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Siva Thiagarajan is BU Head, R&D Platforms and Services, Indegene
Small- and medium-sized pharmas should revisit their pharmacovigilance strategies and adopt smarter end-to-end solutions to keep pace with increased volumes and rapidly changing regulatory requirements, writes Siva Thiagarajan.
The pharma industry faces an urgent need for standardization and intelligent automation in pharmacovigilance (PV) and safety monitoring. The pre-existing process challenges are compounded by adverse event (AE) case volume overload and reporting inefficiencies. This demand is leading to a sharp increase in budgets among large companies for better safety system upgrades and process optimization. However, for small- and medium-sized pharma companies, there is a need to revisit their pharmacovigilance strategies and adopt smarter end-to-end solutions to keep pace with increased volumes and rapidly changing regulatory requirements.
Small-sized companies are prone to compliance risks due to unanticipated spikes in AE case volumes. These risks take highly qualified resources away from high-end safety activities, such as risk and signal management, to firefight spikes in case volume. This increase in case load and growth in activities due to new product launches inevitably require companies to scale through outsourcing. However, the challenge is that vendor partners often lack the required advanced skills and adequate number of experienced resources to support smaller clients. Even internally, small companies tend to have less mature pharmacovigilance processes and hence rely heavily on human judgment, resulting in inconsistent decision-making during case processing. Modern automation can solve some of these issues; however, small companies, unlike large ones, typically do not have the capital to invest in the challenging journey of automation. Hence, for automation to be viable for small and medium pharma companies, it must be affordable, transparent, easy to adopt, and address the challenges of scale, volume fluctuation, and consistency.
Cloud-based applications are already transforming several areas across the drug development life cycle – accelerating clinical, quality, and regulatory processes and providing greater visibility to data-driven insights for better decision-making. With a cloud-based pharmacovigilance solution, any organization irrespective of its size can easily scale its drug safety operations while also standardizing its processes through automation.
The prerequisites for a modern pharmacovigilance solution include the following:
1. Standardized, transparent, and intelligent automation: Other industries have already adopted explainable artificial intelligence (AI) with predictable outputs moving from a black box to a transparent box AI approach. A similar approach can be adopted in drug safety. The first step to adopting AI is to establish a standard business process and minimize subjectivity in activities such as judging a seriousness and causality of a case. The next step is automation of the process using a transparent approach that ensures reproducible and explainable decisions are made by the system, resorting to subjectivity only as a fallback. The result will be a standardized, verifiable, and explainable AI engine that improves consistency and transparency in decision-making, and yields benefits rapidly without a need of several months of onerous machine training.
2. True SaaS-based solution: A safety solution in the cloud makes it easier to stay up-to-date with regulatory requirements and reduces the burden of upgrades. The underlying best practices of eliminating customization in favor of configuration, having a single code base versus multiple code branches across clients, automating IT operations with modern technologies and processes such as DevOps versus doing them manually, and having scalable IT and infrastructure operations are key to a true SaaS solution. Wide adoption of applications such as Workday and SuccessFactors are successful for these reasons. The drug safety domain needs a similar ecosystem.
3. Human capital: As the pharmacovigilance technology landscape evolves, there are challenges related to technology adoption such as building trust in decisions made by AI systems and developing comfort with a SaaS-based model as opposed to having everything in-house. This requires appropriate training on core platforms, understanding of what role machines and humans will play together, monitoring and measuring the performance of machines, and demystifying machine-based decisions for auditors, senior management, and other stakeholders. All of this points to the need for modernizing the workforce for the future of drug safety operations.
"Cloud is already widely adopted in clinical, regulatory, and quality organizations as well as across horizontal functions such as HR and IT with Workday and ServiceNow. With a single code version, cloud vendors can allocate more resources to innovation and have made great strides in providing solutions that are easy to use and administer, while eliminating the traditional costs for maintenance, hardware, and hidden services like disaster recovery that are typical of traditional on-premise systems. As the cloud offers the entire solution as a service, this enables organizations of all sizes to realize the benefits of enterprise applications", says Brian Longo, Senior Vice President and General Manager, Vault Safety, Veeva Systems.
Anand Kiran, EVP and Head of Safety Services and Products, Indegene, adds, "PV processes are fundamentally similar from company to company. Yet, there are differences creating a vast set of variants. Managing such variations has become challenging, particularly now as case volumes are sky-rocketing. While PV automation is coming into the mainstream in large pharma companies, small- and medium-sized pharma still have to deal with basic issues related to safety database maintenance and unpredictable case volumes. We believe this sector will benefit hugely from a plug-and-play reliable SaaS ecosystem with intelligent but transparent automation."
Large pharmaceutical companies still have their legacy processes and systems, and have responded to the PV challenges by adopting automation. However, their current vendors are either technology companies with limited expertise in running advanced safety operations or case processors with little or no proven success in AI and automation. Hence, in the absence of end-to-end solution providers, large pharma companies have taken all the risks themselves by stitching together a safety ecosystem (ie, safety database + automation solution + service provider). Although they have taken on expensive automation initiatives, they have also had to spend money on database upgrades to be compliant with new regulatory requirements and post-M&A integration requirements.
In sum, as the industry grapples with newer challenges, each company is solving the same problems in its own way. Smaller companies that do not have the capital to solve these issues have to wait and watch. These challenges offer a great opportunity for the industry (pharma and service providers alike) to improve processes and reevaluate their human capital skills while enabling the future of pharmacovigilance. A collaborative approach to accomplish this would benefit companies of any size as well as service providers.
Siva Thiagarajan is BU Head, R&D Platforms and Services at Indegene.