STRATEGIC APPLICATION AREA (SAA) OF BIOMARKERS IN NEUROLOGY AND PSYCHIATRY

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Backed by ICM and Aviesan neurosciences ITMO, the SAA relies on a network of researchers, clinicians, industry partners and innovation stakeholders whose aim is to promote the emergence of innovative projects.

The objective of SAA is to promote the identification and use of biomarkers, essential to diagnosis and monitoring of diseases as well as to the development of appropriate treatments.
The SAA establishes a dialogue between researchers, clinicians, industry, and innovation, funding and regulation stakeholders, in order to facilitate the emergence of innovative projects which will provide with relevant biomarkers in neurology and psychiatry.

Context

Despite significant progress in understanding neurological and psychiatric diseases mechanisms, there is currently no effective treatment to prevent these diseases development or lessen their symptoms.

Yet brain diseases are a major burden in our society. Recent epidemiological and health economic analysis (European Neuropsychopharmacology, 2011, 21, 718-779) show that costs associated with these diseases reach in Europe, in 2010, 798 billion euros, or 1,500 euros per European citizen. The same study shows that investment in research on these diseases is paradoxically low, given their societal issue.

Brain researches’ both difficult development and costs have led to a gradual withdrawal of the pharmaceutical industry and a declining interest in neurological diseases. Furthermore, many clinical trials in this area have proved fruitless. Some of these failures can be attributed to the trials’ heterogeneous patient populations, suffering from different subtypes of diseases whose evolution profiles are also variable.

In addition, the blood brain barrier (BBB), a brain’s specificity, requires administering high doses, involving in some cases side effects. Again because of the BBB, it is often difficult to ascertain whether the administered molecules indeed act on their theoretical target.

In this context, biomarkers should enable early diagnosis, consistent stratification of patients, monitoring of disease progression, assessment of prognosis and therapeutic response. Such tools are also valuable for therapeutic research since current treatments are inadequate in both quality and number.

Challenges and expectations

Our brain is the result of a long evolution. With over 100 billion interconnected neurons, research in Neurosciences, Cognitive Sciences, Neurology and Psychiatry, more than any other area of life sciences, faces complexity.

Understanding the logic of the hierarchical assembly of thousands of molecular, cellular and tissue components of the nervous system, their dynamics and their plasticity, is essential to approach the human nervous system complexity. This understanding is also essential to better comprehend the mechanisms underlying neurological and psychiatric diseases and thus be able to develop effective treatments. More than in any other field, identification of biomarkers in neurology and psychiatry is a key issue.

These will allow:

  • On the one hand to better understand the underlying pathophysiological mechanisms and,
  • On the other hand to stratify patients (anticipate side effects or persons at risk of serious side effects), to verify that the drug acts on the identified target (specific biomarker), to assess in advance the treatment’s efficiency.

After consulting academic teams, clinicians and industry, it turns out that the development of biomarkers in neurology and psychiatry is a key issue which the SAA intends to support.

Actions taken by the SAA

The SAA thus proposes to remove some constraints that currently limit biomarkers valuation in neurology and psychiatry.

The first steps are hence to build and share critical data on valuation opportunities in this field, by clarifying the answer to several questions:

•What biomarkers academic research provides?
•What are the unmet or imperfectly satisfied clinical needs?
•What are the good criteria to assess a biomarker’s value in neurology and psychiatry?
•What are the industry’s current and prospective skills?
•What stage international initiatives and competition are at?
•What innovation paths biomarkers will use to reach the market?

Definition of Biomarkers in Neurology and Psychiatry

Within the framework of Strategic Application Area (SAA) of biomarkers in Neurology and Psychiatry, the biomarker is an objective, precise and reproducible feature measuring tool. Amongst others, this enables the distinction between a normal physiological state and a medical condition or a response to a therapeutic treatment, as well as the establishment of subgroups of patients (stratification).

These shall be classified as follow:

the nature of the measured factor :

•Anatomical
•Physiological
•Biochemical
•Molecular
•Immunological
•Physical
•Behavioural

the support technology :

•Genomics
•Transcriptomics
•Proteomics
•Metabolomics
•Lipidomics
•Immunogenetics
•Imaging
•Data analysis
•Questionnaires / clinical scales
•Recordings

the level of complexity :

•Monoparametric
•Multiparametric (determination of a biological signature)

the stage, biomarkers :

•diagnostic and / or predictive
•stage and prognosis
•Research – mechanistic or stage
•efficiency
•toxicity
•pharmacogenomics

Your expertise and role are decisive to identify, promote and realise the valuation opportunities.
Feel free to join the Biomarkers SAA network in Neurology and Psychiatry!

Creation date : March 2015.
Coordinators : Etienne Hirsch, Bernard Poulain and Alexis Brice.
Institut Thématique Multi Organisme neurosciences, sciences cognitives, neurologie, psychiatrie and the Brain and spine institute.
Business development manager : Flavie Pouillot.