Pharmaceutical Strategy and Execution; Drug Metabolism, Pharmacokinetics, Clinical Pharmacology, Drug Discovery and Development, Regulatory Submission, and Drug Approval; IND's, ERC's, NDA's, MAA's

Technical Consultant #1027


Expertise

  • Over 35 years of experience in the discovery and development of novel drugs in multiple therapeutic areas (anti-bacterial, anti-inflammatory, anti-viral, cardiovascular, central nervous system, oncology, ophthalmic, pulmonary, and renal).
  • Strong managerial and leadership skills with scientific expertise in the areas of drug discovery and development, preclinical and clinical drug metabolism, pharmacokinetics, and clinical pharmacology.
  • Directed a drug metabolism and pharmacokinetics department consisting of more than 45 technical professionals with operating and capital budget accountability.
  • Designed and implemented a pre-clinical development process which routinely advanced development candidates from discovery to first dose in humans in six months.
  • Interfaced with different departments in research and development at every stage of drug discovery and development including the support of marketed products and ANDA's.
  • Extensive interactions with the FDA at the pre-IND, end of Phase 1, Phase 2, and Phase 3 meetings.
  • Proven track record of successfully filed over 60 IND's and supported the approval of 10 NDA's/MAA's.

Experience

Undisclosed Firm, 2002 - Present

  • Consultant for the biotechnology and pharmaceutical industry in strategy and execution, drug discovery and development, preclinical and clinical drug metabolism and pharmacokinetics, clinical pharmacology, clinical trials, FDA interactions, and regulatory submissions.

DuPont Pharmaceuticals Company, Newark, DE, 1991 - 2001

  • Executive Director, Drug Metabolism and Pharmacokinetics, 2001
  • Senior Director, Drug Metabolism and Pharmacokinetics, 1998 - 2000

Responsibilities

  • Directed the activities of the Pre-clinical and Clinical Pharmacokinetics Groups, which consisted of 15 Ph.D. and 30 B.S./M.S. scientists
  • Conducted pre-clinical and clinical studies on the absorption, distribution, metabolism, and excretion of new and marketed drugs and drug candidates and their metabolites in the areas of cardiovascular, central nervous system, inflammatory, infectious diseases, and oncology.
  • Supported clinical development of new and marketed drugs and drug candidates by designing clinical pharmacology and clinical pharmacokinetics studies: Activities included writing protocols, analysis of biological samples, data analyses, and preparing clinical study reports.
  • Validated bio-analytical methods using state of the art instrumentations for the identification and quantification of new and marketed drugs and their metabolites in pre-clinical and clinical samples.
  • Partnered with Safety Assessment to conduct dose ranging and GLP studies during acute, sub-chronic, and chronic evaluation of drug candidates; determination of therapeutic index of drug candidates; preparation of risk benefit statements for regulatory submissions.
  • Member of Drug Candidate Review Committee and Product Development Board. These groups consisted of senior research and development management responsible for selecting drug candidates, approve pre-clinical and clinical development plans, and make go/no go decisions on drug candidates at different stages of drug development.
  • Prepared regulatory documents for U.S. (IND, NDA, PLA, etc.) and international (CTX, MAA, etc.) regulatory submissions, clinical investigator's brochures, package inserts, summary basis of approvals, and annual reports to FDA and other regulatory agencies.
  • Interfaced with FDA and international regulatory agencies on drug metabolism, pharmacokinetics, clinical pharmacology, and bio-pharmaceutics questions and issues.

DuPont Merck Pharmaceuticals Company, Newark, DE,1991 - 1997

  • Senior Director, Drug Metabolism and Pharmacokinetics, 1994 - 1997
  • Director, Drug Metabolism and Pharmacokinetics, 1991 - 1994

E. I. DuPont de Nemours & Company, Inc. Newark, DE, 1988 - 1990

  • Sr. Research Manager, Drug Metabolism and Pharmacokinetics

DuPont Critical Care & American Critical Care, Waukegan, IL, 1979 - 1988

  • Section Head, Clinical Pharmacology and Drug Metabolism, 1986 - 1988
  • Group Leader, Drug Metabolism, 1983 - 1985
  • Senior Research Investigator, Drug Metabolism, 1981 - 1983
  • Research Investigator, Drug Metabolism, 1979 - 1981

University of Illinois, Rockford, IL , 1981 - 1986

  • Lecturer in Pharmacology

University of Wisconsin, Madison, WI, 1977-1979

  • Postdoctoral Fellow in Oncology

Honors & Publications

Academic and Professional Affiliations

  • Development Advisory Board, TaiGen Biotechnology, Inc., Taipei, Taiwan
  • American Society for Pharmacology and Experimental Therapeutics
  • International Society for the Study of Xenobiotics
  • American Association of Pharmaceutical Scientists
  • American Chemical Society

Reviewer for

  • Drug Metabolism and Disposition
  • Pharmaceutical Research
  • Journal of Pharmaceutical Sciences
  • Journal of Clinical Pharmacology
  • Journal of Pharmaceutical and Biomedical Analysis

Education

  • Ph.D. Pharmacology, School of Medicine, University of California at Los Angeles, Los Angeles, CA
  • M.B.A. Business Administration, University of Delaware, Newark, DE
  • B.S. Chemistry (With Honors), University of California at Los Angeles, Los Angeles, CA
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