SouthPark Internal Medicine
Littleton, CO

• Practice of Internal Medicine

Women's Health Specialists
Denver, CO.

• Practice of Internal Medicine

Part-time staff physician, National Naval Medical Center, Department of Medicine,
Bethesda, MD.

• Precepted a Physical Diagnosis course for first year medical students

Senior Clinical Reviewer, Food and Drug Administration, Center for Biologics Evaluation and Research (CBER), Office of Vaccines Research and Review, Division of Vaccines and Related Products Applications, Clinical Trials Branch
Bethesda, MD.

IND Review:

• Responsible for the comprehensive review of protocols for Phase 1, 2 and 3 clinical studies.
  
• Assessed the rationale, safety and design of clinical studies submitted to over 80 INDs (Investigational New Drug Applications) for bacterial, viral (including HIV) and DNA vaccines, as well as several biological therapeutic products.
  
• It was my recommendation which determined whether a study was allowed to proceed or placed on clinical hold.
  
• Responsible for training new physicians who joined our Division.

PLA/BLA Review:

• Responsible for the review of clinical data submitted in PLAs (Product License Applications) to support the licensure of new vaccines and other biological products.
  
• Performed a complete review of all clinical data submitted and then formally presented my conclusions and recommendations at an FDA Advisory Committee.

Guidance to Industry:

• Provided guidance regarding the overall clinical development of investigational products, including such topics as the type and quantity of preclinical data necessary to initiate Phase 1 studies, the need for dose-ranging studies, the choice of efficacy endpoints for pivotal Phase 3 trials, and the size of the safety database necessary for licensure.

Policy and Regulatory Document Development:

• Participated in a variety of special FDA projects and committees ranging from combination pediatric vaccines to HIV vaccines to the inclusion of women in clinical trials.
  
• Served on many FDA policy committees and participated in the writing and review of regulatory documents.

Part-time staff physician, National Cancer Institute, Division of Cancer Treatment, Medicine Branch, Retroviral Diseases Section, HIV Clinic.
Bethesda, MD.

• Assisted in conducting Phase 1 and 2 studies of HIV therapeutics.

Fellowship in General Internal Medicine, George Washington University, Department of Health Care Sciences.
Washington, DC

Member of NIH review committee for the Vaccine Treatment and Evaluation Units (VTEUs for HIV vaccine and treatment studies)

Presentation at CHI’s conference “Clinical Risk Management and Safety for Vaccines” entitled “Clinical and Regulatory Considerations for the Development of Vaccines.”  Boston, MA.