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According to a new report from Tufts Center for the Study of Drug Development (Tufts CSDD), although many pharmaceutical companies are increasing the pace of new products by improving the efficiency of clinical trial operations, their medium- and long-term success will increasingly depend on their ability to support more efficient research and development (R&D) models.
Worldwide, the drug industry is expected to increase it’s investment in R&D by only ~2% per year over the next five years, so it’s not more money but new development paradigms that will help ensure future commercial success.
Kenneth Kaitin, director of the Tufts Center for the Study of Drug Development, said:
Pharmaceutical and biotech companies – large and small, established and early-stage – are forging strategic alliances, collaborative partnerships and multi-company consortia. 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.
The Tufts CSDD Outlook 2014 report highlights include:
- Growing concern over expensive, late-stage clinical development failures will lead firms to reassess their use of meta-analyses and subgroup analysis and make more realistic assessments about the likelihood of candidate success.
- Adoption of adaptive clinical trial designs will accelerate, particularly in earlier clinical phases, as cross-functional teams within sponsor companies look to increase program success rates while lowering costs and disruptions from protocol amendments.
- The U.S. Food and Drug Administration will foster greater use of patient-reported outcomes to support labeling 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, spurring further development of alternative financing approaches, e.g., industry based venture capital groups and patient support foundations.
- More approvals of co-developed companion diagnostics and therapeutics are likely, but diagnostics without evidence of positive impact on health outcomes will continue to face reimbursement challenges.