Jim Garner

Clinical-stage diagnostics company revolutionizing food allergy diagnosis and management through AI-driven, epitope-based molecular testing. Led from concept to market leader, positioning for strategic acquisition. • Raised $27M in capital, including SEC-regulated crowdfunding, to establish and scale operations, de-risking technology and positioning for product commercialization. • Developed and executed go-to-market strategy for underserved food allergy market, including thorough landscape assessment, total addressable market analysis, product positioning in diagnostic pathways, and initial messaging to key opinion leaders and global & national luminaries. • Launched two first-in-class molecular diagnostic products via consumer-focused digital clinic and direct-to-provider channels; established telemedicine capabilities for in-home access and delivery. • Built and certified specialized allergy CLIA laboratory in 49 states (New York pending); secured unique billing codes with negotiated CMS pricing for value-based reimbursement. • Orchestrated strategic collaborations with global therapeutic developers, enhancing product pipeline and market expansion. • Communicated vision, mission, and core values to staff, board, investors, stakeholders, providers, caregivers and individuals with food allergies; formulated strategies, policies, and annual budgets while overseeing financial/physical resources and operations.

Grant Committee Member, 501(c)(3) supporting community education and needs.

Founder and Principal, Strategy & Commercialization Advisors Consulting firm advising precision medicine innovators on product development, commercialization, and reimbursement. Clients include Abcodia, Armune BioScience, Counsyl Diagnostics, Integrated Diagnostics, Luminopia, MYnd Analytics, Navigant, ProterixBio. • Guided diagnostics clients through commercialization strategies, execution, and value-based reimbursement, contributing to successful product launches and growth. • Served as interim Commercial Advisor for Abcodia (June 2016 – December 2016), developing overall commercial strategy for ovarian and breast cancer early-detection tests. • Advised Counsyl Diagnostics (April – June 2016) and Navigant (December 2015 – June 2016) on go-to-market planning and operational implementation in women's health and diagnostics.

Advise CEO on commercial strategy and execution

Proteomics-based diagnostics company pioneering non-invasive liquid biopsy for lung cancer detection; positioned for acquisition through successful commercialization of Xpresys Lung product. Responsible for developing and implementing commercialization strategies for novel proteomic diagnostic service company • Key strategy team member de-risking $30M Series A; central in raising $56.5M Series B to fund development and 2013 launch of first product. • Created go-to-market strategy for underserved lung nodule market with disruptive first-in-class technology; conducted market research for agile adoption, established TAM, penetration plans, and positioning. • Built and led 128-person commercial and operations team, including sales (16 outside reps), marketing (3), managed care/reimbursement (2), customer support (3), and operations (92 contractors). • Oversaw product development, marketing initiatives, public/investor relations, medical publication strategy, and outsourced billing; secured reimbursement contracts with government/private payers, including UnitedHealthcare national contract and GSA fee schedule placement. • Developed medical affairs strategy, speakers bureau, advisory boards; led international licensing/distribution in Canada. • Drove $4.8M revenue in 2015 (103% YoY growth); established commercial reimbursement through a national provider network covering 225M+ lives positioning the company for acquisition.

Advise Navigant's diagnostics clients on commercialization strategy and execution.

Led turnaround of underperforming sales organization for Fortune 6 health services company, managing 48-person team across 22 countries serving clients in 58 countries. • Optimized sales force through new leadership, regional/territory restructuring, goal setting, and performance metrics; rebuilt team via top-grading, improving performance within three months. • Grew sales 235% YoY from $89M to $300M+ through aggressive management and strategic focus positioning the company for acquisition

Coordinated global sales efforts for 50+ salespeople targeting high-volume customers. • Engaged C-suite executives at Johnson & Johnson and Wyeth, securing preferred supplier status and driving significant sales increases. • Recognized as top sales performer in 2007 (1 of 750 in Enterprise Service Sector), generating $142M against $40M target.

Corps of Cadets, Company Commander Ross Volunteers