Biochemical Consultant for Designing and Equipping Medical Research Laboratories

Technical Consultant #1116


Expertise

  • 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.

Experience

CONSULTANT

  • 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

Position: CEO

  • Organized research group to develop rapid diagnostics in private start-up biotechnology company.
  • Designed laboratories, hired personnel, equipped laboratory and conducted research.
  • Developed QUIX® 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 QUIX® 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

Position: President

  • 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 (SMART® group A strep).
  • Obtained FDA 510(k) regulatory approval for Streptogen® and SMART® assays, and a syphilis screening test (TRUST).
  • Developed SMART® 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 SMART® and anti-Bioterrorism tests in U.S. DOD Middle East defense program.
  • Developed rapid SMART®-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-Scan® 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.

MILITARY DUTY

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
  • US-IBEX
  • Baltimore Council of Foreign Affairs

Education

B.S., Biochemistry, City College of New York, New York, NY

Immunology & Microbiology Seminars Program, Rockefeller University

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