Biomarkers can save the industry’s “damaged” drug pipeline and open up new areas for therapies, pharma and academia have been told.
Speaking at a recent meeting on biomarkers for Alzheimer’s Disease, Professor Simon Lovestone, director of research, King’s College London, said the drug pipeline was “damaged” because not enough drugs were coming through and many of those drugs that did make it onto the market were “toxic” – think Vioxx – while predicting patient outcomes and responses to drugs was currently very limited. Encouraging the use of biomarkers can help with these issues, he said.
“Biomarkers can also help with the measurement and efficacy of clinical trials and there’s good evidence that work with biomarkers is demonstrating new areas for therapies,” Lovestone added.
In Alzheimer’s Disease, for instance, current biomarkers include a cerebrospinal fluid (CSF) tap and positron emission tomography (PET) scans. However, the CSF tap is an invasive procedure, while the accessibility of PET scans is limited making both options not particularly tenable in the long term, Lovestone said. “So we need to come up with something else.”
Studies are currently underway looking at blood plasma proteins, which could act as biomarkers, as well as MRI brain scans to analyse different brain areas. Lovestone said the best way would be to combine the imaging with the blood protein tests as a biomarker for the disease.
Dr Chris Buckley, Alzheimer’s imaging leader at GE Healthcare, agreed there needed to be an improvement in the biomarkers for Alzheimer’s Disease. Current drugs for the disease tended to be more palliative, he said, targeting the late stage development of the disease.
“Alzheimer’s Disease has a long incubation period making it difficult from a drug development perspective… Where a biomarker would be clinically useful at the moment is to predict the progression from mild cognitive impairment to Alzheimer’s Disease. An ideal biomarker would be a quantitative objective measure that links the causal path between the underlying pathology and clinical presentation.”
The European Medicines Agency is currently consulting on its first qualification opinion on a clinical biomarker for use in humans. The opinion relates to a request from Bristol-Myers Squibb for the use of two CSF biomarkers to select patients for clinical trials in pre-dementia Alzheimer's Disease.
The Alzheimer’s Disease biomarker meeting was hosted by Proteome Sciences, which specialises in biomarkers, particularly in neurological diseases. Together with Kings College, Proteome Sciences was the first to discover more than 30 blood plasma biomarkers in Alzheimer’s disease, with a number of biomarkers developed into assays and others in the pipeline, which are being used to test the efficacy of drug compounds and will be used for early diagnosis.