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An end-to-end drug launch strategy designed by data insights at the global level

11 March, 2021

Diaceutics is no stranger to delivering client delight. This is because of the granularity of insights our pharmaceutical clients receive when they approach us to understand the plan required, to prepare for the launch of a drug that relies on companion diagnostics. This delight is even greater when the insights from our data provide a picture of biomarker readiness from the countries of interest at the global level.

The granularity of insights refers to all relevant aspects of the biomarkers being used in testing by our pharmaceutical clients. Once the project scope is defined, Diaceutics teams take a deep dive into our extensive data repository, to map key aspects of interest which define the strategy of action to effectively plan the launch of a therapeutic depending on the testing of a specific biomarker. The responsibility of delivering on this type of innovation to patients, who benefit greatly, is motivation for all stakeholders involved in ensuring we reduce the unnecessary lengthy time currently taken for the clinical application of these precision therapeutics1.

Additional to biomarker test specific needs, the project scope includes either one or several countries extending to a particular region, or as it is increasingly the case, our clients are requesting Diaceutics to conduct a global analysis to have a comprehensive approach and secure an infallible end-to-end strategy to launch their precision therapeutic.

Our data provides a granular view of testing for a biomarker with regards to whether2:

  • The test is requested
  • The sample is available
  • The test is available
  • The test quality is reliable
  • The test result is on time
  • The test is sufficiently reimbursed

Clinical utility of the biomarker refers to the usefulness of the biomarker testing in terms of beneficial outcomes to the patients, and it is usually linked to a new therapy. The analysis begins with viewing the data to explore whether at this stage, the test is requested or not. It also informs the preferred technologies utilized for testing in each country defined in the scope of the project.

Sample availability provides insights as to where the tissue shortage may come from. For example, if sequential testing is done in the first line setting, subsequent testing will not be possible if patients progress to second, or third lines of treatment, because the tissue was exhausted by testing for one biomarker at the time when defining therapy options in that first line setting. Here, the role of liquid biopsy (LBx) is also examined if potentially relevant and feasible for the biomarker in question to address the unavailability of tissue.

Ensuring whether the test is available in a country of interest is very important. Here distinctions are made as to whether NGS or single-gene testing are available for the biomarker in question. Comparison between countries is also possible, including whether there is coverage or not for different tests.

Defining test quality can be illustrated by the type of accreditation needed by the labs within a country. For example, in countries where labs are required to be ISO15189 accredited, it can be assumed their level of quality is supported by participation in EQA programs, so test performance should be as expected.

For some therapies to be clinically relevant, it is crucial that the test result is in the desk of the clinician within the actionable timeframe. This turnaround time (TAT) of the test results is also part of the compendium of information provided by Diaceutics’ data insights. It has been found in our analyses for example, that single-gene testing methods provide a more rapid TAT compared to NGS. However, in some countries the results from NGS still come back within a clinically meaningful timeframe. The average timeframe of results by country are part of the detailed information which informs and continually delights our customers.

If a test is insufficiently reimbursed, Diaceutics teams can potentially advise on innovative access models for testing, with an understanding of what the possibilities and limitations are in the markets of interest.

Taken together, all these facts contribute to making sure -a soon to be- or registered innovative and companion diagnostic dependent therapeutic is immediately delivered to patients relying on this therapy option.  

By having this granular level of insights based on facts at the country level, the end-to-end strategy can rely on solid base to ensure companies eager to bring their innovations to patients who need them, experience the reward of not underestimating how difficult it is for patients to access their therapy when a test is in their way to do so.

As extensive as the picture is of the map on the state of testing for a relevant biomarker to our clients, they can also count with a diligent set of recommendations to address and solve each and every one of the issues raised in our analytics phase.  

 If you are preparing to launch a therapeutic, tell us about your project


References

  1. Pharma Precision Medicine Report 2020 (diaceutics.com) 
  2. Companion Diagnostics 101 (diaceutics.com)

About Diaceutics

At Diaceutics we believe that every patient should get the precision medicine they deserve. We are a data analytics and end-to-end services provider enabled by DXRX - the world’s first Network solution for the development and commercialization of precision medicine diagnostics. 

Diaceutics has worked on every precision medicine brought to market and provides services to 36 of the world’s leading pharmaceutical companies. We have built the world’s largest repository of diagnostic testing data with a growing network of 2500 labs in 51 countries.