Impact Of COVID-19 On Pharmaceutical R&D

The gravity of the coronavirus consolidated the entire global scientific community in identifying potent treatments and developing vigorous vaccines. Over the past two years, the unsurpassed collective efforts of government, industries, academia and regulatory bodies in clinical trial design, data collection, regulatory strategies have shown the substance of science and humanity. The world saw a seismic shift in the use of technology in healthcare, including clinical trial designs that are more adaptive, inclusive and utilize the cloud-based system for data capture and analysis. All of this together has helped in the discovery of effective vaccines and exterminating the immediate crisis. Even after the pandemic, some of these genies of the digital revolution will be difficult to put back into the bottle as it streamlined the approaches to treat patients.

Like two sides of the same coin, the research and development in the COVID-19 era have been conducive for some and unhelpful for others. While the pandemic accelerated the COVID-19 treatment approach, it also stalled the prevailing clinical trials due to a lack of resources.

Immediate Research Solutions in COVID-19

The pharmaceutical and biotech industries, universities, public research institutes both individually and in collaboration held the healthcare fort to rapidly develop new strategies for effective treatment and vaccine development for COVID-19. According to the World Health Organization (WHO) data, 131 vaccine candidates with 10 in the clinical evaluation were already under the pipeline by the end of May 2020.[1] Furthermore, the vaccine candidates increased to 180, with 35 in the clinical evaluation phase by early September 2020. The National Institute of Health database in the United States disclosed more than 3600 trials on COVID-19 around the globe by the end of October 2020. Out of the potential candidates, about 14 were being developed by Indian companies or collaborating with others.[3]

India proved to be a defining country in the management of COVID-19. Indian Immunologicals Ltd collaborated with Griffith University from Australia and developed a vaccine candidate against SARS-CoV2. Furthermore, a recombinant deactivated rabies virus-containing S1 domain was evaluated against SARS-CoV1 by Bharat Biotech and Thomas Jefferson University. The Indian Pharmaceutical Companies came together in fighting the COVID-19 diligently.[4]

Apart from the colossal pharma domain, the active engagement of the scientific community related to the virus can also be seen in various scientific publications. According to PubMed by the United States National Center for Biotechnology Information, more than 3500 COVID-19 related medical academic journals were already published by mid-April 2020.[3]. Furthermore, the number increased up to 7500 by the end of November 2020. Another survey by Springer Nature and Digital Science revealed 43% of the 3436 surveyed were likely to repurpose their grants for COVID-19 research from 24 May to 18 June 2020.[5]

The surveys found that the United States and China were among the top contributors with active engagement in academic publications, followed by the United Kingdom, Germany, France, Italy, Australia, Canada and India.

Effect of COVID-19 on Research and Development at Venus

Venus Remedies had been involved actively in the management of the COVID-19 scenario in the world. The research and development domain of Venus went through a lot of hurdles yet came out after a much stronger post-COVD-19 wave.

The most significant cornerstone in the entire development process was to ensure the safety of scientists working day and night to better society. The organization put extra effort into ensuring the safety of employees while investigating drug candidates and vaccines for COVID-19. Furthermore, Venus also played a crucial role in importing active pharmaceutical ingredients to various countries in dire need. The organization ensured to keep the supply chain in check to ensure that pharma healthcare provides maximal support to the frontline doctors.

The research and development team at Venus developed a solution for COVID-19 infection control by creating Sterloc - A 100% natural sanitizer and disinfect that is based on supercharged HOCl. The solution proved to be efficacious in reducing infection in affected candidates. Furthermore, the continuous production and supply of essential medicines, disinfectants and sanitizers ensured that people worldwide were provided with the best resources to fight COVID-19.

COVID-19 and Clinical Trial Operations [6]

As mentioned earlier, a severe disruption in the clinical trial operations was seen due to COVID-19. More than 50% of the companies had side-lined recruitment for most trials, and 75% halted their site activation for the majority of trials by May 2020. With the entire horizon shifting towards COVID-19, several deviations, including missed patient visits or fewer enrolments, were observed in other trials.

This led to companies revising core components of their trial policies and only keeping essential trials running. The clinical leaders focused more on operational agility, including remote patient engagement, assessing endpoints virtually, shipping investigational medicinal products directly to patients, and monitoring effectively to ensure the trials. In addition, companies collaborated with contract research organizations across countries to re-evaluate their clinical supply chain and minimize loopholes, even if it came to a higher cost.

COVID-19 and Regulatory Considerations [7][8]

With the advent of the pandemic, the USFDA granted various Emergency Use Authorizations (EUAs) of unapproved drugs and devices to be used in treating or managing COVID-19 and its consequences. Usually, the EUAs for any drug device is granted if there’s some evidence to suggest that it might cater to treat or manage the disease. However, as in the case of COVID-19, with the limited evidence available, EUAs were not granted full approval. Thus, the drug or medical device company were permitted to market their products with restrictions only to the COVID-19 patients who had met a particular criterion. This was crucial for companies to develop real-world evidence with their products that could potentially be used in the future to convert EUA approval to regulatory approval and accelerate their sales revenue.

The COVID-19 has generated an increasing acceptance of utilizing such real-world data to support regulatory filings. The USFDA started to take a logical approach going beyond the stringent requirements for double-blind, randomized controlled trials, which were considered the gold standard. Now, the company with a EUA for either product or device within the United States can seek to convert to a complete regulatory approval and retain access to the profitable United States market segment.

Takeaway

With science being the only exit strategy from COVID-19, the pandemic sparked the unprecedented mobilization of the entire scientific community around the globe. The pharmaceutical companies, biotechnology companies, public research institutions, universities, and subject knowledge experts played a crucial role in understanding the virus, mutation, and developing hundreds of vaccine candidates or other therapeutic interventions over a brief period. It stretched the research and innovation capabilities off their boundaries and revealed gaps required to be filled for future crises.

The vaccination drives worldwide show the resilience and unparalleled spirit of science and humanity. At the same time, the pandemic continues to show the importance of research and development potential and innovation to be prepared for the impending crisis.

References

• WHO (2020), Draft landscape of COVID 19 candidate vaccines, World Health Organization,
• NIH (2020), “National Institutes of Health - US National Library of Medicine”, ClinicalTrials.gov3.
• Bryan, K., J. Lemus and G. Marshall (2020), 3.“Innovation During a Crisis: Evidence from Covid-19”, SSRN Electronic Journal, http://dx.doi.org/10.2139/ssrn.3587973
• https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8216129/
• Baynes, G. and M. Hahnel (2020), “Research Practices in the wake of COVID-19: Busting open the myths around open data”, Springer Nature, https://www.springernature.com/gp/advancing-discovery/blog/blogposts/research-practices-in-the-wake-of-covid/18256280
• COVID-19 implications for life sciences R&D: Recovery and the next normal, Agrawal et al, published May 2020
• https://www.fda.gov/emergency-preparednessand-response/mcm-legal-regulatoryand-policy-framework/emergency-useauthorization#covid19euas
• https://www.fda.gov/medical-devices/ coronavirus-disease-2019-covid-19- emergency
• use-authorizations-medical-devices/faqsemergency-use-authorizations-euas-medical devices-during-covid-19-pandemic