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.
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.
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
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.
Director, Quality Data Sciences
Mark is the Director of Quality Data Science in the Quality Data Science group at Amgen, Inc. In this role Mark is responsible for the application of cognitive computing techniques such as natural language processing and machine learning on manufacturing and quality related data with the goal of unlocking insights and improving operations. Prior to this role, Mark was the Director of Quality Engineering (QE) responsible for statistical support for all areas within operations, including: delivery devices; commercial, clinical and contract manufacturing; analytical method; development, transfer, and validation; product stability; product commercialization; and product characterization
In addition to his QE role, Mark also served as the global network lead for the Product and Process Performance Network (PPP) which is charged with developing and improving the Continued Process Verification (CPV) procedures at Amgen and representing Amgen’s position on CPV externally.
Mark holds a M.S. in applied statistics from DePaul University and a B.S. in cellular biology from the University of Illinois. He is an American Society for Quality Certified Quality Engineer (CQE).
Cloud Solution Architect, Advanced Analytics & AI
Orrin has almost two decades of experience with analyzing, wrangling and curating data. Utilizing everything from embedded devices to clusters of servers to meet the needs of healthcare, financial services and retail organizations, Orrin built financial data solutions for the US Army as a civilian and then spent seven years with a global analytics company serving healthcare & retail customers. There he helped transform the data services organization from an IT cost center to the epicenter of value creation for the company utilizing automated processing, a global workforce, Hadoop, NoSQL and distributed computing platforms. After that, he spent a year with a large consulting firm helping healthcare, financial services, and manufacturing organizations with Hadoop, cloud, predictive analytics and other complex enterprise data solutions.
Since 2016, Orrin has been dedicated to helping healthcare organizations be successful with cloud solution deployments as an architect focusing on data warehousing, machine learning, advanced analytics and AI with Microsoft. With a distinct healthcare focus, he helps organizations extract more value from data while spending less by utilizing the cloud. Orrin has created and lead global technical teams across the US, Canada, UK, and India.
Professor of Anesthesiology, Surgery, Biomedical Informatics and Health Policy
Vanderbilt University School of Medicine
Dr. Jesse Ehrenfeld currently serves as Secretary of the Board of Trustees of the American Medical Association. He is a Professor of Anesthesiology, Surgery, Biomedical Informatics and Health Policy at Vanderbilt University School of Medicine. He divides his time among clinical practice, teaching, and research. He also serves as Director of Education Research for the Vanderbilt Office of Health Sciences Education, Director of the Vanderbilt Program for LGBTI Health, and Associate Director of the Vanderbilt Anesthesiology & Perioperative Informatics Research (VAPIR) Division.
In addition to his work with the AMA, Dr. Ehrenfeld has served on the governing boards of the American Society of Anesthesiologists Resident Component, the Massachusetts Medical Society and the Illinois State Medical Society. He also served as speaker of the house of delegates of the Massachusetts Medical Society for six years.
Born in Wilmington, Delaware, Dr. Ehrenfeld is a graduate of Phillips Academy, Haverford College, the University of Chicago Pritzker School of Medicine and the Harvard School of Public Health. He completed an internship in internal medicine, a residency in anesthesiology and an informatics fellowship at the Massachusetts General Hospital.
A combat veteran who deployed to Afghanistan during both Operation Enduring Freedom and Resolute Support Mission, Dr. Ehrenfeld continues to serve as a Commander in the United States Navy Reserve. He lives in Nashville, Tennessee, with his husband, Judd Taback, and enjoys photography, running and traveling.
Senior Director of Product
Patrick Hall is a senior director of data science products at H2O.ai, a leading AI company. Patrick works with H2O.ai customers to derive substantive business value from machine learning technologies and his internal product work at H2O.ai focuses on explaining complex automated decisions generated by AI and machine learning systems to business decision-makers.
Patrick is also currently an adjunct professor in the Department of Decision Sciences at George Washington University, where he teaches graduate classes in data mining and machine learning. Prior to joining H2O.ai, Patrick held global customer facing roles and R&D research roles at SAS Institute. He studied computational chemistry at the University of Illinois before graduating from the Institute for Advanced Analytics at North Carolina State University.
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.
Andrew is a co-founder of Sphaeric.ai, a data science company focused on bridging the gap between existing business processes and the promise of machine learning, data science and AI. With his team and co-founder at Sphaeric, Andrew works closely with business units in the insurance and health care industries to build and deploy custom AI solutions helping to catalyze organizational change and promote data driven decision making.
Andrew is an experienced problem solver and project manager with five years of railroad management experience and a background in quantitative analysis, BI and data science. He holds a bachelor’s of science degree in civil engineering from the University of New Hampshire and a master’s in public policy analysis from Georgetown University in Washington, D.C.
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.
Lawrence Berkeley National Laboratory
Jesse Livezey hold a Ph.D. in physics from the University of California at Berkeley and is currently completing his post-doctoral research at the Lawrence Berkeley National Laboratory. Jesse’s research involves using deep learning techniques to answer questions in neuroscience. In particular, Jesse has applied deep neural networks to predict speech syllables using neural data. In addition, Jesse contributes to open source deep learning libraries.
Vice President, Global Healthcare Business Development
BSI Group America
Bei Ma serves as a key thought leader in Global Healthcare Business Sector for the British Standards Institution (BSI) Group. Providing global insight, focus and vision, she explores, identifies and leads development of opportunities for BSI in this sector and ensures the alignment of strategies across BSI Global Matrix. Her broad-based thought leadership spans global regulatory affairs, global standards development, emerging technology and innovation, strategic planning, and public-private partnership.
She also serves as advisor in food safety and drug policy for Tsinghua University, China; scientific board member at the Organizing Committee and co-chair at IFPAC® Food Quality, Safety & Analysis Symposium and IFPAC® China.
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.
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 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.
Sundance Capital, LLC
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.
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.
Director, Health Solutions
Microsoft US Health and Life Sciences
Shawn Remacle is Director of Health Solutions for Microsoft US Health and Life Sciences and for the past 10 years has worked various industry market development positions supporting strategic engagements with enterprise/mid-market healthcare customers and industry partners. For the 10 years prior to working for Microsoft, Shawn was the Chief Information Officer at a multi-hospital, integrated health provider in North Carolina.
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.
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.
Portfolio Development Executive
Jeff Spencer helps companies use their data more effectively driving innovation and decision making throughout the total product lifecycle. Recent projects have focused on quality improvements for medical consumable products, improving operational global operational efficiencies and predicting device performance that drives the patient experience. In over 24 years with Siemens Jeff has also worked to help clients build business cases to justify process transformation, architect solutions and use the power of visualization as a tool for communication. Jeff is a graduate of Iowa State University and is active in Siemens efforts with the FDA to bring process innovation into the case for quality.
Program Manager, Case for Quality, Office of Compliance
Cisco Vicenty is currently 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 to increase focus on the quality and performance of medical devices.
Cisco began his career at FDA as a compliance officer in the Cardiac Rhythm and Electrophysiology Branch in the Office of Compliance at CDRH. He then worked as a project manager for the FDA’s Case for Quality initiative. Prior to his current role, Cisco was the Branch Chief of the Respiratory, E/N/T, General Hospital, and Ophthalmic Devices Branch in the Division of Manufacturing and Quality, within the Office of Compliance.
Prior to working with FDA, Cisco Vicenty was a Quality and Reliability Engineer with the Micro-Electronics Business Unit at IBM responsible for emerging server technology lines and network systems along with high volume gaming systems from Nintendo, Sony, and Microsoft.
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.
Executive Director, Quality Data Sciences
Dan is currently the Executive Director for Quality Data Sciences (QDS) at Amgen, Inc. QDS consists of Quality Data Sciences, Knowledge Management & Analytics, Global Quality Engineering (QE), Statistical Engineering, and Quality Excellence. Quality Data Sciences creates and maintains data science solutions that unlock Amgen data and leverage those data to efficiently provide insights and intelligence for the Quality Operation. Knowledge Management & Analytics owns & maintains the Knowledge Marketplace where experience-based knowledge is collected and used by all Amgen staff members. It also assists with visualization/interpretation of data science results. Global QE and Statistical Engineering complete all statistical requirements for product filings, provide statistical support for delivery devices/suppliers, complete product quality analyses for Annual Product Reviews and provides QE expertise to manufacturing sites and other functions that do not have QE support. Quality Excellence drives Lean QC in all Amgen laboratories, owns the Root Cause Analysis program and leads critical root cause analyses. In addition to leading QE and Operational Excellence groups at Amgen manufacturing site and corporate levels for the past 17 years, Dan has led multiple cross-company initiatives. For example, he led the development and implementation of Quality Risk Management, the Standardized Root Cause Analysis program and innovative graphical analysis approaches to resolve significant product investigations.
Prior to joining Amgen in 2000, Dan led an expansion consulting practice focused on Statistical, Technical and Information Services for Pharmaceutical and Medical Device firms, completed similar activities as an independent consultant and served for 12 years as an officer in the US Air Force. During his last four years in the Air Force, Dan was an Associate Professor of Mathematics at the US Air Force Academy and was the Outstanding Military Educator in Mathematics in 1992. As a seminar leader and college professor, he has educated over 2,000 students in all levels of mathematics.
Dan holds a M.S. in applied mathematics from Harvard University and a B.S. in Mathematics from the US Air Force Academy. He is co-author of Straight Talk on Designing Experiments and is an American Society for Quality Certified Quality Engineer (CQE).