Our AI Summit Core Team is made up of the following FDA and industry experts:
Kenneth Ashworth is an expert in clinical trial design, clinical data management and user experience. He is a co-founder and CEO at Bionometrix. Previously he was Founder & CEO at Kiev Biopharma, where he designed innovative MDx studies for Roche, Novartis, Myriad Genetics, Genentech, NCI and NIH. CEO at Green Media Group Ltd, and SVP at J. Walter Thompson. Kenneth was educated at Columbia University and the University of Cambridge.
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.
Bucks County Advisors, LLC
Anthony Barnes is a leading biotech executive and machine learning expert. Chief Science Officer, Bionometrix Inc, and Managing Director at Bucks County Advisors, LLC. He was previously a Founder & CEO at Oncimmune Inc, and SVP at Myriad-RBM. Anthony was responsible for the launch of numerous critical diagnostics products and team leader on several successful pharmaceutical launches. His most recent efforts have focused on how to interface human intelligence with machine intelligence. He has held executive positions at Ciba-Chiron, Lifescan/J&J, Abbott Laboratories Booz-Allen and PRTM. He received his M.B.A. at the University of Chicago and Ph.D. at the University of Illinois.
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.
IT Director - Pharmaceutical Development and Manufacturing Science
The Janssen Pharmaceutical Companies of Johnson & Johnson
Cindi Linvill 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 35 years of IT experience in Life Sciences, Healthcare, and Manufacturing environments. He currently works for CTG as a Principal Consultant and a Solutions Delivery Manager, responsible for advising clients on strategic planning and selection of technology and infrastructure and 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.
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. He is currently working on his Ph.D. in the healthcare area at University at Buffalo.
Head of Enterprise Analytics
Walt is the driving force for Data Analytics at Shire. His vision for an Enterprise Analytics Marketplace is unique to the industry and has positioned Shire to be a leader in Digital Health for rare diseases. The Analytics Marketplace allows all Shire employees that ability to analyze data to make data-driven decisions and integrate data into a model for connected care. Prior to joining Shire, 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.
Divisional Vice President Compliance and Operations Services
Agnes Ortega is Divisional Vice President, Compliance and Operations Services AQR/EHS. She assumed her role in June 2014.
Agnes has responsibility for establishing, implementing and maintaining strategies related to Global EHS, Quality Intelligence and Applications, Quality Operations and Global Compliance. This includes conducting evaluation of internal and external trends to assess risk to Quality and EHS Compliance for Abbott’s established and emerging markets; establishment and maintenance and development of corresponding IT solutions; execution ofGlobal Compliance Audits; and maintenance of AQR/GES Training and Documentation.
Agnes possesses 31 years of robust Quality Management experience in the Pharmaceutical and Medical Devices industry working for major firms such as Warner Lambert, Schering-Plough, AstraZeneca, which includes the successful implementation of remediation actions associated with Consent Decrees.
She earned a bachelor’s degree in biology from University of Puerto Rico, Rio Piedras.
Associate Center Director for Digital Health
Bakul Patel is a digital-health visionary and entrepreneurial leader focused on creating, shaping, and implementing national and international public health strategies. He has over 28 years of experience in leadership business development, marketing, product management, assessing long and short term needs, establishing objectives, improving organizational performance, and resource management.
Patel is an excellent collaborator, experienced in building effective cross functional teams by establishing and maintaining working relationships with diverse set of internal and external stakeholders. He has strong management, technical and regulatory skills in identifying, analyzing, managing, and solving highly complex issues, policies, procedures, federal regulations, and legislative matters in relation to Food Drug and Cosmetic Act. Patel has a detailed understanding of the regulatory infrastructure needed to balance regulatory requirements with national needs while developing policies and regulations.
He has expertise in medical device regulations, product development processes, software engineering, embedded systems, wireless communication systems, and robotics and control systems. Patel holds a master's degree in electronics engineering, M.B.A. in international business, Six Sigma, and Black-belt certified.
Director, Computational Medicine Center
Cincinnati Children’s Hospital Medical Center
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.
Associate Vice President, Technology and Regulatory Affairs
Zach Rothstein is Associate Vice President for Technology & Regulatory Affairs at AdvaMed. In this position, Zach advocates for medical device regulatory policies that are transparent, predictable, consistent, timely, and science-based. 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.
Prior to joining Samsung, Zach was an Associate Attorney in the FDA and Healthcare practice at the law firm of Morgan, Lewis & Bockius LLP.
Senior CPV Engineer
Matt Schmucki began working in the pharmaceutical industry in 2008 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 responsible for the West Chester site's Continued Process Verification Program. Matt is a graduate of the University of Cincinnati where he earned his B.S. in mechanical engineering. He later returned to also earn his M.B.A. as well as his M.S. in business analytics.
Technical Staff Technologist, Support & Deployment Services
Michael is a Technical Evangelist providing vision and leadership through transformational business intelligence and data science initiatives. His insights into supply chain, manufacturing and software services is foundational to his message that a proper perspective should be at the core of all data science and product performance analytics.
Michael enjoys taking the confusion out of Big Data and distilling complex concepts down to tangible examples. His passion for demonstrating real world scenarios of Dells SupportAssist Intelligence Engine, helps people understand that predictive and proactive Business Analytics running at the “Speed of Thought” are feasible platforms for all companies across multiple industry. Michael is an innovator with multiple patents spanning hardware and software methods such as Dell’s Reliable Memory Technology.