Turning COVID-19 Era Regulatory Efficiencies into Long-term Business Growth and Innovation – Pharmaceutical Executive

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COVID-19 pandemic sets new standards for life sciences industry.

The pandemic has upended traditional business practices across all industries, particularly within life sciences. Despite the monumental task handed down to the industry, life sciences companies have achieved unprecedented speed and success in delivering COVID-19 products to market. This has ranged from diagnostic tests to treatments for sick patients and now, to a variety of promising vaccines. To an extent, this has been made possible by greater flexibility and collaboration on the part of regulators, who temporarily loosened pre-pandemic restrictions to usher treatments to market with greater urgency. An exit to pandemic-era practices is on the horizon for the industry. With that in mind, life sciences companies have a momentous opportunity in front of them to reflect upon the regulatory environment changes that have been in effect over the past year and identify new long-term improvements to the status quo.

Adapting trial startup regulatory processes

In-person site investigations waned during the pandemic, and regulators were quick to work with companies to adopt decentralized approaches to trial startup, such as the U.S. Food and Drug Administration (FDA) granting virtual pre-investigational new drug (IND) meetings in under 30 days, and regulators accepting more real-world information to supplement clinical trial data. The unprecedented flexibility of these regulators significantly accelerated the startup of clinical trials at a time when new medical products have been urgently needed to save lives. These processes have opened the eyes of the industry to what is possible when regulatory and industry leaders put their heads together, but we must expect that they will become grounded following the pandemic.

In-person clinical development activities will undoubtedly resume post-pandemic—and are already doing so–and rapid-fire approvals are not likely to continue. However, the ability to leverage new sources of data that have emerged during the pandemic will benefit life sciences companies in the long term. The use of more holistic real-world data in pre-IND reporting paired with wider acceptance from Health Authorities, will enable life sciences companies to achieve faster trial startup times and design smarter and more informed clinical trials. This could ultimately contribute to a safer and more efficient drug development process.

Preparing for decentralized study execution

Decentralized clinical trial formats became the crux of continued momentum in the industry amidst social distancing orders. While mobile and remote formats had been utilized in the years prior to the pandemic, they remained largely nascent due to hesitancy on the part of the industry around properly executing studies with the same degree of control as with an on-site format. Out of this necessity, the industry has come to understand just how expansive the benefits of decentralizing are, ranging from faster patient recruitment and higher retention rates to greater access to specific patient cohorts and, ultimately, improved return on investment. This is momentum that must be continued after the pandemic, particularly when considering the pursuit of more rare disease and precision medicines, which are so often shelved due to the difficulty of study design, recruitment and execution.

As interest in these approaches to clinical research grows and they are explored more deeply by regulators, there will be entirely new regulatory guidance around data privacy, study adherence, and reporting. In order to continue to make strides while mitigating regulatory compliance challenges, companies should focus on integrating automatically logged data from remote trial formats with their systems for regulatory information management. Proper synergy between clinical research and regulatory compliance teams will not only mitigate the possibility of regulatory review bottlenecks but also lead to more comprehensive and accurate reporting.

Streamlining regulatory submissions

The flurry of COVID-related emergency use authorizations (EUAs) granted in the past year became a heavily utilized path to market which will likely die down after the pandemic. However, the acceleration of EUA processes has brought attention to opportunities for improvement in assessing treatment risk versus benefit that the public will not soon forget. During this time, the combination of real-world safety data and extensive technology use for information management and regulatory submissions has enabled these EUAs to happen with a high degree of safety.

In the long term, streamlined regulatory information management technology will be crucial to expedite reporting tasks and improve regulatory submissions. Furthermore, biopharmaceutical companies will benefit from increased adoption of global regulatory outsourcing to drive greater efficiencies. This will help teams navigate country- and region-specific regulatory requirements that are increasingly diverse and complex.

Despite the industry’s history of deep organizational siloes and reticence toward adopting innovative technology, its ability to quickly set aside those notions in times of crisis has ultimately been a key driver in delivering a predicted end to the pandemic. Collaboration and digital connectivity have been the underpinning for extraordinary innovation and success never before seen in the history of medicine—including the delivery of not one but two first-in-their-class mRNA vaccines. The imperative for business leaders and regulators to regroup and strategize around what worked in the last 12 months and what can be adapted for long term improvement cannot be minimized. Those who approach the pandemic as a learning experience rather than a blip in time will position themselves as frontrunners in the industry’s new status quo for the foreseeable future.

Ronan Brown, PhD, SVP and Head of Integrated Global Compliance, IQVIA

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