Coronavirus Offers Opportunities and Challenges for Biopharma R&D


Applied Clinical Trials

The research community is moving quickly to launch clinical trials of potential countermeasures, while regulatory authorities aim to support product development through regulatory flexibility.

The alarming spread of the dangerous virus that emerged several weeks ago in Wuhan, China is prompting small biotech researchers and leading pharma companies to launch a range of initiatives for developing new treatments, preventives, and diagnostics. The research community is moving quickly to launch clinical trials of potential countermeasures, while regulatory authorities aim to support product development through regulatory flexibility.

After appearing to be confined to China, the virus began to emerge in other countries in February 2020, as it showed signs of human-to-human transmission. The World Health Organization (WHO) declared an international health emergency, prompting public health agencies and industry to ramp up efforts to better diagnose infections and provide treatment. As of February 5, the virus (2019-nCoV) had infected more than 24,000 people and caused more than 500 deaths, but these numbers increase daily. Several cases have been identified in the United States, where hundreds of recent arrivals from China have been quarantined in hopes of limiting the epidemic.

A first step for FDA was to grant Emergency Use Authorization (EUA) for the Centers for Disease Control and Prevention (CDC) to distribute a new coronavirus diagnostic, permitting qualified laboratories around the country to use the test, as opposed to just the federal agency. While CDC plays a lead role in monitoring and limiting the outbreak, the Trump Administration appointed a broad committee headed by Health and Human Services (HHS) Secretary Alex Azar to map out a strategy and response to the epidemic. The panel includes top officials from FDA, CDC, the National Institute of Allergy and Infectious Diseases (NIAID) at the National Institutes of Health (NIH), as well as delegates from the State Department, Homeland Security, Department of Transportation, and Office of Management & Budget.

Meanwhile, a number of companies announced plans to test promising and related compounds for effectiveness against the new virus. An early comer is Regeneron, which looks to parlay its research on an antibody against Ebola into a treatment for the new virus. Similarly, Gilead announced plans to test its experimental antiviral drug, remdesivir, which has been in Ebola clinical trials and was administered to a US patient infected with the new virus, with positive, but inconclusive, results. Gilead has provided the drug to Chinese officials who have set up a process for conducting randomized clinical trials on multiple infected patients and with multiple compounds. Several clinical trials sponsored by academic research institutions are testing therapies approved to treat AIDS and hepatitis for effectiveness against the new coronavirus.

Leading biopharma companies also moved to develop vaccines, with Johnson & Johnson announcing a vaccine R&D effort in the Netherlands. The Coalition for Epidemic Preparedness Innovations (CEPI), a global partnership based in Oslo, has announced four projects with biotech firms to develop a vaccine. GlaxoSmithKline also agreed to provide CEPI with access to its pandemic vaccine adjuvant platform to support these efforts. Any successful vaccine development, however, will require leading pharma manufacturers to step in with the capacity to scale up vaccine production quickly.

While research expands, health authorities are looking to contain the virus through quarantines and travel bans; Chinese industry and business came to a halt in many areas, as authorities examine the extent to which nCoV can be spread by individuals without symptoms. So far, the outbreak appears to be traveling faster than the SARS pandemic in 2003 and may be more deadly. While several endemic coronaviruses circulate continuously around the globe, they largely affect animals and cause colds and sometimes pneumonia in children and the elderly but are seldom fatal.

Shortages ahead?       

While researchers seek new therapies to stem the pandemic, fears have grown that the shutdown in China of much manufacturing and production will dry up vital supplies of APIs and some finished medical products. Many Chinese producers extended Chinese New Year breaks for added weeks. In addition, FDA halted staff travel to China, postponing inspections of manufacturing sites and other business. Chinese producers are particularly important for antibiotic production, which could be affected by prolonged closures.

Another concern is that the pandemic could disrupt numerous commercial clinical trials being conducted in China, and notably in Wuhan, for a range of therapies under development by leading biopharma companies. Delays in enrolling and treating research subjects could postpone product development.

These initiatives to stem the outbreak require additional funding and resources. WHO has called on the international community to provide $675 million to bolster preparedness and response over the next three months, including support for research and innovation. The Bill & Melinda Gates Foundation is providing up to $100 million to improve detection, isolation, and treatment efforts; $60 million is earmarked for accelerated development of vaccines, drugs, and diagnostics. HHS has requested leeway to shift funds from other programs to bolster CDC efforts, but added resources will be needed to support more extensive research and response initiative.





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