TECHNOLOGICAL DEMAND 3:
Pharmacological and Analytical Laboratory "Chemical-pharmaceutical and other relevant analysis"

Summary table of the technological challenge 3

Subproject/Technological ChallengeInnovation SectorProducts and tasks
3. harmacological and analytical analyses other chemical pharmacological and others (microbiological) biomarkersPharmacokinetics and analytical chemistry companies (drugs, metabolites, endogenous biomarkers)
Possible studies of intestinal absorption (microbiome).
3a). Development of laboratory methodology for its application in the clinical care routine
3b). Databases of pharmacokinetic and other analytical biomarkers (1e)
3c). Software for the functional interpretation of analyzes (metabolic phenotypes, for example) (4b).
3d). Systematic report based only on pharmacological and analytical biomarkers
3e). Corresponding analyzes in a pilot of 3000 patients for their evaluation
3f). Connection with the PPS in the JARA environment (1e)

For more information: https://www.boe.es/diario_boe/txt.php?id=BOE-A-2018-8151 *JARA Electronic Clinical History, Extremadura Health Service (SES)

Current situation:

In addition to genetic biomarkers, information from physical examination, and the family and personal background, there is information from analytical studies that may be decisive for the selection of a particular drug. Although the analysis of plasma levels of drugs and metabolites have been ordinary, these can be complemented with the study of other endogenous biomarkers that allow knowing phenotypes that determine the response to drugs, these are not usually included in the analysis carried out to monitor the prescription. Additionally, of increasing relevance are other physiological and pathophysiological determinants which establish the absorption, for example, the intestinal perfusion and the microbiome.

Objective:

To develop a systematic analysis of plasma levels of drugs and metabolites, validated, which includes the most commonly prescribed drugs or those in which there is recommendation in the determination of levels or Serious Adverse Reactions. It will be created a Database in JARA, so that this information can be integrated in the prescription algorithm generated in the PPS (challenge 1, subproject 1). The addition of other parameters will be valued: endogenous biomarkers capable of mediating the determination of metabolic phenotypes and others, for example, microbiological analysis determining absorption.
Those relevant to the population of Extremadura, Spain and as far as possible European, will be determined. The possibility of extending to Latin American population will be valued. Application of the methodology developed, at least, to 3000 patients.

Functionality required by the suggested solutions:

Capability to measure plasma levels of drug and metabolites in a fast and accurate way, to measure endogenous biomarkers that can be used to determine the metabolic phenotype, absorption, distribution or elimination.
The capability to perform intestinal perfusion studies and the ability to perform microbiological analysis, microbiome, will also be additionally valued.
All these chemical and microbiological analysis must be interpreted and added to the analytical databases of the PPS in order to be used in the prescription algorithm connected to JARA.

Summary of products and tasks (Table):

3a). Development of laboratory analysis methodology for its application in the care routine.
3b). Databases of pharmacokinetic and other analytical biomarkers (Connected to Subproject 1)
3c). Software for the functional interpretation of analysis (metabolic phenotypes, for example).
3d). Systematic report based only on pharmacological and analytical biomarkers.
3e). Corresponding analysis of the 3000 patients in pilot for its evaluation.
3f). Connection with the PPS in JARA environment (Connected to Subproject 1)

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