Pharmaceutical Industry Expert Witness

Expert Witness No.1271

Alabama

Clinical Practice of Medicine

A Hospital located in Birmingham, AL, 2004 to present. 
Director, Hepatitis Clinic.

Trace Crossings Medical Clinic, Hoover, AL, 2002 to 2006. General medicine, coverage.

Dover Community Clinic, NJ, 1992-1999. General medicine.

Dotoli Medical Group, Nutley, NJ  1989-1991. General medicine and hospital coverage.

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

Medical Staff, Letterman Army Hospital, 1984-1987.

Internship and Residency 1980 to 1983. USF Medical Center Keesler.

Pharmaceutical Industry Experience

Southern Clinical & Regulatory, LLC, President, 1997 to 2006.

Vaxin, Inc.  Clinical Research Consultant. 2000 to present.

Emerging Technology Partners, Nov 1997 to Jan 2000,
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.

PerImmune, Inc., Rockville, MD  7-95 to 7-96; Director, Departments of Medical Research, Regulatory Affairs and Clinical Data Management.

Connaught Pasteur Merieux, Director of Clinical Research, Swiftwater, PA, 3-91 to 7-95
Hoffmann-La Roche, Associate Director of Clinical Research, Antibacterials 1-89 to 3-91

Clinical Research Experience

Cooper Green Mercy Hospital, Birmingham, AL. Director of Hepatitis Clinic,
Written and currently conducting three IRB-approved investigator-initiated clinical protocols.

 Southern Clinical & Regulatory 2000 to 2008.

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

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

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

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

Academic and Institution Affiliations:

Wallace Kettering Neuroscience Institute, Kettering, OH, visiting Research Associate,
2005-current.

University of Alabama, Biomedical Engineering, 2002.

Clinical Assistant Professor, voluntary, Division of General Internal Medicine, Department of Medicine, 9-2007 to present

FDA Experience:

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 radioimmuno diagnostic 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

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, Ft. Detrick, MD

Biological Warfare refresher course, 1-05

Licensures and Certification

National Board of Medical Examiners

Diplomat, American Board of Internal Medicine   9-13-1989

Alabama

DEA

Mississippi 

New York  

BLS and ACLS

Professional Organizations

American College of Physicians, Fellow, member since 1991

Academy of Pharmaceutical Physicians and Investigators

Regulatory Affairs Professional Society, member since 2002

Medical Association of the State of Alabama, member since 2000

Articles Submitted to Peer-Reviewed Journals:

Available upon request

      
Member of the Editorial Board:

The International Journal of Risk & Safety in Medicine