Beyond the EHR: Clinical Trials in the Age of Abundant Data

Michael Ibara, PharmD, Chief Data Officer, Elligo Health Research®

Michael Ibara has more than 20 years of experience in clinical research and development. Throughout his career, Ibara has sought to improve healthcare by bringing together healthcare data and digital technologies. His interests include regulatory and policy implications for digital healthcare, exploring the factors needed to allow interoperability of healthcare data for all stakeholders involved and implications for the use of big data, machine learning and natural language processing to improve our ability to perform regulated clinical research.

Before joining Elligo, Ibara was the Head of Digital Healthcare for the Clinical Data Interchange Standards Consortium (CDISC). There, he led the US Food and Drug Administration (FDA) eSource project and Healthcare Link efforts with registries, clinical trials and mobile health to enable use of real-world data from healthcare for regulated research and decision making. Prior to CDISC, Ibara was Head of Business Development Coordination and Innovation and also Head of Pharmacovigilance Innovation at Pfizer, where he worked for 15 years in various positions, leading implementations of global systems and large-scale technologies.

Michael R. Fronstin, Global Head of Clinical Research and Consulting, Cerner Enviza

Michael joined the organization in 2005 and currently leads the Clinical, Regulatory and Safety team at Cerner Enviza formerly Kantar Health. Michael’s team is responsible for delivering high quality, regulatory grade work to support pre/peri approval clinical research and post approval safety surveillance. The Clinical, Regulatory and Safety team also leads the global Harm Reduction partnerships and separately, Public Health partnerships in Germany. In addition to overseeing the global team, Michael’s accountable for supporting corporate development and product innovation.

Michael’s prior roles include Global Head of Offer and Innovation, General Manager of the Real-World Evidence Group, Chief Operating Officer and Head of Lifesciences Business Development. As a result, Michael brings broad and deep experience related to global clients, P/L portfolio management and operations.

He has broad experience in the healthcare industry. Prior to joining Cerner Enviza, he held various leadership roles spanning industry, payor and consulting organizations.

Michael is a member of the Cerner Enviza Leadership Team and is proud to serve as a board member for International Gardian Limited.

Michael earned a Master of Business Administration from the University of Miami with a certification in healthcare administration. He has a bachelor’s degree in sociology from the State University of New York at Albany.

Seth Hopkins, PhD, Executive Director Translational Medicine, Sunovion Pharmaceuticals Inc.

Seth Hopkins, PhD, is Executive Director Translational Medicine at Sunovion Pharmaceuticals Inc. In his work at Sunovion, he has led and advanced new treatments for CNS disorders from discovery through to regulatory submissions. Prior to his role in translational medicine, Seth has served in a variety of roles including computational chemistry, pharmacology, preclinical and clinical development. During his tenure, he has  advanced programs through clinical development applying clinical pharmacology, experimental medicine, neuroimaging, modeling and simulations. At Sunovion his current research interest is in the application of advanced mathematics and analytics to improve the efficiency of clinical development of breakthrough treatments for psychiatric disorders. Seth was a key contributor to the initiation, clinical development and submission of INDs and NDAs in psychiatric indications.

Seth completed his postdoctoral training at University of California San Francisco and his PhD in biophysics from the University of Pennsylvania.

Doug Lee, Vice President, Operations and Chief Data Officer, Harris Computer

With over 20 years’ experience in business, technology and innovation leadership, Doug Lee has emerged as a change agent. Through precise strategy and dynamic culture development, Doug has demonstrated the ability to help businesses weaponize their data to drive top line growth and profitability.

In his role as Vice President, Operations and Chief Data Officer, Doug is responsible for data strategy, data commercialization, innovation and operational excellence.  He is active in related professional organizations, serving on various boards within the private and public sectors.