The first regulatory science and innovation center on the West Coast
2021 CERSI Immersion Course in Drug Discovery, Drug Development, and Regulation
Date:
Friday, October 1, 2021 - 10:00 am to Friday, December 17, 2021 - 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 2021 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. The course has been updated from last year with the addition of a new session on Chemistry, Manufacturing and Controls of Drugs and Biologics. This is a virtual course comprised of eleven 3-hour sessions held every Friday from October 1, 2021 through December 17, 2021 from 10 am to 1 pm Pacific Time. Each session will generally include lecture and interactive 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 in case participants are not able to attend every session.
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
- 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. Registration closed on September 30, 2021.
| Registration Category | Registration Fee |
|---|---|
| General Admission / Industry | $2,990 |
| Early Bird (Before 9/1/2021) | $2,500 |
| Academic / Government* | $1,000 |
| Trainees* | $250 |
*To register under the academic/government or trainee rate, you must sign up using an email address ending in .edu/.gov/.mil.
Course schedule
Click to download the 
Instructor Biographies.
| Date | Topic(s) | Instructors |
|---|---|---|
| October 1, 2021 |
Welcome Overview of Medical Product Development and Regulation in the United States |
Mark Dresser, PhD (SVP, Biomarker Sciences and Clinical Pharmacology, Gilead; Adjunct Professor, Department of Bioengineering & Therapeutic Sciences, UCSF) Richard Graham, PhD (SVP, Development, Theravance Biopharma) Aine Miller, PhD (VP, Head of Regulatory Affairs and Medical Writing, Theravance Biopharma) Heidi Marchand, PharmD, RPh (Global Head of Regulatory Policy and Intelligence, Gilead Sciences) Terrell Baptiste, MBA (Senior Manager, Regulatory Affairs, Gilead Sciences) |
| October 8, 2021 | Drug Discovery from Target Identification to Lead Optimization |
JW Feng, PhD (Staff Research Scientist, Google Research, Google) James Crawford, PhD (Senior Principal Scientist, Genentech) |
| October 15, 2021 | Translational Preclinical Evaluations (DMPK, Toxicology, Risk Assessment) | Dolo Diaz, PhD (VP, Development Sciences, Denali Therapeutics) |
| October 22, 2021 | 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) |
| October 29, 2021 | Clinical Biomarkers and Companion Diagnostics |
Heleen Scheerens, PhD (Senior Director, Global Head of OMNI-Biomarker Development at Genentech) Rhea Nersesian (Senior Companion Dx Project Leader at Genentech) |
| November 5, 2021 | Applications of Real World Data and Real World Evidence in Drug Discovery and Development |
Kimberly Wilson, MS (Executive Director, Translational Epidemiology, Bristol-Myers Squibb) Patrick Loerch, PhD (SVP, Data Science & Biometrics, Gilead) |
| November 12, 2021 | First-in-Human and Clinical Proof-of-Concept Studies (Phase 1 and Phase 2) |
Nag Budha, PhD (Clinical Pharmacologist, BeiGene) Mika Derynck, MD (Chief Medical Officer, Amunix Pharmaceuticals) |
| November 19, 2021 | Design and Conduct of Pivotal Clinical Trials (Phase 3) |
Mika Derynck, MD (Chief Medical Officer, Amunix Pharmaceuticals) Cornelia Irl, PhD (Vice President, Global Head Data & Statistical Sciences – Oncology, Genentech Inc.) |
| December 3, 2021 | Medical Product Regulation and Decision Making |
Issam Zineh, PharmD, MPH (Director, Office of Clinical Pharmacology, FDA) Abhay Joshi, PhD (Clinical Pharmacology Reviewer/OCP, FDA) Rajanikanth Madabushi, PhD (Associate Director, Guidance and Scientific Policy/OCP, FDA) David Strauss, MD, PhD (Director, Division of Applied Regulatory Science, FDA) Robert Schuck, PharmD, PhD (Deputy Director, Division of Translational and Precision Medicine/OCP, FDA) |
| December 10, 2021 | Portfolio Strategy and Corporate Development |
Andrew McKee, MD (Founder, CEO, and President, Headland Strategy Group) Colin Waycott (Analyst, Headland Strategy Group) |
| December 17, 2021 |
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; Adjunct Professor, Department of Bioengineering & Therapeutic Sciences, UCSF) |
Contact
|
Course Director - Mark Dresser, PhD Senior Vice President, Biomarker Sciences & Clinical Pharmacology, Gilead Sciences Adjunct Professor of Bioengineering and Therapeutic Sciences, UCSF |
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Course Administrator - Lawrence Lin, PhD Executive Director, UCSF-Stanford CERSI |