Peter U. Feig, M.D.

Broad worldwide experience in pharmaceutical development. During 10 years in the pharmaceutical industry, has been responsible for US and International (Canada, Europe and Japan) drug development, including regulatory interactions. Has filed several successful drug applications in the US and Europe. Interested in strategic position in charge of drug development in a pharmaceutical or biotechnology company.


Expertise includes:

Overall drug development strategy Design and writing of trial protocols
Implementation of phases I - IV trials Pediatric population trials
Study reports, ISS, ISE European expert opinion
Regulatory interactions Filings of IND, NDA, NDS
Marketing assessments Safety and Data Monitoring
Portfolio evaluation and licensing  


Therapeutic areas include:

Hypertension Diabetes
Nephrology Hyperlipidemia
Congestive Heart Failure Obesity
Coronary Artery Disease Intermittent Claudication
Attention Deficit Disorder Vaccines
Inflammatory Bowel Disease CNS


Industry Experience:

2000-present: Pharmaceutical Development Initiatives, Potomac, MD.
Member.  Develops compounds with the purpose of out licensing to marketing partners in exchange for royalties.

1999-present: PF Pharmaceutical Development, Farmington, CT.
President. Consults for pharmaceutical and biotechnology industries and to CRO’s. Evaluates portfolios, designs development programs, advises on development strategy, interacts with the FDA.

1997-1999: Medeva Development, Medeva Pharmaceuticals, Westport, CT.
Vice-President, Clinical Development. Was responsible for Drug Development, worldwide strategy and North American operations in the therapeutic areas of CNS, GI and vaccines.

1989-1997 Bayer Corporation, West Haven, CT.
Director and International Clinical Project Manager (1993). Was responsible for supervision of a matrix of project leaders in 10 countries in Europe, Japan, and North America; created strategy for accelerated international development, expansion of indication, and approval of antidiabetic compound; submitted dossier and got approval for antidiabetic drug in Europe, U.S. and Canada; helped establish a worldwide metabolic business unit strategy; provided technical expertise for portfolio expansion through in-licensing and medical expertise for global metabolic marketing plans.

Associate Director (1989) and Acting Director (1991), Cardiovascular Medical Research. Was responsible for study designs, protocols, analysis, and reports for phases II - IV; developed seven drugs in five therapeutic indications (hypertension, angina, hyperlipidemia, intermittent claudication and heart failure) in the U.S.; submitted IND’s; submitted two approved NDA’s in hypertension and one in angina; evaluated candidate drugs for in-licensing; expanded cardiovascular group and managed staff of 25.


Previous Experience:

Associate Professor of Medicine and Epidemiology, School of Medicine and Graduate School of Public Health, University of Pittsburgh and Chief, Hypertension Service, VA Medical Center, Pittsburgh, PA.

Research Affiliate, Department of Physiology, Yale University School of Medicine, New Haven, CT.

Assistant Professor of Medicine, School of Medicine, University of Connecticut, Acting Chairman, Division of Nephrology, School of Medicine, University of Connecticut, Farmington, CT and Chief, Nephrology Section, VA Hospital, Newington, CT.

Assistant Professor of Medicine, School of Medicine, University of Pennsylvania, Director, Clinical Nephrology Program and Home Dialysis Training Unit, VA Hospital, University of Pennsylvania Service, Philadelphia, PA.


Specialty Certifications: American Board of Internal Medicine
  American Board of Nephrology


Medical Licenses: Connecticut
Massachusetts
Pennsylvania




Postgraduate and Graduate Education:

Clinical Fellow (Nephrology), Beth Israel Hospital, Boston, MA.
Research Fellow, Harvard Medical School, Boston, MA.
Teaching Fellow, Tufts University School of Medicine, Boston, MA.
Chief Medical Resident, Newton Wellesley Hospital, Newton, MA.
Medical Resident, Newton Wellesley Hospital, Newton, MA.
Medical Resident, Lemuel Shattuck Hospital, Boston, MA.
Medical Resident, Hospital das Clinicas, University of Sao Paulo, Sao Paulo, Brazil.
Graduate, University of Sao Paulo School of Medicine, Sao Paulo, Brazil.


Professional and Scientific Societies:

American Association for Advancement of Science
American Association of Pharmaceutical Physicians
American College of Physicians (fellow)
American Diabetes Association
American Federation for Clinical Research
American Society of Hypertension
American Society of Nephrology
Drug Information Association
High Blood Pressure Research Council, American Heart Association (fellow)
International Society of Nephrology
Physicians for Social Responsibility


Scientific Reviewer:

American Journal of Cardiology
American Journal of Physiology
Annals of Internal Medicine
Biochemical Pharmacology
Hypertension
Kidney International
Life Sciences
New England Journal of Medicine


Grants:

NIH: Epidemiology of Blood Pressure, Insulin, Salt Transport.
NIH: Behavioral Studies in Cardiovascular Disease.
NIH: The Epidemiology of Cardiovascular Risk Factors in Women (consultant).
VA Merit: Cell Membrane Ion Transport Abnormalities in Genetic Hypertension.
VA RAG: Cell Membrane Ion Transport Abnormalities in Genetic Hypertension.
VA: Regulatory Mechanism of Electrolyte Transport.
Ciba-Geigy: Study of Atenolol and Metoprolol.
Roche: Clinical Study of Cilazapril-HCTZ.
McNeil: Perindopril in Mild to Moderate Hypertension.
Eli Lilly: A Comparative Study of Nephrotoxicity of Gentamicin and Tobramycin.
Am. Heart Assoc (CT. Affiliate): Cellular Sodium Transport in Genetic Hypertension.
UCONN Research Foundation: Cellular Sodium Efflux in Hypertension.



Publications:

Bibliography with 89 original articles, reviews, book chapters and abstracts is available in addition