REGISTRATION DEADLINE - CERSI Immersion Course in Drug Discovery, Drug Development, and Regulation
Thursday, September 30, 2021
The UCSF-Stanford CERSI chapter invites faculty to participate in its 2021 Immersion Course in Drug Discovery, Drug Development, and Regulation. This virtual course on drug development will take place on Fridays from 10 am to 1 pm Pacific time from October 1 through December 17, 2021.
DEADLINE TO REGISTER: THURSDAY, SEPTEMBER 30, 5:00 P.M.
The UCSF-Stanford Center of Excellence in Regulatory Science & Innovation (CERSI) is pleased to present:
CERSI Immersion Course in Drug Discovery, Drug Development, and Regulation
October 1, 2021 – December 17, 2021
Held Virtually on Fridays from 10 am to 1 pm Pacific Time
Information and Registration: https://pharm.ucsf.edu/cersi/2021immersion
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 all eleven sessions will be issued a Statement of Completion from the UCSF-Stanford Center of Excellence in Regulatory Science and Innovation (CERSI).
- 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
- 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
Please visit https://pharm.ucsf.edu/cersi/2021immersion for the course schedule and more information.