Though the details of what will emerge as a result of the wide-ranging initiative remain elusive, researchers were enthusiastic about the initiative and its goals.
Dr. Mark Rubin, director of the Institute for Precision Medicine at Weill Cornell Medical College, attended the press conference with Obama, telling Outsourcing-Pharma.com afterwards that the project could inevitably help discover genetic variants in the US population. “We need to know what the rare variants and the common variants are,” he said, noting that the focus at the press conference “was really not about the numbers but on the approach.”
The new funding will go to not only researchers at the NIH and NCI (National Cancer Institute), but also to help beef up new FDA regulations.
“The concept that the FDA will come up with more rigorous means to understand sequencing assays – I’m happy that this is an important activity, and it shouldn’t get lumped into the same category of getting an approval for a pacemaker,” he said. He also seemed keen on the idea that the FDA is going to go in the direction “of much more rigorous testing” for next generation sequencing technologies.
“For those of us in attendance, the invitations came at such short notice, and I was amazed to see the high-level interest from the nation’s top genomic researchers,” Rubin added.
Breakdown of New Funding
The NIH will see more than half of the new investment in Obama’s budget -- $130m – to develop a voluntary national research cohort of a million or more volunteers to propel the understanding of health and disease and set the foundation for a new way of doing research through “open, responsible data sharing.”
Obama said the database of volunteers will “teach us more about the connections between us,” as the project will “leverage existing research and clinical networks and build on new research models that enable patients to be active participants and partners.” Qualified researchers from multiple disciplines will have access to the cohort’s data, according to the initiative.
Oncology research will also see a small bump in funding as the plan calls for the NCI (National Cancer Insitute) to receive $70m “to scale up efforts to identify genomic drivers in cancer and apply that knowledge in the development of more effective approaches to cancer treatment.”
“One immediate goal of the Precision Medicine Initiative will be to significantly expand efforts in cancer genomics to create prevention and treatment successes for more cancers,” the NIH said in a statement.
The FDA will see a smaller share of the total, with $10m to “acquire additional expertise” and advance the development of “high quality, curated databases to support the regulatory structure needed to advance innovation in precision medicine and protect public health.”
More specifically, the FDA will develop a new approach for evaluating Next Generation Sequencing technologies — tests that sequence large segments of DNA – to help facilitate the generation of knowledge about which genetic changes are important to patient care.