Details
- Type Event
- Date -
- Time -
- Location 1608 Rhode Island Ave NW, Washington DC 1608 Rhode Island Ave NW, Washington DC
About
This is Session 2 of 6. Must register for the entire 2025 Course and not per session.
Session Chairperson:
Paolo Vicini, PhD, MBA, Chief Development Officer, Confo Therapeutics
Lecturers
| Jennifer Allen, PhD |
Executive Director, Medicinal Chemistry, Amgen |
|
| Margaret Faul, PhD | Vice President, Vice President | Manufacturing & Clinical Supply and ATO Operations Site Head | |
| Leslie Floren, PharmD PhD MA |
Associate Dean of Fellowships and Professor, Clinical Pharmacy, School of Pharmacy, UCSF |
|
| Agi Hamburger, PhD | Vice President, Drug Discovery, A2 Biotherapeutics | |
| Brandon W. Higgs, PhD | Vice President, Translational Data Sciences, Genmab | |
| 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 | |
| Michael Maitland, MD PhD |
Vice President, Clinical Development, Pathos |
|
| Saileta Prabhu, PhD | Senior Director, Clinical Pharmacology, Regeneron | |
| Melissa Reuter, MS MBA |
Director, Portfolio Planning, Precision Medicine Unit (PMed), GSK |
|
| Bill Richards, PhD | Vice President, Target & Drug Discovery, 23andMe | |
| Gary Skiles, PhD | Independent Consultant | |
| Paolo Vicini, PhD MBA | Chief Development Officer, Confo Therapeutics | |
| Scott Wasserman, MD | Chief Medical Officer, Kailera Therapeutics |
Additional faculty - case study proctors
| Charlie T. Gombar, PhD | ACDRS Director |
| David Holtzman, MD PhD | Clinical Development Leader, Bill & Melinda Gates Medical Research Foundation |
| Christopher Vinnard, MD PhD MSCE MS | Clinical Development Leader, Bill & Melinda Gates Medical Research Foundation |
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
- Strategies for predicting human PK, exposure-response, and safety
- Determinants of human PK variability
- Co-development of biomarkers, companion diagnostics and devices
- Guidelines and beyond for nonclinical toxicology
- Strategies for successful toxicology investigations
- CRISPR
- Artificial intelligence and machine learning in translational and early clinical applications