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 Expert  729362

Expert in Clinical Diagnostics, Immunoassay Product Development, Clinical Toxicology

Available for your Consulting and Expert Witness Needs

Massachusetts (MA)
Education Work History Career AccomplishmentsPublicationsConsulting Services Expert Witness Market Research

Summary of Expertise:

Listed with other top experts in: 

Expert has two major areas of Expertise: 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


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




Good Laboratory Practice


Good Manufacturing Practice


in vitro diagnostics


in vitro diagnostics Food and Drug Administration code


medical diagnostic test development


protocol development

Show Secondary and Basic Areas of Expertise
Expert may consult nationally and internationally, and is also local to the following cities: Boston, Massachusetts;  Worcester, Massachusetts;  Springfield, Massachusetts;  Lowell, Massachusetts;  Cambridge, Massachusetts;  Brockton, Massachusetts;  New Bedford, Massachusetts;  Hartford, Connecticut;  Manchester, New Hampshire;  and Providence, Rhode Island.

Year   Degree   Subject   Institution  
1999   Ph.D   Pharmacology   Boston University  
1977   B.S   Zoology   University of Massachusetts, Amherst  

Work History:
Years   Employer   Department   Title   Responsibilities

2010 to 2010


Franey Medical Laboratories



Laboratory Co-Director


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.

2007 to 2010


First Light Biosciences


Principal Scientist



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






Chief Scientist


Responsible for formal process of evaluating new biomarkers and technologies for potential new IVD products, and providing scientific leadership. Responsible for evaluating existing scientific and patent literature and drafting patents in support of the company's intellectual property positions. Personal conducted assay development of several particle based homogeneous immunoassay products – Troponin I, Ferritin, and Prealbumin Wrote documents to meet FDA QSR regulations (including Design Control and History, Device Master Records and SOPs) and to meet ISO 13485 standards and EU CE mark requirements Troubleshooting problems in manufacturing and reagent development under FDA Design Control. Conducting and preparing instrument applications and 510(k) add-to-files for Direct TIBC assay and 510(k) submissions for hsCRP and Ferritin immunoassays and calibrators

Career Accomplishments:

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

Consulting Services:
Selected Consulting Examples:
  • Diatech Diagnostics, Boston, MA 1996 -1997 ConsultantResearch to improve production processes for a line of drugs-of-abuse and hormone ELISA assays including management of 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 on-line detection of Lioporotein fractions from Human Serum. Assay and Regeant development
Recent Client Requests:
  • Expert in Immunoassay constultants for consulting on Immuoassay Development.
Click the green button above to contact Expert for a free initial screening call regarding your expert consulting needs.  Expert is available for consulting to corporate, legal and government clients.  Remember, your initial screening call to speak with Expert is free.

Expert Witness:
Recent Litigation Client Requests:
  • Expert witness on immunology blood assays for consulting on ELISA spot assay analyzer.
Click the green button above to contact Expert for a free initial screening call regarding expert testimony, litigation consulting and support, forensic services, or any related expert witness services.  A few litigation needs include product liability, personal injury, economic loss, intellectual property (patent, trademark, trade secret, copyright), and insurance matters.  Remember, your initial screening call to speak with Expert is free.

Language Skills:
Foreign Language   Description
English   Native speaker

Market Research:
Knowledgable in Clinical Immunoassay, Clinical Chemistry, and Clinical Toxicology Marketplaces. Knowledgable of Hospital Aquired Infection Product Marketplace

Click the green button above to contact Expert for a free initial screening call regarding your marketing research, industry research, and company research needs.  For research needs involving multiple experts or secondary research, a Research Director can be assigned to coordinate the work into a custom report for you as a potentially quicker and more cost effective alternative to doing this work yourself or hiring a boutique consultancy.  Remember, your initial screening call to speak with Expert is free.

Additional Skills and Services:

National Registry Of Certified Chemists - Clinical Chemist (Ph.D. Level)


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