The AI Summit speakers were handpicked by the AI Summit Strategic Committee to deliver purpose-driven content that dove below the surface, challenged the status quo, engaged attendees in collaborative dialogue, and provided practical, implementable information. Our speakers were thought leaders who facilitated insightful discussions.
Speakers & Moderators
Laura
Adams
National Academy of Medicine
Senior Advisor
Laura serves as Senior Advisor at the National Academy of Medicine (NAM), leading the Science and Technology portfolio and the NAM’s Artificial Intelligence Code of Conduct initiative. She contributes expertise in digital health and human-centered care through board positions at T2 Biosystems and TMA Precision Health, the Coalition for Health AI Steering Committee, and as advisor for Inflammatix.
Pat
Baird
Philips
Regulatory Head of Global Software Standards
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.
Cameron
Baker
Boston Scientific
Federal Government Affairs Manager
Cameron is a Government Affairs professional with nearly a decade of DC experience. After working with House Leadership at the National Republican Congressional Committee and as an Associate at CGCN Group, she joined Boston Scientific in 2018. As Manager of Federal Government Affairs, she leads lobbying efforts in digital health, AI, data privacy, cybersecurity, and advocates on corporate tax, supply chain, and HR policies.
Alex
Cadotte
MCRA
Senior Director, Digital Health and Imaging
Dr. Cadotte specializes in FDA regulatory strategy and medical device submissions, with expertise in medical writing, clinical trials, and data review. His focus areas include medical device software, Software as Medical Device (SaMD), AI/ML devices, Clinical Decision Support, Predetermined Change Control Plans, and Computer Aided Devices for triage, notification, detection, and diagnosis.
Seth
Carmody
MedCrypt
VP Regulatory Strategy
Seth Carmody serves as Vice President of Regulatory Strategy at MedCrypt, applying his decade of medical device expertise to guide cybersecurity products for regulated medical devices. He focuses on building resilient healthcare infrastructure and developing ROI metrics for cybersecurity investments. Seth earned his PhD from Indiana University, researching chemical synthesis of peptidoglycan probes for novel antibacterial drugs.
Matthew
Diamond
FDA
Chief Medical Officer, Digital Health Center of Excellence
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.
Kathryn
Drzewiecki,
FDA
Digital Health Policy Team Lead, Center for Devices and Radiological Health (CDRH)
Brian
Edwards
Boston Scientific
Fellow, Regulatory Affairs, Digital Health/Cybersecurity
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.
Zillery
Fortner
Honeywell Life Sciences
Industry and Business Development, Life Science
Zillery Fortner serves as Industry Business Development Director, SME at Honeywell, bringing over 30 years of experience spanning surgical assistance, quality assurance, and regulatory affairs. A respected life sciences leader, she advocates for customers and drives innovation. Her contributions include three patents, with more pending, and active involvement in professional organizations shaping quality standards.
Paul
Hanson
Takeda
Head – Life Cycle Management, Innovation, and Strategy
Paul Hanson, a 15-year veteran at Takeda Pharmaceuticals, started in R&D bioprocess development working on successful commercial products. After leading a biologics team in technical operations, he became Head of Lifecycle Management, Innovation, and Strategy in Global Manufacturing Sciences following the Shire acquisition, where he oversees material qualification and AI implementation in manufacturing.
Eric
Henry
King & Spalding
Senior Quality & Regulatory Compliance Advisor, FDA & Life Sciences Practice
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.
Brenton
Hill
Coalition for Health AI (CHAI)
Head of Operations and General Counsel
Cindy
Ipach
Compliance Insight
President & CEO
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.
Mira
Jacobs
FDA
Division Director, Digital Health Policy, Digital Health Center of Excellence, Center for Devices and Radiological Health (CDRH)
Erez
Kaminski
Ketryx
CEO & Founder
Erez is CEO and Founder of Ketryx Corporation, creating the first connected lifecycle management platform for life sciences software development. His decade of experience spans computational mathematics, biotech, and energy, including leading AI/ML at Amgen’s medical device division. He holds an MS in Electrical Engineering and Computer Science and an MBA from MIT, focusing on software solutions for patient care.
Mandar
Karharde
Quench
Chief Artificial Intelligence Officer
Amanda
Klingler
King & Spalding
Partner
Amanda Klingler is a partner in King & Spalding’s FDA & Life Sciences group, bringing 15+ years of experience advising life sciences companies on regulatory matters, enforcement, and compliance. She co-leads the firm’s AI/ML Tactical Operations team, counseling on digital health and AI implementation. Her expertise spans FDA approvals, GMP, product safety, recalls, and product liability litigation involving FDA issues.
Dinesh
Kulkarni
Thermo Fisher Scientific
Vice President, Information Technology within Thermo Fisher’s Pharma Services Group
Qi
Liu
FDA
Associate Director for Innovation & Partnership ,Office of Clinical Pharmacology | Office of Translational Sciences, CDER
Julie
Nadeau
NAMSA
Sr. Reimbursement Strategist
Nick
Ranly
Siemens Digital Industries Software
Account Orchestrator
Hannah
Rosenfeld
FDA
Digital Health Specialist, Digital Health Center of Excellence, Center for Devices and Radiological Health (CDRH)
Hannah Rosenfeld serves as Digital Health Specialist in FDA’s Division of Digital Health Policy, previously working on the Case for Quality pilot. She holds a Master of Public Policy from the University of Michigan and has authored reports on facial recognition and language models. Her experience includes research on COVID-19 testing and medical innovation, and developing diagnostic tools while leading DEI efforts with Out in Tech.
Alison
Sathe
Redica Systems
Senior Vice President, Data Strategy & Analytics
Alison Sathe, Senior Vice President of Data Strategy & Analytics at Redica Systems, leads the company’s data and AI initiatives. With 20+ years in medtech and a biomedical engineering background, she has held executive regulatory and quality roles at both startups and established companies. Her expertise spans FDA interactions, submissions, clearances, and compliance. An entrepreneur, she founded ClearMark, an electronic QMS platform for medical devices, and Regulatory Mark, a consulting firm.
Cassie
Scherer
Medtronic
Senior Director U.S. Regulatory and Global Digital Health Policy
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.
Christina
Silcox
Duke Margolis Institute for Health Policy
Research Director for Digital Health
Seema
Sodhi
Medtronic
Data Science and Data Engineering Leader | Senior Principal Data Scientist
Mohammed
Wahab
Abbott Laboratories
Quality Head, Professional Services – Informatics & Analytics
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.
