Who are we?
NaviDx Consulting creates unique value for the diagnostics industry through proven market-driven strategies.
OUR CORE VALUES
Collaboration
An extension of your team, we are a strategic partner committed to your business goals and commercial success.
Integrity
Everything we do has the best interest of your business in mind.
Commitment
We keep our promises and honor our commitments.
OUR TEAM
Leadership
Kim Arvanites
Co-Founder | Business & Commercial Strategy
Kim is an accomplished molecular diagnostics sales and marketing professional with over 25 years of IVD/Life Sciences experience. She has a proven track record in highly strategic positions at Beckman Coulter, Abbott Molecular, QIAGEN and Sysmex Inostics, developing and launching numerous IVD products throughout her career. Kim co-founded NaviDx in 2015 with a vision to help companies develop products that better meet market needs and improve patient care by refining the best-in-class practices from her corporate career and applying them to the NaviDx process. Kim received her BSc from DePaul University, mentors at University of Chicago Polsky Center for Innovation, co-founded AdVeritasDx and is a partner in Libertas Global.
Michael Reed, PhD
Product & Portfolio Development
Mike is an executive R&D leader with a diverse career of over 20-years directing product-focused life science and diagnostic research and development organizations. Mike has led the development and commercialization of over 300 products in genomic, cellular, hematology and rapid testing markets, providing him with a deep understanding of the practical requirements of commercializing products in highly regulated environments. He has leveraged this background since 2020 in support of the NIH RADx program and co-founding various start-ups, most recently joining Kim to expand the service offerings and reach of NaviDx. He has a PhD from the University of Adelaide and completed the Executive Program in Management at the UCLA Anderson School of Management.
Richard Creager, PhD
Co-Founder | Business & Executive Operations
Richard has more than 30 years’ experience in the in vitro diagnostics (IVD) industry. Richard has led the development and commercialization of more than 170 IVD products (assays and instruments) for infectious disease, cardiovascular disease, fertility, autoimmune disease, cancer, and women’s health in Executive roles at Seegene USA, Beckman Coulter Diagnostics, Sanofi Diagnostics and Kallestad Diagnostics. He used his deep experience in the industry to provide significant support to the NIH RADx program during the pandemic. Richard currently serves on the board of directors for the 1for2 education foundation and OnRamp Bioinformatics and has a B.S. from Muhlenberg College, a M.S. from Duquesne University, and a Ph.D. from the University of Pittsburgh School of Medicine. He also attended The Wharton School of Business for Advanced Management Program.
Market Intelligence & Strategy
Rachel Jones
Market Intelligence & Strategy
Rachel is a proven commercial executive with 27 years in the IVD industry leading commercialization organizations at Biofire, Karius Dx, and Co-Diagnostics.
Dave Kowalski
Market Intelligence & Strategy
Dave led strategic marketing functions at Abbott Molecular and Rapid Diagnostics for over 20 years, impacting millions of lives during the COVID pandemic.
Duane Newton, PhD
Lab Medicine & Public Health
Duane was the Clinical Micro Lab Director at Michigan Medicine for 18 years and has since leveraged that experience in Scientific Affairs roles at BioRad and NaviDx.
Carlos Merino PhD, MBA
Market Intelligence & Strategy
Carlos has had a diverse career over 15 years leading R&D, product management and strategic marketing efforts in genomics, infectious disease and microbiome markets.
Mark Boyle
Business Development & Strategy
Mark has over 35 years experience commercializing in
vitro diagnostic products for global healthcare markets in
Executive roles for Qiagen, Ellume and NAMSA.
Market Access, Quality & Compliance
Michele Schoonmaker, PhD
Market Access & Reimbursement
Michele is a recognized leader in market access strategy with 25 years of public & private experience driving reimbursement & policy strategies for IVD commercialization.
Marielle Lejcher
Regulatory Affairs
Marielle has over 20 years of IVD and related industry experience leading, developing and supporting regulatory and quality systems strategies.
Jose Rosado, MBA
Quality Management Systems
Jose is a seasoned QMS Executive with over 30 years of experience in class I, II and III IVD, RUO, Pharma and combination product environments
Bill Godfrey, PhD
Product Development & Manufacturing
Bill has over 30 years of experience leading R&D and product transfer teams in the development and commercialization of hundreds of products in many RUO and IVD markets
Dung Nguyen
Regulatory Affairs
Dung has had a diverse career leading regulatory affairs teams and strategies for 15 years. During that time she has led multiple FDA interactions and product submission.
Sonia Lecce
Regulatory Affairs
Sonia is a seasoned professional with experience in companion Dx, LDTs and a wide range of Dx devices with 513g, breakthrough, 510(k) and PMA classifications.
Commercial Operations
Ryan Chappelle
Commercial Operations
Ryan has extensive executive sales leadership experience over a 30-year career in laboratory markets selling and marketing IVD products and laboratory IT solutions
Ed Salanga, PMP
Commercial Ops & Project Management
Ed has been leading sales and marketing teams in large IVD manufacturing companies for over 25 years and has deep expertise in marketing to the US lab market.
Jissel Fernandez, MBA
Business Ops & Project Management
Jissel has led large business operations and strategy organizations for 25 years in large global manufacturing and consulting firms across diverse industries.
Dave Flaten
Sales & Marketing
Dave has led numerous sales and marketing organizations for IVD manufacturers and clinical labs in a career spanning over 35 years.
Tracey Ray, MBA
Sales & Marketing
Tracey is a seasoned sales and marketing professional with over 25 years marketing and selling into the clinical lab market
Veronica Alloggia
OTC & Public Health Marketing
Veronica is an accomplished strategic product mgmt and marketing professional with over a decade of expertise in high-growth biotech, infectious disease Dx, and health tech.
Tony Falvo
Commercial Operations
Tony has had a diverse and distinguished career of over 20 years in public health, reference lab and IVD commercial leadership roles.
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