Almac have extensive experience in the discovery of clinically relevant and clinically applicable biomarkers, through our own research and development programs and through developing biomarkers for our partners.
We specialise in working with formalin fixed, paraffin embedded (FFPE) samples, particularly in the development of multigene or multiplex signatures. Our research has led to the discovery and development of several complex signatures, which have been out-licensed to diagnostic partners to use for clinical application.
In our commercial partnerships, we have discovered signatures that have been brought forward and developed into research assays, CLIA / clinical trial assays, and full companion diagnostics.
Our Subtyping Approach to Biomarker Discovery
Our subtyping approach involves profiling large retrospective datasets to identify the underlying subgroups that represent fundamental biology. This same approach can be used for the discovery of biomarkers in a wide range of indications. When it is, the biology discovered represents a class effect that can often be seen in multiple disease areas. This approach has benefited a number of clients where clinical trials had previously been run, during which we either used the datasets they already had access to, or we secured access to datasets by means of our retrospective sample collection services.
We have extensive experience carrying out biomarker discovery in a pre-clinical setting, using both cell line models and animal models. We have also brought signatures discovered in this setting into the clinic, for trial enrichment purposes, in early phase trials.
State-of-the-Art Laboratory Technologies and Experienced Scientists
Our biomarker discovery services are supported by our state-of-the-art laboratory technologies, all of 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 molecular and cell biology, drug discovery and development and diagnostic product development.
We recognise that each study is unique and has its own challenges. Our team will work with you throughout to provide a comprehensive service – from initial study design and planning, all the way through to the interpretation of your results.
We offer complete transparency throughout your study, with all methodology, programs and analytical methods clearly explained and available for you for review. We pride ourselves on quality and we work under standard operating procedures. All analytical methods we use are extensively tested and verified and all results are reviewed and supplied to you with complete information, to enable independent confirmation.
For more details on our laboratory infrastructure, please view our infrastructure page.
Retrospective Sample Collection
With personalized medicine becoming more commonly accepted, an increasing number of drugs in development have a biomarker strategy. In situations where a drug has not performed as well as hoped, a biomarker strategy could potentially rescue the drug or increase market uptake through the use of a companion diagnostic.
We have developed this service to enable biomarker studies to be carried out retrospectively in trials where there was not one in place from the start. It includes obtaining ethical approval and corresponding consent, identification of clinical information for patients in partnership with investigators, contractual arrangements, sample sourcing and providing full logistical and regulatory oversight of sample preparation, shipping, receipt and biobanking.
Benefits to You
Cost (and time) effectiveness.
Accurate project scoping, ready to use documentation, established networks and personal relationships worldwide, extensive experience in all areas of the study lifecycle.
Structured project layout which allows constant review of progress, document communication, risks, benefits and staged decisions on likelihood of achieving objectives, with pre-determined options to alter scope, or halt project.
Working exclusively in the delivery of this service, our established team of experts are highly experienced and have:
- Established workflows for projects of this type
- Expertise and experience of ethical submission and regulatory requirements in a range of countries and institutions
- A prepared bank of template documentation for this type of study, in English and many other languages
- Experience of working with large number of recruiting sites worldwide
- Relationships with many different investigators and background staff in recruiting centers
- Extensive experience in contractual arrangements for sample access and shipping worldwide
- Global capabilities to expedite the process of clinical site participation and sample access
- Experts in sample preparation, packaging and shipping
- Knowledge in dealing with country-specific regulatory requirements for sample export
- Experience in study design and delivery of large research studies which involve a wide range of downstream genomic and proteomic assays that impact upstream sample selection and preparation
- Specialist knowledge and vast experience of working in a range of oncology indications