Expert Details

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

Expert ID: 728850 Washington, USA

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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.

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.

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 - Renton, Washington

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Year Degree Subject Institution
Year: 1985 Degree: PhD Subject: Biochemistry & Biophysics Institution: Oregon State University
Year: 1981 Degree: MS Subject: Biology Institution: University of Denver
Year: 1977 Degree: BA Subject: Biology Institution: Temple University

Work History

Years Employer Title Department Responsibilities
Years: 2006 to 2010 Employer: Luminex Molecular Diagnostics (Toronto) Title: Principal Scientist Department: Product Development Responsibilities: 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.
Years: 2003 to 2006 Employer: Gene News (Toronto) Title: Director Department: Product Development & QA Responsibilities: 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.
Years: 2002 to 2003 Employer: Visible Genetics (Atlanta) Title: Director Department: Technology Transfer Responsibilities: 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.
Years: 2000 to 2002 Employer: Visible Genetics (Toronto) Title: Director Department: Research & Development Responsibilities: 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.
Years: 1997 to 2000 Employer: Visible Genetics (Toronto) Title: Sr. Scientist, then Manager Department: Research & Development Responsibilities: 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
Years: 1993 to 1997 Employer: Hospital for Sick Children (Toronto) Title: Principal Investigator / Scientist Department: Research Institute Responsibilities: 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.
Years: 1991 to 1993 Employer: Caltech Title: Scientist Department: NSF Center for Molecular Biotechnology Responsibilities: Project: SNP detection by automated sequencing/ligation technology. Contributed to construction of human SNP genetic map.

International Experience

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

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

Additional Experience

Training / Seminars
He has developed a 2-hour seminar on Risk Assessment & Design Control
Vendor 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 Relevant Experience
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.

Fields of Expertise

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