Amidst the backdrop of a global pandemic, the life sciences industry has found new ways to collaborate across corporate, regional and country lines to speed up drug development and approvals of COVID vaccines. Industry players, health authorities and partners have learned how to work at breakneck speed in a safe and efficient way that until this year, seemed eons away. In doing so, we have learned what we must do to help end the pandemic and prepare for any future ones. Technological advances by way of automation-enabling solutions will move from nice-to-have tools to necessities for day-to-day operations, as the world bands together to combat the virus that has already taken more than 1.5 million lives.
Lessons learned during the pandemic around global collaboration will push the pharmaceutical industry toward more agile capabilities for regulatory operations and regulators toward an accelerated approval pathway in support of clinical studies. 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 become more flexible or continue the trend toward greater stringency seen prior to the pandemic; however, 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.
This has been especially true in the face of pressing deadlines to deliver set by government initiatives. Looking forward, 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 – regardless of whether 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 and not lose the momentum created by the circumstances of the pandemic.
Real-time surveillance of adverse events will improve public confidence in COVID vaccines. Today, about one in five people are still “pretty certain” they won’t get the vaccine. 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 258,000 US lives and continues to climb by roughly 2,000 more a day as of early December.
Currently, most of industry relies upon aged safety systems for adverse event report management and monitoring. Very limited innovation has 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, expansion of marketing of products in many new geographies and new 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 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 to 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 in 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.
Looking to 2021 and beyond
The acceleration of digital advancements will continue to propel the industry forward as we fight to bring an end to the pandemic. Looking ahead to 2021 and beyond, the industry will pursue new opportunities to adapt and innovate in a more agile way, for greater collaboration, expedited regulatory reviews, and improved drug safety. The industry is in a position in which it can quite literally help save millions to potentially billions of lives. Technology will help them do this, by enabling life sciences companies to deliver upon the pressing demand for faster, safer, more efficient drug development cycles.
Ronan Brown is SVP and Head of IQVIA Integrated Global Compliance, where he connects IQVIA’s global partners with high-tech solutions to manage their compliance challenges. He has spent his career supporting healthcare companies through technological transformation, starting in the UK as a CRA for BRI International. He later joined Glaxo Wellcome, where he focused on respiratory studies in several capacities, including project management, medical affairs and market support.
Joe Rymsza has over 25 years of experience in developing, deploying and managing technology solutions in the life sciences industry. In his current role, he oversees IQVIA’s efforts to harness the power of cutting-edge technology for managing regulatory compliance. Prior to IQVIA, Joe was co-CEO of Foresight Group International, a professional services group focused exclusively on drug safety and risk management.
