Expert Details
Clinical Diagnostics, Immunoassay Product Development, Clinical Toxicology
ID: 729362
Massachusetts, USA
1) He has been involved in all aspects of In Vitro Diagnostic Immunoasasy and Clinical Chemistry Product Development Including Laboratory Research and Development, Transfer to Manufacturing, Documentation to meet QSR including Design History, transfer to manufacturing QC/QA procedures, and drafting patents. He has participated in the development of seven FDA cleared products. He has also participated in the development of new In Vitro Diagnostic platforms
2) He has also been the Responsible Person for a SAMSHA employee drug testing laboratory and Co-laboratory director of a Clinical Toxicology laboratory and can give expert testimony in these fields.
Diatech Diagnostics, Boston, MA 1996 -1997
Consultant
Research to improve production processes for a line of drugs-of-abuse and hormone ELISA assays including management of the installation of HPLC system used for both raw material and process evaluation, and improved purification of conjugates used in products.
Reference Diagnostics - Set-up HPLC system for separation and online detection of Lioporotein fractions from Human Serum. Assay and Regeant development
Education
| Year | Degree | Subject | Institution |
|---|---|---|---|
| Year: 1999 | Degree: Ph.D | Subject: Pharmacology | Institution: Boston University |
| Year: 1977 | Degree: B.S | Subject: Zoology | Institution: University of Massachusetts, Amherst |
Work History
| Years | Employer | Title | Department |
|---|---|---|---|
| Years: 2010 to 2010 | Employer: Franey Medical Laboratories | Title: Laboratory Co-Director | Department: |
Responsibilities:Developed LC-MS-MS method for Ethyl Glucuronide (Biomarker and metabolite of Ethanol).Revised LC-MS-MS method for Buprenorphine, Norbuprenorphine, and Oxycodone. Revised Procedure Manual, Quality Manual, and Safety Manual Served as Co-Laboratory Director and provided Technical expertise resource. |
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| Years | Employer | Title | Department |
| Years: 2007 to 2010 | Employer: First Light Biosciences | Title: | Department: Principal Scientist |
Responsibilities:Nanoparticle reagent optimization using DOE methods for development of Multipath® immunoassay and cellular analysis platform for clinical diagnostics and bioterrorism testing.Providing leadership for assay development and clinical studies for the Multipath® prototype instrument. Participated in grant writing that secured two phase I NIH SBR grants and a large phase II Biodefense grant Drafting patents in support of the company’s intellectual property position Participated in document preparation and implementation of all aspects of company FDA QSR system Served as Company Safety Officer. Drafted Informed Consent Forms and interfaced with contracted commercial IRB |
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Career Accomplishments
| Licenses / Certifications |
|---|
| National Registry Of Certified Chemists - Clinical Chemist (Ph.D. Level) |
| Publications and Patents Summary |
|---|
| He is an inventor on 3 Patents and 5 patent applications |
Additional Experience
| Training / Seminars |
|---|
| National Registry Of Certified Chemists - Clinical Chemist (Ph.D. Level) |
| Marketing Experience |
|---|
| Knowledgable in Clinical Immunoassay, Clinical Chemistry, and Clinical Toxicology Marketplaces. Knowledgable of Hospital Aquired Infection Product Marketplace |
Language Skills
| Language | Proficiency |
|---|---|
| English | Native speaker |
Fields of Expertise
510(k) document, applied clinical toxicology, clinical chemistry, clinical diagnostics, clinical immunology, clinical laboratory, Clinical Laboratory Improvement Amendments of 1988, clinical laboratory regulation, clinical toxicology, Current Good Manufacturing Practice, diagnostic reagent, diagnostic test evaluation, diagnostics, Good Laboratory Practice, Good Manufacturing Practice, in vitro diagnostics, in vitro diagnostics Food and Drug Administration code, medical diagnostic test development, protocol development, In Vitro Diagnostics Directive 98/79/EC, clinical measurement, cardiovascular diagnostics, outcomes research, clinical trial design, in vitro toxicology, clinical instrumentation, clinical laboratory equipment, pathogen detection method development, immunodiagnostics, infectious disease diagnosis, clinical research management, diagnostic instrument, statistics, infectious disease