Online Safety Community

Gottlieb Targets Drug Development Costs, Clinical Development Efficiencies

Posted 11 September 2017 By Zachary Brennan

www.raps.org/uploadedImages/Site_Setup/Regulatory_Focus/News/2017/07/Gottlieb%20converge.jpg" alt="placeholder+image" />

FDA commissioner Scott Gottlieb on Monday explained to attendees of RAPS’ Regulatory Convergence conference some steps FDA is taking to make the clinical end of drug development more efficient and effective.

Opening with a discussion of the ways in which the gap of time between the discovery of the science behind new treatments and the adoption of such treatments has been shrinking, Gottlieb outlined a few of the ways in which the agency is modernizing its approach to collecting and evaluating clinical information.

And on a day when the discussion of how much it costs to develop a new oncology drug is being hotly debated with the release of a new study, Gottlieb also discussed how the costs of drug development “are also high, and growing.

“There’s been criticism of the various estimates of how much it costs to develop a new drug,” he said, according to the transcript of his speech. “Moreover, on a relative basis, in many cases the costs of early stage drug development has grown at a proportionally faster rate than the cost of late stage drug development. In other words, inflation in early stage drug trials is rising faster than inflation in late stage development.

“By front-loading the cost of drug discovery, the broader biomedical community is making it harder to advance new ideas. It’s economically harder to capitalize the cost of an early stage drug program, relative to funding a later stage project. So frontloading the costs are a recipe for reducing the amount of new ideas that can be advanced.”

 

Read More information: http://snip.ly/6ude0#http://www.raps.org/Regulatory-Focus/News/2017...

Views: 5

Comment

You need to be a member of Online Safety Community to add comments!

Join Online Safety Community

Take our poll!

Take our poll!

Latest Activity

kate smith posted a blog post

Documentation of Employee Discussions is all Important

As with law, the dictum for management is this: What is not documented does not exist. One can look back at the age-old Latin adage to this effect -Verba Volant, Scripta Manent, meaning “what is said flies, what is written stays”. This just about summarizes the need for documentation in organizations.Documentation is at the heart of organizations, because when employees take an organization to court for some strong reason such as termination -and there is no dearth of such lawsuits…See More
Friday
rodriguezcecelia posted blog posts
Friday
John Robinson posted blog posts
Friday
Adam Fleaming posted blog posts
Friday

Forum

Differences between Sap devoloper and Sap technical consultant.?

What are the main Differences between Sap devoloper and Sap technical consultant.?Continue

Tags: training, differences, sap

Started by emmablisa Sep 6.

Black Belt Training Course in Reno

Welcome to MSys Training! We thank you for visiting MSys LSSBB training page. Attend our 4 days Lean Six Sigma Black Belt (LSSBB) training program with 100% pass rate, high quality course material,…Continue

Tags: sigma, six

Started by rodriguezcecelia Aug 25.

QlikView 12.10 Service Release 8 and QlikView Governance Dashboard 2.0.4 now available

Hello all,Qlik announced that QlikView 12.10 Service Release 8 [SR8] is now available on Qlik download site.   SR8 is a…Continue

Started by Madison Quinn Aug 22.

PMP Certification Boot Camp Los Angeles

Welcome to MSys Training, North America’s leading training provider. Read some of our reviews on www.trustpilot.com. MSys’ PMP® program…Continue

Tags: PMP

Started by rodriguezcecelia Aug 22.

Safety - A Prerequisite 11 Replies

Whether working at home or outside, to observe safety should be our pre-requisite. The employer before anything must be sure of the safety of its employees especially the ones working in mines or any…Continue

Tags: products, safety

Started by Enna Henry. Last reply by Tara safe Aug 16.

Badge

Loading…

© 2017   Created by Safety Community.   Powered by

Badges  |  Report an Issue  |  Terms of Service