Ceilidh

Michael Zey
futurist3000@aol.com

  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.

  The comments were made in connection with the release today of the Tufts Center's Outlook 2006 report on drug and biotech development trends.

  "As drug development has become more complex and expensive, developers have concentrated their resources on fewer projects. This, in turn, has lead to fewer new drug approvals in the last few years," said 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."

  According to Tufts CSDD, only 58 new drugs in 2002-04 received marketing approval from the U.S. Food and Drug Administration (FDA), a 47% drop from the peak of 110 new drugs in the 1996-98 period.           NUMBERS OF NEW DRUGS RECEIVING U.S. MARKETING APPROVAL                          (By Year of Approval)          1984-86  1987-89  1990-92  1993-95  1996-98   1999-01 2002-04 Priority  NCEs         38       26       37       31       38       34       26 Standard  NCEs         27       29       37       36       72       48       32 Total  NCEs         65       55       74       67      110       82       58    NOTE: NCEs are new chemical entities, therapeutic compounds that         have never been used or tested in human subjects.

  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.

  Other near-term trends cited in the Tufts CSDD's Outlook 2006 report:  

          --  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.  

          --  Use of e-clinical technologies will grow rapidly at                 investigative sites, propelled in part by increased                 regulatory support for data interchange standards,                 consolidation in the vendor market, and improved                 e-technology functionality and technical support.  

          --  The FDA will increase its demand and boost its                 capacity for monitoring industry post-marketing                 commitments, while encouraging drug sponsors to                 formulate and implement their own risk management                 plans.  

          --  Biotech companies developing therapeutic and vaccine                 products will increasingly seek U.S. fast track                 designation to help accelerate clinical development                 programs.  

          --  More prescription-to-over-the-counter switches                 (Rx-to-OTC) will occur in 2006 as pressure grows on                 the FDA to allow them.  

  About the Tufts Center for the Study of Drug Development  

  The Tufts Center for the Study of Drug Development (csdd.tufts.edu) at Tufts University provides strategic information to help drug developers, regulators, and policy makers improve the quality and efficiency of pharmaceutical development, review, and utilization. Tufts CSDD, based in Boston, conducts a wide range of in-depth analyses on pharmaceutical issues and hosts symposia, workshops, and public forums on related topics, and publishes the Tufts CSDD Impact Report, a bi-monthly newsletter providing analysis and insight into critical drug development issues.

Tufts Center for the Study of Drug Development Peg Hewitt - 617-636-2185 peg.hewitt@tufts.edu or Business Communication Strategies Peter Lowy - 781-326-9980 lowy@bus-com.com

01/17/2006 09:00 ET