The AI Summit speakers are hand-selected to deliver purpose-driven content that dives below the surface, challenge status quo, engage attendees in collaborative dialog, and provide practical information that can be implemented. Our speakers are thought leaders who are sure to facilitate insightful discussion.
Chief Medical Information Officer
The Christ Hospital Health Network
After completing his Internal Medicine residency at The Christ Hospital, he pursued a M.S. in clinical and translation research - Informatics track from the University of Cincinnati. Joined UC Physicians as a hospitalist and later the UC Center for Health Informatics where he participated in the I2B2 development and CCTST research requests intake. He later served as an assistant to the UC Health CMIO with Epic validation, implementation and optimization phases. He chaired the UC Internal Medicine clinical decision support workgroup. He become Epic certified physician builder and physician build analytics. He became board certified in the new field of Clinical Informatics by the American Board of Preventive Medicine in 2014. He has a CHIME CMIO Leadership Academy certification.
He is an adjunct assistant professor for the UC College of Medicine and taught the online master’s degree in health informatics for the UC College of Applied Health Sciences. He has hosted periodic undergrad student site visits from the Xavier Department of Health Services Administration and offers an elective in Clinical Informatics for physician residents at The Christ Hospital. He currently serves as the CMIO for The Christ Hospital Health Network since 2015.
Co-Director, Computational Medicine Center
Cincinnati Children’s Medical Center
Regulatory Head of Global Software Standards
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.
Consultant – Global Device Quality Assurance
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 Mobile Medical Applications). 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 MMA QMS and risk management.
He is a member of the AAMI Device Security Working Group responsible for drafting TIR97/Ed.1 Principles for medical device security – Post-market security management for device manufacturers. He has worked for Lilly for the past 15 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.
Executive Vice President
PROSYSTEM, an NSF International Company
Oliver Christ has been active in international standardization efforts for more than 25 years and co-founded PROSYSTEM with the late Dr. Jürgen Stettin in 1999. The company was acquired by NSF International in 2017. In Germany, Mr. Christ has served as chair or co-chair of national committees including Human Factors/Usability for Medical Devices, Risk-Management for Medical Electrical Equipment, and Software for Medical Devices and Networked Medical Systems. Mr. Christ represents Germany on international standard committees for programmable electrical medical systems, human factors, risk management, software life cycle processes, and risk management for IT-networks incorporating medical devices (published as IEC 80001-1:2010). In 2013 Mr. Christ became an international delegate for Germany for the AAMI/UL initiative UL 2800 on Interoperability for Medical Devices. He received the DKE Needle award in 2014.
Director, Office of Pharmaceutical Quality Operations, Office of Regulatory Affairs
Alonza Cruse is Director, Office of Pharmaceutical Quality Operations (OPQO) within the FDA Office of Regulatory Affairs (ORA). His office is responsible for all pharmaceutical quality inspections and investigations, working in conjunction with FDA’s Center for Drug Evaluation & Research (CDER) and Center for Veterinary Medicine (CVM). Additionally, Mr. Cruse continues to lead ORA’s pharmaceutical collaboration efforts under the program alignment initiative.
From 2013-2015 Mr. Cruse served as the Director (Acting) of the Office of Medical Products & Tobacco Operations (OMPTO) within ORA, overseeing activities such as Generic Drug User Fee Amendments (GDUFA) implementation, pharmacy compounding, and the development of a New Inspection Protocols Program (NIPP). From 2000-2015, Mr. Cruse was the Director, FDA’s Los Angeles District Office, where his responsibilities included providing executive leadership to implementing, managing and evaluating FDA's regulatory operations. Mr. Cruse first joined ORA in 1983 as a microbiologist. He received his bachelor of science degree in medical technology from York College (City University of New York).
Program Division Director, Division of Pharmaceutical Quality Operations III, ORA
Mr. Czabaniuk holds a B.S. degree in in environmental health and has 40 years of experience in public and private scientific organizations. Mr. Czabaniuk is currently serving as the FDA/ORA Program Division Director (PDD) for the Division of Pharmaceutical Quality Operations III. He is one of four national PDD’s responsible for pharmaceutical regulatory oversight in 13 Midwest states including, MI, IN, OH, KY, IL, MO, KS, NE, IA, MN, WI, SD, and ND.
Prior to joining the FDA in 2002, Mr. Czabaniuk was an independent consultant in the contract pharmaceutical testing industry. His primary responsibilities were laboratory management and the review of Pharmaceutical analytical data including finished product release and validations related to NDA/ANDA applications. Mr. Czabaniuk began his career in the environmental testing industry (18 years) where he held numerous scientific and managerial positions. Management positions included: Branch Manager, Laboratory Director, VP General Manager for a Division of three multi state environmental testing laboratories, and corporate QA Director for national network of 8 environmental/radiochemical laboratories. He also served as a Project Manager for: nuclear/chemical hazardous waste clean-up investigations; industrial wastewater/groundwater/surface water contamination studies; and source and ambient air pollution studies.
Vice President, Quality and Regulatory Affairs
IBM Watson Health
John joined IBM in May of 2016 and is responsible for ensuring Watson Health’s portfolio complies with all relevant lifescience related regulations. Prior to joining Watson Health, John was with Boston Scientific for nine years and had a number of positions there including the head of International Quality, Distribution and Supply Chain and management board level positions for their Endoscopy and Urology and Women’s Health. Prior to Boston Scientific, John worked for Johnson & Johnson and held quality related positions in their device, diagnostic, and pharmaceutical sectors. John has over 20 years of experience with FDA regulated industries and has special expertise in Design Control, Software Quality, and Quality Systems.
Sr. Clinical Systems Analyst
The Christ Hospital
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.
Data Science Practice Manager
Amazon Web Services
David joined Pfizer in 2013 and currently focuses on the development and implementation of AI solutions. His former research was focused on Predictive Modeling and Automated Control which now combined with the latest AI technologies brings a hybrid perspective to the field. He holds several publications in high impact International Journals and three of them have been in the TOP25 Science direct list. Before joining Pfizer, David worked in other Industries such as aluminum (ALCOA) and renewable energy (Technological Institute of Energy). He completed his Post-doc in the University of Manchester in UK and his PhD in The Polytechnic University of Valencia in Spain. His solutions always try to find the balance between efficacy and efficiency with a close look at the business case.
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 is the R&D Director and co-founder of Bigfinite, a cloud company that provides a 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 and is on the scientific committee of the PDA Europe supporting innovation and technology.
Fellow, Regulatory Science
Boston Scientific Corporation
Mac McKeen has over 25 years of experience in the medical device industry in regulatory and quality roles focused on the development, clinical study, and regulatory approvals 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 on medical device development and is also a Faculty Director within the College of Continuing and Applied Professional Studies. He is actively involved in advocacy and collaboration with the FDA through industry associations including AdvaMed, MDIC 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.
Head of Enterprise Analytics
Walt is the driving force for Data Analytics at Takeda. His vision for an Enterprise Analytics Marketplace is unique to the industry and has positioned Takeda to be a leader in Digital Health for rare diseases. The Analytics Marketplace allows all Takeda employees that ability to analyze data to make data-driven decisions and integrate data into a model for connected care. Prior to joining Takeda, Walt was a Senior Partner with CSC Consulting where is was known as a leader in Data. In 2010, Walt conducted a special research project for CSC’s Leading Edge forum to look at the future of data. His 2011 report, “Data rEvolution,” foreshadows the explosion in Data Analytics that we all see today. Walt received his Ph.D. in neuroscience from the University of Pennsylvania where he conducted Vision Research and studied brain physiology and microcircuitry.
Entrepreneur in Residence - Tech Accelerator
University of Cincinnati
Data & Analytics Leader
The Christ Hospital Health Network
Director, Division of Digital Health, Office of Science of Technology
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 responsible for providing leadership, development, implementing, execution, management and setting strategic direction and regulatory policy and coordinate scientific efforts for digital health, software and emerging technologies.
This includes responsibilities in leading the development on policies for mobile health, health information technology, cyber security, medical device interoperability, and medical device software.
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). The concepts, principles and vocabulary created in harmonized regulatory framework has been used as a foundation in the European union, Japan, Canada, Brazil, Australia and USFDA.
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 effort for the agency in developing an innovative software precertification program in collaboration with all stakeholders to reimagine a regulatory approach for Digital health that that aims for patients and providers to have timely access to safe and effective digital health products.
Prior to joining FDA, Mr. Patel held key leadership positions in the telecommunications industry, semiconductor capital equipment industry, wireless industry and information technology industry. His experience includes Lean Six Sigma, creating long and short-term strategy, influencing organizational change, modernizing government systems, and delivering high technology products and services in fast-paced, technology-intensive organizations. 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.
Director, Xavier Health
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.
Account Executive – Life Sciences
Siemens PLM Software
Nick joined Siemens PLM in 2016 and is responsible for driving Digital Enterprise for Life Sciences companies; connecting a model-based Digital Twin with a collaborative Digital Thread.
Prior to Siemens, Nick managed the Safe Skin clinical program and patient support surfaces portfolio at Hill-Rom, using analytics and technology to help reduce “never events” in the hospital setting.
Earlier in his career, Nick worked for Siemens Industry in various marketing, strategy and analytics positions across the Digital Factory business.
He has an M.B.A. from Xavier University and B.S. in marketing and management from University of Cincinnati. He is active in Xavier Health programs including the CPQA team.
Vice President, Technology and Regulatory Affairs
Zach Rothstein is Vice President for Technology & Regulatory Affairs at the Advanced Medical Technology Association (AdvaMed). In this position, Zach advocates for medical device regulatory policies that are transparent, predictable, consistent, timely, and science-based, with an emphasis on U.S. Food and Drug Administration (“FDA”) and legislative activities. Zach’s particular areas of focus include digital health, medical device software, cybersecurity, labeling, and postmarket surveillance.
Prior to joining AdvaMed, Zach was Deputy Senior Counsel for Public Policy at Samsung Electronics where he was responsible for the company’s medical device and healthcare regulatory and policy issues. In this position, Zach counseled Samsung’s global business units through all stages of product development on U.S. regulations affecting digital health, Health IT, and medical devices. Zach also planned and executed the company’s FDA and healthcare regulatory and legislative policy objectives. While at Samsung, Zach served on the Board of Directors for the Personal Connected Health Alliance (formerly Continua) and the Consumer Electronics Association’s Health and Fitness Technology Division.
Prior to joining Samsung, Zach was an Attorney in the FDA and Healthcare practice at the law firm of Morgan, Lewis & Bockius LLP. In this role, Zach served as outside counsel to various healthcare companies on FDA and HHS regulatory, compliance, and enforcement matters.
Zach earned his J.D. from The Catholic University of America, where he was a Notes and Comments Editor of the Law Review, President of the Moot Court Board, and won first place and best brief awards at the 2009 National Telecommunications Moot Court Competition. Zach received his B.A. in political science and criminal justice from Indiana University, Bloomington.
Zach is an active member of the Food and Drug Law Institute, teaches an introduction to FDA law class at the Johns Hopkins University, and was recognized by i3 magazine as a digital health and fitness innovator.
AI Research Technologist
Michael is a Technical Evangelist providing vision and leadership through transformational AI initiatives. His experience in supply chain, manufacturing and services is foundational in communicating that contextualized analytics is key to #datamonetization. Michael’s passion is demonstrating real-world scenarios with the Dell SupportAssist Intelligence Engine to explain that predictive and proactive AI platforms running at the “speed of thought” are feasible for every industry. Michael has been granted 12 hardware and software patents in eight countries.
Danny Tobey is a medical doctor and software entrepreneur who represents life sciences, technology and healthcare clients in all manner of disputes, from tort and contract claims to regulatory and patent cases. He also advises life sciences companies and funds as outside general counsel. In 2019, Danny received a Burton Award from the Library of Congress recognizing "the best of the best writers in the legal profession" among the nation's top 1,000 largest law firms.
A graduate of Harvard College, Yale Law School, and UT Southwestern Medical School, Danny has litigated successfully some of his clients' most challenging and important cases. He designed the winning scientific case in the first Hatch-Waxman suit in the Eastern District of Texas. He obtained a unanimous reversal in federal appellate court in an R&D tax case of first impression, leading to a highly-cited published opinion and increasing his clients' tax refund from low-six to high-seven figures. He has successfully handled as lead counsel litigations arising from M&A transactions for a molecular diagnostics company and others. He has represented healthcare and hospital clients in matters ranging from credentialing and internal investigation to peer review and business tort claims.
Founder, President and CEO
Mark is a consultant with PwC's Health Industries Advisory practice based out of the San Francisco, CA, office. He has experience working with pharmaceutical and medical device companies to complete programs in quality system design and implementation in the U.S., India, and Ireland, post-merger integration, deals due diligence, and organizational assessments. Mark joined PwC with a background in neural engineering and clinical radiology laboratories. Mark holds a bachelor of science in biomedical engineering and a master of science in biomedical engineering from the University of Southern California.