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Thursday, April 25, 2024
12:30 PM - 1:30 PM EST

Applying Real-World Data: Use cases and FDA guidance

Achieving more pragmatic approaches to clinical evidence generation requires an understanding of potential approaches and regulatory acceptance of such approaches. This webinar will review recent FDA draft guidance regarding the use of RWD/RWE in medical device studies that outline approaches and considerations for more pragmatic research. The webinar will also delve into case studies of companies leveraging RWE, highlighting how each case accounts for regulatory guidance and acceptance. 

Sponsored by
Flatiron

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Josh Buddle

Josh Buddle

Director of Clinical Operations at Flatiron Health

Josh Buddle is the Director of Clinical Operations for Flatiron’s Clinical Research business where he is accountable for efficient and safe prospective study execution and operations across functional areas. Josh has been at Flatiron since 2017 and launched Flatiron’s first prospective real-world study in late 2019, leveraging novel clinical trial data acquisition and oversight technology. Prior to Flatiron, Josh created the Clinical Operations function at the Prostate Cancer Clinical Trials Consortium and was also a Regulatory Manager at MSKCC overseeing MSK’s portfolio of investigational new drugs in oncology. Josh has a bachelor's degree in psychology from the University of Colorado.
Tara Marti

Tara Marti

Clinical Development, Associate Director at Exact Sciences

Tara Marti is the Clinical Development Associate Director for Exact Sciences Precision Oncology business where she is a leader in evidence generation and product development strategy. Tara is passionate and a collaborative problem-solver who values the opportunity to think beyond the way things are. Tara developed the protocol for Exact Science's first prospective precision oncology clinical validation study. Before Exact Sciences, Tara was the research supervisor at Decipher overseeing the acquisition and processing of thousands of study samples and data to validate their prostate cancer prognostic signature. Tara is a certified molecular biologist and CAP inspector with a bachelor's degree in microbiology from the University of Wisconsin-La Crosse.
Jonathan Helfgott

Jonathan Helfgott

Program Coordinator, Senior Lecturer, Regulatory Science at Johns Hopkins University

Jonathan Helfgott is an FDA regulatory, clinical, and market access expert, specializing in the commercialization of medical products at all phases of development. As Co-Founder of Healthcare Innovation Catalysts, Inc Jonathan is responsible for overseeing global clinical research and regulatory activities, including overall product development, approvals, submissions, clinical trial design/conduct, inspections, and communications with health authorities and payors. In addition to his role at Healthcare Innovation Catalysts, Inc. Jonathan serves as Faculty, Senior Lecturer, and Coordinator for the MS in Regulatory Science & Food Safety Regulation Programs at Johns Hopkins University (JHU). Jonathan also serves as the Vice President of the Association of Graduate Regulatory Educators (AGRE) and has lectured extensively at various other academic institutions and professional organizations.

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