Decision Resources, a research and advisory firm focusing on pharmaceutical and healthcare issues, found while most of the biomarker-drug success stories are in oncology, biomarkers play a critical role in pharmaceutical development of chronic conditions and their use in clinical trials of drugs outside of oncology is building.
The strategic insights report, Driving Drug and Diagnostic R&D: The Influence of Biomarkers Beyond Oncology, finds through biomarkers, upcoming chronic disease drugs will target new mechanisms of action, address niche subpopulations and fill the need for safer and more effective treatments. Biomarkers, when placed at the core of R&D programs, can reveal essential information about the drugs in development and/or the target populations.
According to the report, an analysis of ongoing clinical trials using biomarkers reveals a plethora of opportunities for drug R&D in a number of non-oncology therapy areas. Collectively, there are more clinical trials and deals over the last five years involving biomarkers for non-cancer indications than those focusing solely on cancer indications. For instance, all of AbbVie's trials using biomarkers are in non-cancer areas, as are more than half of all biomarker-focused trials sponsored by Merck, Roche, GlaxoSmithKline and Pfizer. While most active clinical trials involving biomarkers are in earlier phases, biomarkers in late-phase trials support label extension or evaluate long-term safety.
"With the advances in biomarker research and in improved diagnostic imaging capabilities, the most notable impact of biomarker-involved drug development, outside of oncology, will be in central nervous system disorders," said Prachi Vora, M.P.H, Decision Resources analyst. "The incorporation of biomarker pathology in the inclusion criteria for a trial of Eli Lilly's solanezumab, an emerging therapy in Alzheimer's disease, is a key step toward mainstreaming biomarkers in CNS therapies."