A key question at the end of a company’s pivotal trial is, “Did we make our endpoints?” While demonstrating safety and effectiveness important, sponsors may be missing an even more important question. That is, “Does the benefit outweigh the risk?” The FDA guidance on Factors to Consider When Making Benefit-Risk Determinations in Medical Device Premarket Approval and De Novo Classifications provides clear direction from FDA on the framework for assessing benefit-risk.
Developing key benefit-risk messages and communicating them effectively are critical in marketing applications, advisory panels and technology assessment committees. A thorough benefit-risk assessment is the foundation for the messages surrounding unmet need, proposed indication, patient population, clinical trial results and broader clinical application. Importantly, these data can provide the cost-benefit evaluation to make reimbursement decisions. The FDA framework considers factors such as the type, magnitude, duration, and probability of benefits; the nature of adverse events and device complications; disease characteristics; patient tolerance for risk; and the availability and benefit-risks of alternative therapies.
Using real-world examples, this presentation provides practice examples for each of the factors that contribute to a positive benefit-risk assessment. It will teach you how to communicate these assessments in marketing applications, and advisory panel presentations.
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Learning Objectives: Upon the presentation’s conclusion, you should be able to:
- Identify the factors that comprise the benefit-risk assessment
- Develop key messages necessary to communicate a positive benefit-risk
- Tailor the benefit-risk messages to each key audience: FDA, advisory panel, payer, patient and health-care-practitioner
Jamie Waterhouse Page, MBA, 3D Communications
Jamie is a project manager at 3D who combines her experience working at FDA and in industry to help clients prepare for FDA meetings. Before joining 3D, Jamie spent seven years at FDA’s Center for Devices and Radiological Health (CDRH). At CDRH, she held positions as: a Lead Reviewer in the Division of Cardiovascular Devices; a Project Manager in the Division of Neurological and Physical Medicine Devices; and a Designated Federal Officer responsible for coordinating Advisory Committee meetings. Jamie has also been involved in a wide variety of other meetings between FDA and industry including Q-Submissions, Pre-IDEs, Early Feasibility Studies, Expedited Access Programs, and Appeals meetings. Previously, Jamie worked as a Field Clinical Engineer at a start-up medical device company. In this role, she was responsible for device programming and providing technical support during implantation and follow-up visits with patients enrolled in clinical trials. Jamie holds a Master’s of Business Administration, a Bachelor’s degree in Biomedical Engineering, and a Master’s Certificate in Project Management.
Todd Gross, PhD, 3D Communications
Todd has more than 25 years of experience in biostatistics and clinical development in the pharmaceutical and medical device industries. Todd uses his expertise in analysis and interpretation of clinical data, clinical study design, endpoint selection, and patient-reported outcomes (PRO) development and validation, to help clients prepare for FDA interactions and advisory committee meetings. Todd was head of biostatistics at Allergan Medical, Kythera, Medtronic Diabetes, and Boston Scientific Neuromodulation. He achieved regulatory approval and market adoption of more than a dozen drug and device products, and was involved in numerous successful advisory committee meetings. Todd has performed research in diabetes, obesity, dermatology, pain management, and audiology, as well as academic research in cognitive psychology and device usability. He has authored two dozen scientific publications on topics from diabetes to medical devices. Todd has a PhD from UCLA, and is currently an Associate Professor of Statistics at the University of California, Santa Barbara.
August 7, 2018
1:00pm - 2:00pm EST
Webinar instructions will be sent within 24 hours of the webinar.