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

Technical Consultant #1461


Expertise

  • 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.

Experience

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.


Education

  • M.D., Faculty of Medicine, University of Rome, Rome, Italy
  • B.A., Sociology, University of Pennsylvania, Philadelphia, PA
Save Resume #1461
to Contact Form?

You must first click "Yes" to save this resume

Submit Request

You have no Saved Resumes

Add resumes within our various Ares of Expertise by clicking "Add Resume(s)" below.

Add Resume(s)