Nanomedicine Drug Development: A Scientific Symposium Entitled “Charting a Roadmap to Commercialization”
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.
KeywordsActive Target Clinical Trial Design Mononuclear Phagocyte System Breakout Session Preclinical Pharmacology
The authors acknowledge the symposium presenters for sharing their data, case studies, and insights and the secretariat of the Nanomedicines Alliance for their excellent skills in organizing the symposium, for serving as scribes for breakout discussions, and for assistance in the preparation of this manuscript. The Nanomedicines Alliance Board of Directors critically reviewed this manuscript.
- 8.Prabhakar U, Maeda H, Jain RK, Sevick-Muraca EM, Zamboni W, Farokhzad OC, et al. Challenges and key considerations of the enhanced permeability and retention effect for nanomedicine drug delivery in oncology. Cancer Res. 2013;73(8):2412–7. doi: 10.1158/0008-5472.CAN-12-4561.PubMedCentralPubMedCrossRefGoogle Scholar
- 17.Casinghino S, Gauthier L, McClintok D, Boldenow E, Nauman C, Freeman G, et al. In vitro methods to predict immune-mediated toxicities of dextran-based nanomaterial precursors in rats. Toxicologist. 2009;108(1):178.Google Scholar
- 19.Stathopoulos GP, Antoniou D, Dimitroulis J, Michalopoulou P, Bastas A, Marosis K, et al. Liposomal cisplatin combined with paclitaxel versus cisplatin and paclitaxel in non-small-cell lung cancer: a randomized phase III multicenter trial. Ann Oncol. 2010;21:2227–32.PubMedCentralPubMedCrossRefGoogle Scholar