Tailoring therapies to target the characteristics of patients’ disease has become the key to success of Precision Medicines (PM). This success is reflected in the improved patient outcomes from these innovations1. The impact of this type of therapeutic innovation is not going unnoticed by the pharmaceutical industry. Increased efforts to develop Precision Medicines are reflected in a pharmaceutical pipeline over the past few years that has resulted in 30% of all FDA approvals between 2018-2020 for Precision Medicines, with 1000 potential therapies in late phase of development2.
This success in PM comes from patient stratification, because by identifying patients with disease characteristics targeted by these therapies, the likelihood that the therapy is effective increases. The way to define whether patients’ disease have those targetable features is by testing patients for the presence of relevant biomarkers. But this stratification also means that the number of patients eligible for targeted therapeutics are reduced, so finding them becomes essential from the time of development all the way through to post market authorization, so patients who benefit do not miss out on these important and innovative treatment options as they come through to the pharmaceutical development pipeline.
Biomarker testing is thus critical both during the development process of the therapeutic, so patients with the relevant disease characteristics are included into clinical trials, as well as post-market authorization for clinical utilization in treatment decision making. Timely enrollment in clinical trials facilitates gathering the evidence required for the health technology assessment that will ultimately allow these therapies into the market. Once on the market, these therapies are deemed safe and effective treatment options for clinical decision making for patients who benefit.
It is for both these reasons that a well-thought-out biomarker development strategy needs to be an intrinsic part of the precision therapeutic development strategy because patient stratification is no easy feat. This is made apparent by the fact that only 2-5% of cancer patients enroll in clinical trials, with 25% of cancer trials failing to recruit and enroll enough patients. Additionally, nearly 80% of clinical trials are delayed given the lack of patients, increasing their costs. In the case of rare disease, the challenge of finding patients is only greater and in the past year this has only been exacerbated by COVID-19.
Digital collaboration can improve the development and commercialization of Precision Medicine diagnostics which are crucial to companion diagnostic (CDx) dependent therapeutics. DXRX-The Diagnostic Network® is the safe and secure digital environment which enables a marketplace that allows for better and faster CDx partnership process3. This, in a safe and secure digital environment, provides access to 100’s of global lab experts that will be key stakeholders in the success of the biomarker testing process crucial to Precision Medicines development and adoption.
DXRX advanced analytics and breadth of coverage provides earlier signals in the patient diagnostic journey by enabling:
- Data driven partnership decisions which are crucial to test availability in key laboratories. Real-world evidence-based decisions result in a more effective go-to market strategy with reduced costs.
- Partnerships on a new diagnostic and developing its awareness earlier in clinical trial phases will support an increase in its availability by launch and more potential eligible patients will be identified for trials and treatments.
- Deep analysis of institute and physician testing behavior provides opportunities for growth. The ability to initiate testing behaviors allows for targeted messaging and education.
- The DXRX network, with its lab and implementation service provider, creates a scalable frame for global roll out of Dx training and quality awareness initiatives. It also provides easy access to engaged and enthusiastic labs who are eager to adopt the latest biomarkers that will enhance their clinical services.
Learn more about the Digitalization of the Companion Diagnostic Process and its impact on commercialization from our recent World CDx Workshop available to view here
To learn more about joining DXRX-The Diagnostic Network® contact us
- Morash M, Mitchell H, Beltran H, Elemento O, Pathak J. The Role of Next-Generation Sequencing in Precision Medicine: A Review of Outcomes in Oncology. Journal of Personalized Medicine. 2018; 8(3):30. https://doi.org/10.3390/jpm8030030 Accessed April 6th, 2021.
- Diaceutics Workshop Post Event Report