• News

    President Douglas P. Kiel, M.D., M.P.H. Testifies at FDA Scientific Workshop on Osteoporosis Drug Development

    Date: November 11, 2015

     

     Dr. Kiel  Dr. Black

    President Douglas P. Kiel, M.D., M.P.H. testifies at FDA Scientific Workshop on Osteoporosis Drug Development.

    Dennis Black, Ph.D. presents
    update on FNIH Bone Quality Project.

    On November 4, ASBMR President Douglas P. Kiel, M.D., M.P.H. presented testimony during the Federal Drug Administration (FDA) Scientific Workshop on Osteoporosis Drug Development: Moving Forward.  Dr. Kiel’s testimony urged the FDA to simplify treatment indication language, allow for more flexibility in clinical trial design, and to consider evidence-based surrogate endpoints for fracture in clinical trials.

    Three sessions at the Workshop covered presentations from FDA and industry on osteoporosis treatment and prevention indication language and target population, osteoporosis clinical trial design, and the future of osteoporosis trials and surrogate endpoints for fracture. In the third session, FDA outlined the process to qualify biomarkers for potential approval as surrogate endpoints for fracture in clinical trials. Dennis Black, Ph.D. , PI for the FNIH Bone Quality Project which ASBMR is supporting, provided an update on the project’s study of potential biomarkers for qualification. The meeting highlighted the need and potential for ASBMR‘s key role in advancing the treatment of osteoporosis, closing the treatment gap and identifying new endpoints for clinical trials, one of ASBMR’s  four new strategic priorities. To read Dr. Kiel’s full testimony, click here. To view the agenda and materials for the FDA Workshop, click here.