Scientific Publications by FDA Staff

AAPS J 2014 Jul;16(4):698-704

Nanomedicine drug development: a scientific symposium entitled "charting a roadmap to commercialization".

Finch G, Havel H, Analoui M, Barton RW, Diwan AR, Hennessy M, Reddy V, Sadrieh N, Tamarkin L, Wolfgang M, Yerxa B, Zolnik B, Liu M

The use of nanotechnology in medicine holds great promise for revolutionizing a variety of therapies. The past decade witnessed dramatic advancements in scientific research in nanomedicines, although significant challenges still exist in nanomedicine design, characterization, development, and manufacturing. In March 2013, a two-day symposium "Nanomedicines: Charting a Roadmap to Commercialization," sponsored and organized by the Nanomedicines Alliance, was held to facilitate better understanding of the current science and investigative approaches and to identify and discuss challenges and knowledge gaps in nanomedicine development programs. The symposium provided a forum for constructive dialogue among key stakeholders in five distinct areas: nanomedicine design, preclinical pharmacology, toxicology, CMC (chemistry, manufacturing, and control), and clinical development. In this meeting synopsis, we highlight key points from plenary presentations and focus on discussions and recommendations from breakout sessions of the symposium.