Designing First-In-Human Trials for Small Molecules and Biologics Published 2021-04-15 Download video MP4 360p Recommendations 55:02 Planning for Co-development of Companion Diagnostics 2:03:33 A Deep Dive: FDA’s Model-Integrated Evidence (MIE) Industry Meeting Pilot Program for Generic Drugs 04:55 10 Facts about What FDA Does and Does Not Approve #FDAFacts 1:30:38 Conversations on Cancer: Transforming Patient Lives by Therapeutic and Regulatory Innovations 05:55 10 datos sobre lo que la FDA aprueba y no aprueba #DatosDeLaFDA 03:17 How does the FDA approve new drugs? 1:02:25 FDA New Era of Smarter Food Safety Tech-Enabled Traceability Video Series: Supply Chain Technology 04:50 A Conversation With Janet Woodcock, M.D. and Namandjé Bumpus, Ph.D. 02:21 What does the FDA do after drugs are approved? 06:05 Episode 3 - On The Road with Jim Jones - Jan 2024 05:19 Episode 2 - On The Road with Jim Jones - Nov 2023 19:43 Bridging Gaps in Health Equity: A Conversation with Dr. Claudia Baquet 06:14 A Day in the Life of an Import Investigator 00:26 ¿Sabes que los medicamentos de fórmulas magistrales no están aprobados por la FDA? #DatosDeLaFDA Similar videos 31:53 Getting to First-in-Human for Small Molecules and Biologics 36:56 FDA’s Clinical Regulatory Perspective: Designing First-In-Human Trial for Cellular and Gene Therapy 13:03 Designing Trials Efficiently: An Introduction Part 1 58:50 Animal Scale Up and First-in-Human Studies with Dr. Jerry Collins 44:18 Jim Wells and Michelle Arkin(UCSF) Part 1: Introduction to Drug Discovery 56:24 CMC Considerations for Biotechnology Product Development: A Regulatory Perspective 1:19:35 Chemistry, Manufacturing, and Controls (CMC) for an IND (7of14) REdI 2018 16:00 Introduction to Clinical Study Design: Where to Start Part 1 54:28 Overview of Non-clinical Assessment in Drug Development (8/14) REdI 2017 1:01:10 Webinar: Phase I trials in oncology: Pros and cons of current designs 05:21 (Review) First-in-Human Studies - PMDA-ATC Learning Videos 1:02:19 Chemistry and Manufacturing Requirements for Early Clinical Development: What’s in there? Prove it. 56:21 Practical Model-based Approaches for Phase 1 Oncology Trials 54:26 What Oncology Drug Developers Should Expect from the FDA’s Project Optimus 46:11 Clinical Development of Radiopharmaceuticals a Theranostic Pairs and Dosimetry Considerations 15:40 From idea to medicine | Drug development at Roche 39:35 Bayesian Optimal Interval Design Fundamentals 57:06 Small Molecules, Biologics, and Vaccines: Three Uniquely Divergent Roads to FDA CMC Approval 02:06 What are Biologics? More results