AI Initiative Strategic Committee
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.
Associate Director Regulatory Policy, BD
Jeff Ballyns is an Associate Director of Regulatory Policy at Becton Dickinson and Company (BD). BD designs, manufactures, and sells a wide range of medical devices, including in vitro diagnostic (IVD) products worldwide. He is responsible for gathering, assessing, and communicating new regulatory policy requirements impacting BD businesses.
Prior to working at BD, Ballyns worked in the Center for Devices and Radiologic Health (CDRH) at the U.S. Food and Drug Administration for eight years. While at the FDA, he served as a lead reviewer, Branch Chief and Division Director in the Division of Radiological Health within the Office of In Vitro Diagnostics and Radiological Health. He was responsible for the pre-market review and post-market regulation of radiological imaging devices and artificial intelligence (AI) image analysis software applications. Ballyns received his bachelor’s and doctorate degrees from Cornell University in mechanical and aerospace engineering and biomedical engineering, respectively.
CMO for Digital Health, FDA-CDRH Digital Health Center of Excellence
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.
Data Integration Team Lead, The Christ Hospital Health Network
Steve Frigon is a Senior Clinical Systems Analyst at The Christ Hospital in Cincinnati, Ohio. He has specialized in Application Development, Data Integration, and Data Management solutions in the Pharmaceutical and Healthcare industries for the past 21 years. In this position, Frigon develops various technology strategies and adaptation techniques in the areas of interoperability, web services, and Digital Health. His focus in the AI framework is on explicability, validation, and adoption, which stimulates the development of trust in patients and physicians alike.
Prior to joining The Christ Hospital, Frigon was a Data Integration Consultant with HC Tech, Inc. and a Data Integration Manager at Mercy Health.
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 ultimate 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.
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.
Director of Health Technology Initiatives, AFDO/RAPS Healthcare Products Collaborative
Before becoming the Director of Health Technology Initiatives at AFDO/RAPS Healthcare Products Collaborative, Timothy Hsu was a member of the AI Initiative’s Core Strategic Team. He’s also spent several years working with the GMLP, AIO, and AI@POC teams in varying capacities under the Xavier Health Artificial Intelligence Initiative.
Hsu has served across the clinical, operational, and administrative spectrums in healthcare systems at pediatric, academic, research, and community hospitals. His roles in healthcare systems have included work in strategy, planning, perioperative, service line, and population health divisions. Hsu was a Product Manager in Clinical Intelligence at Premier Inc., where he was the product owner of Service Line Analytics, Cost Accounting, Patient Analytics, and Clinical Professional Partnerships. He was the market research strategist for healthcare market futures at GBBN Architects.
Cynthia A. Ipach
President and CEO, Compliance Insight
Cynthia Ipach, President and CEO of Compliance Insight, Inc., founded the company in 2000. With over 30 years of experience in the pharmaceutical, medical device, dietary supplement, and biologic industries, Ipach has supported hundreds of companies in their pursuit of FDA compliance.
She began her career in Analytical Research and Development and later moved to Regulatory Affairs and Quality Assurance positions within the Pharmaceutical Industry. In 2000, Ipach left the corporate environment and her position as Director of Scientific Affairs for Pharmacia. She started the Quality Assurance and Regulatory Affairs consulting firm known as Compliance Insight, Inc.: The organization’s mission is to align with client compliance initiatives to move beyond the regulations to compliance that makes sense.
Recently, Ipach has been active in the AI in Operations Group (AIO) of AFDO/RAPS (formerly Xavier Health). She also contributed to the “Perspectives and Good Practices for AI and Continuous Learning Systems in Healthcare” white paper, August 2018, and co-led the team that developed the AI Maturity Level Characterization Model 2020 and the Maturity Level Characterization of Artificial Intelligence (AI) Capabilities for Self-Assessment white paper, June 2021.
Director of Quality/Regulatory Affairs, Best Sanitizers
Cindi Linville is the Director of Quality for Best Sanitizers, and has worked at Best Sanitizers for nine years. Prior to working at Best Sanitizers, Linville was the Facility Quality Assurance Manager for Avnet. She has a degree in IT security, electrical engineering, organizational management, and a master’s degree in business management. Overall, Linville has worked in Quality for more than 20 years. She also has ASQ certifications as a Quality Engineer, Biomedical Auditor, and in Pharmaceutical GMPs.
Co-founder and CSO, Aizon
Manzano is the co-founder and CSO of Aizon, a cloud company that provides big data and AI SaaS platform for the Biotech and Pharma industry. He is also co-leading CPV and Biomanufacturing groups at the PDA, and he teaches AI subjects at the University (OBS and UAB). Manzano is a member of the Science Experts in the Spanish Parliament on big data and artificial intelligence topic and an AI expert with the United Nations for biopharma. He has written numerous articles in the Pharma field and holds a dozen international patents related to the encryption, transmission, storage, and processing of large volumes of data for regulated environments in the cloud. Manzano is a Physicist, Master in Information and Knowledge Society, and postgraduate in quality systems for manufacturing and research pharmaceutical processes.
Fellow, Regulatory Science, Boston Scientific Corporation
Mac McKeen has 30 years of experience in the medical device industry in regulatory and quality roles focused on the development, clinical study, and regulatory approval of cardiovascular devices and is currently a fellow at Boston Scientific with previous leadership roles at Guidant, Medtronic, St. Jude Medical, Cardiac Science, and Phillips-Medisize. He also serves as an adjunct professor at the University of Minnesota instructing a graduate level course on Medical Device Development and TPLC Journey to Market. McKeen is a faculty director within the College of Continuing and Professional Studies.
CEO, Electronic Registry Systems, Inc.
CEO & Co-Founder, Band Connect, Inc.
Rohit Nayak currently leads Electronic Registry Systems, Inc., a cancer informatics firm that is at the forefront of providing cancer programs nationwide with a valuable foundation of data and insights that provide for the best cancer care for every patient. He also serves as an Advisor/Board Member for several early stage companies and not-for-profit organizations.
Nayak has a successful track record as strategic global leader and change catalyst, leveraging digital innovation, commercial execution, and P&L management skills across Fortune 500, start-up, and emerging growth organizations, most recently in healthcare. Notably, he’s led a healthcare technology start-up from vision to capitalization to execution and eventual sale / exit to a Fortune 500 company.
Most recently, Nayak led the formation of the global Digital Health team at Baxter with responsibilities to drive innovative software-enabled solutions leveraging their med device portfolio. Prior to Baxter, Rohit had several roles with increasing responsibilities at Quest Diagnostics, where he was responsible for successfully developing and growing a P&L delivering customer-facing healthcare analytics solution across the ambulatory, acute, and payer markets. He previously co-founded and led an ePrescribing healthcare software company that was subsequently acquired by Quest Diagnostics.
Senior Director, Global Digital Health Strategy & Regulatory, Google
Bakul Patel is the Senior Director, Global Digital Health Strategy & Regulatory focused on helping build a unified digital health strategy for Health@Google that is aligned with the global regulatory needs. He is responsible for global regulatory affairs strategy and regulatory science engagement with public and private stakeholders for Health efforts Google and Alphabet.
Patel’s vision for his role at Google is to help realize the potential of digital health that is poised to be a game-changer in heralding a new era for healthcare generally — one that is ubiquitous and poised to deliver care to all individuals, including preventing and predicting disease and keeping people healthy and out of the hospital.
Prior to joining Google, Patel held the position of the Chief Digital Health Officer of Global Strategy and innovation and Director for Digital Health Center of Excellence, at the Food and Drug Administration (FDA) providing thought leadership and shaping responsible regulation for this emerging field of Digital Health.
In his 13-year tenure at the FDA, he was instrumental in setting a national strategy and policy for how digital health technologies and software can be evidence based. In 2013 he coined the term software as a medical device (SaMD) and ultimately built a framework that set the foundational standard for medical device regulators globally. He is known for the launch of the software precertification pilot program and, more recently, the framework for Artificial Intelligence/Machine Learning (AI/ML)-Based Software.
Patel brings several years of leadership experience in several sectors including the telecommunications industry, semiconductor capital equipment industry, wireless industry, and information technology industry. He earned an MS in electronic systems engineering from the University of Regina, Canada, and an MBA in international business from The Johns Hopkins University.
Data Analyst, Corporate Quality & Strategy, AstraZeneca
Matt is a Data Analyst for AstraZeneca’s Corporate Quality & Strategy department. He supports the Quality Management Systems by addressing business problems related to data and analytics. For over the past decade, Matt has supported many types of products from oral solid dose to biopharmaceutical combination products with startups, CMOs, and top pharmaceutical and biopharmaceutical companies. Matt is a mechanical engineer from the University of Cincinnati with his 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.
Quality Head, Professional Services – Informatics & Analytics, Abbott Laboratories
Mohammed Wahab has over 21 years of experience in Software Engineering, Compliance, and the Healthcare industry. He led several teams that delivered healthcare products at Abbott Laboratories, GE Healthcare, and Allscripts. Wahab contributed to many efficiency improvements at Abbott by designing a modern Agile methodology-based Quality Management System: The QMS has been used to launch several successful products.
Wahab currently heads the Quality Assurance organization for a Professional Services Business Unit at Abbott that develops business and clinical insights using Data Science and Analytics. He also leads a team that develops algorithms for efficient Complaints Investigations. Wahab was the co-founder and CTO for Casheer, a Fintech start-up in Crypto Currency space. He holds a master’s degree in computer science and also has a bachelor’s engineering degree in electronics and instrumentation.