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Aisummit 2023 Horz

2023 AI Committee

Pat

Baird

Regulatory Head of Global Software Standards

Philips

Pat Baird works at Philips as the Head of Global Software Standards. Baird likes to think of his job as “Policy Engineering” – understanding the unmet needs (and frustrations) of regulators and developers, and developing standards, white papers, and training to meet those needs. His current passion is related to artificial intelligence in healthcare; he is co-chair of multiple AI committees including AAMI, ISO/IEC TC215, CTA, MITA, and MDIC.

Matthew

Diamond

Chief Medical Officer, Digital Health Center of Excellence

FDA

Matthew Diamond, MD, PhD is the Chief Medical Officer for Digital Health at FDA’s Center for Devices and Radiological Health (CDRH), where he is the senior clinical expert and focal point of contact for clinical issues related to digital health medical devices. In his role at the CDRH Digital Health Center of Excellence, Dr. Diamond provides leadership for digital health policy development and implementation for emerging technologies including artificial intelligence.

Brian

Edwards

Fellow, Regulatory Affairs, Digital Health/Cybersecurity

Boston Scientific

Brian Edwards is a Regulatory Fellow specializing in Digital Health and Cybersecurity for Boston Scientific. He is focusing on internal and external global advocacy efforts related to Digital Health, Medical Device Software, AI/ML, Cybersecurity, and Quality Systems. He has over 30 years of experience in the medical device industry and over 25 years of experience as a Regulatory Affairs Professional. He holds a BS in Chemical Engineering and an MS in both Biomedical Engineering and Biostatistics. Brian has worked in R&D, Clinical Research, Quality Systems, and Regulatory Affairs. He has successfully led Regulatory Affairs Departments for medical device companies in the orthopedic, cardiovascular, audiology, electrotherapy, digital health, and neurosurgical product industries.

Steve

Frigon

Data Integration Team Lead

The Chris Hospital Health Network

Steve Frigon is a Senior Clinical Systems Analyst at The Christ Hospital in Cincinnati, Ohio, with 21 years of experience in Application Development, Data Integration, and Data Management in the Pharmaceutical and Healthcare industries. He develops technology strategies in interoperability, web services, and Digital Health, focusing on AI explicability, validation, and adoption to build trust in patients and physicians. Before joining The Christ Hospital, Frigon was a Data Integration Consultant with HC Tech, Inc., and a Data Integration Manager at Mercy Health.

Lacey

Harbour

Regulatory Affairs Manager

Thermo Fisher Scientific

Lacey Harbour is a classically trained Molecular Biologist turned Regulatory, Quality, and Clinical Strategist. Her experience includes the Clinical Laboratory, R&D, Pharmaceuticals, and Medical Devices industries. Leveraging a diverse background, she has led or supported teams that have brought orthopedic, in vitro diagnostic, SaMD, dental, physiotherapeutic, and other FDA Class I to Class III devices to the global market with high quality. Starting from the exposure of validating predictive systems in the operational and diagnostic sides of the clinical laboratory, proving safety and effectiveness of machine learning algorithms in the total product life cycle of healthcare has been a passion for many years. As an advocate of protecting patients while taking a risk-based, least burdensome approach, Harbour considers joining think tanks like AFDO/RAPS as an honor. Her goal is to ensure that the future of medical care is state of the art while maintaining safety and effectiveness and, hopefully, encouraging global accessibility of good healthcare products.

Eric

Henry

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

King & Spalding

Eric Henry is a 30-year industry veteran currently serving as Senior Quality Systems and Compliance Advisor in the FDA and Life Sciences practice of the law firm King & Spalding. In this role Henry advises King & Spalding clients on a variety of regulatory compliance matters including Quality System establishment and remediation, establishment of quality organizations, audit and inspection management and response, compliance-related due diligence reviews for M&A, training, and serving as an expert witness during litigation. Before he joined King & Spalding, Henry led global quality, compliance, and technology organizations for several large and medium-size medical device companies.

Cindy

Ipach

President & CEO

Compliance Insight

Cynthia Ipach, President and CEO of Compliance Insight, Inc., founded the company in 2000. With over 30 years of experience in pharmaceuticals, medical devices, dietary supplements, and biologics, she has supported hundreds of companies in FDA compliance. Ipach started in Analytical Research and Development and transitioned to Regulatory Affairs and Quality Assurance. Before starting Compliance Insight, she was Director of Scientific Affairs at Pharmacia. Recently, she has been active in AFDO/RAPS’s AI in Operations Group and co-led the development of AI maturity models and white papers on AI in healthcare.

Rohit

Nayak

CEO

Electronic Registry Systems, Inc.

Rohit Nayak leads Electronic Registry Systems, Inc., a cancer informatics firm. He also serves as an advisor and board member for various early-stage companies and nonprofits. Nayak is a strategic global leader with expertise in digital innovation, commercial execution, and P&L management across Fortune 500 and emerging growth organizations. He has successfully led a healthcare tech start-up from inception to acquisition by a Fortune 500 company. Previously, Nayak formed Baxter’s global Digital Health team and held key roles at Quest Diagnostics, where he grew a P&L for healthcare analytics solutions. He co-founded an ePrescribing software company, later acquired by Quest Diagnostics.

Bakul

Patel

Senior Director, Global Digital Health Strategy & Regulatory

Google

Bakul Patel is the Senior Director of Global Digital Health Strategy & Regulatory at Health@Google, overseeing global regulatory strategy and engagement. He aims to harness digital health to revolutionize healthcare by preventing and predicting disease. Before Google, Patel was the Chief Digital Health Officer at the FDA, where he shaped digital health regulations and coined the term “software as a medical device” (SaMD). He led initiatives like the software precertification pilot and AI/ML-based software framework. Patel has diverse leadership experience in telecommunications, semiconductors, wireless, and IT. He holds an MS in electronic systems engineering from the University of Regina and an MBA from Johns Hopkins University.

Dharmesh

Patel

Associate Director Regulatory Policy

BD

Dharmesh Patel joined BD in January 2023 as Associate Director, Regulatory Policy. He is developing and advancing BD’s regulatory policy positions with a focus on International Harmonization, Digital Health, Software, and AI/ML. Prior to joining BD, Dharmesh was at FDA/CDRH as the Assistant Director of the PMA, HDE, Q-Submission and Device Lifecycle Tracking policy team. Dharmesh first joined CDRH in 2011 as a lead scientific reviewer in the Division of Cardiovascular Devices and has worked in various policy areas such as Digital Health and the Third Party 510(k) program before moving onto his leadership role in PMA policy. Dharmesh has a Bachelor’s degree in Electrical Engineering, a Master’s degree in Engineering, and a MBA.

Cassie

Scherer

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

Medtronic

Cassie Scherer is the Senior Director of U.S. Regulatory and Global Digital Health Policy at Medtronic. In her position, she leads global policy work relating to digital health technology, including AI/ML-enabled products, as well as U.S. FDA regulatory policy work. Before Medtronic, Scherer served at U.S. FDA where she was 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 is the Associate Director for data automation and engineering for Vertex Pharmaceutical’s manufacturing data and analytics applications. He supports both internal manufacturing and external contract manufacturing partnerships by setting up standardized data ingestion mechanisms for data analytics. Over the past decade and a half, Matt has supported many types of products from oral solid dose to combination products, with companies ranging from startups and CMOs to top pharmaceutical and biopharmaceutical companies. Matt is a mechanical engineer from the University of Cincinnati with a Doctorate in Business Intelligence. Matt is also a Guest Lecturer for Xavier University for both the Quality Science Regulations and Industrial Product Development programs. These lectures introduce undergraduate students to concepts and practices fundamental to the pharmaceutical and medical device industries.

Bradley

Thompson

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

Epstein Becker & Green

Bradley Thompson is a shareholder at Epstein Becker & Green, P.C., in Washington DC, where he advises software, medical device, and drug companies on FDA regulatory issues and leads the firm’s AI practice. He also serves as Chairman of the Board and Chief Data Scientist of EBG Advisors, Inc., a consultancy helping health care and life sciences companies navigate regulatory challenges. Thompson has been counsel to various trade associations and coalitions, taught Food & Drug Law at Indiana University School of Law, and held leadership roles in legal committees. He holds degrees from the University of Illinois and the University of Michigan, including a Master of Applied Data Science.

Mohammed

Wahab

Quality Head, Professional Services – Informatics & Analytics

Abbott Laboratories

Mohammed Wahab has over 21 years of experience in software engineering, compliance, and healthcare. He has led teams at Abbott Laboratories, GE Healthcare, and Allscripts, contributing to efficiency improvements and designing an Agile-based Quality Management System at Abbott. Currently, he heads the Quality Assurance organization for a Professional Services Business Unit at Abbott, focusing on business and clinical insights using data science and analytics. Wahab was also the co-founder and CTO of Casheer, a fintech startup in the cryptocurrency space. He holds a master’s degree in computer science and a bachelor’s degree in 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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