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
Sign up to be notified when registration opens
Information on course access will be sent to registrants in early September 2025.
Registration Category | Registration Fee |
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General Admission | $2,990 |
Early Bird (by 8/1/2025) | $2,500 |
University/Government * | $1,000 |
University/Government-Affiliated Trainees ** (students/residents/fellows/postdocs) | $250 |
*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
Date | Topic(s) | Instructors |
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OPTIONAL September 5, 2025 |
Welcome and Networking This will take place in person at the UCSF Mission Bay campus. RSVP required. |
Rebecca Erickson, PhD DABT (Executive Director, Toxicology, DICE Therapeutics, a wholly owned subsidiary of Eli Lilly and Company ) |
SESSION 1: September 12, 2025 |
Introduction
Overview of Medical Product Development and Regulation |
Rebecca Erickson, PhD DABT (Executive Director, Toxicology, DICE Therapeutics, a wholly owned subsidiary of Eli Lilly and Company) |
SESSION 2: September 19, 2025 |
Drug Discovery (e.g., Target Identification, Small Molecule and Protein-based Therapeutics Discovery) |
Max Osipov, PhD (Director, Medicinal Chemistry, Septerna) |
SESSION 3: September 26, 2025 |
Translational Preclinical Evaluations (DMPK, Toxicology, Risk Assessment) |
Rebecca Erickson, PhD, DABT (Executive Director, Toxicology, DICE Therapeutics, a wholly owned subsidiary of Eli Lilly and Company) |
SESSION 4: October 3, 2025 |
Chemistry, Manufacturing, and Controls of Drugs and Biologics |
Gayle Derfus, PhD (Executive Director, Pre-Pivotal Cell Line & Cell Culture Biologics Development, Gilead Sciences) |
SESSION 5: October 10, 2025 |
Clinical Pharmacology, Biomarkers and Companion Diagnostics: Development and Regulation |
Katherine Block, PhD, PMP (Principal Companion Diagnostics Development Leader, Genentech) |
SESSION 6: October 17, 2025 |
First-in-Human and Clinical Proof-of-Concept Studies |
Nag Budha, PhD (Executive Director, Clinical Pharmacology, BeiGene) |
SESSION 7: October 24, 2025 |
Pivotal Clinical Trials (e.g., study design and regulatory considerations) |
Cornelia (Conny) Irl, PhD (Vice President, Global Head Data & Statistical Sciences – Oncology, Genentech) |
SESSION 8: October 31, 2025 |
Applications of Real World Data and Real World Evidence to Drug Discovery and Development |
Janie Shelton, PhD, MPH (Director, Translational Epidemiology, Bristol Myers Squibb) |
SESSION 9:
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Medical Product Regulation and Decision Making (e.g., overview, benefit-risk assessments, case studies) |
Rajanikanth (Raj) Madabushi, PhD [Associate Director, Guidance and Scientific Policy, Office of Clinical Pharmacology, US Food and Drug Administration (FDA)] to be confirmed |
SESSION 10: November 14, 2025 |
Portfolio Strategy and Corporate Development |
Andrew McKee, MD (Founder, CEO, and President, Headland Strategy Group) |
SESSION 11: November 21, 2025 |
Artificial Intelligence Virtual Career Panel |
Juan Pinelli, MMS (Director, Digital Innovation- Strategist for R&D, Pfizer) To be confirmed |
Staff
Rebecca Erickson, PhD, DABT Executive Director, Toxicology, DICE Therapeutics, a wholly owned subsidiary of Eli Lilly and Company |
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Carla Washington, PhD Adjunct Professor, Bioengineering and Therapeutic Sciences, UCSF |
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Jaime Kenyon, MPH
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Please email [email protected] with any questions.