OPINION:
Shortly after the World Health Organization learned of “a pneumonia of unknown cause … in Wuhan, China,” leading U.S. research firms started working around the clock to learn more about the novel coronavirus. In just three months, dozens of promising treatments and vaccines have entered the pipeline. Some are already in human trials.
This record-breaking pace is thanks, in part, to the dedicated efforts of America’s biopharmaceutical industry. Every day, our nation’s scientists research treatments for various diseases. That’s why the government can count on them in times of crisis.
On March 24-25, I tuned in for a virtual summit hosted by the Biotechnology Innovation Organization, where industry leaders and senior government officials discussed the many ways they’re already working together to fast-track a cure. Participants also brainstormed other ways they might be able to cooperate.
Public health crises require an all-hands-on-deck approach. We can’t afford to have scientists working in isolation. That’s why the public-private cooperation highlighted at BIO’s summit was such an inspiration.
Consider some examples.
Leading biotech Moderna quickly partnered with the National Institutes of Health’s National Institute of Allergy and Infectious Disease (NIAID) to develop a vaccine candidate using mRNA technology. Phase I clinical studies were launched on the candidate in March. The NIAID is also conducting phase III clinical trials for Gilead’s investigational antiviral drug, remdesivir.
Johnson & Johnson is collaborating with Health and Human Services’ Biomedical Advanced Research and Development Authority to screen potential antiviral compounds that could lead to a new treatment and to use existing technologies to help hasten the development of a vaccine. And Roche has teamed up with BARDA to initiate phase III clinical trials for Actemra, a potential intravenous treatment for adults with COVID-19 pneumonia.
This is how things are supposed to work in a pandemic, where speed is key. But stakeholders can do even more to accelerate our response to the COVID-19 outbreak in the coming months. As a start, policymakers and research firms should work to safely expedite regulatory and approval processes.
This could begin by encouraging scientists — whether federally funded or working at a private research firm — to share data on how the virus progresses in different patients. When designing and conducting clinical trials, this knowledge could help researchers quickly adjust.
At the FDA, policymakers should consider expanding the “Animal Rule” — a regulation that permits the approval of certain products based on safety testing in humans and efficacy testing in animals — to COVID-19 therapies. Designed for quick development during public health emergencies, the FDA first approved a drug under this rule when it fast-tracked BioThrax, an anthrax vaccine.
The public and private sectors should also work to accelerate manufacturing capacity once a diagnostic, therapy or vaccine is successfully developed.
Linking small biotechs with larger companies can help make such large-scale manufacturing possible. Already, biotech giants like Biogen are working with firms like Vir Biotechnology and WuXi Biologics to mass-produce human antibodies that could treat COVID-19.
The federal government can help expedite this by investing in more facilities capable of rapidly manufacturing vaccines and antivirals. Health and Human Services recently took an important step by launching the “Rapid Aseptic Packaging of Injectable Drugs” (RAPID). The new public-private consortium will build a network of eight complexes capable of churning out hundreds of millions of pre-filled medicines at low cost.
Finally, policymakers should work with the private sector to ensure that the right resources are going to the right partners at the right time. How quickly research scientists have been able to advance investigational therapies and vaccines into clinical trials is a testament to the power of collaboration. But private companies and government agencies must continue to find new ways of operating with speed and efficiency.
The progress we’ve already made against COVID-19 demonstrates the importance of preserving our nation’s world-class biopharmaceutical industry. Politicians from both parties may attack drug developers in good times, but crises like COVID-19 remind us that the men and women of the biopharmaceutical industry are heroes, not villains.
The pandemic also reminds us of the important but separate roles the public and private sectors play. Trade associations like the Biotechnology Innovation Organization can play an important part in forging connections between the biopharmaceutical industry and key partners in academia, the federal government and other public health stakeholders. Putting the pedal to the floor on these partnerships will ensure we defeat this virus quickly — and for good.
• Peter J. Pitts, a former FDA Associate Commissioner, is president of the Center for Medicine in the Public Interest.
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