NIH corrals biopharma companies, regulators and trial networks to coordinate Covid-19 R&D
Francis Collins’ grand plan to bring order to the chaotic rush for Covid-19 vaccines and treatments is here.
The public-private partnership that the NIH director teased a few days ago will be known as ACTIV or Accelerating COVID-19 Therapeutic Interventions and Vaccines. By compiling resources, leveraging existing networks, lobbying regulators and setting up a steering committee to prioritize promising candidates, the goal is to generate more comprehensive data quicker.
“We want to do this in the most compelling scientific way,” Collins said in a telebriefing, where he echoed earlier comments that he hopes to find 3 to 4 treatments that show benefit around June or July.
Aside from government agencies — the FDA and its European counterpart, the HHS and the CDC — 16 biopharma companies were also named to the group: AbbVie, Amgen, AstraZeneca, Bristol Myers Squibb, Evotec, GlaxoSmithKline, J&J, KSQ Therapeutics, Eli Lilly, Merck, Novartis, Pfizer, Roche, Sanofi, Takeda and Vir.
There are currently more than 400 clinical trials evaluating potential Covid-19 drugs and vaccines, according to clinicaltrials.gov — a number that grows by the day. A working group within ACTIV will take all the databases currently out there, from BioCentury’s resource center to the Milken Tracker and merge them to get a good idea of everything that’s out there, Collins said.
Then they will begin ranking all the candidates and, when necessary, rejig current arrangements:
A number of trials, as you know, are underway with hydroxychloroquine and chloroquine. One of the things that the group is trying to do is to get an inventory of exactly how many trials of what size and what severity of patients are there, because it may well be that we already have enough to information to be able to assess whether there’s benefit or not, in which case those trials might better be adapted to some other candidate therapeutics. The remdesivir trial which NIH is running has already enrolled 800 participants when it only needed 500 to be powered. One of the questions is should that particular trial network, already existing, now be adapted to try a different approach, a different candidate therapeutic, so that we can learn things as quickly as possible.
Also part of the plan: designing, launching and sharing master protocols that use a single control arm. It would presumably be an expansion of ACTT, the adaptive trial that the NIAID has already launched with Gilead’s remdesivir and Eli Lilly’s Olumiant. Existing NIH networks that are previously focused on everything from HIV to organ transplants have also pledged to help.
While any company is still free to move on with their own therapeutic candidates, there may now be less room for them to do so. Between all the players involved in ACTIV, Collins added, they will likely have control of the majority of public and private clinical trial networks.
For the 40-plus vaccine programs, the main focus is on developing assays, consolidating data on immunological responses and figuring out surrogate endpoints.
But it also goes beyond what’s already in the clinic, with mandates to standardize preclinical evaluation and increase access to validate animal models, which tripped up researchers in the early days.
Like the FDA’s Coronavirus Treatment Acceleration Program, it’s all intended to find something, anything, that can reduce the disease’s devastating toll as the White House instructs states to consider lifting movement restrictions in May. In its days of existence, critics have lamented that CTAP has not lived up to its promise; it remains to be seen whether a “national strategy” can speed things up on the ground.
“There’s a lot of resources already devoted to this,” Collins said, citing congressional funding and the pharma partners’ commitments. ‘They need to be directed in the best way.”
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