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Future Proofing: Key DIA GAM 2021 Themes Inform Global Pharmacovigilance and Risk Management Strategies 2022

Alan Hochberg
Jeremy Jokinen
Bristol Myers Squibb Company
Meredith Smith
Alexion Pharmaceuticals

hen the DIA community gathered for DIA GAM 2021 last June, the pandemic had turned clinical safety and benefit-risk balance into household words. Both industry and governments worldwide were endeavoring to manage a flood of continuously evolving data and interpret it for the public under conditions of high uncertainty. Ultimately, one key contemporary challenge for pharmacovigilance has been high-quality communication: transmitting accurate information regarding both vaccine safety and efficacy in a clear, transparent, timely, and actionable manner, spanning numerous purposes and various stakeholders. What might this recent past mean for our future?

COVID-19 provided the opportunity for regulators and industry to collaborate and move more efficiently into and through drug development, review, and approval. But will these learnings continue into the post-pandemic period and help shape our response to the high unmet need that persists for efficacious treatments for many other diseases as well?

“Before COVID, quite frankly, few people in the public knew what pharmacovigilance was. Pharmacovigilance was more of an internal function within the healthcare or pharmaceutical domain. COVID and its significant media attention have made pharmacovigilance and drug safety front page news. The public is now consuming all this information (and misinformation) and it is not necessarily very easy or clear how to interpret the data and information they’re provided,” suggests Annette Williams of IQVIA, who serves on the program committee for DIA Global Pharmacovigilance and Risk Management Strategies 2022. “Fortunately, organizations such as the COVID-19 Prevention Network established by the National Institute of Allergy and Infectious Diseases are working to provide community education and setting the foundation for local awareness, literacy, and support of COVID-19 prevention and clinical research. It is critical that the public retains confidence in the accuracy of the safety information they receive about medicines and vaccines so they can make informed benefit-risk decisions for themselves and their families (whether COVID-related or not).”

“High-quality communication has always been a challenge,” continues Steve Knowles of Halozyme Therapeutics, another program committee member. “We’re in safety, we’re all scientists and we speak scientific language, but it’s not the language that most people understand. It’s important to communicate with high quality but also to be understandable. As pharmacovigilance and clinical development professionals, and as regulatory authorities and governments, we want to minimize disinformation and give people information that is accurate and that they can make informed decisions upon. This whole area of misinformation is a huge challenge.”

“Our 2022 keynote speaker is going to talk about research into modifying some of the behaviors we see in social media by people who post this kind of disinformation. He’s published the results of scientific studies looking at ways of modifying people’s behavior online to reduce the spread of disinformation,” Knowles adds.

Robotic process automation, machine learning, and artificial intelligence are making headway in refining or replacing routine tasks and in specialized areas such as image analysis. However, pharmacovigilance entails a range of complex activities such as determining if an adverse event confounded by indication does or does not represent a drug reaction or writing a risk-management plan for a teratogenic drug, among many other examples. These are critical safety responsibilities requiring clinical judgment for which machine algorithms cannot be developed easily. These responsibilities will likely not be turned over to machines any time soon.

Assessing the effectiveness of risk minimization measures is another ongoing challenge. Our systems continue to fall short in creating a continuous learning feedback loop to improve the conduct of risk management itself, a loop in which the results of risk-minimization evaluations are used to directly inform the next round of program modifications. Systems theory and mixed methods research hold promise here, but these approaches are not yet widely used in the pharmacovigilance community.

In certain contexts, such as evaluating new indications for marketed drugs, regulators and the industry are moving ahead with the use of real-world data to assess drug efficacy and safety. This puts new demands on the safety community to continually monitor the benefit-risk balance of these new approved products and indications and ensure that they remain positive.

Another issue of growing importance—some might call it an imperative—for drug safety organizations is to foster a culture of patient-centricity and embed patient-centric awareness and skills among their team members. For drug-safety organizations, patient-centricity means (among other things) listening to and addressing concerns regarding adverse events affecting patients’ quality of life and adherence to their medication regimen, even if they do not meet the applicable regulatory definition of “medically serious.”

Several themes tie together the above points. One is digital technology and data. Another is real-world evidence: both its promise (e.g., generating data faster and cheaper than traditional randomized clinical trials) and its challenges (e.g., data provenance, bias, making it suitable for growing use in regulatory safety and efficacy assessments). A third is patient-centricity, the increasing role of patients in all aspects of drug development from pre- to post-approval, which is emerging as a vital competency in drug safety and risk management.

“The challenge within the COVID world has been how to analyze these huge amounts of data that’s collected globally over a very short period of time. The world is expecting decisions about risks in a hurry. Part of vaccine safety management is how you handle all that data and how you detect safety issues, because that’s a challenge when things have been moving so fast,” Knowles suggests. “Companies and regulatory agencies are trying to figure out how to handle such huge amounts of real-world data. Over 240 million Americans have received at least one dose of a COVID-19 vaccine. How do you look at these huge amounts of data generated from potentially 240-plus million people in the US alone who have received a dose of vaccine?”

“COVID fundamentally changed the way we operate. Pharmacovigilance has historically been a conservative discipline where we follow rigorous SOPs and work instructions and do not deviate. But through the pandemic and the transitions it required, we had to become more agile to address the new types of data that came forward in such vast amounts and at ever increasing rates,” Williams continues. “It created the right environment for automation to be embraced. We saw significant pulling forward of investments in technology and a genuine willingness to try new technologies. This resulted in piloting of automation and artificial intelligence to help pharmacovigilance professionals obtain, parse, assess, and synthesize data. The varied application of automation and artificial intelligence across the PV landscape has led to the ‘future proofing’ of organizations.”

To learn more, plan to attend DIA Global Pharmacovigilance and Risk Management Strategies 2022.