Almac Diagnostic Services can also help Biopharma clients validate reliable Pharmacodynamic (PD) Biomarker assays that can help provide invaluable guidance within their drug development programs.
Almac also has extensive experience in the discovery of clinically applicable biomarkers, through our own range of Almac proprietary assays (DDIR, Prostate Dx, ColDx, Angio, and EMT) and through developing biomarkers for our partners.
As part of our commercial CDx partnerships, we have discovered novel molecular pathways that have been brought forward and developed into Research Assays, Clinical Trial Assays, and full Companion Diagnostics.
Our Subtyping Approach to Biomarker Discovery
Our subtyping approach involves expertise in working with FFPE tissue, profiling large retrospective FFPE tumor datasets to identify the underlying molecular structure that allows us to subtype a range of specific disease indications. This same approach can be used for the discovery of biomarkers. Using this approach, the biology discovered represents a class effect that can often be seen across multiple disease areas and have application for multiple drugs in a particular drug class.
We have used this approach for a number of our clients using cohorts that they already have available to them or by additionally supporting them in securing access to required datasets by means of our retrospective sample collection services.
We have extensive experience carrying out biomarker discovery in a pre-clinical setting using various model systems. Signatures discovered in this setting have also been brought to the clinic, for trial enrichment purposes, in early phase trials.
The benefits of the Almac Diagnostic Services approach to Biomarker Discovery are:
- Provides a fundamental biology which can link to novel therapeutic targets
- Can function across multiple disease areas and clinical decision points
- Delivers a robust assay which is easily transferable across multiple platforms
State-of-the-Art Laboratory Technologies and Experienced Scientists
Our biomarker discovery services are supported by our state-of-the-art laboratory technologies which are ideally suited to biomarker discovery, development and delivery in a clinical setting. We also have a team of highly qualified and experienced scientists, bioinformaticians, and biostatisticians with substantial knowledge and experience in high tech molecular and cell biology technologies including NGS and multiplex qPCR, drug discovery and development and diagnostic product development.
We recognize that each study is unique and has its own challenges. Our team will work with collaborators and clients throughout the project to provide a comprehensive tailored service – from initial study design and planning, all the way through to the interpretation of results, and will integrate seamlessly as part of your extended team.
We offer complete transparency throughout every study, with all methodology, programs and analytical methods clearly explained and available for review. We pride ourselves on quality and we work under strict standard operating procedures. All analytical methods we use are extensively tested and verified and all results are reviewed and provided with complete information to enable independent confirmation.
Retrospective Sample Collection
With personalized medicine now being adopted as best practice, the majority of drugs in development have a biomarker strategy. In situations where a drug has not performed as well as hoped, a biomarker or companion diagnostic strategy could potentially rescue the drug or increase market uptake.
Given the market demand, we have also developed our biomarker discovery capabilities as a service to enable biomarker discovery to be carried out retrospectively in trials originally run without a biomarker strategy and where samples were not collected in the clinical trial.
Over many years’, our established team of experts have honed skills in retrospective sample collection on behalf of clients. We specialize in the following:
- Sample Sourcing
- Obtaining ethical approval and corresponding consent
- Full logistical & regulatory oversight of sample preparation, shipping, receipt and biobanking
- Identification of clinical information for patients in partnership with investigators
- Contractual arrangements