Accelerating pharmaceutical agility in the digital age

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1 Accelerating pharmaceutical agility in the digital age As the pharmaceutical industry embraces digital transformation, what are the critical steps for success? How can pharmaceutical companies capitalise on the rise of mobility and end-user computing to outperform their competition in terms of sales effectiveness, responsiveness, operational excellence, and collaboration with internal and external stakeholders? The global pharmaceutical industry has enjoyed steady growth in recent years, in spite of lingering economic uncertainty in many parts of the world. However, faced with looming patent expiries, stricter regulations, and fierce competition, pharmaceutical organisations are looking for new avenues to profitability and industry dominance. Against this backdrop, global merger and acquisition activity in this sector continues unabated. Recent notable deals include Pfizer s bid to acquire Allergan for USD 150 billion. Outsourcing of non-core activities in the pharmaceutical value chain, such as product development, clinical trials, manufacturing, sales, and distribution, is also a key theme in this sector, with many players choosing to focus on their core activity of drug development in order to sharpen their competitive edge. Advancements in technology continue to fuel the metamorphosis of the pharmaceutical industry, with mobility and end-user computing emerging as key trends. Increasingly, CIOs are focusing their efforts on mobilising business processes and empowering their sales and marketing teams through the use of mobile devices such as tablets.

2 Productivity on the move According to John Addeo, Vice President Business Development Pharmaceutical Vertical, incorporating an end-user computing approach into your sales strategy can greatly enhance the productivity of your pharmaceutical salespeople. These individuals are typically highly mobile, often travelling vast distances to different appointments every day, he explains. By ensuring that they re tablet-enabled and are making use of technologies such as GPS, scheduling, and diary management, you ll optimise their productivity. GPS enables salespeople to manage their calendars more efficiently, and book, validate, or update appointments, depending on their location. They can also log data in pharmaceutical sales management systems while they re on the road, and receive product updates, which eliminates the need for them to plough through a backlog of administrative tasks when they return to the office. They can also stay up-to-date with the latest sales enablement materials, something that s a regulatory requirement in many countries. Product detailing goes digital For decades, product detailing has been the method used by pharmaceutical companies to share information about drugs with healthcare personnel. The emergence of devices such as tablets, coupled with increasing competition among pharmaceutical companies and the limited time that doctors have in their busy schedules to spend with salespeople, has prompted the development of e-detailing tools and applications. While paper is supremely portable, it remains fixed in time. In contrast, a laptop is always up-todate with the latest data, but is awkward to use away from a desk or other flat surface. Today, rather than plough through a PowerPoint presentation or leave behind a pamphlet or brochure and hope that, at some point, they ll be read salespeople can deliver more flexible content that s tailored for the viewer using a tablet. They can sit down with doctors and share the very latest data in multiple presentation formats, for example, via infographics, interactive charts, or videos, and also link to detailed support data in real-time. During the appointment, salespeople can now also access resources to answer doctors questions or fulfil their requests immediately. In recent years, the role of e-detailing has evolved well beyond simply performing a sales enablement function. Today, it also fulfils the role of helping doctors to educate their patients about the benefits and effects of various drugs. Interestingly, this trend has been fuelled by the passing of new regulations aimed at ensuring greater transparency and eliminating unethical behaviour in the industry. The Physician Payments Sunshine Act requires manufacturers of drugs, medical devices, and biologicals that participate in US federal healthcare programmes to report certain payments and items of value that they give to physicians and teaching hospitals. Likewise, physicians are required to keep track of and report on payments, transfers of items that have value, and ownership interests that they receive. The Sunshine Act does, however, allow for certain exclusions, for example, if items or materials are used to directly educate patients. Peter Lutz, Enterprise Architect, explains: If a pharmaceutical representative provides a doctor with a tablet that contains medical articles or integrated learning management systems that he would use for his or her own benefit, it could be deemed to be a gift and reported to comply with the Sunshine Act. So the practice of including patient educational materials on tablets, for example, those that demonstrate the benefits of a procedure that involves the use of a particular drug or device, is gaining popularity.

3 Collaborate securely A further benefit of providing doctors with tablets is that the pharmaceutical organisation is able to control the platform; it can be set up in such a way that it s linked to the pharmaceutical organisation s content management and learning systems, and collaboration platforms. For example, if a surgeon has a question about the use of specific surgical drugs, he can use the tablet s collaboration platform to engage directly with researchers within the pharmaceutical organisation. Today s e-detailing platforms are also designed such that doctors can access the very latest drug information, explains Lutz. Therefore they need to be connected with the best online content management services, for example, Oracle s Eloqua, and learning management systems such as Saba. This allows doctors to use the platform to do online learning and thereby gain the education credits they need to retain their certifications. With physicians now engaging directly with pharmaceutical companies systems, the question arises as to whether this introduces a new layer of risk. Lutz believes that pharmaceutical companies need to ensure they have the appropriate levels of access control to devices and applications in place. You need to ensure that doctors have unique user accounts and passwords for their devices, and that there s strict control over the issuing and removal of access rights. Even though the marketing and educational materials contained on these devices are unlikely to be highly sensitive, you need to be able to deactivate a device if it s not been used for a certain period, or the doctor reports it lost or stolen. Pharmaceutical companies would also do well to engage the services of an IT services provider that can work with online learning platform providers to host the content, and make sure that it s securely linked back to their devices. Compliance conundrums Lutz cautions that there are a number of compliance considerations that need to be factored in, if you re going down this path. The underlying technology that supports any system that provides information about pharmaceutical drugs needs to be FDA Part 11 compliant, he explains. In terms of this regulation, data needs to be secured appropriately, and there needs to be a clear definition between the testing and development functions. Other stipulations of FDA Part 11 include: adequate and traceable testing of IT systems that handle clinical records used for the development of pharmaceutical medical products and devices readily available, accurate, and up-to-date information about IT systems comprehensive audit logs that provide information about who has access to data dedicated resources and networking equipment Lutz explains that for many pharmaceutical organisations, the requirement for dedicated resources raises the question of the viability of using cloud services. It is in fact an option, explains Lutz, but one that needs to be carefully planned. Companies like Dimension Data with deep cloud expertise can help pharmaceutical clients explore how they can reap the many benefits of a cloudbased consumption model and still remain FDA Part 11 compliant. Pharmaceutical companies would also do well to engage the services of an IT services provider that can work with online learning platform providers to host the content, and make sure that it s securely linked back to their devices. Beware informal IT and mobile device sprawl Lutz believes that pharmaceutical companies should consider the enablement of their sales and marketing teams in the context of their overarching mobile device management strategy. Many larger pharmaceutical organisations have thousands of salespeople around the globe and are struggling to manage their sprawling mobile estates. In addition, many are choosing to outsource the sales function, as part of their efforts to focus on their core activity of drug development. Salespeople working for outsource providers will be assigned and reassigned to different pharmaceutical companies on an ongoing basis. Considering that these representatives access and share data about different pharmaceutical companies using the same device, the task of managing and controlling those devices and the data they contain, becomes complicated. Lutz advises that while visibility and control are important, an overly restrictive approach to mobile device management will ultimately slow you down something that pharmaceutical organisations can ill-afford in a fast-paced and constantly changing marketplace. The pharmaceutical industry remains in a state of flux, and competition is fierce, he explains. Your approach to end-user computing needs to enable rather than hamper agility, and accelerate decisionmaking. You need to be able to provision assets and capacity quickly as you embark on new drug development projects and shut them down just as quickly if for any reason they re discontinued, for example, due to the discovery of negative side effects of certain drugs. You need to be able to manage and move your mobile estate as your circumstances change, for instance, in the event of a merger or acquisition. If you don t have mature processes, you won t know which assets belong to which areas of the business. The procurement of IT outside of the traditional IT department is another consideration. Today, the mobile device management approaches that pharmaceutical companies have in place are generally very basic, says Lutz. Oftentimes the procurement and issuing of these devices is undertaken by divisions within the sales organisation, without the involvement of the IT department. This lack of management can make FDA Part 11 compliance difficult.

4 Steps to success All these considerations and dependencies point to the need for an integrated enterprise mobility and end-user computing strategy, and a secure cloud platform. While embracing mobility and end-user computing to empower your internal teams and grow revenue can deliver impressive results, you can t adopt a piecemeal or reactive approach, cautions Jeremy Horey, Group Consulting Practice Director, End-user Computing. By doing so, you ll create complexity, run the risk of incurring unwelcome costs, and introduce security vulnerabilities. Worse still, you ll likely create misalignment between IT and the business. According to Horey, developing an approach for end-user digital enablement should include consideration of the following elements: Business and IT alignment: Taking an inclusive, long-term view is critical for effective end-user digital enablement. Start by ensuring that the business and IT are aligned. These two parts of the organisation need to work towards the same business goals with performance measures that make sense to both. Keeping the needs and preferences of your users top of mind is also key. Dimension Data often undertakes consulting services for clients which include a review of where the organisation is today and where it wishes to be in the future. We then work with the leadership team to develop a roadmap to build a secure and robust infrastructure that will enable them to maximise their mobility investment. We then set a strategy that matches the transformational growth required for the business. This process will typically include: determining which business processes to mobilise identifying the requirements of different types of users within the organisation ascertaining how different applications should be delivered to different devices addressing the risks associated with shadow IT prioritising projects such as consolidation or infrastructure refreshes defining access rights creating policies ensuring access rights are removed in a timely manner, when required Security: As we ve discussed, ensuring the security of applications and data stored on mobile devices is an important element of the plan. You need to build an IT platform that allows you to mobilise applications and data securely. This includes authentication and network access control systems, mobile device management, and remote-wipe functionality that allows you to remove all corporate data from a lost or stolen device. Regular penetration testing is also important. Compliance: Consider engaging the services of a mobile device security management partner to ensure secure systems access and rapid. This will ensure compliance with regulations such as FDA Part 11. Also bear in mind that compliance requirements differ across the world. Integration: A secure and robust infrastructure comprises many elements: devices including mobile phones, tablets, laptops, and desktops security, the network, data sources, and the applications and operations that serve users needs. However, fitting these elements together isn t easy, so it s not uncommon for organisations to work with a partner that has strong integration capabilities, as well as a solid understanding of and experience in end-user computing, to help them accelerate their journey. Effective integration is also about managing mobile device sprawl, and regional sales management system variations. For more information about Dimension Data s approach to end-user computing, visit workspacesfortomorrow.com/productivity or contact us at industries@

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