New drug development still takes 8 years despite faster FDA review, according to Tufts CSDD

Jan 08, 2009

While the U.S. Food and Drug Administration Drug has quickened review and approval of new medicines, the complex nature of diseases for which new therapeutics are being developed has resulted in longer clinical development times, according to the Tufts Center for the Study of Drug Development.

The average time for the FDA to approve new drugs declined to 1.1 years in the 2005-07 period, but longer average clinical phase time means combined clinical and approval time continues to hover around eight years, according to Tufts CSDD.

"Even though the total time to bring new drugs to market has remained essentially unchanged in recent years, drug developers are making progress," said Tufts CSDD Director Kenneth I Kaitin, who made his comments in connection with the release today of the Tufts Center's Outlook 2009 report on pharmaceutical and biopharmaceutical trends.

"Many factors are leading to longer clinical times, including a focus on complex diseases and more complicated development design protocols," he added.

Drug companies have taken steps to speed clinical development, according to Kaitin, including improving project management, expanding use of partnerships and licensing arrangements, and increasing use of surrogate endpoints and adaptive clinical trials.

"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," he said.

Among the near-term trends cited in the Tufts CSDD's Outlook 2009 report are the following:

• 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.

• Continued shortages of experienced personnel, especially among upper level managerial staff, will continue to hamper the FDA's ability to fulfill its mandate, as will advisory committees vacancies depleted by new conflict of interests and public disclosure rules.

• The recent trend of more candidates entering clinical study each year enhances prospects for new monoclonal antibody (mAb) approvals. Currently, 22 mAbs are available in the U.S. and more than 200 are in the pipeline worldwide.

• U.S. payers, including health insurance companies and managed care organizations, will increase their use of formulary management tools to contain costs, particularly with regard to specialty pharmaceuticals.

• Demand for services from contract research organizations (CROs) is expected to grow by more than 15% annually, as sponsors face capacity constraints and a rising volume of large, complex global clinical trials.

Source: Tufts University

Explore further: French hospital plans wine bar to cheer patients' last days

add to favorites email to friend print save as pdf

Related Stories

Body by smartphone

5 minutes ago

We love our smartphones. Since they marched out of the corporate world and into the hands of consumers about 10 years ago, we've relied more and more on our iPhone and Android devices to organize our schedules, ...

The DNA thief

May 31, 2013

Evolutionarily speaking, we humans are doing pretty well. Over the last few million years, we've developed big brains, social structures and more recently, culture, cities, philosophy, airplanes and the Internet. ...

Research casts doubt on theory of cause of chronic fatigue

Mar 21, 2011

A high-profile scientific paper that gave enormous hope to patients diagnosed with chronic fatigue syndrome, and even prompted some to begin taking potent anti-HIV drugs, has been largely discredited by subsequent research.

Discovery halts breast cancer stem cells

Nov 23, 2010

Breast cancer stem cells (CSCs), the aggressive cells thought to be resistant to current anti-cancer therapies and which promote metastasis, are stimulated by estrogen via a pathway that mirrors normal stem cell development. ...

Recommended for you

Exploring 3-D printing to make organs for transplants

Jul 30, 2014

Printing whole new organs for transplants sounds like something out of a sci-fi movie, but the real-life budding technology could one day make actual kidneys, livers, hearts and other organs for patients ...

High frequency of potential entrapment gaps in hospital beds

Jul 30, 2014

A survey of beds within a large teaching hospital in Ireland has shown than many of them did not comply with dimensional standards put in place to minimise the risk of entrapment. The report, published online in the journal ...

Key element of CPR missing from guidelines

Jul 29, 2014

Removing the head tilt/chin lift component of rescue breaths from the latest cardiopulmonary resuscitation (CPR) guidelines could be a mistake, according to Queen's University professor Anthony Ho.

User comments : 0