Pharmaceutical Industry Expert Witness

Expert 1271

Alabama

PHARMACEUTICAL INDUSTRY EXPERIENCE

A local Medical Legal Consulting firm Principal, 1997 to present,

Medical consulting on pharmaceutical industry and drug adverse effect issues

A Local Clinical and Regulatory firm, President, 1997 to present.

A contract clinical research and regulatory affairs organization.

Emerging Technology Partners, Nov 1997 to Jan 2000, the biotech division of Economic Development Partnership of Alabama, Senior Vice President, Clinical Research and Regulatory Affairs.

Immunomedics, Inc., Morris Plains, NJ  7-96 to 1-97; Vice President, Clinical Research

Director, Departments of Medical Research and Clinical Data Management Programs:

PerImmune, Inc., Rockville, MD  7-95 to 7-96

Director, Departments of Medical Research, Regulatory Affairs and Clinical Data Management

            Clinical Programs:

Connaught Pasteur Merieux (now Aventis Pasteur), Director, Clinical Research,

Swiftwater, PA, 3-91 to 7-95

  Hoffmann-La Roche, Associate Director Anti-bacterials 1-89 to 3-91

CLINICAL PRACTICE OF MEDICINE

Internship and Residency 1980 to 1983.

Medical Staff, Letterman Army Hospital, 1984-1987.

Private Practice, Internal Medicine 7-87 to 12-88

Dotoli Medical Group, Nutley, NJ  1989-1991

Dover Community Clinic, NJ, 1992-1999

A Local Medical Clinic, Hoover, AL, 2002 to present.

A Local Clinic, Birmingham, AL, 2004 to present

CLINICAL RESEARCH EXPERIENCE

USAF Medical Center Keesler, Clinical Research Laboratory, 6-80 to 6-83

Letterman Army Institute of Research, Division of Blood Research, 6-83 to 6-87.

Hoffman La Roche, Connaught, Immunomedics, PerImmune, as outlined above

Emerging Technology Partners, Vaxin, and Tranzyme, as outlined above

Southern Clinical & Regulatory

FDA EXPERIENCES :

Annual reports, and protocol presentations to CBER, CDER, NIH and NCI

Outside inspections of IND's and NDA's for corporate partners

Preparation of PMAs and 510K for in-vitro diagnostic devices

Preparation of  MAA and PLAs for radioimmunodiagnostic agents and ASI

Preparation of INDs.

UNDERGRADUATE EDUCATION

1968-1971 - Santa Monica College

1970-1972 - California State University, San Bernardino, (B.A., December, 1972)

GRADUATE EDUCATION

1972-1973 - University of California, Riverside, Department of Plant Physiology

1973-1977 - University of California, Los Angeles, Department of Bacteriology, Ph.D. Microbiology, December 1977. Thesis Area:  Comparative Immunology of Graft Rejection

MEDICAL EDUCATION

1976-1980 - University of California, Los Angeles, School of Medicine, (M.D., June 1980)

June 1980-June 1983 - Residency in Internal Medicine, USAF Medical Center, Keesler AFB, MS

MILITARY EDUCATION

Officers Candidate School, June 1976

Medical Indoctrination for Medical Service Officers, June 1980

Air Command and Staff College, graduate, June 1984

Biological Warfare Course

LICENSURES AND CERTIFICATION

National Board of Medical Examiners

Diplomat, American Board of Internal Medicine 1989

State: Alabama 23209

DEA: Expires 2007

New Jersey: Expires 2004

Mississippi: Expires. 2005

New York: Expires. 2005

PROFESSIONAL ORGANIZATIONS

American College of Physicians, FELLOW

American Academy of Pharmaceutical Physicians,

Regulatory Affairs Professional Society

Drug Information Association

Jefferson County Medical Society

Medical Association of the State of Alabama

American Society of Microbiology

HOSPITAL AFFILIATIONS:

Brookwood Medical Center, Birmingham, Alabama

Cooper Green Hospital, Birmingham, AL

PATENTS:

Non invasive genetic immunization, expression products therefrom and uses thereof.

Vaccination by Topical Application of Genetic Vectors.

Non invasive genetic immunization, expression products therefrom, and uses thereof