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Steve Kates

STEVEN A. KATES, Ph.D is a pharmaceutical executive with thirty years experience in research and development for human therapeutics.

Biography

STEVEN A. KATES, Ph.D is a highly experienced pharmaceutical executive with ~ thirty years in R & D for both life science products and human therapeutics and has advanced several compounds through drug development from early pre-clinical to early clinical development. He currently serves as Vice President, Regulatory Affiars at Dicerna Pharmaceuticals and has held senior positions at Takeda, Lakewood-Amedex, Ischemix, Citius Pharmaceuticals, Surface Logix, Consensus and Millipore Corporation. He has been responsible for the successful development of clinical candidates for both 505(b) 2 and NCE applications. Dr. Kates is a world-leading chemist and industry expert in peptide design and manufacture. He has written or co-authored more than 100 articles, reviews, and patents. Dr. Kates has served as editor of Solid-Phase Synthesis: A Practical Guide and ADMET for Medicinal Chemists, A Practical Guide; guest editor of Biopolymers; and as a member of the Editorial Board of International Journal of Peptide Research and Therapeutics. A Visiting Professor of Chemistry at Brandeis University, Dr. Kates earned his B.S. in chemistry from Bates College and his Ph.D. in Synthetic Organic Chemistry from Brandeis University, and conducted post-doctoral studies at The Massachusetts Institute of Technology.

Professional Experience

Dicerna Pharmaceuticals, Vice President, Regulatory Affairs

Takeda Pharmaceuticals, Director, Regulatory Affairs

Lakewood-Amedex, Inc CSO and Vice President Regulatory Affairs,

Ischemix, LLC  Vice President of Research & Development, Regulatory Affairs

Citius Pharmaceuticals, LLC Acting Vice President of Regulatory Affairs, Head of Operations

Surface Logix, Inc. Senior Scientist

Consensus Pharmaceuticals, Inc. Director, Chemistry

Millipore Corporation, Director of Peptide and Small Molecule Combinatorial Chemistry

Professional Activities & Accomplishments

24 Reviews, 80 Papers, 8 Patents, 23 Abstracts and Meeting Contributions

  • ADMET for Medicinal Chemists (Katya Tsaioun and Steven A. Kates, Wiley and Sons, New York, 2011)
  • Solid-Phase Synthesis: A Practical Guide (Steven A. Kates & Fernando Albericio, Marcel Dekker, New York, 2000)
  • International Journal of Peptide Research and Therapeutics (formerly Letters in Peptide Science) (Editorial Board, 1999)
  • Guest Editor, Biopolymers, Peptide Science: Comprehensive Reports & Reviews, “Handles and Supports for Solid-Phase Synthesis”, Volume 47, Number 5, 1998, pp. 309-411.
  • Applied Clinical Pharmacology and Toxicology (Editorial Board, 2017)

Education

PhD from Brandeis University (1988)

Area of Expertise

2, 510K, Accelerated pathways), amendments, Annual reports, BLA, Budgets, Business Development, CE Mark, Clinical, Clinical (Phase 1, CMC, Contract Negotiation, CSRs, DS/DP method, eCTD, Gastroenterology, IND, Infectious Disease, Innovation / R&D, Management (Project Management, Medical Affairs, Metabolism, NDA/ANDA, New Product Development, Oncology, Operations Management, Ophthalmology, Pharmacovigilance, PMA, PMR)), Pre-clinical, R/D, Renal, SOPs, specifications, Strategic & Project Planning), Techinal R(egulatory, Therapeutic Experience (Cardiovascular, Vaccines, validation