87 TWENTYFOURSEVENBIOPHARMA Issue 3 / October 2025 It enables fully electronic trial management – from data capture and randomization to telehealth and specimen tracking – through a single, unified database. With built-in AI tools, it also means we can generate protocols in days rather than months, which is critical when developing urgently needed products for the military. Customization for a transient population, security, and flexibility are what set military trials and the infrastructure behind them apart. With so many different players involved government agencies, CROs, biotech companies how do these military and government-funded research projects actually work? The U.S. government typically funds these projects through Government-wide Acquisition Contracts (GWACs), large IDIQ (Indefinite Delivery, Indefinite Quantity) contracts, or Other Transactional Authority (OTA) consortia. Think of it as a long-term partnership, usually five to ten years, with a select group of prevetted, down-selected companies. These might include CROs like Emmes or product developers like Emergent Biosolutions. You go through a competitive process, showcasing your past performance, capabilities, and how you’d approach certain types of work. Once you’re selected, the government can quickly award work, like running a clinical trial, without starting from scratch each time. Another key model is public-private partnerships (PPPs), where smaller biotech companies, often funded by U.S. agencies or international research institutions, collaborate with CROs like Emmes to run studies and navigate regulatory pathways. These projects are mission-driven focused on national security or public health not just commercial viability. It’s also important to understand that government funding is not centralized, and that DoD, NIH, and the VA each have their own budgets and priorities. Right now, we’re seeing consistent growth in DoD funding. You really do need lots of experience to handle these trials effectively. With our extensive experience, it’s beneficial for us to actively focus on supporting that space. What is perhaps less appreciated, however, is that there is still a massive role for private sector innovators. So while we are engaging with government sponsors this week, we are most definitely trying to meet with private biotechs in both clinical and preclinical stages that may have a military or military/ civilian use case. These sponsors need a CRO partner that can manage the logistical, technical and even, tacit barriers these trials present. From military settings, we might be dealing with a brand-new disease, and that sounds like a huge investment. Are researchers building everything from scratch, or can they adapt something that already exists? That’s an interesting question, and in reality, it depends. In some cases, manufacturers can repurpose an existing platform like one developed for COVID-19, Zika, or Malaria and simply swap in the active ingredient to target a new pathogen. Other times, they have to start from scratch, sequencing the virus and building a new vaccine entirely. To speed things up, many are now investing in flexible platform technologies like mRNA. With the platform already built, you can pivot quickly to target new threats like COVID-19, RSV, even emerging biothreats. That’s how companies like Moderna and BioNTech responded so fast during the pandemic as they had their mRNA platforms already established. The challenge is that these diseases often don’t offer a commercial return, so big pharma isn’t always interested. That’s where the Department of Defense, BARDA, NIH and nonprofit funders step in. Their focus is on protecting “warfighters”,preparing for public health threats, and improving clinical standards for U.S. civilian populations, not chasing profits. However, once a vaccine is developed and stockpiled by the DoD and BARDA, there’s often a civilian use case benefit too – for example, making a new vaccine available through travel health clinics for people headed to high-risk regions. This dual-use model allows manufacturers to earn certain and immediate additional revenues through DoD contracts, while also supporting broader public health needs. Beyond infectious disease, what other areas are emerging as priorities in military clinical research? Neuroscience is a major focus, especially conditions like traumatic brain injury (TBI), PTSD, depression, and other mental health challenges affecting both active-duty personnel and veterans. These aren’t just health issues, they’re tied directly to both operational readiness and a successful acclimation back into civilian life after discharge. We’ve supported studies on treatments like hyperbaric oxygen for TBI and drug-device combos for PTSD. One of the most promising and fast-moving areas here is psychedelic therapy. Substances like psilocybin are gaining traction with both the Defense Health Agency and FDA, given their potential to treat PTSD, BIOTECH
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