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Pharmaceutical Consultant Specializing in Cardiovascular Drug Development, Drug Safety and Medical Writing

Technical Consultant #1461


  • Drug development, specializing in cardiovascular therapeutics.
  • Expert witness and the evaluation of cardiovascular drugs.
  • Drug safety.
  • Medical writing: Protocols, study reports, manuscripts, FDA submission (NDA) briefing documents and investigation of new drugs (IND).
  • Product support-promotional review and medical information.
  • Evaluation of previously monitored clinical studies.

Principal Investigator in the following areas:

  • Vasodilator and inotropic drugs.
  • Vasodilator therapy for acute myocardial infarction.
  • Nitrates and hydralazine in heart failure.
  • Controlled trial of nitrates in heart failure.
  • Ticrynafen in hypertension.
  • Oxprenolol in hypertension.
  • Atenolol in hypertension.
  • Minoxidil in heart failure.
  • Amrinone in heart failure.
  • Pharmacokinetics of flecainide in heart failure.
  • Enalapril in heart failure.
  • Nitrendipine in hypertension.
  • Catecholamine Inhibition in heart failure.
  • Efficacy of transcutaneous nitroglycerin in heart failure.
  • Digitalis vs. Vasodilators in experimental heart failure.
  • Efficacy of digitalis.
  • Digoxin vs. Captopril in heart failure.
  • Indoramin in heart failure.
  • Vasodilator heart failure.
  • SCH 19927 in hypertensive heart failure.
  • Safety of Flecainide in heart failure.


Independent Consultant, 1995 - Present

  • Pharmaceutical and health care consultant

Ciba-Geigy, Pharmaceutical, Summit, NJ, 1991 - 1995

Executive Director and Head, Medical Department

  • Led the research department with a team of 75 providing, product support, drug safety, epidemiology, and pharmacoeconomics.
  • Involved in: Marketing, sales, drug regulatory affairs, FDA compliance, public relations, technical operations and international group companies and FDA.
  • Restructured and redesigned processes resulting in major cost reductions while eliminating all backlogs and bringing all functions into full compliance with regulations.
  • Introduced new research methods reducing time and cost of clinical trials completion.
  • Introduced a new response system for medical inquiries, eliminating intermediary steps, resulting in quicker and better customer service.
  • Introduced matrix management and initiated cross-functional interdepartmental teams improving productivity and teamwork.

Executive Director Medical Services, 1992 - 1993

  • Heading a team of 40, responsible for drug safety, pharmacoepidemiology, medical information, biostatistical support of medical affairs, package inserts, labeling and medical relations.
  • Interacting with: Marketing, sales, drug regulatory affairs, public relations, technical operations and international group companies.
  • Streamlined work flows resulting in greater efficiency and compliance with regulations.
  • Led a team in designing and integrating a system for handling all drug safety information into a single worldwide on-line database.

Executive Director Medical Services, 1991 - 1992

  • Responsible for a team of 40, running clinical trials and marketing activities.
  • Interfacing clinical development, marketing, and drug regulatory affairs.
  • Introduced new budget procedures resulting in cost savings.
  • Revised and implemented all operating procedures resulting in time and cost savings.
  • Improved relations with internal customers resulting in greater productivity.

Independent Consultant, West Orange, NJ, 1990- 1991

  • Medical and drug development issues for various pharmaceutical companies and related businesses.
  • Obtained contracts with major pharmaceutical companies and contract research organizations.
  • Represented clients as an expert in clinical development; produced protocols, clinical plans, and manuscripts; evaluated study proposals, licensing opportunities, and budgets; and reviewed registration documents.

Zambon Corp., East Rutherford, NJ, 1988 - 1990

Vice President, Research and Development

  • Responsible for designing, building, implementing and leading all R&D functions.
  • Produced long-term strategic plan and recruited professional staff (M.D.s, Ph.D.s).
  • Produced development plans for several compounds.
  • Implementing study protocols and made presentations and submissions to FDA
  • Assessed licensing candidates and joint venturing opportunities.
  • Instituted global systems for R&D planning and drug safety monitoring.
  • Revised pre-existing clinical plans resulting in expedited FDA approval of plans and shortened development time by 2 years.

ICI Pharmaceuticals Group, Wilmington, Delaware, 1986 - 1988

Director, Cardiorenal Drugs, Clinical and Medical Affairs

  • Headed group responsible for clinical development and medical affairs activities of all cardiovascular products.
  • Responsible for all phase I-IV trials and marketing support activities.
  • Submitted 5 NDAs, with 3 being approved (Tenoretic; Zestril; Tenormin for acute heart attack myocradial infarction, MI).
  • Prepared expert report for European registration of Corwin; obtained quickest approval on record.
  • Obtained IND approval for novel clinical plan combining phases I & II for a PDE inhibitor resulting in shortened time to a, "no go" decision and major savings of development costs.

Honors & Publications

Many hospital appointments.

Publications: Many books, chapters and publications.


  • M.D., Faculty of Medicine, University of Rome, Rome, Italy
  • B.A., Sociology, University of Pennsylvania, Philadelphia, PA
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