Pharmaceutical FDA Expert: FDA Reviews and Detection and Identification Biochemical Agents Related to Homeland Security

Expertise

• Center for Drug Evaluation and Research (CDER), former FDA employee.
• FDA review of new drug (NDA) and generic drug (ANSA) application submissions, FDA national Field operations, FDA compliance.
• Research and development programs related to homeland security.
• Department of Defense force protection and agent detection (novel devices, sensors and samplers) for the detection and identification of chemical and biological agents.
• Technology related to infectious disease countermeasures.
• Analytical chemistry related to drugs.
• Pharmaceutical analysis: Chromatography; Data quality evaluations; Computational chemistry.
• Development of major technical proposals for federal contract and grant applications to NIH and DoD agencies.
• Patent review and technical evaluations.
• Delivery device technology evaluation for needle-free delivery of new pharmaceuticals and vaccines for treatment and prevention of infectious diseases.
• Active network of contacts in private, federal and academic research and development of infectious disease countermeasures.

Experience

Independent Consultant, 2003 - Present

University of Texas at Austin, Biochemical and Chemical Defense Institute for Advanced Technology, 2000 - 2003

• Senior Program Analyst

FDA, Center for Drug Evaluation and Research, St. Louis, MO, 1990 - 2000

• Chief, Methods Research Branch FDA Division of Testing and Applied Analytical Development

National Institute of Standards and Technology, Gaithersburg, MD, 1978 - 1990

• Supervisory Research Chemist and Physical Science Administrator

Frederick Cancer Research Center, Frederick, MD, Head, Chemistry, 1972 - 1978

• Interacted directly with Division Director and other parts of Center for Drug Evaluation and Research (CDER) and FDA with wide latitude in the formulation and oversight of programs of priority need.
• Instrumental in planning and initiating new areas of methods research for pharmaceuticals covering new molecular entities, new and existing biotechnology pharmaceuticals, drug consistency measures, post-market surveillance and ORA support.
• Provided support for FDA review of new (NDA) and generic (ANSA) drug application submissions, FDA national field operations, and compliance, and for CDER Director and Commissioner projects.
• Interacted with MD-Ph.D. review chemists in method validation testing for NDA and ANDA submissions.
• Developed collaborative interactions with research and development Chemists in the pharmaceutical industry in new areas of emerging measure technologies.
• Provided guidance to advanced methods development in chemical separations based on HPLC, LC-MS, CE, etc., and in characterization techniques based on high-field NMR, high-resolution MS, ESI-MS and so on.
• Worked on the analysis of drug impurities, drug enantiomers, consistency of impurity profiles (drug fingerprinting), conformational analysis of protein-based drugs, assessment of generic equivalence of ANDAs and proposed ANDAs to innovator products and blockbuster drugs.
• Provided support and development in collaborative in vivo and in vitro metabolism studies with the National Center for Toxicological Research in drug safety studies and clinical studies of thalidomide used as an antiviral in AIDS therapy.
• Examined metabolic studies of potentially toxic antibacterials to assess potential risk to surgeons and or nurses.

Honors & Publications

Publications

• Over 140 papers published in peer-reviewed journals or presented at national or international scientific meetings.
• Author of two technical books.
• Literature citations of recent publications available upon request.

Education

• Ph.D. Analytical and Physical Chemistry, Georgetown University, Washington, DC
• M.S. Biochemistry, North Carolina State University, Raleigh, NC
• B.S. Chemistry, Wagner College, New York, NY