From Promise to Reality: How AI Is Transforming Registries for Post-Approval Evidence Generation

Dr. Rich Gliklich is Founder and CEO of OM1, an outcomes and technology company focused on using deep clinical data and advanced analytics to measure and predict health outcomes for real-world evidence and value-based care. Rich was Founder and CEO of Outcome Sciences, a registries and comparative effectiveness company that served more than 2500 healthcare organizations and a majority of the global top 30 life sciences companies. Rich led Outcome for 13 years through its acquisition by Quintiles in 2011 and then stayed on at Quintiles through its 2013 IPO. After that, Rich joined General Catalyst Partners as an XIR focused on investments in healthcare companies until founding OM1 in 2015. Rich is PI and senior editor of the Agency for Healthcare Research and Quality (AHRQ)’s Registries for Evaluating Patient Outcomes: A User’s Guide, 1st - 4th editions. This is the worldwide reference document for understanding quality in real-world studies and registries. Rich is leading a U.S. government-funded effort to standardize health outcomes measurement across and within conditions called the Outcomes Measures Framework. Stakeholders for that effort include HHS, FDA, CMS, NIH, specialty societies, payers, and patient advocacy organizations. Rich holds patents in medical outcomes systems and devices, and multiple applications around the use of AI with medical data for real-world evidence and personalized healthcare.

Rich is a graduate of Yale University and Harvard Medical School and a former Charles A. Dana Scholar at the University of Pennsylvania. Rich is also a surgeon and is the Leffenfeld Professor at Harvard Medical School.

Michelle Leavy, MPH, is the Senior Director, Registries at OM1, where she oversees prospective observational studies and patient registries as well as projects related to improving patient registry methodology and harmonizing data and outcome measures across patient registries and clinical practice. Michelle was the managing editor of Registries for Evaluating Patient Outcomes: A User’s Guide, and she led a federally funded effort to harmonize outcome measures across registries and clinical care to support depression research. She previously managed efforts to develop harmonized outcome measures for use in patient registries under the Outcome Measures Framework (OMF) project. At OM1, she leads the Registry Center of Excellence, which provides internal and external consulting on observational study best practices. Michelle is a graduate of Columbia College and the UNC Gillings School of Global Public Health. Ms. Leavy is a recognized international expert in registry and longitudinal study design and operations.