2023 UCSF-Stanford CERSI Immersion Course in Drug Discovery, Development, and Regulation

Date:

Friday, September 15, 2023 - 10:00 am to Friday, December 1, 2023 - 1:00 pm

Location:

Virtual Event - Times Shown in Pacific Time

Overview

The UCSF-Stanford Center of Excellence in Regulatory Science and Innovation (CERSI) is pleased to announce the 2023 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, including small molecules, biologics, and gene therapies.

This is a virtual course comprised of eleven 3-hour sessions held on Fridays, with some exceptions, from September 15, 2023 through December 1, 2023 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 CME or PMP 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 the different types and applications of biomarkers in clinical drug development
Describe the current state and future directions of applications of real-world data (RWD) and real-world evidence (RWE) to 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
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 immuno-oncology and gene therapies

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: Thursday, August 31, 2023 at 11:59 pm PT

Deadline for refunds: Friday, August 25, 2023

Information on course access will be sent to registrants in August 2023.

Registration Category	Registration Fee
General Admission	$2,990
Early Bird (by 8/1/2023)	$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
OPTIONAL September 8, 2023	Welcome and Networking This will take place in-person at the UCSF Mission Bay campus. RSVP will be required.	Mark Dresser, PhD (SVP, Biomarker Sciences and Clinical Pharmacology, Gilead Sciences) Dolo Diaz, PhD (Global Head and SVP, Development Sciences, Altos Labs)
SESSION 1: September 15, 2023	Introduction Overview of Medical Product Development and Regulation	Mark Dresser, PhD (SVP, Biomarker Sciences and Clinical Pharmacology, Gilead Sciences) Dolo Diaz, PhD (Global Head and SVP, Development Sciences, Altos Labs) Richard Graham, PhD (SVP, Research and Development, Theravance Biopharma) Heidi Marchand, PharmD (Head, Global Regulatory Policy and Intelligence, Gilead Sciences) Terrell Baptiste, MBA (Associate Director, Regulatory Policy and Intelligence, Gilead Sciences)
SESSION 2: September 22, 2023	Drug Discovery (e.g., Target Identification, Small Molecule and Protein-based Therapeutics Discovery)	Max Osipov, PhD (Associate Director and Principal Scientist, Small Molecule Discovery, Denali Therapeutics) Rob Wells, PhD (Principal Scientist, Denali Therapeutics)
SESSION 3: September 29, 2023	Translational Preclinical Evaluations (DMPK, Toxicology, Risk Assessment)	Dolo Diaz, PhD (Global Head and SVP, Development Sciences, Altos Labs) Rebecca Erickson, PhD, DABT (Senior Director, Toxicology, DICE Therapeutics)
SESSION 4: MONDAY October 9, 2023	Chemistry, Manufacturing, and Controls of Drugs and Biologics	Gayle Derfus, PhD (Executive Director, Drug Substance Process Development, Gilead Sciences) Eric Gorman, PhD, MS (Director, Formulation & Process Development, Gilead Sciences)
SESSION 5: THURSDAY October 12, 2023	Clinical Biomarkers and Companion Diagnostics: Development and Regulation	Heleen Scheerens, PhD (Senior Director, Global Head of OMNI-Biomarker Development at Genentech) Priti Hegde, PhD (Head of Research, Kite Pharma) Rhea Nersesian, MS (Senior Companion Diagnostics Project Leader, Genentech)
SESSION 6: October 20, 2023	Applications of Real World Data and Real World Evidence to Drug Discovery and Development	Janie Shelton, PhD, MPH (Director, Translational Epidemiology, Bristol Myers Squibb) Kim Van Naarden Braun, PhD (Senior Scientific Director, Translational Epidemiology, Bristol Myers Squibb) Anand Chokkalingam, PhD (Executive Director and Head, Real-World Evidence, Virology, Gilead Sciences)
SESSION 7: October 27, 2023	First-in-Human and Clinical Proof-of-Concept Studies	Nag Budha, PhD (Executive Director, Clinical Pharmacology, BeiGene) Mika Derynck, MD (Chief Medical Officer, Amunix Pharmaceuticals)
SESSION 8: November 3, 2023	Pivotal Clinical Trials (e.g., study design and regulatory considerations)	Mika Derynck, MD (Chief Medical Officer, Amunix Pharmaceuticals) Cornelia Irl, PhD (Vice President, Global Head Data & Statistical Sciences – Oncology, Genentech)
SESSION 9: WEDNESDAY November 15, 2023	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, FDA) Jeffry Florian, PhD (Associate Director, Division of Applied Regulatory Science, Office of Clinical Pharmacology, FDA) Anuradha (Anu) Ramamoorthy, PhD, FCP (Master Scientist & Policy Lead, Guidance and Scientific Policy, Office of Clinical Pharmacology, FDA) Hobart Rogers, PharmD, PhD (Reviewer, Office of Clinical Pharmacology, FDA) Cristina Miglis, PharmD, MS (Reviewer, Office of Clinical Pharmacology, FDA)
SESSION 10: November 17, 2023	Portfolio Strategy and Corporate Development	Andrew McKee, MD (Founder, CEO, and President, Headland Strategy Group) Ken Shimokawa, PhD (Partner, Headland Strategy Group) Bobby Brown, MS (Associate, Headland Strategy Group) Melissa Metcalf, PhD (Associate, Headland Strategy Group)
SESSION 11: December 1, 2023	Discovery and Development of Immuno-Oncology Therapies and Gene Therapies Virtual Career Panel	Mary Newman, MS (Founder and CEO, Alchemy Development Partners) Justine Cunningham, PhD, DABT (Vice President, Development Sciences, REGENXBIO, Inc.) Dolo Diaz, PhD (Global Head and SVP, Development Sciences, Altos Labs)