PANDEMIC RESPONSE
An example of a CRADA’s inherent flex- ibility is the 2016 Ebola CRADA and subsequent other-transaction agreement between Gilead and JPEO-CBRND. In that instance, the agreement included a CRADA whereby a substantial amount of the work was scheduled to take place at the USAMRDC’s USAMRIID. Accord- ing to Kelly, that’s when the USAMRDC legal team stepped into the fold to ensure the various agreements were aligned and, in a turn of legal parlance, “spoke to each other.”
LEGAL ELITE “Our legal team here at USAMRDC is actually recognized well beyond the Army in terms of its capability to provide legal solutions
to facilitate FDA-regulated
medical product development,” said Kelly. “Our expertise and the way that we staff these agreements is very unique to the federal government. Our attorneys are right there alongside our contract teams, making sure that the intellectual property, technical data-rights provisions and the FDA regulatory provisions are all aligned in such a way that the government's not only going to achieve its short term goals, but it's actually going to be structured in a way that, if the data is supporting, would result in an FDA-approved, licensed, or cleared product. We are the DOD’s recog- nized legal experts in medical product development, including intellectual prop- erty and FDA regulatory law. We are all passionate about our mission and bringing to bear our expertise to help our clients defeat this virus."
According to Bob Charles, chief of medi- cal-research law with USAMRDC, the command has anywhere between 800 to 900 active CRADAs at any given time, efforts that have led to more than $400 million in direct funding from collaborat- ing partners for research-and-development efforts.
“I don’t think there’s any organization within the federal government that utilizes a tech transfer authority like the CRADA function as frequently as MRDC does,” said Kelly.
Opportunities for CRADAs, Charles said, normally begin at the scientist or researcher level, and can start with something as simple as a scientist reading about prom- ising research in a journal, or perhaps even hearing about a new technology during a conference. In other words, the CRADA process employs (and encourages) a kind of grassroots, bottom-up approach to help gather initial momentum.
“Our scientists generally have a very good handle on what’s out there in the scien- tific community and who would be great to partner with,” said Kelly on the process. “Tere are folks who do a ton of market research continually to see who is doing what with what molecule out there.”
With regard to remdesivir, that kind of awareness (combined with the previously described close relationship between
USAMMDA and JPM CBRN Medi- cal) enabled all entities involved to move quickly. Kelly and his team began almost immediate development of a CRADA, and—operating through USAMMDA— secured 100 treatment courses of remdesivir (for military use only) through Gilead, with an option for an additional 100 later. For reference, 100 treatment courses is approximately 1,100 doses.
“Te ability for us to rapidly use the CRADA authority to [process] remde- sivir has saved lives,” said Kelly. “And that’s not hyperbole. It’s literally saved lives. It would’ve been a real question mark as to who would take the ball and run with it if we weren’t able to use our CRADA authority to rapidly partner with Gilead.” Meanwhile, he added, the other-transaction authority and CRADA mechanisms established to study remdesi- vir for use against Ebola continues.
LIGHTNING IN LANDSTUHL Back in the Force Health Protection office at USAMMDA, Parriott is still manning the phones—they are, after all,
https://asc.ar my.mil 31 MEDICAL PRACTICE
Video image of active efforts taking place in a USAMRDC lab. The video was recorded as part of a taped video presentation on behalf of the USAMRDC’s contribution to an October AUSA event. (Video image courtesy USAMRDC Public Affairs)
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