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 Expert  728850

Expert in Design & Development of Molecular IVD Assays, including Design Control, Risk Analysis, Submissions


Available for your Consulting and Expert Witness Needs

Washington (WA)
USA
Education Work History Career AccomplishmentsPublicationsConsulting Services Expert Witness

Summary of Expertise:

Listed with other top experts in: 

Expert has 15 years' work experience in the development of nucleic acid -based in vitro diagnostic (IVD) devices. He has both theoretical knowledge and hands-on experience, spanning the entire IVD pathway, which includes biomarker discovery, preclinical & clinical assay validation, design control, pilot & scale-up manufacture, QC & QA, risk analysis, regulatory submissions and post-approval monitoring. He was an integral member of teams in two companies that obtained successful FDA clearances for HIV-1 genotyping (BK020005), CFTR genotyping (K060627, K083845, K083846), and detection of a panel of respiratory viruses (K063765, K091667). His work experience builds upon a rigorous academic training in protein & nucleic acid biochemistry & biophysics, in world-class laboratories. He is a coauthor on 45 peer-reviewed scientific papers and coinventor on 11 US Patents.

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assay

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clinical virology

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DNA

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DNA analysis

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DNA technology

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diagnostic reagent

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diagnostic test evaluation

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genetic disease

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in vitro diagnostics

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in vitro diagnostics Food and Drug Administration code

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molecular diagnostics

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molecular genetics testing


Show Secondary and Basic Areas of Expertise
Localities:
Expert may consult nationally and internationally, and is also local to the following cities: Seattle, Washington;  Tacoma, Washington;  Bellevue, Washington;  Everett, Washington;  Federal Way, Washington;  Kent, Washington;  Bellingham, Washington;  Lakewood, Washington;  and Renton, Washington.

Education:
Year   Degree   Subject   Institution   Honors
1985   PhD   Biochemistry & Biophysics   Oregon State University   Presidential Graduate Fellowship
1981   MS   Biology   University of Denver   Sigma Xi (scientific), Phi Lambda Upsilon (chemistry), University Graduate Scholarship (University of Denver),
1977   BA   Biology   Temple University   Summa cum Laude, phi beta kappa

Work History:
Years   Employer   Department   Title   Responsibilities

2006 to 2010

 

Luminex Molecular Diagnostics (Toronto)

 

Product Development

 

Principal Scientist

 

Direct supervision of scientific/technical staff (BS, MS, Ph.D.). Design Control, Risk Analysis: genotyping and infectious disease assays. Preclinical & Clinical Validation: genotyping and infect. disease assays. Team member for regulatory submissions to FDA, Health Canada, EU. Design & qualification of BSL-2 laboratory; corporate Biosafety Officer.

2003 to 2006

 

Gene News (Toronto)

 

Product Development & QA

 

Director

 

Preclinical R&D: assays for mRNA expression profiles from blood. Pilot Mfg.: IUO diagnostic kits for colon cancer, osteoarthritis. Designed & Implemented Quality System for R&D, Pilot Mfg. Designed Chain-of-Custody Procedures for Sample Handling. Conducted biosafety audits (process & site specific). Management Representative: Health & Safety.

2002 to 2003

 

Visible Genetics (Atlanta)

 

Technology Transfer

 

Director

 

Site Design (Cleanroom for manufacture of positive controls). Validation studies, for kit transfer from Development to QC & Manufacturing. Design & Manufacture of Calibrators for DNA Sequencing System. CAPA and OOS, Vendor Qualification Audits, Risk Analyses.

2000 to 2002

 

Visible Genetics (Toronto)

 

Research & Development

 

Director

 

Preclinical R&D to support FDA 510(k): HIV-1 Genotyping kit. Validation studies to support Manufacture/QC of Genotyping kits. Design & Manufacture of Positive Controls for Genotyping kits. CAPA and OOS Investigations, Vendor Qualification Audits.

1997 to 2000

 

Visible Genetics (Toronto)

 

Research & Development

 

Sr. Scientist, then Manager

 

Preclinical R&D to support FDA 510(k): HIV-1 Genotyping kit. Preclinical R&D on Hepatitis B,C Genotyping kits. Technology Development: Dried Reagents, DNA Sequencing. Ligation-Based Assays for SNP Detection. Microelectrophoresis chips, Automated DNA Sequencing. Technology Assessment: strategic reports for CEO. Scientific Communication: proposals, patents, publications

1993 to 1997

 

Hospital for Sick Children (Toronto)

 

Research Institute

 

Principal Investigator / Scientist

 

Responsible for directing an independent academic research program. Focus: Zebrafish as model system for embryonic tumorigenesis. Funding: successful competition for peer-reviewed grant support. Academic cross appointment: Dept. Medical Genetics, U. of Toronto. Scientific Communication: seminars, peer-reviewed publications.

1991 to 1993

 

Caltech

 

NSF Center for Molecular Biotechnology

 

Scientist

 

Project: SNP detection by automated sequencing/ligation technology. Contributed to construction of human SNP genetic map.


Career Accomplishments:
Awards/Recognition

BA summa cum laude (Temple University), Phi Beta Kappa, Sigma Xi (scientific), Phi Lambda Upsilon (chemistry), University Graduate Scholarship (University of Denver), Presidential Graduate Fellowship (Oregon State University), NIH 3-year Post-doc Fellowship (University of Oregon), Weizmann Fellowship, Scientist Rank.


Publications:
Publications and Patents Summary

Coauthor on 45 peer-reviewed scientific papers, and coinventor on 11 US Patents.

Selected Publications and Publishers  
 - Journal of Clinical Virology  
 - American Journal of Medical Genetics  
 - Electrophoresis  
 - Current Opinion in Biotechnology  
 - Biochemistry and Cell Biology  

Consulting Services:
Selected Consulting Examples:
  • He was a consultant to a Toronto startup company, Xagenic, where he worked on a proof-of-principle project for detection of influenza viruses using a novel, non-enzymatic label-free diagnostic technology.
  • He was a consultant to a Toronto startup company, ArcticDx, where he worked on a pre-IDE application to FDA, for a multi-analyte index assay for age-related macular degeneration.
  • He was a consultant to a Toronto startup company, Visible Genetics, where he was co-inventor of a novel ligation-based mutation scanning technology, and also of an early version of a lab-on-a-chip diagnostic platform.
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:
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.

International Experience:
Years   Country / Region   Summary
2000 to 2003   USA, Belgium   He was part of a team that conducted a number of Supplier audits in US and Belgium

Additional Skills and Services:
Training/Seminars

He has developed a 2-hour seminar on Risk Assessment & Design Control

Supplier and Vendor Location and Selection

While at Visible Genetics, he participated in many audits of suppliers of enzymes, oligonucleotides, acrylamide, etc. as part of a 2-person team, together with a QA auditor.

Other Skills and Services

PROFESSIONAL SKILLS – IVD Development Path: Theory and practical experience with Quality Systems (FDA, ISO); Practical experience in Design, Analytical, and Process Validation; Design & Qualification of BSL-2 Labs and Manufacturing Clean rooms; Design and Implementation of Document & Change Control Systems; Pilot Manufacuring, Tech Transfer, OOS & CAPA investigations, Vendor Audits; Failure Mode Analysis, Fault Tree Analysis, Risk Management. 8Contributing author on pre(IDE)s, 510k submissions. 8Post-approval monitoring, complaint handling processes / systems.


 

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