Ensuring the development of appropriate global Precision Medicine and Digital Health regulatory strategy(s) and their execution for assigned precision medicine and digital health asset(s) supporting across the GSK therapeutic portfolio.

Consulting activities for emerging medical device and biologics manufacturers - Regulatory and commercialization strategy for diagnostic medical devices, including AI/ML-enabled wearables and CDx devices- CDx strategy support for developers of therapeutic products- Network advisor for TEDCO (Maryland Technology Development Corporation)- FDA submissions, including two successful FDA clearances, in the infectious disease and software as a medical device (SaMD) spaces- Quality system development for medical device companies, diagnostic laboratories and independent diagnostic testing facilities- IVDR gap analysis

Provide fractional executive support for ASELL's Quality Assurance and Regulatory Affairs initiatives, including Quality System gap analysis, supplier audits, internal audit hosting, support for FDA submissions, and support for ASELL's development partners.

● Built and led ASELL's regulatory consulting activities in support of IVD and medical device partners. Key areas of focus/expertise include:- EUA and pre-EUA submissions, including a successful EUA authorization of a home-use antigen test for SARS-CoV-2 on behalf of a commercial client - Regulatory strategy, with a focus on infectious disease and CDx devices (both on the pharma and diagnostic side)- Breakthrough device determination requests, including two successful submissions on behalf of commercial clients- Pre-submissions- Quality system development, internal and supplier audits, with a subspecialty in quality system development for single-site IVD products- Design controls and risk management training work products● Led quality and regulatory activities in support of ASELL's IVD radiation biodosimetry product development: - Led the implementation of ASELL’s Quality Management System (QMS) to meet FDA requiements - Led ASELL’s regulatory affairs activities; served as primary point-of-contact with FDA - Provided oversight of suppliers to ensure compliance with FDA regulations, contract requirements, and other company interests. Coordinated and participated in supplier audits. - Provided regulatory support for ASELL's development partners.

● Led successful effort to achieve corporate ISO 13485:2016 certification for PGDx’s IVDdesign and manufacturing program.● Built the design quality and regulatory compliance functions for PGDx’s FDA-compliantmedical device Quality System.● Developed and implemented the PGDx risk management program per ISO 14971.● Led audit hosting responsibilities for internal and external IVD audits.● Developed the framework for quality oversight of next-generation sequencing (NGS) liquid biopsy CE-IVD kit

● In collaboration with the clinical laboratory community, developed strategies forassisting CLIA/CAP-compliant laboratories with FDA quality system development,particularly for companion diagnostic (CDx) tests.● Team leader for PMA manufacturing module reviews for CDx oncology IVD devices,including both distributed tests and single-site laboratory-based testing services.● Matrix management (team leader) of 4-7 reviewers.● Regulatory compliance oversight for issues direct-to-consumer (DTC) genetic testing andlaboratory developed tests (LDTs) in the molecular oncology space.

● Led a premarket review team in the successful De Novo clearance of a novelimmunology IVD test.● Collaborated with FDA colleagues and the academic community to perform a “mockregulatory review” of proteomic assay submissions.● Premarket review of 510(k)s, presubmissions, PMA manufacturing sections, PMA annual reports and supplements for immunology and hematology products, IHC, molecular and companion diagnostics.

● Executive team member with responsibility for the company’s R&D program.● Developed and commercialized >100 new products for the company’s immunoassayproduct line, increasing the size of the company’s product offering by 33% over a 2-yearperiod.● Developed products under design controls per ISO9001.● Managed an R&D team of 4-7 scientists.

● Initiated Celadon’s laboratory operations. Completed the Phase 1 portion of a SmallBusiness Innovative Research (SBIR) contract with NCI, drafted progress reports andscientific paper.● Planned and budgeted the Phase 2 SBIR project, which will include analysis of >1000oligonucleotide samples. Supervised one Ph.D. scientist.● Drafted requirements document for a Laboratory Information Management System(LIMS). Sourced and selected LIMS vendor; worked with vendor to design andimplement system into laboratory.● Drafted joint academic/commercial (STTR) grant application.

● Developed, validated and implemented incoming receiving test methods for incomingmaterial and manufactured bulks.● Designed and execution of validation protocols for scale-up of critical materials undermedical device/IVD quality system regulation (QSR) requirements, with a projected costsavings of $0.5MM over five years.● Coordinated and advised R&D Product Development on new product scale-up anddesign transfer.● Quality management, including investigating nonconformities (NCRs), internal audits forISO9001, audit of contract manufacturer.

● Developed and implemented automated/high-throughput test methods intoOperations, leading to a 75% reduction in direct labor costs.● Developed test methods for quantification of in-process and finished products.● Developed and scaled up a proprietary production process.● Developed and presented training modules for Operations personnel.