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Hayes D.F.,University of Michigan | Allen J.,Friends of Cancer Research | Compton C.,Critical Path Institute | Gustavsen G.,Health Advances | And 9 more authors.
Science Translational Medicine | Year: 2013

Despite prodigious advances in tumor biology research, few tumor-biomarker tests have been adopted as standard clinical practice. This lack of reliable tests stems from a vicious cycle of undervaluation, resulting from inconsistent regulatory standards and reimbursement, as well as insuf cient investment in research and development, scrutiny of biomarker publications by journals, and evidence of analytical validity and clinical utility. We of er recommendations designed to serve as a roadmap to break this vicious cycle and call for a national dialogue, as changes in regulation, reimbursement, investment, peer review, and guidelines development require the participation of all stakeholders. Copyright © 2013, American Association for the Advancement of Science. Source


Miller I.,bioMerieux | Pothier K.,Health Advances | Dunn M.,Health Advances
Personalized Medicine | Year: 2010

Multiple stakeholders play a role in the adoption of personalized medicine, including payers, patients, policy makers, diagnostic manufacturers and providers, and clinicians. These stakeholders span multiple positions, institutions and points of view, and are interested in making sure that each diagnostic launch covers a particular, sometimes contradictory, market need. A growing number of advocacy groups have emerged to unify these stakeholders in this increasingly complex marketplace. This perspective will identify examples of these advocacy efforts in personalized medicine today. It will discuss how far these groups have been able to go, what they are currently pursuing and how they and others can continue to work to move personalized medicine from concept to reality. © 2010 Future Medicine Ltd. Source


Pothier K.,Health Advances | Gustavsen G.,Health Advances
Personalized Medicine | Year: 2013

We are entering an era of unprecedented complexity in personalized medicine. Therapeutic targets, biomarker detection technologies, regulatory and reimbursement pathways, and commercialization strategies have all reached new levels of intricacy. These complexities are occurring in the context of the current economic environment, in which outsourcing offers a way for innovators to decrease large internal investment. These factors combine to create a perfect setting for a partnership explosion. Now, and as we move into the future, it will be critical for innovators to access outside expertise with a diverse set of partners in order to bring novel personalized medicine products to the market successfully and economically. Only companies that truly embrace this trend and adopt a collaborative approach will emerge successful. © 2013 Future Medicine Ltd. Source

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