Policy issues in the development and adoption of biomarkers for molecularly targeted cancer therapies : workshop summary

A Long-held Goal In Oncology Has Been To Develop Therapies That Target The Specific Abnormalities In Each Patient's Cancer Rather Than Simply Treating Cancers Based On The Tissue Of Originches In The Past Decade, Advances In Technology Have Enabled Researchers To Relatively Quickly And Inexpensively Determine, In Minute Detail, The Genetic Makeup Of Tumors. Although Relatively Few Targeted Cancer Therapies Are Currently Available In The Clinic And It Is Not Yet Clear Whether All Cancers Are Driven By Genetic Changes That Can Be Targeted, There Is Widespread Optimism In The Cancer Community That This New Ability To Assess The Genetic Abnormalities In Tumors Will Ultimately Lead To Better Cancer Treatments And Improved Patient Outcomes. Policy Issues In The Development And Adoption Of Biomarkers For Molecularly Targeted Cancer Therapies Is The Summary Of A Workshop Convened In November 2014 By The Institute Of Medicine's National Cancer Policy Forum To Discuss Recent Trends In The Development And Implementation Of Molecularly Targeted Cancer Therapies And Explore Potential Policy Actions To Address Specific Challenges. This Report Highlights The Presentations And Discussions At The Workshop. Sharyl J. Nass, Jonathan Phillips, And Margie Patlak, Rapporteurs ; National Cancer Policy Forum, Board Of Health Care Services, Institute Of Medicine Of The National Academies. Title From Pdf T.p. Includes Bibliographical References. Issued Also In Print (xx, 85 Pages : Illustrations). This Project Was Supported By Contract No. Hhsn261200900003c And Contract No. Hhsn263201200074i (task Order No. Hhsn26300052) Between The National Academy Of Sciences And The Centers For Disease Control And Prevention And The National Cancer Institute/national Institutes Of Health, Respectively, And By The American Association For Cancer Research, The American Cancer Society, The American Society For Radiation Oncology, The American Society Of Clinical Oncology, The American Society Of Hematology, The Association Of American Cancer Institutes, Astrazeneca, Bristol-myers Squibb, The Cancer Support Community, C-change, The Ceo Roundtable On Cancer, Emd Serono, Helsinn Healthcare Sa, The Livestrong Foundation, The National Comprehensive Cancer Network, Novartis Oncology, The Oncology Nursing Society, And Sanofi Oncology. The Views Presented In This Publication Do Not Necessarily Reflect The Views Of The Organizations Or Agencies That Provided Support For The Activity. Mode Of Access: World Wide Web. "One of the challenges in treating cancer is the disease's complexity and variation among patients. Cancer manifests differently in each patient, so treatments that are effective in one patient may not be effective in another. As cancer care becomes more personalized, subpopulations of individuals will be given preventive or therapeutic interventions based on their susceptibility to a particular disease or their predicted response to a specific treatment. However, before the use of personalized cancer care can reach its full potential, the health care system must resolve a number of technological, regulatory, and reimbursement issues. To explore these policy challenges, the National Cancer Policy Forum held the workshop Policy Issues in the Development of Personalized Medicine in Oncology in June 2009. Experts provided presentations on the current state of personalized medicine technology, as well as issues in the validation of, regulation of, and reimbursement for the predictive tests that underpin personalized medicine. Participants discussed the obstacles and possible solutions to further developing and using personalized medicine technologies. This document summarizes the workshop"-- Publisher's description

A long-held goal in oncology has been to develop therapies that target the specific abnormalities in each patient's cancer rather than simply treating cancers based on the tissue of origin. In the past decade, advances in technology have enabled researchers to relatively quickly and inexpensively determine, in minute detail, the genetic makeup of tumors. Although relatively few targeted cancer therapies are currently available in the clinic and it is not yet clear whether all cancers are driven by genetic changes that can be targeted, there is widespread optimism in the cancer community that this new ability to assess the genetic abnormalities in tumors will ultimately lead to better cancer treatments and improved patient outcomes.

Policy Issues in the Development and Adoption of Biomarkers for Molecularly Targeted Cancer Therapies is the summary of a workshop convened in November 2014 by the Institute of Medicine's National Cancer Policy Forum to discuss recent trends in the development and implementation of molecularly targeted cancer therapies and explore potential policy actions to address specific challenges. This report highlights the presentations and discussions at the workshop.