innovations in treatment of CNS disorders

“The stars are aligning for a new wave of breakthroughs in the treatment of CNS disorders. Unprecedented scientific progress and digital disruption are changing the fundamentals of CNS innovation.” – Markus Gores, VP at IQVIA

The last few years have been rather disappointing in terms of R&D for new treatments of CNS (= central nervous system) disorders, but now, due to the digital transformation, a new era is dawning. Advancing science allows a more detailed and comprehensive understanding of the (biological) processes and background of CNS disorders. In addition, technological progress is creating a variety of new technologies for use in the diagnosis, treatment and monitoring of CNS disorder patients.

The white paper ‘A New Dawn: At the Cusp of the CNS Decade‘ by M. Gores shows how the pharmaceutical industry and corporations can use technological innovations and which success factors are decisive for CNS R&D innovators. In the 1990s through the early 2000s, the healthcare and pharmaceutical sectors experienced their first boom – after which stagnation ensued. However, even in the current era where we are again experiencing an upswing, there are still certain obstacles to overcome as innovators in the fields of mental health and neurological disorders.

Most problematic is the fact that in the diagnosis of many mental health and neurological disorders, assessment is used that is based on subjective criteria, such as the MMSE* for AD. Diagnosing patients who are in a pre-symptomatic stage, i.e. in an early stage, is almost impossible without the help of more advanced biomarkers because tools such as the MMSE are just not sensitive enough at this stage of the disease. The selection of certain patient groups for clinical trials is also difficult using these subjective test procedures. Here, for example, ki:elements speech-based biomarkers can be used, saving time and costs and even identifying the appropriate patient group over the phone. Combining the biomarkers with disruptive new technology, such as AI and machine learning and with digital health tools – like apps or wearables – offers a low cost engagement possibility into the everyday life of for example patients in clinical trials and an innovation in early detection and diagnosis of CNS disorders. Since “Speech and language, captured on a mobile or voice activated device, provide rich insights into patients’ cognitive function and mood and thus represent promising novel biomarkers for a deeper understanding of CNS disorders, with emerging diagnostic applications”  (M. Gores, VP at IQVIA)

According to M. Gores, there are 5 important points to consider as an R&D innovator in the pharmaceutical market. First, the massive potential of digital disruptive technologies like for example advanced neuroimaging techniques or biomarkers must be exploited. These technologies are enablers for success. Second, innovators need to incorporate new designs into their development, especially in terms of clinical trials, such as patient-friendly virtual clinical trials and patient-centered endpoints. This can initiate better patient selection and thus faster trial initiation. Third, to exploit the full potential of disruptive technologies in the field of CNS diseases and their benefits, integration into the patient’s daily life to obtain real life data is important. Furthermore, it is important for innovators to engage in risk and value sharing, because the innovations in the field of CNS disorders pose major budget challenges to the healthcare system. Lastly, it is important to note that the existing diagnostic and treatment infrastructures of the healthcare system must be adapted to take advantage of the innovations. Therefore, innovators need to show a high level of commitment to the healthcare system.

Together with budget difficulties, the outdated infrastructure is a barrier to the successful incorporation of innovations in the marketplace that needs to be overcome. There needs to be a multi-stakeholder debate about society’s healthcare priorities and a redistribution of funds and resources to ensure that the full potential of innovations such as ki: elements speech biomarkers for more efficient clinical trials can be realized.

* MMSE is a test consisting of 25 questions and tasks related to orientation, memorization, attention, recall and calculation skills