Many drugmakers are continuing to improve the operational efficiency of their clinical trials to increase the pace of new product introductions, but these firms’ medium- and long-term success will increasingly depend on their ability to embrace more efficient R&D models, says a new report.
“Pharmaceutical and biotech companies – large and small, established and early-stage – are forging strategic alliances, collaborative partnerships and multi-company consortia,” notes Kenneth Kaitin, director of the US Tufts Center for the Study of Drug Development (Tufts CSDD), which produced the study.
“Early results indicate that sharing knowledge and leveraging resources is helping sponsors find new drugs to treat many of today’s most challenging and complex indications,” he adds.
Dr Kaitin points out that the drug development model has not fundamentally changed since 1962, when US Senator Estes Kefauver and Representative Oren Harris’s Drug Efficacy Amendment established the current standard for clinical testing of investigational drugs in the US.
“Perhaps the greatest gain from clinical design improvements and new partnership models will be the development of industry best practices, which will enable companies to maximise their formidable R&D investment and help ensure future commercial success,” he suggests.
His comments came as Tufts CSDD launched its Outlook 2014 report on pharmaceutical and biopharmaceutical trends, among which it expects the most significant this year to include:
- growing concern over expensive, late-stage clinical development failures, which will lead drugmakers to reassess their use of meta-analyses and subgroup analysis and make more realistic assessments about the likelihood of candidate success;
- accelerated adoption of adaptive clinical trial designs, particularly in earlier clinical phases, as cross-functional teams within sponsor companies look to increase their programmes’ success rates while lowering costs and disruptions from protocol amendments; and
- the US Food and Drug Administration (FDA) will foster greater use of patient-reported outcomes to support labelling claims in drug applications, and make greater use of social media and the Internet to communicate with patients, caregivers and patient advocates.
Sustaining the recent pace of investments in new biotech companies will be a major challenge in 2014, and this will spur further development of alternative financing approaches such as industry-based venture capital groups and patient support foundations, the report goes on.
It also expects to see more approvals of co-developed companion diagnostics and therapeutics, and that diagnostics which lack evidence of positive impact on health outcomes will continue to face reimbursement challenges.