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01 Feb, 2021

Preparing For Change: The Case For Progressive Innovation And Collaboration

These issues have created a pressing need for companies to reconsider the roles of players across the business – drug development, scientific information, sales, etc. – in order to become a partner within the healthcare system across the entire value chain. That, in turn, means companies’ processes must become much more open to the external environment, and that’s a big change for industry.

In the past, each function considered the drug development and commercial process without really taking into account external factors. Yes, companies conducted research into the disease they were seeking to treat, but the focus tended to be more on achieving a goal – regulatory approval, market access, product uptake – rather than the specific needs of the key stakeholders, including healthcare professionals, patients, and the regulators.

The challenge from a change management perspective, therefore, is to develop this new mindset within companies, build new skill sets that enable each function to understand external factors and then interact in an open, collaborative way with the external world.

How, though, can companies work with the broader healthcare community to address gaps, ensure patients have access to the medicines they need – including advanced therapeutics that are both more costly and more complex to deliver – while also remaining profitable?

Addressing the gaps

Digital innovation, combined with a collaborative approach, can help to address the gaps and challenges the healthcare industry faces. However, the concept of disruptive innovation is the wrong starting point for the industry. Instead, we would argue what we need is progressive innovation, which starts with recognising that each country or region has different healthcare systems and therefore needs a different approach. Progressive innovation is about understanding that healthcare is a deeply sensitive field that deals with people’s lives. Each situation needs to be managed carefully, with a careful assessment of the situation, before implementing a digital solution that is right for the circumstance.

One of the huge advantages of digital is the opportunity to generate large amounts of data along the diagnostic pathway of each patient, which could improve treatment of disease. However, there are a couple of issues holding the healthcare industry back. The first is that to generate this data, digital technologies need to be embedded in every process; however, many of these processes are deeply entrenched, which makes change more difficult. The second barrier is that healthcare organisations are often unwilling to share data with pharmaceutical companies, which can stymy progress.

By way of example, BIP is working with a large pharma client on a disease management pathway for a debilitating condition. The objective is to deploy new technology for managing the patient at home through virtual visits from the physician. The project has completely transformed the traditional face-to-face visit with a virtual follow-up, without giving up any of the clinical actions performed in the standard visits. This is an example of a new process enabled by new technology. Bip and the client are at the stage where a huge amount of data could be generated from the project, including data about the advantages of a virtual visit in terms of costs, how effective it is, outcomes and patient support. It is currently proving challenging to convince all stakeholders (e.g. the hospitals) about the opportunity presented by sharing, all the data being generated, which would help to show the regulator the additional value of the digital visit.

There are many reasons why progressive innovation – that taps into technology, data and collaborative change management approaches – can help the broader mission of stakeholders in healthcare, which is to improve lives.

Chaucer and BIP, which recently merged with Chaucer, work with many pharmaceutical companies to try to help them make their initiatives more future-oriented and in line with the specific needs and expectations of the healthcare system. Key to driving better outcomes is convincing healthcare stakeholders to collaborate with the pharmaceutical industry on projects that will improve healthcare processes, enable cost savings, provide access to innovations and offer better outcomes for patients. Importantly, digital innovations are also key to safeguarding data, but such innovations do require trust and collaboration.

In a recent initiative to ensure the integrity of data and documentation in a clinical trial for innovative therapies, Chaucer worked with other partners to establish an innovative hub for the compliant storage and integration of data and documents used in early phase clinical trials.

The challenge when developing innovative therapies is that the data and documentation is often both larger in quantity and gathered from multiple sources. To ensure the integrity and compliance of this vast amount of sensitive patient information, any solution must allow seamless integration of technologies across the lifecycle with the flexibility to address future challenges, such as integrating quality information during the manufacturing process.

The initiative included a platform to import and store data, a way to convert raw data into a useable format, secure data transfer mechanisms, an advanced electronic trial master file system and purpose-built integration and governance processes from Chaucer to ensure compliance requirements are met.

None of this is possible without disruptive, or better yet progressive innovation, collaboration and a willingness by all stakeholders in healthcare to accept and integrate change management processes. Ultimately, we believe that digital innovations will bring about a win-win for all parties.

To find out more about how Chaucer supports the Life Sciences sector, please contact Michael Whitworth; Michael.Whitworth@chaucer.com