Overview
Overview
The University of California, San Francisco (UCSF) is pleased to announce that the 2026 Immersion Course in Drug Discovery, Drug Development, and Regulation is open for enrollment. Participants will have the opportunity to learn the scientific and regulatory aspects of drug discovery and development from leading scientists and experts in the biotechnology/pharmaceutical industries and academia. Different therapeutic modalities will be covered, with a focus on small molecules and biologics.
This virtual course is comprised of eleven 2.5-hour sessions held on Fridays from September 11, 2026 through November 20, 2026 at 10:00 am – 12:30 pm Pacific Time. Each session may include pre-reading assignments, lectures, and discussion of case studies. Participants who successfully complete the course will be issued a Statement of Completion from UCSF. Sessions will be recorded and available to all participants for the duration of the course.
Learning Objectives
- Discuss how Artificial Intelligence is being used today in the end-to-end drug development process, including current use cases and areas of future opportunity
- Discuss the current regulatory system and structure relevant to drug development and describe two key FDA submissions: the Investigational New Drug (IND) Application and New Drug Application (NDA) / Biologics License Application (BLA)
- Discuss contemporary approaches to small and large molecule drug discovery, including target identification, hit-to-lead, and lead optimization
- Explain the role of toxicology, pathology, and drug metabolism and pharmacokinetics in the selection and evaluation of drug candidates for clinical testing
- Describe CMC and quality considerations in the manufacture of drugs and biologics to support all phases of development
- Explain drug-drug interactions caused by metabolic enzyme- and transporter-mediated interactions, and applications of different types of biomarkers in clinical drug development.
- Explain the principles of first-in-human studies and starting dose determinations (Phase 1 studies)
- Describe study design and regulatory considerations for proof-of-concept (Phase 2) and pivotal (Phase 3) clinical studies
- Describe the current state and future directions of applications of real-world data (RWD) and real-world evidence (RWE) to drug development
- Discuss key factors for regulatory decision-making, such as benefit-risk assessments
- Explain the fundamentals of a portfolio strategy and corporate development
Target Audience
- Early- to mid-career industry scientists and regulatory professionals who would like a broad overview of the latest developments in the field
- Faculty members interested in understanding drug development to advance discoveries into products
- Trainees who would like to complement their training and research in basic and applied sciences with a course on the nuts and bolts of drug discovery and development
Course Co-Directors
Rebecca Erickson, PhD DABT
Executive Director, Toxicology
Eli Lilly
Carla Washington, PhD
Adjunct Professor, Bioengineering and Therapeutic Sciences
UCSF School of Pharmacy
Instructors
- Terrell Baptiste, MBA, Senior Director, Regulatory Policy and Intelligence, Gilead Sciences
- Katherine Block, PhD PMP, Principal Companion Diagnostics Development Leader, Genentech
- Nag Budha, PhD, Executive Director, Clinical Pharmacology, BeOne Medicines USA, Inc.
- Gayle Derfus, PhD, Executive Director, Pre-Pivotal Cell Line & Cell Culture Biologics Development, Gilead Sciences
- Dolo Diaz, PhD, Global Head and SVP, Development Sciences, Alto Labs
- Eric Gorman, PhD MS, Director, Formulation & Process Development, Gilead Sciences
- Charlie Harris, MD PhD, Associate Vice President, Diabetes, Obesity and Complications | Early Clinical Development, Eli Lilly
- Jonathan Maher, PhD DABT ATS, Senior Director, Nonclinical Safety, Moderna
- Andrew McKee, MD, Founder, CEO, and President, Headland Strategy Group
- Max Osipov, PhD, Director, Medicinal Chemistry, Septerna
- Juan Pinelli, MMS, Director, Digital Innovation- Strategist for R&D, Pfizer
- Anuradha Ramamoorthy, PhD FCP, Master Scientist & Policy Lead, Guidance and Scientific Policy, OCP, US FDA
- Heather Rogan, PhD, Engagement Manager, Headland Strategy Group
- Janie Shelton, PhD MPH, Senior Director, Translational Epidemiology, Bristol Myers Squibb
- Amanda Singer, PhD MPH, Senior Director, Real-World Evidence - Virology, Gilead Sciences
- Ryan Takahashi, PhD, Senior Director, DMPK and Clinical Pharmacology, Tenvie
- Rob Wells, PhD, Principal Scientist, Denali Therapeutics
- Na Xu, PhD, Executive Director, Quantitative Science, Revolution Medicines
- Felix Yeh, PhD, Director & Senior Principal Scientist, Translational Medicine | OMNI, Genentech
For more information: https://pharm.ucsf.edu/cersi/2026immersion
