Karin A. Hughes, Ph.D.

I lead a seasoned team of regulatory experts who provide clients with scientific and strategic solutions aimed at successful market authorization to accelerate diagnostic commercialization and assure total product life cycle compliance. 94% of our clients rate us higher than other CROs. Why? Because our partnerships with life science companies are defined by access, adaptability, and relentless accountability. Those partnerships accelerate MedTech innovations to market through agility and precision. As an agile MedTech CRO, we bring deep expertise across medical devices, in vitro diagnostics, and emerging technologies, supporting complex regulatory requirements, clinical trial execution, and data needs with clarity and discipline. We have a reputation for agility and therapeutic expertise. Our experience includes: • 20+ years of experience • 500 plus regulatory submissions including 510(k)s, PMAs, IDEs, and CE Marks• 4,000 plus clinical study sites worldwide • 1,000 plus clinical trials across diverse indications and testing platforms • 2,600 clinical professionals in more than 50 countries

I am regularly invited to appear as a speaker, keynote, or panelist at industry and related events. Recent representative engagements include: • CDx in Motion: Where Are U.S. and EU Regulators Headed? [Conference session]. Festival of Biologics USA. San Diego, California, April 2025. • The EU COMBINE Project. [Conference session]. Association of Medical Diagnostics Manufacturers Fall IVD Focus Meeting. Los Gatos, California, October 2024. • Clinical Trials with Companion Diagnostics - Navigating the Complexity of the IVDR. [Conference session]. 16th Annual Next Generation Dx Summit. Washington, D.C., August 2024. • The Current State of Laboratory Developed Tests (LDTs) and Implications of FDA’s Final Rule on the Future of LDT Testing. [Chapter Meeting]. San Diego Regulatory Affairs Network, San Diego, California, July 2024. • Differences Between US and EU Regulations Related to Investigational IVD Performance Studies. Guest Class Lecture, In Vitro Diagnostic (IVD) Regulations Course, San Diego State University Center for Regulatory Science, San Diego, California, June 2024. • Exploring the CDx Landscape - Understanding and Overcoming Common Clinical Challenges [Conference session]. Q1 17th Annual IVD Clinical and Regulatory Affairs Conference. Chicago, Illinois, May 2024. • How to Manage Diverging Regulatory Strategies within a Global Market (China, US and EU) – US Perspective [Conference session]. 2023 TOPRA Symposium. Lisbon, Portugal, October 2023. • IVDR Panel [Conference session]. 2023 AMDM Annual IVD Regulatory Meeting. Bethesda, Maryland, April 2023. • Ensuring Compliance with Clinical Requirements [Conference session]. Q1 14th Annual IVD Clinical & Regulatory Affairs Conference, Virtual, October 2020. • IVDR Regulatory Considerations for Product Lifecycle Management [Conference session]. Q1 14th Annual IVD Clinical & Regulatory Affairs Conference, Virtual, October 2020.

Astute Medical was acquired by bioMérieux, a global leader in In Vitro Diagnostics with a presence in 43 countries. I advised the Legal and Medical Affairs teams on the regulatory and government climate that would affect proposed San Diego’ site activities and made recommendations for continued compliance.

I was a senior leadership team member of this privately-held, venture capital funded developer of biomarker-based diagnostics intended to help physicians rapidly identify and treat acute conditions for critically ill patients. In this role, I provided strategic leadership in regulatory, quality, and clinical affairs. I designed and implemented regulatory strategies including managing, planning, coordinating, and preparing all global submissions (US, EU, LATAM and APAC registrations) for market expansion of first-of-kind AKI test and pipeline products; and led strategic planning and implementation of the EU IVDR.

Responsibilities included providing de-risking strategies and opportunity evaluation to accelerate product development/commercialization; directly communicating the same to CEO, CSO, Board of Directors and potential investors and implemented as agreed. I actively contributed to corporate strategic planning, company fundraising, business development and out-licensing. In addition, I led the development and implementation of the corporate Quality Management system and Regulatory Affairs policies, procedures and best practices (pre-market and post-market) commensurate with the requirements and risks of a rapidly growing company. Achieved FDA (de novo) clearance for first-of-kind test for risk assessment of acute kidney injury significantly reduced time-to-market for Company’s flagship product.

Biosite was acquired by Inverness Medical. In this role, was responsible for the vision, strategy and goals for the San Diego site Regulatory Affairs function. I developed and implemented global regulatory strategies for product registrations while ensuring regulatory compliance for the Cardiology, Drugs-of-Abuse and Oncology Strategic Business Units. I led, developed and managed 15 regulatory professionals and provided regulatory counsel to Corporate’ satellites with limited regulatory personnel. I reviewed worldwide (US, EU, Canada, Asia Pacific, Latin America) regulatory submissions (Q-submissions, IDEs, 510(k)s, CLIA categorizations, CE marking, and international device licenses) and authored Traditional and Special 510(k)s, Technical Files (self-certification) and IVDD Design Dossiers (Annex III.6 certification), leading to the successful clearance and launch of several cardiovascular and drugs of abuse products (Class II, laboratory, POC and self-test portfolio). I also served as the strategic liaison with regulatory agencies (FDA, Health Canada, CMS) and was the main contact for regulatory service providers (Authorized Representative, Notified Body, Marketing Authorization Holder, etc).

Biosite was a publicly traded, mid-sized diagnostic discovery and commercialization company specializing in novel immunoassay-based, rapid, point-of-care diagnostics. Within their organizational structure, I had responsibility for developing and executing strategic plans including product concepts and market research, market development and launch plans in support of Biosite’s pipeline products (Sepsis Panel, Protein C Test and Stroke product).

I held world-wide responsibility for a $48 MM biochemical/cell signaling/immunology research reagent product portfolio (>8,000 products) with the objective of expanding global presence and revenue. Under my leadership, we doubled year-over-year (2004-2005) organic growth for responsible product portfolio. I assessed new technologies and intellectual property for strategic fit and long-term growth potential and developed and executed detailed marketing plans incorporating analysis of available technologies, competitors, and bottom up projections of market potential and revenue streams.

Clients included Accelerator Corporation, Excite Optics, Gemini Biosciences, and Cambrex Bioscience.

As a member of the senior management team, I was responsible for strategic and tactical management of R&D resources. I contributed to corporate strategic planning, technology acquisition and out-licensing, business development, and company fundraising. I managed and directed multidisciplinary research and development team responsible for creating new products to penetrate targeted proteomics and genomics markets and increase revenue. I also advised the CEO on target markets, research direction, development of technology and products, and intellectual property; and actively contributed to corporate budgeting, milestones, and forecasting/pro forma.

I managed all functions within applications development and product manufacturing; established aggressive reagent product development pipeline to support targeted genomic and proteomic markets; co-authored, reviewed and edited corporate communications including press, point of sale, internet marketing, and corporate publications ensuring technical accuracy and consistency of message and terminology.