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Pharmaceutical Research and Development Consulting: Obtaining As Much Information As Possible to Guide Drug Research
Pharmaceutical Development, Re-Purposing, and Comparsisons using MOST-EEGThere are multiple contexts in which drug investigations using MOST-EEG analysis is suitable. For example, our process using MOST-EEG can be used for (1) bringing a new drug to market, (2) re-purposing an existing accepted drug for other applications, (3) comparing how multiple drugs affect the brain.
The Steps In Our ProcessOur objective is to provide the drug developer with as much information as possible describing how their drug under investigation affects human brain function and the disease they wish to treat. To meet this objective, we work closely with the drug developer to tailor a relationship that is suitable for each unique drug development situation. In general, the process that we follow in a drug development and evaluation study has 5 main steps.
Our initial steps with the developer are to:
(1) work with the developer to design the EEG data collection paradigm, and (2) consult and provide guidance in the data collection process to ensure the best possible brain activity analysis results.
Once data have been
collected, we:
(3) analyze the acquired EEG using our proprietary software to construct a data-driven model of the brain function that occurred during data collection.
To
improve the developer’s understanding of how the pharmaceutical affects multiple
parts of the brain and the coordination among brain areas,
we follow a two stage analysis process. In Stage I,
we:
(4) present brain function analysis results to the developer in terms of each experimental condition separately, and as a difference between on-drug and off-drug conditions.
After
deliving the results of Stage I analysis, we squeeze out any additional
information about brain function that might be contained in the EEG
data in a Stage II analysis process. Stage II analysis differs
from Stage I analysis. In Stage II analysis
we fine-tune our existing algorithms or apply new
'in-development' algorithms based on our observations in Stage
I. On completion of this stage, we:
(5) provide the drug developer with the Stage II analysis results that were calculated using our latest ‘experimental’ algorithms, data representation methods, and experimental condition comparisons. There are multiple contexts in which a drug developmer might benefit from our services and technology. These contexts include (1) the standard drug development process (2) drug re-purposing with the intention to maintain exclusivity of a particular compound by finding new treatment applications, (3) comparing existing drug compounds to determine which of a comparison set performs best with the fewest side-effects. A description of each context and how our organization would participate in a client's drug development and evaluation process is given below in terms of the typical drug development pipeline.
I. Drug Development: Tell me
as much about the drug as possible-- as soon as
possible
Figure 1 illustrates how we participate in the development of a new pharmaceutical and how the information we generate from our analysis impacts pharmaceutical development. The information about brain function derived from our analysis impacts pharmaceutical development in 2 ways: (1) Phase III testing of the drug being examined can be made more efficient by obtaining information in Phase II about how the drug impacts brain function in terms of both sensory-motor, and high-level cognition. Such information can help avoid problems that might arise in Phase III and identify unexpected 'other' effects that might indicate potential in unanticipated markets. (2) the information that can be obtained in Phase II can have an impact on future drug design. Information can be obtained that identifies how a particular type molecule interacts with human brain function and can inform the design of the next molecule.
Figure 1. Block diagram illustrating where in the drug development pipeline our services our involved, the list of services we provide, what impact the results we obtain can have, and how these results can impact drug development in our client's organization. II. Drug
Re-purposing: Can my approved drug be used for other
applications?
Figure 2 illustrates our participation in the endeavor to re-purpose an existing pharmaceutical. Re-purposing of a drug might be a strategy for a drug development organization that has a drug nearing the end of its patent. We can provide data acquisition and analysis that can help a drug developer identify applications of the drug for which it is not already being used. Our role in this endeavour is to run what is essentially a small-'n' 'Phase II' study where brain activity analysis is the primarly component of the study protocol.
Figure 2. Block diagram illustrating how our services can provide information about an existing approved drug that might identify other applications for the drug. III.
Comparing Existing Drugs: Which Drug Is Best?
Multiple generic drugs, drugs in development, or a competitor’s drug product line can be compared to determine which has the most positive impact on brain function. Such a study provides information to aid in the design of future molecules or can provide information towards deciding which drug to use in which application. For example, a clinician might like to have a comparative evaluation of a set of drugs so that they can provide patients with the drug that has the least negative cognitive impact and maximally affect the disorder being treated. Figure 3 illustrates how we would participate in such an evaluation.
Figure 3. Block diagram illustrating how our services can provide information about existing approved drugs in a comparison study to see which drug has the best performance.
Other information on this site inclused: details of the MOST-EEG brain activity analysis algorithm , a description of the standard drug development pipeline. For more information about MOST-EEG or its application, visit the Applied Brain and Vision Sciences Inc. corporate site .
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