NOT-SO-SECRET WEAPON
REGULAR REGULATION Saving lives is, indeed, one of ORA’s broader goals—one that feeds into the command’s overall mission and vision. As its name suggests, the Office of Regulatory Affairs is chiefly tasked with monitoring all regulatory affairs of USAMRDC and is responsi- ble for all clinical, quality and internal regulatory efforts within the command to help advance promising military products to the warfighter. If that sounds like a lot of weight to carry, that’s because it is. Teir work is front and center, and provides more value and impact than most people realize. ORA is known for maintaining a sprawling infrastructure that touches just about every corner of the command, and sometimes beyond.
“A lot of business at MRDC—things like getting regulated prod- ucts out to the warfighter, for example—wouldn’t happen if ORA wasn’t here,” said ORA director Lisa Borek as she described a sort of brass-tacks breakdown of the organization’s impact. “A lot of people don’t fully understand what we do and how we func- tion as the centralized regulatory capability available to both USAMRDC and the DOD; and that’s a shame because we’re a pretty big group.” Tat work, which boils down to providing the knowledge and regulatory guidance required to navigate the occasionally tricky regulatory affairs pathway, is critical to the mission of USAMRDC and, to a larger extent, DOD as well.
Te process of helping usher a product down an oftentimes complex regulatory pathway, makes the organization an integral
part of the overall research, development and acquisition effort. Normally, the development of medical products regulated by the U.S. Food and Drug Administration (FDA) follows rigorous approval paths to ensure safety and effectiveness. ORA’s main function is to act as the facilitator between military medical research and the FDA. By acting as a navigator of sorts, ORA helps to develop regulatory strategies through those pathways, applying and interpreting FDA regulations and guidance for partner organizations.
MAKE IT HAPPEN “We are everywhere,” said ORA deputy director Maj. Victor Zottig. He described the organization’s role as that of a facilita- tor between product developers and the FDA. “We deal with a very interesting and innovative space, and we have to come up with creative solutions to make sure those products pass FDA muster—but then also get to the warfighter as soon as possible.”
ORA’s portfolio includes more than 100 different and varied products across all stages of research and development (as the saying goes around the office, you never see the same thing twice, and it never gets boring). Currently, ORA is partnering with the U.S. Army Medical Materiel Development Activity (USAM- MDA) Warfighter Brain Health project management office on proper protocols for a pair of adaptive clinical trials, along with a slew of vaccines and therapeutics to help combat everything from infectious diseases to traumatic brain injury and post-traumatic stress disorder. Since compliance efforts usually last the entire life cycle of a given product, it’s common for ORA to provide oversight and regulatory consultation for anywhere from a couple years to the better part of decade, if need be.
Te benefits of connecting with ORA early in the product devel- opment process include, perhaps most importantly, opportunities for industry partners to plan for a more efficient allocation of financial resources. For example, knowing whether a product may require a specific study to gain FDA approval will likely help a team use money and time more effectively and efficiently. Indeed, even if an industry partner is unsure whether the prod- uct they’re developing needs to meet any FDA requirements at all—products like software or certain types of diagnostics, for instance—ORA can answer those questions before the work even begins.
TEAMWORK
Cyndi Donovan, center, poses with USAMMDA staffers during a site visit to Germany in 2020. (Photo courtesy of Cyndi Donovan)
“By interacting with us early, we hopefully can avoid some of the shortcomings of the product development process,” Zottig said. “A lot of pre-clinical trial research doesn’t necessarily require extensive FDA oversight, but by the time you need FDA guidance
16 Army AL&T Magazine Fall 2022
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