Mar 29, 2023
Reimagining R&D Webinar Series presenting “Five Dos or Don’ts of Pre-IND Meetings”.
Vivpro Corporation has partnered with experts and industry leaders to discuss critical pharma and biotech topics. Our goal is to share valuable information and allow the audience to engage with questions while they receive real-time feedback.
For our March session, we are joined by Dr. Immo Zdrojewski, Head of Global Regulatory Policy and Regulatory Intelligence at Moderna.
Session Overview
Listing Key Objectives of Pre-IND Meetings
Setting Strategy
Frame the regulatory meeting questions
List things to-do before the meeting
Understand what to do during the meeting.
About Dr. Immo Zdrojewski, PharmD, PhD
Dr. Zdrojewski received his license to practice as a pharmacist in January 2003 from the Westfaelische- Wilhelms University in Muenster, Germany and subsequently his Ph.D. in pharmaceutical sciences from the University of Florida, Dept. of Pharmaceutics in 2008. Dr. Zdrojewski completed his doctoral research on interactions between grapefruit juice and HMG-CoA reductase inhibitors under the supervision of Dr. Hartmut Derendorf.
Prior to joining Moderna as Head of Global Regulatory Policy, he served as EMD Serono’s Head of Global Regulatory & Scientific Policy (GRASP) US. Dr Zdrojewski completed his 8-year public service in 2016 during which he worked as a clinical pharmacologist in FDA’s CDER Office of the Center Director and as clinical pharmacology team lead in FDA’s Office of Clinical Pharmacology. While serving at FDA, Dr. Zdrojewski successfully evaluated and completed over 13 NME, 90 NDA and 250 IND submissions in the Metabolism and Endocrinology therapeutic area.
