Fred T. Fiedorek

Experienced drug developer and clinical researcher with over 20 years working in the pharma industry across both biopharma and biotech companies; in-depth knowledge with both strategic and tactical experience in diabetes, cardiovascular disease, other metabolic / endocrine, and several other therapeutic areas of drug development; management and functional leadership of clinical research professional and drug development teams spanning Phase 1 through Phase 4 clinical trials. Thorough working knowledge of cell and molecular biology, drug discovery, and pre-clinical & clinical drug target validation; animal model pharmacology; clinical pharmacology and proof-of-concept early clinical studies; toxicology and drug safety assessment; small and large clinical trial design and operations, data management, and clinical data interpretation; and regulatory dossier preparation and health authority (HA) responses.Participated in the preparation and filing of multiple NDAs and MAAs, including FDA Advisory Committee preparations and presentations and other HA interactions, leading to the successful registration of several drug products. Specific clinical and regulatory experience with development programs involving medicines for type 2 diabetes, cardiovascular disease, orphan disorders (lipodystrophy), HIV, hepatitis B, organ transplantation, schizophrenia / affective disorders, and prostatic hypertrophy.Excellent, hands-on writing and composition skills with clinical development and regulatory documents; highly involved with many drug development programs leading to FDA NDA / BLA and global regulatory approvals.Extensive business development, scientific technical assessment, and business alliance experience across early- and late-stage development and commercialization programs.