Deep Dive Bootcamp Day

Monday August 30, 2021
8.30am-5.00pm EDT | 5.30am-2.00pm PDT

CAR-TCR 101 Bootcamp

Regulations Bootcamp

8:30 am A History of CAR-TCR: Providing an Overview of a Cutting-Edge Industry

  • Adrian Bot Vice President - Scientific Affairs & Translational Medicine, Kite Pharma Inc

9:00 am Fundamental Biology of CARs vs. TCRs

  • Christopher Kloss Assistant Principal Scientist, Cell & Process Designer, Merck & Co

9:30 am Outlining the Cell Therapy Development Space, Considering the Pros & Cons of Emerging & Established Constructs

  • Faraz Zaman Director & Lead - Global Medical, Amgen Inc.

10:00 am Developing Platforms for Target Identification & Safety Validation for Solid Tumors

  • Marvin Gee Co-Founder & Head of Target Discovery, 3T Biosciences

10:30 am Break

11:00 am Outlining the Advantages, Limitations & Applications of Novel Constructs

11:30 am Addressing Translational Challenges to Allogenic Cell Therapies for Cancer

  • Indu Ramachandran Director, Head of Translational Development, Century Therapeutics

12:00 pm Managing Clinical Safety & Toxicity for Improved Patient Outcomes

  • William Go Senior Vice President & Head of Development, A2 Biotherapeutics

12:30 pm Lunch

1:30 pm Developing Manufacturing & Quality Control Platforms for Cell Immunotherapy

  • Moonsoo M Jin Associate Professor - Biomedical Engineering & Radiology, Weill Cornell - Cornell University

2:00 pm Fundamentals of Vector Manufacturing

  • Hemant Dhamne Head of Vector & CAR-T Cell Processing, Immuneel Therapeutics Pvt. Ltd.

2:30 pm Examining Regulatory Frameworks, Expectations & Requirements for Starting Materials

From Pre-IND Meetings to Filing

9:00 am FDA’s Efforts to Facilitate the Development of the Next Generation of CAR-T Cells

9:30 am A Journey from IND to BLA

  • Nadia Agopyan Vice President - Regulatory Affairs, Marker Therapeutics, Inc.

10:00 am Sharing the GSK Parent-Child Cell Therapy Development Strategy: A Novel Clinical & Regulatory Framework to Maximize Efficiency in Execution & Regulatory Filing

  • Laura Pearce Senior Director - Oncology Cell, Gene Therapy & Clinical Development Lead, GlaxoSmithKline

10:30 am Break

Pre-BLA Development

11:00 am Sharing Tools to Maximize Efficiency & Streamline Processes in Early Development

  • Mingxiao He Process Development Scientist III, Eureka Therapeutics

11:30 am Sharing Regulatory Considerations for Next Generation Cell Therapy Development

12:00 pm The Journey to Market – Regulatory CMC Challenges & Considerations

  • Agnes Yeboah Executive Director, Global Regulatory CMC, Biologics & Cell Therapy, Bristol-Myers Squibb

12:30 pm Lunch

Post-BLA Approval Strategies

1:30 pm Working with Regulators on REMs Programmes & Safety Assurance

  • Manisha Patel Global Program Regulatory Director - Oncology CAR-T Therapy Program, Novartis

2:00 pm Maintaining Documentation at Scale to Ensure Regulatory Compliance

  • Renu Vaish VP Global Regulatory Affairs, Kite Pharma Inc

2:30 pm Roundtable Discussion: Reflecting on the Journey to Market

  • Manisha Patel Global Program Regulatory Director - Oncology CAR-T Therapy Program, Novartis
  • Renu Vaish VP Global Regulatory Affairs, Kite Pharma Inc
  • Agnes Yeboah Executive Director, Global Regulatory CMC, Biologics & Cell Therapy, Bristol-Myers Squibb
  • Elena Spanjaard Global Head of Regulatory Affairs, Celyad
  • Nadia Agopyan Vice President - Regulatory Affairs, Marker Therapeutics, Inc.

3:00 pm Networking

4:30 pm Diversity in CAR-TCR: Prioritizing Diversity, Equity & Inclusion in the Cell & Gene Field

  • Delfi Krishna Head of Strategic Operations Cell & Gene Therapy, Immatics GmbH
  • Jane Grogan Formerly Head of Adaptive Cell Therapy & IO, Genentech
  • Shon Green Senior Director of Translational Sciences, Umoja Biopharma
  • Tam Soden Executive Director & Global Head of Quality Control, Kite Pharma Inc

End of Deep Dive Day