How COVID-19 Is Changing Pharmaceutical Research and Development

The climbing death toll of the coronavirus is pushing the pharmaceutical industry to respond quickly, and for many, only a vaccine or effective treatment options will help them return the world back to some semblance of normalcy.

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But pharmaceutical research and development is typically a long process. On average, it can take a new medication ten years from initial discovery to market.

Vaccine development is equally as complex as there are three phases of clinical development before the vaccine can be mass produced. And for good reason.

The first phase assesses the vaccine’s safety and appropriate dosage on a small number of people. In phase two, a larger number of people, typically of similar characteristics, all receive the vaccine. And in the final phase, the vaccine is given to a large group of people to determine efficacy and safety. Each of these phases can last several weeks, months, or years.

Effective treatment and vaccines for the coronavirus may seem far off. But many are hopeful that the urgency of the coronavirus pandemic is pushing the industry to speed up these typically long processes. The healthcare system has already reported massive transformation stemming from the pandemic in which decades-old challenges – like telehealth implementation and team-based care – are being overcome seemingly overnight.

There is a balance in pharmaceuticals, though, between pushing out findings quickly and maintaining scientific rigor that proves effectiveness.

“The pharmaceutical industry is playing an incredibly critical and integral role,” Jocelyn Ulrich, MPH, deputy vice president of policy, research, and membership at PhRMA, told PharmaNewsIntelligence.

It is indisputable that pharmaceutical research and development are fundamental to the coronavirus response. But as the industry shifts their workflows and speeds up their general practices for a timely response, they are also altering the expectations of research and development moving forward. Balancing science with a quick response will be critical to upholding the industry’s integrity and ending the pandemic. 

Getting a Fast Start  

On March 16, 2020 the National Institutes of Health (NIH) announced the start of a clinical trial for a potential coronavirus vaccine. This was less than two months since the first COVID-19 case appeared in the United States.

Even though research and development is a traditionally long process, the urgency of the coronavirus has sparked a novel response from the industry.

Part of the fast response is because of the familiarity with the disease. COVID-19 is a strain of coronavirus of which SARS, MERS, and the seasonal flu are relatives. So, isolating the genetic component was faster than it would have been for a truly novel disease.

“We are very lucky in that we have an industry that has long been invested in infectious disease,” Ulrich furthered. “Prior research on Ebola, SARS, and HIV has pivoted very quickly to try and find drugs that could have additional activity against COVID-19. These are things we have already invested in, so that allowed us to respond very quickly.”

Because COVID-19 is related to these other known diseases, researchers had a starting point for vaccine and treatment development. Early results are seen quicker as a result.

For example, on May 15, the NIH announced an investigational vaccine had protected monkeys from the coronavirus. And on May 18, Moderna Inc. reported promising results from a phase one clinical trial of a coronavirus vaccine.

“We’ve seen a huge amount of resources and energy being directed to trying to solve COVID-19,” Ulrich explained. “The whole industry pivoted and focused on this problem very quickly.”

Everyone understands the urgency of development, which is why there is an unprecedented response rate and potential vaccines are emerging faster than ever before.

Drive for Innovation

Technology and innovation also play a critical role in the speed of research and development.

“On the vaccine side, we’re seeing an unprecedented amount of innovation where companies are moving very quickly into clinical trials faster than we’ve ever seen in the history of drug development. It has really been incredible,” said Ulrich.

One key innovation is the growth of virtual clinical trials. Traditionally, patients are recruited for a clinical trial from a hospital or clinic. Now that many patients are only seeking on-site care for emergent cases, telehealth is playing a critical role in patient care. So, it also is playing a growing role in clinical trials.

Virtual or decentralized clinical trials allow patients to be entered into the trial virtually and monitored remotely. Researchers can still have a large sample of patients while keeping them safe.

“We’ve had a few early adopters of virtual clinical trials or decentralized clinical trials,” Ulrich explained. “People are going to get a lot more comfortable with using technologies to collect data and use remote monitoring. These challenging times are rapidly getting people to think creatively and try new ideas. I hope that some of those changes will stay in place for the longer term because this will help people implement new ways of doing things very quickly.”

Remote monitoring technology is one of key reasons these trials are possible. They allow patients vital signs to be tracked from their home and sent to the hospital or research data center.

“New tools really benefit the entire research ecosystem. The more efficient we can make a clinical trial and the research and development process, the better we are going to be at getting more treatment options to patients faster,” Ulrich furthered.

Growing Partnerships

The pharmaceutical industry is often criticized for its competitiveness. Companies compete for drug patents, wanting to be the first to market a novel drug.

But the coronavirus has sparked partnerships across the industry. Formal partnerships on drug development and clinical trials have sped development, and informal data sharing is making previously inaccessible data available to scientists across the globe.

“Rather than worrying about competition, you have companies working together to set up a master protocol where all the different potential treatments can be tested at the same time in the most efficient way,” Ulrich pointed out.

For example, Pfizer and BioNtech are co-developing a potential COVID-19 vaccine. The organizations recently announced they were starting phase one and two clinical trials for the drug.

Alveo Technologies and Janssen Pharmaceuticals, a part of Johnson & Johnson, are also partnering to advance at-home testing for viral infections, including COVID-19.

“We’re seeing all kinds of new partnerships, people sharing data, scientists and researchers sharing information,” Ulrich pointed out. “People are posting all of their early research findings in open source so other scientists can access it and learn.”

Collaboration is speeding development. Rather than competing, organizations can put their resources together, share data, and expedite the research and development process to unlock a vaccine sooner.

Manufacturing Capacity

When a vaccine is found, it needs to be mass produced quickly and dispensed across the globe. This will require countless resources and supply chain management to ensure the continuous manufacturing of the vaccine.

Urlich said many organizations that do not have the capacity or resources to research a vaccine are preparing for the moment they will need to begin making and dispensing vaccines.

“A lot of companies are already starting to build up manufacturing capacities even before they have a product,” she continued. “They’re partnering or looking for other contract manufacturing organizations that have the capacity and reallocating resources.”

Global manufacturers will need to work together once a vaccine is found.

“We’ll have to collaborate and solve the challenge of getting millions of doses out and available to patients in all different areas of the world,” Ulrich said. “There are some partnerships that have already been announced and they’re looking at even more.”

Failing to create the manufacturing capacity needed to supply the world with a vaccine risks the continuous spread of COVID-19. Many organizations are preparing for the moment a vaccine is found so they can flip a switch to begin manufacturing and shipping doses across the globe.
Continuous Monitoring

The public health emergency means decision-makers cannot wait for years for full and complete data on treatment and vaccine effectiveness. Fast decisions need to be made based on good science but small sample sizes.

In order to continue validating the science, though, clinical trials are continuing to enroll patients after effective COVID-19 drugs are authorized for use.

For example, the drug remdesivir was approved for an Emergency Use Authorization by the Food and Drug Administration (FDA) after small scale clinical trials showed modest impacts on patient outcomes. But participants are still being enrolled in clinical trials to show the drug's large-scale efficacy.

“We need to ensure that we’re getting answers about the true effectiveness of that treatment, but we know enough now to know that there’s a benefit. That was a really good sign we now want to confirm with more data,” Ulrich emphasized.

Getting potentially lifesaving treatment to patients is critically important right now. But it is also important to ensure that the scientific justification behind using these medications is sound. So, drug effectiveness must be continuously monitored.  

“Right now, the critically important thing is that we make sure that patients are being randomized into the large clinical trials that are going to get us the answers we can have confidence in rather than answering questions with small patient sample sizes,” said Ulrich.

There is a balance between having enough data to feel comfortable treating patients and continuing to collect information for scientific validity.

Moving forward, decision-makers will need to keep this at the forefront of their minds in order to make safe and efficacious recommendations to patients. 

“It’s been incredible to watch what our members have been doing and to track what they’ve been achieving so far,” Ulrich concluded. “It’s really been an incredible time to see how important science is and how important innovation is. Our lives are going to depend on getting this right.”