Pharmacodynamic or response biomarkers are critical for the development of precision therapies. At Ace Therapeutics, we are committed to providing our clients with discovery, characterization and validation of pharmacodynamic biomarkers for psychiatric disorders. Our comprehensive solutions and reliable results can provide a scientific basis for the development of personalized therapies for psychiatric disorders. In addition, our validated pharmacodynamic markers can be used as surrogate endpoints to significantly shorten the cycle of antipsychotic drug development.

Why Develop Pharmacodynamic Biomarkers for Psychiatric Disorders?

Pharmacodynamic or response biomarkers have many potential roles in psychiatry, including:

• Such biomarkers may be related to safety, efficacy, tolerability, or target engagement (i.e., drug action).
• Pharmacodynamic biomarkers can be used in drug development and repurposing. They can be used to demonstrate quantifiable responses and facilitate trial success through processes such as sample stratification (e.g., enrichment by those demonstrating evidence of target involvement or pathway modulation), exposure optimization, and dose discovery.
• For psychotropic drugs, there is an urgent need for pharmacodynamic biomarkers to identify subgroups that are more likely to respond (or not) as well as levels of exposure early in drug development (e.g., exposure optimization).
• Pharmacodynamic biomarkers that predict clinical outcomes can be used for targeted therapies and may function similarly to predictive or prognostic biomarkers.

Fig. 1 The potential of pharmacodynamic biomarkers to aid in drug development, repurposing, and precision therapeutics in children and adolescents. (Stancil, S. L.; et al., 2022)

Our Psychiatric Pharmacodynamic Biomarker Development Services

Pharmacodynamic biomarker discovery and characterization services

We help our clients deeply analyze molecular changes in biological samples through multi-omics technologies, high-throughput screening and bioinformatics analysis tools to help them identify biomarkers associated with drug response. These markers can be used as predictors of drug efficacy, accelerating the drug screening and development process.

Pharmacodynamic biomarker validation services

We validated potential psychiatric biomarkers by ligand binding assays, cell-based assays, flow cytometry, molecular assays, and liquid chromatography/mass spectrometry to determine their specificity and sensitivity in psychiatric disorders.

Pharmacodynamic biomarker development services

At Ace Therapeutics, we are investigating the association between validated biomarkers and specific antipsychotic drugs in animal models. Our strategies include:

• Quantification of drugs and/or metabolites in body fluids of isolated animals and assessment of changes in biomarker levels before and after drug treatment.
• We integrate neuroimaging and electrophysiology techniques to analyze in depth the changes in biomarkers in brain tissue samples from animals under the influence of drugs.

Through comprehensive experimental design. We can help our clients identify the appropriate pharmacodynamic biomarkers for psychiatric disorders.

Our Pharmacodynamic Biomarker Identification Techniques

• Second generation genome sequencing
• Bioinformatics mutation analysis
• In vivo and in vitro pharmacodynamic biomarker identification
• Biomarker development and characterization
• Quantitative western blot, FACS analysis
• Immunohistochemical assays
• DNA sequencing

Ace Therapeutics is committed to providing you with comprehensive solutions to help characterize pharmacodynamic biomarkers associated with psychiatric disorders. Please contact us for more details and we will be happy to assist you.

Reference

1. Stancil, S. L.; et al. Target to treatment: a charge to develop biomarkers of response and tolerability in child and adolescent psychiatry. Clinical and translational science. 15.4 (2022): 816-823.