Although it is often thought of as a disease of the past, 1.7 million people die every year from TB.

 

Click for CPTR Summary


Click for CPTR Statement of Principles


Click for Wall Street Journal Article

WSJ

Critical Path to TB Drug Regimens (CPTR)

 

 

With the rapid growth of tuberculosis (TB) as a global problem and the increasing threat of drug-resistant TB strains, speeding the development of new drug regimens for TB is no longer just an option, but a major public health imperative.

The Critical Path to TB Drug Regimens (CPTR) is a broad collaboration of pharmaceutical companies; government, regulatory, and multilateral agencies; donors; academia; advocates; and NGOs that aims to accelerate the development of new, safe, and highly effective tuberculosis treatment regimens with shorter durations of therapy. By forming innovative partnerships, CPTR will significantly accelerate development and delivery of new TB medicines - an urgent public health need - with the goal of saving millions of lives.

Joining the Bill and Melinda Gates Foundation and the TB Alliance as CPTR founding organizations, the Critical Path Institute will provide overall program management for this initiative and lead one component, the CPTR Regulatory Science Consortium.

THE CHALLENGE

TB and Drug-Resistant TB are Major Threats to Global Health:

  • Although it is often thought of as a disease of the past, 1.7 million people die every year from TB.
  • One-third of the world's population is infected with the TB bacterium and approximately 9.8 million people develop active TB disease annually.
  • The rise of drug-resistant TB further exacerbates the global epidemic. Strains of TB that are resistant to all major anti-TB drugs have emerged and drug resistance can be found in every country.
  • Each year, there are more than 500,000 cases of multidrug-resistant and extensively drug-resistant TB world-wide.

Unless these trends are reversed, drug resistance raises the specter of future, untreatable TB epidemics.

OUR GOALS

The CPTR, as a public-private partnership, will work to sharply reduce the treatment time and number of drugs needed for TB - that will:

Develop and promote innovative regulatory science essential for supporting new combination drug development through the CPTR Regulatory Science Consortium, led by C-Path, that includes:

  • Data standards and integration
  • FDA/EMA qualified biomarkers
  • Quantitative disease progression (natural history) models
  • Disease response metrics and assays
  • New pharmacokinetic/dynamic measures of drug interactions

Work to develop new TB drugs in combinations through the CPTR Drugs Coalition, led by the TB Alliance, including:

  • Developing new clinical trial designs
  • Collaborating to test TB drug candidates in combination regimes early in the development process and continuing into late-stage trials using best industry practices and respecting intellectual property rights

Ensure the Initiative's success by providing the adequate infrastructure, through the CPTR Infrastructure, led by the Bill and Melinda Gates Foundation, including:

  • Building clinical trial site capacity for late-stage combination TB drug trials
  • Ensuring global regulatory harmonization
  • Exploring creative new funding streams for combination TB drug trials

PARTICIPANTS

Founding partners:

  • Bill & Melinda Gates Foundation
  • Critical Path Institute
  • TB Alliance

Participating organizations:

  • Anacor
  • AstraZeneca
  • Bayer
  • European and Developing Countries Clinical Trials Partnership
  • GlaxoSmithKline
  • Johnson & Johnson
  • Pfizer
  • sanofi-aventis
  • Sequella
  • Treatment Action Group
  • U.S. Food and Drug Administration

C-Path Regulatory Science Consortium for TB Leadership Team

  • Marietta Anthony, PhD
  • Chris Hanson, CAE, Project Manager