Advancing Precision Medicine

Precision medicine is an emerging approach for disease treatment and prevention that takes into account individual variability in genes, environment, and lifestyle for each person. Although significant advances in medicine have been made for selected cancers, the practice is not currently in use for most diseases.

To advance medicine, President Obama wants to establish the Precision Medicine Initiative with $215 million. The funding would go to NIH www.nih.gov/precisionmedicine, FDA www.fda.gov, and five million to the Office of the National Coordinator (ONC) for HIT www.healthit.gov. The plan is to pioneer a new model of patient-powered research to accelerate biomedical discoveries. ONC’s responsibilities would include developing interoperability standards and requirements related to privacy and the secure exchange of data across systems.

The Precision Medicine Initiative is going to provide clinicians with new tools, knowledge, therapies, and the ability to select the treatments that will work best for specific patients.

Support for this effort would include $130 million to NIH to develop a voluntary national patient powered research cohort to include one million or more volunteers to provide open and responsible data sharing to increase understanding of health and disease.

Each volunteer would share their genomic information and biological specimens. This information along with clinical data from EHRs will help researchers understand how genomic variations and other health factors affect the development of disease.

On February 11-12, 2015, NIH will be hosting the workshop “Building a Precision Medicine Cohort” www.nih.gov/precisionmedicine/workshop.htm online to hear leading experts from many disciplines and sectors discuss the opportunities and challenges around building a large research cohort focused on precision medicine. A presentation will be given on the “Million Veteran Program Cohort” which is an example of a successful large scale health system-based cohort.

Other presentations will discuss using mobile technologies to help people track and understand their health. Discussions will also take place on informatics requirements and EHRs, how to best aggregate and analyze data from heterogeneous EHR systems, and lastly, how to best provide data access and sharing but at the same time, be able to protect the data.

Other agencies will take part in the Precision Medicine Initiative. The National Cancer Institute www.cancer.gov would receive $70 million to scale up efforts to identify genomic drivers in cancer and apply that knowledge to develop more effective approaches to cancer treatment.

Ten million would go to FDA to acquire additional expertise and develop high quality curated databases to support the regulatory structure needed to advance innovation in precision medicine that includes providing privacy.

As part of this effort, FDA will develop a new approach for evaluating Next Generation Sequencing (NGS) technologies where a single test can potentially be used to identify thousands and even millions of genetic variants carried by a single individual.

Last year, FDA authorized the marketing of Illumina’s MiSeqDx Instrument, the first NGS, sequencing instrument and its two tests for cystic fibrosis mutations. Illumina Inc. www.illumina.com is collaborating with Lockheed Martin www.lockheed.com on scalable and affordable genomics solutions to provide personalized healthcare for national populations.

The alliance brings together Illumina’s NGS tools with Lockheed Martin’s expertise in large scale information systems and integration to help countries as they begin to integrate genomics into their national health systems.

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