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  • Nanomedicines

    Addressing the Scientific and Regulatory Gap

    Nanomedicines

    Addressing the Scientific and Regulatory Gap

    Organizers: Raj Bawa (Bawa Biotech LLC; Rensselaer Polytechnic Institute), Scott E. McNeil (Nanotechnology Characterization Laboratory – Frederick National Laboratory for Cancer Research), Stefan Mühlebach (Vifor Pharma Ltd.; University of Basel, Switzerland), Melanie Brickman Stynes (The New York Academy of Sciences), and Melinda Miller (The New York Academy of Sciences)
    Keynote Speaker: Sally Tinkle (Science and Technology Policy Institute, IDA)
    Presented by the New York Academy of Sciences
    Reported by Don Monroe | Posted April 11, 2014

    Overview

    Nanomedicine is the application of nanotechnology to health care for the treatment, diagnosis, and monitoring and control of biological systems. Nanomedicines exploit the nanoscale manipulation of materials to improve medicine delivery, and researchers hope these technologies will enable breakthroughs in many disease areas, especially in cancer therapy. Several approaches have been proposed for delivering medicines using nanoparticles, with some success in the market. But the rapid development of these approaches has left both regulatory frameworks and scientific assessment tools struggling to keep up. On November 21, 2013, the Academy hosted a conference titled Nanomedicines: Addressing the Scientific and Regulatory Gap to identify barriers to realizing the promise of nanomedicines and to sketch solutions.

    In principle, it would be most efficient to set up one drug approval process that would apply in all countries. However, the very different legal frameworks in operation make such regulatory harmonization seem like a distant goal. Follow-on products illustrate especially well the challenges inherent in evaluating nanomedicines, but recent efforts may clarify the regulatory processes that are needed for nanodrugs. The conference featured four case studies of nanomedicines in different stages of development. Recurring requirements for successful development included robust manufacturing processes and sophisticated characterization tools.

    Use the tabs above to find a meeting report and multimedia from this event.

     

    Presentations available from:
    Yechezkel Barenholz, PhD (The Hebrew University Hadassah Medical School, Isreal)
    Raj Bawa, MS, PhD (Bawa Biotech LLC; Rensselaer Polytechnic Institute)
    Scott E. McNeil, PhD (Nanotechnology Characterization Laboratory – Frederick National Laboratory for Cancer Research)
    Stefan Mühlebach, PhD (Vifor Pharma Ltd.; University of Basel, Switzerland)
    Ritu Nalubola, PhD (U.S. Food and Drug Administration)
    Lawrence Tamarkin, PhD (CytImmune Sciences)
    Sally Tinkle, PhD (Science and Technology Policy Institute, IDA)


    eBriefing Sponsor

    • Non Biological Complex Drugs Working Group

     


    Presented by

    • The New York Academy of Sciences

     

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