Artificial Intelligence Initiative Strategic Committee

Artificial Intelligence – Advancing the Pharmaceutical and Medical Device Industries

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Strategic Committee Charter

The Strategic Committee is responsible for setting the vision, strategy and scope for the Healthcare Products Collaborative Artificial Intelligence Initiative. Part of the strategy of the Artificial Intelligence Initiative is to utilize the annual Healthcare Products Collaborative AI Summit to bring industry members together to advance the understanding of the industry on how best to make use of artificial intelligence, and to establish industry work teams that will collaboratively address AI challenges and develop AI solutions.

Pat Baird

Regulatory Head of Global Software Standards, Philips

Pat Baird works at Philips as the Head of Global Software Standards. Pat likes to think of his job as “Policy Engineering” – understanding the unmet needs (and frustrations) of regulators and developers, and working to develop standards, whitepapers, and training to meet those needs.

Past roles have included software developer, engineering manager, project manager, lead engineer, and most recently he was the Director of Risk Management at Baxter Healthcare. Drawing on 20 years’ experience in product development, he has published and presented over 50 papers regarding product development. He has an M.B.A. and a master’s in healthcare quality and patient safety from Northwestern University.

Jeff Ballyns

Associate Director Regulatory Policy, BD

Jeff Ballyns, Ph.D., 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, Dr. Ballyns worked in the Center for Devices and Radiologic Health (CDRH) at the US 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. Dr. Ballyns received his bachelor’s and Ph.D. degrees from Cornell University in mechanical and aerospace engineering and biomedical engineering respectively.

Bob Banta

Associate Senior Consultant—QA, Eli Lilly

In his current role, Bob authors global medical device quality standards and common quality practice documents. He also provides oversight to changes to the Lilly device QMS in order to support Lilly digital device initiatives (including AI/ML-based SaMDs). Bob also provides global device quality support with respect to medical device QMS auditing, risk management governance including medical device cybersecurity risk governance, product lifecycle management (PLM), and device regulatory surveillance. He has twice presented at past FDA/Xavier University Global Medical Device Conferences on SaMD QMS and risk management.

He is a member of the AAMI Device Security Working Group (SM-WG05 – Device Security WG) which was responsible for authoring AAMI TIR97:2019/Ed.1 Principles for medical device security – Post-market security management for device manufacturers; the SM-WG05 Group is currently drafting a proposed new American National Standard—AAMI SW96, Standard for medical device security—Security risk management for device manufacturers. Bob is also a member of the AAMI Artificial Intelligence (AI) Committee. He has worked for Lilly for the past 19 years with prior extensive experience as a technical communication specialist in software, aerospace and manufacturing. He holds a bachelor of arts in journalism from Indiana University—Bloomington.

Steve Frigon

Sr. Clinical Systems Analyst, The Christ Hospital Health Network

Steve Frigon is a Senior Clinical Systems Analyst at The Christ Hospital in Cincinnati, Ohio. Specializing in Application Development, Data Integration and Data Management solutions in the Pharmaceutical and Healthcare industries for the past 21 years. In this position, Steve 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 that stimulates the development of trust in Patients and Physicians alike.
Prior to joining The Christ Hospital, Steve was a Data Integration Consultant with HC Tech, Inc. and a Data Integration Manager at Mercy Health.

Lacey Harbour

Sr. Regulatory and Quality Manager, Lima Corporate

Lacey Harbour is the Sr. Regulatory and Quality Manager at LimaCorporate U.S.A. Inc. with a decade of exposure to machine learning algorithms within the clinical laboratory to medical device manufacturing and products, and over 20 years’ experience in highly regulated life science industries. Lacey joins the Xavier Health Summit with the goals of helping to determine practical and correct ways to establish confidence and prove reliability for “AI” in operations and within Medical Devices to meet global Regulatory requirements and expectations.

Eric Henry

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

Eric Henry is a Senior Quality Systems and Compliance Advisor in the FDA and Life Sciences practice of the law firm King & Spalding. Eric is a 30-year industry veteran having led and coached global organizations through a wide variety of quality and compliance challenges. Complementing his leadership experience is an extensive hands-on skillset including audit management and response, Quality System remediation, software quality (including cybersecurity and AI/ML), medical device design controls, risk management, and regulatory due diligence.
Prior to King & Spalding, Eric led global technical and quality functions at Philips, Medtronic, GE Healthcare, Boston Scientific, and Hologic.
Prior to entering the medical device industry, Eric led a software quality management and program management office consulting capability in the Washington, DC area and held software design and development leadership roles in a small startup, a mid-size healthcare software company, a large financial services regulator and stock market, and a large retail organization.

Timothy Hsu

Director of Health Technology Initiatives, AFDO/RAPS Healthcare Products Collaborative

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, Cynthia 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, Cynthia left the corporate environment and her position as Director of Scientific Affairs for Pharmacia to start the Quality Assurance and Regulatory Affairs consulting firm known as Compliance Insight, Inc., whose mission is to align with client initiatives to move beyond the regulations to compliance that makes sense.

Cindi Linville

QA Manager, 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, Cindi was the Facility Quality Assurance Manager for Avnet. She has a degree in IT Security, Electrical Engineering, Organizational Management, and a Masters in Business Management. Overall, Cindi has worked in Quality for over 20 years. Cindi also has ASQ certifications as a Quality Engineer, Biomedical Auditor and in Pharmaceutical GMPs.

Toni Manzano

Co-founder and CSO, Aizon

Toni Manzano is co-founder and CSO of Aizon, a cloud company that provides big data and AI SaaS platform for the Biotech and Pharma industry. Since 1996 he has led software projects for international pharmaceutical companies covering the entire production process and supply chain (R&D, clinical trials, production, laboratory, quality assurance, warehousing and logistics). In pharma manufacturing he was specifically dedicated to biotech processes, always improving critical operations. He has also led projects implementing solutions based on the 3 ICH (Q8, Q9 and Q10) and executing audit, qualification and validation tasks. Nowadays Toni is in the scientific committee of the PDA Europe supporting annual events for the innovation and technology in pharma.
He worked as a researcher at the University of Barcelona as physicist and he teaches Big Data and Artificial Intelligence subjects related with the Pharma Industry in specific postgraduate courses at the University (UAB). 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. Toni is Physicist, Master in Information and Knowledge Society and post graduated in quality systems for manufacturing and research pharmaceutical processes.

Mac McKeen

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 4000 level course and graduate level course on medical device development and is also a faculty director within the College of Continuing and Professional Studies.
He is actively involved in advocacy and collaboration with the FDA through industry associations including AdvaMed, MDIC, RAPS and Medical Alley. He holds a B.S. in Industrial Technology from Iowa State University and an M.B.A. from the University of Dallas and is RAC certified.

Rohit Nayak

CEO, Electronic Registry Systems, Inc.

Rohit 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.
Rohit 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, startup, and emerging growth organizations, most recently in healthcare. Notably, he’s led a healthcare technology startup from vision to capitalization to execution and eventual sale / exit to a Fortune 500 company.
Most recently, Rohit 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 solutions 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.

Steve Niedelman, Lead Quality System & Compliance Consultant, King & Spalding

Steve Niedelman

Lead Quality System & Compliance Consultant, King & Spalding

Mr. Niedelman retired from the Food and Drug Administration in 2006 after a 34-year distinguished career, where he served as the Deputy Associate Commissioner for Regulatory Affairs and as Chief Operating Officer of the Office of Regulatory Affairs. He ensured consistent interpretation of FDA’s regulatory policies by directly overseeing offices at the headquarters of the Office of Regulatory Affairs (ORA), including the Office of Regional Operations, Office of Enforcement and Office of Criminal Investigations. While at ORA, Mr. Niedelman served as the principle liaison to the Center for Devices and Radiological Health, and was a member of the Global Harmonization Task Force (GHTF) Steering Committee, FDA/Medical Device Industry Grassroots Initiative Steering Committee and the CDRH Post Market Initiative Steering Committee. He joins King & Spalding from Crowell & Moring LLP, where he was a senior consultant in its health care group. Previously, he was executive vice-president of Quintiles Consulting. Mr. Niedelman specializes in regulatory, enforcement and policy matters involving industries regulated by the U.S. Food and Drug Administration. He provides strategic advice, insight and guidance to the medical device, pharmaceutical, biologics and food industries to ensure compliance with the requirements of the federal Food, Drug and Cosmetic Act.

Bakul Patel, MSEE, MBA

Chief Digital Health Officer of Global Strategy and Innovation, FDA

Bakul Patel is Director for Division of Digital Health, at the Center for Devices and Radiological Health (CDRH), at the Food and Drug Administration (FDA). Mr. Patel is leading regulatory policy and coordination of scientific efforts for digital health, software and emerging technologies. Mr. Patel also led the creation of the globally harmonized regulatory framework for “software as a medical device” (SaMD) at the International Medical Device Regulators Forum (IMDRF). Mr. Patel is the FDA liaison between the Federal Communications Commission (FCC) and the Office of the National Coordinator (ONC). Mr. Patel is currently leading the software precertification program in collaboration with all stakeholders to reimagine a regulatory approach for Digital health. Mr. Patel earned an M.S. in electronic systems engineering from the University of Regina, Canada, and an M.B.A. in international business from The Johns Hopkins University.

Marla Phillips, CEO & President, Pathway for Patient Health

Marla Phillips

Director, Xavier Health, Xavier University

Dr. Marla A. Phillips joined Xavier University in 2008 as the Director of Xavier Health, where she leads initiatives with FDA officials and Pharmaceutical and Medical Device professionals. Marla began working in the pharmaceutical industry for Merck in 1996 where she took on roles of increasing responsibility, culminating in position of Head of Quality Operations at the Merck North Carolina facility. She holds a B.S. in chemistry from Xavier University, and a Ph.D. in organic chemistry from the University of North Carolina – Chapel Hill.

Matthew Schmucki

Lean Coach, AstraZeneca

With over a decade of pharmaceutical experience, Matt began with supporting the startup of Amylin Pharmaceuticals. He later joined Patheon Pharmaceuticals supporting granulation production before joining AstraZeneca in 2013. He is still with AstraZeneca and is a Lean Coach that provides tools and training to manufacture in a Lean format. Matt is a graduate of the University of Cincinnati where he earned his B.S. in mechanical engineering. He later returned to earn his M.B.A. as well as his M.S. in Business Analytics.

Mohammed Wahab

Quality Head, Professional Services – Informatics & Analytics, Abbott Laboratories, Diagnostic Division

Mohammed 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. Mohammed 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.
Mohammed 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. Mohammed was also the co-founder and CTO for Casheer, a Fintech startup in Crypto Currency space. Mohammed holds a master’s degree in computer science and also has a bachelor’s engineering degree in electronics and Instrumentation.