Pharmacodynamic Biomarker Testing

 
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Pharmacodynamic Biomarker Testing

Pharmacodynamic (PD) biomarkers are extremely important in early drug development trials and can be used to measure the level of response to an administered drug, whether it is biologically active & can help to determine target engagement and mechanism of action (MOA).

PD Biomarkers assist investigators to understand if the drug is having the intended pharmacologic effect and be used to guide appropriate clinical dose-response studies as part of the agreed overall clinical trial protocol.

Almac PD Biomarker Testing Service

Almac Diagnostic Services can help Biopharma clients validate reliable PD assays that can help provide invaluable guidance within their drug development programmes.

Almac can develop and perform PD testing on multiple technology platforms across multiple sample types for qPCR and Next Generation Sequencing (NGS) from our global CLIA and CAP-accredited labs.

Clients may wish to provide previous existing data from matched pre- and post-treatment samples and our bioinformatics team can provide solutions for selection of an appropriate PD biomarker, alternatively, clients may already have a pre-defined PD biomarker they would like Almac to test for them.

Almac Diagnostic Services has over 10 years’ experience in PD Biomarker Testing. As part of our overall Clinical Trial Solutions we can deliver for clients either:

  • An independent PD Biomarker measurement
  • A PD Biomarker measurement integrated with a predictive clinical trial assay (CTA)

If a client chooses Almac for combined delivery of both the predictive and PD biomarker within their clinical trial programme Almac can deliver significant efficiencies in terms of time and cost savings.

Specific efficiencies can be gained through centralised sample management, pathology review & nucleic acid extraction resulting in a more streamlined and cost-effective downstream testing process.

Benefits

Streamlined Process & Combined Efficiencies

Utilising Almac as a centralised provider, rather than outsourcing PD biomarker work and CTA development work to multiple CRO vendors, creates a much more streamlined process. This also results in logistics efficiencies and reduced risk for client’s drug development programmes.

Cost & Time Savings

This can directly translate into savings for clients with a ‘same sample, same lab’ approach of combined PD biomarker and CTA testing saving time and reducing cost with one provider.

Better Informed Decision Making

Combining drug development data with biomarker efficacy data from Almac focused PD biomarker measurements provides critical information to help inform key drug development milestone decisions much earlier on in the process.

Almac claraT – Unique tool to aid Biomarker Discovery

Almac’s unique gene expression report claraT also allows cancer researchers to discover novel insights within pharmacodynamic (PD) biomarker discovery. By allowing multiple biologies to be evaluated in parallel, the claraT Total mRNA Report supports the identification of pre and post expression changes within novel pathways and biologies that may play a role in response to therapeutic targets.

Example of Almac PD Biomarker Process integrated with a Clinical Trial Assay

PD Biomarker and predictive CTA combined activity in the same Almac laboratory providing streamlined efficiencies for clients.

Pharmacokinetic Analysis

For clients also interested in Pharmacokinetic (PK) analysis, Almac Group can provide this service through our Almac Sciences business unit.

Almac has the ability to provide both bioanalysis and PK data on an interim basis facilitating our clients to make decisions on a continuous basis. This is particularly useful at the ‘Proof of Concept’ phase or ‘Dose Escalation’ studies where the pharmacokinetic data is often crucial to making important safety decisions regarding dosing.

Almac Sciences has 4 study directors for bioanalysis & PK studies, each with more than 20 years’ experience in the field.

Find out more – To view a full list of Bioanalysis / PK assays.

Contact Us

Interested in PD Biomarker testing in conjunction with predictive biomarker testing as part of your Clinical Trial? Get in touch with Almac Diagnostic Services for a quote.

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