With the implementation of PDUFA VI, the FDA is setting into motion a series of regulatory actions that will guide the future of drug development – and ultimately the success of approval and market access.
A key area of focus is making sure patients are involved in the overall process to review and approve new treatments. With the increasing power of the patient voice, it will be essential that developers demonstrate that their drugs are valuable to patients by integrating the patient perspective into early-stage drug development.
Those who are successful in answering this question will be better positioned to mitigate and avoid the risk of research gaps and unanswered needs when a compound gets to Phase III. They will also be better aligned with future FDA guidances.
Basic: Content is introductory in nature and requires no requisite knowledge or experience to grasp concepts and related exercises. Basic educational activities are meant to establish a foundation of knowledge and/or competence that will be expanded upon in practice or in higher level activities.
Upon the webcast's conclusion, you will be able to:
- Have an overview of the PDUFA VI patient focused initiatives;
- Understand the challenges and considerations facing developers, regulators, venture capitalist and angel funders; and
- Know best practices for integrating patient perspectives and communicating value in early drug development.
Who should attend
- Regulatory Professionals
- Clinical Development Professionals
- Senior Management
Eileen Fein, communications and advocacy specialist, 3D Communications, http://3dcommunications.us/bio/eileen-crowley/
Allison May Rosen, communications specialist, 3D Communications, http://3dcommunications.us/bio/allison-rosen/