Our AI Summit Core Team is made up of the following FDA and industry experts:
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.
Manager, Data Integration and Data Management
The Christ Hospital
Hima Chalasani has more than 15 years of IT experience in the Healthcare, Technology and Manufacturing industries. She is the Manager of the Data Integration & Data Management teams at The Christ Hospital Health Network. In this position, Hima oversees the development and implementation of a successful Clinical and Business Intelligence program, which relies on an effective Data Management, Data Integration and Interoperability strategies. Her focus is enabling data access combined with AI and Analytics which empowers clinicians and patients towards better health care delivery. She has a Master's Degree in Health Information Management.
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.
Paul is a co-founder and managing partner of Sphaeric.ai, a data science company which offers a full suite of capabilities ranging from business intelligence to AI modeling and deployment. Paul is experienced in working with clients in both the private and public sectors analyze, model, and deploy smart solutions with their data that fit their business needs.
Prior to co-founding Sphaeric.ai, Paul worked for management consulting firm Grant Thornton in Washington, D.C., as a data scientist. Paul has a strong background in statistics and machine learning which he developed while obtaining a master’s degree from Georgetown University, and has expertise in developing modern cloud-based solutions to building and deploying AI models.
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.
Kumar Madurai has over 35 years of IT experience in Life Sciences, Healthcare, and Manufacturing environments. He currently works for CTG as a Principal Consultant and a Solutions Manager, responsible for advising clients on strategic planning and selection of technology and infrastructureand for developing and implementing custom solutions to solve today’s complex business problems. He has experience designing, developing, and implementing ontology-based solutions using advanced semantic technologies for predictive quality assurance and knowledge engineering by linking enterprise data from multiple structured and unstructured data sources.
As Data Scientist for the Medical Informatics Products team, he has used exploratory data analysis and applied machine learning algorithms for population health predictive analytics using claims and clinical data. He is currently working on his PhD at University at Buffalo, with the focus of his research on the use of blockchain in healthcare. Prior to joining CTG in 2009, he spent 25 years at Fisher-Price/Mattel, serving as Director of Technology group leading applications, infrastructure and technical teams.
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.
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.
Data & Analytics Leader
The Christ Hospital Health Network
Goverdhan Pallerla is a Data & Analytics Leader at The Christ Hospital Health Network. He has a Master of Science degree in Health Informatics and is a certified Project Management Professional (PMP). He comes with an extensive experience in Professional Services delivering Information Technology services across multiple business sectors. Goverdhan leads the Analytics Center of Excellence at TCHHN formed with a mission to transform the network into a data-driven organization, facilitating and promoting the use of analytics to achieve business objectives across the enterprise through adaptive governance.
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 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.
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.
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.
Cincinnati Children's Hospital Medical Center
Dan Santel is a biomedical informatics Research Fellow at Cincinnati Children’s Hospital, researching applications of artificial intelligence in healthcare with Dr. John Pestian. After receiving his Ph.D. in high energy physics at the University of Cincinnati in 2013, he worked at Certica Solutions (née Cincinnati-based Academic Benchmarks) using AI to help academic publishers match materials to state education requirements. From there, he joined Dr. Pestian’s team at Cincinnati Children’s. Amongst other things, the Pestian research group is currently developing an iPhone app that detects suicidal language in spoken conversations. Dan's current research includes the use of AI and natural language processing in identifying other psychiatric disorders from conversational language.
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.
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.