Research and Innovation in the Defense Health Agency

Transcription

1 Research and Innovation in the Defense Health Agency RADM Mary C. Riggs Deputy Assistant Director DHA Research & Development (J-9) 28 November 2018

2 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. 2

3 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 3

4 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 4

5 Why is innovation hard? 5

6 What is innovation? 6

7 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 7

8 Defense Health Program s research priorities execute the Secretary s priorities! 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) 8

9 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 9

10 Example: Creating an idea The Sirkin-Hiles Rail System (SHRAIL) 10

11 Creating an Innovative Culture: Incubate and Activate Incubate Fail fast and fall forward Co-create and collaborate across organizational silos Cultivate a transparent environment Identify investment through the piloting of ideas Activate Identify partners and new technologies Actively monitor successes and failures Incorporate lessons learned from failures Scale successes to the enterprise Identify continuous opportunities for improvement 11

12 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 & timeconsuming to complete, and may miss important forms of TBIrelated impairment With support from CDMRP and USUHS, DVBIC has performed technology development and validation to establish nextgeneration TBI assessment combining eye tracking and EEG 12

13 Fusion Brain Assessment: Technology Development Sensors track eye movements, pupil response, button presses, and optional EEG Quickly & automatically evaluates visual, cognitive, and motor functioning Eye movements, pupil response, button presses Fusion Laptop Platform Fusion VR Platform Brain activity (EEG) 13

14 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 (from Ettenhofer et al., Brain Injury) 14

15 How can the DHA Foster Innovation? Requirements and priorities Process Regulatory and Policy 15

16 Defense Health Program s research priorities FY19 NDAA Sections 711(e) &

17 Defense Health Program s Research Changes Implement Sec 711 and 736 Additional likely changes More health services research More coordinated clinical investigations More coordinated/centralize human subjects protection More emphasis on Knowledge Transition Agreements More emphasis on transitioning research to practice More coordinated/centralized Strategic Partnerships and Alliances A DHA Technology Transfer Office & Procedural Instruction 17

18 How can the DHA Foster Innovation? Requirements and priorities Process Regulatory and Policy 18

19 Examples of Regulatory Innovation Public Law 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 21 st Century Cures Act on December 13, 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. 19

20 Examples of Regulatory Innovation Waiver of Advanced Informed Consent for Minimal Risk Research Enacted as Section 3024 of the 21 st Century Cures Act on December 13, 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. 20

21 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 21

22 Overcome Challenges Challenges for Innovation in DoD Changing landscape(s) Science & Medicine Battlefields (current & future) Organizations Competing Missions Many Customers Regulation Cost 22

23 Defense Health Program s Research Changes Improve Innovation Components of Successful Innovation Mission alignment Understanding the Customer Needs Limitations Environments Multifunctional advancements Ease of use & integration Cost 23

24 Activity Example Activity Example 24

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