Speaker Profile

Gregory M. Hockel

Ph. D.

Dr. Hockel has 35 years of experience in the pharmaceutical industry (large pharma, biotech companies, and contract research organizations), including both drug discovery and development. Dr. Hockel has supervised the planning, submission, and maintenance of numerous INDs and NDAs/BLAs to both CDER and CBER and has organized and conducted well over 100 meetings (Pre-IND, End-of-Phase 2, Pre-NDA/BLA) with the Food and Drug Administration and Health Canada. From a submissions perspective, Dr. Hockel has submitted and maintained over 150 INDs, involving all therapeutic Divisions within CDER and CBER, and provided strategic input into and the compilation of over 40 NDAs/BLAs (both 505(b)(1) and 505(b)(2) applications), more recently in the Common Technical Document format. He has provided input into Fast Track applications, Special Protocol Assessment (nonclinical and clinical) submissions, and has written and submitted numerous Orphan Drug Applications (including use of the common application form for simultaneous US and EU submissions). During his career, Dr. Hockel has also been responsible for Regulatory Operations, Drug Safety and Pharmacovigilance, Clinical Trial Supply Management, Quality Assurance, and Medical Writing. Dr. Hockel has presented at numerous symposia and DIA meetings on a variety of regulatory issues and holds a Ph.D. degree in renal physiology from Indiana University School of Medicine and an M.B.A. degree from Rensselaer Polytechnic University.

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