Participants will gain a comprehensive and rigorous overview of regulatory and scientific considerations for medical product development.
Details
- Type Event
- Date -
- Time -
- Location Virtual
About
Overview
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
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 29, 2026 at 11:59 pm PT
Deadline for refunds: Saturday, August 29, 2026
Information on course access will be sent to registrants in early September 2026.
| Registration Category | Registration Fee |
|---|---|
| General Admission | $2,990 |
| Early Bird (by 8/10/2026) | $2,500 |
| University/Government/Nonprofit * | $1,000 |
| University/Government/Nonprofit-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. For nonprofit, please contact [email protected].
**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 |
|---|---|---|
OPTIONAL September 10, 2026 | Welcome and Networking This will take place in-person at the UCSF Mission Bay campus. RSVP required. | Rebecca Erickson, PhD DABT (Executive Director, Toxicology, Eli Lilly) Carla Washington, PhD (Adjunct Professor, Bioengineering & Therapeutic Sciences, UCSF) |
SESSION 1: September 11, 2026 | Introduction
History of Drug Discovery and Development
Artificial Intelligence | Rebecca Erickson, PhD DABT (Executive Director, Toxicology, Eli Lilly)
|
SESSION 2: September 18, 2026 | Drug Discovery (e.g., Target Identification, Small Molecule and Protein-based Therapeutics Discovery) | Max Osipov, PhD (Director, Medicinal Chemistry, Septerna) Rob Wells, PhD (Principal Scientist, Denali Therapeutics) |
SESSION 3: September 25, 2026 | Translational Preclinical Evaluations (Toxicology, Risk Assessment & ADME) | Jonathan (Jon) Maher, PhD, DABT, ATS (Head of Nonclinical Safety, Pliant Therapeutics) Ryan Takahashi, PhD (Senior Director, DMPK and Clinical Pharmacology, Tenvie) |
SESSION 4: October 2, 2026 | Chemistry, Manufacturing, and Controls of Small Molecule Drugs and Biologics | Gayle Derfus, PhD (Executive Director, Pre-Pivotal Cell Line & Cell Culture Biologics Development, Gilead Sciences) Eric Gorman, PhD, MS (Director, Formulation & Process Development, Gilead Sciences) |
SESSION 5: October 9, 2026 | Biomarkers and Companion Diagnostics: Development and Regulation | Katherine Block, PhD, PMP (Principal Companion Diagnostics Development Leader, Genentech) Felix Yeh, PhD (Director & Senior Principal Scientist, Translational Medicine | OMNI, Genentech) |
SESSION 6: October 16, 2026 | First-in-Human and Clinical Proof-of-Concept Studies | Nag Budha, PhD (Executive Director, Clinical Pharmacology, BeOne Medicines) Charlie Harris, MD PhD (Associate Vice President, Diabetes, Obesity and Complications | Early Clinical Development, Eli Lilly) |
SESSION 7: October 23, 2026 | Pivotal Clinical Trials (e.g., study design and regulatory considerations) | Charlie Harris, MD PhD (Associate Vice President, Diabetes, Obesity and Complications | Early Clinical Development, Eli Lilly) Na Xu, PhD (Executive Director, Quantitative Science, Revolution Medicines) |
SESSION 8: October 30, 2026 | Applications of Real World Data and Real World Evidence to Drug Discovery and Development | Janie Shelton, PhD, MPH (Director, Translational Epidemiology, Bristol Myers Squibb) Amanda Singer, PhD, MPH (Senior Director, Real-World Evidence - Virology, Gilead Sciences) |
SESSION 9:
| Global Medical Product Regulation and Decision Making (e.g., overview, benefit-risk assessments, case studies) | Anuradha (Anu) Ramamoorthy, PhD, FCP (Master Scientist & Policy Lead, Guidance and Scientific Policy, Office of Clinical Pharmacology, US Food and Drug Administration) Terrell Baptiste, MBA (Associate Director, Regulatory Policy and Intelligence, Gilead Sciences) |
SESSION 10: November 13, 2026 | Portfolio Strategy and Corporate Development | Andrew McKee, MD (Founder, CEO, and President, Headland Strategy Group) Heather Rogan, PhD (Engagement Manager, Headland Strategy Group) |
SESSION 11: November 20, 2026 | Hot Topic Virtual Career Panel | Speaker to be confirmed Panelists to be confirmed |
Staff
| Rebecca Erickson, PhD, DABT Executive Director, Toxicology, Eli Lilly |
| Carla Washington, PhD Adjunct Professor, Bioengineering and Therapeutic Sciences, UCSF |
| Jaime Kenyon, MPH
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Please email [email protected] with any questions.