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.
Senior Vice President, Global Quality, Technical Operations
Charlene is accountable for the global Quality function at Shire, a global biotechnology company focused on meeting unmet medical needs of patients with rare diseases and specialty conditions. In partnership with her colleagues at Shire, Charlene and her team provide a safe and ready supply of quality products and services to our patients and healthcare providers.
Charlene has more than 25 years in the biopharmaceutical industry bringing new products and technologies to fruition through robust team partnerships. Prior to joining Shire, she held leadership positions at Gilead Sciences, Cell Genesys and Chiron Corporation. She holds a Bachelor of Science degree in biochemistry from the University of California, Davis and a Masters in international business from Saint Mary’s College in Moraga, California.
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.
Director, Foundational Innovation
IBM Watson Health
Eric Brown is the Director of Foundational Innovation for IBM Watson Health. Eric is located at the IBM T.J. Watson Research Center in Yorktown Heights, NY. Eric's team is responsible for developing, piloting, and incubating advanced cognitive technologies for healthcare and life sciences, including big data, NLP, reasoning, and learning. Eric's team works closely with Watson Health offering management and development to incorporate advanced innovation and Research technologies into Watson Health Offerings.
Eric received his B.S. in computer science, summa cum laude, from the University of Vermont, and M.S. and Ph.D. in computer science from the University of Massachusetts, Amherst. Eric has been at IBM since 1995. Prior to moving to Watson Health, Eric was a scientist and director in the IBM Research division and a technical lead on the Watson Jeopardy! Grand Challenge project. Eric has conducted research and development in information retrieval, question answering, text analysis, and biomedical informatics. Eric was recognized by Adweek as one of the 50 Most Indispensable Executives in Marketing, Media and Tech in 2016, received the UMass CS Alumni Outstanding Achievement in Technical Development in 2015, and he and his team were awarded the AAAI Fiegenbaum Prize in 2013.
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.
Head of Small Molecule Operations
David has over 28 years of experience in the Pharmaceutical and Biotech Industries and has experience living and supplying medicines in Europe, the Middle East, Japan and the US. His experiences include roles working for Ciba Geigy, SPIMACO, Rhone Poulenc Rorer, Eli Lilly, and Genzyme in a variety of functions. He currently leads the supply chain organization for the Specialty Pharmaceuticals Division for Shire, based in Wayne, Pennsylvania and operates a fully outsourced supply model.
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.
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, 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.
Electrical Engineer, CDRH
Berkman Sahiner holds a Ph.D. in electrical engineering from the University of Michigan. He has been in the Health Care Industry for over 25 years, first as a faculty member at the University of Michigan Radiology Department for over 15 years, and since 2009, as a researcher with the Division of Imaging, Diagnostics and Software Reliability at the FDA.
He has led many projects as the PI of multiple grants, including grants from the NIH, U.S. Army Medical Research and Materiel Command, Office of Women’s Health at the FDA and the Critical Path at the FDA. He is an author/co-author of over 100 peer-reviewed journal publications and holds two international patents. He is an associate editor of Medical Physics and Technology in Cancer Research and Treatment Journals. He is the chair of American Association of Physicists in Medicine (AAPM) Computer Aided Detection in Diagnostic Imaging Sub-Committee.
His interests include computer-aided diagnosis, machine learning, image perception, clinical study design, and performance assessment methodologies.
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.
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.
Chief Technology Officer
Oliver Yu founded FDAzilla in 2010 on the belief that liberating data and information from the Food & Drug Administration provides significant value. He directs all technical aspects of the business, which includes data sourcing, software development as well as AI applications.
Prior to founding FDAzilla, Oliver worked in a data science role at Genentech, getting data out of factory control systems and analyzing large-scale cell culture data to increase yields and decrease process variability. He holds both a Master's in Chemical Engineering and a Bachelor's in Biological Engineering from Cornell University.
Program Manager, Office of Compliance
FDA – CDRH