Biopharmaceuticals (includes Biologics)
Finding innovative and meaningful ways to interact with regulatory bodies outside of the traditional IND/NDA pathway is challenging. Yet drug companies, advocacy organizations, academic groups, public-private partnerships and other collaborative groups often want to pursue meaningful interaction with regulators to expedite and improve drug development without focusing on approval of a specific medicinal product. FDA is also supportive of these collaborative efforts to expedite and increase innovation and efficiencies in the drug development process. Regulatory professionals are often called upon to suggest ways in which this regulatory interaction and input can be obtained within these precompetitive frameworks, and can help fill this need by providing their teams with information on the alternative ways to engage with FDA and EMA through advancing the regulatory science of DDTs. Examples of such interactions include pursuing qualification of clinical outcome assessments or prognostic biomarkers for use in clinical trials or fit for purpose endorsement of modeling based projects that enhance enrollment and design of clinical trials. Attendance and participation in this session will provide regulatory professionals with the knowledge needed to explain the concepts, processes, resources and timelines associated with regulatory outcomes for innovative tools. Enhanced knowledge of opportunities to engage in regulatory science based projects positions regulatory professionals to lead regulatory strategy within collaborative frameworks and to facilitate decision making on the pros and cons of such approaches.