2025 UCSF-Stanford CERSI Immersion Course in Drug Discovery, Development, and Regulation

Overview

The UCSF-Stanford Center of Excellence in Regulatory Science and Innovation (CERSI) is pleased to announce the 2025 Immersion Course in Drug Discovery, Drug Development, and Regulation. 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 is a virtual course comprised of eleven 3-hour sessions held on Fridays from September 12, 2025 through November 21, 2025 from 10 am - 1 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 the UCSF-Stanford Center of Excellence in Regulatory Science and Innovation (CERSI). 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 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
• Discuss emerging and evolving topics such as artificial intelligence

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

Registration

The registration fees for this course are shown below.
A group registration discount is available when registering 10 or more people at the same time. Please contact [email protected] for more information.

Deadline to register: Saturday, August 30, 2025 at 11:59 pm PT

Deadline for refunds: Saturday, August 30, 2025

Information on course access will be sent to registrants in early September 2025.

*To be eligible for the University/Government rate, you must be currently affiliated with a university or government institution and sign up using an email address ending in .edu/.gov/.mil.

**To be eligible for the University/Government-Affiliated Trainee rate, you must provide proof of CURRENT affiliation with a university or government trainee program, and you must sign up using an email address ending in .edu/.gov/.mil. Examples of acceptable documents include an enrollment verification certificate, class schedule for the current academic term, or acceptance letter into the current trainee program. Please email proof of trainee status to [email protected] upon registering.

Course Schedule

Staff

	Rebecca Erickson, PhD, DABT Course Co-Director Executive Director, Toxicology, Eli Lilly		Carla Washington, PhD Course Co-Director Adjunct Professor, Bioengineering and Therapeutic Sciences, UCSF
	Jaime Kenyon, MPH Course Administrator

Please email [email protected] with any questions.