2022 UCSF-Stanford CERSI Immersion Course in Drug Discovery, Development, and Regulation

Date:

Friday, September 16, 2022 - 10:00 am to Friday, December 2, 2022 - 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 2022 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 from September 16, 2022 through December 2, 2022 from 10 am - 1 pm Pacific Time. 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 drug discovery, including target identification and computational methods used to design drugs
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 is Wednesday, September 14, 2022 at 5:00 pm PT

Registration Category	Registration Fee
General Admission / Industry	$2,990
Early Bird (Before 8/1/2022)	$2,500
University / Government *	$1,000
University / Government Trainees *	$250

*If eligible for the university/government or trainee rate, you must sign up using an email address ending in .edu/.gov/.mil.

Course Schedule

Date	Topic(s)	Instructors
OPTIONAL September 9, 2022	Welcome and Networking This will take place in-person at the UCSF Mission Bay campus from 3:30 pm to 5 pm PT. Sign-Ups for the reception are now closed.	Mark Dresser, PhD (SVP, Biomarker Sciences and Clinical Pharmacology, Gilead Sciences) Dolo Diaz, PhD (SVP, Development Sciences, Denali Therapeutics)
SESSION 1: September 16, 2022	Introduction Overview of Medical Product Development and Regulation	Mark Dresser, PhD (SVP, Biomarker Sciences and Clinical Pharmacology, Gilead Sciences) Dolo Diaz, PhD (SVP, Development Sciences, Denali Therapeutics) Richard Graham, PhD (SVP, Development, Theravance Biopharma) Áine Miller, PhD (VP, Head of Regulatory Affairs and Medical Writing, Theravance Biopharma) Terrell Baptiste, MBA (Associate Director, Regulatory Policy and Intelligence, Gilead Sciences)
SESSION 2: September 23, 2022	Drug Discovery (e.g., Target Identification, Small Molecule and Protein-based Therapeutics Discovery)	JW Feng, PhD (Staff Research Scientist, Google Research, Google) James Crawford, PhD (Senior Principal Scientist, Genentech)
SESSION 3: September 30, 2022	Translational Preclinical Evaluations (DMPK, Toxicology, Risk Assessment)	Dolo Diaz, PhD (SVP, Development Sciences, Denali Therapeutics) Rebecca Erickson, PhD (Senior Director, Toxicology, DiCE Molecules)
SESSION 4: October 7, 2022	Chemistry, Manufacturing, and Controls of Drugs and Biologics	Roshy Pakdaman, PhD (VP, Formulation & Process Development, Gilead) Gayle Derfus, PhD (Executive Director, Drug Substance Process Development, Gilead Sciences)
SESSION 5: October 14, 2022	Clinical Biomarkers and Companion Diagnostics: Development and Regulation	Heleen Scheerens, PhD (Senior Director, Global Head of OMNI-Biomarker Development at Genentech) Rhea Nersesian, MS (Senior Companion Dx Project Leader at Genentech)
SESSION 6: October 21, 2022	Applications of Real World Data and Real World Evidence to Drug Discovery and Development	Frank Sifakis, PhD, MPH, MBA (Vice President, Real-World Evidence at Gilead) Kim Van Naarden Braun, PhD (Senior Scientific Director, Translational Epidemiology at Bristol Myers Squibb)
SESSION 7: October 28, 2022	First-in-Human and Clinical Proof-of-Concept Studies	Nag Budha, PhD (Clinical Pharmacologist, BeiGene) Mika Derynck, MD (Chief Medical Officer, Amunix Pharmaceuticals)
SESSION 8: November 4, 2022	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: November 10, 2022 (NOTE: Thursday)	Medical Product Regulation and Decision Making (e.g., overview, benefit-risk assessments, case studies)	Issam Zineh, PharmD, MPH (Director, Office of Clinical Pharmacology, FDA) David Strauss, MD, PhD (Director, Division of Applied Regulatory Science, FDA) Rajanikanth Madabushi, PhD (Associate Director, Guidance and Scientific Policy, FDA) Hobart Rogers, PharmD, PhD (Reviewer, Office of Clinical Pharmacology, FDA) Henrietta Abodakpi PharmD, PhD (Reviewer, Office of Clinical Pharmacology, FDA)
SESSION 10: November 18, 2022	Portfolio Strategy and Corporate Development	Andrew McKee, MD (Founder, CEO, and President, Headland Strategy Group) Ken Shimokawa, PhD (Senior Engagement Manager, Headland Strategy Group) Bobby Brown, MS (Life Science Business Analyst, Headland Strategy Group)
SESSION 11: December 2, 2022	Discovery and Development of Immuno-Oncology Therapies and Gene Therapies Course Wrap Up	Akintunde (Tunde) Bello, PhD (VP, Clinical Pharmacology and Pharmacometrics at Bristol-Myers Squibb) Justine Cunningham, PhD, DABT (VP, Toxicology & Biodistribution, Sana Biotechnology, Inc.) Mark Dresser, PhD (SVP, Biomarker Sciences and Clinical Pharmacology, Gilead Sciences) Dolo Diaz, PhD (SVP, Development Sciences, Denali Therapeutics)
OPTIONAL: December 9, 2022	Career Panel Discussion	TBD