Current status of Academy advocacy efforts in the following areas:
21st Century Cures Act
The 21st Century Cures bill passed the Senate by 94-5. The House held their signing ceremony on December 8. The bill was signed by the President on Tuesday, December 13, 2016 at the White House.
As expected, the bill contains a great deal of detail on NIH under Division A including the following topics:
- the reauthorization of the Agency, requiring a 6-year strategic plan,
- Triennial reports to congress,
- increased accountability through term appointments,
- supporting young emerging scientists,
- review of regulations and policies,
- reproducibility issues,
- high risk/high reward research grants,
- expanding NCATS support of clinical trials (CTs),
- increased collaboration and coordination,
- researching pregnant women and importance of demographic data (inclusion) in CTs, greater access to data,
- pediatric research.
Highlights of the bill:
- It provides $4.8B over 10 years to NIH (through the Office of the Director) that will be for the Cancer Moonshot ($1.802bil), the BRAIN Initiative ($1.564bil) and the Personalized Medicine Initiative ($1.4bil) which is allocated annually. Funding will be from the Prevention and Public Health Fund ($3.5bil) and the rest from drawing down from the Strategic Petroleum Reserve.
- It provides $500mil over 10 years to FDA and additional $30 mil to FDA for regenerative medicine.
- Continues Patient-Focused Drug Development at FDA and increases reporting of patient experience.
Why This Matters
The bill provides critically needed funding for the NIH, Cancer Moonshot, the BRAIN Initiative, PMI, and the FDA. It allows research to be funded that would not happen through any other mechanism. For patients, it means an increase in clinical trials and a greater emphasis on women’s reproductive health. For researchers, it provides support for young researchers and expands grant opportunities to engage in high risk/high reward research. The bill also requires greater reporting accountability to ensure funds are being spent effectively.
The Interagency Working Group on Medical Imaging (IWGMI)
The White House Interagency Working Group for Medical Imaging (IWGMI), established under the President’s National Science and Technology Council. Members of this group representing agencies across the government are charged with coordinating federal efforts in imaging research that cross agencies. The IWGMI has held four “listening sessions” between October 2015 and September 2016 where Academy and CIBR’s presented their thoughts on the gaps and opportunities within imaging research and specifically articulated how this group could move the paradigm. NIBIB Director Roderic I. Pettigrew, PhD, MD, and NIST Director of Special Programs Office, Richard Cavanagh PhD, serve as co-chairs to the IWGMI and under their leadership our community will continue to support the IWGMI, which is a direct result of the Academy’s in-house grassroots initiative to create a “home for imaging at the White House.
“The presenters all made a point of suggesting contributory roles for all of the federal agencies involved in the IWGMI, and painted a picture of a ‘future state’ in which medical imaging’s contributions would be maximized and enhanced by a coordinated federal investment. In brief, all of the marvelous presentations to IWGMI could be ‘organized’ into 3 key clinical initiatives, including: 1) risk assessment and early detection of disease; 2) precision diagnosis of the complete nature of an individual patient’s condition; and 3) recommendation for a ‘rational therapy’ ‘either ‘medical’ or ‘surgical’, including targeted image-guided procedures.” -Steven Seltzer, MD, Academy of Radiology Research Science Policy Fellow
Why This Matters
The imaging community has sometimes been an overlooked sector when science policy and research funding are considered. Representing the imaging community, the Academy seeks to be an integral part of all science policy and research funding.
Cancer Moonshot Initiative
The Academy strongly supports the President’s effort to advance cancer research and cures through a proposed investment of $1.0 billion that will be used to “accelerate progress in preventing, diagnosing, and treating cancer,” by supporting research and infrastructure. Scientists from the imaging research community should be called upon to use their extensive expertise and experience to help inform and facilitate the Administration’s efforts. Our Policy Statement on the Cancer Moon Shot articulates how imaging experts can contribute to this endeavor:
- Role of imaging in cancer research and treatment.
- Computational science and big data.
- Supporting educational pathways for young researchers to improve research and treatment outcomes.
- Role of the Interagency Working Group on Medical Imaging (IWGMI) to advance cancer research.
- Imaging research integral to FDA efforts on novel products.
The Academy met with Vice President Joseph Biden’s staff, other senior administration leaders and NIH leadership to discuss the vital role of imaging to cancer research. As a result of these meetings, the Academy was invited to send a representative to attend the Cancer Moon Shot Summit in Washington DC held on June 29, 2016. Academy leadership chose Etta Pisano, MD to represent the Academy and the broader imaging community. Academy board member Sanjiv Gambhir, MD, PhD holds a position on the Precision Prevention and Early Detection Working Group. The Blue Ribbon Panel report describes recommendations by seven working groups, each identifying the scientific gaps and opportunities. Imaging is mentioned between pages 48-53.
Why This Matters
The Academy is actively advocating to ensure imaging has a seat at the table. The Moonshot is an important initiative and engaging the expertise of the imaging community to assist the program will be critical to improvements in the following areas:
- Imaging tools that can be used to facilitate early cancer detection;
- Structural, functional and molecular imaging tools to perform non-invasive phenotyping and integrating imaging data with clinical, genomic and other patient-specific data to facilitate the precision diagnosis of cancer subtypes;
- Techniques of image-guided, minimally invasive interventions.
- Including quantitative imaging data in the multi-dimensional ‘deep learning’ process that can help risk stratify patients and contribute to computer-assisted precision diagnosis;
Report to the Office of Management and Budget (OMB)
On August 23, 2016, the Academy met with a lead budget analyst at OMB who handles the NIH budget requests. The purpose of the meeting was to introduce the Academy, as well as to highlight our advocacy work on behalf of the imaging community in support of federal funding for imaging research, that ranges from support for the entire NIH, to support for the individual institutes and centers within NIH, through support for strategic, scientific initiatives. Ensuring OMB is aware of the vital role of imaging is a strategic variable important to our long-term advocacy.
The Academy highlighted examples of the revolution taking place in imaging research, with major developments in enhancing the capability of structural imaging, functional imaging, molecular imaging, quantitative imaging, deep learning and image-guided therapy. Further illustrated were new technologies and capabilities catalyzed by federal research funding and now emerging into clinical practice.
Why This Matters
The OMB’s function is to make recommendations to the President for his annual submission to Congress regarding funding of all federal agencies. The Academy’s relationship with OMB is very important as we serve an advisory role working with the OMB to educate them on what needs funding and how past funding levels were appropriate or need to be increased. The Academy has a vital role in ensuring that NIBIB and all the other federal agencies that affect imaging research and the radiology community receive appropriate funding levels in the Presidents proposed budget to Congress.
Precision Medicine Initiative (PMI)
On January 20, 2015, President Obama announced the Precision Medicine Initiative in his State of the Union address. The plan seeks to develop better data and understanding of how genetic, behavioral, and environmental factors impact disease development and management. A standardized treatment protocol is advocated in disease treatment, but the success rate varies widely. Precision medicine takes into account the different factors impacting a particular patient. This has resulted in huge advances in diseases like melanoma and a variety of other cancers with the aid of molecular testing.
The President requested $215 million for PMI in fiscal year 2016; $130 million went to the NIH, and of that $70 million was allocated to the National Cancer Institute.
This new program is just ramping up and there is at present no action being taken by the Academy. We do, however, expect that to change shortly as members begin to participate in this program and many are already engaged in this strategic approach to disease treatment.
Why This Matters
Many physicians and researchers are taking this new and innovative approach to treating diseases that have multiple causes and variables and require a unique approach to their treatment. Since genetics, environment and patient behaviors all impact disease formation and progression, targeting them on a molecular and cellular level is resulting in cures, or better management, of many diseases for which treatments were previously ineffective. The Academy expects to advocate on behalf of research funding for the NIBIB and other related NIH Institutes and Centers that will participate in this exciting and promising initiative.