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Whitepaper
An Atos company. Powered by EMC2
and VMware
Pharmaceutical R&D ecosystem:
How emerging business technologies wi...
2 | Whitepaper
I. Introduction
The era of blockbuster drug has been shaken up. Increasing
regulatory and competitive press...
Whitepaper | 3
An Atos company. Powered by EMC2
and VMware
II. The current clinical trial strategy followed is not sustain...
4 | Whitepaper
Processes
Strategy& Planning
Sub-Ecosystem
Execution
Sub-Ecosystem
Analysis& Reporting
Sub-Ecosystem
Protoc...
Whitepaper | 5
An Atos company. Powered by EMC2
and VMware
III. An integrated clinical trial ecosystem will arise
Recent d...
6 | Whitepaper
Optimized tools and infrastructure
Powerful tools:
Traditional data management tools will be replaced by in...
Whitepaper | 7
An Atos company. Powered by EMC2
and VMware
The ecosystem will address the existing problem areas
Due to it...
8 | Whitepaper
Stakeholder Stakeholder Benefits Sponsor Benefits
Patients •	 Have more comfort and convenience through
pat...
Whitepaper | 9
An Atos company. Powered by EMC2
and VMware
IV. A successful transformation is much more than a collection ...
10 | Whitepaper
Implementation strategies
Once a strategic vision has been established, and a careful analysis over potent...
Whitepaper | 11
An Atos company. Powered by EMC2
and VMware
Figure 4: Types of implementation strategies for a clinical tr...
12 | Whitepaper
Quiet and off the radar, this kind of project usually is done by early adopters and enthusiasts. It practi...
Whitepaper | 13
An Atos company. Powered by EMC2
and VMware
V. Security advantage in the cloud
•	 Compared to other indust...
14 | Whitepaper
VI. Conclusion
Emerging Business Technologies are changing the game for pharma companies by enabling
effic...
Whitepaper | 15
An Atos company. Powered by EMC2
and VMware
1.	 Invention reinvented, McKinsey perspectives on pharmaceuti...
An Atos company. Powered by EMC2
and VMware
Contact: 	 www.canopy-cloud.com
	info@canopy-cloud.com
	 +44 (0)20 8555 1637
M...
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Cloud Enabled Pharma R&D Trials

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Technology is disrupting the process behind drug development. Growing realization that current clinical trial strategies are not sustainable or feasible means one thing - change. But, where do pharmaceutical companies go from here? An integrated clinical trial ecosystem will arise through leveraging emerging business technologies. But, are companies prepared to take advantage?

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Cloud Enabled Pharma R&D Trials

  1. 1. Whitepaper An Atos company. Powered by EMC2 and VMware Pharmaceutical R&D ecosystem: How emerging business technologies will enable a new model for clinical trials Helping pharmaceutical companies understand the potential and practical implications of a clinical trial ecosystem that is enabled through disruptive technologies
  2. 2. 2 | Whitepaper I. Introduction The era of blockbuster drug has been shaken up. Increasing regulatory and competitive pressures, rising popularity of generics, and heightening focus on price reduction has the pharmaceutical industry in a flux. In this paper we describe how pharmaceutical companies can leverage emerging business technologies in clinical trials to create an integrated ecosystem characterized by deeper collaboration among stakeholders, standardized processes, and optimized tools and infrastructure. Embracing this ecosystem will address pressing problem areas within clinical trials and position the company to proactively shape the future of the industry. Contents I. Introduction 2 II. The current clinical trial strategy is not sustainable 3 III. An integrated clinical trial ecosystem will arise 5 IV. A successful transformation is much more than a collection of tools 9 V. Security advantage in the cloud 13 VI. Conclusion 14 Why read this paper? Pharmaceutical companies are often cautious when adopting new technologies, historically characterized by making incremental changes. The disruption about to shake the clinical trials’ sphere is so deep that narrow, tactical changes will leave a company far behind from competition ready to embark on broader transformation. In order to shape the industry in the future, pharma companies must take a strategic approach and fully understand the potential unveiled by emerging business technologies. This paper offers guidance on the key considerations for the executive suite. Even though the technologies are still evolving, the time to start planning is now. A change is necessary Over the past decade, the pharmaceutical industry has been challenged by a number of problems. To address these, a common response has been to look for external solutions, which has produced mediocre results. A new factor at play is emerging business technologies. Employing these technologies, and also taking a fresh, intelligent look at the root causes of the problems is necessary for pharma companies to remain relevant in this new environment. An integrated ecosystem will transform clinical trials An ecosystem, with effective collaboration channels and appropriate incentives, standardized processes, and optimized tools and infrastructure will arise. The ecosystem will address current problem areas and create a win-win system for all stakeholders. Despite vendor claims, no such ecosystem is currently available in the market, and companies must be careful when analyzing different options to select ecosystem components that best suit the company’s unique needs. A strategic approach with a clear future state underlines a successful transformation True integration cannot be achieved without a strategic approach. Questions around sourcing, alignment of business and IT, and what is the most appropriate implementation strategy are not only complex, but also far reaching in their consequences: History holds many examples of companies taking uncoordinated steps with emerging technologies, often losing resources, time, and experiencing negative outcomes. As such, these decisions play an important role not only in defining the competitive edge of the company, but also in ensuring its long-term viability. Key takeaways
  3. 3. Whitepaper | 3 An Atos company. Powered by EMC2 and VMware II. The current clinical trial strategy followed is not sustainable 1. High cost The cost of clinical trials has increased by approximately 37% between 2003 and 20106 . Currently a significant proportion of costs are driven by IT; dedicated infrastructure needed to run clinical trials is expensive to set up and run. It is typical that the IT needs vary throughout the trial, meaning that in order to meet the demand at peak times much capacity is sitting idle otherwise, representing a costly inefficiency. Additionally, the computational capacity needed to use new technologies such as advanced pharmacological modeling and simulations is high. Moreover, IT is usually considered an overhead cost and having a detailed understanding of true IT costs can be challenging. With the expected revenue per new drug continuing to decrease year by year, controlling costs becomes increasingly important. 2. Low approval rate A small molecule is 5% less likely to get approved than a decade ago. Regulators are demanding more compelling evidence on drug efficacy and safety. In addition, as most new drugs now compete with existing ones, differentiation has become a challenge. A typical trial involves multiple locations across geographies, thus controlling different sites and making decisions on resource allocation can be challenging, especially as various systems are used. Only few molecules will pass through all trials successfully, thus the potential savings of terminating trials promptly are calculated in millions of Euros/Dollars. Without clear E2E visibility and appropriate analytical tools these decisions cannot be based on facts. 3. Long time to market The cost of delaying a drug that will eventually pass through all trials is estimated at USD 1 million per day in unrecognized revenue. Therefore, minimising time to market is critical; yet 70% of clinical trials experience delays. Major factors contributing to the delays are inefficient communication and poor information sharing practices (and tools). In addition, the complexity and number of procedures in clinical trials has been increasing, even though approximately 30% of data collected is never used7 . These unnecessary tasks increase the time to market, as well as make running trials more burdensome for MDs and patients, resulting in lower satisfaction levels. In fact, 25% of MDs and patients are unhappy and state they will not participate in another trial8 , meaning that companies will need to identify and train new participants for subsequent trials. 4. Poor data quality Clinical trials are ultimately the process of collecting and analyzing data. A typical trial involves various tools and methods of collecting, transporting, and analyzing data. As the variety of methods in use increases, so does the risk of inconsistencies and errors. Complying with strict regulations, for example by showing proof that data is authentic and secure, is challenging. Data quality impacts both the time needed to send a drug for approval and the time it takes for it to get through the approval process. As such, improved data quality by definition has a positive impact on both the duration of the overall process, and the bottom line. External measures are not sufficient to restore R&D profitability Increased spending in pharmaceutical R&D has not led to a proportional increase in new molecule entities (NMEs), resulting in a productivity crisis. New drugs are less likely to get approved than a decade ago and the cost per new drug has been increasing at an annual rate of approximately 8%. Meanwhile, the drugs that do reach the market are earning lower return than in the past. With an IRR now lower than the industry cost of capital1 , pharmaceutical companies have been looking for external remedies to combat this downward trend. Horizontal M&A has become a common response to pressures such as patent expirations and gaps in the company’s R&D pipeline, as pharma companies seek to gain access to promising molecules or to already existing products2 . Studies conclude that the majority of such deals, however, fail to create sustainable value and only provide a short term fix for the balance sheet3 . Companies have also turned to outsourcing to reduce cost and speed up the development process of new drugs. While outsourcing usually brings some value, the net benefits are reduced by additional challenges such as added complexity, loss of control, and reduced visibility over the process. Consequently, despite the trend towards increased outsourcing of clinical trials4 , the overall cost per trial has increased over the last decade, while the time per trial has remained roughly the same or even slightly increased5 . M&A and outsourcing are both external remedies for the productivity crisis and try to treat the symptoms rather than the actual root causes. Instead of looking externally, pharma companies should shift their focus towards internal processes, as it is within the R&D value chain where the underlying issues prevail. To keep up with competition and remain relevant in the future, pharma companies must be prepared to transform internally and leverage the new opportunities created by disruptive technologies that are shaking up the global business landscape. Solving four key problem areas within clinical trials must be a top priority Clinical trials tend to be the longest and most expensive phases of pharmaceutical R&D. Molecules need to pass through various levels of rigorous testing in a highly controlled environment, requiring the involvement of various stakeholders such as patients, regulators, MDs, nurses, investigators, KOLs, trial site managers, and many others. In a pursuit to reduce the cost and time needed to complete trials, pharma companies have been increasingly turning to CROs (Clinical Research Organizations), making this the most outsourced part of R&D. The complexity of the current set up and the fact that technological advancements offer great potential particularly in this R&D area, make clinical trials a great starting point for R&D transformation. So what are the pressing problem areas in clinical trials?
  4. 4. 4 | Whitepaper Processes Strategy& Planning Sub-Ecosystem Execution Sub-Ecosystem Analysis& Reporting Sub-Ecosystem Protocol Development Site selection & feasibility Site setup Data management and analysis Reporting Patient recruitment Safety Treatment Monitoring Collaboration Pharma Ecosystem Pharma R&D Department 02 Department 01 Key Opinion leaders MDs & Nurses Hospitals Patients Regulators A good understanding of the current issues is the starting point for looking for solutions. Technological advancements offer multiple solutions that can help solve current issues. It is important to remember, however, that the greatest benefits will come from thinking about clinical trials as a whole, and not trying to solve separate issues independently. Current clinical trial environments foster some of the problems The problem areas are symptoms of a broken system. Exploring how clinical trials are typically run highlights various pain points within the sphere. Only by understanding these pain points can pharmaceutical companies start to systematically address them. The pain points arise on three different layers: collaboration, processes, and tools and infrastructure. Collaboration pain points Clinical trials are joint efforts of various stakeholders. Stakeholders communicate with each other on a point-to-point basis, making the process very complex. As complexities increase, so does the likelihood of errors and duplicated work. For example, informing trial participants of trial protocol changes can be inconsistent and delayed. As multiple systems are used, creating proper audit trails becomes burdensome. Processes pain points Processesanddepartmentalstructures often encourage work in silos. Many trials are set up in pieces, causing data and information breaks along the way, hindering information sharing and making it prone to errors. There is no E2E visibility over the complete trial, let alone a global visibility over all trials. This makes resource allocation decisions challenging. In addition, processes do not tend to be standardized, increasing the need for training and communication. Tools and infrastructure pain points Legacy systems prevail. Most companies tend to rely on tools and infrastructure that have been running for years: servers are underutilized, and many point-to-point interfaces exist providing multiple sources of truth (MSOT). Also duplicated application functionality is common. These systems simply do not have the capability to take advantage of the latest technological advancements, inhibiting the company from evolving with the latest innovations. Toolsandinfrastructure Pharma R&D Department 02 Department 01 Department 03 App1, App 2 App3, App4 Patients Sites * Diagram is illustrative & simplified * Diagram is illustrative & simplified * Diagram is illustrative & simplified
  5. 5. Whitepaper | 5 An Atos company. Powered by EMC2 and VMware III. An integrated clinical trial ecosystem will arise Recent developments in the pharmaceutical industry give informative pointers on how clinical trials will evolve in the near future. Three major drivers, enabled by emerging business technologies (EBT), are gaining traction. These drivers will be at the core of clinical trials over the following years. Collaboration Pre-competitive collaboration: Pharmaceutical companies have already taken the first steps towards working more closely with each other. A prominent example of such collaboration is the launch of TransCelebrate BioPharma, a nonprofit supported by ten major biopharmaceuticals aiming to identify and capture efficiencies in clinical trials9 . In the past, this kind of collaboration has been unheard of and perceived as dangerous for fierce competitors. However, new trends and developments almost necessitate it. Advantages, such as risk sharing, economies of scale, and the ability to shape the direction of clinical research, fuel this trend and outweigh the risks (real and hypothetical). Pharmaceutical companies are increasingly participating in joint initiatives10 , with many already forming part of more than one group, and we expect this trend to grow with time. Collaboration among stakeholders: Stakeholders (study sponsors, CROs, hospitals, MDs, nurses, regulators, and others involved) will work more closely with each other throughout the process. Centralized communication and data platforms will be a key components in enabling deeper collaboration, while ensuring adequate levels of security and compliance. For example, by enabling more efficient communication and information sharing among internal and external stakeholders, a large pharma company is expecting to save USD 9 million in document management costs and reduce time to market by 10,000 working days11 . Standardized process Process efficiency: Lean processes will be a key focus. Having clear links between objectives and process steps across the value chain will reduce the number of non-value added tasks. Standardization and automation will also increase, reducing costs and errors. Reutilization of documents and knowledge across phases and projects will reduce the workload. For example, increased visibility over tasks enables better alignment between objectives and procedures, reducing the number of tasks by approximately 25%12 . Innovation: Companies will innovate and try new ways of conducting clinical trials, utilizing new technologies such as mobile solutions and big data. One such example is Pfizer’s virtualized trial, which was the industry’s first attempt to run a trial completely remotely13 . Even though this attempt was unsuccessful, benefits such as patient comfort and the ability to reach patients across geographies will motivate companies to experiment more with similar trials. Emerging Business Technologies enable a new way forward Emerging business technologies (EBT) are disruptive advancements in the IT field include cloud computing, mobility, big data, and social media. When applied intelligently, EBT enable new value creation and sustainable competitive advantage. These advancements are not discrete hardware or software offerings per se, but rather a combination of systems that must be designed and deployed as a collaborative effort by IT and business executives to address a specific need. The industry analysts have their technical definitions of these technologies, as do the hardware and software vendors. Canopy proposes that it is the concept of ‘intelligent application’ of these technologies that matters far more than their technical definitions. In this paper, we present the concept of a clinical trial ecosystem that is a combination of people, processes and intelligent application of EBT. The ecosystem will transform the way clinical trials are run, enabling pharma companies to address the problem areas described.
  6. 6. 6 | Whitepaper Optimized tools and infrastructure Powerful tools: Traditional data management tools will be replaced by intelligent applications which integrate all data from collection to analysis. The need for manual inputs and data transfer on spreadsheets will be eliminated; there will be only one central location for data, providing a single source of truth (SSOT). Real time, 24/7 access to data will also become the norm, with E2E visibility over the whole process and across the portfolio. For example, a large pharma company integrated huge volumes of data behind a single access point, reducing search time by 50%, saving millions. In addition to general productivity increases, the new system improved knowledge sharing, reducing the need for training by 10% and new staffing requirements by 1.2%, resulting in USD 13.4 million savings14 . Optimized infrastructure: Cloud-based infrastructure will become more common and utilized, enabling flexible and scalable computing resources. Even if core infrastructure is maintained in-house, bursting capabilities will be used to handle peak loads. Eli Lilly, for example, needed a 64-machine cluster computer to run a specific task. Instead of having to acquire, install, qualify and run the cluster in-house, the company tapped into third party computing resources, and was able to complete the task within 20 minutes at a cost of USD 6.4015 . Why an Ecosystem? Referring to an ecosystem highlights the symbiotic nature of the relationships between stakeholders within clinical trials. Traditionally, all stakeholders have participated in the value chain independently, incentivized to finish their tasks and meet disparate KPIs. In the ecosystem, all stakeholders are united under one overarching goal – creating value for the patient. All steps throughout the process contribute to and are measured in terms of the final outcome. All stakeholders need to be engaged in the overall goal – not in short term wins rewarded by the sponsor. An ecosystem that works as a one, cohesive unit is best equipped to deliver what really matters. EBT is what enables this ecosystem and ensures it works in the most efficient way; processes will be streamlined, level of standardization and automation will be high, and technology (apps, platform and infrastructure) as well as organization (people, processes, innovation) will be closely aligned. As an example, companies like Medikly16 are expanding from social media tracking of MDs for marketing purposes, to identifying those that are candidate clinical trial investigators. Social media behavior provides a richer, deeper profile of candidate investigators compared with the traditional MD profiles. It also provides new ways to engage with them. A company seeking to speed up the clinical trial process might deploy a system like Medikly to work with investigators, Medidata for study design and budgeting, and MedNet17 for clinical trials management. These tools would likely be deployed in phases, over 2-3 years. To maximize ROI, companies must not only coordinate these technology changes, but also holistically plan for and execute the stakeholder and process changes needed to make use of these tools. Canopy sees the future state clinical ecosystem as a flexible model that can be adjusted to suit the specific needs of any firm in the industry. The three tools presented in this example may not be right for every firm, or they may be 3 of 6 tools that a particular firm needs to build out its ecosystem. Figure 1: Future state clinical trial ecosystem In practice, the ecosystem will enable a more efficient manner of running clinical trials, addressing the key problem areas currently facing pharmaceutical companies, while creating a win-win environment for all stakeholders. The ecosystem – One infrastructure platform, interlined applications feeding off SSOT – Single source of truth (SSOT) – Point-to-hub collaboration – Streamlined processes and incentives – Data access management – Interlinked applications feeding off one data truth Study Sponsor Platform While companies have already started exploring opportunities in the areas of collaboration, process streamlining and tools and infrastructure, the current approach has been tactical and opportunistic. To gain the most from EBT, companies must take a strategic approach and be ready to embark on a full transformational journey, both in terms of infrastructure and organization. The end state will be an integrated ecosystem where data, processes and people all work as one towards a common goal of increasing efficacy, safety, and quality of clinical trials to ultimately serve patients.
  7. 7. Whitepaper | 7 An Atos company. Powered by EMC2 and VMware The ecosystem will address the existing problem areas Due to its inherent capabilities of improved collaboration, standardized processes and optimized tools and infrastructure, the ecosystem will address the existing problem areas around cost, approval rate, time to market and data quality. The ecosystem will create a win-win environment for all stakeholders What ultimately ensures the sustainability of the new ecosystem model is the fact that it is beneficial not only for the pharmaceutical company - the study sponsor - but also for the other stakeholders. Clinical trials are a joint effort, thus it is important all participants are aligned and benefit from contributing towards a common goal. Here are a few examples of how different stakeholders can benefit from a clinical trial ecosystem. 1. Lower cost Lower cost will be achieved by optimizing the cost base (pay per use; flexible allocation of workloads; bursting capabilities; reduced maintenance and handling costs; potential risk and cost sharing of collaborative agreements) and increasing efficiency (elimination of non-value added tasks; integration, point-to-hub interfaces). 2. Higher approval rate A higher approval rate can be attained by focusing on projects with the highest probability of success (E2E visibility enabling fact based decision making and resource allocation; focus on the right projects while making others ‘fail fast’) and minimizing potential problems in the approval process (data collection planned with the end state in mind; higher quality documentation with automatic audit trails and increased security). 3. Faster time to market Faster time to market will be realized by increasing the speed of study set up (Infrastructure available on demand; reutilization of documents, processes, and knowledge) and completion (streamlined processes with increased standardization; enhanced collaboration; flexibility to adapt best practices; automation of tasks). 4. Higher data quality A higher approval rate will be reached by reducing errors (data collection, transport and analysis all integrated; a SSOT) and by improving security and access (central, secure location for all data; access to all information via a web browser; role-based access rights).
  8. 8. 8 | Whitepaper Stakeholder Stakeholder Benefits Sponsor Benefits Patients • Have more comfort and convenience through patient centric study design • Utilize remote monitoring and self-reporting • Identify right patients faster, e.g. by using cloud based high throughput molecular profiling techniques • Gain access to patients in remote locations Regulators • Stay up to date with current trends and technologies through better and immediate collaboration and communication • Ensure only necessary data is collected • Facilitate approval process by automating audit trails MDs and nurses • Gain access to resources and tools that significantly reduce the burden of running clinical trials • Achieve higher level of engagement from MDs and nurses who have a better understanding of the complete process and are instantly updated on the progress Sites • Improve processes and communication • Learn from adapting best practices • Set up sites more quickly • Build relationship with main sites and reutilize processes reducing the work necessary • Improve site management Investigators and KOLs • Participate in a wide range of projects and collaborate with industry leaders from different organizations • Increase innovation from getting the best minds working together CROs • Gain greater access to resources • Receive accurate and up to date inputs to the study design and processes • Strengthen the overall portfolio through intelligent utilization of CROs Creating an integrated ecosystem is a long term project that involves a full transformation of IT and organization. There are various possible sourcing models, each accompanied with its own benefits, challenges, and implications. How the transformation will be conducted - implementation - is another key aspect to consider as early successes or failures can have great impact on overall transformation. In order to ensure that all pieces come together to create a unified ecosystem, a strategic approach is fundamental. Figure 2: Practical implications of ecosystem Traditional environment EBT EBT-enabled ecosystem  Flexibleworkloadallocation  SSOT  Powerfultools for analysis  Centralizedlocation for data  Underutilizedservers,outdated technology  MSOT,duplicatedfunctionality  Inefficientinformation exchange (calls, paperwork,email…) Tools and infrastructure  Streamlinedprocesses  E2Evisibilityacross projects andportfolios  Integrateddataflow through trials  Siloedprocessview–no E2E visibility  Complexprocess layers,various stakeholders  Process anddataflow vary across sites Processes  Automatedtasks  Integratedinformation  Automaticaudittrails  Streamlinedcommunication Multiplestakeholdersleadto:  Complexity,errorsand duplicatedwork  Multiplepoint-to-point interfaces  Burdensome audittrails  Complicatedcommunication Collaboration
  9. 9. Whitepaper | 9 An Atos company. Powered by EMC2 and VMware IV. A successful transformation is much more than a collection of tools Before embarking on any transformation, Canopy strongly advices pharmaceutical companies to create a strategy that includes sourcing considerations as well as tactical implementation. While some vendors are offering all-encompassing ecosystems, the market is not mature and no single solution currently available is able to provide an integrated ecosystem as discussed. A successful end state will require a careful plan that enables the company to take advantage of the latest developments while understanding the limitations and implications of using internal and external components. A strategic approach is needed to get the full benefits Any transformation, especially one based on emerging technologies, requires careful planning and analysis. Here are three reasons why spending time on a strategy roadmap for transformation is important: 1. Align business & IT to create business value: The ultimate goal of IT is to enable business to create value. Now more than ever, IT has the ability to become a differentiator in terms of how it facilitates business, ensuring that there is a shared vision that all business units work towards. Here are examples of questions to ask when both IT and business leaders are present in the same room: • How will the new realities change our relationship (for example, better charge back options, new pay-per-use utility models)? • How does this change the role of IT within the clinical trials, now that many of the functions can be sourced? • Is the internal IT department able to provide business with the best services, at the most competitive prices? 2. Understand the potential outcomes and future states: A clear understanding of tools and materials must precede building anything. This sounds self-evident, yet many companies venture into building their future IT landscapes without a solid understanding of the building blocks. EBT hold much promise and potential – understanding the strategic implications of emerging technologies provides decision makers with the right tools. This understanding can come from leveraging internal and external experts. 3. Track progress and align the course: The best way, and maybe the only way, to track progress effectively is to understand the bigger picture and define clear metrics for measuring success. A strategy roadmap helps in the long term by comparing the real milestones that will take place against the envisioned ones, and allows changing course with much less impact on the bottom line. Performance metrics can be defined to ensure that business benefits are realized and value is created. Organizational changes are often disregarded when IT changes are made. Canopy’s whitepaper on governance examines the organizational changes that should accompany a move to using cloud technologies. People, processes and technologies will all need to be rethought and aligned so that EBT becomes a true enabler of value, not just an IT solution. Similar aspects should be included in the transformation strategy of clinical trials. Sourcing models Once the company has a clear vision of its desired future state and necessary functionalities, it can start to consider how to build the ecosystem. At the core, pharmaceutical companies have three options: • Build the cloud IT backbone for the ecosystem • Cloud source all of the components • Hybrid - do an intelligent mix of built and sourced IT components
  10. 10. 10 | Whitepaper Implementation strategies Once a strategic vision has been established, and a careful analysis over potential sourcing options has been conducted, companies can start looking at different implementation strategies. Independent of the implementation model used, there are a few core steps18 that are fundamental in helping organizations embrace change. 1. Measure what really matters: Enforcing a change starts with defining the purpose, and identifying the main contributing drivers. Surprisingly KPIs often measure aspects that do not directly contribute towards the main purpose, but rather serve as the foundation for disparate motivators for stakeholders, who end up driving to different directions. In order to guide a transformation, the organization must be clear on what is the ultimate goal, what factors contribute to it, and finally, be sure that what is measured really is important. 2. Create a shared purpose: To act as change agents, people need to be emotionally attached to the program. Sharing success stories and remembering to celebrate important milestones is important for overall motivation. It is important to show stakeholders their influence and contribution to the ultimate goal that overarches and unites all stakeholders. 3. Create financial and non-financial incentives: All stakeholders need to be incentivized to work in the intended direction. Stakeholder will act to be rewarded, thus if incentives do not point to the ultimate goal, no transformation will be successful. Figure 3: Different options to shape the future trials ecosystem In order to determine which sourcing model is optimal for each organization, internal (size and type of company) and external (market and vendor maturity and functionality provided) factors need to be considered. For more insights on this subject, please refer to Canopy whitepaper on Governance. Description  Platform andappsbuiltin house  Infrastructureon-premisewithbursting capabilitiesforpeaktimes  Platform andappssourcedfrom existing vendors, withan internal hub that connects them  Infrastructurepartiallyor completely off-premise  Platform andappsa mixtureof built andsourced  Infrastructurepartiallyor completely off-premise Benefits  Custom built,tailoredto company requirements  Reliabilitydependenton internal measures  Choose bestavailablecapabilitieswith frequentupdates  Focus on core competencies  Bestof both -buildwhenexistingis too riskyor otherwiseunsuitable Challenges  Expensiveandtimeconsuming to build andmaintain  ‘Re-inventthe wheel’  Constant updatingto remainrelevant  Dependenceon vendors  Orchestration to ensurecompatibilityof varioussystemsandvendors  Complex– possible duplication of functions  Orchestration to ensurea single source of truth Build it: Internal cloud Provider Source it: Leverage existing platforms Hybrid: Mix of built and sourced 1 2 3 ClinicalTrial IT landscape Cloudapplication built ‘in house’ Cloudapplication sourcedfrom vendor Hub connectingexternal and internal platforms External Platform 1 External Platform 2 Hub Internally built Platform Infrastructure* Infrastructure* External Platform 1 External Platform 2 Internally built Platform Infrastructure*
  11. 11. Whitepaper | 11 An Atos company. Powered by EMC2 and VMware Figure 4: Types of implementation strategies for a clinical trial ecosystem *All scales areoutof 10 Pilot project TankerCruiserSpeedboatSubmarine Cost ComplexityRisk Impact Set a new sustainable direction for a therapeutic area Take a fastapproach to testnew waterson one molecule Single pilot project under the radarof Internal communication Set a new sustainable, long-term course for the CT environment Description Entire clinicaltrial environment Therapeutic area Molecule 6 8 8 8 5 5 7 7 3 3 5 5 1 1 3 3 There is no right or wrong approach, and the decision will depend on many factors, including: • Size and type of company (big pharma vs. small biotech company) • Level of enthusiasm towards new technologies and resistance to change • Appetite for investments and budget constraints • Skills available within the organization Note: All scales are out of 10
  12. 12. 12 | Whitepaper Quiet and off the radar, this kind of project usually is done by early adopters and enthusiasts. It practically requires no or little budget and at the beginning gets no visibility. Pros: Usually done by people who understand, care, and are eager to promote change through the organization. Cons: It is usually small and can easily go unnoticed. Industry example: Pilot project to outsource a small part of the compute and storage capacity to the cloud as test mode. Implementation starting point: Focus on optimizing infrastructure. SUBMARINE 04 Smaller and more agile, this kind of project gains speed fast and is easier to turn around. However, because of its size, it might take a while for organization wide change to take place. An example of the scope of the project is to change a tool or process for a single molecule. Usually this type of a project gets little CxO visibility and patronage. Pros: More manageable to implement than Tanker and Cruiser types. Cons: Might need a succession of these projects to create an organization-wide change, because of its scope, and limited executive sponsorship. Hypothetical industry example: Using EBT based collaboration tools for one of the molecules that are being developed. Continuously learning from the experience and sharing this knowledge with the wider audience. Implementation starting point: Identify potential SaaS applications and cloud infrastructure. SPEED BOAT 03 Expensive and visible, this kind of project gets attention and gets things done, provided it is approved in the first place. The executive sponsor is usually the SVP/VP/Director. The project typically spans departments and/or geographies, changing an entire therapeutic area. Pros: If it succeeds, this kind of project could act as a strong catalyst for positive change within the organization. Cons: Condensing risk on one therapeutic area. Industry example: Pfizer conducting (first) virtual clinical trial. The results were not successful, but this was a great learning opportunity for Pfizer. Implementation starting point: Focus on building or sourcing a platform. CRUISER 02 An organization-wide project that spans departments and geographies, takes a considerable amount of time and budget to implement. The executive sponsor is usually the CxO, and/or the board. Pros: If it succeeds, the project could become a viable long term competitive advantage. Also, the budget and scope of these projects lead to a strong CxO support and oversight. Cons: These projects are complex, with many moving parts and stakeholders. As a result, these projects need a lot of resources (time, money). They often take considerably longer to implement than originally planned, and it is not uncommon for them to run over budget. Industry example: Pfizer completely overhauled its supply chain, making it cloud based. The first phase took 18 months, and success was not guaranteed. Now, however, this project brought considerable competitive advantage for Pfizer. Implementation starting point: Invest time and resources in the strategic roadmap for a long term vision of how EBT can bring competitive advantage. TANKER 01 Tactical types of projects
  13. 13. Whitepaper | 13 An Atos company. Powered by EMC2 and VMware V. Security advantage in the cloud • Compared to other industries, pharma companies have been relatively slow to adapt cloud solutions mostly due to concerns around security. The industry is highly regulated and any data compromized can have severe consequences, justifying this cautious approach. Especially HIPAA, and the need to report any breaches to it, has pharma companies concerned about the reputational damages. While it is important to have carefully planned procedures regarding data management, most concerns around cloud solutions are misplaced. In fact, the following three factors highlight how cloud can offer an advantage in terms of security and compliance. 1. Data is securely stored online: • No need to transport data: Out of the 21 million security breaches reported to the US government since 2009, the majority (66%) were the result of lost or stolen equipment (laptop) or storage media (flash drive)19 . Instead of relying on email and data sheets for information sharing, cloud solutions securely store data in the cloud, providing access to authorized users via web browser. This eliminates the need for transporting data on devices, abolishing the cause for the majority of recorded breaches. • Controlled access to data: Admin portals enable easy control over who has access to what information. This reduces the burden of providing parties with access to certain data, automating a task that would traditionally be cumbersome. In addition, role-based access rights are easy to modify and stay up to date, reducing the number of ghost accounts. • Enforcement of security policies: Cloud-based systems also facilitate the enforcement of security policies such as encryption. Traditionally, when users download files, store them on local disks and transport them via email, enforcing such policies is rather impossible. When data is stored online, companies can easily ensure it is encrypted and compliant with other company policies. 2. Data is compliant with regulations: • Good Clinical Practice, incl. CFR 21 Part 11 & EU commission directive 2005/28/EC and ICH E6: Various offerings currently on the market come with capability to comply with industry regulations regarding audit systems, systems validation, audit trails, electronic signatures etc. The solutions come with certifications, meaning that they do not need to be independently validated. • HIPAA, US-EU Safe harbor, incl. EU Directive 95/46/EC: As SaaS providers, vendors tend to comply with data privacy acts across geographies20 . This means the same software can be used in different countries without additional considerations on validation and certification of the like. 3. Economies of scale in safety • Physical security: The amount of data stored by vendors tends to be very large. Due to economies of scale, they are able to provide higher levels of physical security in their data centers than a single company inside its own. • Specialization: Vendors will not be successful unless they can prove they provide a safe environment for customer data. This makes security a key operational component and differentiator; vendors tend to employ best of breed practices, regular updates and constant tests when it comes to security. An individual company can rarely dedicate as much time and money on testing their environment than cloud providers can. • Disaster recovery: Cloud providers need to have well-planned disaster recovery plans in order to meet customer requirement and SLAs. They tend to be geographically dispersed and employ latest technologies, ensuring data can be easily moved to a secure location if one location is compromized. For companies still employing paper records or older technologies, this is impossible.
  14. 14. 14 | Whitepaper VI. Conclusion Emerging Business Technologies are changing the game for pharma companies by enabling efficiency and value creation like never before. In order to fully take advantage of these new opportunities, companies must embark on a full transformation journey guided by a clear vision, a long term strategy on an optimal sourcing model, and a detailed implementation plan. True integration and collaboration can only be achieved when decisions and plans are made holistically, considering the whole ecosystem with its internal and external components as one cohesive unit working towards an overarching goal of creating value for the patient. It is time to break the silos and organizational boundaries, and rethink the set up for clinical trials leveraging EBT not as a solution, but as an enabler of value for all stakeholders involved.
  15. 15. Whitepaper | 15 An Atos company. Powered by EMC2 and VMware 1. Invention reinvented, McKinsey perspectives on pharmaceutical R&D 2010 2. http://www.nber.org/reporter/fall06/danzon.html 3. http://www.ngpharma.com/article/Money-for-Nothing/ 4. http://www.contractpharma.com/issues/2012-03/view_features/clinical-trial-outsourcing-report 5. R&D cost of a new medicine, Mestre-Ferrandiz et al., Office of Health Economics, 2012, 6. R&D cost of a new medicine, Mestre-Ferrandiz et al., Office of Health Economics, 2012, 7. http://www.mdsol.com/sites/default/files/documents/library/wp/accelerate_time_to_revenue.pdf 8. http://www.mdsol.com/sites/default/files/documents/library/wp/accelerate_time_to_revenue.pdf 9. http://transceleratebiopharmainc.com 10. http://www.lifescienceleader.com/component/k2/item/4368-the-rise-of-precompetitive-collaboration 11. https://www.google.co.uk/url?sa=t&rct=j&q=&esrc=s&source=web&cd=2&ved=0CDoQFjAB&url=http%3A%2F%2Fdownload. microsoft.com%2Fdownload%2FF%2FD%2F4%2FFD4CF170-94DD-46B4-A627-37578E93920D%2Fsanofi_aventis.pdf&ei=dSc3Uo3jL_ DT7AayxYDoBg&usg=AFQjCNEa6e8CcIBdwb5cak2pQnEFeoYCrw&sig2=GAfT5WfpthD34BMF_e_50g&bvm=bv.52164340,d. ZGU&cad=rja 12. http://www.mdsol.com/sites/default/files/documents/library/wp/accelerate_time_to_revenue.pdf 13. http://lifescienceleader.com/blogs/contributing-editors-2/item/4363-pfizer-perseveres-in-pioneering-virtual-clinical-trials 14. http://www-01.ibm.com/software/success/cssdb.nsf/CS/JHUN-94H69Y?OpenDocument&Site=default&cty=en_us 15. http://www.kellyocg.com/uploadedFiles/Content/Knowledge/Ebooks/Cloud%20Computing%20and%20Pharma%20-%20A%20 Prescription%20for%20Success.pdf 16. http://medcitynews.com/2013/06/can-a-digital-platform-for-pharma-marketers-also-accelerate-clinical-trials/ 17. http://www.mednetstudy.com/enlighten.htm 18. Porter, M. E. & Dr. Lee, T. H. (2013, September, 24). The Strategy that Will Fix Healthcare [webinar]. 19. https://m.healthcareitnews.com/blog/cloud-computing-reduces-hipaa-compliance-risk-managing-genomic-data 20. http://www.mdsol.com/about/quality.htm
  16. 16. An Atos company. Powered by EMC2 and VMware Contact: www.canopy-cloud.com info@canopy-cloud.com +44 (0)20 8555 1637 Mail: Canopy Ltd 4 Triton Square, Regents Place London NW1 3HG About Canopy Cloud Canopy www.canopy-cloud.com is a one-stop-cloud- shop for enterprises. It provides strategic consultancy; development, migration and test environments; secure on- and off-premise private cloud implementation; and access to a growing eco-system of business solutions and processes through a SaaS Enterprise Application Store. Canopy is an independent company, founded by Atos, EMC and VMware. Headquartered in London, Canopy is global in scope, with consultancy teams operating across Europe, North America and Asia Pacific. Canopy Consulting is a trusted cloud computing advisor to leading private and public sector organizations around the world. Staffed almost exclusively with professionals trained at tier one strategic advisory firms, we focus on helping senior executives achieve business objectives by leveraging cloud technologies. About the Authors Ahmed Mitwalli is the Managing Partner at Canopy Cloud – Consulting. Prior to Canopy, Ahmed was with McKinsey & Company for 12 years where he was a Partner and a leader in the Business Technology Office. He has a PhD in Electrical Engineering and Computer Science from MIT, and is a holder of five US technology patents. ahmed.mitwalli@canopy-cloud.com +1 917 982 5435 Jeremy Brann is an Associate Partner at Canopy Cloud – Consulting and a leader in the field of enterprise cloud strategy. Prior to Canopy, Jeremy was a Lead in Cloud Consulting at Hewlett-Packard where he designed IT transformation roadmaps and ran workshops for Fortune 500 companies. Jeremy is also a regular speaker at VMWorld, Gartner events, and CIO summits. Jeremy.brann@canopy-cloud.com +18594200733 Kirsten Fischer is an Engagement Manager at Canopy Cloud – Consulting and an expert in the field of business strategy. Prior to joining Canopy, Kirsten worked at Booz & Company where she supported clients on strategy development, change management and cost transformation programs. Kirsten holds an MBA from IESE Business School. Kirsten.fischer@canopy-cloud.com +491751831186 Canopy Contributors Loic Lavoue Reinout Schotman Dmitriy Synyak Eeva Maki-Uuro Copyright © 2013 Canopy Cloud Ltd Canopy - The Open Cloud Company and its logo are trademarks of Canopy Cloud Ltd. All rights reserved.

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