-
Development and Regulatory Challenges for Drug-device Combination Products*
Tuesday, November 13
8:30 am – 11:00 am
Symposium
ACPE #073-999-07-577-L04
Traditionally, pharmaceutical devices are developed as diagnostic products, surgical aids and replacement organs such as heart valves and replacement joints. Also devices such as metered dose inhalers and pre-filled syringes are used in drug delivery. Due to the advancement of medical and pharmaceutical science/technology, modern devices are combining the device and drug delivery technologies to offer better treatment options for complicated disease conditions. One example of this is the drug-eluting stents. From a pharmaceutical development perspective, such combination products pose a number of significant technical and regulatory challenges because of complex science and technology as well as lack of clear regulatory guidance. The purpose of this symposium is to discuss the developmental and regulatory challenges both from the industry and regulator’s perspectives. Case studies may be included to illustrate the nature of the challenges and how they were overcome.
Moderators
Nirdosh K. Jagota, Ph.D.
Wyeth Pharmaceuticals
Prabu P. Nambiar, Ph.D.
Cubist Pharmaceuticals
Development Challenges in Drug-device Combination Products: Industry Perspective
Semih Oktay, Ph.D.
CardioMed Device Consultants, LLC
Regulatory Challenges in Developing Drug-device Combination Products: Industry Perspective
Steven R. Koepke, Ph.D.
SRK Consulting, LLC
Regulatory Challenges in Developing Combination Products: FDA Perspective
Patricia Love, M.D.
U.S. Food and Drug Administration
Regulatory Challenges of Drug-device Combination Products: FDA Perspective
Ashley Boam, Ph.D.
U.S. Food and Drug Administration
*Session tentatively scheduled to be recorded.
Back to Top