Deloitte’s Evidence PlatformDriving innovation, how a leading biopharmaceutical company is thinking about data

CASE STUDY

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Start the conversationTo learn more about how Deloitte can help you make data driven decisions, visit us at www.deloitte.com or contact us directly:

Brett DavisPrincipal and General ManagerConvergeHEALTH by DeloitteDeloitte Consulting LLPbrettdavis@deloitte.com

Jinlei LiuVP Product DevelopmentConvergeHEALTH by DeloitteDeloitte Consulting LLPjinlliu@deloitte.com

Executive Summary

State of the Market

The Growing Imperative for RWE

Investing in Insights

Results

Return on Investment

Conclusions

Contents

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ConclusionsThis leading Biopharmaceutical organization knew they wanted to lead the shift toward value-based, personalized health care to help patients live longer healthier lives. To drive that level of innovation, they needed evidence to understand what worked for whom, why and at what cost. The enterprise transformation to become data-driven was an executive level led initiative with implications across the entire organization. They worked with Deloitte to create an end to end evidence strategy to leverage their internal assets as well as partner with the larger health care ecosystem for a richer, more complete evidence ecosystem. In addition to consulting services, the organization also leveraged the product maturity of ConvergeHEALTH to create a cloud based knowledge management system.

ConvergeHEALTH’s Miner Platform connects silos of data to powerful analytics and visualization tools that enable researchers to easily generate and explore hypotheses. The ability to interrogate Real World Evidence and clinical data can be used to understand risk-benefit profiles in the safety space, respond to regulators quickly, replicate clinical trials for enhanced patient understanding, drive acceleration and approvals in single arm trials, conduct comparative effectiveness studies, and inform business development and portfolio strategies.

Executive Summary“..a state-of-the-art platform and go live within six months of the commitment. That's unheard of. But it also tells you the pace of change and the pace required to adopt that change to stay at the bleeding edge of the new world of data and technology”

An explosion of health information is disrupting almost every aspect of the product life cycle from R&D to commercialization and driving value-based personalized treatment trends. A large biopharmaceutical company recognized the power in the volume, variety, and velocity of health data to impact core business function and ultimately improve patient outcomes. Their leadership understood the need for a strategic method to leverage their data more effectively, while also partnering with the larger health ecosystem for deeper insights. In collaborating with Deloitte, the organization was able to devise an enterprise wide, end-to-end strategy to leverage data including a cloud based knowledge management system internally, while also harnessing an expanding network of collaborators to build out their real world evidence capabilities.

The cloud based ConvergeHEALTH Miner Platform offered a modular suite of components to help accelerate evidence generation and management across the evidence life cycle. Miner's components helped unlock the full potential of data by spanning organizational groups, technology silos, and fragmented systems and processes. Ultimately providing improved visibility into data assets, enhanced and expedited analyses, and greater collaboration.

-Client testimonial

The explosive growth in the democratization, digitalization, and diversification of scientific data and electronic health information has the ability to transform the understanding of health and human disease.

State of the MarketThe health care ecosystem is in a period of transition driven by regulatory imperatives, technological advancements, and new collaborative models that have major implications for Life Science organizations and the way they develop and commercialize products. At the heart of this evolution is the patient, and a more personalized approach for treatment. The emphasis on a patient’s unique health journey is driving market trends in precision medicine by shaping research to focus on the variability in genes, environment, and lifestyle for each person, resulting in targeted products. Additionally payment models are adapting as reimbursement evolves from traditional volume-based models to value-based models, prompting innovative product strategies to deliver robust product value propositions. This type of personalization involves an understanding of what works for whom, why, and at what cost; historically, the right data has not existed to answer those detailed questions effectively—until now. The explosive growth in the democratization, digitalization, and diversification of scientific data and electronic health information has the ability to transform the understanding of health and human disease. This includes everything from the way breakthrough scientific innovations and insights occur to drug development, the regulatory approval process, and the reimbursement frameworks for innovative therapeutics.

TRADITIONAL CLINICAL TRIAL DATA

GENOMIC DATA REAL WORLD EVIDENCE

The market shift and the proliferation of health care data is generating new opportunities for innovation, but often requires companies to manage evidence differently throughout the product life cycle and across the various channels of the health care ecosystem. As concepts mature into products, evidence management may enable an organization to generate value and maximize a product’s potential for clinical and commercial success by leveraging traditional clinical trial data, genomic data, and routinely collected medical data to segment patient populations for the most effective therapeutic response. Evidence strategies can advance biomedical research to drive innovation, support value-based health care delivery, and fulfill the promise of precision medicine and enable data-driven decision making.

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Return on InvestmentDeloitte worked with the client to develop their new strategy and operating model that focused on providing enterprise governance, transparency, efficiencies and foster collaboration across functions. That strategy translated that into an execution framework that leveraged the ConvergeHEALTH Miner suite. The resulting cloud based Big Data platform has helped tem generate data insights and drive efficiencies across the organization as well as support external collaborations with scientific and commercial partners.

Improved time to insights with collaborators both internally and externally.

65X faster performance vs SAS in complex cohort definition. Example cohort filter involves 50 million patients spanning 9 years that took over 6 hours to return a result in SAS and took under 6 minutes in Cohort Insight.

3x increase in performance vs. existing environment.

Greater transparency in documenting cohort definition.

An ecosystem of external partnerships including health systems, data vendors, and technology experts speeds organizational learning and uncovers new opportunities for collaboration

The diverse background of the team coupled with the latest cloud architectures allowed Deloitte to quickly and cost-effectively build and deliver a flexible and extensible ecosystem of both data and analytical tools to help accelerate research and empower researchers. The improved the organizational intelligence around the application of data and analytics enabled a transition from descriptive to predictive analyses. Deloitte’s Evidence Platform has become a key enabler of innovation at the large organization.

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Improved decision support throughout the product lifecycle using Real World Evidence e.g.ability to design phase IV studies using existing data sources

Solutions at the speed of change

The Growing Imperative for RWE

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MarketAccess

R&D SalesOperation

Other Safety HEOR Epidemiology

Biggest OpportunityPotential OpportunitySome Opportunity

Many companies perceive the biggest opportunities for RWE are in the market access and R&D

When thinking about the two main drivers of drug development costs, time and failure, RWE holds promise to address both if applied correctly. Many are targeting the use of RWE to improve trial design and patient recruitment.

54%Project Underway

0%Our Organization is not Analyzing RWD

33%RWD

Analytics Capability

Exists

13%Other

RWD is recognized as important across the industry, with half of respondents investing in their RWE programs

Real World Evidence (RWE) comes from secondary analysis of observational data from the health care system and, increasingly, patients themselves, as digital health and the Internet of Things become reality in many therapeutic areas. These data sources reflect the patient experience from a mix of individuals taking a drug or using a device in real world settings, as opposed to controlled clinical trials.

The bipartisan 21st Century Cures Act, signed by President Obama in December 2016, charges the Food and Drug Administration (FDA) with evaluating the expanded use of RWE, including its potential to support the approval of new indications for previously approved drugs. The new law and growing imperative for sciences companies to demonstrate value to payers and health authorities will likely shift research and development (R&D) and commercialization strategies towards those that develop innovative products and are effective in gaining coverage and optimal pricing. RWE can have a broad set of applications and many life sciences companies and other health care stakeholders (payers, providers, regulators, and patients) are increasingly making high-impact decisions using an expanding array of electronic real-world data (RWD) sets beyond traditional claims and electronic medical records (EMR) data.

Source: Getting real with real-world evidence

Life sciences companies can use this RWD to better understand what is happening during episodes of care at a much larger scale than is possible with clinical trials: it can enable researchers to characterize patient experience with a condition and therapy across millions of patients versus the few thousand that are part of a typical clinical trial. Insights generated from RWE may affect decisions across the entire product life cycle, from R&D through commercialization. An End-to-End evidence management strategy could be a key ingredient in realizing RWE’s potential because it helps decision-makers act at an enterprise level based on rigorous, data-driven insights versus a traditional siloed approach.

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Investing in InsightsA leading biopharmaceutical organization operating in traditional functional siloes, noticed natural pockets of data and analytics used throughout the organization. As the proliferation of health care data continued to accelerate, leadership recognized a need for an enterprise wide strategy to rethink how the organization organizes around, and harnesses these data to inform decision-making across the value chain.

Advances in analytics, computational tools and data platforms combined with new and existing data sources promised greater insight into diseases for tailored therapies and a more personalized approach for patients. The organization needed a cloud based platform to serve as the foundation for facilitating information discovery, access, analysis, governance and enable collaboration across franchises and functions. Specifically this integrated approached would improve R&D productivity, product launch effectiveness, and overall operational excellence.

The big data and next generation analytics platform integrates the technology solution with internal organizational processes and best practices for real world evidence generation. The new analytical workflow supports fast and robust generation of real world evidence whilst upholding safeguards and controls around data governance and privacy. This facilitated organizational awareness of the firm’s real world evidence capabilities and how they can be used to support decisions throughout the product lifecycle including the ability to design phase IV studies using existing data sources.

The organization realized investing in their data alone would be an incomplete strategy to accelerate and enable the future success of the company and the patients they serve. The organization needed to expand their partnerships to fill in information gaps and leverage the entire health care ecosystem. This collaborative approach allows for novel insights based on real world care approaches and a more complete understanding of the patient experience to power the organization’s core decision-making.

Partnership Ecosystem

Cloud Based Knowledge Management System

An End-to-End Strategy

Enable Real World Evidence

“There's no one company that can move this, it is too much of an enormous undertaking and it's going to take everybody working together to really begin to have a meaningful impact for patients.”

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Exploring

Deloitte builds and operate technology enabled solutions (IP) that, when combined with our services, platforms, and ongoing support, help our clients innovate and add value to their core business functions

Data Asset Explorer is a cloud based application to enable a standard & collaborative way to simplify the process of information management, exploration, sharing, and governance

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ConvergeHEALTH MinerTM is a solution suite for evidence management to provide a flexible, ecosystem solution to big data challenges that can be optimized for the unique client situation. The organization adopted the cloud-based end to end evidence management platform to pull together data across the entire evidence spectrum for quick analyses and targeted insights. This enables data scientist to leverage new tools, but importantly, it also democratized the data, through new visualization technologies, to allow scientist, business leaders, and other clinical leaders to interrogate and make sense of this plethora of new data that's available. The platform also enables the organization to understand the data assets it currently has to better asses the information gaps they will need to fill to continue a development initiative.

In this case, the Miner solution was deployed on the AWS cloud for appropriate data security and elastic computing power for analyses. Additionally, this centralization provided researchers access to all types of data at all points in the development lifecycle. The configuration of the solution included a data layer, analysis layer, and knowledge management layer. The layers were built with proprietary Miner modules as well as third party and open source components based on the best in class capability for that use case. The architecture promotes an efficient and seamless user experience to best leverage high-value data.

Technology alone is just an enabler, Deloitte engaged the full complement of services to help the organization accelerate their transformation, including data science, analytics, information management, strategy as well as operating model re-design to ensure future innovation and growth.

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“The miner platform is the backbone of the technology platform. It’s industry leading. Without it, I think it is like a buying a car with three wheels. It could drive. It's just not very effective.”

ResultsThe partnership between Deloitte and the client produced a new strategy, operating model, and platform to shift the employees’ mindsets and improve the organizational intelligence around how data and analytics can be applied. ConvergeHEALTH Miner was configured for the client to move from descriptive to predictive analytics resulting in:

Ability to share insights and collaborate Advanced, integrated network of strategic partners

Transparency into available data

Coordinated data network strategyNew insights from advanced analytical tools and visualizations from combining disparate data sets

End UsersClaims

EMR

Registry

Next gen

Common data

model

Data layer

Analysis layer

Data asset explorer

Measure library

Software code library

Study & partner library

Access Control

• Analyst

• Data scientist

• Data steward

• Legal and compliance

• Collaborators

• etc

Knowledge management

Apps and syndicated reports

Next generation analytical tools and sandboxes

Evidence 20/20 Platform

Deeper understanding of skills requirements including expanded data scientist capabilities

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