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Single Source

For life sciences companies, faster time to market can yield millions in additional revenue to fuel important research; however, the sector continues to struggle to bring novel therapies to approval, formulary and market quickly. A report from Tufts Center for the Study of Drug Development estimates the cost of bringing a new product through this process is $2.6 billion (1,2), and the average time it takes in the US has not been significantly reduced in the last decade. Part of the challenge is a clinical development process that, in many organisations, is managed through a combination of paper processes and disparate systems that isolate different groups along the value chain.

Product development involves thousands of documents that span research, from clinical to commercial. Coordinating processes and document versions to better collaborate upon, manage and exchange key content has long been time-consuming, manual and error-prone. Mistakes are made, and limited visibility and workflows cause inefficiencies that hinder the process.

In addition, life sciences businesses are starting to branch out into new markets – working with more local affiliates, more partners and even broader groups of customers. Simultaneously, they are engaging with a wider network of stakeholders. Organisations of all sizes are now dealing with the complexities of working with affiliates and partners around the world – often without solid foundations for effective collaboration. Gens & Associates’ Regulatory Information Management (RIM) benchmark study found that 40% of affiliate time is spent coordinating and managing regulatory information, with approximately 25% of that focused on activities offering no added value, such as re-entering data.

t is clear – now more than ever – that better internal and external content collaboration is not just ideal, it is also the difference between bringing a product to market quickly, and struggling with delay-causing complexity.

Lengthy Procedure

Consider the typical procedure for making one protocol change: what should be a simple update can span many fragmented processes. A medical writer creates the protocol in a submissions-focused system, and then emails it to a colleague in clinical. The clinical user imports and then re-approves the protocol in the electronic trial master file (eTMF) system. The study is executed, and documents – including 1572s and investigator CVs – are collected, sometimes across hundreds of sites. Those documents are exported and emailed back to the regulatory team, which packages and finalises the submission, and sends it to the appropriate health authorities.

After product approval, the commercial team often leverages clinical study reports (CSRs) from the submission to support promotional claims. To do this, they will likely export the CSR from the submissions system, add it to the promotional materials management system, approve it again, and then relate it to a claim. Now, imagine that there is a change in, or amendment to, just one of those documents. Determining the impact of the modification and identifying all the items that require updating could take days, or even weeks, to accomplish.

When all is said and done, this full process can span more than 25 steps, duplicate information and increase risk, since updates to documents may not be fully propagated.

Damage Limitation

The industry has tried to simplify the technology environment and streamline information sharing, with varying degrees of success. Early systems consisted of custom integrations, and resulted in convoluted applications that were loosely joined and drove users towards email workarounds or costly paper shipments. Some companies tried replicating content, copying documents from main repositories into multiple other repository instances. Invariably, backend databases crashed or became corrupted, resulting in loss of critical information. Businesses also attempted to maintain single, monolithic repositories with various applications working against them. This made it exceedingly challenging to align governance and validation schedules between groups. All of these solutions proved difficult to maintain, support and keep up-to-date – and, inevitably, these technologies fell behind.

It was not until the advent of cloud technology that a feasible way to implement a single source of globally accessible content emerged. The flexibility of the cloud allows applications to be scaled, updated and changed as needed, in line with business and regulatory requirements. Companies are freed from the burden of maintaining and updating multiple software environments – a multi-tenant cloud architecture means the application painlessly delivers a constant stream of innovation – and all departments are upgraded at once, so no one team is held up. Furthermore, because the cloud is easily and securely accessible worldwide through a simple web login, it can serve as the single source of documents for all users – regardless of location – without the need for file transfer protocol or virtual private networks. Internal and external stakeholders can come together in real-time, eliminating information siloes and enabling full collaboration and visibility.

Historically, life sciences firms were largely unable to use generic cloud systems that had not been built to accommodate the industry’s specific regulatory requirements. But new applications, designed to address the need for controlled content across the enterprise, are now available. Gens & Associates’ 2015 RIM survey shows that, in fact, these solutions are gaining significant traction across the global market (3). Although cloud technologies were necessary to solve this problem, they were not sufficient. The architecture of the platform is a critical element that enables businesses to strike the right balance between corporate control and local autonomy for different departments or regions.

Enterprise-Wide Collaboration

The next wave of life sciences content management applications – combining a robust, cloud-based content platform with best-of-breed applications for each distinct business process – have already been launched. For the first time, individual documents created in one application can be used across different business processes – whether in a submission, trial master file (TMF) or promotion. Previous attempts to link documents did not allow different groups to manage documents within their own context. Contextual links can make documents easier to create, organise and access for different users, meaning all content is traceable throughout its lifecycle and enabling a controlled source of information, regardless of where and how the document is used.

With a single source of content, process complexity is drastically reduced. In a single-source environment, those 20-plus steps that must be completed during a traditional protocol process can be reduced by more than 50%, saving precious time and reducing the risk of error. The protocol can be authored by the medical writer, incorporated into a clinical TMF, distributed to investigator sites, used in a study report, incorporated into a submission and, ultimately, referenced by a promotional claim, without ever creating a copy of that content. This not only saves time, but also increases control. A simple chain of custody connects clear contextual audit trails, allowing users to see the impact of content changes in real-time.

Case Study: Kythera

Rapidly growing biopharmaceutical firm Kythera, needing to accelerate the development of its newest product candidate, turned to a cloud-based solution to globally connect its document repositories across functional areas. The company selected an end-to-end, regulated content management cloud platform, which included a family of business-specific applications, allowing for easily connected work streams across the company.

“We looked for an enterprise-wide solution that could effectively serve diverse masters across the business – regulatory, clinical, sales, marketing, HR, finance, legal, and chemistry, manufacturing and controls – with different requirements for user knowledge, compliance and security,” said Jeff Webster, Kythera’s Chief Operating Officer. “Today, we have a foundation that brings together the entire organisation.”

In addition to connecting the company’s teams, the new system’s cloud architecture allows it to focus on its core business of developing innovative therapies for facial aesthetics – rather than spending time managing hardware and software upgrade projects. As Renee Fate, Senior Manager of Document Management, explained: “We no longer have to manage servers, updates are pushed out automatically without disrupting our teams, and our mobile workforce can access the system from anywhere across the globe, with any device.”

Kythera is moving towards deepening its content management capabilities by enabling cross-linking of documents across applications. Having described the value of creating a document once and using it in multiple instances, Fate continued: “Connecting content processes enables an unprecedented level of business agility, and helps us get to market faster. Without ever physically moving a document or sacrificing security or agility, this technology allows us to share information seamlessly with everyone involved – from internal groups to external partners across the ecosystem.”

Wide-Ranging Benefits

Cloud-based benefits span beyond the development process, and into product launch and commercialisation. For instance, with a single source of content, when regional brand teams are designing new product packaging, they can leverage assets from corporate headquarters, safe in the knowledge that the information is up-to-date, without needing to track down or re-enter the same details.

Document reuse can be extended to medical, marketing and sales teams for websites, self-directed digital details, email, mobile, and even face-to-face interactions between field sales representatives and healthcare professionals. Connected content can be shared between business applications, and each functional team can manage the documents according to their specific needs.

Modern Landscape

Traditionally, life sciences companies have had to choose between inflexible centralised repositories – that supported content sharing and corporate control, but added enormous complexity in governance and operations – and decentralised solutions – that met local or departmental requirements, but limited content reuse and tracking. Either efficiency or progress would be compromised, since there was no ability to address process, efficiency and compliance across the board. Today’s cloud-based content management solutions change that landscape, providing a single content source, while streamlining governance and reducing overall complexity.

The current state of the life sciences organisation belies the vast and sweeping forces transforming the industry. Every year, the rate of change seems to increase and – as the sector becomes more globally distributed and interconnected – consensus is growing that critical systems must follow suit. A fully unified content landscape, supported by flexible and life sciences-focused cloud solutions, can help close information gaps. By offering the necessary visibility, access and control it can advance pharma’s mission of providing life-changing therapies patients need, faster.

References

1. Tufts Center for the Study of Drug Development, Drug sponsors challenged to contain health care costs while boosting productivity, 8 January 2015. Visit: csdd.tufts.edu/news/ complete_story/pr_outlook_2015
2. Herper M, The cost of creating a new drug now at $5 billion, Forbes Magazine, 11 August 2013. Visit: http://www.forbes.com/sites/matthewherper/2013/08/11/how-the-staggering-cost-of-inventing-new-drugs-is-shaping-the-future-of-medicine
3. Gens S and Brolund G, 2015 Next generation RIM and intelligence: Strategy, investments, status, Gens & Associates, January 2015. Visit: http://gens-associates.com/wordpress/ wp-content/uploads/2015/02/Executive_RIM_Whitepaper_Gens- Associates_Winter_2015.pdf

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Rik van Mol is Vice President, R&D Strategy at Veeva Systems, where he is responsible for strategy and product marketing for the company’s Development Suite of Applications, focusing on the European market. He has 15 years of business/ IT consulting and regulated content management experience in the global life sciences sector. Prior to joining Veeva, Rik spent 12 years with IBM and PricewaterhouseCoopers, and was responsible for some of the industry’s largest and most complex content management programs. He holds a Master’s degree in Commercial Sciences and Information Technology Management from the University of Brussels, Belgium.
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