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This comprehensive resource covers product change evaluation, postmarket surveillance, audit/inspection compliance, and various other laws and regulations pertaining to maintaining a product on the market.
Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
This event is brought to you by:
According to an Aetion analysis, 78% of FDA’s decisions in 2020 included a real-world evidence (RWE) study to support safety and/or effectiveness—up from 53% in 2019. RWE continues to play a growing role in FDA decision-making, and as the agency iterates on its approach to using RWE, it has issued draft guidance to inform industry’s regulatory submissions.
Aetion’s team of scientific and regulatory experts have been tracking FDA’s use of RWE to date and collaborating with the agency and industry to inform standards on the role of RWE in regulatory decision-making. In this webcast, the experts at Aetion will explore FDA’s RWE guidance landscape, including how new draft guidance fits into the current ecosystem and the implications for biopharma organizations as they develop evidence generation strategies.
The panel discussion will be followed by a live Q&A.
Upon conclusion of the program, attendees will be able to:
Audience Learning Level: Intermediate: Content is designed based upon the assumption that individuals have basic knowledge of the topic(s) and/or demonstrated competence related to the topic(s). Higher-level concepts are introduced during lectures; exercises requiring synthesis and/or application of concepts are incorporated into the activity.
Nirosha Mahendratnam Lederer
Director, Real-World Evidence Strategy
Nirosha Mahendraratnam Lederer is an outcomes researcher with nearly 10 years of health services and policy research experience. She serves as director of real-world evidence (RWE) strategy at Aetion. Immediately prior, she was a managing associate at the Duke-Margolis Center for Health Policy. In this role, she led the Center’s RWE portfolio including the RWE Collaborative, a multi-stakeholder group of c-suite healthcare decision makers and leading scientists dedicated to advancing regulatory use of real-world evidence. During this time, she supported the COVID-19 Evidence Accelerator in designing the Remdesivir Parallel Analysis strategy. Previously, she served as a subject matter expert in the Oncology Center of Excellence at FDA, where she helped implement patient-focused drug development in cancer products, including clinical trial study design and product review. Lederer has also served in various roles at Avalere Health, Genentech and Bristol-Myers Squibb, and served on Capitol Hill during the passage of the Affordable Care Act. She received her PhD in health outcomes and policy from UNC Chapel Hill and her MSPH in health policy and management from Johns Hopkins Bloomberg School of Public Health..
Co-Founder & President
Jeremy Rassen is an epidemiologist and computer scientist with nearly 25 years of experience in the science and technology of big data. He is co-founder and president of Aetion, a healthcare technology company that delivers real-world evidence for life sciences companies, payers, and regulatory agencies. He leads the Aetion team in their scientific research collaboration with FDA, using advanced analytical techniques to answer questions about the use of diagnostics and medications for COVID-19, and risk factors for COVID-19-related complications. Prior to founding Aetion, Rassen was assistant professor of medicine at Harvard Medical School, where he focused on methods to improve the quality and validity of real-world data studies. Rassen also has worked at various technology companies, including Hewlett-Packard and Epiphany Inc. His focus was on high-performance software for the creation and analysis of large databases. He is a Fellow of the International Society for Pharmacoepidemiology. He received his masters and doctorate degrees in epidemiology from the Harvard T.H. Chan School of Public Health.
Nicolle Gatto, PhD, MPH
Chief Science Officer
Nicolle Gatto is an epidemiologist with 20 years of industry experience. In her role as chief science officer at Aetion, she serves as a senior scientific voice ensuring appropriate and principled use of real-world data/evidence, designing and communicating scientific frameworks, standards and methodologies, and collaborating with stakeholders globally. Prior to Aetion, Gatto was the group head for vaccines and oncology with the epidemiology group at Pfizer, providing strategic leadership, oversight of comprehensive epidemiology strategies to examine the safety of medicines, consultation on design of pragmatic trials and hybrid studies, and expertise on methods-related epidemiologic issues. She has designed and implemented primary and secondary data collection observational studies and pragmatic trials and has presented to and negotiated these studies with FDA and EMA. Gatto is Fellow of the International Society for Pharmacoepidemiology and an adjunct assistant professor of epidemiology at Columbia University and Tulane..
Lowell Schiller, JD
Chief Legal & Regulatory Officer
Lowell Schiller is the chief legal and regulatory officer of Aetion. Previously, Schiller served in several senior leadership roles at the US Food and Drug Administration (FDA), most recently as the principal associate commissioner for policy. In this role, he led FDA’s Office of Policy, managed agency-wide development of regulations and guidance and provided policy leadership on cross-cutting and high-profile issues across FDA’s jurisdiction. Earlier in his tenure at FDA, he served as acting chief counsel and as the senior counselor to the commissioner. Prior to FDA, Schiller served as senior counsel to Chairman Lamar Alexander on the Senate Committee on Health, Education, Labor, and Pensions (HELP). Earlier in his career, he was a litigator in private practice. Schiller clerked for the Honorable Jane R. Roth of the US Court of Appeals for the Third Circuit. He earned his law degree from Harvard Law School.
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