Side Effects

Biotech and Pharma in a Post-COVID World
Written by Allison Dempsey

While COVID changed the world, it also changed the very industries working to treat it. Whatever our new normal will be as the pandemic transitions to an endemic, COVID’s long-term effect on biotech and biopharma’s medication development schedules, patient testing, and disease prevention, will continue.

As many from the biopharma sector hurried to create medicines and vaccines during the pandemic and biotech companies were forced to deal with never-before-seen upheavals, new health and safety protocols arrived, with masking, at-home testing, and social distancing being just a few.

While the pandemic itself was a global tragedy, its mandated safety protocols created an unexpected decline in infections from common respiratory viruses like influenza and respiratory syncytial virus (RSV). As international travel came to a halt, mask use became commonplace, and the six-feet-apart and isolation rules came into play.

According to a special report from Fierce Biotech, the pandemic also had the unintended consequence of reviving interest in vaccines, which helped the pharmaceutical industry discover new strategies for accelerating vaccine development and approval. Pfizer was able to accelerate its work on RSV with all the resources acquired from generating a hugely successful vaccine and therapy, and additionally, thanks to the accessibility and familiarity of mRNA technology, researchers now have another approach that may be effective in treating RSV.

In the same way that work on the RSV injection helped shape the vaccination that would become Spikevax, Moderna already had an RSV shot in development when the pandemic struck. However, the renowned biotech’s work on COVID has now made the program possible.

COVID hasn’t been nearly as kind or generous to the lesser-known biotechs, however. Many small companies joined the effort to find treatments or vaccines, testing unproven therapies just to see whether they would work, only to watch attempts flame out and be overshadowed by giants like BioNTech and Moderna, who have become household names over the past three years and are now positioned to help bolster the industry itself.

That bolstering comes from the companies’ methodology, which has gained widespread recognition and validation over the past few years. As a result, future mRNA medicines and vaccines will have an easier time gaining public acceptability and passing regulatory requirements. For instance, Moderna is concentrating on RSV, HIV, and cancer and recently began dosing in two clinical trials for several HIV vaccinations, while an RSV injection successfully entered phase 3, according to Fierce Biotech.

Certainly, there were very few upsides to the pandemic as it spread worldwide, but according to PPD Clinical Research, the emergence of decentralized clinical trials (DCT) as a crucial tactic was one of them.

DCTs use digital technologies and other techniques to give clinical research access to patients, to gather and monitor data remotely, and to facilitate communication between researchers and subjects.

Sponsors continue to view different trial designs as a chance to gather data more broadly and effectively when the world reverts to a “new normal.” In a poll conducted by PPD, more than half (55 percent) of participants identified “challenges with patient recruitment in clinical trials” as the greatest organizational pain point. DCTs are a potential solution to the problem since they provide a way to engage and recruit a larger patient base outside the bounds of a centralized facility.

Survey participants who have not yet implemented DCT strategies predicted that by 2024, 27 percent of their trials would be decentralized, according to PPD. By 2024, organizations already utilizing DCTs anticipate that another 24 percent of their trials will follow suit.

It’s obvious this format will get stronger as long as companies keep developing new tools and infrastructure to enable DCT operations, and biopharma and biotech companies should look for a DCT partner whose digital-based trial strategy is centred around enhancing patient experience, engagement, and retention, and is anchored in speed, deep regulatory understanding, and a technology-agnostic approach.

In the medical industry as a whole, processes are becoming more and more digital, and this is also true for clinical trial operations, with new technologies being quickly embraced by organizations to address issues with recruitment and trial efficiency.

According to PPD Clinical Research, leaders in the biopharmaceutical and biotech industries were polled, and 62 percent acknowledged using digital technologies including cloud computing, APIs, and digital platforms in their trial operations. New digital tools will develop as DCTs and hybrid trials take up a growing portion of the clinical trial landscape to simplify necessary process adjustments and guarantee regulatory compliance.

In addition to helping organizations reach underserved patient populations and enhance patient experiences, digitalization offers a promising way to address issues with patient retention and recruitment.

With many trials now adopting a “BYOD” (bring your own device) strategy rather than supplying study-issued tablets or other devices for data collection, the increased popularity of electronic clinical outcome assessment (eCOA) technologies propelled by COVID has been sustained. Trial sponsors gain reduced expenses and quicker setup times by allowing participants to use their own devices, and participants are consequently more likely to adhere to study protocols when reminders and data collection are made possible by a gadget that’s already a part of their everyday lives. Apps and wearable technology innovation will rise to align with these practices as this becomes a larger component of more trials.

Also according to the poll, 55 percent of respondents cite patient recruitment as their top organizational problem, along with patient retention and patient diversity, as the largest pain point for biotech and biopharma companies. For that reason, the capacity of drug developers to lower barriers to participation and give sites and patients support and training will be crucial to attaining and maintaining diversity in the group. The importance of inclusive trial design should be stressed by sponsors who are thinking about partnering with community organizations and advocacy groups to progress their investigations.

We might be past the worst of the pandemic, but there’s still more vital COVID-related work for biotech ahead. While the symptoms and devastating effects of COVID on individuals are painfully well-documented around the world, its long-term effects are barely known and won’t be fully understood for years—or even decades—to come.

However, the term “long COVID” is becoming a more and more common phrase as many continue to suffer in various ways long past their initial infection. Neurological symptoms or mental health difficulties such as depression or anxiety, headaches, sleep issues, vertigo, pins and needles sensations, loss of smell or taste, and muscular or joint discomfort are just a few of the ongoing issues reported by those who have endured even a “mild” case of COVID.

According to KFF, the uncertainty regarding how long COVID will affect both people and employment depends on the degree of limitations and whether they are permanent. Estimates of the numbers of those in the workforce affected by long COVID range from 500,000 or less up to 4 million people.

Uncertainty around the count of people who are actually suffering long COVID highlights how challenging it is to treat, and only a small number of biotech companies are attempting to generate interest—and funding—to develop a cure, which means many of its victims live with fatigue, sleep issues, and brain fog.

According to Fierce Biotech, while many huge pharmaceutical companies have made billions from COVID vaccinations and therapies, few have proposed solutions to combat long-term COVID. One notable exception is Pfizer, which is conducting two separate trials of Paxlovid, an approved COVID medication, in collaboration with Stanford and Yale. The more recent Yale research has received approval for enrolment, while Ensitrelvir, a therapy from Japanese Big Pharma Shionogi, is also being evaluated as a long-term treatment. When compared to a placebo, the risk of long COVID was lowered by 45 percent with 125 mg of Ensitrelvir, according to exploratory data from the company’s phase-3 trial.

What has led to the shortage of funding for long COVID? Two distinct but connected developments, the first being a tighter private biotech market that has been less willing to take a chance on hazardous technologies. Trying to treat long COVID is one of the riskier bets due to patient heterogeneity and lack of reliable biomarkers.

The second problem is that COVID is no longer receiving as much federal attention. Although the ending of the national public health emergency won’t directly affect the FDA’s authority to grant emergency use authorizations, the agency has recently shown more restraint.

The federal government is making efforts, however: more than 15,000 individuals, pregnant women, and children have already signed up for the NIH-sponsored RECOVER Initiative, which is a series of large-scale observational studies of COVID patients to gain a deeper understanding of the biology of long COVID, potentially providing new opportunities for drug researchers to discover new treatments.

While the pandemic has had a dramatic impact on our daily lives and changed our world forever, it was the tireless research and diligent work of the biotechnology sector that has helped finally bring it to a close. The world has changed, however, for better or worse, and biotech and pharma have been forced to change with it, maybe most importantly positioning the industries to tackle the problem of health equality.

Galvanized by COVID, research and development, more inclusive clinical trials, commercial planning, and the identification and mitigation of bias impacting education and product development are all big changes that won’t take place immediately, but biopharma is poised to excel and possibly even take the lead.

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