John A. Ziemniak, PhD

Dr. Ziemniak has over 30 years of experience in pharmaceutical drug development including various preclinical and clinical activities having been involved in the conception, filing, and approval of over 15 NDAs and > 25 INDs encompassing a variety of drugs and indications. These activities cover an array of delivery systems, routes of administration, and chemical entities including conventional molecules as well as biologics. In his career, he has conducted >400 clinical studies worldwide, on a variety of preclinical and clinical related topics (drug delivery, pharmacokinetics, pharmacology, efficacy studies, etc.) spanning drug discovery to post-approval marketing for a broad range of therapeutic areas and clinical indications. He has comprehensive experience in the conception, execution, and composition of regulatory submissions (pIND, IND, NDA, CTD, BLA, 510k, etc.) to advance regulatory/developmental strategies for both large and small-size pharmaceutical companies and clients. Dr. Ziemniak has approximately 50 scientific publications and numerous patents on various preclinical, drug development and clinical topics and products.