Urgent need for biomarkers to fix damaged pipeline

By Nick Taylor

- Last updated on GMT

Related tags Alzheimer

Biomarkers are urgently needed to help fix the damaged Alzheimer's drug development pipeline and improve outcomes for patients, according to experts.

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.

 

Inadequate understanding

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​”.

Measuring outcomes

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.

Related news

Show more

Related products

show more

The Right CDMO Can Unlock Faster Drug Development

The Right CDMO Can Unlock Faster Drug Development

Content provided by Lonza Small Molecules | 15-May-2023 | Interview

Drug development presents biotech companies with ever-changing challenges. Enabling a faster end-to-end process requires seamless flexibility and extensive...

SDTM supplemental qualifiers explained

SDTM supplemental qualifiers explained

Content provided by Formedix | 12-May-2023 | White Paper

What are SDTM supplemental qualifiers? In short, these are variables in non-CDISC datasets that cannot be mapped to a variable that matches the SDTM standard....

Plan for success with process liquid and buffer preparation

Plan for success with process liquid and buffer preparation

Content provided by Thermo Fisher Scientific - Process Liquid Preparation Services | 25-Apr-2023 | White Paper

Setting the groundwork for successful scale-up is essential for getting a therapeutic to market quickly and efficiently, but navigating the unknowns associated...

Related suppliers

Follow us

Products

View more

Webinars