Product Manager – Single Use Mixing, Cytiva
Nagaraj Rao - Principal Analysis and Modelling Engineer, Cytiva

11:30am - 12:00pm

Revolutionizing Cell Therapy with Automated Manufacturing and Testing Solutions

Shawn (Xueyuan) Wang - Director, Process Development, Kite Pharma

12:00pm - 12:30pm

Scalable and Cost-Effective Pluripotent Stem Cell Expansion: Enabling Commercialization

Wonjong Si - Director of Cell Therapy Process Development, Bayer

12:30pm - 1:00pm

Enabling Rapid, High-Quality IND Filings for Cell and Gene Therapies: Platform Solutions for Plasmid and Viral Vector Manufacturing

Huiyi Zhu - Head of Hopewell Site Project Management Team, ProBio Inc

11:30am - 12:00pm

Expanding the Upstream Toolbox: Enabling High-Productivity, Robust, and Scalable AAV Production

Huize Yan - Sr. Process Development Scientist – Upstream, Spark Therapeutics

12:00pm - 12:30pm

Rapid Development of AAV Purification Process Without Sacrificing Recovery

Hunter Reese - Scientist II, AskBio

12:30pm - 1:00pm

Accelerated Downstream Development of Viral Vectors Using High-Throughput Process, Analytical, and Formulation Technologies

Kevin Vera - Scientist II, Process Development, Pharma Services Group, Thermo Fisher Scientific
Junyan Zhang - Sr Manager, Downstream Process Development, Pharma Services Group, Thermo Fisher Scientific

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Break

1:00pm - 2:10pm

Lunch in the Exhibit Hall

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Development of Emerging Cell & Gene Therapies

Cell Therapy Manufacturing & Analytics

Gene Therapy Manufacturing & Analytics

2:10pm - 2:15pm

Chairperson’s Opening Remarks: Development of Emerging Cell & Gene Therapies

Mark Farmery - Chief Development Officer, Anocca AB

2:15pm - 2:45pm

Case Study from Editas Medicine

2:45pm - 3:15pm

Prime Editor Lipid Nanoparticles: From Development to Scalable Manufacturing

Weiyi Li - Senior Manager, LNP Formulation, Prime Medicine

3:15pm - 3:45pm

Shrinking the Timeline: Reaching the Clinic in Record Time with Innovative CRISPR mRNA Manufacturing Solutions

Max Sellman - Senior Product Manager, Gene Editing, Aldevron

2:10pm - 2:15pm

Chairperson’s Opening Remarks: Cell Therapy Manufacturing & Analytics

Shashi Prajapati - Director, Cell & Gene Therapies Analytical Development, Vertex Pharmaceuticals

2:15pm - 2:45pm

Advanced Potency Assay Strategies for Cell Therapy Product Characterization

Lena Yang - Senior Scientist, Cell Therapy Analytical Development, Takeda

2:45pm - 3:15pm

Potency Assay for Commercial Product – Which One to Select?

Therese Choquette - Head of Analytical and Translational Sciences, Tigen Pharma

3:15pm - 3:45pm

Multilayered QC in CGT: From Vector Fidelity to Epigenetic Regulation

William Mauck - Team Lead Manager, Molecular Biology Lab, Solvias

2:10pm - 2:15pm

Chairperson’s Opening Remarks: Gene Therapy Manufacturing & Analytics

David Dobnik - Research Councillor, National Institute of Biology

2:15pm - 2:45pm

Bioprocessing Innovation: Developing Forward-Looking Strategy with Fiber Chromatographic Clarification Platform from Discovery to Manufacturing

Eric Vélez Justiniano - Senior Bioprocess Applications Engineer, Solventum

2:45pm - 3:15pm

Application of Novel Technologies to Deliver AAV Downstream Processes with Higher Yield and Better Quality

Junfen Ma - Head of Genomic Medicine Purification Process Development, Sanofi

3:15pm - 3:45pm

Optimizing AAV and LV Purification and Analytics: Accelerated High-Quality Processes using CIM® Monoliths and PATfix®

Hana Jug - Product Manager (Enveloped viruses, VLPs and EVs), Sartorisu BIA Separations

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Break

3:45pm - 4:30pm

Networking Refreshment Break in The Exhibit Hall

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Development of Emerging Cell & Gene Therapies

Cell Therapy Manufacturing & Analytics

Gene Therapy Manufacturing & Analytics

4:30pm - 5:30pm

Panel Discussion: Cell and Gene Therapy CDMO Selection and External Manufacturing Best Practices

Shankar Swaminathan, PhD - Team Lead, Drug Product Development, CMC-Tech Ops, Astellas Institute for Regenerative Medicine
Maura Hobson - Executive Director, External Manufacturing, Sana Biotechnology
Jeffrey Masten - Senior Vice President CMC, Secretome Therapeutics
Matthew Provencal - Executive Director Gene Therapy BDS Manufacturing, Sarepta
Shawn Roach - Associate Principal Consultant, Regulatory CMC, Halloran

4:30pm - 5:00pm

Best Practices for Developing Robust Potency Assays for Cell Therapies

Mariska ter Haak - Senior Director Analytical Development, IN8bio

5:00pm - 5:30pm

Analytical Development to Assess T Cell Therapy Product Potency: A Matrix Approach

Dong Xu, Ph.D. - Associate Director, TScan Therapeutics

4:30pm - 5:00pm

Detectability and Propagation of MVM in HEK293 Cells: What it means for your Viral Safety Strategy

Dana Schreffler - Sr. Manager QC Viral Safety, Regeneron

5:00pm - 5:30pm

Mastering hcDNA: A Harmonized CMC Approach in AAV Therapies

Parag Kumthekar - Gene Therapy Downstream Process Development Lead, UCB Pharma

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Break

5:30pm - 6:00pm

Transport for Biotech Week Boston Party from Boylston Street

6:00pm - 9:30pm

Innovation After Dark: Networking Party at the Museum of Science, Boston

9:30pm - 9:35pm

Close of Day Two