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FAR-GALenia

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PERSONALIZED MEDICINE

FAR-PRO-PKgen

According to Canadian National Research Council, Personalized Medicine involves tailoring medical treatments to the individual characteristics of each patient. This entails the ability to identify patients who differ in their susceptibility to a particular disease, in the biology and/or prognosis of that disease, and in the response or the adverse effects they experience after the administration of a specific treatment. This identification is achieved through the analysis and integration of genomic data and molecular imaging techniques with clinical data and the patient’s environment.
Personalized Medicine will be a highly valuable tool for the clinicians when it comes to selecting the treatment or dose most suitable for each patient. In this context, genomics, together with pharmacokinetics, is beginning to make its way into the healthcare process as a guide in drug dosage. This will contribute to improving the quality of healthcare and promoting the development of personalized medicine, enabling the optimization of drug efficacy and ensuring patient safety.

Age-related Macular Degeneration (AMD)

The main objective of this project is to achieve a proper stratification of the response to anti-VEGF treatment in patients with wet age-related macular degeneration ( AMD ), using a comprehensive integration of imaging techniques, pharmacokinetics, and pharmacogenetics. Within this main objective, the following secondary objectives are defined:

  • Development of methodologies based on artificial vision that allow the characterization of age-related macular degeneration (AMD) on OCT (Optical Coherence Tomography) and OCTA (OCT Angiography) images. Associated with this characterization, demonstrate and standardize the treatment response (Image).

  • Precisely showcase the pharmacokinetics of anti-VEGF following intravitreal administration in patients with AMD and assessing its relationship to therapeutic response in treat-and-extend (T&E) regimens (PK)

  • Analyze if there are significant differences in pharmacokinetic variables regarding treatment response in patients receiving rabinizumab, both at the germinal variation level and in expression through the analysis of miRNAs, allowing us to stratify patients into responders and non-responders (Gen).

  • Establish a population pharmacokinetic model that integrates available information and evaluates intrinsic and extrinsic factors to explain observed differences in ranibizumab exposure and its relationship with response markers, enabling accurate stratification of patients into responders and non-responders.

IMMUNE-MEDIATED
OPHTHALMIC DISEASES

Currently, a prospective multicenter observational study in underway with the aim of stratifying patients with uveitis undergoing adalimumab treatment into responders and non-responders, this is achieved through the characterization of clinical, pharmacokinetic,s, pharmacogenetic, and proteomic variables that may be related to treatment response. The objectives of the current project are::

  • Analyze the pharmacogenetic profile of germinal variations that allow us to stratify responders versus non-responders to adalimumab treatment.
  • Analyzing the the population pharmacokinetic profile that allows characterizing the evolution of adalimumab over time in individuals with uveitis based on clinical and preclinical data.
  • Analyzing the tear protein profile to identify proteins with potential utility as biomarkers for response to adalimumab treatment.
  • Correlate drug levels with response and, concurrently, with genetic variants, immunogenicity, proteomics and clinical parameters to identify factors associated with the clinical response to adalimumab treatment.

In parallel with the clinical study, a preclinical study will be conducted to investigate the intravitreal pharmacokinetics of adalimumab, using radiolabeling and molecular imaging techniques (microPET) for that purpose. This research line has been funded through AES2020 as part of the Health Research Projects (PI20/00719).

SCHIZOPHRENIA AND LONG-ACTING (DEPOT) ANTIPSYCHOTICS

The project’s objective is to conduct a pharmacogenetic-pharmacokinetic analysis of patients undergoing treatment with long-acting injectable antipsychotic drugs, aiming to adjust doses and prevent adverse reactions.

The development of the current project involves the following stages:

  • Establish a pharmacokinetic determination method in blood plasma for aripiprazole and dehydroaripiprazole using UPLC-MS/MS.

  • Development of pharmacogenetic analysis for CYP2D6 using OpenArrayTM technology.

  • Patient inclusion and performance of pharmacokinetic and pharmacogenetic determinations.
  • Correlation between pharmacokinetic and pharmacogenetic data and clinically observed outcomes in terms of efficacy and safety through the analysis of different covariables.

  • Development and validation of a population model for depot aripiprazole based on the resulting data and the analyzed covariables.

This project has been funded in the 2021 work groups call from the Spanish Society of Hospital Pharmacy (SEFH)
(Neuropsychiatry and PK-Gen).

NEW NON-INVASIVE METHODS FOR THERAPEUTIC INDIVIDUALIZATION OF LINEZOLID

Prospective observational study with the objective of clinically implementing new non-invasive pharmacokinetic monitoring methods for linezolid in patients with osteoarticular infection, linked to the development of a population pharmacokinetic model and to the identification of platelet toxicity prognostic factors that enable individualized treatment.

Specifically, the current proposal focuses on the following points:

  • Development of new non-invasive methods for the determination of linezolid and its metabolites in capillary blood and saliva, enabling patient self-sampling by the patient and at-home monitoring of this drug.
  • Development of a population pharmacokinetic model that enables individualized dosing for patients with osteoarticular infection using non-invasive monitoring methods.
  • Proteomic analysis and mitochondrial function analysis to study the mechanism of platelet toxicity associated with linezolid and identify potential biomarkers for future patient stratification based on the risk of developing thrombocytopenia.
  • Preclinical pharmacokinetic study using radiolabeling techniques and molecular imaging in an animal model to investigate concentrations and variations in the distribution of linezolid in different organs that make obesity a risk factor for therapeutic refractoriness.

This project has been funded in the 2022 Strategic Health Action call by the Carlos III Health Institute PI22/00038.

DIGITAL HEALTH

(e-Salud)

The term digital health has its roots in eHealthwhich is defined as "the use of information and communication technology in support of health and related fields". In this context, the unit is committed to projects focused on integrating technology to improve patient health and personalized medicine.

NEmecum

Digital tool intended for facilitating the search and prescription of nutrition and infant artificial formulas.

The market for enteral and oral nutrition formulas, as well as artificial infant formulas, is extensive. Unlike medications, there is no standard format for presenting information on each formula, and there is no application that allows for a comprehensive and independent search for them. All these aspects are left to the laboratory that markets each of them and, in many cases, it is challenging to find detailed information on the formulas and conduct comparisons between them. At the hospital level, it is impossible to have all the formulas on the market at hand, so making exchanges that require specific knowledge of the available options is often needed.



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