The Brain Resource International Database Cutting edge assessment of brain function is critical for effective biomarker identification and dose-response assessment in pharmaceutical trials.

                                                                                                                    

 

The Brain Resource International Database provides standardized methods and norms that are used to generate integrative reports about brain function and cognition to the pharmaceutical industry.It would be desirable to explain 'evidence based' reports. What are they, in a few words?

The Brain Resource International Database is the first standardized International Database on the human brain. Through the use of this international brain database, we are able to make integrated assessments of brain structure and brain function, and to find using our new ways to ways to analyse the brain. A consortium of the world's leading scientists (the Brain Dynamics Centre) has brought together complementary elements about the brain that are usually assessed in isolation. These elements were selected to bring together information about individual differences, overall brain function, brain structure, genetics and performance - to reflect a profile of information for pharmaceutical trials.

Strict standardization also allows across site pharmaceutical trials to be undertaken, highlighting reproducible insights uncontaminated by the methodological vagaries of different laboratories. Only by strict standardization of all variables across participating laboratories (each subject carries out precisely the same protocols), can we combine information and perform direct comparisons between the data.

Technical standardization required agreement from the consortium of scientists around the world, on precisely which equipment to use for every test. To ensure that the task instructions were delivered in an identical fashion, a recorded voice reading the test instructions are replayed in each brain function laboratory through identical headphones. As part of the strict quality control, all data recording hardware and software are likewise identical in each of the ten brain function laboratories around the world. Over 1500 normal subjects have been acquired over the past two years and data from a rang e of neurological and psychiatric disorders has begun to be collected.

There are Brain Function Laboratories in the USA, Europe and Australia. A Brain Resource laboratory can be set up anywhere in the world under the supervision of our BRC staff in a very short period of time . It is literally a "turnkey" approach. Every lab is identical, collecting data in exactly the same way.

All the data is sent to a large central brain analysis facility, which allows the standardization to b e maintained with respect to artifact rejection, outlier removal and many details of analysis - also allowing unprecedented efficiencies in processing the huge amounts of complementary information .

It is from the central analysis facility that the " fee for service " reports are sent to pharmaceutical companies around the world.

These conclusions may be clear to scientists, but not to a layman. We should clarify how these two graphs are useful.

Using the Brain Dynamics Centre methodologies Pharmaceutical companies can:

·          Determine the best biological markers of their new compounds

·          Determine the most effective dose-response relationships

·          BRC's New analyses provide new insights

·          Determine selective advantages of the psychoactive compound

·          Integrative complementary evidence

·          Collect data that is robust and reproducible (including across sites)

·          ·          Succeed or fail fast in terms of compound assessment

Identifying the best biomarkers (brain indices) and dose - response effects of new compounds , is crucial for pharmaceutical trials. the Brain Dynamics Centre unique integrative datasets give provide pharmaceutical companies the best opportunity to achieve this for compounds that are targeted to stabilize cognition , as well as to highlight the most reliable and reproducible results in relation to new compounds.

This is the first time we are using the expression 'integrative datasets'. We should explain, and relate it to the earlier part of this text.

BRC's standardised and integrative methodology approach allows pharmaceutical companies the best chance of procuring the most efficient and effective 'succeed or fail fast' outcome when evaluating new compounds.

Pharmaceutical companies can select from all the available the Brain Dynamics Centre method options (and new analysis methods), which elements they wish to use for each trial.