WEBINAR: SURF screening tool to determine suitability of using real-world evidence – VIEW ON DEMAND
Free Webinar
SURF screening tool to determine suitability of using real-world evidence
View now on demand
SURFing the Waters of Real-World Evidence: A Suitability Assessment Tool
Join Laura Dormer (Editor, The Evidence Base) as she explores the US FDA’s regulatory approach to real-world data and non-randomized studies in product applications, and discusses the new publication, ‘SURF: A Screening Tool (for Sponsors) to Evaluate Whether Using Real-World Data to Support an Effectiveness Claim in an FDA Application Has Regulatory Feasibility.’
Attendees will hear from the Aetion authors of SURF and will learn more about:
- Key considerations outlined in FDA guidance for generating RWE of effectiveness to support applications and how these considerations are taken into account by the SURF screening tool.
- Applications of the SURF tool, showcasing retrospective application of the tool to publicly available use cases.
- Leveraging SURF to make an early determination of whether RWE may be a successful strategy for a given clinical development program so that resources may be allocated accordingly.
- Strategic uses of RWE to rationalize non-randomized pivotal evidence approaches and address other critical needs for optimized clinical development programs.
This webinar will offer attendees insights into the regulatory acceptability of real-world data and the practical application of the SURF tool, providing a concise overview of its construction and the types of evidence needed for successful real-world data integration in FDA applications. We will also discuss how to integrate the generation of this and other evidence into clinical development to help ensure resources are optimized and regulatory goals are met.
Speakers
Nicolle Gatto, PhD, MPH
Chief Science Officer, Aetion
Nicolle is an epidemiologist with more than 20 years of industry experience. She serves as a senior scientific voice ensuring appropriate and principled use of real-world data and real-world evidence, designing and communicating scientific frameworks, standards, and methodologies, and collaborating with stakeholders globally.
Before Aetion, Nicolle 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. Nicolle is Fellow of the International Society for Pharmacoepidemiology and an Adjunct Assistant Professor of Epidemiology at Columbia University and Tulane, teaching pharmacoepidemiology, causal inference, and confounding control methods courses.
Ulka Campbell, PhD, MPH
Head of Scientific Strategy, Aetion
Ulka Campbell is the Head of Scientific Strategy at Aetion. In this role, she provides methodological and regulatory expertise on studies across therapeutic areas and leads research to inform regulatory real-world evidence best practices. Previously, she was at Pfizer for 14 years working in the regulatory epidemiology group and later as the Head of Safety Surveillance Research at Pfizer.
Nicholaas (Nick) Honig, JD
Senior Regulatory Counsel, Aetion
Nicholaas Honig is a Senior Regulatory Counsel at Aetion. In this role he advises clients on regulatory approaches involving real-world evidence and analyzes FDA approval decisions to understand real-world evidence precedent. Prior to joining Aetion, Nicholaas worked at Pfizer in the company’s Chief Business Office. He also has practical experience with FDA’s Office of Chief Counsel and the Massachusetts General Assembly’s Joint Committee on Healthcare Financing.
What will you learn?
- FDA considerations for generating RWE of effectiveness
- Applications of the SURF tool
- Using SURF to make an early determination of RWE feasibility
- Strategic uses of RWE
In association with
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