Pharma R&D productivity poised to improve, study says
The willingness of drug developers to use new discovery tools, such as pharmacogenomics, and the aggressive management of clinical trials, through advanced data analysis and outsourcing to lower cost
By on Jan 26, 2006The willingness of drug developers to use new discovery tools, such as pharmacogenomics, and the aggressive management of clinical trials, through advanced data analysis and outsourcing to lower cost sites around the world, are the two main drivers accelerating the pace of turning basic research into viable drug candidates, says Kenneth Kaitin, Tufts CSDD Director.
As drug development has become more complex and expensive, developers have concentrated their resources on fewer projects, says Kaitin. This, in turn, has lead to fewer new drug approvals in the last few years.
Turning this around will require the industry, working with regulators, to embrace strategies and technologies that will enhance development of more complex drugs of high therapeutic value while improving assessments of product safety and effectiveness, he adds. It's a tall order, but it can be done."
Kaitin says as drug development becomes more complex and expensive, developers tend to concentrate available resources on fewer projects, in turn, leading to fewer new drug approvals.
According to Tufts CSDD, only 58 new drugs were approved for marketing by the US Food and Drug Administration from 2002 to 2004. That is a 47% drop from a peak of 110 new drugs approved in the period from 1996 to 1998.
The research-based drug industry faces several significant challenges, Kaitin says, including safety concerns, increasing public anxiety over the industry's ability to develop new vaccines in sufficient quantity and at the right time to fight potential pandemics and rising drug prices, which have fueled public distrust of the industry.
Tufts also predicts drug developers will increase their reliance on licensing and outsourcing strategies and co-development agreements between large and small firms to boost R&D productivity. The group also believes the use of e-clinical technologies will grow rapidly at investigative sites.
In addition, the FDA will increase its demand and boost its capacity for monitoring industry post-marketing commitments and encourage drug sponsors to formulate and implement their own risk management plans, the group forecasts.
Other developments, according to Tufts, will include an increase in the use by US biotech companies of fast track designation to help accelerate clinical development programs for therapeutic and vaccine products.
And the group says more prescription to over-the-counter switches will occur in 2006 with increased pressure on the FDA to allow them.
In a separate study, Tufts says faster drug development speeds can be, at least in part, attributed to the use of contract research organizations (CROs).
Drug sponsors who are more extensive users of CROs, the group says, tend to complete projects faster, especially during the study close-out period, while maintaining quality comparable to submission involving minimal use of CROs.
In addition, projects involving high CRO participation are typically submitted more than 30 days closer to the projected FDA submission date than those with low CRO participation, Tufts says.
The study is based on an analysis of 83 new drug applications and biologic license applications submitted to the FDA between 2000 and 2005. In 2004, the most recent year for which data are available, leading CROs managed nearly 23,000 Phase I-IV studies at 152,000 clinical sites worldwide.
The results of our study challenge the conventional notion that CROs are simply vendors providing capacity for a specific project, says Ken Getz, Senior Research Fellow at Tufts CSDD and author of the study. Clinical outsourcing offers a development speed advantage at comparable quality. And as the volume and scope of clinical research activity worldwide continues to grow, CROs increasingly are providing a workforce that is essential to the long-term viability of the enterprise."
The group estimates that $5.5 billion, or 15%, of global drug development spending, excluding pass-through fees (e.g., central lab costs and investigator grants), went to contract clinical services in 2004. This compares to 12% in 2001.
The group also says overall development spending by sponsors has grown 9% annually since 2001, while clinical development headcount growth has been flat.
To learn more about the studies, visit the Tufts CSDD Web site at www.csdd.tufts.edu .