How long does drug development take? - Pharmaceutical Technology

Latest Issue
PharmTech

Latest Issue
PharmTech Europe

How long does drug development take?


Despite the fact that FDA has quickened its review and approval of new medicines, clinical development is taking longer because of the complex nature of the diseases for which the new therapeutics are being created. The average time for FDA to approve new drugs declined to 1.1 years in the 2005–2007 period, but longer average clinical phase time means that combined clinical and approval time is approximately 8 years.

"Even though the total time to bring new drugs to market has remained essentially unchanged in recent years, drug developers are making progress," says Kenneth I. Kaitin, Director of CSDD. "Many factors are leading to longer clinical times, including a focus on complex diseases and more complicated development design protocols."

Companies have attempted to speed up clinical development by improving project management, expanding the use of partnerships and licensing arrangements, and increasing the use of surrogate endpoints and adaptive clinical trials. Kaitin says: "Still, in drug development, the race — and rewards — go to the swiftest and most efficient drug sponsors; those that can deliver safe and effective new medicines in the shortest time."

The findings come from the Tufts Center's Outlook 2009 report on pharmaceuticals and biopharmaceuticals. Among other trends cited, the report expects that firms will continue globalization of their preclinical and clinical development activities to overcome local capacity constraints, increase speed-to-market and expand their presence in emerging markets.

http://csdd.tufts.edu

ADVERTISEMENT

blog comments powered by Disqus
LCGC E-mail Newsletters

Subscribe: Click to learn more about the newsletter
| Weekly
| Monthly
|Monthly
| Weekly

Survey
FDASIA was signed into law two years ago. Where has the most progress been made in implementation?
Reducing drug shortages
Breakthrough designations
Protecting the supply chain
Expedited reviews of drug submissions
More stakeholder involvement
Reducing drug shortages
70%
Breakthrough designations
4%
Protecting the supply chain
17%
Expedited reviews of drug submissions
2%
More stakeholder involvement
7%
View Results
Eric Langerr Outsourcing Outlook Eric LangerRelationship-building at Top of Mind for Clients
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerRisk Reduction Top Driver for Biopharmaceutical Raw Material Development
Jill Wechsler Regulatory Watch Jill Wechsler Changes and Challenges for Generic Drugs
Faiz Kermaini Industry Insider Faiz KermainiNo Signs of a Slowdown in Mergers
Ebola Outbreak Raises Ethical Issues
Better Comms Means a Fitter Future for Pharma, Part 2: Realizing the Benefits of Unified Communications
Better Comms Means a Fitter Future for Pharma, Part 1: Challenges and Changes
Sandoz Wins Biosimilar Filing Race
NIH Translational Research Partnership Yields Promising Therapy

Click here