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.
Director, Office of Pharmaceutical Quality Operations, Office of Regulatory Affairs
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.
Senior Director of Product
Chief of Technology, Healthcare and Life Sciences
Director of the Office of Pharmaceutical Quality
Lawrence Berkeley National Laboratory
Head of EU
Lachman Consultant Services
David G. Lonza is Head of EU at Lachman Consultants. Mr. Lonza is a leader with significant regional and global management experience who understands the complexities involved in the international pharma industry. He has a successful track record building and directing organizations and is recognized as an exceptional leader with strong commitment to consensus management, team building, and people development. He is adept at developing long-term strategic plans, executing strategies, and handling crises.
David Lonza’s expertise includes servicing pharmaceutical/biopharmaceutical/biotech clients to meet international Regulatory challenges and Operational Readiness.
Fellow, Regulatory Science
Boston Scientific Group
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 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.
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.
Portfolio Development Executive
Program Manager, Office of Compliance
Cisco Vicenty is the Program Manager for the Case for Quality (CfQ) within the Office of Compliance, Center for Devices and Radiological Health (CDRH), FDA. This effort is part of the CDRH strategic priorities for 2016 and 2017. This strategic priority will improve access and outcomes for patients by engaging industry, payers, providers, and patients in order to increase focus on the quality and performance of medical devices.
Quality Head, Professional Services - Informatics & Analytics
Abbott Laboratories, Diagnostic Division
Mohammed has over 19 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.
Mohammed currently heads the Quality Assurance organization for a Professional Services 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.