- In depth experience designing and equipping medical research laboratories, including hiring personnel.
- Familiar with Good Clinical Laboratory Practices, GMP, and FDA compliance.
- Experience working with both CDRH and CBER branches of FDA to ensure company compliance with FDA guidelines and 21 CFR regulations.
- Involved in the commercialization of more than 20 medical products.
- Conducted clinical trials at established hospital clinical laboratories and obtained approval for several medical diagnostic tests.
- Consulting to biotechnology industry in areas of R&D management, Regulatory FDA issues
- QA/QC issues, international marketing, and business development.
UNIVERSAL HEALTH RESEARCH AND DEVELOPMENT, INC., Columbia, MD
- Organized research group to develop rapid diagnostics in private start-up biotechnology company.
- Designed laboratories, hired personnel, equipped laboratory and conducted research.
- Developed QUIXÂ® rapid blood test format for HIV diagnosis and HIV confirmation, HIV peptide antigens for detection of antibody to HIV-1 and HIV-2, and rapid chemiluminescent bacterial surveillance monitor.
- Submitted PMA for QUIXÂ® HIV 1-2-O rapid blood test for diagnosis of HIV infection (AIDS) and received FDA 510(k) approvals for cholera and E. Coli 0157. Designed peptides for HIV vaccine.
UNIVERSAL HEALTHWATCH, INC., Columbia, MD
- Organized a research group to develop rapid diagnostic tests.
- Coordinated R&D, QA, and Process Engineering, and the filing of the appropriate FDA applications.
NEW HORIZONS DIAGNOSTICS CORPORATION, Columbia, MD
Position: Vice President, R&D
- Group developed a novel simple colloidal gold-based rapid test for group A streptococcal pharyngitis (SMARTÂ® group A strep).
- Obtained FDA 510(k) regulatory approval for StreptogenÂ® and SMARTÂ® assays, and a syphilis screening test (TRUST).
- Developed SMARTÂ® tests for Anthrax, Botulism toxin, SEB, Bacillus globigii for the US Army during Desert Storm.
- The company was awarded a U.S. Department of Defense Commendation award for our rapid turn around time from R&D to delivery of SMARTÂ® and anti-Bioterrorism tests in U.S. DOD Middle East defense program.
- Developed rapid SMARTÂ®-R tests for NASA, Lyndon Johnson Space Flight Center enabling astronauts to perform self diagnosis in space.
- Collaborated on rapid HIV-1 for Epitope Inc. (Beaverton, OR) and Sickle cell anemia test for Isolab Inc. (Akron, OH).
BECTON DICKINSON & COMPANY, Baltimore, MD
1974 - 1984
- Developed therapeutic drug monitoring test kits for human serum/plasma.
- Issued U.S. Patents for an immunoassays for small molecular weight analytes. ~Developed CMV-ScanÂ® rapid Cytomegalovirus test, and a rapid Hepatitis B radioimmunoassay.
- Developed potent antisera using various protein and polysaccharide vaccines. Developed methods for affinity purification of proteins from blood products.
ROCKEFELLER UNIVERSITY, New York, NY
- Developed assays to monitor autoimmune rheumatoid factor-like products and antibodies to streptococcal components in human plasma.
U.S. Army, Walter Reed Army Institute for Research, Honorable Discharge
Madigan General Hospital, Fort Lewis, WA Research and Hematology
Honors & Publications
- American Society for Microbiology
- American MENSA
- Baltimore Council of Foreign Affairs
B.S., Biochemistry, City College of New York, New York, NY
Immunology & Microbiology Seminars Program, Rockefeller University