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:
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
2024-04-12, [Free Online] Innovative Life Science Technologies in the Drug Development Toolbox: From Cancer Organoids and Biomarker Profiling to Label-Free Multiplex QES Assays
|
2024-04-26, [In-Person] Oncology Clinical Dose Optimization in Light of FDA Project Optimus
|
2024-05-06, [In-Person] Human Mass Balance and Metabolite Profiling Studies: Strategies, Technical Approaches, Regulatory Guidance, Applications and Case Studies
|
2024-05-13, [Free Online] Highlights of 2023 FDA Drug Approvals
|
2024-05-21, [In-Person] Nonclinical Safety Studies for IND and NDA Filing for Small Molecules: Nuts, Bolts and Best Practices
|
2024-05-30, [Online Workshop] Career Transition for Research Scientists
|
2024-06-13, [In-Person] CMC Strategies and Activities for IND and NDA Filing for Small Molecules: Nuts, Bolts and Best Practices
|
2024-06-20, Alzheimer's Disease: untangling what we thought we knew and future Precision Medicine Diagnostics and Therapeutics
|
2024-09-10, [In-Person] Rethinking Translational PK/PD and Human Dose Projections for Novel Therapeutic Modalities: Covalent Inhibitors, PROTACs, Molecular Glues, ADCs, Ocular and Neuro delivery, Vaccines, Bispecifics, Cell and Gene Therapies
|
2024-09-20, [In-Person] Non-clinical safety assessments of biologics and novel modalities for IND/NDA Filing: Nuts, Bolts and Best Practices
|
2024-10-10, [In-Person] Regulatory Global Submission: Strategies and Best Practices for FDA, EMA and PMDA
|