Expert Details

Expert in Clinical Diagnostics, Immunoassay Product Development, Clinical Toxicology

Expert ID: 729362 Massachusetts, USA

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ExpertSiek 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

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 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

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 - Providence, Rhode Island

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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 Responsibilities
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.
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
Years: to Present Employer: Undisclosed Title: Chief Scientist Department: Responsibilities: 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

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

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