- The National Institutes of Health has launched a sweeping public-private partnership with 16 drugmakers, including Pfizer, Amgen, Bristol Myers Squibb and GlaxoSmithKline, to help speed up and organize a now-sprawling search for COVID-19 treatments.
- The partnership, dubbed Accelerating COVID-19 Therapeutic Interventions and Vaccines, aims to help develop a more "coordinated research response" to the pandemic. Some 657 COVID-19 trials are listed in the clincialtrials.gov database, many of which are meant to test similar therapies.
- The partnership is the latest, and perhaps broadest, example of industry giants' willingness to work together, and share data to help trial COVID-19 treatments as quickly possible.
The coronavirus pandemic is forcing biopharma companies and regulators to act quicker than they ever have to speed treatments to approval. And that, in turn, is leading to creative collaborations rarely seen before.
Some examples are already in place. The Bill & Melinda Gates Foundation and Wellcome, for instance, joined with regulators, non-governmental organizations and drugmakers in March to form the COVID-19 Therapeutics Accelerator. More than a dozen pharmaceutical companies and biotechs, and a few venture firms, recently created the "COVID R&D" consortium. Large rivals are joining forces on individual projects, too, like Sanofi and GlaxoSmithKline's plan to co-develop a coronavirus vaccine, or Takeda and CSL Behring's joint work on a plasma-derived therapy for COVID-19.
"We are seeing an unprecedented level of collaboration across the innovation ecosystem to address this global health crisis," said Pfizer chief scientific officer Mikael Dolsten, in a statement.
They aim to cut down the amount of duplicative work and to move treatments through testing faster. There are more than 100 potential therapeutics already in development for COVID-10, but that work has largely been disorganized and chaotic, as recently reported by the Washington Post. As of Friday, 657 COVD-19 trials testing prospective COVID-19 therapies, such as antivirals, vaccines or repurposed medicines, were listed in the clinicaltrials.gov database — 304 of which are active or recruiting.
The proliferation of studies can have real consequences in how quickly testing of the most promising can advance. Even in hot spots, there are only so many patients who are eligible for clinical studies, and only so much capacity on the part of investigators and hospitals to adequately manage trials. Overwhelming trial centers with dozens of study initiations could result in fewer studies meeting their enrollment targets.
The urgent need for therapies, meanwhile, has thrust into the spotlight unproven drugs, including some with notable side effects. The resulting rush to allow early patient access outside of trials may mean important data is not collected or delayed.
Today's announcement by the NIH represents perhaps the most wide-ranging effort to help organize the chaos.
The initiative brings together 16 pharmaceutical and biotech companies, two regulatory agencies (the Food and Drug Administration and the European Medicines Agency), NIH, the the Centers for Disease Control and Prevention and the Health and Human Services Office of the Assistant Secretary for Preparedness and Response.
The Accelerating COVID-19 Therapeutic Interventions and Vaccines, or ACTIV, aims to form a "collaborative framework" to pick the right treatments to advance and streamline the studies they move through. That means pharma companies used to competing with another will put aside their individual goals and work together to evaluate and develop possible COVID-19 drugs.
Drugmakers in the collaboration, for example, will provide cash, infrastructure, and existing drug candidates and share associated data with one another. They will sift through their own arsenals to amass an inventory of medicines that work differently and have "acceptable safety profiles." They'll partner to design trial protocols and agree on study goals and, in the case of vaccines, possible 'surrogate' markers for effectiveness. ACTIV will form a steering committee — consisting of FDA, NIH and biopharma R&D leaders — to rank possible treatments and pick which ones to prioritize and quickly test.
"We need to bring the full power of the biomedical research enterprise to bear on this crisis," said NIH Director Francis Collins, in a statement.
"Now is the time to come together with unassailable objectivity to swiftly advance the development of the most promising vaccine and therapeutic candidates that can help end the COVID-19 global pandemic."