Consulting Services: IVD, Medical Devices, Molecular Diagnostics, Assay Development, Technology Assessment, Strategy, Startup Oversight

Part of senior management. Delineated and executed company’s short-term and long-term strategic plans. Defined operational strategy, project plans, goals, and timelines. Managed IVD test menu development under FDA-mandated Design Controls on the existing and next-generation diagnostic platforms. Supported all on-market IVD tests. Actively managed a team of 20 PhD, Masters, and Bachelor level scientists and provided cross-functional leadership across Clinical and Regulatory Affairs. Managed Design Transfer activities for all assays and led multiple initiatives to improve quality of the manufactured test consumables.• Led assay development efforts in the enteric and respiratory areas resulting in successful FDA clearance of the following IVD tests: Enteric Pathogens (EP) and Respiratory Panel (RP Flex)• Directed the test consumable and lyophilized reagent development for Atlas, the company’s next generation platform. Ensured the test consumable was room-temperature stable and was a closed system during testing, both critical customer requirements• Introduced multiple initiatives to control incoming quality of critical reagents including enzymes that reduced non-conformances to less than 5%, down from 15-20% • Directed the development of a unique Enteric Pathogens test panel with ~30 targets spanning the majority of Enteric Pathogens including parasites, bacteria, and viruses• Successfully managed a sample preparation program that required lysing the spectrum of pathogens including hardy parasites and delicate RNA viruses in stool backgrounds and deliver inhibition-free, high-efficiency nucleic acid extraction• Increased multiplexed PCR amplification capabilities by 5-fold on the next generation platform.

Directed all assay development programs to populate company’s infectious disease IVD test menu. Collaborated closely with Clinical Affairs and Regulatory to ensure successful FDA and other regulatory clearances and approvals. Supported product pre-launch, launch, and post-market surveillance activities.• Led the development of sample-to-result, multiplexed molecular diagnostic/IVD tests for blood stream infections (sepsis) on the company’s Verigene Platform. Both multiplexed gram‑positive (BC‑GP) and gram-negative (BC-GN) panels have received 510(k) clearance and CE‑IVD Marking and are currently market-differentiating products of the company• Instrumental in obtaining PMDA approvals for BC-GP and BC-GN in Japan; these are the first sepsis IVD molecular tests to be approved in Japan• Strengthened and grew the assay development team. Maximized efficiencies across all elements including Feasibility, Development, Validations, and Design Transfer to allow the development of multiple assays in parallel• Directed a microbiology laboratory dedicated to support assay development needs; implemented infrastructure for curating organisms. Emphasized biosafety and drove sustainable initiatives, including eliminating the use of open needles and syringes

Directed the infectious disease Assay Development program to populate the Verigene System’s IVD test menu. Worked collaboratively with Clinical and Regulatory Affairs.• Directed the transfer and integration of “off-board” assay development activities, including nucleic acid extraction, multiplexed RT-PCR, and a gold nanoparticle probe-based end-point detection, on to a “sample-to-result” automated device platform, Verigene System• Managed the development of a fully automated IVD test for detection of respiratory viruses on the Verigene System • Collaboratively conducted multi-site clinical evaluations for the automated multiplexed respiratory virus test, and successfully collaborated on the FDA submission to obtain 510(k) clearances

Created, staffed, and managed company’s infectious disease division of Assay Development• Technical lead and Program Manager for the development of company’s first infectious disease assay• Led a lean Assay Development team from feasibility through FDA clearance including managing a multi-site clinical evaluation for a semi‑automated IVD test for the detection of respiratory viruses

Developed company's proprietary detection technology, expanded capabilities, and applied the detection technology to develop novel detection assays.• Awarded a multi-million dollar federal contract for the development of a biological warfare agent detection system: Contract was 1 of 6 federal awards out of a field of over 12,000 applicants• Technical lead for the biological warfare agent contract. Expanded the scope of the contract. Delivered a ruggedized, field-ready detection device with a multiplexed biological warfare agent panel. • Received a multi-million dollar NIH grant for the development of PCR-less SNP detection assays that led to company’s first FDA-cleared genetic test: Grant received one of the top scores in the study section• Co-developed all aspects of the gold nanoparticle technology platform that allowed the breakthrough PCR-less SNP detection in unamplified human genomic DNA: Overcoming human genomic DNA complexity to permit SNP identification was previously thought to be insurmountable without PCR