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How real-world research can streamline post-marketing studies in oncology

The complexity of post-marketing requirements (PMRs) and commitments (PMCs) in oncology is growing as many drugs are approved using an expedited program. This puts increased strain on an already stretched clinical research ecosystem, with most common approaches to satisfy PMR/PMCs resulting in inefficient use of valuable research resources and delays in meeting regulator deadlines. Real-world research approaches are well-suited to support or fulfill several categories of PMR/PMCs, bridging the gap between care and research and help advance post-marketing approval research.

In this webinar, experts from the Reagan-Udall Foundation for the FDA, Flatiron Health, and Johnson & Johnson will:
  • Highlight the value of post-marketing studies and key frameworks for efficient and impactful evidence generation
  • Present an overview of PMR/PMCs in oncology and opportunities for real-world evidence generation approaches
  • Share examples of more pragmatic approaches to PMR/PMCs
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Ashita Batavia

Ashita Batavia

Head of Hematology Oncology, R&D Data Science & Digital Health, Innovative Medicine, Johnson & Johnson

Ashita S. Batavia, MD, MS is Head of Hematology & Oncology Data Sciences for Johnson & Johnson Innovative Medicine. She is an industry leader in using Data Sciences to accelerate drug development. She was previously at McKinsey & Co. where she counseled Fortune 50 executives on precision medicine and using advanced analytics to drive impact. Dr. Batavia is an Assistant Professor at Weill Cornell Medicine and has been a practicing physician for over 15 years. She has received numerous research awards and has multiple peer-reviewed publications. Dr. Batavia is passionate about using data and technology to improve the health of patients.

Neal Meropol

Neal Meropol

VP, Research Oncology, Flatiron Health

Neal Meropol, MD is a medical oncologist, clinical investigator, outcomes researcher and health tech executive. At Flatiron, he oversees the clinical teams supporting retrospective and prospective evidence generation, providing scientific and clinical leadership in leveraging Flatiron’s technology platforms to close the gap between research and clinical care. He is the current co-chair of the NCI Streamlining Clinical Trials Working Group, and previously served as chair of NCI Clinical Trials and Translational Research Advisory Committee (CTAC), and as a member of the American Society of Clinical Oncology (ASCO) Board of Directors.

Prior to joining Flatiron, Dr Meropol was Professor and Chief of the Division of Hematology and Oncology at University Hospitals Cleveland Medical Center and Case Western Reserve University, and Associate Director for Clinical Research at the Case Comprehensive Cancer Center.

Daniel Sanchez

Daniel Sanchez

Associate Director, Oncology Data Science & Digital Health, Johnson & Johnson Innovative Medicine

Daniel Sanchez serves as an Associate Director in the Oncology Data Science & Digital Health group at Janssen Pharmaceuticals. He joins most recently from Komodo Health where he was Head of Data Strategy, overseeing data acquisition and contract/data use rights negotiations. Prior to Komodo Health, Daniel led the healthcare sector of a quantamental proprietary research team at Point72 Asset Management. He has also worked in sell-side equity research on Wall Street covering specialty biopharmaceuticals and a healthcare economics data and technology company which was acquired by Decision Resources Group.

Carla Rodriguez-Watson

Carla Rodriguez-Watson

Director of Research, Reagan-Udall Foundation for the FDA

Carla Rodriguez-Watson, PhD, MPH, is an epidemiologist and health services researcher currently serving as the Director of Research for the Reagan-Udall Foundation for the FDA. The Foundation is focused on continuously developing and enhancing a portfolio of work that leverages real-world data and experiences to inform and conduct clinical and post-market drug safety and effectiveness studies. Projects include those focused on developing and advancing frameworks and tools to systematically describe data sources and methods for use in pre- and post-market studies of product safety and effectiveness; as well as the Innovation in Medical Evidence, Development and Surveillance (IMEDS) Program – where such tools can be leveraged and tested for regulatory and non-regulatory studies. Carla brings her extensive background in public health surveillance, health outcomes research, and pharmacoepidemiology to this work.

Matt Reynolds
moderator

Matt Reynolds

VP, Scientific Engagement, Flatiron Health

Matt Reynolds, PhD is an epidemiologist who has been in the pharmaceutical and consulting arena for 24 years with expertise in real-world data and its fitness of use for pharmaceutical needs. At Flatiron, he works closely with biopharma customers to understand their unique oncology evidence needs, scope and define scientific solutions tailored to address these goals, and advance Flatiron's capabilities in Evidence Solutions.