Phase III failures of treatments for Alzheimer's are costly, driving desire among biopharm to kill compounds earlier. To make these decisions predictive safety and efficacy data is needed and biomarkers have a role to play in this, and other, areas of drug development.
“Biomarkers are critical to answering many, if not most, drug development questions”, says Judith Abdalla, executive director, global strategic drug development at Quintiles. Abdalla was speaking at an Alzheimer's conference organised by Proteome Sciences.
Reducing attrition will require predictive biomarkers capable of anticipating the safety and efficacy of symptomatic or disease modifying neurotherapies. These biomarkers should be developed alongside the therapeutic, says Abdalla.
Biomarkers can also enable stratification of patients, by giving an understanding into how the disease will progress in an individual, and Abdalla discusses this in greater depth in the embedded video.
Biopharm is currently hindered by inadequate understanding of diseases, says Marie-Christine Betard executive director, global strategic drug development unit at Quintiles, and biomarkers can also help in this area.
Greater understanding of possible Alzheimer's development pathways is a side-effect of a biomarker research collaboration between the Institute of Psychiatry, King’s College London and Proteome Sciences.
The collaboration is focused on developing blood biomarkers, and led to a licensing deal with Millipore, but has also added evidence of the role the complement system plays in Alzheimer's, says Simon Lovestone, of the Institute of Psychiatry, King’s College London.
Understanding the pathways underpinning Alzheimer's could lead to creation of therapeutics that prevent or delay the onset of disease, as opposed to just slowing its progress after symptoms emerge.
Chris Buckley, Alzheimer’s imaging leader at GE Healthcare, is also working towards this goal. Biomarkers can give insight into the nature of Alzheimer’s, says Buckley, and this could “help bring about an early stage therapy”.
Therapeutics developed in the coming years may also benefit from improvements in the measurement of outcomes. Current techniques struggle to “see the signal among the noise”, says Lovestone, but biomarkers may also help in this area.
PET imaging of amyloid and cerebrospinal fluid (CSF) testing can be used to measure outcomes but suffer from limited access to scanners and invasiveness respectively. As such, Lovestone is working to develop better tests.