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Symposium

SOT-PBSS Joint Spring Symposium: Immuno-oncology: Opportunities, Therapeutic Approaches, and Safety Considerations


Speakers: Keith Bahjat (Bristol-Myers Squibb), Haleh Saber (FDA), Sunjay Sethi (University of California Davis), Henry QX Li (Crown Bioscience), Greg Bannish (Envigo), Rodney Prell (Genentech), Herve Lebrec (Amgen Inc.), Allyson Byrd (Genentech)
Organizers:
Date: 4/27/2018
Time: 8:00-17:00
Registration fee (USD): Regular: $50;
Location: South San Francisco Conference Center (255 South Airport Boulevard, South San Francisco, CA 94080)
Major Sponsor:
Vendor show vendors registered to date: (1)PHARMout Laboratories
Registration: http://www.PBSS.org
Registration deadline:4/22/2018  (it will close sooner if the seating cap is reached)

About the Topic

Over the past decade, tremendous progress has been made in understanding the interplay between the immune system and cancer. Consequently, cancer immunotherapy (aka immuno-oncology), which is intended to induce or enhance an immune response to the cancer, has had several recent approvals and seen remarkable growth in discovering and developing new and exciting technologies. Many research institutions and pharmaceutical companies have promising research programs which involve novel drug targets on immune cells, or which utilize therapeutic approaches designed to engage the immune system to kill the cancer cells.

This year’s joint symposium between NorCal SOT and PBSS will involve presentations describing the interplay between the immune system and cancer and therapeutic approaches which harness the power of the immune system as a means to treat cancer. There will also be in-depth presentations on safety assessment for new immuno-oncology drugs, including presentations by pharmaceutical safety assessment scientists on several of the leading therapeutic approaches- checkpoint inhibitors, T-cell redirecting therapies and adaptive cell transfer/CAR-T cells, as well as perspectives from an FDA reviewer on the unique challenges with developing cancer immunotherapeutics. In addition, there will be presentations summarizing animal models to support preclinical research, clinical challenges in developing immune therapies and how the microbiome can influence the immune system and thus cancer immunotherapies.

 

Agenda 

Morning Session 

7:30 am – 8:30 am            Registration & Breakfast

8:30 am – 8:45 am            Opening Messages from the NorCal SOT & PBSS Presidents

  • Doris Zane, PhD, DABT, Senior Director, Preclinical Development, Intarcia Therapeutics, Inc.
  • Shichang Miao,PhD, Vice President, Preclinical Development and Clinical DMPK, ChemoCentryx Inc.

8:45 am – 9:25 am            Presentation 1: A Brief History of Immunotherapy,

  • Keith Bahjat, PhD, Director, Bristol-Myers Squibb

9:25 am – 10:10 am          Presentation 2: Immune-Oncology: Nonclinical Challenges

  • Haleh Saber, PhD, Deputy Director, Division of Hematology Oncology Toxicology, FDA

10:10 am – 10:25 am       Coffee Break

10:25 am – 10:50 am       NorCal Student Award presentation: Influence of Genetic Background onPolychlorinated Biphenyl (PCB) Developmental Neurotoxicity

  • Sunjay Sethi, Graduate Student, University of California Davis

10:50 am – 11:30 am       Presentation 3: Are You Choosing the Right Model? A Guide to Selecting Your Next Immuno-Oncology Model

  • Henry QX Li, PhD, Senior Vice President, Global Scientific Research and Innovation Division, Crown Bioscience 

11:30 am – 12:10 pm       Presentation 4: Title TBD (Topic – Preclinical development – animal models for selecting/optimizing drug candidates)

  • Greg Bannish, PhD, Vice President, Biopharmaceutical Development, Envigo 

12:10 pm – 1:40 pm         Lunch Break: Lunch with Experts, Posters

 

Afternoon Session

1:40 pm – 1:55 pm           Chapter Announcements and Acknowledgements 

1:55 pm – 2:35 pm           Presentation 5: Nonclinical Safety Challenges for Cancer Immunotherapeutics

  • Rodney Prell, PhD, DABT, Principal Scientist/Toxicologist, Genentech 

2:35 pm – 3:15 pm           Presentation 6: Nonclinical Safety Assessment of CARTs: A Multipronged Approach

  • Herve Lebrec, PhD, DABT, Scientific Director, Amgen Inc. 

3:15 pm – 3:30 pm           Coffee Break 

3:30 pm – 4:00 pm           Presentation 7: Microbiome Research as an Innovative Platform for Biomarker and Drug Discovery

  • Allyson Byrd, PhD, Genentech 

4:00 pm – 4:05 pm           Closing Remarks 

4:05 pm – 5:00 pm           Reception & Networking

 


2019-04-25, Tox 21 and New Approach Methodology (NAMs): Using Emerging Technologies to Improve Translational Research and Safety Assessment Predictions (jointly by SOT-NorCal & PBSS)
2019-05-06, CMC Development for Biologics: Purification, Formulation, Analytical Characterization, Production Systems, Regulatory and Product Development
2019-06-11, Advances in Immuno-Oncology (A Joint Symposium by PBSS and BioScience Forum)
2019-07-26, Advances in Enzyme Engineering (tentative)
2019-09-13, Biotransformation and Disposition of Larger Molecules: Peptides, Nucleotides, Proteins, mAbs, and ADCs
2019-10-03, Small-Molecule Bioanalytical Method Validation & Regulated Bioanalysis: Fundamentals, the New FDA Guidance and Regulatory Trends
2019-10-18, Physiologically Based Pharmacokinetic (PBPK) Modeling: Fundamentals, Regulatory Guidance & Applications
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