NIH-OSTP Listening Session - August 11, 2021

Statement by Dr. Mitchell D. Schnall, President, Academy for Radiology and Biomedical Imaging Research

Thank you for the opportunity to provide comments related the proposed (ARPA- H). I am speaking on behalf of the Academy for Radiology and Biomedical Imaging Research.

The Academy represents a community spanning academia, industry, professional organizations and patient advocacy groups focused broadly on advancing biomedical imaging which includes imaging technology platforms, molecular targeted ligands for diagnosis and treatment and AI based analytics.

As a technology focused community, we are passionate about the development of biomedical imaging based solutions to diagnose and treat disease. Our work spans nearly every disease entity including cancer, neurologic diseases (including Alzheimer’s disease), heart disease and more. Our tools are critical to nearly every aspect of medical practice and medical science.

We have closely followed the proposal for the ARPA-H concept. Like many in the research community, the Academy recognizes the potential benefits of ARPA-H to accelerate image targeted diagnostics and cures, building on our foundational knowledge. Like many in the research community, the Academy firmly believes that the creation of ARPA-H should complement and not detract from NIH’s core, baseline mission supporting basic, investigator-initiated research.

Our community embraces the collaborative, ambitious use driven project culture envisioned in ARPA-H.

Our technology impacts multiple disease areas and doesn’t fall neatly into disease focused institutes. Our opportunities to advance our high risk, high reward ideas into working solutions with broad impact across disease areas are limited by the modest size of NIBIB the technology oriented institute we identify with.

We have previously worked with OSTP to develop the Intergovernmental Working Group on Medical Imaging to coordinate the Federal investment in medical imaging research and develop a strategic plan for future development. We embrace the opportunity to work with ARPA-H moving the working group’s strategy to solutions for the American public.

As an example, the working group envisioned a diagnostic cockpit, aggregating advanced imaging data from large scale and portable point of care diagnostic devices leveraging advanced artificial intelligence technology to enable the early detection, and diagnosis of disease and empower appropriate treatment decisions, and even monitor the community for early warning signs of emerging pandemics.

In response to the COVID19 pandemic our community worked with NIBIB on the Medical Imaging Data Resource Center and RADx programs to begin to make this vision a reality. 

We believe strong collaboration between ARPA-H and NIH would be valuable to provide ARPA-H access to research communities and to leverage resources and expertise needed for clinical validation.

While we support the ARPA-H initiative, several questions regarding process have been raised by our membership:

  • Given the references to the ARPA model, is it expected that ARPA-H will not have the traditional NIH peer-review process? How will project selection and peer review work?
  • Will there be opportunity for input from the scientific community into important leadership positions at ARPA-H including the director and important program manager positions? Will nominations be solicited?
  • We assume a goal of ARPA-H is to increase public-private collaboration? If yes, how will ARPA- H incentivize those partnerships?
  • How will regulatory systems like FDA be incorporated into the process to ensure breakthroughs will have an opportunity to reach market efficiently?

We appreciate that ARPA-H in in the early phase of development and these questions may not yet have answers, but we think they are important to consider and hope they are topics for further discussion with the broad research community.

Finally, we appreciate the opportunity to participate in this session and look forward to learning more about the development of ARPA-H.
 

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