Perspectives on Study Endpoints to be Shared at Global Conference, December 5-6 in Washington, DC

DIA, the premier professional community and knowledge exchange for global health care product development, announced today Dr. Janet Woodcock, Director, Center for Drug Evaluation and Research, US Food and Drug Administration (FDA) has been confirmed as a keynote speaker for DIA’s Advancing the Science of Study Endpoints conference, December 5-6 in Washington, DC. 

Dr. Woodcock will give a keynote address, Perspectives on Study Endpoints: Where Are We Now and Where Are We Going?, on Dec. 5, in which she will discuss the role and evolution of study endpoints in the current environment, and the future of study endpoints in a changing landscape of therapeutic advances and reimbursement schemes.

Study endpoints play a central role in the evaluation of the safety and efficacy of new drugs. For regulatory approval, the selection of an endpoint should represent a clinically meaningful benefit as a direct measure of how a patient feels, functions, and survives.  This year’s conference will examine global strategies for selecting study endpoints, and the impact of study endpoints during analysis of clinical evidence in the various types of drug approval processes. 

“We are thrilled to have Dr. Janet Woodcock speak at this year’s conference.  It is critical that our members understand the latest Agency initiatives and have the opportunity to interact with key regulators, address critical questions and help generate potential solutions to challenges associated with determining study endpoints and outcomes,” said Barbara Lopez Kunz, Global Chief Executive, DIA. 

To learn more about or to register for DIA’s Advancing the Science of Study Endpoints conference, visit DIAglobal.org/Endpoints.