Alliance Between Pharma and Nonprofits to Speed Development of Tuberculosis Therapies - Pharmaceutical Technology

Latest Issue
PharmTech

Latest Issue
PharmTech Europe

Alliance Between Pharma and Nonprofits to Speed Development of Tuberculosis Therapies


ePT--the Electronic Newsletter of Pharmaceutical Technology

AstraZeneca, Bayer, Sanofi, Tibotec, TB Alliance, and the World Health Organization agreed to share information on tuberculosis (TB) compounds within their respective drug pipelines, according to the Critical Path to TB Drug Regimens (CPTR). The purpose of the agreement is to promote information sharing around scientific and clinical studies so that partners can identify opportunities to test compounds in combination. Under the agreement, if two or more organizations choose to work together to further develop a regimen, they will enter into a separate arrangement that defines the rights and responsibilities of each party.

“Today’s announcement will accelerate efforts to simplify and improve TB drug regimens,” said Mel Spingleman, president and CEO of TB Alliance, in a press release. “It is critical that we decrease the complexity and duration of treatment, make the treatment of multidrug-resistant TB significantly easier and more tolerable, and make new regimens available to all those who need them as quickly as possible.”

CPTR is working closely with regulatory scientists at FDA, EMA, and other regulatory bodies in China, India, and African countries to develop the tools that will allow testing of new TB drugs in combination. The group’s goal is to shorten the development timeline. Under the leadership of the Critical Path Institute, CPTR’s Regulatory Science Consortium focuses on establishing consensus about preferred standards, methods, and tools for developing new TB drug regimens, and on obtaining official acceptance from international regulatory authorities. CPTR was cofounded by the Bill & Melinda Gates Foundation, the Critical Path Institute, and the TB Alliance with the purpose of fostering collaboration to reduce the time it takes to develop novel TB drug regimens, regardless of sponsor.

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
38%
Breakthrough designations
13%
Protecting the supply chain
38%
Expedited reviews of drug submissions
13%
More stakeholder involvement
0%
View Results
Jim Miller Outsourcing Outlook Jim Miller Health Systems Raise the Bar on Reimbursing New Drugs
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerThe Mainstreaming of Continuous Flow API Synthesis
Jill Wechsler Regulatory Watch Jill Wechsler Industry Seeks Clearer Standards for Track and Trace
Siegfried Schmitt Ask the Expert Siegfried SchmittData Integrity
NIH Translational Research Partnership Yields Promising Therapy
Clusters set to benefit from improved funding climate but IP rights are even more critical
Supplier Audit Program Marks Progress
FDA, Drug Companies Struggle with Compassionate Use Requests
USP Faces New Challenges
Source: ePT--the Electronic Newsletter of Pharmaceutical Technology,
Click here