OM1 Expertise

Leading life sciences companies trust OM1’s 20+ years of expertise, thought leadership, and unparalleled technology capabilities

OM1 experts have been leading best practices in registries and observational studies for decades, including the AHRQ Registries for Evaluating Patient Outcomes: A User’s Guide, now in it’s 4th edition.

OM1’s experts have extensive experience building study designs that use RWD, offering a potential tool for the efficient generation of RWE to inform regulatory decision-making.

Read: Using real-world evidence to support a changing paradigm for cancer screening: A commentary

Meet our Registries Expert

Richard Gliklich, MD

Dr. Richard Gliklich, MD is the CEO of OM1, Inc. Previously, he was founder and CEO of Outcome, which he led from inception through its acquisition by Quintiles.

Dr. Gliklich is well known in the areas of registries, outcomes and analytics. He is senior editor of the landmark publication by the U.S. Agency for Healthcare Research and Quality (AHRQ) handbook "Registries for Evaluating Patient Outcomes: A User's Guide” and the PI for the Outcomes Measures Framework, which focuses on standardization of outcomes measurement.

He has led several key national and international efforts focused on evaluating the safety, effectiveness, value and quality of healthcare. Dr. Gliklich also holds several patents for both health outcomes systems and medical devices.

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

Meet our Head of Healthcare Research & Policy

Michelle Leavy, MPH

Michelle is Head of Healthcare Research & Policy at OM1, where she oversees projects related to improving patient registry methodology, harmonizing data and outcome measures across patient registries, and using real-world data sources to understand treatment patterns and outcomes.

She leads a federally-funded effort to harmonize outcome measures across registries and clinical care to support depression research, and she previously managed efforts to develop harmonized outcome measures for use in patient registries under the Outcome Measures Framework (OMF) project. In addition, Ms. Leavy is the managing editor of Registries for Evaluating Patient Outcomes: A User’s Guide.

Meet our Integrated Evidence Generation Expert

Sonja Wustrack, MPH

Sonja Wustrack, MPH is the Managing Director of Integrated Evidence Generation at OM1, responsible for the design and execution of OM1 retrospective and prospective registries using networks and platforms. Sonja has over 20 years experience working in the Pharma/CRO space in various positions across Operations, Sales, Account Management and Strategy.

Prior to OM1, Sonja was at Verana Health where she led the Commercial Operations teams. Sonja spent a number of years in the CRO space, most recently at IQVIA, where she held a number of positions from Account Management, Demand Generation, Clinical Delivery and RWE offering development. Sonja has a MPH in Epidemiology from Tulane University School of Public Health and a BA in Biology from Vassar College.

Meet our RWE Research Expert

Kathryn Starzyk, ScM

Kathryn is the Vice President of Real World Evidence at OM1. Previously, she was the Senior Director of Epidemiology and Outcomes Research at Outcome (now part of the late phase division of IQVIA).

Prior to Outcome, she served as lead for safety and risk management for products from clinical development through to post-marketing, with particular expertise in rare diseases, biologics and gene therapy applications at Genzyme.

She has also held research positions at the NIH, Columbia and Harvard.

Kathryn is a graduate of Dartmouth College and the Harvard T.H. Chan School of Public Health.