Preparing for success in modernizing the science behind the development and regulation of medical products
ACDRS 2023 Session 2 - Learning Trials: From Discovery to First in Human
Date:
Wednesday, March 29, 2023 - 8:00 am to Friday, March 31, 2023 - 4:00 pm
Location:
UCDC, 1st floor meeting room
1608 Rhode Island Ave NW, Washington DC
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
Jennifer Allen, PhD |
Executive Director, Medicinal Chemistry, Amgen |
Ashley Boam, MSBE | Director, Office of Policy for Pharmaceutical Quality, US Food and Drug Administration |
Patrick Collins, PhD | Director, Functional Genomics, 23andMe |
Margaret Faul, PhD | Vice President, Vice President | Manufacturing & Clinical Supply and ATO Operations Site Head |
Agi Hamburger, PhD |
Vice President, Drug Discovery, A2 Biotherapeutics |
Diane K. Jorkasky, MD FACP | Consultant to Pharma |
Jacqueline Kinyamu-Akunda, DVM PhD | Senior Scientific Director, Nonclinical Safety, Janssen |
Lois D. Lehman-McKeeman, PhD ATS | Vice President, Pharmaceutical Candidate Optimization, Bristol Myers Squibb |
Saileta Prabhu, PhD | Senior Director, Clinical Pharmacology, Regeneron |
Bill Richards, PhD | Vice President, Target & Drug Discovery, 23andMe |
Hansjorg Sauer, PhD JD |
Deputy General Counsel and Vice President, 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
Jaspreet Arora, PhD | Associate Director, Formulation Development |
Sean Downing, PhD | Senior Director of Biomarker Development and Technologies, Center of Excellence for Biomarker and Bioanalysis Sciences and Technologies, Takeda Pharmaceuticals |
Maria Flynn, PhD | Senior Pharmaceutical Quality Assessor, Application Technical Lead, Division of Immediate and Modified Release Products II, Office of Lifecycle Products, Office of Pharmaceutical Quality, Center for Drugs & Evaluation Research, US Food and Drug Administration |
Charlie T. Gombar, PhD | ACDRS Director |
Jennifer S. Thompson, MD | Global Clinical Program Lead, Therapeutic Area Inflammation, Boehringer Ingelheim |
Topics (subject to change)
- 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
- Functional genomics approaches for drug discovery