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