There is almost no part of the globe that will remain entirely unaffected by the COVID-19 pandemic, in terms of healthcare or a resulting financial recession. Awareness is increasing of the short and long-term impacts of COVID-19 on clinical research, drug development and manufacturing, and pharma industry regulation, which we will discuss in this article.
Apart from possibly Antarctica, there is almost no corner of the globe that will remain entirely unaffected by the COVID-19 pandemic, in terms of healthcare or a resulting financial recession. The causative virus, human SARS-CoV-2, of the family Coronaviridae, is similar to several other severe respiratory conditions, such as Severe Acute Respiratory Syndrome (SARS) and Middle East Respiratory Syndrome (MERS). Manifestations of the virus continue to bewilder the world’s finest researchers and clinicians, presenting as fatal pneumonia in some patients while also traveling undetected in asymptomatic carriers.
As a result of its high transmission capability, either through droplets or contamination of surfaces, and higher mortality compared to other SARS viruses, COVID-19 has necessitated the implementation of sweeping, world-wide changes to the way life is lived and work is conducted.
To slow transmission, aggressive social distancing policies have been enacted. These range from stay-at-home orders to workplace occupancy quotas designed to maintain the minimum 6 feet distance recommended by the U.S, Centers for Disease Control (CDC). The World Health Organization (WHO) at the time of this writing recommends a less stringent minimum of 1 meter (3 feet) of distance.
With millions of people now unemployed and governments issuing unprecedented financial assistance, it is clear that the virus has caused devastating economic repercussions in addition to healthcare woes. The pharmaceutical industry is positioned to lend a lifesaving hand through its fast-paced efforts at identifying therapeutics and developing a vaccine for the virus.
However, awareness is increasing of the short and long-term impacts of COVID-19 on clinical research, drug development and manufacturing, and pharma industry regulation, which we will discuss in this article.
Regulatory, inspections, & audits
The pharmaceutical industry is heavily regulated to maintain safety and transparency of drug development and production. Until recently, a large portion of regulatory activities were conducted via in-person audits and QA/QC monitoring. Beginning with the implementation of pandemic-related travel bans and social distancing guidelines, however, the in-person nature of regulatory efforts have become more challenging.
Auditing measures in this time of crisis have had the fortunate support of existing guidelines put forth by the European Medicines Agency (EMA) and the United States Food and Drug Administration (FDA), which allow for remote monitoring done by a “Qualified Person” (QP). In Europe, the QP is responsible for assessing QC efforts.
Assuming they are given access to all necessary digital information, the QP will make a decision on whether every batch of the drug produced meets the standards set forth by national law, as well as Marketing Authorization (MA) and Good Manufacturing Process (GMP) guidelines. Remote monitoring helps “essential businesses,” such as pharmaceutical manufacturers, stay afloat and maintain the world’s supply of necessary medications in a time of crisis. Further support is being provided through the extension of lab accreditation and validation procedures, allowing a more lenient timeframe for labs without evidence of issues.
A positive outcome of the shift in regulation and auditing procedures is the increased visibility of potential for utilizing remote auditing modalities over the long-term. While the hope is that we will never again encounter a pandemic like COVID-19, there is the chance that it – or another crisis – will occur in the future, necessitating reimplementation of similar restrictions. In this case, the processes and procedures will have been tested, allowing for decreased transition time and better continuity of everyday business activities.
Impact on clinical trials across all disease areas
The race for antiviral therapeutics and the development of a vaccine has fueled intense research efforts on a global scale, which has in turn led to a number of short and long-term effects on the pharmaceutical industry. In many ways, the pandemic has attracted positive visibility to “big pharma,” demonstrating its necessity and utility in times of healthcare crisis.
Existing drug development and research endeavors have undoubtedly seen the short-term impact of COVID-19. Short-term challenges involve many of the same logistical issues affecting auditing activities, including stay-at-home orders, travel bans, social distancing requirements, and a shortage of personal protective equipment (PPE). Clinical trial implementation requires that lab staff interact with patients, and drug development/bench research necessitates that certain tasks are done by actual humans in the lab setting.
Clinical trial personnel and research teams are creating workarounds based on their respective needs, whether it’s using remote monitoring techniques, developing drive-up patient testing, conducting patient home visits or, in the case of drug development, staffing only those “essential” employees who are needed to conduct non-automated tasks. Larger organizations have also gone as far as implementing front-door temperature checks for all employees entering a facility, and some are staffing employees in separate shifts.
This strategy both reduces the risk of virus transmission and provides back-up options via employees on other shifts to continue work.
Difficulties obtaining APIs
Other short-term impacts of the pandemic involve direction of resources away from existing projects, and in some cases, shortages of necessary drug ingredients. With COVID-19 related research gaining momentum, labs and organizations often don’t have the staff or facility access to accommodate existing research endeavors as well as more urgent current activities.
Hence, existing projects are temporarily sidelined in favor of working on therapeutic and vaccine development goals for COVID-19. In some cases, this is also impacted by lack of access to necessary active pharmaceutical ingredients (APIs) or excipients, which are either unable to be shipped, being used in bulk by COVID-19 researchers, or have had their manufacture and distribution greatly reduced in order to make other compounds.
Shipments of APIs from India and China have been particularly impacted, due to reductions in production and fear of internal shortages. There have been reports of labs and research organizations collaborating to source supplies and establish appropriate sites for continuing their bench or clinical research activities. This collegial behavior will hopefully set the stage for future cooperation in an industry that is often viewed as highly competitive.
Not all impacts will be negative
Long-term impacts of the COVID-19 crisis on the research and drug development communities are not entirely negative. As therapeutics are identified and a vaccine is developed, the focus will eventually begin to shift back to existing research efforts and drug development projects. This onslaught of work will undoubtedly create jobs and propel the industry forward, helping to spur the global economy. Additionally, as discussed above, developing and enacting crisis guidelines for activities like audits or patient encounters will help to establish a protocol for similar situations in the future, and possibly allow greater flexibility of work locations even during normal times.
Logistics, service, and supply chain
The pharmaceutical industry, by functioning on a global scale, has increased reliance on logistics compared to many other fields. As discussed earlier, the logistical challenges presented by the current pandemic have led to a number of downstream effects. Shipping delays have become the norm, as decreased staffing of warehouses and fulfillment facilities continues. Depending on the social regulations of specific geographic areas, workers in drug or supply manufacturing facilities may also be unable to do their jobs at full, or even reduced, capacity, further squeezing the supply pipeline.
In addition to collaborative sourcing efforts, research teams and drug manufacturers have begun developing workarounds to address future supply chain and service needs. Other solutions being explored reportedly involve building relationships with new supply chain partners and service vendors, maintaining more robust internal supplies. Looking forward, these new relationships and arrangements may prove beneficial, setting the stage for more productive work in the future.
The current pandemic has undoubtedly changed the way life and business are being conducted on a global scale, and it is safe to assume that things will probably not be done the same way in the future. As we move to a new normal, it is important to take away some of the helpful solutions developed and implemented during this time of crisis, as they may offer opportunities for increased efficiency, scientific collaboration across the globe, and innovation in the future.
- https://www.gmp-compliance.org/gmp-news/home-office-is-a-remote-release-possible; https://www.europeanpharmaceuticalreview.com/article/116145/covid-19-update-coronavirus-and-the-pharmaceutical-supply-chain/;