How Life Sciences’ Shift to Digital is Improving Collaboration and Patient Focus
At the Veeva R&D and Quality Summit, experts showed how they are leveraging the data in the cloud to improve drug development and manufacturing.
Chris Moore, President, Veeva Europe
As companies emerge from the disruptions and urgency of COVID-19, the industry is reflecting on the major changes that took place over the past two years and their future implications. At the Veeva R&D and Quality Summit, experts agreed that the industry is never going back to the old pre-COVID-19 days. It must embrace technology to lock in the incredible advances in drug development, registration, and manufacturing that were made during this time. Providing some real-life examples, companies that have adopted cloud-based approaches showed how they are improving clinical trials, pharmacovigilance, regulatory compliance, and quality management.
From data to insights
One of the industry’s biggest challenges is leveraging all the value hidden in the huge volumes of data it gathers. In some cases, data points remain siloed in different functional locations, limiting the cross-functional collaboration required for innovation. “Life sciences is incredibly data rich, but our ability to mine this data is still dramatically low,” Regis Simard, president of Pharma Supply Chain at GSK, said in his keynote.
This will need to change, he suggested. “As the fields of human genetics and artificial intelligence converge, the rate of innovation is accelerating at a pace never seen before,” he said. The industry is also using new tools that will require better use of data. Simard cited increased use of in-silico modelling and digital twins for process development. “These approaches will fundamentally change how the industry develops and manufactures medicines,” he commented.
Deeper collaboration
At the same time, most companies have shifted from an internally focused business model to an extended ecosystem involving partnerships with contract research organizations and contract development and manufacturing organizations (CROs and CDMOs). As the industry moves to predictive analytics, there is a growing need for automated and real-time exchange of data, noted Simard.
In the process, quality is being viewed as a competitive advantage and is moving from a reactive to a proactive approach. For relationships with contract partners, Simard said, companies will shift from focusing on who is accountable for what, to deep collaboration using connected and automated processes.
The importance of collaboration was a theme that ran throughout Summit. “Partnerships are key to success in accelerating the delivery of new molecular inventions to market,” emphasized Iris Koenig, senior director and head of global site management at LEO Pharma.
For AstraZeneca, the end game for R&D is to develop products that will stand the test of time as systems and infrastructures evolve, said chief medical officer Dr. Ann Taylor. “The focus is on creating a harmonized vision for R&D and using this over the long-term,” she said. In the future, collaboration promises to lead to new therapeutic modalities, including combinations of two or three drugs, Taylor noted. Simard agreed, and foresees this “combo” model becoming a standard approach to drug development in the future, as biological agents are combined to modulate the human immune system in increasingly sophisticated ways.
This spirit of partnership also extends to quality and manufacturing systems. Three collaborators — argenx, an innovator company that is moving into commercial-stage work; Epista Life Sciences, an expert in validation and project management; and Veeva — are partnering to streamline argenx’s quality systems and documentation and integrate it with other key drug development data. They plan to implement five cloud-based management systems for regulatory, quality, and clinical trial management, in such a way that data can be easily transferred and accessed between the systems.
Discussing the Veeva Vault Quality Suite rollout, argenx noted that advanced planning and clear and frequent communication have been critical to the project so far. “We are moving together as one team,” said Klass Boone, the company’s senior director of business information systems.
Need for metrics and standardized practices
Better metrics will be needed to guide company and CDMO efforts in quality, noted Mark Grothkopp, research associate at the University of St. Gallen’s Institute for Technology Management. The US FDA has been funding the Institute’s research into life sciences quality metrics and operational excellence for the past four years. As Grothkopp said, key performance indicators are needed, not only to improve work processes that limit results, but to drive organizational improvements and a more mature quality culture.
Andrew Sharrock, quality director at AstraZeneca, shared lessons learned in optimizing approaches to CAPAs, audits, and quality events (such as out of specification) in a project that replaced an older document management system with Veeva’s Vault Quality Management System. “We need to be more agile and competitive,” he noted. The previous solution did not permit standardized reporting and processes, some of which were still handled on paper. The next phase of this project will roll out a Validation Lifecycle Management module that will show when quality deviations, complaints, and audit risks are tied to individual pieces of equipment, allowing for immediate response.
Automating and digitizing are crucial
Automation will be key to freeing teams from mundane tasks so that they can focus on science and patient-centric drug development. As Simard asked attendees, “Why are we, as an industry, using highly trained and motivated people to handle repetitive and simple tasks that only a machine could perform without error?”
Addressing this topic from the standpoint of clinical operations, KCR and AstraZeneca shared best practices on how they are moving away from manual, paper-based approaches. Adopting unified and standardized processes lets their teams share crucial data more efficiently, both internally and with outsourcing partners, and to better focus on core efforts that improve results for patients.
Pharmacovigilance professionals, responsible for ensuring the safety of therapies, also discussed the move to simplified and digital processes. In a Veeva customer roundtable, Matt Tutton, pharmacovigilance manager at Bionical Emas, explained his company’s need for a scalable safety solution that could match the growth trajectory of the business. Similarly, BMS’ pharmacovigilance lead Chris Ward, who heads up the company’s product safety master file operations globally, discussed the move from a SharePoint-based system that was managed differently at each of its sites. Having a unified, standardized approach has automated processes to increase control and allow for closer collaboration, he said.
Sustaining momentum toward patient centricity
Challenges that companies have faced during the pandemic have made the path to patient centricity much clearer, particularly for clinical research and pharmacovigilance. “Try to facilitate a mindset shift in your organization, from thinking about how things have always been done to what’s possible in the future,” said Amy Kisken, senior director of study start-up and conduct specialists at Bayer.
Maintaining momentum will be especially important in the months and years to come, she said, adding, “Organizations should really leverage this opportunity to fast track and become more efficient and effective in patient-centric clinical trials. There’s momentum in the industry to keep up with the advancements we’ve seen so far during COVID-19.”
As the pace of innovation continues to quicken and competition intensifies, the way ahead promises to be challenging but the industry can’t look back. Fully leveraging life science data, as Simard remarked, is “a problem to solve, not a reason to pause.” As evidenced at the Summit, more companies are tackling this challenge head on.
Watch key presentations on demand from the 2021 Veeva R&D and Quality Summit Connect, Europe.