Enabling Personalised Medicine
 At Almac we offer a complete Pharmacodynamic (PD) Biomarker solution for pharmaceutical and biotechnology drug development programs. With the modern targeted approach to drug design, traditional dose escalation endpoints such as toxicity are often not valid. The application in a phase I study may represent a much more viable endpoint.
At Almac we can manage your PD biomarker strategy from initial discovery in model systems right through to commercialisation. We recognise the increasing importance of PD biomarker identification and development within drug development. PD biomarkers have many potential uses ranging from early research to preclinical and clinical development.
Our Approach:
Study Design
An experienced project manager will work in collaboration with you to identify appropriate pre-clinical models which will reliably reproduce the activity of the test drug. A comprehensive study design is then completed by the pre clinical biomarker team and specialist biostatisticians.
PD Biomarker Discovery
We work with both in vitro and ex vivo model systems. For ex vivo systems we work with whole blood and/or Peripheral Mononuclear Cells (PBMCs). We have the infrastructure in place to deal with these studies including ethical approval management, donor sourcing, phlebotomy, PBMC extraction and full cell culture facilities.
We utilise appropriate technology to interrogate models of drug activity to identify suitable PD biomarkers. Our technology includes:
- Cell line modelling
- Gene Expression Microarray
- SNP Microarray
- qPCR
- ELISA
- IHC
Test Development and Delivery
Having identified and validated a suitable PD biomarker, we have the capacity to develop this marker into a test using a suitable technology platform. Primarily we focus our test delivery methods on qPCR, IHC and ELISA. We can then offer these tests in our laboratories in the EU and USA.
Applications
At Almac we work with biomarkers in a variety of clinical settings and applications including:
- Providing proof of mechanism of action of a drug
- Selection of optimal dose and schedule of drug administration
- Understanding of response/resistance mechanisms
- Designing rational combination therapies.
|
