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

Date: 2020-10-19
Time: 8:45-17:00 Pacific Time
Registration fee: (USD):
Location: SF Bay Area: Foster City Crowne Plaza
Major Sponsor:
Vendor show vendors registered to date: (5)BioAgilytix Labs; ICON Clinical Research; PPD; SCIEX; Three Pillars Biotechnology Consulting
Registration deadline:2020-10-19  (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®.



  • Understand factors that govern the biodistribution, clearance, and mechanism of action of cell-based therapies
  • Develop a preclinical FiH package from a pharmacology/PKPD/tox/immunogenicity perspective
  • Develop a Clinical Pharmacology Plan for cell therapies
  • Understand clinical development and regulatory strategy for cell therapies
  • Understand manufacturing processes and challenges



8:45 am           Welcome note and speaker introductions (Chunze Li, PhD, Director & Principal Scientist, Clinical Pharmacology; Vittal Shivva, PhD, Scientist, PKPD, Genentech)

Keynote Address

9:00 am           Clinical Development of BCMA Targeted Immunotherapies in Multiple Myeloma (Kristen Hege, MD, Senior Vice President, Early Clinical Development, BMS)

Regulatory Perspective

9:45 am           Regulatory Perspectives on cell therapy (Xiaofei Wang, PhD, Pharmacologist, FDA CBER)

10:15 am         Break 

Session 1:        Introduction to Cell Therapy, Non-Clinical and Clinical Considerations

10:45 am         A Research Perspective on Cell-based Immunotherapies: concepts, considerations and challenges  (Sascha Rutz, PhD, Senior Scientist, Cancer Immunology, Genentech)

11:15 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)

11:45 pm         Clinical Pharmacology Considerations for cell therapy (Weirong Wang, PhD, Scientific Director, Janssen R&D, J&J)

12:15 pm         Lunch break

Session 2:        Clinical Development and CMC Considerations

1:15 pm           Clinical Development of Cell based Therapeutics (Yu-Waye (Wayne) Chu, MD, Senior Vice President, Fate Therapeutics)

2:00 pm           CMC considerations for Cell Based Therapies: Controlling Living Drugs (Karen Walker, Senior Advisor, Cell and Gene Therapy Manufacturing, Genentech)

2:45 pm           Break

Session 3:        Case Studies

3:15 pm           Clinical Pharmacology and Biomarkers Associated with Clinical Outcomes Supporting Approval of YESCARTA® (Vicki Plaks, LLB, PhD, Principal Scientist, Translational Medicine, Kite, A Gilead Company)

3:45 pm           Biodistribution/Preclinical PKPD of Kymriah (Karen Thudium Mueller, PhD, Clinical Pharmacologist, Novartis)

Panel Discussion and Wrap-up

4:15 pm           Panel Discussion (All Speakers) and Q&A (Moderator: Vittal Shivva, PhD, Scientist, PKPD, Genentech)

4:45 pm           Wrap-up & Closing remarks (Amrita Kamath, PhD, Director & Principal Scientist, PKPD, Genentech)

2020-09-17, Regulated Large Molecule Bioanalysis: Fundamentals, the New FDA Guidance and Beyond
2021-07-29, Development of Inhalation Therapeutics (a joint symposium by AAPS-BADGE / PBSS / Genentech)
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