Is the pharma business model ready for precision medicine?

Fred Bassett|11th June 2018

We are experiencing the dawn of precision medicine. With sales projected to rise to $141bn per annum between now and 2026, there can be no doubt that medicine is poised for the rapid acceleration of the precision era, which is why we have dedicated this edition of our ‘Perspective’ magazine to this weighty topic.

The promise of the precision medicine approach is well understood and often talked about. It exists at the convergence of genomic sequencing, biomarker research, bioinformatics and big data analysis. In short, it promises improved outcomes for the patients identified as suitable for treatment.

In the era of precision medicine, greater response rates will reduce the human and economic cost of ineffective treatment. Couple this with a reduction in research and development expenditure, through smaller clinical trial costs and reduced time-to-market, which is estimated to save $26bn annually and the positive impact for all stakeholders becomes clear.

There can be no doubt that the levels of investment in precision medicine will fuel and accelerate its growth. From targeted therapeutics to diagnostic tools, from next-generation sequencing to data informatics, there has been an influx of capital and resultant innovation. The evidence is compelling. Precision medicine is gathering momentum. The question is: are we ready for it?

This is not an idle question. Across a broad spectrum of healthcare stakeholders, significant challenges remain, which need to be addressed for the full promise of precision medicine to be realised. As patient populations are stratified through increasingly sophisticated biomarker strategies, the challenges of identifying trial participants increases, as does the level of competition between trials for increasingly scarce patients.

 "There is an often-quoted view that the precision of customer engagement should be enhanced to compliment this new approach to treating patients."

Trial design is evolving to include so-called ‘basket’ designs, where the candidate drugs are matched to the somatic mutations found. This differs from traditional tumour type or ‘adaptive’ trials where the predictive biomarker is not clearly identified at trial commencement.

However, despite these developments, clinical trial recruitment remains difficult. Top of this list is patient recruitment, with a meagre 3% of potential patients volunteering to participate in oncology clinical trials. This challenge is being addressed through many approaches, one of which is discussed by Clinical Trail Connect later in this edition of our 'Perspective' magazine.

Assuming the clinical trial is positive, the pharmaceutical company will experience a more complex launch that will likely include one or more partners, as well as an increase in the number of stakeholders to engage. There is an often-quoted view that the precision of customer engagement should be enhanced to compliment this new approach to treating patients. As an organisation, Blue Latitude Health has built its business on this approach, spending the last 15 years developing tailored and personalised strategies for the commercialisation of products and services. Yet although precise therapies are emerging, there will need to be more initiatives across the sector and major challenges remain.

Medical organisations in pharma have been set up to support population medicine. However, the education they will undertake and the queries they will answer will become increasingly patient-specific. This will require medical organisations to adopt sophisticated one-to-one stakeholder engagement practices. They will also need access to larger and more complex data sets and to develop the analytical capability to analyse them.

Precision medicine is often presented as a panacea for patients and the headline benefit of better and more certain outcomes will doubtless help many. Dig beneath the surface, however, and challenges immediately present themselves. The investment may be flowing and the science gathering pace, but there is still some way to go before we are properly ready for precision medicine. 

 

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