TRUSTED ADVISORS TO HEALTHCARE AND LIFE SCIENCE EXECUTIVES

2016 Axendia, Inc.

UNIFYING APPLICATIONS TO DRIVE EFFECTIVENESS,

EFFICIENCY AND COMPLIANT COLLABORATION

By: Sandra K. Rodriguez, Market Analyst

USING A CLOUD PLATFORM TO CONNECT THE LIFE SCIENCE VALUE CHAIN

Pharmaceutical, Bio-Tech and Medical Device companies are increasingly adopting cloud platforms to drive effectiveness and efficiency throughout the value chain. These organizations are unifying applications that support the total product lifecycle in a compliant manner, without losing sight of what matters most – product quality. This shift from disconnected point solutions to a platform approach became clear at the Veeva Systems Global Summit for Clinical, Regulatory, and Quality in Philadelphia on October 17-19, 2016, where I joined over 600 attendees representing 154 companies. Client presentations ranged from start-up to multi-national Life-Science companies including Regeneron, Shire and Johnson & Johnson. A list of presenters can be found here. Jennifer Goldsmith, Senior Vice President, Veeva Vault kicked off the event by celebrating the five-year birthday of Vault. This was my first time covering the event and I was immediately surprised by the opening keynote delivered by Peter Gassner, CEO at Veeva Systems. He revealed that over the past three years, the company has consistently doubled its customer base across all three of its product offerings – Vault Clinical, Vault Quality and Vault Regulatory. Sessions were offered across all three areas including a track on platforms and a focus on small and mid-size organizations. Attending case study sessions and in discussions with customers during breakfast and lunch, it became clear the rapid growth of Veeva’s customer base can be attributed to both organic growth, as well as the addition of new customers. THE CLOUD PLATFORM

The platform approach appears to be resonating with Life-Science companies of all sizes. Some of the biggest names in the businesses, as well as start-ups, are taking advantage of Veeva Vault’s 12 application suite to support a single source of truth across the value chain, from R&D through commercialization. They seek to gain visibility, drive effectiveness & efficiency and

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UNIFYING APPLICATIONS TO DRIVE EFFECTIVENESS,

EFFICIENCY AND COMPLIANT COLLABORATION

support compliant collaboration throughout the product lifecycle by streamlining workflows internally and with external partners. Veeva Vault encompasses the following suites: Clinical, Quality and Regulatory. New applications include Vault CTMS in the Clinical Suite and Vault QMS in the Quality Suite. Also announced for Clinical was Vault EDC, planned for April 2017 and Vault eSource planned for December 2017. These products are all the direct result of the company listening to its customer base and building addition modules to support their business needs across the platform. With over 42 million documents currently being managed in the cloud, users are able to view documents on average within 1.3 seconds.

A RAPIDLY DEPLOYED, GLOBAL QUALITY SOLUTION

Customer presentations focused on rapid deployments and the immediate benefits of increased effectiveness and operational efficiencies in business processes via a unified application suite. It became clear during the customer case studies that many organizations embraced the platform approach because they had simply outgrown their existing, disconnected systems. Whether home grown or off-the-shelf, they were no longer a fit. In most cases, they were disparate, silo’d sources of information that supported a paper-driven process. One such case study from Shire was unique in that the company it acquired had undergone two mergers and name changes during the implementation of Vault. However in just six months, the acquired company managed to successfully transition more than 20,000 internal and external users from multiple systems to Vault QualityDocs. Yet with the implementation of any new system or change to an existing process, organizations face a real struggle when it comes to people changing their behavior. As part of the opening keynotes, Anthony Waclawski, VP of Global Submissions & Regulatory Policy with Bristol-Myers Squibb addressed cultural change and how to achieve organizational effectiveness. An organizations performance ultimately depends on the behavior of its workforce. To achieve effectiveness, companies must close the loop in three core areas:

Behavior

Cooperation

Effectiveness To ease the coming transition, the team that successfully transitioned 20,000 users did just that by building a complete internal marketing campaign announcing the project and an ongoing communication plan throughout and post go-live. In smaller companies or start-ups with no existing systems, Veeva is a natural one-stop shop to manage clinical, quality, and regulatory content and processes. Not only does a cloud platform

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UNIFYING APPLICATIONS TO DRIVE EFFECTIVENESS,

EFFICIENCY AND COMPLIANT COLLABORATION

eliminate the need for a small army to run an IT organization, it eases the pain of validation. By taking a risk-based approach, bluebird bio was able to reduce the validation effort of a release from 5 business days to 1. The company owns Vault QualityDocs, Vault RIM, and Vault QMS and pointed out a standard platform offers countless benefits and creates natural efficiencies in the business process. Also noteworthy is the consistent user experience across business applications. Regardless of the size of the organization, companies have a real expectation of built-in industry best practices to avoid customization.

HOW DOES DATA INTEGRITY ENABLE GOOD DECISION MAKING?

As companies large and small continue to operate in outsourced models ranging from trial management to research and manufacturing, having a single source of truth for all external partners is crucial to ensuring product quality. While the operational paradigm has changed, quality systems and technology infrastructures have not kept pace. As a result, managing quality and compliance activities in an increasingly fragmented ecosystem is difficult and labor intensive process. The VP of Information Systems at a large West Coast biopharmaceutical company pointed out “information becomes a strategic asset and differentiator for companies that can bring it together.” His company is not unique in that the majority of their data resides outside of their own four walls due to outsourced business functions. However if outsourcing is here to stay, customization is going away. Another rapid deployment came from a large multi-national medical device, pharmaceutical and consumer packaged goods manufacturer. The company’s 12-month roll out included 214 locations, 60 countries and 15+ languages. The team, who stated IT systems are typically customized up to 40% to meet their business needs, was able to take advantage of 80% of out-of-the box functionality. Although many of the locations were small (1-20 people per location), templates and workflows were standardized ensuring ease of use for all locations. The biggest challenge the team faced was not the timeline, but overcoming the adoption barrier due to organizational/cultural change management and shifting its user base from a document-centric to a data-centric environment. Sites had to learn how to manage, analyze, and organize content using data attributes rather than traditional folder trees. The company addressed this challenge by building an internal user community that provided a ‘voice of the customer’ platform for feedback and issue resolution. There is tremendous power in learning the work of others and through collaborative problem solving and cooperation. Companies of all sizes are seeking to leverage the Vault platform across core functional areas for visibility into clinical, regulatory, and quality data and ultimately pulling it together in a meaningful way.

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UNIFYING APPLICATIONS TO DRIVE EFFECTIVENESS,

EFFICIENCY AND COMPLIANT COLLABORATION

CONCLUSION

Open dialogue between companies about the lessons learned in cultural change management while attending a technology conference is a refreshing change. Making the shift from paper to data and leveraging a life sciences cloud for content management is a process, not a project. I was happy to see the Microsoft Office Online integration, which enables real-time collaboration by allowing users to share, edit and review documents online. These continuous process improvements result in a heightened level of quality that benefits all stakeholders, as does increasing transparency between internal and external partners and throughout the value chain. Inevitably the adoption of cloud platforms will continue to increase as life sciences companies seek to work more effectively outside of their own four walls and increase efficiencies to enable better business outcomes across the value chain. Effective quality management can unify internal and external parties and functional areas for seamless change management, risk mitigation and traceability of events from identification to correction. Whether a company manufactures Pharmaceutical, Biopharmaceutical or Medical Devices, the goal is not only to lower costs but to improve on efficiencies and shorten time to market in a compliant manner, without losing sight of what matters most – product quality.

The opinions and analysis expressed in this brief reflect the judgment of Axendia at the time of publication and are subject to change without notice. Information contained in this document is current as of publication date. Information cited is not warranted by Axendia but has been obtained through a valid research methodology. This document is not intended to endorse any company or product and should not be attributed as such.

About Axendia: Axendia, Inc. is a leading trusted advisor to the Life-Science and Healthcare industries. We provide trusted counsel to industry stakeholders on Business, Regulatory and Technology issues. For more information, visit www.axendia.com or contact us at info@axendia.com

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Published December 2016