The concept of personalised medicine – where drugs are tailored to a particular patient's needs or prescribed based on likelihood of therapeutic benefit - emerged in the late 1990s when advances in genomics made it possible to quickly and cheaply analyse a person’s genetic fingerprint.
Outsourcing-pharma.com spoke with Michael Sloan, VP of Business Development at Almac Diagnostics, who said that in addition to opening up the possibility of creating more effective treatments, personalised medicine has changed the drug development paradigm.
“We have seen a significant change in the adoption of biomarkers by pharmaceutical and biotech companies over the last few years,” Sloan said, explaining that “It is typical now that Pharma will require that all new drugs in development will have an associated biomarker.”
He added that the effect is being seen from the very earliest stages of the development cycle though to late stage clinical trials where sponsors and the contractors the work with are using biomarkers for patient enrichment and to support efforts to gain regulatory approval.
“In early phase trials utilising biomarkers for trial enrichment will provide data on the drugs performance in a biomarker positive patient group. This allows the developer to have an early indication of the performance of the drug and the need for a biomarker. If the biomarker hypothesis is correct, it is likely that response rates will be higher in this group thus justifying and de-risking a larger registrational trial.
“Conversely, if there is not a sufficient response rate, it may allow the developer to fail the drug earlier without incurring the burden of a late stage failure.
“Further to this,” Sloan continued “there are many companies now initiating and running Phase III registration studies with a view to launching their compounds with a companion diagnostic.”
Further evidence of the services sector’s focus on diagnostics came last month when Thermo Fisher Scientific cited Life Technologies’ capabilities in diagnostics as one of the key drivers for its planned $13.6bn takeover.
Sloan told us that the proposed mega-merger is another indicator of the progression and the importance of the diagnostics market for drug development going forward.
“From Almac’s perspective, we work with these and many other similar businesses already and we see their commitment to this space as very positive. These acquisitions should lead to more commercialised companion diagnostics which will help to drive the market forward.”