Blog June 1, 2020

Coronavirus Impacts on Industry: Part 2

Pandemic Slowing Other Aspects of Drug R&D

Bionest experts discuss some of the impacts of the COVID-19 pandemic on pharma

In the first part of this post, we discussed how the COVID-19 pandemic is spurring world-wide efforts to discover and develop new diagnostics, vaccines and treatments aimed at preventing infection or mitigating its most severe effects. In Part 2, we report on how the pandemic is causing a slow-down in other industry activities.

One of the areas experiencing the greatest impact is the conduct of clinical trials for treatments unrelated to coronavirus infection. Some companies, including Pfizer, Bristol-Myers Squibb, and Lilly, have paused enrollment in a number of ongoing clinical studies, with others postponing trials altogether for the foreseeable future. Some smaller biotech and pharmaceutical companies, with more limited financial resources to deal with long delays, are greatly paring back the number of their development programs, knowing that development timelines are likely to be significantly extended. 

Several factors are influencing the delays. As major U.S. medical centers and other potential trial sites deal with the growing number of coronavirus cases requiring hospitalization, it has been difficult to gain mindshare for studies and administrative needs unrelated to the virus. In some areas, site identification and patient enrollment has been slowed by restrictions on population movement. According to a 40-country survey by ICON, 65% of global clinical sites have been affected by the pandemic. Similarly, in mid-March, Continuum Clinical Survey reported that approximately 39% of clinical sites said the coronavirus pandemic would have a big or extremely big deleterious impact on their ability to recruit patients for new trials or keep patients in ongoing studies, due to scheduling problems. In the mental health space, some companies and CROs are postponing trials, leaving investigators and patients who are actively seeking to participate in studies with no opportunities to take part.

The pandemic has caused business concerns in other areas as well. Manufacturing is being affected both by supply chain delays, especially for those reliant on imported active pharmaceutical ingredients and excipients, and by employee absences. Lockdowns have severely limited pharmaceutical manufacturing activities in Baddi, Himachal Pradesh, India, a key center for drug manufacture, either shutting down firms or limiting capacity to 35% or less. As a result, U.S. hospitals are starting to experience shortages of key drugs, especially anesthetics and pain medications. In response, the FDA is temporarily allowing hospitals to source hard-to-find drugs from compounding pharmacies to treat certain patients with severe COVID-19, and the Drug Enforcement Agency (DEA) is permitting increased production of certain controlled substances, including fentanyl, ketamine, phenobarbital and diazepam. On the positive side, companies with significant manufacturing resources, such as Pfizer, have promised to use their excess manufacturing capacity and potentially to shift production to support other companies in getting needed COVID-19 breakthroughs to patients as quickly as possible.

Significant delays have also hit the FDA, which has warned companies of the likelihood of the pandemic affecting its ability to meet current user fee goal dates. As a result, the agency has begun re-writing its schedule on drug reviews, and prioritizing COVID-19 related matters over activities related to most other drugs. The FDA has also been postponing inspections of foreign facilities, while increasing their scrutiny of products at U.S. ports of entry.

In addition, Cancer Research UK (CRUK) — that nation’s largest funder of cancer research — has been forced to make 20% funding cuts across its existing grants, institutional funding, and at its national network of cancer centers. These cuts mean a total loss of US $54 million across the institution’s entire research portfolio. CRUK also expects donations to fall by as much as 25% this year, as a result of the economic impact of the pandemic.