Strategic Field of Development (DVS) Biomarkers in Neurology and Psychiatry

The DVS Biomarkers in Neurology and Psychiatry is aimed at encouraging the identification and use of biomarkers that are essential for diagnosing diseases and developing appropriate treatments.

The DVS is organising a close dialogue between researchers, clinicians, manufacturers and those involved in innovation, funding and regulation, in order to facilitate the emergence of innovative projects to help provide relevant biomarkers for neurology and psychiatry.

Background

Despite considerable advances in terms of understanding the mechanisms behind neurological and psychiatric disorders, there are currently no effective treatments to prevent these diseases from developing or progressing, or to alleviate their symptoms.

However, brain disorders place a substantial burden on our societies. Recent epidemiological and medico-economic analyses (European Neuropsychopharmacology 2011, 21, 718-779) show that the cost associated with these conditions in Europe was €798 billion in 2010, i.e. €1,500 for every European citizen. The same study shows that investment in research on these disorders is paradoxically low, given their challenge to society.

The difficulty of developing brain research and the costs involved have led to a gradual withdrawal by the pharmaceutical industry and a declining interest in neurological disorders. Moreover, many clinical trials in this field have proved fruitless. A share of these failures can be attributed to the heterogeneity of the populations of patients enrolled in trials, who suffer from different disease subtypes, which in turn have different patterns of development.

Furthermore, the presence of the blood-brain barrier (BBB), a specific feature of the brain, necessitates the administration of high doses, which involves side-effects in some cases. Again because of the BBB, it is often difficult to determine whether the drugs administered are acting properly on their theoretical target.

In this context, the availability of biomarkers should enable early diagnosis, consistent stratification of patients, monitoring of disease progression, and assessment of the prognosis and response to treatment. The availability of such tools is also invaluable to therapeutic research, since the treatments currently available are inadequate both in quality and number.

Challenges and expectations

Our brain is the product of a long evolution. With over 100 billion interlinked neurons, research in Neurosciences, Cognitive Sciences, Neurology and Psychiatry, more than any other life science, is confronted by the issue of complexity.

Understanding the logic of the hierarchical assembly of the thousands of molecular, cellular and tissue components of the nervous system, and of their dynamics and plasticity is essential in dealing with the complexity of function of the human nervous system. This understanding is also essential to a better understanding of the mechanisms underlying neurological and psychiatric disorders, and hence the ability to develop effective treatments.

More than in any other field, identification of biomarkers in neurology and psychiatry is an essential challenge. The latter will enable:

  • on the one hand, a better understanding of the underlying physiopathological mechanisms and,
  • on the other hand, stratification of patients (to anticipate side-effects or persons at risk of serious adverse effects), verification that the drug acts on the target identified (companion biomarker) and prior assessment of treatment efficacy.

After consultation with academic, clinician and industrial teams, it appears that the development of biomarkers in neurology and psychiatry is an essential challenge that the DVS intends to support.

Actions planned by the DVS

The DVS thus proposes to remove a certain number of constraints that currently limit the commercial development of biomarkers in neurology and psychiatry. Thus, the first steps will be to construct and share crucial data on opportunities for development in this sector, by clarifying the response to several questions:

  • What biomarkers do we have in academic research?
  • What are the unmet or incompletely met clinical requirements?
  • What are the right value criteria for a biomarker in neurology and psychiatry?
  • What are the present and future competences in the industry?
  • What is the current progress of international initiatives and competition?
  • What are the routes to innovation that will enable biomarkers to advance toward the market?

With backing from Aviesan’s ITMO Neurosciences, and in close association with the Brain and Spinal Cord Institute (ICM), this DVS is expected to rely on a network of researchers and clinicians, together with industrial partners and innovators keen to encourage the emergence of innovative projects.

Your expertise and role are decisive in identifying, promoting and realising opportunities for development. Do not hesitate to contact the network for DVS Biomarkers in Neurology and Psychiatry!

Date created: March 2015
Coordinators: Etienne Hirsch, Bernard Poulain and Alexis Brice
Coordinating organisations:Multi-Organisation Thematic Institute (ITMO) for Neurosciences, Cognitive Sciences, Neurology and Psychiatry, and the Brain and Spinal Cord Institute
Project Leader: Flavie Pouillot

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