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

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