depression, and suicidal ideation. Our experience in complex neuro/psych trials, coupled with our DoD track record, puts us in a strong position to support this emerging space and we are directly engaged with DoD for pilot projects for psychedelic research and trial endpoint creation. How do you recruit patients for neurological or mental health studies within military populations? What are the main challenges? Recruiting for military trials is very different from a commercial setting. A typical study might rely on traditional research hospitals,community sites, or commercial site networks, but military studies require you to go where the active-duty service members are and that means military treatment facilities (MTFs) and VA medical centers. For example, That’s where active duty military personnel and their families receive care during and after deployments. For veteran populations, we turn to VA hospitals, where they continue to receive long-term care after discharge. There are added layers of complexity here, from site feasibility to data-sharing and data use agreements, which is where Emmes brings a lot of value. We already work with partners who have active CRADAs (Collaborative Research and Development Agreements) in place with the DoD MTFs. That means the legal and operational frameworks for clinical trials are already established, allowing us to bring MTFs into studies more efficiently. And on the VA side, we also collaborate with patient advocacy groups and VA-focused non-profits who can help us identify the right medical centers and ensure we’re reaching the veterans who truly need these therapies. So it’s not just about knowing the science, it’s also about knowing the ecosystem. What are some key learnings from military trials that can be applied to broader clinical research? A big takeaway is patient retention amongst a transient population. Military trials often involve participants who are relocating around the country over few years or transitioning out of service, so you learn quickly how to keep them engaged and compliant with each protocol, which provides lessons that are valuable across all types of studies. Another is trial design. The DoD has been an advocate forplatform trials, also called master protocols, especially in the mental health space. Instead of running separate studies for different PTSD treatments, they use a single protocol with multiple arms testing, say, a pill, a nasal spray, and an IV treatment all in one trial. It’s efficient, supports subgroup analysis, and accelerates decision-making by putting multiple investigational products head-to-head to generate data to see what product(s) graduate to Phase III and beyond. This type of platform trial or basket trial approach was originally created for oncology trials, where patients had little other treatment options and so multiple targets and approaches were used within a single trial. Emmes has supported many government trials over the years. How do these partnerships actually work and what should biotechs know if they want to enter that ecosystem? Does Emmes play a role? Absolutely. We’ve been in the government research space for decades, but what’s new is how many biotechs now come to us saying, “We have a promising candidate but don’t know how to approach the DoD, BARDA, or NIH for funding.” That’s where our CRO support services and knowledge of government funding pathways and mechanisms help these companies, often through small consulting agreements navigate the funding landscape. That might mean refining grant proposals, aligning trial designs with agency expectations, and/or building budgets for Phase I, II, and III studies still 5-7 years in the future. It’s especially valuable for companies new to the space who need guidance to compete for non-dilutive funding as nontraditional government contractors and grantees. Agencies like DoD are actively funding areas like infectious disease, neurology, and biodefense. But breaking in can be tough if you’re unfamiliar with the process. The best piece of advice for biotechs would be that there are a few consortia set up by the DoD, BARDA, and ARPA-H – you should consider joining if this space is of interest. These include the Medical Technology Enterprise Consortium (MTEC), the Medical CBRN Defense Consortium (MCDC), BARDA’s Rapid Response Partnership Vehicle (RRPV), and the ARPA-H Customer Experience Hub. These groups often get early visibility into upcoming solicitations and funding opportunities. So, if you’ve got a high-potential therapy and you’re exploring non-traditional funding routes, government partnerships can be incredibly strategic. We’ve built our model to help companies do exactly that. BIOTECH WILL CHU Editor 24/7 BIOPHARMA 88TWENTYFOURSEVENBIOPHARMA Issue 3 / October 2025
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