John A. Ziemniak, Ph.D.
Specialties: Drug Development, ADME
Biography
John A. Ziemniak, Ph.D, is a Senior Consultant, Clinical Pharmacology/DMPK for Aclairo Pharmaceutical Development Group and 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 a broad array of delivery systems, routes of administration, and chemical entities including conventional molecules as well as biologicals. In his career, he has conducted >400 clinical studies worldwide, on a variety of clinically related topics (drug delivery, pharmacokinetics, pharmacology, efficacy studies, etc.) spanning first in human IND initiation studies 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 a variety of drug development topics and products.
Prior to Aclairo, he was the Chief Medical Office for FemmePharma and Vice-President, Research and Development for Therox Pharmaceuticals.
Dr. Ziemniak was awarded a Ph.D in Pharmaceutics from SUNY Buffalo. He has authored or co-authored over 50 Journal articles and is frequent speaker at a variety of conferences in the North American and Europe.