The COVID-19 Pandemic Could Forever Change Biopharma | Deloitte US has been saved
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By Mike DeLone, vice chairman, US life sciences leader, Deloitte LLP
We have entered a pivotal point in history that will likely create unprecedented challenges for companies of all sizes and in all sectors. While it will take time and effort, this crisis can become an opportunity to move forward. More than two months have passed since the World Health Organization (WHO) declared COVID-19 a pandemic. Since then, biopharma companies from across the globe have been racing to deliver needed supplies and develop new vaccines and novel therapeutic interventions. We are seeing unprecedented levels of cooperation among many of these companies as they seek first to help patients.
While nearly 135 vaccines are now in the research pipeline, developing, testing, and approving an effective vaccine is expected to take up to 12-18 months (as of mid-May, 2020). However, some drugs and antiviral treatments could be repurposed for treatment of COVID-19 much sooner. More than 215 novel and re-purposed therapies were in the pipeline in mid-May.2 Once effective antivirals have been identified and approved, drug manufacturers will need to rapidly scale up production and distribution capabilities to meet a massive demand.
How is the coronavirus impacting pharma companies today?
The pandemic is affecting most parts of the pharmaceutical ecosystem—from supply chain to research and development (R&D) to commercial operations. Although pharmaceutical companies typically have a sufficient reserve of supplies to deal with supply chain disruptions, we are in unprecedented times. While the coronavirus forced some drug factories in China to close, manufacturing disruptions have not yet been substantial, and production has since resumed. For branded drugs and biologics, travel restrictions, quarantines or worker illness, and changes in demand could be disruptive. Branded drug sales, for example, could slow as patients opt to delay new treatment starts or elective medications. Moreover, some next-generation therapies might not be available to patients if hospitals don’t have the resources to prep and treat those patients.
Along with searching for new vaccines and therapies to prevent and treat COVID-19, pharmaceutical companies should also continue day-to-day business operations including R&D. But some pharmaceutical companies have had to slow or stop patient recruitment for clinical trials to reduce the risk to patients who could be exposed to the virus. Some companies are delaying trials and opting not to launch new ones to reduce the burden on health care systems.3
Many commercial field teams are now working from home. Market access and medical teams that are accustomed to meeting customers in clinical settings should be selective and thoughtful about how much to engage critical health care resources.
Five ways COVID-19 could change biopharma
Once this health emergency passes, we expect biopharmaceutical companies will find themselves on an accelerated path to the future of health that Deloitte envisions. Our response to this global outbreak is already changing business processes for pharmaceutical companies in the following four areas:
1. Greater focus on vaccines and prevention: Biopharma business models could look much different by 2040. Twenty years from now, we expect that biopharma companies will place greater attention on early detection and prevention, which means the onset of some diseases could be delayed or prevented altogether. Biopharma companies are already turning their attention to the development of more vaccines and anti-virals. Lessons learned from this pandemic could lead some biopharma companies to shift R&D investments to prevention of infectious diseases.
2. Increased adoption on artificial intelligence (AI): In response to a request from the White House, five large research organizations released an open research dataset of scholarly literature about COVID-19, SARS-CoV-2, and the coronavirus group.4 Artificial intelligence (AI) could be used to mine the data—which includes nearly 40,000 machine-readable articles about the virus, the disease it causes, and other viruses in the same family—to learn more about COVID-19 and potential treatments. AI could help speed drug discovery by analyzing research data more effectively and screening chemical libraries, de-novo drug design, drug repurposing, and pre-clinical testing, according to a November 2019 report from our colleagues in the United Kingdom. Some biopharma companies that have vaccine and/or infectious disease experience are partnering with AI drug-discovery companies.5
3. Smart automation: Like many industries, pharma is quickly learning how much work can be done remotely, or with fewer onsite employees. Some manufacturing sites have increased the space between workers or are considering more shifts to spread workers out and minimize the risk of spreading infection. While some manufacturing employees always need to be on-site, the pandemic has illustrated how many jobs can be done virtually. Sales teams, for example, can no longer visit hospitals and other clinical settings. In response, some pharmaceutical reps are conducting online meetings with their clients. As more work is done virtually, companies should consider strategies to ensure customer-engagement, productivity, and a sense of team among employees.
4. Digital clinical trials: The need to limit potential exposure to the virus has brought the idea of virtual/digital clinical trials to the forefront. Research facilities tend to be located in metropolitan areas, which might be difficult for some people to reach and could create a risk of exposure to patients who might already be dealing with an illness. The process for recruiting and retaining patients for clinical trials has changed little over the past 30 years, as my colleague Dawn Anderson explained in a recent blog. But many facets of a clinical trial could be done remotely through the use of connected digital devices and the internet. Virtual clinical trials could lead to deeper pools of potential candidates, improve convenience for patients, and lead to more efficient trials. Further, some companies are now exploring new ways of delivering clinical supplies directly to a patient’s home, rather than from the site of the clinical study. We are optimistic that when we recover from this crisis, there will be even faster adoption of the technologies and approaches needed to make digital clinical trials a reality.
5. Regulatory flexibility: FDA, the European Medicines Agency (EMA), and other regulatory bodies have acted to protect both patients and clinical staff involved in clinical trials by relaxing some rules. Both agencies have emphasized the importance of patient safety. FDA recently created a special emergency program, called the Coronavirus Treatment Acceleration Program (CTAP), to approve possible COVID-19 therapies more quickly.6 On March 30, the US Department of Health and Human Services (HHS) announced that its Biomedical Advanced Research and Development Authority (BARDA) is working with a division of Johnson & Johnson to accelerate clinical trials for a COVID-19 vaccine.7 We could see more private-public collaboration in response to the pandemic.
Once the world recovers from this global pandemic, there will be a new normal. We expect the biopharma sector will help lead us through this emergency and will come away with new and more effective business processes that can help prevent future pandemics
This article was originally published April 7. Updates were made May 19
1. HHS accepts donations of medicine to Strategic National Stockpile as possible treatments for COVID-19 patient, HHS.gov, March 29, 2020
2. COVID-19 treatment and vaccine tracker, Milken Institute, March 30, 2020
3. Amid coronavirus, disruptions to clinical trial, drug development, accelerate, STAT, March 23, 2020
4. Call to action to the tech community on new machine-readable COVID-19 data set, White House press release, March 16, 2020
5. Catching up to coronavirus: Top 60 treatments in development, Genetic Engineering & Biotechnology News, March 18, 2020
6. Coronavirus Treatment Acceleration Program, FDA, March 31, 2020
7. HHS Accelerates Clinical Trials, Prepares for Manufacturing of COVID-19 Vaccines, HHS, March 30, 2020
Mike, a principal in Deloitte Consulting LLP, is the national sector leader for Deloitte’s Life Sciences practice. In this role, he leads a multi-disciplinary team who serves clients in the pharmaceutical, biotechnology, medical technology, and consumer health care segments through consulting, advisory, audit, and tax services. Mike is responsible for the overall strategic direction of the life sciences practice as well as its go-to-market strategies and resources. He also serves in the role as life sciences consulting leader. With 20 years of experience dedicated to the life sciences sector, Mike has demonstrated exceptional leadership and practice development. He has led tech and information management teams as well as services at some of our largest biopharmaceutical and medical technology clients, helping them with the definition and implementation of technology and business strategies, related organizational and business alignment. His client work has been presented as examples of leading practices at prominent industry conferences.