The years of declining R&D productivity will be a thing of the past according to The Tufts Center for the Study of Drug Development Outlook 2006 report on drug and biotech development trends. "Key to improving R&D productivity is the willingness of drug developers to use new discovery tools, such as pharmacogenomics, to accelerate the pace of translating basic research into viable drug candidates, and the aggressive management of clinical trials, through advanced data analysis and outsourcing, to lower cost sites around the world," said Tufts CSDD Director Kenneth I. Kaitin. "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. It's a tall order, but it can be done," Mr. Kaitin continued.
With the cost and complexity involved with drug development, many companies have concentrated their Resources on fewer projects resulting in fewer new drugs approvals in the U.S. According to Tufts CSDD, only 58 new drugs in 2002-04 received marketing approval from the FDA, a 47% drop from the peak of 110 new drugs in the 1996-98 periods.
Mr. Kaitin noted that the research-based drug industry faces significant challenges, among them: safety concerns in the U.S., which have made regulators more cautious about the drugs they approve; increasing public anxiety over the industry's ability to develop new vaccines in sufficient quantities at the right time to fight potential pandemics; and ever rising end-user drug prices, which have fueled public distrust of the industry.
Some imminent trends cited in the Tufts CSDD's Outlook 2006 report include more licensing and development agreements, advanced clinical technologies, FDA's support of the industry, accelerated vaccine development, and more Rx-to-OTC switches.
The Tufts study claims that drug developers, in order to boost R&D productivity, will increasingly rely on licensing and outsourcing strategies as well as co-development agreements between large and small firms. Also, the use of e-clinical technologies will grow rapidly at investigative sites, driven to some degree by increased regulatory support for data exchange standards, consolidation in the vendor market, and improved functionality and technical support for e-technology.
Additionally, the Tufts report maintains that the FDA will increase its demand and capacity for monitoring industry post-marketing commitments, while encouraging drug sponsors to formulate and implement their own risk management plans. Also, biotech companies developing therapeutic and vaccine products will increasingly seek U.S. fast track designation to help accelerate clinical development programs, according to the report. Lastly, as pressure mounts on the FDA to allow more Rx-to-OTC switches, it will be essential for Pharma companies to develop new prescription drugs.