From the Desk of the Executive Director

renee

A Retrospective on IWGMI

 

How an Academy Initiative Led to the Creation of the Federal Government’s
Inter Agency Working Group on Medical Imaging (IWGMI)

Dear Academy friends and supporters,

We are writing to provide a progress report on an important, high-profile Academy initiative, the establishment and eventual funding of a ‘Medical Imaging Research Initiative’ for the entire federal government.

Background

The Academy was created in 1995 with the sole mission of establishing what is now known as the National Institute of Biomedical Imaging and Bioengineering (NIBIB); essentially a home for imaging and bioengineering research at the NIH.  This mission was successful and NIBIB was established at the NIH in 2000.

The mission of the Academy since the establishment of NIBIB has expanded to: 1) advocate for maximum possible federal funding for NIBIB; 2) increase the profile and resources available for imaging research across all NIH Institutes (beyond NIBIB), as well as across other federal government agencies.  The Academy has been and always will be stewards of NIBIB.  However, supporting NIBIB is necessary, but not sufficient to promote the cause of federal investments in medical imaging research.  As you likely know, the majority of imaging research is conducted outside of NIBIB at other institutes and agencies with large imaging portfolios [the National Cancer Institute (NCI), National Heart, Lung and Blood Institute (NHLBI), National Institute of Neurological Disorders and Stroke (NINDS), National Science Foundation (NSF), Department of Defense (DOD), Veterans Affairs (VA), etc.].

The Academy’s efforts have been successful and the magnitude of funding for biomedical imaging research across NIBIB and other NIH institutes has increased approximately 7-fold over the past 20 years, rising even during a period of deflationary funding for NIH.  The other federal agencies listed above have also grown their investment in imaging research.

There is clearly an opportunity to enhance medical imaging research funding by advocating for the coordination of imaging research efforts across NIH and other federal agencies (not easy to do).  To pursue this trans-agency effort to increase federal funding for imaging research, the Academy launched a new initiative in 2015 that was intended to be a way to bring together leaders from these federal programs under one umbrella and by doing so, accelerate the Administration’s overall goals for scientific innovation.

A new, tactical opportunity to achieve this goal of multi-agency investment in imaging research has been identified.  Specifically, the Academy’s leadership has been monitoring the success of novel initiatives to generate an additional federal funding commitment to biomedical imaging research, over and above the annual appropriation to NIH, NSF, DOD and DOE.  Specifically, prior to 2014, the ‘conventional wisdom’ in the medical research advocacy community was that advocacy efforts needed to be focused on Congressional appropriators and be fairly ‘general’ in nature.  Focused efforts to fund research on a specific disease or for a specific NIH institute would have been frowned upon. Advocates worked within an “a rising tide raises all boats” environment.

Interestingly, new advocacy tactics emerged towards the end of the Obama administration.  During the 2014-2016 time frame, NIH funding dropped in both absolute and relative terms, only a few, new scientific initiatives emerged from NIH and, as a consequence, several research interest groups changed their strategy away from general advocacy with Congress and towards encouraging the White House to champion federal investment in targeted research areas.

Working with the Executive Branch’s Office of Science and Technology Policy typically focused advocacy efforts found success in describing, launching and funding several multi-million dollar investments.  The Brain Initiative nearly doubled its budget in the last three years to over $150 million, and the Cancer Moonshot (as part of the 21th Century Cures Act specifically received $1.8 billion of the nearly $4.8 billion earmarked for the NIH resulting in high-profile successes.

Over this same period-of-time, the imaging research advocacy community developed convincing data that demonstrates federal investments in imaging research return economic benefits as well as health improvements. The Nature Biotechnology article, “Patents As Proxies: NIH Hubs of Innovation1” demonstrated that imaging research sponsored by the NIBIB generates far more patents per $100M in grants than any other NIH institute.  This report was confirmed and extended by the Batelle report 2015.

Armed with this exciting, persuasive new data, the Academy determined that the time was propitious to advocate for a more targeted federal imaging research initiative that, like the successful Brain Initiative and Cancer Moonshot, would be catalyzed by the OSTP.  The Academy’s proposal was to organize and fund a coordinated, federal government-wide effort to generate a road map of high priority medical imaging research and lobby to fund these new programs.  Expected outcomes included: coordination of the capabilities and interests of federal agencies outside NIH, description of high yield research initiatives that could improve the health of the American people, generate intellectual property and jobs, as well as to fuel American competitiveness in imaging research and development.

Why did we believe this new initiative was needed?

In addition to its role in patient care, medical imaging’s use as a vital research tool has exploded in the past ten years. Some of the NIH’s other prominent initiatives, including the Big Data Initiative, the Neuroscience Blueprint, as well as the BRAIN Initiative and Cancer Moonshot. They all rely on advanced imaging technology to augment their understanding of disease. Moreover, the National Institute of Biomedical Imaging and Bioengineering (NIBIB)’s development of medical imaging technology provided and continues to provide the R&D basis for one of our country’s strongest export industries. This sector helps to create American jobs.  Imaging research is the most economically productive science at the NIH, and NIBIB’s patent production rate is more than 3 times that of the other Institutes.

While there are multiple federal agencies involved in imaging research, their efforts are often non-collaborative and siloed. Agencies like NIBIB, NIST, NSF, and the DOE support basic research into the technology development for imaging research. Other agencies, including the NINDS, NCI, NHLBI, NIA, DoD, and VA take the tools created by NIBIB and apply them to translational research. In addition, the Food and Drug Administration (FDA), Centers for Medicare and Medicaid Studies (CMS), Environmental Protection Agency (EPA), and the Department of Commerce (DOC) all have divisions to approve, regulate, and define market conditions for delivering imaging to patients. Given these agencies’ diverse constituencies, complementary roles, and economic significance, a federal strategy to better coordinate and accelerate imaging research is needed across the federal government. Academy leadership felt that this initiative would accelerate the collective goals of individual entities and maximize existing federal resources. The end-result will be improved patient care, better research tools, and a strong domestic market for medical imaging devices.

IWGMI history

The effort to generate and fund a federal medical imaging research initiative is long, complex and multi-dimensional.  The balance of this report describes progress to date and identifies next steps.

Step 1. Following the example of the other targeted federal research initiatives cited above, the first step for the Academy in this new advocacy effort was to convince Congress to instruct the White House to create a task group charged with developing a national imaging research plan.

The Academy drafted legislative language, identified, collaborated with and secured congressional champions to assist with the legislation.  Additionally, Academy leadership and staff met with the White House Office of Science and Technology Policy to share the Academy’s vision.  Several Academic Chairs within the Academy communicated directly with their Members of Congress to further solidify support and CIBR industry partners engaged their leadership.

In 2015, this preliminary step was completed enabling legislative language to direct the Executive Branch to establish an imaging research working group, its charter and reporting responsibilities (See Figure 1).

Step 2. The following year, the Interagency Working Group on Medical Imaging (IWGMI) was created.  The IWGMI is led by co-chairs Roderic I. Pettigrew, PhD, MD, Director of the National Institute for Biomedical Imaging and Bioengineering (NIBIB) and Richard Cavanagh, PhD, Director of Special Programs Office at the National Institute of Standards and Technology (NIST).  More than a dozen Federal Agencies were asked to participate in the Working Group initially.  The complete list is presented in Figure 2.  The breadth of expertise and interests represented in the Working Group is unique and notable.

The Working Group’s goal was to define a national imaging research roadmap and report it to Congress.  With assistance and facilitation from the Academy, the Working Group developed its agenda and timetable to complete its work by the end of 2016.  To collect input on research priorities, the Working Group hosted 4 listening sessions, all held in Washington, DC.   Each listening session heard presentations from groups of stakeholders, including national radiology organizations, academic radiology departments/senior investigators, industry and patient advocacy groups. We are proud to note that all 16 groups and organizations invited by the White House to present to the IWGMI are Academy members.  The final listening session was held on September 1, 2016, and a calendar of these sessions is presented in Figure 3.

Step 3. The Working Group has completed the task of analyzing the input it received and identifying a number of priority areas for research investments from a broad array of government agencies.  Their work is listed on line at:

https://obamawhitehouse.archives.gov/blog/2016/12/22/advancing-high-value-imaging-support-patient-care-and-research,

A final written report will be completed shortly.

IWGMI future

Step 4.  The Working Group and the Academy face substantial challenges in order to: 4.1) have the IWGMI report ‘endorsed’ as federal policy;  4.2) transform the report into actionable projects and; 4.3) secure new funding via a congressional appropriation.

The results of the November 2016 election have introduced uncertainty in several relevant arenas.  First, we do not know the future make-up or charter of the OSTP. The majority of Obama-era OSTP members have departed and we have not heard about the new administration’s plans for this body (there is no requirement that the White House even have an OSTP), and, in order to succeed, the IWGMI’s initiatives will need champions in the Executive Branch.  Second, many of our congressional supporters who helped establish the OSTP are no longer serving in Congress.  The Academy is actively cultivating new congressional champions. Third, the future leadership and funding for the NIH are uncertain. The FY17 budget is being funded with a continuing resolution (CR) and the current administration’s willingness to invest in initiatives like IWGMI that would hopefully be funded in addition to the NIH budget is unknown.  If we follow the path blazed by the Brain Initiative and Cancer Moonshot, we will need greater clarity on these issues to help select tactics to advance the IWGMI initiatives.

In the short term, there is advocacy on which the Academy can focus. The IWGMI Charter expires in March 2017, and the Academy is distributing a “Dear Colleague” letter that will show congressional support for and recognition of the efforts of IWGMI.  This will enable us the wave the IWGMI flag and call attention to this incredible collaborative effort.

The IWGMI will be finalizing their recommendations soon, and when that happens we will most certainly be ready to mobilize to support their plan.

The Academy and its, division CIBR, are engaged in raising awareness about the potential of implementing the IWGMI priorities.  CIBR represents academic institutions, industry and patient advocacy groups, and we are well positioned for this work.

Action Items to Advocate for IWGMI:

  • Advocate for renewal of the IWGMI Charter
    • Meet with Congressional offices to garner support
  • Continue to inform the imaging community about Academy efforts to create and sustain the IWGMI
    • You are reading this article!  Success.
  • Mobilize out member societies, academic departments and industry partners to assist us with grassroots efforts

Summary

In summary, the conceptualization, organization and work to create a roadmap of imaging research priorities that span more than a dozen government agencies has been successful so far.  Turning this roadmap into funded research projects will be difficult, but the Academy has demonstrated its effective advocacy many times in the past, particularly with its signature success of establishing the NIBIB seventeen years ago.

We will keep you informed and be asking for your help and support as we pursue Step 4 and success of the IWGMI initiatives.

Sincerely,

                                                                

Renee Cruea, MPA                                                                   Steven E. Seltzer, MD

1Patents as proxies: NIH hubs of innovation”, Michael J KalutkiewiczRichard L Ehman Nature Biotechnology 32, 536–537 (2014) doi:10.1038/nbt.2917 Published online 09 June 2014

Figures

  1. Congressional language creating and charging the IWGMI
  2. List of federal agencies participating in IWGMI
  3. Working Group calendar

Figure 1.  Congressional language creating and charging the IWGMI

Senate Report 113-181 FY2015

Medical Imaging Research Initiative.— The Committee believes there is potential in the near future to accelerate revolutionary new imaging technology for medical professionals and researchers to combat disease and support high-skilled manufacturing jobs in the United States. Such advances will require inter-agency coordination of Federal medical imaging research and development initiatives to accelerate the transfer of new technologies into commercial products manufactured in the United States and strengthen innovative research programs. Since many Federal agencies have existing and complementary roles on medical imaging research, there is a strong need for a Federal strategy that will coordinate and accelerate such research. The Committee directs OSTP, in cooperation with the National Institutes of Health as the lead agency, to establish, through the National Science and Technology Council’s Committee on Science, a Medical Imaging Subcommittee [MIS] to coordinate Federal investments in imaging research. The MIS should be required to develop a roadmap for the full scope of imaging research and development, including: basic STEM science and technology creation, medical and translational research, evidence generation, clinical implementation, workforce and training support, and export-oriented manufacturing incentives.

Figure 2. List of federal agencies participating in IWGMI

Figure 3. Working Group calendar

November 5, 2015 IWGMI Listening Session with Imaging Societies’ Leadership

March 24, 2016 IWGMI Listening Session with CIBR Industry Members

June 29, 2016 IWGMI Listening Session with Academic Researchers

September 1, 2016 IWGMI Listening Session with Patient Advocacy Groups