Access specialist case studies covering all aspects of diagnostics, targeted therapies and business development

These case studies provide invaluable insights which will help build corporate knowledge and internal expertise for all aspects relating to diagnostics.

 

Results FunctionalAreaType
Laboratories – the forgotten stakeholder
"Pathologists and laboratories are often overlooked as key stakeholders by pharma and this factor can have a considerable impact on the uptake of targeted therapies." This case study considers the role of laboratories in relation to uptake, including how a choice of technology can impact on laboratory test adoption, as the technology preferences of laboratories can vary considerably. "   Download this case study to learn more.
Selling,Laboratories,Access,Regulatory,Partnering,
An Inside Look at Diagnostics
This case study illustrates the evolution of the diagnostic industry across different continents, diagnostic companies' evolving business models, stakeholder networks and the critical drivers of personalized medicine adoption in the diagnostic industry. It will help you understand:
  • The three market models in diagnostics
  • That most labs create their own diagnostics
  • How the lab sector differs from the diagnostic sector
Download this case study to learn more.
Overview,Strategy,Adoption,Clinical,Marketing,Selling,Financial,Laboratories,Access,Lifecycle,Regulatory,Partnering,
What is Test Adoption?
This case study provides an overview of the core concepts of diagnostic adoption and its main drivers. It will also give you an understanding of how publications, guidelines and hands-on studies can impact on adoption and how diagnostics often undergo successive generations of improvement after their first launch. It will help you understand:
  • The core concepts of Dx adoption and its main drivers
  • The impact of publications, guidelines and hands-on studies on Dx adoption
  • How diagnostics often undergo successive generations of improvement after their first launch
Download this case study to learn more.
Strategy,Adoption,Lifecycle,
PM Educational Opportunity: Enabling Physician-Patient Communication
This case study describes the importance of informed communication. Physicians are the main source of information and advice for patients, however, many physicians are concerned about their ability to communicate test results and answer their patients' questions on molecular diagnostics. It will help you understand:
  • That many web-based sources of information ultimately leave the physician to provide definitive guidance on molecular diagnostics and targeted therapies
  • That consequently, more patients ask their physician for information and advice on molecular tests and targeted therapies
  • That many physicians do not feel entirely confident that they have the knowledge and information to provide such advice, for clinical and non-clinical reasons
Download this case study to learn more.
Overview,Strategy,Adoption,Clinical,Marketing,Selling,Financial,Laboratories,Access,Lifecycle,Regulatory,Partnering,
Epzicom/HLA B*5701
This case study highlights GSK's Epzicom and how, in some patients, it induced hypersensitivity which in turn contributed to a loss in market share. GSK initiated a hands-on study which showed that a diagnostic could be used to prevent the side effect of the drug. Alongside this, it prepared a major marketing campaign in the US to encourage adoption. This led to increased test demand and restored Epzicom's revenue growth. It will help you understand:
  • How GlaxoSmithKline (GSK) drugs containing abacavir (ABC) were discovered to induce hypersensitivity in a small number of patients
  • How the hypersensitivity scare meant that Gilead’s Truvada was able to capture a bigger share of the market
  • How hands-on use studies, to demonstrate unequivocally the role of the test in eliminating the abacavir hypersensitivity problem, helped to restore Epzicom's revenue growth
Download this case study to learn more.
Overview,Strategy,Adoption,Clinical,Marketing,Selling,Financial,Laboratories,Access,Lifecycle,Regulatory,Partnering,
Selzentry/CCR5
This case study shows that a sub-optimal diagnostics strategy can impact on a drugs revenue. Using Selzentry as an example, it highlights how failure to address several key issues around testing logistics, such as test performance and slow turnaround time, can directly impact on sales. The study shows how these issues resulted in first year sales for Selzentry of $24m rather than the $150m forecasted. It also discusses the importance of investing in the market perception of a diagnostic test. It will help you understand:
  • How a less than optimally planned and executed diagnostic strategy can impact on a drug's revenue
  • That the testing critical to a drug's use must be available without access barriers and adopted broadly by physicians
  • That it is important to manage the messaging around the test/therapy
Download this case study to learn more.
Overview,Strategy,Adoption,Clinical,Marketing,Selling,Financial,Laboratories,Access,Lifecycle,Regulatory,Partnering,
Dx Regulatory Pathways in the US
This case study considers whether the test required to enable a therapy should be an LDT or an IVD kit and explains their different regulatory pathways. It will help you understand:
  • Whether the test required to enable a therapy should be an LDT or an IVD kit
  • The role and importance of a Target Test Profile (TTP)
  • How the TTP will point towards an LDT or an IVD kit
Download this case study to learn more.
Overview,Strategy,Adoption,Clinical,Marketing,Selling,Financial,Laboratories,Access,Lifecycle,Regulatory,
Does Personalized Medicine Fit?
This case study is based on a patent-applied-for technique that generates, for a given drug, a numerical index relating to various aspects of suitability for a personalized (test-based) marketing strategy. This index is then compared to values derived both from drugs which are currently marketed using a personalized strategy and those that are not, to indicate whether the drug in question may benefit from a personalized marketing strategy. It will help you understand:
  • How companion diagnostic strategies can help to competitively reshape therapy markets.
  • The way one-size-fits-all therapies compete with targeted therapies in the marketplace under unanticipated rules.
Download this case study to learn more.
Overview,Strategy,Adoption,Clinical,Marketing,Selling,Financial,Laboratories,Access,Lifecycle,Regulatory,Partnering,
Herceptin/HER2
This case study shows why a pharma company with an Rx asset dependent on a test should take a proactive approach to managing the Dx environment from the outset, in order to drive adoption and avoid implementation flaws. Reviewing Herceptin, the case shows how physicians can be discouraged from using a promising new targeted therapy if the diagnostic environment is not a straightforward exercise optimized to suit their needs It will help you understand:
  • Why Roche, in hindsight, did not optimally manage the operational implementation of Human Epidermal Growth Factor Receptor 2 (HER2) testing
  • How Roche's lack of proactive Dx optimization impacted physicians’ initial experience of Herceptin as a targeted therapy
  • The negative financial impact that this suboptimal Dx implementation most likely had on Herceptin's brand performance
  • The most important areas of 'leakage' in the Dx program that led to the loss of patients for Herceptin
Download this case study to learn more.
Overview,Strategy,Adoption,Clinical,Marketing,Selling,Financial,Laboratories,Access,Lifecycle,Regulatory,Partnering,
Enabling Personalized Medicine Markets
This case study demonstrates how diagnostic strategies can significantly improve the return on investment of a therapy outside of drug response testing. It will help you understand:
  • Three strategies that are worth considering to improve ROI
  • Differentiating the therapy
  • Preparing the market
  • Reducing the impact of adverse events
Download this case study to learn more.
Overview,Strategy,Adoption,Clinical,Marketing,Selling,Financial,Laboratories,Access,Lifecycle,Partnering,
Marketing Overview
It is often assumed that the availability of a clinically meaningful laboratory test will drive its use. However, Diaceutics' adoption research has shown the importance of proactive marketing and awareness-building initiatives around the launch of a novel CDx. This case study provides selected examples of such initiatives. It will help you understand:
  • The importance of marketing a diagnostic
  • How Diaceutics' research on test adoption has shown the impact of proactive marketing and awareness-building initiatives around the launch of a novel CDx
  • That the availability of a clinically meaningful laboratory test will not necessarily drive its use
Download this case study to learn more.
Marketing,Selling,Financial,
Zelboraf/Clinical Trial Length
This case shows how Rx/Dx co-development can enable faster regulatory approval and a shorter and cheaper clinical trial program. It highlights the particular features and success factors that enabled Roche to use a targeted strategy to streamline the Zelboraf clinical trial program. It will help you understand:
  • How Roche, by targeting Zelboraf through the BRAF biomarker, was able to obtain regulatory approval with a considerably shorter and cheaper clinical trial program, thereby fulfilling one of the original personalized medicine promises to pharma
  • The particular features and success factors that enabled Roche to use such a targeted strategy to streamline the Zelboraf clinical trial program
  • How this approach by Roche has resulted in BRAF mutation testing being embraced, despite initial reimbursement issues
Download this case study to learn more.
Overview,Strategy,Clinical,Laboratories,Regulatory,Partnering,
Financial Drivers
This case study looks at how a number of diagnostic drivers can impact on a targeted therapy's return on investment. It shows that it is important to have a robust and well-defined diagnostic strategy with an understanding of where diagnostic drivers impact revenue therapy flows. It also looks at how to optimize the different drivers in order to build and analyse the business case. It will help you understand:
  •  That there are a number of diagnostic drivers that can impact on therapy return on investment
  • That a personalized medicine strategy has the potential to enhance as well as destroy value, compared with a traditional non-targeted, or 'one size fits all' Rx strategy
  • How propensity to prescribe (P2P) can be influenced by issues around testing
Download this case study to learn more.
Selling,Financial,Access,
Design Risks in Personalized Medicine: An Emphasis on Litigation
This case study will help you understand how personalized medicine will change the legal landscape in ways that are as yet uncharted. It also discusses the importance of reflecting on any potential areas of legal exposure and addressing these in the clinical development program to minimize risks related to the companion diagnostic. It will help you understand:
  • How personalized medicine will change the legal landscape in ways that are as yet uncharted
  • The importance of reflecting on any potential areas of legal exposure and addressing these in the clinical development program to minimize risks related to the companion diagnostic
Download this case study to learn more.
Overview,Strategy,Adoption,Clinical,Marketing,Selling,Financial,Laboratories,Access,Lifecycle,Regulatory,Partnering,
Personalized Medicine Educational Opportunity: Physicians’ Knowledge
Stakeholders in personalized medicine are currently missing out on the considerable opportunity to offer physicians information and education on molecular testing. This case study examines how the physicians' education gap might impact on your Rx/Dx launch. It will help you understand:
  • That there are gaps in physicians' knowledge about genomic-based medicine, however, they are willing to learn more
  • What potential sources of information physicians would like to use to learn more about genomic-based medicine
  • That awareness alone does little to prompt usage of molecular tests as most physicians require a thorough understanding to order tests
Download this case study to learn more.
Overview,Strategy,Adoption,Clinical,Marketing,Selling,Financial,Laboratories,Access,Lifecycle,Regulatory,Partnering,
Test Reimbursement
This case study explains the global differences in test reimbursement and reveals that for some tests the laboratories own costs aren't even covered. It concludes that pharma must sometimes commit to subsidized testing but in doing so will create a win-win test launch for all stakeholders. It will help you understand:
  • The global differences in reimbursement
  • That test reimbursement is often inconsistent and, for some tests, may not even cover the laboratories' own costs
  • That pharma must sometimes commit to subsidized testing
Download this case study to learn more.
Access,
Dx Launch Risks
This case study shows how a risk management strategy for possible recalls could prevent disruption, not only to a biomarker's market progress, but to an entire company. It will help you understand:
  • How a risk management strategy for recalls should be agreed upon with the diagnostic partners
  • That no biomarker is immune to a potential recall
  • How a recall can be disruptive, not just for a test but the company as a whole
Download this case study to learn more.
Overview,Strategy,Adoption,Clinical,Marketing,Selling,Financial,Laboratories,Access,Lifecycle,Regulatory,Partnering,
Partnering with Diagnostic Companies
This case study focuses on partnerships with diagnostics companies and why they need to be clearly defined. It outlines the core principles of partnering in the diagnostic space, highlighting the partner selection process steps and timelines that can enable an optimal CDx strategy. It will help you understand:
  • That partnerships with diagnostic companies are not as simple to set up and manage as they seem
  • While much of the CDx strategic and tactical plan can and should be executed by the diagnostic partner, pharma must maintain the role of strategic architect
  • The core principles of partnering in the diagnostic space and the partner selection process steps and timelines
Download this case study to learn more.
Overview,Partnering,
The Public Side of Diagnostics
This case provides an overview of the global diagnostics industry and its potential for growth. It shows how the diagnostic market is complex and fragmented and that it is important to understand costs at every stage of the diagnostics value chain to maximize profitability. It will help you understand:
  • That the diagnostic market is growing but is still only six per cent the size of the pharmaceutical industry
  • How the diagnostic market is complex and fragmented
  • The cost of developing a test
Download this case study to learn more.
Overview,Strategy,Adoption,Clinical,Marketing,Selling,Financial,Laboratories,Access,Lifecycle,Regulatory,Partnering,
Personalized Medicine – The Future of Diagnostics
This case study provides an introduction to personalized medicine and its increasing relevance to the diagnostics industry, explaining core concepts, trends, awareness growth and major drivers of change. It will help you understand:
  • Personalized medicine awareness growth over the last decade
  • Personalized medicine's increasing relevance to many physicians' daily routine, predominantly those in oncology
  • Growth potential for personalized medicine across therapeutic areas
Download this case study to learn more.
Overview,Strategy,Adoption,Clinical,Marketing,Selling,Financial,Laboratories,Access,Lifecycle,Regulatory,Partnering,
Xalkori/ALK
This case study highlights the importance of co-development and co-approval processes to achieve rapid approval of both the test and therapy. Using Xalkori and the development of an ALK test as an example, the case study recommends communications strategies are put in place to communicate with payers about the cost of the test. It will help you understand:
  • That co-development of the anaplastic lymphoma kinase (ALK) test was pivotal for a successful launch of Xalkori by Pfizer
  • How the cost of a test can be a major issue for payers and patients
  • How test technology can influence a test's adoption and prescribing rates
  • How, during the six months in the market since receiving FDA approval, the ALK mutation test enjoyed a fast adoption.
Download this case study to learn more.
Overview,Strategy,Adoption,Clinical,Marketing,Selling,Financial,Laboratories,Access,Lifecycle,Regulatory,Partnering,
Tysabri/JCV Antibodies
This case study shows how taking a proactive approach to risk stratification by means of a diagnostic test, even in the case of severe adverse events, can help rescue and reposition an otherwise highly effective drug. Using Tysabri as an example, the case study also shows that the diagnostic lifecycle can evolve depending on the changing testing requirements for a drug. It will help you understand:
  • That a rare but serious adverse event, only discovered after the approval of natalizumab (Tysabri), changed the commercial trajectory for this highly promising novel multiple sclerosis therapy
  • How Biogen Idec and Elan took a very proactive approach to identifying the key risk factor for this serious adverse event and to developing a commercially available risk test, aided by strategic diagnostic partners
  • How the development and launch of the novel JC virus (JCV) diagnostic test was set to help reposition Tysabri, gain market share and recover lost Tysabri value
  • How the diagnostic lifecycle may evolve depending on a change in testing  and any adjustments a drugowner has to make
Download this case study to learn more.
Overview,Strategy,Adoption,Clinical,Marketing,Selling,Financial,Laboratories,Access,Lifecycle,Regulatory,Partnering,

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