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Agility and better decisions depend on managing risk and gaining insights from data by prioritizing patient and end-user needs. Companies of all sizes, including GSK, Boehringer-Ingelheim, Sanofi, AstraZeneca, and AbbVie, share best practices.
As patients take a more active part in their own healthcare, focusing on their needs is helping drug companies develop better treatments and improve business results. But the simplicity and emotional appeal of the phrase patient centricity belies the fact that it depends on a growing number of rapidly moving parts. As the speed of regulatory and business change increases, greater scientific rigor must be matched by an increased emphasis on operational execution, risk, and data management.
More than 2,000 life sciences professionals exchanged real-world experiences, best practices, and strategies for improving operations and delivering value to patients at Veeva Systems’ recent R&D and Quality Summit in Boston. Below are insights from industry leaders on ways to advance operations to become more patient-centered.
Understanding risk and cross-functional expectations in pharmacovigilance
Efforts typically start with simplifying and standardizing processes. Then, fragmented data is consolidated to permit trending and analysis and enable cross-functional collaboration. Results depend on having a clear understanding of risk and how to manage it to improve operations.
Better risk management is making new approaches possible, such as real-time product testing and release. It is also enabling more proactive quality and safety management. As Linda Scarazzini, head of patient safety at AbbVie, put it, “We can only minimize risk. We cannot eliminate it, and we must be brave in addressing it.”
AbbVie is unifying data and documents for an end-to-end approach to managing safety data and enabling time-consuming processes to be automated. One month after implementing cloud-based applications to support this effort, the company’s pharmacovigilance team is processing more than 2,000 adverse events daily. Ultimately, Scarazzini sees drug safety data as crucial to improving product development and broader business decisions.
Solving a Multivariate Rubik’s Cube in Clinical Trials
Understanding the perspectives of patients, end-users, and all the stakeholders involved with any technology is essential for managing complex activities with many variables. “One needs to know what ‘good’ looks like to each stakeholder group,” said Mayank Anand, vice president and global head of data strategy and management at GSK. This is easier said than done in clinical research, as trial protocols become more complex and require more—and more diverse—data. In trials where gene sequencing data is linked to primary endpoints, for instance, one terabyte (Tb) of data is now the norm.
Data, risks, and process analysis from the viewpoint of patients, research sites, sponsors, and HCPs is the critical next step. Richard Young, vice president of Veeva Vault CDMS, likens the effort to solving a Rubik’s cube when one can only see a few faces of the problem at any time.
Despite the degree of difficulty, progress is being made across all functions within life sciences. Importantly, it is all about a patients-first mindset with technology being leveraged to improve clinical development speed and quality, and clinical trial site and patient value, noted Uli Broedl, senior vice president of global clinical development and operations at Boehringer Ingelheim.
Boehringer Ingelheim, the world’s largest fully family-owned pharmaceutical company, has been advancing clinical research on both the human and the technology fronts. In March, it began work on its One Medicine platform, a holistic digital platform for clinical trials, using Veeva’s Vault clinical operations and data, quality, and regulatory applications. Broedl sees the platform as Boehringer Ingelheim’s foundation of connected clinical trial information flow, leading to process efficiencies while improving customer satisfaction.
For years, he explained, the industry has been challenged by complex workflows due to “best of breed” data systems that offer limited interoperability while creating disjointed user interfaces. Sponsors need a single source of truth, and the ability to automate processes with high quality is critical, while at the same time, sites and patients rightfully expect great user experience while working with our systems and applications, he said.
Broedl envisions a day when patient and site experiences can be further enhanced as data from clinical and business platforms such as CRM converge. The physician care provider and physician investigator are the same person and leveraging data from the One Medicine Platform and CRM offers the potential to improve patient recruitment, retention, and patient care. “Ultimately, the success of our new digital cloud-based platform is based on patient outcomes–bringing life-saving treatments to patients faster,” Broedl said.
Gaining Value from Clinical Data
GSK is also adopting new clinical data strategies and a unified, connected approach to clinical trials to improve agility, patient focus, and business results. In 2021, the company introduced an advanced EDC system and set new clinical trial benchmarks that have led to significant improvements. In 2020, it took 12-to-21 weeks to build a clinical study, but GSK’s teams can now do this in less than eight weeks, and database locks within four weeks.
Efforts had to move beyond the EDC since most clinical data can no longer be managed there. GSK needed a central point for managing data and worked with Veeva on the new CDB data workbench, which the company and its CRO, Syneos Health, are now using in 30 clinical trials. Connecting EDC and external data so that aggregation, cleaning, and storage occur in one place will permit new insights to be gained from data and better future results from artificial intelligence, imaging, and natural language processing (NLP).
Reimagining Quality and Democratizing Regulatory Data Access
A sharper focus on patients is also changing perceptions of the quality management function, which, in pharma, has traditionally focused on compliance. In reality, quality’s role has always been to control disruptive variation and enable processes to be carried out right the first time, explained Anthony Morandi, vice president of quality at AstraZeneca. Heightened patient expectations and compressed production cycles drive more senior executives to connect improved quality management with better operations.
Morandi emphasized the need for pharma companies to work more closely with suppliers and contract partners and to share tasks and data in a far more integrated way than they have in the past. Improved approaches will require viewing quality as a set of interdependent, interwoven processes so that tasks and data flow without distinct boundaries across processes that have traditionally been separated, including risk management, change control, training, documentation, CAPA, and complaints, he said.
In any pharma function, making data available to the right people at the right time and in the best form is key to driving efficiency. In managing its regulatory data, Sanofi is democratizing data access so that users in all functions and levels of the organization can access and use information more easily.
The company centralized fragmented regulatory data and documents on a single cloud platform, eliminating 88 different IT systems, slashing IT support calls by more than 70%, and outages from 28 in 2018 to zero in 2022, said Joe McLaughlin, head of regulatory business practice and innovation. The shift has also allowed Sanofi to react more quickly to accelerating change, for example, handling more than 40 new releases each year, compared to one every five years with their previous systems.
The company rejected customization in favor of standardized approaches. “We stopped Sanofizing” things, commented Jean-Baptiste de Courson, head of global regulatory affairs operations. Connecting regulatory operations with safety and quality allowed the company to create a new global user-support ecosystem to enable real-time cross-functional data access and collaboration. Introduced this year, the platform allows more than 11,000 global users to have live data-based conversations. As a result, decisions that once took days or weeks can now be made within minutes, McLaughlin said.
Inspiration from Patients Underscores the Need for Speed
Sean McNiff, vice president of regulatory platforms and systems at GSK, made the strongest and most poignant case for improving data management to focus on patient needs. He shared his 15-year-old daughter’s experience growing up with a rare disease for which no cure is available. Access to better treatments, including a device that continuously monitors her condition, has made a huge difference.
Eliminating delays in patient access to better treatments defines the mission McNiff has set for his team, which focuses on improving the efficiency of regulatory data management. Initially, some long-standing corporate practices, including having different regulatory systems for pharmaceuticals vs. vaccines, had limited results. Unifying approaches was crucial to improvement, and that goal drove the first part of a modernization project that began in February 2019 for investigational products and went through eight improvement phases to cover all pharmaceuticals and vaccines.
In January 2022, GSK’s team completed the final phase of an end-to-end regulatory cloud platform for 10,000 users. So far, efforts have consolidated legacy IT platforms, significantly reduced SOPs and work instructions, and harmonized millions of data points.
These results show what is possible using data and technology to bring value to patients. But, in the end, inspiration from patients can drive innovative approaches to manage complex and interconnected data, risk, and quality. Progress wouldn’t be possible without a clear understanding of their needs.