Case Studies | Diaceutics

Case Studies

Access specialist case studies covering all aspects of diagnostics, targeted therapies and business development
All
Commercialization
Diagnostics
Laboratories
Market Access
Marketing
Patients
Test
Testing
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, includ...

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 ind...

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 un...

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 pati...

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 ...

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 turnaro...

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 ...

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 der...

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 c...

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 Diffe...

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...

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 ...

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 ...

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 t...

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...

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 cre...

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...

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 ...

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...

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 m...

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 ...

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,...

Latest Blogs

Blogs

Webinars & Podcasts

August 9th, 2018
Podcast: Oncology Patient Research
Why do we need to talk biomarkers with patients? Senior Director of Market Research at Diaceutics, Marianne Fillion, recently spearheaded an effort to gather insights directly from oncology patients to get an understanding of what they know about ...
April 20th, 2018
Podcast: PM Readiness Report 2018
Peter Keeling discusses the landscape and challenges for precision medicine, companion diagnostics, CDx or biomarker and conduit diagnostics are discussed including global laboratory test data analysis and forecasts for budget impact and value.

Publications

September 11th, 2018
BRAF mutation testing in melanoma – Poster presented at European Congress of Pathology 2018
BRAF mutation testing in melanoma: a study including Austria, Germany and UK, highlighting concordance for current technologies, and potential requirement of more sensitive technologies in future applications.
August 3rd, 2018
A Way Forward: Leveraging Advanced Diagnostic Testing to Unlock the Value of Precision Medicine
Read about how advanced diagnostic testing, ensuring that right patient gets the right therapy, at the right time, particularly with respect to therapies where the test result determines whether or not the therapy should be used (precision medicin...

Expert Insights

April 19th, 2018
The CMS National Coverage Decision on NGS
I. Introduction On March 16, 2018, the Centers for Medicare and Medicaid Services (CMS) finalized a National Coverage Determination (NCD) that cove...
January 19th, 2018
What does the EU IVD Regulation mean for companion diagnostics and LDTs?
Dave Smart, PhD, Director at Diaceutics, discusses the introduction of the EU IVD Regulation. While it is considered a necessary step, the Regulati...

Competitive Benchmarking Reports

March 16th, 2018
PM Readiness Report 2018 Summary
March 14th, 2017
Pharma Readiness for Diagnostic Integration 2017
All
Commercialization
Diagnostics
Laboratories
Market Access
Marketing
Patients
Test
Testing
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, includ...

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 ind...

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 un...

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 pati...

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 ...

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 turnaro...

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 ...

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 der...

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 c...

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 Diffe...

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...

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 ...

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 ...

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 t...

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...

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 cre...

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...

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 ...

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...

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 m...

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 ...

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,...

Blogs

Webinars & Podcasts

August 9th, 2018
Podcast: Oncology Patient Research
Why do we need to talk biomarkers with patients? Senior Director of Market Research at Diaceutics, Marianne Fillion, recently spearheaded an effort to gather insights directly from oncology patients to get an understanding of what they know about ...
April 20th, 2018
Podcast: PM Readiness Report 2018
Peter Keeling discusses the landscape and challenges for precision medicine, companion diagnostics, CDx or biomarker and conduit diagnostics are discussed including global laboratory test data analysis and forecasts for budget impact and value.

Publications

September 11th, 2018
BRAF mutation testing in melanoma – Poster presented at European Congress of Pathology 2018
BRAF mutation testing in melanoma: a study including Austria, Germany and UK, highlighting concordance for current technologies, and potential requirement of more sensitive technologies in future applications.
August 3rd, 2018
A Way Forward: Leveraging Advanced Diagnostic Testing to Unlock the Value of Precision Medicine
Read about how advanced diagnostic testing, ensuring that right patient gets the right therapy, at the right time, particularly with respect to therapies where the test result determines whether or not the therapy should be used (precision medicin...

Expert Insights

April 19th, 2018
The CMS National Coverage Decision on NGS
I. Introduction On March 16, 2018, the Centers for Medicare and Medicaid Services (CMS) finalized a National Coverage Determination (NCD) that cove...
January 19th, 2018
What does the EU IVD Regulation mean for companion diagnostics and LDTs?
Dave Smart, PhD, Director at Diaceutics, discusses the introduction of the EU IVD Regulation. While it is considered a necessary step, the Regulati...

Competitive Benchmarking Reports

March 16th, 2018
PM Readiness Report 2018 Summary
March 14th, 2017
Pharma Readiness for Diagnostic Integration 2017
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