Key Sessions
Hari Pujar
Keynote: In Vivo CAR-T Therapies Product Development and Clinical Advances
Tessera Therapeutics
Arvind Natarajan
Keynote Panel Discussion: Scaling Cell Therapies- Lessons from Pioneers for Smarter, Faster, and More Affordable Ex Vivo Cell Therapy Manufacturing
Iovance Biotherapeutics
Craig Malzahn
Keynote Panel Discussion: Strategies for Scaling Up, Accelerating and Commercializing Gene Therapy Manufacturing
Regenxbio
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Thursday 24th September - Conference Day Two - ET (Eastern Time, GMT-05:00)
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Thursday 24th September - Conference Day Two - ET (Eastern Time, GMT-05:00)
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Development of Emerging Cell & Gene Therapies
8:50am - 9:00am
Chairperson’s Opening Remarks: Development of Emerging Cell & Gene Therapies
- Nicola Ambler - Co-Founder, CGT Circle
9:00am - 9:30am
Keynote: In Vivo CAR-T Therapies Product Development and Clinical Advances
- Hari Pujar - Chief Operating Officer, Tessera Therapeutics
9:30am - 10:00am
Regulatory Considerations for In Vivo CAR-T
- Christopher Bravery - Consulting Regulatory Scientist, Advbiols
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Development of Emerging Cell & Gene Therapies
11:30am - 11:45am
High-Throughput Signal Peptide Engineering for Cell and Gene Therapy: From Single Chains to Multichain Biologics
- Tero-Pekka Alastalo - CEO, Avenue Biosciences
11:45am - 12:30pm
Designing for the Unknown: How Do You Plan CGT Manufacturing Facilities When the Patient Count is a Moving Target?
- Samir Gondalia - Director, Business Development and Marketing, Hart Companies
- Kristi Ballard - Senior Director, Cell Therapy Manufacturing, Bristol Myers Squibb
- Adam Bartley - Chief Operating Officer, Chrysalis
- Kelly Kral - VP of CMC Strategy & Ops, Genetix Biotherapeutics
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Development of Emerging Cell & Gene Therapies
2:40pm - 2:45pm
Chairperson’s Opening Remarks: Development of Emerging Cell & Gene Therapies
2:45pm - 3:15pm
Leveraging Platform-Based, Multi-Attribute LC Assays to Characterize Multi-components Prime Editing (PE) RNA-LNP
- Minjia Wang - Analytical Development Scientist II, Prime Medicine
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Development of Emerging Cell & Gene Therapies
4:30pm - 5:30pm
Panel Discussion: Starting with the End in Mind: Designing Smart and Phase Appropriate Manufacturing for Successful Cell and Gene Therapy Development
- Khandan Baradaran - Principal, Mill Creek Consulting LLC
- Shankar Swaminathan, PhD - Team Lead, Drug Product Development, CMC-Tech Ops, Astellas Institute for Regenerative Medicine
- Amy Shaw - Senior Director, Process Development, Genetix Biotherapeutics
- James Warren - SVP, Global CMC Development, Ultragenyx
- Nathan Moore - Technology and Digital Innovation Leader | Cell Therapy Manufacturing, Independent Consultant
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