Post by Marcel Kenter

Registration is now open! On October 27th, 2025 we will start with the next edition of our revamped 5-week interactive, hands-on online course Clinical Product Development. In this course you will explore the challenges of product development through real-world teaching case studies featuring diverse product types including an antibiotic and antibody both with a new mechanism of action. You will learn to use NOAEL and MABEL approaches to determine a safe starting dose for a First-in-Human trial (FiH) and you will develop critical reading skills by analyzing a real-world Investigator’s Brochure (IB). The course features engaging exercises and our Netflix-style series, QUESTIONS!, presented in six episodes. It demonstrates how to use a Real Option-based project valuation methodology, rather than traditional risk-adjusted Net Present Value calculations, for the development of new products. Contributions are from Hans-Georg Eichler (Senior Medical Officer, EMA), Rick Kuntz (former CMO/CSO Medtronic), Koen Andries (former discovery scientist, The Janssen Pharmaceutical Companies of Johnson & Johnson Pharmaceutica), Paul Stoffels (former CSO J&J and former CEO Galapagos), and others. Your mentor Marcel Kenter. For more information go to: https://lnkd.in/dFBBPksD #ClinicalDevelopment, #MedicinalProduct, #EMA, #FDA, #ProfessionalLearning, #OnlineLearning, #ClinicalTrial

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