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David is a research biochemist and pharmacologist by academic training and since earning his Ph.D. degree, has accumulated well over 35 years of pharmaceutical regulatory strategic and project leadership experience from the early R&D development stage through all Phases of clinical development leading to successful NDA submissions / approvals across multiple therapeutic areas, with a focus on CNS-related disorders (specifically forms / types of schizophrenia and Alzheimer’s disease), Metabolism (specifically Type I and Type II diabetes) and Cardiovascular disease therapeutic targets (specifically primary and secondary stroke prevention and hypertension) in the United States, Europe and other regulatory jurisdictions.
David’s expertise and “comfort zone” is in the very hands on development and implementation of regulatory strategies and accompanying documentation that support the conduct of pharmaceutical development programs leading to optimized product profiles / labels that benefit the patient. The development / submission / approval of a product including such an optimized product profile is only possible based upon establishing a strong relationship with the relevant health authorities based on solid data-driven strategies and documents. David has a long and successful track record with FDA and EMA in ensuring that this is an essential component of all programs under his responsibility. Over his more than 35-years of pharmaceutical industry regulatory experience, David has led and been principally responsible for the successful conduct of an extraordinary number of project specific FDA interactions (e.g., all Type A, B, and C interactions via face-to-face or teleconference) on complex, multidisciplinary project issues. David has led his company and project development team through the preparation and successful conduct of three FDA Advisory Committee meetings.
David has a long history of establishing internal company policies and procedures relating to the specific clinical and CM&C development of NCE’s, NBE’s, and biosimilars. He has led and been responsible for leading successful development teams including critical clinical and cGMP compliance issues as well as project teams responsible for the development of product profile / CFR compliant labeling and the associated promotional / commercial messaging and advertising.
On a personal note, David is an FAA licensed private pilot, a certified scuba diver, and maintains dual citizenship in the US and the EU, with established residencies in both New York and Vienna, Austria.