Publications | Diaceutics

Publications

As a thought leader in the diagnostic space, and with expertise in diagnostic strategy, launch, commercialization and the patient journey, Diaceutics publishes articles on a variety of topics in dedicated industry journals
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...
July 3rd, 2017
Pushing forward with precision medicine: how deep data analysis will change the patient journey
An explosion in computational power and vast collections of data are making precision medicine a reality, starting with diagnostics and leading to individualised treatment for patients.
July 3rd, 2017
Data for life: new partnership with IBMS is another step forward in accelerating market penetration
Most of the talk around data is about driving efficiency in areas like commerce, finance and public services – all fine as far as they go, but data-enabled diagnostics aims to change the face of medicine and, with it, wellbeing.
May 30th, 2017
A new disease level precision medicine model; starting with melanoma
A new model for melanoma that offers clinical and financial benefits in precision healthcare will provide substantial improvements in outcomes and costs by shifting the management of melanoma to earlier interventions when the condition is curable.
May 23rd, 2017
Transforming the pharma business model to prevent lost treatment opportunities and optimize return on investment
Ideally, when diagnostics are used appropriately at specific stages of the patient pathway, patients can receive the right treatment at the right time. However, in the real world clinical setting, achieving synchronization of test and therapy is p...
May 15th, 2017
Realizing the Value of Precision Medicine: Today
For eight years, a group of 200 healthcare experts from six different stakeholder groups set aside their competitive agendas to search for an answer to the complex question: how can we advance precision medicine?
February 28th, 2017
Q&A: Diaceutics’ Jordan Clark on industry, FDA gap on Rx/Dx codevelopment principles
Jordan Clark discusses the FDA draft guidance of 2016, which outlines the principles for simultaneously developing a drug and diagnostic for companies planning a treatment that relies on a test for its use.
September 1st, 2016
Great expectations for personalized medicine outside oncology
Oncology has always been the front runner in personalized medicine, so this is where targeted therapies and diagnostics have mainly been focused. However, biomarker and targeted approaches outside this area are proving successful.
March 1st, 2016
Using effective partnering for managing the risk of legal liability
It is time for industry players to begin considering the long-term potential legal liabilities that may arise when incorporating pharmacogenomics into the process of drug development.
March 1st, 2016
The absence of model changing financial incentives
While there are clear economic benefits to aspects of personalized care, there may be no compelling drivers for radical change for payers and the pharmaceutical industry. The best they can hope to achieve is that the balance sheet is just that – i...
March 1st, 2016
Role of Opportunity To Test index in integrating diagnostics with therapeutics
The Opportunity to Test index helps to quantify the level of risk a pharma company has to the complexity of its therapy-dependent diagnostic test. It scores on reimbursement, turnaround time, test administration, interpretation and patient engagem...
October 7th, 2013
Why PM1.0 will not create radical healthcare change prompting the need for PM2.0
Peter Keeling analyses the 2.0 concept of second generation trajectories and applies this to the development of personalized medicine.
May 1st, 2013
Effective sales and marketing strategies for drugs with companion diagnostics
The ability to accurately diagnose specific patient subsets is allowing drugs to be targeted only at those patients who will respond to treatment. But to fully exploit the commercial advantages of companion diagnostics, pharma needs to rethink its...
January 14th, 2013
Towards a balanced value business model for personalized medicine: an outlook
A new ‘balanced value’ business model allows pharmaceutical companies to charge prices for targeted therapy below the likely future thresholds for payers’ willingness to pay, while preserving attractive margins for the drug developers.
January 10th, 2013
Laboratories are the forgotten stakeholder: A corporate profile of Labceutics
In the delivery of personalized therapies to physicians worldwide, laboratories are often the forgotten partners, yet the highest quality laboratory networks are needed to truly leverage the power of companion diagnostics.
January 1st, 2013
Preparing the Company for Long-Term Sustainability in a Rapid Changing World
What are the goals and challenges for Diaceutics in working with pharmaceutical development teams, particularly to improve overall ROI as they commercialize and launch targeted therapies?
June 16th, 2012
The economics of personalized medicine: commercialization as a driver of return on investment.
This article considers the benefits of optimizing commercial planning in the personalized medicine space and the potential negative impact in failing to make the best of that planning.
October 16th, 2011
The impact of genetic biomarkers on drug and companion diagnostic return on investment
Paywall
January 1st, 2010
Driving PM-capturing max NPV and optimal ROI
This report describes a benchmarking and financial model specifically designed for personalized medicine. It explains how its use can help capture the maximum net present value of targeted therapies and help to realise optimal return on investment.
November 1st, 2008
The Options for Test Index (OFTi)
The ‘one size fits all’ therapy model does not apply to personalized medicine, so Diaceutics has developed the Options for Test index to help define the critical elements necessary to assess a PM scenario much earlier in the therapy development pr...
October 1st, 2008
IP considerations in early biomarker development in PM
With the increased focus on early stage co-development of biomarkers, and the potential post-launch dependency of new therapies on the biomarker result, more consideration must be given to ownership of any intellectual property created during thes...
October 1st, 2008
Getting Personalized
There are reasons why personalized medicine hasn’t taken off yet but they’re not the ones you might expect. Stop worrying about shrinking the market for your drug and start figuring out how the ‘test and treat’ business model works....

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.

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
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...
July 3rd, 2017
Pushing forward with precision medicine: how deep data analysis will change the patient journey
An explosion in computational power and vast collections of data are making precision medicine a reality, starting with diagnostics and leading to individualised treatment for patients.
July 3rd, 2017
Data for life: new partnership with IBMS is another step forward in accelerating market penetration
Most of the talk around data is about driving efficiency in areas like commerce, finance and public services – all fine as far as they go, but data-enabled diagnostics aims to change the face of medicine and, with it, wellbeing.
May 30th, 2017
A new disease level precision medicine model; starting with melanoma
A new model for melanoma that offers clinical and financial benefits in precision healthcare will provide substantial improvements in outcomes and costs by shifting the management of melanoma to earlier interventions when the condition is curable.
May 23rd, 2017
Transforming the pharma business model to prevent lost treatment opportunities and optimize return on investment
Ideally, when diagnostics are used appropriately at specific stages of the patient pathway, patients can receive the right treatment at the right time. However, in the real world clinical setting, achieving synchronization of test and therapy is p...
May 15th, 2017
Realizing the Value of Precision Medicine: Today
For eight years, a group of 200 healthcare experts from six different stakeholder groups set aside their competitive agendas to search for an answer to the complex question: how can we advance precision medicine?
February 28th, 2017
Q&A: Diaceutics’ Jordan Clark on industry, FDA gap on Rx/Dx codevelopment principles
Jordan Clark discusses the FDA draft guidance of 2016, which outlines the principles for simultaneously developing a drug and diagnostic for companies planning a treatment that relies on a test for its use.
September 1st, 2016
Great expectations for personalized medicine outside oncology
Oncology has always been the front runner in personalized medicine, so this is where targeted therapies and diagnostics have mainly been focused. However, biomarker and targeted approaches outside this area are proving successful.
March 1st, 2016
Using effective partnering for managing the risk of legal liability
It is time for industry players to begin considering the long-term potential legal liabilities that may arise when incorporating pharmacogenomics into the process of drug development.
March 1st, 2016
The absence of model changing financial incentives
While there are clear economic benefits to aspects of personalized care, there may be no compelling drivers for radical change for payers and the pharmaceutical industry. The best they can hope to achieve is that the balance sheet is just that – i...
March 1st, 2016
Role of Opportunity To Test index in integrating diagnostics with therapeutics
The Opportunity to Test index helps to quantify the level of risk a pharma company has to the complexity of its therapy-dependent diagnostic test. It scores on reimbursement, turnaround time, test administration, interpretation and patient engagem...
October 7th, 2013
Why PM1.0 will not create radical healthcare change prompting the need for PM2.0
Peter Keeling analyses the 2.0 concept of second generation trajectories and applies this to the development of personalized medicine.
May 1st, 2013
Effective sales and marketing strategies for drugs with companion diagnostics
The ability to accurately diagnose specific patient subsets is allowing drugs to be targeted only at those patients who will respond to treatment. But to fully exploit the commercial advantages of companion diagnostics, pharma needs to rethink its...
January 14th, 2013
Towards a balanced value business model for personalized medicine: an outlook
A new ‘balanced value’ business model allows pharmaceutical companies to charge prices for targeted therapy below the likely future thresholds for payers’ willingness to pay, while preserving attractive margins for the drug developers.
January 10th, 2013
Laboratories are the forgotten stakeholder: A corporate profile of Labceutics
In the delivery of personalized therapies to physicians worldwide, laboratories are often the forgotten partners, yet the highest quality laboratory networks are needed to truly leverage the power of companion diagnostics.
January 1st, 2013
Preparing the Company for Long-Term Sustainability in a Rapid Changing World
What are the goals and challenges for Diaceutics in working with pharmaceutical development teams, particularly to improve overall ROI as they commercialize and launch targeted therapies?
June 16th, 2012
The economics of personalized medicine: commercialization as a driver of return on investment.
This article considers the benefits of optimizing commercial planning in the personalized medicine space and the potential negative impact in failing to make the best of that planning.
October 16th, 2011
The impact of genetic biomarkers on drug and companion diagnostic return on investment
Paywall
January 1st, 2010
Driving PM-capturing max NPV and optimal ROI
This report describes a benchmarking and financial model specifically designed for personalized medicine. It explains how its use can help capture the maximum net present value of targeted therapies and help to realise optimal return on investment.
November 1st, 2008
The Options for Test Index (OFTi)
The ‘one size fits all’ therapy model does not apply to personalized medicine, so Diaceutics has developed the Options for Test index to help define the critical elements necessary to assess a PM scenario much earlier in the therapy development pr...
October 1st, 2008
IP considerations in early biomarker development in PM
With the increased focus on early stage co-development of biomarkers, and the potential post-launch dependency of new therapies on the biomarker result, more consideration must be given to ownership of any intellectual property created during thes...
October 1st, 2008
Getting Personalized
There are reasons why personalized medicine hasn’t taken off yet but they’re not the ones you might expect. Stop worrying about shrinking the market for your drug and start figuring out how the ‘test and treat’ business model works....

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.

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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