Toxicology, Drug Development, and Clinical Pharmacology Expert

Technical Consultant #1915


Expertise

  • Over 30 years' experience in pharmaceutical research and development.
  • Clinical pharmacology, toxicology, drug development, regulatory affairs and clinical research at major pharmaceutical companies.
  • Led the research teams that discovered and developed misoprostol (Cytotec®), a worldwide anti-ulcer drug
  • Worldwide clinical research at major pharmaceutical companies.
  • Educator: Pharmacology and toxicology to medical, dental and pharmacy students.

Expert Witness Experience

  • Provides scientific consultation, advice and litigation support since 1993 for the defense and plaintiff.
  • Drug injury causation, drug-related medical malpractice, pharmacy malpractice, medication errors, drug product liability (e.g., warning, designs, formulations, labeling), alcohol and Industrial chemicals, forensic aspects of alcohol and drug Intoxication (Driving Under the Influence - DUI).
  • Pharmaceutical patents litigation and Contract Research Organizations (CROs) support.

Experience

Undisclosed Company, President and Founder, CRO,1993 - Present

  • Provide drug development, scientific consulting and litigation support services.
  • Consulting services cover clinical research, pharmacology, toxicology, regulatory affairs, pharmaceuticals and patents.
  • Litigation support and testimony services cover the fields of drug injury causation, drug-related medical malpractice, medication errors, drug product liability (e.g., warnings, designs, formulations, labeling), adverse effects of health, beauty products, alcohol and industrial chemicals, forensic aspects of alcohol and drug intoxication, pharmaceutical patent litigations and CROs activities.

G.D. Searle and Co., Skokie, IL, 1972 - 1993

Director, Clinical Research, 1987 - 1993

  • Directed worldwide clinical research and development (Phases I-IV).
  • Provided consultation services and actively interacted with clinical, regulatory affairs, legal, marketing, business development and licensing groups.

Director, Cytotec Scientific and Medical Affairs, 1985 - 1986

  • Directed Phase-IV clinical research activities with misoprostol (Cytotec).
  • Assisted in the worldwide launch of misoprostol.
  • Provided consultation services and actively interacted with clinical, regulatory affairs, sales and marketing, business development, licensing and legal groups.
  • Carried out worldwide medical communication to lay and scientific media.

Assistant and Associate Director, Gastroenterology Clinical Research, 1980 - 1985

  • Responsibilities included development of clinical plans, budgets, writing protocols, study placements, monitoring and preparation of clinical and regulatory reports.
  • Interacted with clinical, regulatory affairs, consumer products, marketing, business development and licensing groups.

Chairman, Gastrointestinal Diseases Committee, 1974 - 1980

  • Directed the research of a multi-disciplinary group (M.D. and Ph.D. level scientists) which resulted in the discovery of several interesting drugs.
  • One drug, (Cytotec) was marketed. Actively interacted with clinical, regulatory affairs, legal (patents), consumer products and business groups (marketing, sales, licensing and acquisition).

Group Leader, Department of Pharmacology, 1974 - 1980

  • Planned, conducted and directed research in gastrointestinal pharmacology and physiology.

Senior Research Investigator, 1972 - 1974

  • Planned, conducted and directed research in gastrointestinal pharmacology and physiology.

Rohm and Hass Research Laboratories, Spring House, PA, Senior Pharmacologist, 1968 - 1972

  • Directed and conducted research in gastrointestinal, cardiovascular and central nervous system pharmacology and toxicology.

Auburn and Purdue Universities, Graduate Teaching Assistant, 1964 - 1968

  • Taught pharmacy, pharmacology and toxicology to undergraduate pharmacy students.

Other teaching Experience

  • Adjunct Professor of Medicine, Loyola University Chicago
  • Adjunct Professor of Pharmacology, Chicago Medical School
  • Adjunct Professor of Medicine, UCLA
  • Adjunct Associate Professor of Pharmacology

Honors & Publications

Credentials

  • Licensed to practice pharmacy in the State of Alabama

Academic and Professional Affiliations

  • Fellow of the American College of Gastroenterology FACG
  • American Society for Pharmacology and Experimental Therapeutics
  • Scientific and American Gastroenterological Association
  • Professional American College of Gastroenterology
  • Societies: European Association for Gastroenterology and Endoscopy
  • Association for Academic Minority Physicians
  • Society for Experimental Biology and Medicine
  • American Federation for Clinical Research
  • American Pharmaceutical Association
  • Gastroenterology Research Group
  • New York Academy of Sciences.
  • Chicago Society of Gastroenterology
  • Philadelphia Gastrointestinal Research Forum
  • Gastrointestinal Pharmacology Group
  • Chicago Biotech Network (Founder)

Awards

  • Won the prestigious Edgar M. Queen Award (Monsanto), distinguished achievements in science and business.
  • Won the Distinguished Alumnus Award from the Department of Pharmacology and Toxicology, Purdue University.
  • Rho Chi Pharmaceutical Honorary Fraternity
  • Phi Kappa Phi Honorary Fraternity
  • Listed in several Marquis Publications for Medicine and Healthcare
  • Listed in the American Men and Women of Science

Publications and Patents

  • Author and Co-Author of collegiate textbooks, book chapters, research papers, abstracts and presentations totaling over 260.
  • 10 U.S. patents.

Education

  • Ph.D. Pharmacology and Toxicology, Purdue University, West Lafayette, IN
  • M.S. Pharmacology and Medicinal Chemistry, Auburn University, Auburn, AL
  • B.S. Pharmacy, University of Missouri at Kansas City, KS
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