17
Crawl, Walk, Run: BioPharma’s Guide to Leveraging Real-World Evidence Actionable Success Strategies to Supercharge R&D and Commercialization SHYFT Analytics SHYFTANALYTICS.COM @SHYFTANALYTICS Brian Irwin, Senior Vice President, Strategy

Crawl, Walk, Run - SHYFT Analytics€¦ · Crawl, Walk, Run: BioPharma’s Guide to Leveraging. Real-World Evidence. Actionable Success Strategies to Supercharge R&D and . Commercialization

  • Upload
    others

  • View
    7

  • Download
    0

Embed Size (px)

Citation preview

Page 1: Crawl, Walk, Run - SHYFT Analytics€¦ · Crawl, Walk, Run: BioPharma’s Guide to Leveraging. Real-World Evidence. Actionable Success Strategies to Supercharge R&D and . Commercialization

Crawl, Walk, Run:BioPharma’s Guide to LeveragingReal-World Evidence

Actionable Success Strategies to Supercharge R&D and Commercialization

SHYFT Analytics

SHYFTANALYTICS.COM @SHYFTANALYTICS

Brian Irwin, Senior Vice President, Strategy

Page 2: Crawl, Walk, Run - SHYFT Analytics€¦ · Crawl, Walk, Run: BioPharma’s Guide to Leveraging. Real-World Evidence. Actionable Success Strategies to Supercharge R&D and . Commercialization

EXECUTIVE SUMMARY

SHYFTANALYTICS.COM @SHYFTANALYTICS

1

Stakeholders across the biopharma enterprise are challenged by a myriad of issues when it comes to collecting, interpreting, standardizing, and applying RWD

From emerging specialty biotech organizations to global pharmaceutical corporations, real-world evidence (RWE) is permeating the landscape and demonstrating value throughout all stages of drug conceptualization, development, and commercialization.

According to industry sources, there’s a $1 billion opportunity for large pharmaceutical companies that harness the capabilities of RWE throughout the entire product lifecycle.1

A McKinsey survey revealed that all of the top-10 biopharmas are using real-world data (RWD) to inform product development and commercial decisions, using it as a tool to better understand disease states, perform safety studies and design clinical trials, and assess efficacy in subpopulations. Among other benefits, this data can help gain market access versus incumbents, maintain formulary status, and drive product use — all while considerably cutting development times.2

What’s taking so long for RWE to become the foundational data asset for innovators in life sciences?

Stakeholders across the biopharma enterprise are challenged by a myriad of issues when it comes to collecting, interpreting, standardizing, and applying RWD. Many cite a lack of access to this critical data and the technology that powers it, in addition to a lack of internal personnel expertise to navigate the space.

Across the lifecycle — from research and development (R&D), to pre-launch and launch phases, to post-market surveillance and commercial performance — RWE has shown immense value for companies that have invested the resources to track, measure,

1 Hughes, Benjamin, et al. “BreakingNew Ground with RWE: How Some Pharmacos are Poised to Realize a $1 Billion Opportunity.” IMSHealth.com, IMS Health Incorporated, 2014, https://www.imshealth.com/files/web/Global/Services/Services%20TL/rwes_break-ing_new_ground_d10.pdf

2 Cattell, Jamie, et al. “How can phar-macos take advantage of the real-world data opportunity in healthcare?” McK-insey & Company, October 2011.

Page 3: Crawl, Walk, Run - SHYFT Analytics€¦ · Crawl, Walk, Run: BioPharma’s Guide to Leveraging. Real-World Evidence. Actionable Success Strategies to Supercharge R&D and . Commercialization

EXECUTIVE SUMMARY

SHYFTANALYTICS.COM @SHYFTANALYTICS

2

Key decision makers will be equipped to crawl, walk, and eventually run into the new era of big data and RWE in healthcare — and the incredible value it can reap for organizations, providers, and patients.

and apply it meaningfully.

This white paper will explore RWE opportunities across the lifecycle and throughout various departments within a life sciences company, and provide insights into how these companies can implement beginner, intermediate, and advanced strategies as they get acclimated.

The Promise and Disillusionment of Real World EvidenceThe shift toward collecting RWD and using it to generate actionable RWE is catalyzed by the healthcare industry’s shift from volume-based to value-based care. Drug manufacturers, payers, providers, and other industry stakeholders feel growing

competitive pressure to speed their products’ time-to-market, deliver optimal health outcomes based on proven data, and continue transpar-ently feeding their own performance and outcomes data into the collec-tive cycle. While this can be intimidating, there is a plethora of uses and benefits to enacting an RWE-based strategy.

Supportive case studies demonstrate how RWE has shown incredible promise for uniquely impacting each of these stages:3

• Clinical developmento Trial enrollment improvemento Fewer flaws in strategic trial designo Enhanced product profile design

• Launch pricing and market accesso Market access submission accelerationo More effective price negotiation, payment by

use/indication

3 Hruby, Gregory William, et al. “ A centralized research data reposito-ry enhances retrospective outcomes research capacity: a case report.” Academic.oup.com, Oxford Academic, https://academic.oup.com/jamia/arti-cle/20/3/563/741943

Page 4: Crawl, Walk, Run - SHYFT Analytics€¦ · Crawl, Walk, Run: BioPharma’s Guide to Leveraging. Real-World Evidence. Actionable Success Strategies to Supercharge R&D and . Commercialization

THE PROMISE AND DISILLUSIONMENT OF REAL WORLD EVIDENCE

SHYFTANALYTICS.COM @SHYFTANALYTICS

3

Data shows that pharmaceutical companies invest roughly $3-5 billion to bring a new molecule to market over the course of discovery to launch (an estimated 12 to 15 years).

• Launch planning and trackingo Launch improvement from patient pool

segmentationo Rapid adjustment of resource

allocation/messaging

• In-market safety and valueo Formulary improvemento Label change avoidance

• Commercial spend effectivenesso Brand growth from RWE-enabled marketingo Improved promotion from physician-patient

segments

Market Opportunity Data shows that pharmaceutical companies invest roughly $3-5 billion to bring a new molecule to market over the course of discovery to launch (an estimated 12 to 15 years). However, a recent study estimates that across the development, launch, and in-market stages for top-10 pharmaceutical companies, the RWE opportunity is valued at $1 billion — an opportunity that could save more than 30 percent of drug investment costs.4

Market access and R&D are two of the top departments with high po-tential to see results from an RWE application strategy. Other top func-tions include sales operations, health economics and outcomes research (HEOR), safety, and epidemiology.

4 Hughes, Benjamin, et al. “Breaking New Ground with RWE: How Some Pharmacos are Poised to Realize a $1 Billion Opportunity.” IMSHealth.com, IMS Health Incorporated, 2014, https://www.imshealth.com/files/web/Global/Services/Services%20TL/rwes_break-ing_new_ground_d10.pdf

Page 5: Crawl, Walk, Run - SHYFT Analytics€¦ · Crawl, Walk, Run: BioPharma’s Guide to Leveraging. Real-World Evidence. Actionable Success Strategies to Supercharge R&D and . Commercialization

MARKET OPPORTUNITY

SHYFTANALYTICS.COM @SHYFTANALYTICS

4

Many biopharmas cite the regulatory environment and a lack of access to quality-controlled data as the most significant challenges.

Adoption ChallengeDespite its promise, the industry could use a jump-start to begin more purposefully weaving RWE into the fabric of operations. The reasons differ from organization to organization, but the main culprits are typically related to technical barriers and a lack of internal expertise.

Many biopharmas cite the regulatory environment and a lack of access to quality-controlled data as the most significant challenges. Other challenges include an inability to analyze and interpret the data, a perceived lack of acceptance by healthcare providers and payors, an unclear understanding of how and where RWE can be applied, and a general lack of big data familiarity and expertise among the organization’s members.5

There are no limits or strict definitions for which data or sources qualify as RWD, which can further complicate the process of accessibility.

Even when an organization has access to the right data, there’s still more work to be done before it can be meaningfully applied to the business model. For example, a significant amount of RWE data isn’t collected for research purposes, and must therefore be “cleaned” by data scientists using widely accepted and statistically valid techniques before it qualifies for its intended uses.

Today’s biopharmas must also consider patient protection issues and potential data breaches once they’ve gained access to these high volumes of confidential patient data.

5 Rönicke, Volker, et al. “Revitalizing pharmaceutical R&D: The value of real-world evidence.” Strategyand.PwC.com, Strategy&, https://www.strate-gyand.pwc.com/media/file/Revitaliz-ing-pharmaceutical-RD.pdf

Page 6: Crawl, Walk, Run - SHYFT Analytics€¦ · Crawl, Walk, Run: BioPharma’s Guide to Leveraging. Real-World Evidence. Actionable Success Strategies to Supercharge R&D and . Commercialization

MARKET OPPORTUNITY

SHYFTANALYTICS.COM @SHYFTANALYTICS

5

Companies should evaluate the business case, targeted function(s), and end goals before deciding to build, outsource and customize, or license a technical solution.

With these considerations in mind, it’s important to approach the RWE puzzle with a strategic focus before a technical one. Companies should evaluate the business case, targeted function(s), and end goals before deciding to build, outsource and customize, or license a technical solu-tion.

DIY vs. Consultancies vs. SaaS Manufacturers face the prospect of choosing among three main options when addressing these challenges: do-it-yourself (DIY) strategies, partnerships with data consultancies, and software-as-a-service (SaaS) solutions that can be implemented on the cloud or on-premises.

Each approach has its own unique challenges and benefits, such as:

• A DIY approach can save consultation and software costswhile bolstering autonomy and control over results.However, it requires extensive resource management,internal expertise (which may translate into a need forrecruitment and training) and time – lots of it.

• Consultancies offer customized strategies and deepexpertise, often with positive results. On the other hand,they can be costly and businesses have less control overthe processes and value of results, which may beuncertain in the initial stages of the partnership.

• SaaS solutions are known for being scalable, accessible,cost-effective, and resilient. But without proper planning,companies may find themselves vulnerable to issues likeintegration with other systems and enterprise adoption.

The “Adoption Curve”As promise morphs into practice within the inner workings of pharmaceutical companies, some departments lend themselves more naturally to accessing and applying RWE. In many companies, health economic outcomes research (HEOR) and epidemiology departments are pioneering RWE efforts and are paving the way for others, while illustrating the massive value potential that it can bring to the commercial space.

Page 7: Crawl, Walk, Run - SHYFT Analytics€¦ · Crawl, Walk, Run: BioPharma’s Guide to Leveraging. Real-World Evidence. Actionable Success Strategies to Supercharge R&D and . Commercialization

RWD APPLICATION AND USE CASES BY DRUG STAGE

SHYFTANALYTICS.COM @SHYFTANALYTICS

6

If executed well, this model could mean the launch of products in the PoC stage, soon after phase IIa in a conventional cycle — which could theoretically cut cycle time by five years and cut R&D investment per product by 60 percent.6

Across the clinical and commercial continuum, manufacturers share a universal set of needs that must be met for optimal brand performance and peak revenue growth. Among these needs are the ability to strengthen their value profiles, drive adherence, reduce costs, accelerate their drug’s time to market, and scale rapidly and profitably when needed.

But there’s another line of needs that uniquely lends itself to the power of data and its ease of access: RWE can help organizations to strength-en their value proposition. For some, this may mean re-orienting their market strategy based on new outcomes data for long-standing ther-apies. For others, it may mean tapping into RWE to grow opportuni-ty size of a new niche-buster drug among a smaller patient pool. It’s critical that manufacturers meet their business’s unique needs across the product lifecycle while staying competitive in the market, and data surrounding RWE use proves its enormous benefits in supporting these initiatives and goals.

Let’s examine three critical stages of the drug lifecycle — R&D, pre-launch, and post-market — and how biopharmas can enhance each stage through RWE.

R&DPwC investigated the implementation of a fully-integrated integrated RWE model in the R&D phase. This model combines evidence-based approaches and randomized controlled trials, which would in turn cre-ate three key benefits: quickly establishing a reliable proof of concept (PoC), a good safety profile, and protocols based on clinical effective-ness as opposed to additional clinical efficacy in trials.

Applications in Clinical Trial Design, Execution, and AnalysisReal-world evidence can have a profound impact on clinical research and the strategy for designing, developing, and releasing products to market. Design. In this stage, clinical researchers can use RWE for a

more holistic understanding of patients and the underlying biology that top-performing products must cater to. RWE helps researchers to target hyper-specified patient populations, while providing the foundations to explore critical biomarkers and facilitate the development and optimization of traditional and alternative trial designs.

6 Rönicke, Volker, et al. “Revitalizing pharmaceutical R&D: The value of real-world evidence.” Strategyand.PwC.com, Strategy&, https://www.strate-gyand.pwc.com/media/file/Revitaliz-ing-pharmaceutical-RD.pdf

Page 8: Crawl, Walk, Run - SHYFT Analytics€¦ · Crawl, Walk, Run: BioPharma’s Guide to Leveraging. Real-World Evidence. Actionable Success Strategies to Supercharge R&D and . Commercialization

RWD APPLICATION AND USE CASES BY DRUG STAGE

SHYFTANALYTICS.COM @SHYFTANALYTICS

7

“This is not about Big Data - this is about understanding the way patients interact with medications in their everyday lives. Our unique technology supports understanding of NHS data to bring the right drugs to market quicker, whilst providing timely and accurate information on safety and cost for payers and patients alike.”

- Professor Martin Gibson,

NorthWest EHealth Chief

Executive

Execute. Data shows that nearly 80 percent of clinical trials are delayed due to failure in meeting recruitment projections.7 RWE can provide a tangible solution to this recurring issue, helping to ensure the availability of patients and cohorts and assist with selection and qualifying of trial sites. It can also help to reduce the trial’s control arm.

Analyze. RWE helps to reinforce the integrity and quality of a biopharma’s data. Those that leverage guided software with user-centric design will experience a more streamlined and targeted analytics process to propel products into the launch

stage.

GlaxoSmithKline’s (GSK) Salford Lung Study is the world’s first pragmatic randomized controlled trial (pRCT) of a pre-licensed asthma medication. In the past, double-blind randomized controlled trials (RCT) conducted before the drug’s approval have indicated the best asthma treatment. However, this type of trial has highly-selective criteria for eligibility, enrolling patients who may not be representative of the average patient and who are more adherent to their clinical plan.8 The comprehensive design of the RCT makes it best for measur-ing efficacy under ideal conditions, while the pRCT helps to examine effectiveness in real-world, routine clinical practice after the drug has been approved.

For the study, GSK partnered with several UK organizations, including NorthWest EHealth, The University of Manchester, Salford Royal NHS Foundation Trust, and several community pharmacists. Through the study, GSK’s treatment Relvar Ellipta showed twice the odds of improving a patient’s asthma in comparison to patients who continued their usual care medicines.

7 Bose, Subrata Kumer, et al. “Clinical Tri-als: A Data Driven Feasibility Approach,” PharmOutsourcing.com, Pharmaceutical Outsourcing, 1 Feb 2017, http://www.pharmoutsourcing.com/Featured-Arti-cles/333830-Clinical-Trials-A-Data-Driv-en-FeasibilityApproach/

8 “Relvar Ellipta significantly improved asthma control in Salford Lung Study patients compared with their usual care.” GSK.com, GlaxoSmithKline, 5 May 2017, http://www.gsk.com/en-gb/media/press-releases/relvar-ellipta-significantly-improved-asthma-control-in-salford-lung-study-patients-compared-with-their-usu-al-care/

Page 9: Crawl, Walk, Run - SHYFT Analytics€¦ · Crawl, Walk, Run: BioPharma’s Guide to Leveraging. Real-World Evidence. Actionable Success Strategies to Supercharge R&D and . Commercialization

RWD APPLICATION AND USE CASES BY DRUG STAGE

SHYFTANALYTICS.COM @SHYFTANALYTICS

8

RWE can help commercial teams uncover a wealth of invaluable data for positioning their products into an increasingly competitive landscape.

Pre-Launch The industry is seeing a trend in precision therapeutics that’s having a significant impact on manufacturers: as therapy becomes more focused, patient populations are shrinking. This in turn puts increased pressure on manufacturers to enhance their acuity across the board, and RWE is a vehicle to help do so.

RWE can play a critical function in solidifying the launch phase by helping organizations to identify the essential steps needed to unlock value in various use cases. This includes the types of data needed to answer important questions along the product launch journey. Companies that have their ducks in a row can recognize billions of dollars in launch upside.

RWE Applications by DepartmentMARKET ACCESS AND HEOR. RWE can be pivotal in re-orienting around value and determining strategies that are the most financially viable and beneficial to the market. For example, it can help in formulating and rapidly exploring cost equations that surround patient cohorts, treatment paths, and their resulting outcomes.

Through more comprehensive testing and input confirmation from several big data sets, RWE can help to fortify a new drug’s value dossier and health economic model. This bolsters pricing strategies and ultimately drives better confidence in strategy.

RWE helps manufacturers explore and test various hypotheses on a market’s disease burden and its subsequent impact on the patient journey. In terms of identifying unmet needs and balancing them with drug access, RWE can help to identify cost-prohibitive treatment areas where pockets of patients experience negative impacts on conditions and outcomes.

MARKETING AND SALES. RWE can help commercial teams uncover a wealth of invaluable data for positioning their products into an increasingly competitive landscape. Rich data can assist in discovering new opportunities — deep patient insights that span across the entire treatment journey. Commercial teams have the ability to enhance segmentation and targeting strategy while informing the design process for more accurate end-to-end marketing campaign development, from launch to broader brand messaging and identity.

Page 10: Crawl, Walk, Run - SHYFT Analytics€¦ · Crawl, Walk, Run: BioPharma’s Guide to Leveraging. Real-World Evidence. Actionable Success Strategies to Supercharge R&D and . Commercialization

RWD APPLICATION AND USE CASES BY DRUG STAGE

SHYFTANALYTICS.COM @SHYFTANALYTICS

9

“SGLT-2 inhibitors are being prescribed with greater frequency for patients with type-2 diabetes, so it is vital that we have a clear understanding of the safety profile of these medicines and examine their effectiveness in a real-world setting.”

- Elisabeth Björk,

AstraZeneca Vice President,

Head of Cardiovascular and

Metabolic Diseases, Global

Medicines Development

Segmentation data powers messaging that addresses the needs of various cohorts, all of which can be tested and supported with granular, audience-targeted outcomes data. This process builds a positive feedback loop in which outcomes data fuels strategy, which in turn can be fine-tuned as needed to continue fueling outcomes. This has an added benefit for brand and portfolio-level forecasting, which becomes malleable and “real time” as opposed to when it’s supported solely by less flexible data streams like analyst reports and PMR.

RWE can also bolster primary market research’s (PMR’s) return on investment by improving the design of information capture. Analysts can hone, trim, and optimize the data for lean output, working to eliminate issues like repetitive market landscape questions that often dilute PMR. As a result, primary research can focus on attitudinal, qualitative questions while secondary research can have a descriptive, quantitative focus where desired.

Comparative effectiveness is one of the hardest metrics to prove, but AstraZeneca did just that. In its first large RWE study, the company assessed data from more than 300,000 type 2 diabetes (T2D) patients in six different countries. The CVD-REAL study showed that in comparison to other T2D medicines, treatment with SGLT-2 inhibitors, including its own Farxiga, reduced hospitalization rates for heart failure by 39 percent and death from any cause by 51 percent.9

The analyses were conducted with anonymized patient data from Germany, Denmark, Norway, United Kingdom, Sweden, and the United States. Data was sourced from claims databases, medical records, and national registers, marking the first of several CVD-REAL analyses to come.

Post-MarketOnce the product has launched, biopharmas can continue using RWE to constantly evaluate its performance, while working to optimize partnerships and market placement. Continuous patient and drug performance data provides representatives and medical science liaisons (MSLs) with unique in-field opportunities to build relationships with providers and segment market territories.

9 “AstraZeneca’s CVD-REAL study shows SGLT-2 inhibitors significantly reduced death and hospitalisations for heart failure versus other type-2 diabetes medicines.” AstraZeneca.com, AstraZen-eca, 19 March 2017,

https://www.astrazeneca.com/me-dia-centre/press-releases/2017/astrazeneca-s-cvd-real-study-shows-sglt-2-inhibitors-significant-reduced-death-and-hospitalisations-for-heart-fail-ure-versus-other-type-2-diabetes-medi-cines-19032017.html

Page 11: Crawl, Walk, Run - SHYFT Analytics€¦ · Crawl, Walk, Run: BioPharma’s Guide to Leveraging. Real-World Evidence. Actionable Success Strategies to Supercharge R&D and . Commercialization

RWD APPLICATION AND USE CASES BY DRUG STAGE

SHYFTANALYTICS.COM @SHYFTANALYTICS

10

“By linking the ultimate cost of this drug to its real-world clinical efficacy, this agreement truly puts patients at the center of focus.”11

- Michael Sherman,

Harvard Pilgrim Chief

Medical Officer

RWE Applications by DepartmentMARKET ACCESS. Manufacturers can streamline negotiations and identify opportunities for long-term partnerships with payers, providers, and other critical third parties. Comprehensive, transparent data sharing of evidence-based medicine fosters open and trusted relation-ships, which in turn foster the development of value-based contracting and pricing.In a PwC Health Research Institute survey, 60 percent of U.S. health insurance companies stated that as part of formulary negotiation, drug makers are expected to demonstrate comparative clinical benefits as part of their formulary negotiation process. With the right solution in place, RWE data can provide these insights with minimal strain on a manufacturer’s resources.Monitoring, tracking, and analyzing real-world product performance gives manufacturers the ability to identify needs in coverage management or contract re-evaluation with payers and providers. To drill down even further, strategists can unearth insights on the individual physician and practice level to track and measure post-launch penetration as matched to the drug label’s cohort.

Amgen secured a two-year outcomes-based contract with Harvard Pilgrim Healthcare for its blockbuster drug Enbrel — the first contract of its kind for a rheumatoid arthritis (RA) drug. According to the contract, Enbrel patients will be tracked based on key criteria including medication compliance, adding or switching drugs, steroid interventions, and dose escalation.

These real world data points will be crunched into an “effectiveness algorithm,” which will determine Enbrel’s efficacy. If patients score below a certain threshold, the contract states that Harvard Pilgrim will pay less for the drug. In addition to this contract, Harvard Pilgrim has a similar deal with Eli Lilly based on treatment adherence rates for its self-injected osteoporosis medicine Forteo.

10 Rönicke, Volker, et al. “Revitaliz-ing pharmaceutical R&D: The value of real-world evidence.” Strategyand.PwC.com, Strategy&, https://www.strate-gyand.pwc.com/media/file/Revitaliz-ing-pharmaceutical-RD.pdf Palmer, Eric.

11 “Amgen strikes Enbrel ‘outcomes’ con-tract with Harvard Pilgrim.” FiercePhar-ma.com, Fierce Pharma, 22 Feb 2017, http://www.fiercepharma.com/pharma/amgen-strikes-outcomes-contract-for-en-brel-as-biosimilar-competition-lurks

Page 12: Crawl, Walk, Run - SHYFT Analytics€¦ · Crawl, Walk, Run: BioPharma’s Guide to Leveraging. Real-World Evidence. Actionable Success Strategies to Supercharge R&D and . Commercialization

RWD APPLICATION AND USE CASES BY DRUG STAGE

SHYFTANALYTICS.COM @SHYFTANALYTICS

11

“By linking the ultimate cost of this drug to its real-world clinical efficacy, this agreement truly puts patients at the center of focus.”11

- Michael Sherman,

Harvard Pilgrim Chief

Medical Officer

MARKETING AND SALES. Commercial teams can use de-identified RWE to strategically build intelligent in-field approaches to hyper-target practices and physicians at the therapeutic area level. Triggering and alerting actions based on real-time prescriber dynamics can reveal territories with the highest densities of ideal patients, alerting reps of potential prescribing opportunities. Using these guidelines, teams can build relationships that are based on knowledge, trust, and specificity.

Once RWE data has helped to identify where to go, it can help repre-sentatives to develop and hone their marketing messaging and commu-nications based on needs, treatment paths on target physician levels as well as peer and population health levels, and existing outcomes and access. These teams can develop value messages based on patient and physician segmentation strategies, while sharing cutting-edge indi-cations and outcomes information, including optimal treatment paths based on efficacy, line of therapy, reimbursement, and driving adher-ence.

Three Ways to Get Started TodayIn order to successfully implement an enterprise-wide RWE strategy, biopharmas will need to take an approach that spans multiple dimen-sions of the business, from staff to governance to technology. One of the keys to approaching and scaling these efforts is to identify the scope and nature of each application. Companies that see the highest rewards will be the ones that implement RWE systematically as opposed to reactively based on immediate needs.

10 Rönicke, Volker, et al. “Revitaliz-ing pharmaceutical R&D: The value of real-world evidence.” Strategyand.PwC.com, Strategy&, https://www.strate-gyand.pwc.com/media/file/Revitaliz-ing-pharmaceutical-RD.pdf Palmer, Eric.

11 “Amgen strikes Enbrel ‘outcomes’ con-tract with Harvard Pilgrim.” FiercePhar-ma.com, Fierce Pharma, 22 Feb 2017, http://www.fiercepharma.com/pharma/amgen-strikes-outcomes-contract-for-en-brel-as-biosimilar-competition-lurks

Page 13: Crawl, Walk, Run - SHYFT Analytics€¦ · Crawl, Walk, Run: BioPharma’s Guide to Leveraging. Real-World Evidence. Actionable Success Strategies to Supercharge R&D and . Commercialization

THREE WAYS TO GET STARTED TODAY

SHYFTANALYTICS.COM @SHYFTANALYTICS

12

For biopharmas working toward systematic adoption and implementation of RWE, there are several key considerations across various dimensions of the organization. The approach should begin with a strategy that states a clear vision for how RWE will be incorporated into the company’s business model.

Then, senior leadership must be fully on board, working to mobilize the company hierarchy and develop the teams and expertise needed to manage the project. After the model is engineered, data sources can be strategized and managed, along with the tools and systems for analytics and modeling. At this stage, sharing, regulation, and compliance issues should also be closely examined.

When this is complete, the organization can move on to development and execution – finding the right technology distributors and vendors, determining if the system should be deployed on-premise or on the cloud, and considerations for data security and dependability.Understandably, organizations should implement RWE on a smaller scale before making systematic, high-investment changes. Let’s examine some steps that pharmaceutical companies can take to gradually implement RWE strategies into their operations – in other words, how to crawl before they run.

R&DCrawl: Use RWE to determine the feasibility of a clinical trial. Apply the proposed inclusion and exclusion (I/E) criteria against a population’s actual medical records to determine if your potential patient base is below the threshold for your clinical trial concept to be worth the time and costs.

Walk: In a standard RCT, relax some constraints to better reflect daily conditions that are present in clinical practice. In practical clinical trials, patients might be randomized to treatments under study, with subsequent or additional care determined by the doctor based on clinical judgment. Practical trials also usually include a comparison group that receives standard care as opposed to a placebo control group.12

12 Jadhav, Sujay. “Using Real World Data to Enhance Clinical Trials.” ClinicalIn-formaticsNews.com, Clinical Informat-ics News, 13 Jan 2017, http://www.clinicalinformaticsnews.com/2017/1/13/using-real-world-data-to-enhance-clini-cal-trials.aspx

After the model is engineered, data sources can be strategized and managed, along with the tools and systems for analytics and modeling.

Page 14: Crawl, Walk, Run - SHYFT Analytics€¦ · Crawl, Walk, Run: BioPharma’s Guide to Leveraging. Real-World Evidence. Actionable Success Strategies to Supercharge R&D and . Commercialization

THREE WAYS TO GET STARTED TODAY

SHYFTANALYTICS.COM @SHYFTANALYTICS

13

Based on this information, a targeted marketing campaign can be developed to send a decision aid to practitioners.

Run: Assess clinical outcomes and quality of lifemeasures as reported by patients with new disease diagnoses. Use RWE data to anonymously identify patients, recruit them into your study, and have them fill out questionnaires at three separate points. Link the survey data to EMR data for a comprehensive variable set available for analysis.

Pre-LaunchCrawl: Drill down into standard patient ABCD segments and expand them to become more detailed and powerful based on actual patient numbers of those who meet the target profile — this can vary ten-fold across similar healthcare provider sites. This strategy can help to boost product uptake in pilot markets.

Walk: Use RWE to target patient clusters that are undertreated for a specific condition. To do this,query EMR data for positive lab results that weren’t subsequently followed-up with treatment. Based on this information, a targeted marketing campaign can be developed to send a decision aid to practitioners.

Run: Assess burden of illness and healthcare resource utilization for a particular disease that’s treated in primary care settings. Use different metrics, including use of primary care healthcare,medication costs, and healthcare resource utilization as reported by patients.

Page 15: Crawl, Walk, Run - SHYFT Analytics€¦ · Crawl, Walk, Run: BioPharma’s Guide to Leveraging. Real-World Evidence. Actionable Success Strategies to Supercharge R&D and . Commercialization

THREE WAYS TO GET STARTED TODAY

SHYFTANALYTICS.COM @SHYFTANALYTICS

14

Monitor new-to-brand prescription volumes in physician-specific de-identified patient data.

Post-MarketCrawl: Rationalize your sampling strategy by tracking and analyzing responsiveness to your promotions at the physician level. By rationalizing your sampling strategy, you may discover inefficiencies like over- or under-sampling in certain physician segments.

Walk: Go beyond looking at national trends whentrying to improve market performance. Monitor new-to-brand prescription volumes in physician-specific de-identified patient data.Then, alert in-field reps of when patients start andadd on therapies, so that reps can focus the discussion more on the “whys” instead of the “whats.”

Run: Instead of conducting an explanatory phaseIV clinical trial, conduct a pragmatic clinical trial. These trials have high external validity, larger sample sizes, simpler designs, and more diversesettings in comparison to explanatory trials. Thismay be a particularly effective technique in caseswhere RCT data may have limited scope or resources, such as high-cost disease areas ororphan drugs for rare conditions.

Page 16: Crawl, Walk, Run - SHYFT Analytics€¦ · Crawl, Walk, Run: BioPharma’s Guide to Leveraging. Real-World Evidence. Actionable Success Strategies to Supercharge R&D and . Commercialization

CONCLUSION

SHYFTANALYTICS.COM @SHYFTANALYTICS

15

The data is undeniable: the earliest systematic adopters of RWE are the pharmaceutical companies that realize the most value and efficacy from their operations — they have the ability to pre-qualify their clinical hypotheses, develop quality products based on proven results, develop data-driven market strategies, and continuously monitor and hone performance to maximize outcomes.

There are myriad approaches and opportunities for companies to harness the power of RWE, scaled on a spectrum of reactionary to proactive. When entering the space, it’s important to first evaluate each unique opportunity to develop a customized strategy that includes personnel, processes, data, and technology that suits the capabilities and goals of the organization.

Page 17: Crawl, Walk, Run - SHYFT Analytics€¦ · Crawl, Walk, Run: BioPharma’s Guide to Leveraging. Real-World Evidence. Actionable Success Strategies to Supercharge R&D and . Commercialization

SHYFTANALYTICS.COM @SHYFTANALYTICS

About SHYFTSHYFT is the leading analytics platform for life scienceswith products designed specifically for the unique needsof the pharmaceutical, biotech, and medical deviceindustries. SHYFT’s Data Analytics Platform is the most efficient and scalable way to transform massive amounts of complex healthcare data into on-demand clinical and commercial insight.

CONTACT [email protected]