Research and Innovation in the Defense Health Agency

RADM Mary C. RiggsDeputy Assistant Director

DHA Research & Development (J-9) 28 November 2018

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Disclosures

∎ Presenter has no conflict of interest to disclose.

∎ The views and opinions presented are those of the speaker, and do not necessarily represent the position of The Defense Health Agency, the Department of Defense, the Department of the Navy, or the United States Government.

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Learning Objectives

At the conclusion of this activity, the participant will be able to:

1. Describe how the DHA Research and Development supports the mission of providing a medically ready force and a ready medical force

2. Understand the Defense Health Program’s research priorities and advancements

3. Explain how DHA’s Research and Development initiatives have improved clinical care and patient safety

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J-9 Vision and Mission

Vision

The bridge to the future of military health and readiness

Mission

J-9 leads the discovery, development, and delivery of enhanced pathways to military health and readiness

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Why is innovation hard?

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What is innovation?

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What are obstacles to innovation?

∎ Obstacles can come in many forms, but some include: Lack of a defined innovation strategy No specific innovation process or framework Limited budget or leadership capacity The sheer size of an organization, with larger businesses tending to be

bureaucratic and slow moving

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Defense Health Program’s research prioritiesexecute the Secretary’s priorities!

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Secretary of Defense Priorities Readiness and Lethality Strengthen Alliances Bring Business Reforms to

DoD

R&D Goals Listen better for new ideas Invent and innovate faster and

better Implement best-practice

business processes Move research (facts) to

knowledge (practice) To the clinic To the battlefield

Implement Innovation Science (Open Innovation)

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Creating an Innovative Culture: People and Environment

Innovation starts with people∎ Identify unmet needs and assess

trends∎ Foster a culture of experimentation∎ Encourage conversations that inspire

partners and employees∎ Develop mechanisms for sharing

thoughts and ideas

Ideate and prioritize∎ Leverage your ecosystem to identify

ideas∎ Crowdsource opportunities where

appropriate∎ Develop partnerships with start-ups∎ Curate, prioritize and filter ideas

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Example: Creating an idea

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The Sirkin-Hiles Rail System (SHRAIL)

Creating an Innovative Culture: Incubate and Activate

∎ IncubateFail fast and fall forwardCo-create and collaborate across

organizational silosCultivate a transparent

environmentIdentify investment through the

piloting of ideas

∎ ActivateIdentify partners and new

technologiesActively monitor successes and

failuresIncorporate lessons learned from

failuresScale successes to the enterpriseIdentify continuous opportunities

for improvement

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Example: Next-Generation Assessment of TBI

∎ Effective TBI assessment is critical for treatment planning and determining cognitive readiness to return to duty

∎ However, conventional assessments can be difficult & time-consuming to complete, and may miss important forms of TBI-related impairment

∎ With support from CDMRP and USUHS, DVBIC has performed technology development and validation to establish “next-generation” TBI assessment combining eye tracking and EEG

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Fusion Brain Assessment: Technology Development

∎ Sensors track eye movements, pupil response, button presses, and optional EEG

∎ Quickly & automatically evaluates visual, cognitive, and motor functioning

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Eye movements, pupil response, button presses

Brain activity (EEG)Fusion Laptop Platform Fusion VR Platform

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Fusion Brain Assessment: Validation & Dissemination

∎ Promising evidence for effectiveness∎ 6 peer-reviewed publications: Brain Injury (journal), Journal of

Neuropsychiatry and Clinical Neurosciences, Journal of Clinical and Experimental Neuropsychology , Archives of Clinical Neuropsychology, PLoS One, International Journal of Psychophysiology

∎ Used for TBI research across multiple settings Military: Naval Medical Center San Diego, Naval Hospital Camp

Pendleton, San Antonio Military Medical Center Veteran: VA San Diego Healthcare System, Washington, DC VA Medical

Center Civilian: NIH Clinical Center, UC San Diego

∎ Next steps: commercialization, phase III trials, FDA review, research predicting return-to-duty

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(from Ettenhofer et al., 2018 - Brain Injury)

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How can the DHA Foster Innovation?

∎ Requirements and priorities∎ Process∎ Regulatory and Policy

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Defense Health Program’s research prioritiesFY19 NDAA

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Sections 711(e) & 736

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Defense Health Program’s Research ChangesImplement Sec 711 and 736

∎ Additional likely changesMore health services researchMore coordinated clinical investigationsMore coordinated/centralize human subjects protectionMore emphasis on Knowledge Transition AgreementsMore emphasis on transitioning research to practiceMore coordinated/centralized Strategic Partnerships and Alliances A DHA Technology Transfer Office & Procedural Instruction

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How can the DHA Foster Innovation?

∎ Requirements and priorities∎ Process∎ Regulatory and Policy

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Examples of Regulatory Innovation

∎ Public Law 115-92 Expanded Emergency Use Authority (EUA) and Enhanced FDA Engagement Expanded DoD’s ability to use EUAs beyond CBRN threats to cover battlefield trauma Provided a DoD-unique mechanism to expedite development, review and approval of DoD medical product

priorities; Forced DoD and FDA to meet regularly to review DoD’s medical product portfolio Key outcomes: the EUA for French Freeze Dried Plasma, FDA approval of tefenoquine for malaria

propholaxis, FDA approval of Dsuvia for battlefield pain management, and the approval of the atropine autoinjector for the treatment of nerve agent exposure. All these products are on the DoD “Priority List” for enhanced engagement with FDA.

∎ Material Threat Medical Countermeasure Program Enacted as Section 3086 of the 21st Century Cures Act on December 13, 2016. Provides a powerful incentive to drive investment in the CBRN medical countermeasure space. Any applicant obtaining FDA approval if a material threat MCM receives a priority review voucher entitling

the company to a 6 month review of its next application (or the firm can sell the voucher to the highest bidder and invest the capital). PRVs have sold for $350 million with the company investing that income into future medical R&D.

PRVs have spurred significant investment in DoD medical R&D.

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Examples of Regulatory Innovation

∎ Waiver of Advanced Informed Consent for Minimal Risk Research Enacted as Section 3024 of the 21st Century Cures Act on December 13, 2016.DoD was precluded from doing several observational medical device studies on the

battlefield or in trauma centers because advanced informed consent was not possible. MRMC JAG and ORP led the effort to harmonize FDA’s regulations with HHS's Common Rule,

which permitted such minimal risk studies with a waiver of advanced informed consent. This waiver provision will now allow feasibility and operational utility testing of diagnostic

and monitoring medical devices, regulated by FDA, at point of injury, pre-hospital transport, and in the emergency department. This law will help close a research gap will improve trauma care worldwide.

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Future - DHP Research Innovations

Medically Ready Force∎ Better protection from infectious

disease (gene-based precision medicine)

∎ Predictive Biomarkers∎ Tissue regeneration for wound

healing∎ Facial transplants∎ Hand transplants

A Ready Medical Force∎ Treatments for military relevant

deployment, from infectious diseases to TBI

∎ Far forward blood products∎ Freeze dried plasma∎ Innovation of field transfusion

methods∎ Patient warming methods

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Overcome Challenges

Challenges for Innovation in DoD∎ Changing landscape(s) Science & Medicine Battlefields (current & future)Organizations

∎ Competing Missions ∎ Many Customers∎ Regulation∎ Cost

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Defense Health Program’s Research ChangesImprove Innovation

∎ Components of Successful InnovationMission alignmentUnderstanding the Customer

Needs Limitations Environments

Multifunctional advancements Ease of use & integration Cost

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Activity Example

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Activity Example

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