ACDRS 2022 Session 2 - Learning Trials: From Discovery to First in Human

Date: 
Monday, March 7, 2022 - 10:00 am to Friday, March 11, 2022 - 3:00 pm
Location: 
virtual/online

This is Session 2 of 6. Must register for the entire course and not per session.

Session Co-chairpersons:
Paolo Vicini, PhD, MBA, Chief Development Officer, Confo Therapeutics
Gary Skiles, PhD, Independent Consultant

Lecturers

Cynthia A. Afshari, PhD

Vice President, Global Head Toxicology and Nonclinical Safety, The Janssen Pharmaceutical Companies of Johnson & Johnson

Jennifer Allen, PhD

 Executive Director, Medicinal Chemistry, Amgen
Lauren E. Black, PhD Distinguished Scientist/Advisor, Charles River Laboratories
Ashley Boam, MSBE Director, Office of Policy for Pharmaceutical Quality, US Food and Drug Administration
Margaret Faul, PhD Vice President, Drug Product Technologies, Amgen

Agi Hamburger, PhD

 Vice President, Drug Discovery, A2 Biotherapeutics

Dean Hickman, DPhil

 Vice President, Preclinical and Translational Sciences, Arclight Therapeutics
Diane K. Jorkasky, MD FACP Consultant to Pharma
Saileta Prabhu, PhD Vice President, Global Head, Clinical Biomarker Innovation & Development, Takeda
Malcolm Rowland, PhD Adjunct Professor, School of Pharmacy, University of California, San Francisco

Hansjorg Sauer, MS PhD JD

 Deputy General Counsel for Intellectual Property, Biotechnology Industry Organization

Gary Skiles, PhD

 Independent Consultant
Paolo Vicini, PhD MBA Chief Development Officer, Confo Therapeutics
Geoffrey Walford, MD Distinguished Scientist, Translational Medicine, Merck & Co., Inc
   

Additional faculty - case study proctors

Yelizaveta Babayan, PhD Principal Research Scientist, CMC Global Regulatory Affairs, Eli Lilly & Company
Lisa Boyette, MD PhD Vice President, Medical Affairs, Recursion
Charlie T. Gombar, PhD ACDRS Director
Anne Kasmar, MD MSc Lead Medical Director, Early Clinical Development, OMNI, Genentech
Marco Petrillo, PhD Associate Director, Clinical Biomarker Innovation and Development, Takeda
Dinko Rekić, PhD Global Project Leader, AstraZeneca (Sweden)
Robert Schuck, PharmD PhD Deputy Director (Acting), Division of Translational and Precision Medicine, Office of Clinical Pharmacology, Office of Clinical Pharmacology, US FDA

Topics

  • Pharmacokinetics (PK), pharmacodynamics (PD) and absorption, distribution, metabolism, & excretion (ADME)
  • Discovery chemistry
  • Discovery of biologics
  • Chemistry, manufacturing, and control (CMC)
  • Selection criteria for therapeutic monoclonal antibodies
  • Strategies and approaches for preclinical to clinical translation
  • Intellectual property in drug discovery and development
  • Strategies for predicting human PK, exposure-response, and safety
  • Determinants of human PK variability
  • Guidelines and Beyond for nonclinical toxicology
  • Strategies for successful toxicology investigations
  • Devices to support early drug development