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Pharmacovigilance: An Opportunity for Technology Investment for the Future
By Richard Wolf, Executive Director, Pv Operations, Global Clinical Safety & Pharmacovigilance (GCSP), CSL Behring and Maureen Martini, Director of Business Process and Technology, CSL Behring, Pharmacovigilance
A little about Pharmacovigilance (Pv)
If you are not in the field of Pv, you might wonder why the technology industry has not solved a basic information management problem. All pharma companies have similar challenges and accountabilities to their stakeholders to those that existed 15 years ago. Ultimately, Pv is about keeping patient safety first, maintaining accurate benefit/risk profiles, acting decisively when new information becomes available, and remaining compliant with regulations in countries where their products are marketed and/or in development.
To meet the challenge, every biopharmaceutical company has to:
1. Receive, process, assess, and report Individual Case Safety Reports (ICSRs) to Health Authorities (HAs) and other key stakeholders in a timely manner;
2. Analyze, summarize, and report aggregate information regarding the benefit/risk profile;
3. Ensure oversight across the company’s agents acting on their behalf;
4. Develop and maintain risk management strategies throughout the development program.
The current situation
At the core of a Pv systems landscape is an Individual Case Safety Reports (ICSR) processing application, such as Oracle’s Argus. Used by 29 out of the top 30 pharmaceutical companies, Oracle safety products are regarded by many as best-in-class. The Argus platform has streamlined case workflow and ICSR reporting and is capable of being enhanced to meet global and local regulations for companies with global reach.
Many biopharmaceutical companies are moving from on-premise solutions to SaaS. Many are attempting to implement state-of-the-art reporting tools such as RxLogix’s Pv Reports. Others are working aggressively to establish optimized intake solutions, such as My Meds and Me’s Reportum or ArisGlobal’s Inbound Receipt Triage (IRT), to standardize and simplify the data coming into Argus.
This complex arrangement of systems is one of the reasons most mid to large sized pharma companies have established Pv Systems groups within the Pv function. Detailed understanding of evolving regulations and greater expectations for detailed explanations of systems under inspection are some of the reasons that the Pv Systems Head and other resources have historically been placed closer to the business than to the IT organization. Yet, this does not eliminate the need for IT to ensure proper infrastructure including sufficient security and quality standards.
No biopharmaceutical company can remain complacent in this space and maintain good standing with health authorities around the world. A significant amount of awareness, insight and agility is required to maintain compliance and ensure comprehensive, yet efficient operations.
The silver bullet?
While some are discussing the idea of eliminating end-to-end ICSR case processing using Natural Language Processing (NLP) and Robotic Process Automation(RPA), most are hesitant to go to production given the extraordinary global regulatory framework. Companies must ask themselves, is it worth the high risk of being tagged as non-compliant, incurring fines, a negative impact to reputation, and risking potential restriction of marketing authorizations, in exchange for the chance to receive the benefit of improved cost structure in Pv?
The big question is whether this is the moment where technology has evolved sufficiently and requirements have stabilized enough to automate this highly operational work in Pharmacovigilance. Will RPA and artificial intelligence (AI) solutions be able to align well with the complex Pv ecosystem and stand up under regulatory inspection? And what benefits can we truly expect and at what cost?
Another big question for us is how the Pv technology space will look coming out of this inflection point. Will companies like Oracle incorporate RPA and AI directly into their software? Will industry collaborations, such as Oracle’s Argus Cloud Consortium or solutions from Transcelerate help the industry standardize and automate together as a group?
Investments for the future
One area that has not been addressed by technology in the Pv space is how to establish and effectively monitor Pharmacovigilance Agreements (PVAs). These legal agreements are required to define how two partners exchange safety information with one another. These arrangements cover important types of partnerships in the marketing and patient support areas. The complexity in the documents, however, is considerable given European laws and regulations (e.g. GVP Module I). No standard system offering exists that solves this problem, yet regulators have increased their focus in proper oversight of this area.
Another topic which calls for innovation in Pv is the interaction between clinical Electronic Data Capture(EDC) and the safety system. Shouldn’t biopharmaceutical companies have enough standardization by now to allow interoperability between systems? There has been some success here, but it is very limited and will be disrupted again temporarily as companies transition to the new E2B R3 standard.
And while there has been some progress, we would like to see some further focus and improvement toward Clinical Safety Risk Management activities, including analytics solutions to better support signal management. Enhanced solutions for generating reports from the safety database will assist in important signal evaluation efforts. A modernized document management system for the development of periodic aggregate safety reports, Risk Management Plans (RMPs), etc., could enhance quality and efficiencies by improving workflow, review cycles, implementation, and tracking.
We have a base to build upon thanks to foundational solutions like Oracle’s Argus. We also have some exciting technologies that may prove instrumental such as RPA, AI, and possibly even Blockchain. The goal is that technology enables the industry to do this extraordinarily important and necessary but highly operational and sometimes manual work.
Long-term, we see a future where Pv Operations groups have significantly evolved. For example, tomorrow’s Pv professional may develop and train bots to perform routine Pv tasks, a striking contrast to today’s Pv professional. We also see reinvestment of operational dollars onto the medical side, enabling safety physicians to focus on delivering critical medicines to patients around the world, patients who enjoy better quality of life from our products.