{"id":45012,"date":"2021-12-10T12:07:33","date_gmt":"2021-12-10T17:07:33","guid":{"rendered":"https:\/\/www.arisglobal.com\/?p=45012"},"modified":"2021-12-10T12:07:33","modified_gmt":"2021-12-10T17:07:33","slug":"vaccine-safety-covid-pharmacovigilance","status":"publish","type":"post","link":"https:\/\/www.arisglobal.com\/blogs\/vaccine-safety-covid-pharmacovigilance\/","title":{"rendered":"Vaccine Safety in the Public Eye: How COVID-19 Brought Pharmacovigilance Center-Stage"},"content":{"rendered":"

The coronavirus pandemic ushered in a new era of public scrutiny for the pharmaceutical industry. The general population was traditionally most invested in novel medicines in clinical trials \u2013 news reports and medical journal articles about new, promising drugs would make headlines, especially when they looked to treat afflictions that had few readily available treatment options.<\/span>\u00a0<\/span><\/p>\n

But like so much else,\u00a0the pandemic\u00a0fundamentally changed public opinion and perception of pharmaceutical development.\u00a0Now, pharmacovigilance is the most visible phase of modern drug development. The\u00a0SARS-CoV-2\u00a0pandemic \u2013 and\u00a0biopharmas\u2019 near-immediate response\u00a0to\u00a0develop vaccines and treatments\u00a0\u2013 increased\u00a0public attention\u00a0to\u00a0and scrutiny\u00a0of\u00a0pharmaceutical\u00a0safety.<\/span>\u00a0<\/span><\/p>\n

\"\"<\/p>\n

Most\u00a0biopharmas\u00a0are additionally increasingly challenged by static or shrinking budgets. The\u00a0pandemic\u2019s\u00a0global financial effect\u00a0resulted\u00a0in\u00a0the reduction or reallocation of funds\u00a0for\u00a0most, if not all, organizations.\u00a0This only further highlighted\u00a0an industrywide need for greater efficiencies across the spectrum of Safety\u00a0functions.<\/span>\u00a0<\/span><\/p>\n

Safety teams have\u00a0faced\u00a0increased complexity\u00a0in recent years,\u00a0including\u00a0more complex\u00a0drugs,\u00a0data from\u00a0accelerated and\u00a0decentralized trials, ever-growing data sets,\u00a0and\u00a0more\u00a0global and diverse patient groups and partnerships.\u00a0And the workload is\u00a0expanding\u00a0in volume, too –\u00a0Safety\u00a0caseloads\u00a0are growing, on average, 15% year over year. These teams are managing these compounding variables,\u00a0all while working with a static or shrinking budget.\u00a0Artificial intelligence\u00a0(AI)\u00a0\u2013\u00a0including\u00a0repetitive, predictive, and cognitive\u00a0automation\u00a0\u2013 will be table stakes to keep up with the industry\u2019s changing demands\u00a0while keeping costs low.<\/span>\u00a0<\/span><\/p>\n

Efficiency and accuracy are\u00a0crucial\u00a0for meeting compliance standards, ensuring patient safety,\u00a0and earning the public\u2019s trust. Technology will play a critical role in enabling the kind of rapid breakthroughs COVID-19 demanded while not\u00a0sacrificing safety or compliance.\u00a0<\/span>\u00a0<\/span><\/p>\n

COVID-19 and Public Perception<\/span><\/b>\u00a0<\/span><\/p>\n

The coronavirus pandemic changed public perception of pharmaceuticals in two primary ways: it drastically increased expectations for the speed at which treatments should be brought to market, and it heightened sensitivity to adverse events.\u00a0<\/span>\u00a0<\/span><\/p>\n

The\u00a0biopharmas\u00a0that brought COVID-19 vaccines to market in 2020 were able to do so with incredible speed because of the convergence of several factors.\u00a0Emergency government funding certainly played a role in making it feasible for the companies to focus\u00a0extraordinary\u00a0efforts on developing a vaccine. The novel use of mRNA\u00a0had the biggest impact on the compressed development timeline, since it eliminated the need to\u00a0identify\u00a0a harmless piece of the\u00a0novel coronavirus\u00a0or otherwise render the virus ineffective before creating the vaccine itself. But even once the vaccine was ready to be tested, technology\u00a0further\u00a0sped up the process by enabling simultaneous, remote, parallel trials and faster data analysis through\u00a0<\/span>artificial intelligence and machine learning.<\/span><\/a>\u00a0<\/span><\/p>\n

Thanks to new research,\u00a0an influx of government funding,\u00a0and technological advancements, scientists accomplished a task that once took a decade or longer in under a year. This compression of the\u00a0entire research and development (R&D) process, from ideation through clinical trials,\u00a0both\u00a0drastically altered\u00a0public expectations of reasonable time to market\u00a0and\u00a0put Safety in the spotlight.\u00a0These\u00a0expectations and reservations\u00a0will persist even after the pandemic has subsided.\u00a0<\/span>\u00a0<\/span><\/p>\n

\"\"<\/p>\n

Pharmacovigilance Challenges<\/span><\/b>\u00a0<\/span><\/p>\n

The greatest challenge in pharmacovigilance today is handling a steady increase in the quantity of Safety data.\u00a0Case volumes have been growing nearly 15% year\u00a0over\u00a0year, while the teams that manage the workload\u00a0face\u00a0static budgets and inefficient processes. Rote tasks like data input and reporting take up hours of time, often keeping the organization\u2019s valuable\u00a0employees\u00a0from focusing on\u00a0the work that requires human input and oversight, like\u00a0analysis and risk assessment.\u00a0<\/span>\u00a0<\/span><\/p>\n

\u00a0<\/span>Adverse Event Case Management<\/span>\u00a0<\/span><\/p>\n

Globalization has increased the range and complexity of case management considerably, which in turn has made\u00a0collecting adverse event reports more challenging than ever.\u00a0Plus, technology has expanded the scope of reporting mechanisms, opening the possibilities for easier self-reporting and even new reporting channels, like social media.\u00a0<\/span>\u00a0<\/span><\/p>\n

In the case of COVID-19, managing these reports\u00a0is\u00a0further complicated by the sheer magnitude of doses being administered\u00a0in\u00a0such a\u00a0short period.\u00a0To date,\u00a0<\/span>over 200 million people in the United States<\/span><\/a>\u00a0have\u00a0been fully vaccinated against COVID-19.\u00a0By comparison, the last federal push to vaccinate everyone in the country\u00a0\u2013\u00a0in 1976, when\u00a0President Gerald Ford\u00a0aimed\u00a0to inoculate the nation against swine flu \u2013 resulted in\u00a0<\/span>40 million immunized\u00a0individuals<\/span><\/a>\u00a0over the course of a year.\u00a0According to Bloomberg,\u00a0more than\u00a0<\/span>8\u00a0billion doses<\/span><\/a>\u00a0of the COVID-19 vaccines\u00a0have been administered worldwide\u00a0as of December 2021.<\/span>\u00a0<\/span><\/p>\n

Much of the strain of identifying these adverse events could be lifted with automation technology that can collect, organize, and\u00a0analyze adverse event data, even if it comes in an unstructured form. In the\u00a0<\/span>2021 ArisGlobal State of the Industry repor<\/span><\/a>t<\/span>, 59% of survey respondents said their intake and triage efforts would be greatly benefitted by automation.\u00a0<\/span>\u00a0<\/span><\/p>\n

Aggregate Reporting<\/span>\u00a0<\/span><\/p>\n

Compiling sums of data \u2013 especially those\u00a0as large\u00a0as\u00a0produced by a global vaccine response \u2013\u00a0into reports that may identify a pattern again takes valuable human resources away from more cerebral tasks. Of those surveyed in the\u00a0<\/span>industry report<\/span><\/a>,\u00a046% saw an opportunity to automate processes around reporting and analytics visualizations.\u00a0<\/span>\u00a0<\/span><\/p>\n

Signal Intelligence\u00a0and Risk Management<\/span>\u00a0<\/span><\/p>\n

Analyzing the risks and benefits of any given treatment requires taking huge amounts of data into account.\u00a0When looking at data sets that\u00a0massive,\u00a0artificial intelligence and machine learning can go a long way in enhancing efficiency and transparency.\u00a0Of\u00a0<\/span>the industry report<\/span><\/a>\u00a0survey respondents, 74% said automation in signal identification and risk management would be very beneficial to their organization.<\/span>\u00a0<\/span><\/p>\n

Automation\u00a0in signal intelligence and risk management\u00a0increases\u00a0efficiency by detecting signals faster,\u00a0and\u00a0artificial intelligence and machine learning enable deeper pattern detection than\u00a0is\u00a0readily apparent to the human eye or mind\u00a0in such large data sets.\u00a0Together, these advanced technologies significantly improve patient safety by making signals easier to identify and assess, ultimately reducing the occurrence of false positives and bringing genuine risks to light earlier.\u00a0<\/span>\u00a0<\/span><\/p>\n

Automation Trends Emerging in Pharmacovigilance<\/span><\/b>\u00a0<\/span><\/p>\n

Automation is reshaping drug Safety.\u00a0While\u00a0it\u00a0has traditionally been seen as a cost\u00a0center and mandatory expense, new technology is enabling\u00a0Safety\u2019s\u00a0evolution\u00a0into a\u00a0value opportunity\u00a0for life sciences organizations. By automating collection and report generation, employees are free to focus on the bigger questions, like risk analysis. And by leveraging\u00a0artificial intelligence\u00a0and\u00a0machine learning, these employees can work smarter, realizing gains in efficiency, transparency, and cost effectiveness,\u00a0all while maintaining compliance.\u00a0Better yet, these new standards are elevating patient safety, mitigating the risks of medication and enabling greater global health.\u00a0<\/span>\u00a0<\/span><\/p>\n

As public expectations rise, pharmacovigilance will continue to be a highly visible phase in drug development. Life sciences organizations can benefit by investing in\u00a0<\/span>the technology<\/span><\/a>\u00a0that will take Safety from a business cost to a strategic value driver.\u00a0<\/span>\u00a0<\/span><\/p>\n

To learn more about pharmacovigilance automation and see\u00a0ArisGlobal\u2019s\u00a0LifeSphere\u00a0Safety platform in action, visit\u00a0arisglobal.com\/lifesphere\/safety.\u00a0<\/span>\u00a0<\/span><\/p>\n

\"\"<\/p>\n","protected":false},"excerpt":{"rendered":"

The coronavirus pandemic ushered in a new era of public […]<\/p>\n","protected":false},"author":27,"featured_media":48213,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[67],"tags":[83],"class_list":["post-45012","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-blogs","tag-arisglobal-blogs"],"acf":[],"yoast_head":"\nVaccine Safety in the Public Eye: How COVID-19 Brought Pharmacovigilance Center-Stage | ArisGlobal<\/title>\n<meta name=\"description\" content=\"The pandemic, and widespread awareness of the vaccines made to combat it, have made pharmacovigilance the most visible phase of modern drug development.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.arisglobal.com\/blogs\/vaccine-safety-covid-pharmacovigilance\/\" \/>\n<meta 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