The current COVID-19 pandemic continues to gravely affect the lives of those infected, those in home isolation, and the global economy as a whole. Pharmaceutical companies are on the front lines of this crisis. What short-term and lasting effects does the coronavirus pandemic have on the industry, and how are companies reacting?
The recent outbreak of the coronavirus epidemic caught the world off guard. SARS-CoV-2 (the virus causing COVID-19) being a previously unknown and highly contagious virus, the still-unfolding pandemic continues to force governments, the health industry, and the general population to adapt to a fast-evolving situation globally.
Short-term, the pharma industry’s role in overcoming the global crisis will be in providing medication for various symptoms, especially in high-risk groups. As the virus is expected to mutate, vaccination will be the only long-term solution for controlling the disease and avoiding the threat of subsequent waves of infections.
The pharmaceutical R&D sector was quick to engage with the disease. No treatment against SARS-CoV-2 is currently available, but the first COVID-19 prototype vaccine was developed in just 42 days, and further research is focusing on possible treatment options.
There are already a number of COVID-19 therapeutics in clinical trials, and more than 20 types of vaccines in development around the world. Even as pharma companies work with regulators and health authorities to fast-track development, it could take another 12-18 months before a successful vaccine is approved and made available on the market.
Diagnostics is another issue. Lacking adequate point-of-care testing, samples must be sent to a centralized lab, and results may take days to return to the hospital where the patient was admitted. Heavy mobilization in the health industry has already resulted in the first 45-minute express test receiving Emergency Use Authorization from the FDA. The demand for testing kits around the world is still drastically increasing as governments are striving to ramp up their testing capacities.
In the meantime, various repurposed drugs (medication already licensed and used to treat other illnesses) are being analyzed to assess their effects on clinical outcomes for patients with COVID-19. Some healthcare providers have already started stockpiling these in case they are shown to be effective, causing temporary shortages that affect patients who take it for other conditions. Therefore, many pharmaceutical companies are now focusing on finding ways to scale production capacity once a medication or vaccine is shown to be effective against SARS-CoV-2.
Production of non COVID-19-related drugs continues even as global supply chains stall because of the pandemic. As of late March, only limited spot shortages of drugs are reported in certain areas and product types, despite China and India playing a critical role in the supply of APIs (active pharmaceutical ingredients) and generics. That may well change as the pandemic evolves, forcing pharma companies to analyze the integrity of their supply chains and manufacturing capabilities.
Pharmaceutical developers need to take steps to pressure-test their supply chains and, if necessary, relocate production to alternate supply sources in the near future. Some may need to develop infrastructure and innovate ways to ramp up the manufacturing of products related to COVID-19 care to keep up with growing demand.
Ongoing clinical trials may also be disrupted or delayed by the COVID-19 outbreak, prompting pharma companies to categorize their projects based on business criticality.
Yet, as something of a silver lining, we should note that this current pandemic also means opportunities for pharma developers. Those able to adapt now can benefit in the long run.
So far, lessons learnt from this COVID-19 epidemic suggest that in the long run, pharma companies may need to focus on improving their flexibility, scalability, and reaction time.
The experts we talked to for this article stress that pharma companies should consider (and may be legally required down the road) to build redundancy and resilience in their supply chains. Some pharma developers are already talking about a need for onshoring, or bringing back manufacturing capabilities to Europe or the US even despite higher production costs. The localization and higher integration of pharmaceutical supply chains is also expected to positively impact reaction times to market changes in general.
While it’s currently a global emergency forcing the fast-tracking of delivery pathways, this temporary acceleration is predicted to have a long-term impact. Pharmaceutical developers can use this epidemic situation to build out valuable capabilities. In the future, being able to promptly adjust their manufacturing capabilities to emerging needs could prove to be an important asset.
There is increasing interest around modular or “podular” approaches to constructing biopharma facilities. These structures are faster to deploy than traditional plants, and enable the fast and low-cost reconfiguration of equipment as needed.
To further enhance flexibility, experts forecast that pharma companies will accelerate the digitalization of their pharmaceutical development processes. While stepping up data analytics and AI capabilities may be necessary future steps, pharmaceutical developers can now start with simply moving existing processes to digital platforms.
By accelerating digital documentation and the validation of manufacturing systems, these companies can realize immense time and cost savings, contributing to a more flexible, scalable, and responsive organization.
Pharmaceutical companies, suppliers, and pharma manufacturing system integrators may need to consider hastening their planned digital transformation strategies. Updating their processes and infrastructure sooner rather than later, they can secure a leading position in the post-COVID-19 market environment.
Intland Retina is a state-of-the-art eQMS platform for Pharma Project Validation & Quality Risk Management. Combined with Intland’s Pharma GAMP® 5 Template, the platform can greatly accelerate and simplify pharmaceutical systems validation and quality management. To find out more, download our informational brochure (PDF) below!