The year to come in life sciences safety and regulatory practices

The fruitful endeavors of the life sciences industry are impossible to miss. The year 2021 begins with two Covid-19 vaccines developed, tested and approved for use in just under a year along with multiple treatments, diagnostics and other medical technology. Amidst the backdrop of a pandemic, biopharmaceutical and medical technology companies and regulators alike collaborated in an unprecedented manner around the world to accelerate testing, treatment and vaccine delivery, while preserving the necessary standards for safety and efficacy. Industry players, health authorities and partners have had to adapt to working at a breakneck speed that had previously seemed almost impossible. In view of this new normal, the industry sentiment about automation and cloud technologies is rapidly evolving from nice-to-have to do-or-die, to support regulatory and safety compliance and deliver more positive health outcomes.

The life sciences industry will move toward more agile capabilities for regulatory operations and regulators toward an accelerated approval pathway in support of clinical studies, drawing from lessons learned during the pandemic around global collaboration.

The expedited push to bring reliable Covid-19 treatments to market has truly been a combined and global effort on the part of life sciences companies and regulatory bodies around the world. We don’t yet know whether global regulatory guidance will remain more flexible or continue the trend toward greater stringency seen prior to the pandemic. Regardless, the whole of the industry has seen first-hand the need for agility in regulatory compliance to further the prospects of rapid, global delivery of Covid-19 treatments and vaccines.

Agility has shown itself to be of paramount importance in the face of pressing delivery deadlines set by government initiatives. On the road ahead, life sciences companies will benefit from automation and supporting technological advances in artificial intelligence, machine learning and natural language processing to keep pace with rapidly changing regulatory standards on a country or regional level—whether or not regulations tighten or loosen following the pandemic. The adoption of holistic tools and processes that mitigate the need for manual input will be critical for companies to manage their time and costs while maintaining the momentum created by the circumstances of the pandemic.

Adverse event reporting, surveilled in near-real-time, will improve public confidence in Covid vaccines. Today, about 31 percent of Americans report that they do not want the vaccine once it becomes available to them. Real-time post-market surveillance of Covid vaccines will help the life sciences industry to almost immediately report any unintended side effects (adverse events, or AEs) of vaccines. This is critical to encourage public trust in taking vaccines that have been developed to combat a virus that has taken more than 445,264 U.S. lives as of early February 2021.

Currently, most of the industry relies upon aging and disparate safety systems for adverse event monitoring and report management.  Very limited innovation had occurred within these systems over the past decade.  Amidst the backdrop of a global pandemic, companies are increasingly accepting that these systems are inadequate, and fundamental changes are necessary within their safety systems and processes to keep pace with increasing data volume, analytical and regulatory requirements.

Reported adverse events have risen by 20 percent annually over the past six years—due to new product launches, marketing expansion to new geographies and new data input channels such as social media platforms and community-driven registries. The industry has been forced to realize it isn’t feasible to hire or outsource the required number of people needed to gather, analyze and evaluate this massive amount of data quickly and efficiently. The question is not “should I change” as much as it is “how do I change, when, and for what?”

The idea of a life science-specific, purpose-built AI-powered SaaS solution for safety and pharmacovigilance is no longer a lofty dream or empty promise. In 2021 and beyond, systems that employ machine learning, natural language processing and enable real time signal detection will become essential tools used by safety teams to identify, capture, share, analyze and report patient data from across multiple domains.

In addition, the ability to leverage AI tools to gather, analyze and evaluate patient reactions to medications will have a beneficial impact on vaccine therapy development and evolution. For example, ongoing Covid-related surveillance and signal detection activities will provide insights that drug developers can later combine with data derived from other vaccine surveillance processes like those conducted around seasonal influenza. This opens the door to accelerating the development of a single therapy that can address multiple viruses, thanks to AI-supported analysis and the reduced likelihood of human error during the research process.

One critical challenge around adopting AI for pharmacovigilance will be proving to governments and regulators that the insights delivered through these AI-powered solutions are accurate. In 2021, we will see much of industry implement authority-facing strategies to address their use of AI and ML solutions given the criticality of ensuring patient safety.

The future for life sciences companies is digital
Digital transformation will continue to propel the industry forward as the fight to eradicate the pandemic by way of mass vaccination begins to roll out. Looking ahead, the precedent set by Covid-19 will shift the needle on expectations around agility and collaboration in a historically slow and siloed space. The pharmaceutical industry is positioned to help save millions and even billions of lives with the aid of new technology advances as well as lessons learned around opportunities for more global collaboration in 2020. Technology will be instrumental in this progress, helping life sciences companies bring treatments to market faster and keeping them there with stronger capabilities for safety and regulatory adherence.

Photo: Nuthawut Somsuk, Getty Images

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