UCSF Immersion Course in Drug Discovery, Development, and Regulation

The Immersion Course in Drug Discovery, Drug Development, and Regulation provides an 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 from 10 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. Sessions will be recorded and available to all participants for the duration of the course.

Note: This course is intended for professional development and is not accredited for any continuing education credit.

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

Information and registration:  https://pharm.ucsf.edu/cersi/2026immersion  
Discounted registration fee for trainees in government, academia, & nonprofit is $250.00 while fee for those in academia, government, & nonprofit is $1,000.00 .