The one thing we can control in military life sciences research and development: effort

As biomedical research and development evolves worldwide, military routes stay their course. Attention and consideration to military life sciences and biomedical research and development (R&D) is of industry-wide interest. This consideration is also of interest for the service member populations, globally. Do military departments lead in R&D quality and value? Do military departments partner to the maximum? Are there areas in which identified improvements could be supported? Is there efficiency and collegiality to data sharing, intellectual property policy and product access? We may not all have matched expertise of those working in the military R&D field, yet we can advocate for organization and structure. We can better understand, support and partner in military R&D efforts toward medicine, therapeutics and technological innovation of life sciences. The one thing we can control in military life sciences research and development is effort

1.Commit to the effort of being as productive as we can.

Biomedical innovation productivity and efficiency is not clear cut. Components to life science research may or may not be tangible. Many of us won’t understand, and maybe will not place value on, the successes of cellular insight compared to a product that stops a hemorrhage. Additionally, it is unclear how involved or responsible militaries are alongside national biomedical research R&D, and it is unclear who the professionals are leading the way. There is not much detail or structure to international life sciences agenda and prioritization. Despite the subjective nature of innovation measurement, there are several ways in which military medical research can partner, and be partnered with, to assure effort is maximized.

*Commit to realistic and good security policies with information disclosure. While much of military R&D is of secretive status, biomedical work is often hailed in the headlines. Partnerships involving a cooperative research and development agreement (CRADA), patents and other research formalities make news headlines for militaries worldwide, including for the US, UK and China (1, 2, 3). Additionally, informal courtesies, academic partnerships and scientific collegiality create information pathways. Realistic and secure public disclosure of non-specific projects assists in partnerships worldwide, and policies should seek to clarify minimal risk to security alongside biomedical advancement efforts.

*Organize the portfolio. Biomedical innovation begins with what we are currently studying, what needs have been identified and where we can go with research. Detail the biomedical research recently and currently underway for militaries. Categorize by life sciences, including ecology, physiology and botany, and indicate the areas for potential human health impact. While 36 U.S. Department of Defense medical research laboratories (4) have been noted, partner laboratories are important to include. Overseas laboratories are also critical to count. Detail the funding and private/industry partnerships. This could be done on a national and international level. Innovation that leads to product purchases by other militaries should also be better understand and detailed as a crosswalk addendum.

*Identify operational differences to research based on type and border. As in most countries, the US has no national accreditation for clinical research, though medical laboratories, research professionals and research education programs are all associated with credentialing and accreditation bodies. Establishing accreditation for clinical research assures standards across any military partnership with academic medicine. Establishing accreditation standards for all components to biomedical innovation, including the laboratory itself, can be applied overseas and across militaries worldwide. Springboards for clinical research accreditation have been initiated (5) and could be incorporated, or have components incorporated, alongside laboratory accreditation.

*Understand military research structure across borders. How involved are these units in academic and national life science R&D? What are the credentials, and who is responsible for the laboratories? Make the effort to understand and detail this insight.

*Evaluate, and fund for, research quality. Effort should include quality components to the design and approval of research, required build from previous data, required literature review where applicable, epidemiologist and statistician consultation if applicable and integrity to publication. Specify basics for R&D of biomedical materials. Consider collegiality across research departments, specialties and international biomedicine to be a potential measure. Consider FDA and other regulatory agency checks during planning. Advance small study criterion alongside civilian clinical trial innovation work.

*Create necessary structure to crossover life sciences, such as botany with biomedicine or physiology with biocomputational science.

*Make the effort to address what experts believe is achievable and possible, and where we are in grading approvals without bureaucratic bias.

2.Effort is measured by setting goals and goals results.

*Create national and international strategic plans with biomedical innovation for the military. Let national plans be tailored to national defense, and let international plans be tailored to the soldier’s health. Tier the biomedical and life sciences R&D by human health impact. Necessary, critical and life-saving biomedical innovation should be shared. This is true for allied militaries, and it is true for all militaries. There is no reason why new innovation data around hemorrhagic treatments, materials for wound healing, treatment for chemical exposure, helmet or eye protection materials, hearing assistants, foot protection, 3D and other amputation care, limb preservation materials, robotic surgical instruments, precision medicine algorithms, biometric materials on the battlefield, nanotechnology, laboratory innovation, radiological innovation, new vaccines or other innovation should be withheld from soldiers or armed personnel anywhere in the world. If the research materials are available, the trial could be offered. Studies of products that impact a service person’s health, or health quality of life, should see participation, and access to the eventual product available. Goals to improve processes, international collegiality, international regulations, fast-track of trials, patent negotiations, academic assistance, open access publication and other areas of efficient streamlining should be established.

*Understand consultant partnerships in military R&D. There are hundreds of contracting companies and academic medicine partners worldwide. National goals should be inclusive of international military alliance harmonies in biomedical innovation, avoiding repetition and waste. Examining a partner like Deloitte provides the US with Military Health System (MHS) possibilities for both delivery and treatment. Virtual health may bring the experts to the overseas or remote base service member. Augmented reality technology can assist training and education for clinicians. Robotic surgery capabilities and blockchain work may also contribute to improved operations. Regenerative medicine, 3D capabilities and automated intelligence may assist in treatment (6). Areas with serious consultant attention should be better understand, tracked alongside civilian work and considerate of contractor bias or influence.

*Commit to the intellectual property and technology transfer components of military biomedical innovation. Identify areas where there isn’t enough literature, as well as areas where consistent reporting could be expected and operationalized. Literature on technology transfer and reports on management of intellectual property (7) have identified strategies for national and international improvements. Be accountable to measurable success. Utilize organization that needn’t reinvent the wheel. In example, a recent report determined that several key components could drive technology transfer for military innovation: ensuring effective research offices (for US, ORTA and similar structures), organization and staffing, empowering, training, and rewarding researchers, managing intellectual property, using technology transfer mechanisms to their full potential, managing and monitoring technology transfer processes, marketing laboratory technologies and capabilities to industry and building partnerships. Recommendations such as dedicated staffing for technology transfer management and oversight or private industry partnerships could be a component to any strategic plans. Developed plans could be measurable, including through timeliness, standardization of patient cooperation treaties (PCT), training on disclosure, training on intellectual property and quality improvement to CRADA processes (screening of technical, financial and partnership criteria for CRADAs, invoicing systems, implementation time standards), the clustering of patients across services and marketing and media communications improvements. Communication and meetings between licensees, CRADA partners, and other collaborators could ensure common agreements. Technology loan programs, to share technology developed by a DoD laboratory with other Federal, State, and local organizations, should be measured and better understood across borders. Best practices and benchmarking of technology transfer metrics should be implemented, with studies and evidence based guidance. This will be imperfect, yet measuring the effort should start anyway (7).

*Review, analyze and apply appropriate intellectual property reforms and recommendations in military biomedical innovation partnerships. The literature continues to evolve on medical and intellectual property, and military work should not be excluded. Additionally, dual partnerships between civilian and military biomedical innovation should be understood, including the differences by country (8). Consideration of company selection and definition of success measures could also assist in efficiency of work, partnerships for research quality and product development (9).

*Make the effort best. Targeted goals should be backed by R&D estimates, policy and regulatory barriers and resolutions, and estimated deliverables to specific military populations. These goals should also be inclusive of ethics.

3.Make the commitment to get the results.

*Commit to evidence-based practice for best results. Transformative innovation trials and implementation should be accompanied by supportive practice. In example, 3D printing of prosthetics should be accompanied by evidence-based strategies, as well as patient compliance and navigation, to allied health support. In a second example, automated intelligence that seeks to address behavioral health, such as non-human interaction for soldiers with PTSD, should be accompanied by holistic EBP. It is not enough to offer new alternatives, alternatives that challenge our perception of human condition. With evidence, there should be ongoing evaluation of an individual’s meaningful human relationships, boundaries, realities, compassion, empathy and other psychological considerations. As a final example, enhancements for soldiers, such as ocular or auditory assistance, should be accompanied by publicly available data, similar to post-market surveillance. Quality assurance should also be required as support. Biomonitoring should also be undertaken with continuous quality assurance. New materials for trauma should be accompanied by funding for long term outcome data aggregation automatically built in.

*Commit to the structure. Structure should be detailed for international understanding. In example, the U.S. has structure with the Armed Services Biomedical Research Evaluation and Management (ASBREM) and Joint Technical Coordinating Groups (JTCG), and these units have established 9 working groups to help service persons be better prepared, better protected and better cared for (10). NATO has specific goals in several key areas for biodefense and biomedical innovation, inclusive of enhancements to soldiers (11) and many of the specific desirables have projected decades to completion. The structure of military decisions making, responsibilities and oversight in R&D can be clarified and sharpened.

*Commit to structured partnerships for military biomedical innovation. There are partnerships with military and veteran medicine everywhere and much of these are based on academic medical capabilities. John Hopkins has recently partnered with NATO biomedical innovation education (12) and many institutions provide specialty service partnerships. Greater industry harmonies should be realized, and regenerative medicine could lead the way. Military innovation in regeneration medicine is often touted (13) alongside academic medical support.Regenerative medicine with military interest could be accompanied by guaranteed access to specialist teams, pharmaceutical access, patient adherence support and ethicist availability. Regenerative medicine could be approached with federal regulation and international organization at the industry level. Even if countries vary on regulation, variance could be understood and watched (14,15,16). Categories of regenerative medicine (17) could be of international code, and measurements of success defined separate from product approval counts. This is an area where a specific international team could assist in regulation development and standards, with consideration to evidence of clinical benefit. Federal investment in regenerative medicine should always involve armed forces science (18), as well as ensure an organized approach to collegiality among academic medicine. Biobanking, stem cell work and other avenues without standard policies across agencies and medicine could be tightened up for efficiency. International collaborations could be evaluated not for effort of ranking but for basics in operations, outcomes, materials, and other areas where standards can be developed, disseminated and expected (19). Open access and data repository work could assist. Additionally, translation should be defined (20, 21). Military innovation in regeneration should be accompanied by dedicated funding to standards in education and training, including for injury pathophysiology and for technological opportunities (22). Informal relationships between international peer institutions should be supported with formal funding. Access to technology could be assessed based on current and projected need for the population, need for research, need for medical delivery training, or other parameters, and those deemed (23). Structured partnerships could see international strategic movement and should be a great effort for our global population. Crossover into civilian care is a constant for militaries, whether within borders in advanced hospitals or in the field delivering charitable international care. Regenerative medicine work is a R&D and innovation field of which international civilian partnership structure should be expected.

*Identify international regulatory and economic partnerships for military innovation. Quality improvement should be a continued focus, and concepts not yet listed, such as supply chain integrity, should also be addressed(24).

*Dedicate international attention and governance to military biomedical innovation as it pertains to weapons, threats and ethics. Advances in military research should be understood from a biological and chemical warfare threat. Warfare that seeks to psychologically harm should be classified in an internationally accountable means, similar to chemical and biological weaponry. In example, NATO materials that indicate avenues to cause mass hysteria could be considered for rejection on the grounds of medical, health and ethical concerns Additionally, biomedical advances should be assessed for potential use and misuse. The alteration of a soldier’s genome, as an example, should be part of today’s discussion on biomedical innovation and military research. Innovation should also be understood from concerns related to artificial intelligence, robotics and other potential misuse. International attention should be given to terms such as “super soldier” and “enhanced soldier”. What are these individuals signing up for, and who is protecting their rights? Who is looking after long term health outcomes to “enhancements”? Keeping the innovation work a secret, or keeping it out of public eye, is not the solution either. Because irreversible loss of trust with biomedical research involving the armed forced is never an intelligent trade, ethics and commitment to the service person must by priority. Ethical considerations may seem second priority, yet international attention and guidance can prevent grey area exacerbation. If organizations such as SIPRI are committed to the literature leadership, ask them to take the responsibility in accompanying global governance(25). Possibilities and creation of biomedical advances do not always translate to better. With clarity to international structure and accountability to national metrics, we can assess biomedical oversight. If we step back and remember those JTHC goals of better prepared, better protected and better cared for, we have a basis for analyses. The international community must commit to military R&D review of long term outcomes, data and application of use, accompanied by ethics. International governance, national oversight and bioethicists must commit to make the effort for the public, as well as make the effort for the individual service person. Because we hold militaries in high regard, others willingly to protect us at any cost, setting these expectations supports the preservation of their identities.

The one thing we can control in military life sciences research and development is effort. Let’s make the most of our efforts, with international collegiality, civilian partnerships, attention to technology transfer, commitment to evidence, commitment to ethics and emphasis on transparency to structure. Let’s make the most of our efforts to support military life science R&D by committing to our best, and by prioritizing the rights and health of the service person first.

Traveling with the Refs:

1.https://www.natlawreview.com/article/china-s-academy-military-medical-sciences-patent-application-gilead-s-remdesivir

2.https://apnews.com/press-release/business-wire/d93c671bf67d4353858679ccf3084277

3.https://www.arl.army.mil/business/broad-agency-announcements/

4.https://www.rand.org/content/dam/rand/pubs/rgs_dissertations/RGSD300/RGSD321/RAND_RGSD321.pdf

5.https://www.acresglobal.net/ https://www.nejm.org/doi/full/10.1056/NEJMp1806934#full

6.https://www2.deloitte.com/content/dam/insights/us/articles/4818_Innovations_military_health/DI_Innovations-military-health.pdf

7. https://apps.dtic.mil/sti/pdfs/ADA582099.pdf

8.https://www.tandfonline.com/doi/abs/10.1080/10242694.2010.491681

9.https://www.researchgate.net/publication/315467032_Patents_and_Dual-use_Technology_An_Empirical_Study_of_the_World's_Largest_Defence_Companies

10.https://defenseinnovationmarketplace.dtic.mil/wp-content/uploads/2018/04/ASBREM_Integrated_RD_Strategy_2017.pdf

11.https://www.nato.int/nato_static_fl2014/assets/pdf/2020/4/pdf/190422-ST_Tech_Trends_Report_2020-2040.pdf