Innovation in drug development remains a key challenge, says Tufts
Drug development cycle times have not improved, costs continue to increase and drug development has become riskier than ever
Although pharmaceutical companies have long aspired to improve drug development efficiency, the process remains highly inefficient and fraught with delays and rising costs, according to R&D leaders participating in a roundtable recently hosted by the Tufts Centre for the Study of Drug Development.
‘Drug development cycle times have not improved, costs continue to increase and drug development has become riskier than ever; only 11.8% of products that enter clinical testing receive regulatory approval, which is about half the rate of the 1990s,’ said Ken Getz, Associate Professor and Director of Sponsored Research at Tufts CSDD.
He added: ‘The pay-off for companies that can reduce clinical time and cost is potentially large, as our research has found. For example, a 10% improvement in cycle time and success rates can shave US$634m off the total capitalised cost of the $2.6bn required, on average, to bring a new drug to market.’
Roundtable participants noted that several factors are converging to alter traditional practices and processes to improve efficiency, performance and success rates. They include the emergence of engaged and empowered stakeholders, including patients and advocacy organisations, new technologies and analytical techniques that capture and integrate real-time, patient-level data with life sciences data, and a push by payers, patients, clinicians and healthcare delivery networks for more cost-effective care.
Other points made at the Tufts CSDD Executive Forum include the following:
- Mobile and wearable technologies are gaining ground as operational tools because they can be used within existing trial frameworks with minimal disruption and used across multiple therapeutic areas and geographies.
- Big data has great potential to deliver value, but key questions need answering. Who owns the data and who can use it? Who will pay to integrate it?
- Although strategic partnerships between sponsors and CROs are projected to grow by 11% between 2013 and 2020, many of the benefits of partnering have yet to be realised, as sponsor-CRO relationships still tend to be more transactional than strategic.
The next Executive Forum, on patient retention and recruitment, will be held on 12 November at Tufts CSDD.
