FDA Oncology Drug Development Overview – Past to Present Published 2021-04-08 Download video MP4 360p Download video MP4 720p Recommendations 37:34 Designing First-In-Human Trials for Small Molecules and Biologics 1:56:15 Understanding FDA Inspections and Data 54:28 Overview of Non-clinical Assessment in Drug Development (8/14) REdI 2017 44:31 Nonclinical Safety Assessment for Small Molecules and Biologic Drug Development (6of14) REdI 2018 1:30:38 Conversations on Cancer: Transforming Patient Lives by Therapeutic and Regulatory Innovations 31:53 Getting to First-in-Human for Small Molecules and Biologics 1:20:20 Chemistry, Manufacturing Controls (CMC) in an Investigational New Drug (IND) (7/14) REdI 2017 36:56 FDA’s Clinical Regulatory Perspective: Designing First-In-Human Trial for Cellular and Gene Therapy 24:28 Introduction to the Drug Master File (DMF) Review Process 37:46 Clinical Pharmacology Regulatory Sciences in Drug Development and Precision Medicine 1:35:35 Conversations on Cancer, Real Talk: Our Stories as Black Oncologists at the FDA 1:07:37 Cracking the Code for Clinical Pharmacology-Related Prescription Drug Labeling (6/9) Labeling 2017 04:50 A Conversation With Janet Woodcock, M.D. and Namandjé Bumpus, Ph.D. 06:14 A Day in the Life of an Import Investigator 05:19 Episode 2 - On The Road with Jim Jones - Nov 2023 14:18 Federal Resources for Innovative Cancer Startups: More Than Just Funding 19:43 Bridging Gaps in Health Equity: A Conversation with Dr. Claudia Baquet 06:05 Episode 3 - On The Road with Jim Jones - Jan 2024 7:06:50 FDA-MHRA-HC 2024 Joint Symposium (Day 1) 00:26 ¿Sabes que los medicamentos de fórmulas magistrales no están aprobados por la FDA? #DatosDeLaFDA Similar videos 50:09 An Overview of FDA's Project Facilitate Oncology Expanded Access Program 35:06 Oncology Drug Development in the Era of Precision Medicine: FDA Perspective 15:50 Oncology Center of Excellence Introduction and Overview of the Oncology Therapy Development Workshop 59:00 What is FDA Project Optimus and How Will it Impact Oncology Drug Development? 1:14:48 Oncology Drug Modalities: A New Era in Oncology Drug Development 01:24 FDA Oncology Center of Excellence’s Project Facilitate 2:15:33 2/26 FIN UConn Health Center Economic Growth Informational Forum 1:01:47 Conversations on Cancer: Bringing Innovation to People Facing Cancer 42:27 What you should know about FDA Project Optimus for your oncology drug approval 1:15:11 The Good, the Bad & the Ugly of Oncology Drug Development 1:05:36 Project Optimus – FDA’s New Dose Optimization & Selection Paradigm in Oncology Drug Development 54:02 OSI’s Role in the Drug Development Process and Impact of COVID-19 54:26 What Oncology Drug Developers Should Expect from the FDA’s Project Optimus 04:09 Oncology Therapy Development Workshop Overview, Day Two 12:07 The FDA’s "Project Optimus" and Oncology Drugs More results