IND Seminar Series
Sponsored by the Canary Center at Stanford for Cancer Early Detection and the Stanford Cancer Center Clinical Trials Office
The series is designed to cover the logistics and the process of IND (and Exploratory IND) filing, the regulatory strategy required for IND approvals, and successful communications with the FDA. Attendees will learn tools and resources from experienced regulatory professionals that are necessary for filing IND submissions with the FDA.
Target Audience: Cancer institute members and faculty researchers in the Molecular Imaging Program at Stanford.
Seminars:
- Seminar 1: Introduction to Drug Development and Regulatory Environment
- Seminar 2: IND Submissions
- Seminar 3: IND content: Pharmacology/ADME/Toxicology
- Seminar 4: CMC (Chemistry, Manufacturing, Control) and Clinical Supplies
- Seminar 5: IND: Clinical Development
- Seminar 6: Types of INDs / Exploratory INDs / Expert Panel Discussion
- Seminar 7: Stanford Specific Regulatory Requirements for INDs
Every seminar will include case studies and an overview of available resources.
Presenters Include:
- Linda De Young, Ph.D.; Founder, IND Enabling Consulting (IEC)
- Larry De Young, Ph.D.; Consultant in New Product Planning
- Robert Elfont, M.D.; Former V.P. of Clinical Development at Medivation
- Louise C. Johnson, M.S.; Regulatory Affairs Consultant
- Priti Joshi, PMP, RAC; Regulatory, Quality and Project Management Consultant
- Véronique Lauriault, Ph.D., D.A.B.T.; Biochemical Toxicology Consultant
- Russ Lehrman, Ph.D.; Founder, Lehrman Biopharma
- Ann M. Lowe, M.D.; Clinical Research and Development Consultant
- George Mills, M.D.; V.P. of Medical Imaging and Consulting for the Perceptive Informatics
- Jay Stoudemire, Ph.D.; Consultant for Nonclinical Development
- M J Whitehouse, Ph.D.; Founder, JumpStart BioDevelopment
- Jennifer Brown, R.N.; Manager, Regulatory Education and Services, Spectrum
- Lee Doherty, Ed.M.; Regulatory Manager, Cancer Clinical Trials Office
For questions please contact:
Lee Doherty, Ed.M. |
Daniela Starcevic, Ph.D. |
Trial Administration