Expert Details
Design & Development of Molecular IVD Assays, including Design Control, Risk Analysis, Submissions
ID: 728850
Washington, USA
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.
Education
| 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 |
|---|---|---|---|
| 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. |
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| Years | Employer | Title | Department |
| 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. |
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| Years | Employer | Title | Department |
| 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. |
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| Years | Employer | Title | Department |
| 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. |
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| Years | Employer | Title | Department |
| 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 |
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| Years | Employer | Title | Department |
| 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. |
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| Years | Employer | Title | Department |
| 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. |
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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 |
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| Coauthor on 45 peer-reviewed scientific papers, and coinventor on 11 US Patents. |
Additional Experience
| Training / Seminars |
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| He has developed a 2-hour seminar on Risk Assessment & Design Control |
| Vendor Selection |
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| 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
assay, clinical virology, DNA, DNA analysis, DNA technology, diagnostic reagent, diagnostic test evaluation, genetic disease, in vitro diagnostics, in vitro diagnostics Food and Drug Administration code, molecular diagnostics, molecular genetics testing, medical diagnostic test, cancer diagnosis, In Vitro Diagnostics Directive 98/79/EC, clinical measurement, CE Marking, biochemical genetics testing, clinical genetics, medical diagnostic test development, diagnostic instrument, diagnostic instrumentation, biomedical diagnostic instrumentation