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Aisummit 2023 Horz

2023 AI Committee

Pat

Baird

Regulatory Head of Global Software Standards

Philips

Pat Baird is the Head of Global Software Standards at Philips, where he describes his role as “Policy Engineering” – addressing the unmet needs and challenges of regulators and developers by creating standards, white papers, and training. He is passionate about artificial intelligence in healthcare and co-chairs several AI committees, including those for AAMI, ISO/IEC TC215, CTA, MITA, and MDIC.

Matthew

Diamond

Chief Medical Officer, Digital Health Center of Excellence

FDA

Matthew Diamond, MD, PhD serves as Chief Medical Officer for Digital Health at FDA’s Center for Devices and Radiological Health (CDRH). As senior clinical expert at the Digital Health Center of Excellence, he leads digital health policy development and implementation, particularly for emerging technologies like artificial intelligence.

Brian

Edwards

Fellow, Regulatory Affairs, Digital Health/Cybersecurity

Boston Scientific

Brian Edwards serves as Regulatory Fellow at Boston Scientific’s Global Advocacy Group, focusing on Digital Health, Cybersecurity, and Medical Device Software. With over 30 years in medical devices and 25 in Regulatory Affairs, he leads global advocacy for Digital Health, AI/ML, and Quality Systems. He holds degrees in Chemical and Biomedical Engineering and has led Regulatory Affairs across multiple medical sectors.

Steve

Frigon

Data Integration Team Lead

The Chris Hospital Health Network

Steve Frigon serves as Senior Clinical Systems Analyst at The Christ Hospital, bringing 21 years of experience in healthcare technology and data management. He develops strategies for interoperability and Digital Health, specializing in AI implementation. Previously held roles as Data Integration Consultant at HC Tech and Data Integration Manager at Mercy Health.

Lacey

Harbour

Regulatory Affairs Manager

Thermo Fisher Scientific

Lacey Harbour is a Molecular Biologist turned Regulatory, Quality, and Clinical Strategist, experienced in bringing diverse medical devices to market. She specializes in validating machine learning algorithms in healthcare, focusing on safety and effectiveness. Through AFDO/RAPS involvement, she advocates for state-of-the-art medical care while ensuring patient safety and global accessibility.

Eric

Henry

Senior Quality & Regulatory Compliance Advisor, FDA & Life Sciences Practice

King & Spalding

Eric Henry, Senior Quality Systems and Compliance Advisor at King & Spalding’s FDA and Life Sciences practice, brings 30 years of industry experience. He advises clients on regulatory compliance, quality systems, audits, M&A due diligence, and serves as an expert witness. Previously, Henry led global quality, compliance, and technology organizations for several medical device companies of varying sizes.

Cindy

Ipach

President & CEO

Compliance Insight

Cynthia Ipach, President and CEO of Compliance Insight, Inc., founded the company in 2000. With over 30 years in pharmaceuticals, medical devices, dietary supplements, and biologics, she has guided hundreds of companies through FDA compliance. Starting in Analytical Research and Development, she moved to Regulatory Affairs and Quality Assurance before serving as Director of Scientific Affairs at Pharmacia. Recently, she co-leads AFDO/RAPS’s AI in Operations Group, developing AI maturity models for healthcare.

Rohit

Nayak

CEO

Electronic Registry Systems, Inc.

Rohit Nayak leads Electronic Registry Systems and advises early-stage companies. A strategic leader in digital innovation, he’s grown healthcare tech companies from startup to acquisition, including an ePrescribing company bought by Quest Diagnostics. He formed Baxter’s global Digital Health team and at Quest Diagnostics led healthcare analytics P&L growth. His expertise spans digital health, commercial execution, and P&L management across Fortune 500 and emerging companies.

Bakul

Patel

Senior Director, Global Digital Health Strategy & Regulatory

Google

Bakul Patel serves as Senior Director of Global Digital Health Strategy & Regulatory at Health@Google, driving healthcare innovation through digital health technologies. Previously as FDA’s Chief Digital Health Officer, he pioneered “software as a medical device” (SaMD) regulations and led key initiatives in AI/ML software. With experience across tech sectors, he holds degrees from University of Regina and Johns Hopkins University.

Dharmesh

Patel

Associate Director Regulatory Policy

BD

Dharmesh Patel serves as Associate Director of Regulatory Policy at BD, focusing on International Harmonization, Digital Health, Software, and AI/ML. Previously, he was Assistant Director of PMA policy at FDA/CDRH, following roles in Digital Health and Third Party 510(k) program. He holds degrees in Electrical Engineering, Engineering, and an MBA.

Cassie

Scherer

Senior Director U.S. Regulatory and Global Digital Health Policy

Medtronic

Cassie Scherer serves as Senior Director of U.S. Regulatory and Global Digital Health Policy at Medtronic, leading policy initiatives for digital health technology and AI/ML-enabled products. Previously, she held key positions at the U.S. FDA, including Associate Chief Counsel in FDA’s Office of Chief Counsel and Director of Strategy and Regulatory Operations in CDRH’s Office of the Center Director.

Matthew

Schmucki

Associate Director of Automation Engineering

Vertex Pharmaceuticals

Matt serves as Associate Director for data automation and engineering at Vertex Pharmaceuticals, managing manufacturing data analytics across internal and external partnerships. With 15+ years supporting various pharmaceutical products, he brings expertise from startups to major pharma companies. He holds a mechanical engineering degree from University of Cincinnati and Doctorate in Business Intelligence, and guest lectures at Xavier University’s Quality Science programs.

Bradley

Thompson

Attorney and Chief Data Scientist focused on FDA, FTC & AI Regulation

Epstein Becker & Green

Bradley Thompson serves as shareholder at Epstein Becker & Green and Chairman/Chief Data Scientist at EBG Advisors, advising on FDA regulatory issues and leading the firm’s AI practice. He has counseled trade associations, taught Food & Drug Law at Indiana University, and held legal committee leadership roles. He holds degrees from Illinois and Michigan universities, including a Master’s in Applied Data Science.

Mohammed

Wahab

Quality Head, Professional Services – Informatics & Analytics

Abbott Laboratories

Mohammed Wahab leads Quality Assurance for Non-Product Software Validation and Cybersecurity at Abbott, bringing 25+ years of expertise in Software Engineering and Healthcare. His career spans key roles at GE Healthcare and Allscripts, and he co-founded fintech startup Casheer as CTO. He holds degrees in Computer Science and Electronics and Instrumentation.

The AFDO/RAPS Healthcare Products Collaborative is a joint venture established in 2022 between the Association of Food and Drug Officials and the Regulatory Affairs Professionals Society. Learn more.

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