Commentary: where and how could biomarkers be used in 2016?

Since the beginning of the human genome project there has been considerable speculation about how this resource and the knowledge creation it enabled would change therapeutic discovery, development, and delivery. As the project neared completion, considerable claims and predictions were made about the changes that soon would be forthcoming. Many of these early predictions failed to materialize, however, leading to further speculation about the reasons, including the role of the pharmaceutical industry in realizing the promise of "genomic medicine." During this same period, considerable strides were made in other areas of molecular biology and medicine, and in response scientific thinking naturally evolved. Researchers and regulators moved from a genotype-centric view to a view that all biomarkers are potential tools to improve drug development and therapeutic decision making. Molecular biology is now seen as encouraging more "personalized medicine"-the closer alignment of biological information (derived from molecular diagnostics) and therapy selection. Meanwhile, there are growing concerns that increasing expenditures in pharmaceutical research and development are not sustainable and not reaping sufficient gains for shareholders or society at large. Thus, there is new speculation about how biomarkers, personalized medicine, and the industry will interact and create value for patients. This overview seeks to explore the issues driving pharmaceutical productivity and the likely contribution of biomarkers in the future.

Integrating genomics technologies in health care: practice and policy challenges and opportunities.

To consider broadly the potential impacts of new genetic technologies on clinical practice, a conference was convened at the Banbury Center of the Cold Spring Harbor Laboratories. Stakeholders from all sectors (industry, academia, basic and applied research, clinical genetics, medicine, law, patient advocacy, bioethics, and policy and regulatory) were brought together to explore areas of agreement and disagreement on how best to foster these changes and to guide future deliberations. We first examined the current state of technology development and potential applications. Next, current genetic applications in medicine were reviewed with the goal of identifying lessons learned and practices that can be applied to new applications. Last, the group explored regulatory and policy environments necessary for translating new technologies and knowledge into practice. We sought to better define and facilitate the necessary interaction between research, application, and policy and regulation. This perspective provides a summary of the collective thinking that emerged and a tool to identify issues for consideration and aid future discussions.