About Pharmacodynamic Biomarker

Pharmacodynamics (PD) biomarkers are molecular indicators of the effect of drugs on biological targets, which can guide drug treatment programs or targeted therapy research, enhance the rationality and hypothesis testing capabilities of the entire drug development, and lead from preclinical models compound selection to first-in-human trials. As clinical trials are designed for smaller, molecularly defined patient populations and as targeted therapies are developed, there is an increasing need for PD biomarkers in drug development. PD biomarker research is often combined with drug development, which can not only provide information on whether the drug reaches the expected target to help prove the mechanism of action of the drug, but also offer information on whether the drug target can change biology. Reliable PD biomarkers allow early decision-making by providing critical information on lead compound selection, on-target effects, biological responses, effects of targeted drug combinations, target engagement in vivo, and how to optimize drug regimens.

Fig. 1. Five essential characteristics of PD (pharmacodynamic) biomarker for biosimilars. (Li J, et al., 2020)

Access Our PD Biomarker Services

The drug development process has struggled to keep pace with the rapid discovery and testing of drugs that act on a variety of molecular targets. Rational development of such drugs requires an understanding of the drug's effect on its intended target. Ace Therapeutics has a professional ocular pharmacodynamic biological research matrix to provide valuable guidance for customers' drug development. Our ocular pharmacodynamic biomarker solutions help speed up our customers' early drug development decisions and support the advancement of clinical trials. And through a variety of detection and analysis techniques, eye PD biomarkers can be accurately qualitatively and quantitatively identified to ensure the success of your drug development.

Our scientists have developed multiple advanced technologies to assess ocular PD biomarkers in a large variety of samples. Explore our capabilities to support your program.

• Genomic Analysis

Including quantitative real-time RT-PCR, whole-genome sequencing, and next-generation sequencing (NGS).

• Immunological Detection

Including multiplex cytokine assays, flow cytometry (FC), enzyme-linked immunosorbent assay (ELISA), enzyme-linked immunosorbent spot (ELISpot), ECL, RIA, multiplex immunohistochemistry (IHC), ISH, FISH, etc.

• Liquid Chromatography/Mass Spectrometry (LC-MS)

Our experienced scientists have developed PD biomarker assays to detect low levels of endogenous biomarkers in the ocular stroma and other biological fluids, and tested pairs of compounds for safety and efficacy.

• Bioinformatics

Our data analysts can accurately analyze different experimental data, and provide clear, detailed and professional reports.

What Can We Provide?

• Research on the mechanism of action.
• Response prediction.
• Immunotoxicity testing.

Our services are tailored to the needs of our clients' individual programs. To help our clients achieve their specific goals for PD biomarker discovery, Ace Therapeutics is proud to offer the most comprehensive service. If you are interested in our services, please feel free to contact us or send us an inquiry directly.

Reference

1. Li J, Florian J, Campbell E, Schrieber SJ, et al. Advancing Biosimilar Development Using Pharmacodynamic Biomarkers in Clinical Pharmacology Studies. Clin Pharmacol Ther. 2020;107(1):40-42.

• Omics-Based Ocular Biomarker Discovery and Analysis Services
• Ocular Matrix Biomarker Discovery and Analysis Services
• Ocular Imaging Biomarker Services
• Ocular Predictive Biomarker Identification Services
• Ocular Prognosis Biomarker Services
• Ocular Transformational Biomarker Services
• Custom Ocular Biomarker Development Services

• * Name:
• Phone:
• * Email:
• * Services or Products of Interest:
• Project Description:
• * All of our services and products are intended for preclinical research use only and cannot be used to diagnose, treat or manage patients.

  * Tick to confirm the Research Use Only (RUO) statement.

• Submit