Pharmaceutical & BioScience Society, PBSS

Symposium

[Free Online Symposium] Preclinical and Clinical Development of Cell-based Cancer Immunotherapies (co-organized by GCTP community of AAPS)

Speakers: Timothy Campbell, BMS; Haiqing Wang, Takeda; Liz Mutter-Rottmayer, Genentech; Vibha Jawa, BMS; Louis Joslyn, Genentech; Xu (Sue) Zhu, AstraZeneca; Max Tejada, Kite/Gilead; Maurice Morillon, FDA; Yaming Su, J&J
Organizers: Vittal Shivva (Genentech), Prathap Shastri (Janssen), Chunze Li (Genentech), Amrita Kamath (Genentech) and Saileta Prabhu (Takeda)
Date: 2022-11-14- 11/15/2022
Time: 9:00-12:30 Pacific Time
Registration fee: 0
Location: Online via Zoom
Major Sponsor:
Vendor show vendors registered to date:
Registration: http://www.PBSS.org
Registration deadline:2022-11-11 (it will close sooner if the seating cap is reached)

About the Topic

Co-organized by American Association of Pharmaceutical Scientists, this two half-day symposium will discuss latest developments in discovery technology, preclinical and clinical development aspects of cell-based cancer immunotherapies. Presentations will include topics related to emerging trends and approaches in preclinical and translational PKPD, biomarkers, bioanalysis, immunogenicity risks and clinical development related topics, specifically related to clinical pharmacology approaches. The symposium will discuss the latest developments in addressing some of the challenges we face while advancing these therapies to patients.

AGENDA

Day 1 (Monday, Nov 14th 2022)

Theme: Preclinical Development of Cell based therapeutics

Time (PST)	Time (EST)	Topic
9:00 am	12:00 pm	Welcome Note (Day 1) Vittal Shivva, PhD, Senior Principal Scientist, PTPK, Genentech
Session 1:		Keynote presentation
9:15 am	12:15 pm	Advancing Translational Learnings During Development of Autologous CAR T cell Therapies Timothy Campbell, Executive Medical Director, ECD, BMS
Session 2:		Translational PKPD, Safety, Regulatory Considerations and Immunogenicity Moderator: Prathap Shastri, PhD, Scientific Director, Experimental PKPD, J&J
10:00 am	1:00 pm	Challenges and Opportunities in Preclinical to Clinical Translation of CAR Cell Therapy Haiqing Wang, Director and Group Leader, Oncology DMPK, Takeda
10:30 am	1:30 pm	Early Investigative Safety Assessment for TCR T Cell Therapy Products Liz Mutter-Rottmayer, Principal Scientist, Safety Assessment, Genentech
11:00 am	2:00 pm	Preclinical Considerations for Cellular Therapies: A CBER/FDA Perspective Maurice Morillon, Pharm/Tox Reviewer, CBER/OTAT, FDA
11:30 am	2:30 pm	Developing a Translational (Preclinical to Clinical) Immunogenicity Risk Assessment Strategy for Cell Therapy Products Vibha Jawa, PhD, Executive Director, Non-clinical Disposition & Bioanalysis, BMS
Panel Discussion
12:00 pm	3:00 pm	Panel Discussion (All Speakers) Moderators: Vittal Shivva, PhD, Senior Principal Scientist, PTPK, Genentech Prathap Shastri, PhD, Scientific Director, Experimental PKPD, J&J
12:30 pm	3:30 pm	Wrap-up of Day-1 Symposium

Day 2 (Tuesday, Nov 15th 2022)

Theme: Clinical Development of Cell based therapeutics

Time (PST)	Time (EST)	Topic
9:00 am	12:00 pm	Welcome note (Day 2) & Day1 recap Chunze Li, PhD, Executive Director & Distinguished Scientist, Clin Pharm, Genentech
Session 3:		CMC, Clinical Pharmacology, M&S and Clinical Development Insights Moderator: Amrita Kamath, PhD, Executive Director & Distinguished Scientist, PTPK, Genentech
9:15 am	12:15 pm	CMC Perspectives on Product Characterization for Cellular Therapies Max Tejada, Executive Director, Analytical Development, Kite/Gilead
9:45 am	12:45 pm	Clinical Pharmacology Considerations in CAR-T Therapy Development Xu (Sue) Zhu, Director, Quantitative Clinical Pharmacology, AstraZeneca, Boston, MA
10:15 am	1:15 pm	Challenges and Opportunities of PKPD Modeling of Chimeric Antigen Receptor (CAR) T-cell Therapy Using Ciltacabtagene Autoleucel Yaming Su, Scientific Director, Clinical Pharmacology and Pharmacometrics, J&J
10:45 am	1:45 pm	Cellular Dynamics of Engineered TCR T cell Therapies and Future Direction: A QSP Modeling Perspective Louis Joslyn, Senior Scientist, Translational Systems Pharmacology, PTPK, Genentech
Panel Discussion and Closing Remarks
11:15 am	2:15 pm	Panel Discussion (All Speakers) Moderators: Chunze Li, PhD, Executive Director & Distinguished Scientist, Clin Pharm, Genentech Amrita Kamath, PhD, Executive Director & Distinguished Scientist, PTPK, Genentech
11:45 am	2:45 pm	Wrap-up (Day-2) & Symposium Closing Remarks

Co-sponsored by AAPS and presented with support from AAPS members Haiqing Wang, Vibha Jawa, Louis Joslyn, Vittal Shivva, Amrita Kamath, Prathap Nagaraja Shastri, and Saileta Prabhu

Note: This is an online meeting, The Zoom link will be sent to the registrants 1+ days before the event.

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