Government and pharma search for post-pandemic silver linings

Regulatory NewsRegulatory News
| 12 March 2021 | By Kari Oakes 

Where will biopharmaceutical research head once the pandemic abates? This week, the Milken Institute assembled leaders from federal agencies, nonprofit organizations, and the pharmaceutical industry for an hour-long discussion to answer the question of whether there may be post-pandemic silver linings for biomedical innovation.
Though some things were done right, some things could have been done better, said Janet Woodcock, MD, acting commissioner of the US Food and Drug Administration. Woodcock cited a recently published Nature Reviews study she co-authored that examined the COVID-19 clinical trial landscape.
“What we discovered is that only five percent of… trials that were registered and ongoing were both randomized and adequately powered to yield actionable information, so there was a tremendous amount of duplication -- a lot of small trials, investigator-instigated trials that yielded, basically, tantalizing information that sent people off here and there using treatments that potentially were not useful and were potentially harmful.”
Added Woodcock, "The bottom-line lesson of that particular learning is that, you know, in the global emergency we need to have more central coordination, because we should really randomize the first patient when something like this happens and learn from every single person.  We could learn much, much faster."
Woodcock, not for the first time, made the point that community-based clinical research is more important now than ever. “This relates to something I've been pushing on for a long time, which is what we discovered -- and this included the ACTIV trials and other trials that were done and it relates to what Francis [Collins] said -- is that if we don't have research infrastructure in the community where people get their health care, where they are used to going, then we're not going to reach those communities in an emergency.”
Richard Moscicki,MD, executive vice president of science and regulatory advocacy and chief medical officer at PhRMA, spoke of the importance of not squandering the investment in innovation that came with COVID-19. He also believes that the new spirit of collaboration among former competitors will be durable.
“You saw companies that are fierce competitors put that aside very quickly to work with each other -- to work alongside and to share -- and not just with each other, but also with the [National Institutes of Health (NIH)] and with FDA and with regulators around the world. We really saw a coming together of this.”
Not just pre-clinical data and animal models were swapped between major players in the pharmaceutical industry, he noted. “We were sharing actual patient-level data” through platforms such as TransCelerate, the nonprofit that aims to foster global collaboration in biopharmaceutical research and development.
Not only did companies collaborate on development, but “we’ve also seen an unprecedented willingness to share manufacturing facilities,” noted Moscicki. “I think this has been just a very remarkable time. And what can we carry forward? I don’t know. I hope we continue to think… I think we’ll make a difference in the future as well.”
NIH director Francis Collins, MD, PhD, and Woodcock both touched on how biomedical research has affected, and was affected by, the intersection of the pandemic and America’s longstanding problems with racism. After a deep exercise of self-examination at NIH following George Floyd’s death and a summer of protests, Collins said that the institution is ramping up intensive efforts to diversity its own workforce, while it continues to work with investigators and pharmaceutical companies to increase diversity in clinical trials.
“I can’t tell you how many Saturday mornings I’ve spent…meeting with the leadership of the companies that were running those trials trying to do what we could to boost up the participation with diverse individuals – because it was not going well at the beginning,” said Collins.
One way forward, said Woodcock, is by decentralizing clinical trials, especially for some “pressing questions” that can be answered in the primary care setting.
Returning to a common theme, she noted that diversifying enrollment was a challenge in COVID-19 vaccine and therapeutic trials. “One of the reasons we could not reach those populations as well as everyone desired is that they didn’t have the clinical trials infrastructure support, the research personnel; the investigators didn’t have training; they hadn’t been doing research because they hadn’t been supported in doing research,” she said.
“We have to move clinical research out into the community, and we have to support that if we’re going to be successful,” said Woodcock.
Milken Institute


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