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Symposium

[Free Online Symposium] Preclinical and Clinical Development of Cell-based Immunotherapies: Translational PKPD, Safety, Biomarker, CMC, Clinical Pharmacology & Clinical Trials


Speakers: Kristen Hege (BMS); Sascha Rutz, Karen Walker (Genentech); Neehar Bhatia (Stanford University); Justine Cunningham (Sana Biotechnology); Vicki Plaks (Kite, A Gilead Company); Xiaofei Wang (FDA CBER); Weirong Wang (J&J); Yu-Waye (Wayne) Chu (Fate Therapeutics)
Organizers: Amrita Kamath, PhD, Vittal Shivva, PhD, Chunze Li, PhD, and Saileta Prabhu, PhD (Takeda)
Date: 2020-10-19- 10/20/2020
Time: 8:00-13:30 Pacific Time
Registration fee: (USD):
Location: Online via Zoom
Major Sponsor: (2)BioAgilytix Labs; Lonza Pharma & Biotech
Vendor show vendors registered to date:
Registration: http://www.PBSS.org
Registration deadline:2020-10-18  (it will close sooner if the seating cap is reached)

About the Topic

The symposium will cover the preclinical and clinical strategies employed in the development of cell-based therapies. Topics include preclinical data package to support first in human studies, clinical pharmacology, design of early clinical trials, CMC considerations and regulatory expectations. The symposium will discuss the current strategies employed and address some of the challenges we face while advancing these therapies to patients. Additionally, topics such as biodistribution and “clearance” mechanisms, immunogenicity, translational PKPD, the relevance of preclinical models, projection of efficacious dose, etc will be addressed. Case studies will include development of CAR T-cells such as Kymriah® and Yescarta®.

Outcomes

  • Understand factors that govern cellular kinetics, dynamics, biodistribution, toxicity and immunogenicity of cell-based therapies
  • Develop a preclinical FIH package from a pharmacology/PKPD/safety/immunogenicity perspective
  • Understand manufacturing processes and challenges
  • Develop a Clinical Pharmacology Plan for cell therapies
  • Understand clinical development and regulatory strategy for cell therapies

 

AGENDA (Note: All times are in Pacific Standard Time (PST))

Day-1 (October 19th, 2020)

Theme: Preclinical Development of Cell based therapeutics

8:00 am Welcome note (Day-1)
Amrita Kamath, PhD, Director & Principal Scientist, PKPD, Genentech 

Session 1: Keynote Address

8:10 am Clinical Development of BCMA Targeted Immunotherapies in Multiple Myeloma
Speaker: Kristen Hege, MD, Senior Vice President, Early Clinical Development, BMS
Moderator: Amrita Kamath, PhD, Director & Principal Scientist, PKPD, Genentech

9:00 am. Major Sponsor Presentation - Lonza Pharma & Biotech

9:10 am. Break

Session 2: Introduction to Cell Therapy, Academic perspective and Non-Clinical and Immunogenicity Considerations
Moderator: Vittal Shivva, PhD, Scientist, PKPD, Genentech

9:30 am A Research Perspective on Cell-based Immunotherapies: concepts, considerations and challenges
Sascha Rutz, PhD, Senior Scientist, Cancer Immunology, Genentech

10:00 am Translating Cell Therapies: An Academic Perspective
Neehar Bhatia, PhD, Director, Laboratory of Cell and Gene Medicine, Stanford University 

10:30 am PharmTox Considerations for Cell Therapy: A broad overview of the Pharmacology and Safety studies to support FIH study
Justine Cunningham, PhD, Vice President, Toxicology & Biodistribution, Sana Biotechnology

11:10 am.  Break

Session 3: Case Study
Moderator: Vittal Shivva, PhD, Scientist, PKPD, Genentech

11:30 am Clinical Pharmacology and Biomarkers Associated with Clinical Outcomes Supporting Approval of YESCARTA®
Vicki Plaks, LLB, PhD, Principal Scientist, Translational Medicine, Kite, A Gilead Company

12:00 pm Panel Discussion (All Speakers) and Q&A
Moderator: Vittal Shivva, PhD, Scientist, PKPD, Genentech 

12:30 pm Wrap-up of Day-1 Sessions
Amrita Kamath, PhD, Director & Principal Scientist, PKPD, Genentech 

 

Day-2 (October 20th, 2020)

Theme: Clinical Development of Cell based therapeutics 

8:00 am Welcome note (Day-2)
Saileta Prabhu, PhD, Vice President, Clinical Biomarker Innovation & Development, Takeda 

Session 4: Keynote Address

8:05 am CMC considerations for Cell Based Therapies: Controlling Living Drugs
Speaker: Karen Walker, Senior Advisor, Cell and Gene Therapy Manufacturing, Genentech
Moderator: Saileta Prabhu, PhD, Vice President, Clinical Biomarker Innovation & Development, Takeda 

9:00 am. Major Sponsor Presentation - BioAgilytix Labs

9:10 am. Break

Session 5: Regulatory Perspectives, Clinical Pharmacology and Clinical Development Considerations
Moderator: Chunze Li, PhD, Director & Principal Scientist, Clinical Pharmacology, Genentech 

9:30 am Regulatory Perspectives on cellular therapies for Immuno-oncology indications
Xiaofei Wang, PhD, Pharmacologist, FDA CBER 

10:00 am Clinical Pharmacology Considerations for cell therapies
Weirong Wang, PhD, Scientific Director, Janssen R&D, J&J

10:30 am Clinical Development of Cell based Therapeutics
Yu-Waye (Wayne) Chu, MD, Senior Vice President, Fate Therapeutics 

11:10 am.  Break

Session 6: Considerations for Immunogenicity
Moderator: Chunze Li, PhD, Director & Principal Scientist, Clinical Pharmacology, Genentech 

11:30 am Immunogenicity of cell based therapeutics
Jim McNally, PhD, Chief Scientific Officer, BioAgilytix

Panel Discussion and Closing Remarks

12:00 pm Panel Discussion (All Speakers) and Q&A
Moderator: Chunze Li, PhD, Director & Principal Scientist, Clinical Pharmacology, Genentech 

12:30 pm Wrap-up (Day-2) & Symposium Closing remarks
Chunze Li, PhD, Director & Principal Scientist, Clinical Pharmacology, Genentech


2020-10-29, [Free Online Symposium] No More Undruggables: Unconventional Approaches for Drug Discovery and Design - prodrugs, PROTACS, fragment-based design, directed evolution and beyond
2020-11-13, [Free Online Symposium] The Drug Discovery and Development Journey of Polivy™ (Polatuzumab Vedotin): An Antibody-Drug Conjugate for the Treatment of Diffuse Large B-cell Lymphoma
2021-07-29, Development of Inhalation Therapeutics (a joint symposium by AAPS-BADGE / PBSS / Genentech)
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