Skip to Main Content

RTI uses cookies to offer you the best experience online. By and clicking “accept” on this website, you opt in and you agree to the use of cookies. If you would like to know more about how RTI uses cookies and how to manage them please view our Privacy Policy here. You can “opt out” or change your mind by visiting: http://optout.aboutads.info/. Click “accept” to agree.

Accept
RTI International
  • About
    • Office Locations
    • Executive Leadership
    • Corporate Governance
    • Partner with Us
      • U.S. Government
      • Clients and Funding Agencies
      • Industry and Commercial Clients
      • Foundations and Associations
      • Bilateral Agencies and Multilateral Banks
      • Universities and Academic Research Institutions
      • Suppliers and Small Businesses
    • Commitment to Quality
      • RTI's Client Listening Program
    • Ethics and Human Research Protection
    • Living Our Mission
    • Veteran Opportunities at RTI

    About

  • Practice Areas
    • Health
      • Public Health and Well-Being
      • Health Care Transformation
      • Behavioral Health
      • Health Behavior Change
      • Precision Medicine
      • RTI Health Solutions (RTI-HS)
      • RTI Center for Community Health Evaluation and Economics Research
      • Health Equity
    • Transformative Research Unit for Equity​
      • Equity Capacity Building Hub
      • Social and Economic Justice Research Collaborative
      • Narrative Research and Community Engagement Lab
    • Education and Workforce Development
      • Early Childhood
      • K-12 Education
      • Postsecondary Education
      • Career and Adult Education and Workforce Development
      • Education Policy, Systems, and Governance
      • Education Research Methodologies
      • Education Technologies
    • International Development
      • Energy for Development
      • Environment
      • Global Food Security, Agriculture, and Nutrition
      • Global Health
      • Governance
      • International Education
      • Monitoring, Evaluation, Research, Learning, and Adapting (MERLA)
      • Youth and Economic Opportunity
      • Building Resilience Against COVID-19 in Developing Countries
      • Water
    • Climate Change
      • Clean Energy Technology and Renewables
      • Climate Finance
      • Climate Justice and Equity
      • Climate Planning, Preparedness and Resilience
      • Climate Policy
      • Climate Vulnerability, Adaptation, and Mitigation
      • Economic Impacts of Climate Change
    • Water
      • Food-Energy-Water Nexus
      • Water Quality
      • Water Sector Governance
      • Urban Sanitation
      • Water Service Provider Strengthening
      • Water Resources Management
    • Energy Research
      • Carbon Capture and Utilization
      • Biomass Conversion
      • Natural Gas
      • Energy Efficiency
      • Industrial Water
      • Syngas Processing
    • Environmental Sciences
      • Air Quality
      • RTI Center for Water Resources
      • Urban Sustainability
      • Toxics
      • Climate Change
      • Building Resiliency in the FEW Nexus
      • Climate Change Sciences and Analysis
      • Environmental Policy
      • Environmental Justice
      • Sustainable Materials & Waste Management Solutions
    • Justice Research and Policy
      • RTI Center for Community Safety and Crime Prevention
      • RTI Center for Policing Research and Investigative Science
      • Child Well-Being and Family Strengthening
      • RTI Center for Forensic Sciences
    • Food Security and Agriculture
      • Market Systems Strengthening
      • Food Safety
      • Food and Nutrition
      • Global Food Security, Agriculture, and Nutrition
      • Climate-Smart Agriculture
      • Youth in Agriculture
      • Agricultural Innovation
      • Obesity Prevention
    • Innovation Ecosystems
      • Innovation Advising
      • Innovation for Economic Growth
      • Innovation for Emerging and Developing Economies
      • Innovation for Organizations
      • Research, Technology, and Innovation Policy
      • Technology Acceleration
    • Military Support
      • Military Behavioral Health
      • Military Health and Human Performance
      • Military Sexual Assault, Harassment, and Domestic Violence Prevention

    Practice Areas

  • Services + Capabilities
    • Surveys and Data Collection
      • Survey Design
      • Instrument Development
      • Survey Methodologies
      • Data Collection
      • Establishment Surveys
      • Health Registries
      • Data Analysis and Reporting
      • Research Operations Center
    • Statistics and Data Science
      • Survey Statistics
      • Environmental Statistics
      • Coordinating Centers for Multisite Studies
      • Analysis and Design of Complex Data
      • Biostatistics
      • RTI Center for Data Science
    • Evaluation, Assessment and Analysis
      • Evaluation Design and Execution
      • Advanced Qualitative, Quantitative, and Mixed Methods
      • Evaluation, Monitoring, and Assessment
      • Economic Analysis
      • Evaluating Communication Interventions and Campaigns
      • Evidence Synthesis for Policy and Practice
      • Risk Assessment and Prediction
    • Program Design and Implementation
      • Systems Strengthening and Scaling
      • Capacity Assessment and Building
      • Policy Reform Support
      • Curriculum and Teacher Professional Development
      • Interventions and Prevention Programs
      • Implementation Science
    • Digital Solutions for Social Impact
      • Human-Centered Design of Digital Solutions
      • Digital Product Development
      • Digital Communication Campaigns
      • Digital Data Analytics
    • Research Technologies
      • Survey Technologies
      • Data Management and Decision Support Systems
      • Geospatial Science, Technology, and Visualization
      • ICT for Limited-Resource Settings
      • Mobile Applications
      • Web Applications
      • Bioinformatics
    • Drug Discovery and Development
      • Medicinal Chemistry
      • Molecular Design and Cheminformatics
      • Behavioral Pharmacology
      • Drug Metabolism and Pharmacokinetics (DMPK)
      • In Vitro Pharmacology, Bioassay Development, and High-Throughput Screening (HTS)
      • Isotope Labeling
      • Regulatory Consulting and Support for Medical Products
    • Analytical Laboratory Sciences
      • Bioanalytical and Toxicology Research
      • Forensic Sciences
      • Physicochemical Characterizations
      • Metabolomics
      • Proficiency Testing and Reference Materials
      • Quality Assurance and Regulatory Compliance
      • Microbiology
      • Analytical Chemistry and Pharmaceutics
    • Engineering & Technology R&D
      • Biomedical Technologies
      • Decarbonization Sciences
      • Environmental Exposure & Protection
      • Materials & Environment
      • Sustainable Energy Solutions

    Services + Capabilities

  • Centers
    • RTI Center for Advanced Methods Development
    • RTI Center for Communication Science
      • Communication Research
      • Communication Design
      • Communication Delivery
    • RTI Center for Data Science
    • RTI Center for Education Services
      • Teaching and Learning
      • Education Leadership
      • Peer Learning Networks
      • Strategic Consulting
    • RTI Center for Forensic Sciences
    • RTI Center for Global Noncommunicable Diseases
      • Program Financing & Economics for NCDs
      • Health Systems Strengthening for NCDs
      • Communication Science and Behavior Change for NCDs
      • Implementation Science for NCDs
    • RTI Center for Newborn Screening, Ethics, and Disability Studies
      • Disability Studies
      • Ethics
      • Newborn Screening
    • RTI Center for Water Resources
      • Water Resources Sectors
      • Water Resources Services
      • Water Resources Tools
    • RTI Global Gender Center
    • North Carolina Center for Optimizing Military Performance
    • NCCU-RTI Center for Applied Research in Environmental Sciences
    • RTI Center for Climate Solutions

    Centers

  • Impact
    • Newsroom
    • Insights Blog
    • Events
    • Publications
    • RTI Press
      • About the RTI Press
      • Instructions for Authors
      • RTI Press Collections
    • Projects
    • Global Reach
      • Asia
      • Eastern Europe and Central Asia
      • RTI International India
      • Africa
      • Middle East and North Africa (MENA)
      • Latin America and the Caribbean (LAC)

    Impact

  • Experts
    • Our Experts
    • In-Depth With Our Experts
    • Related News
    • Experts In the Media
    • RTI Fellow Program

    Experts

  • Emerging Issues
    • COVID-19 Research
    • Artificial Intelligence
    • Global Health Security
    • Cannabis Research
    • Opioid Research
      • Interventions for Opioid Use Disorders
      • Preventing Opioid Misuse and Overdose
      • Treating Opioid Use Disorders
    • Policing Research and Investigative Science
    • Drone Research and Application
    • E-cigarette Research
    • Zika Virus Research
    • Integrated Governance

    Emerging Issues

  • COVID-19 Research + Response
  • Global Reach
  • Insights Blog
  • Newsroom
  • RTI Press
  • Publications
  • Partner With Us
  • Careers
  • Facebook IconTwitter IconInstagram IconYouTube IconLinkedin Icon
Impact

Global Alliance for TB Drug Development

  • Home
  • Impact
  • Global Alliance for TB Drug Development

Advancing promising compounds through preclinical and clinical studies for regulatory approval

Found in every country on the map, tuberculosis is the leading infectious cause of death worldwide. Each year, 9.6 million people fall ill from TB and 1.5 million die. The disease disproportionately affects women, children, and those living with HIV infection, and brings with it economic devastation, trapping families and communities in a cycle of poverty and illness. Perhaps more alarming, TB bacteria are becoming increasingly resistant to available drugs, which means the disease is becoming more deadly and difficult to treat.

Current treatment approaches for TB are prolonged, expensive, and sometimes toxic to patients. Treatments for multidrug resistant tuberculosis (MDR-TB) have more in common with cancer therapy regimens than with treatments for other types of infection. Treatment courses can take years, patients may require surgery, and the mortality rate ranges as high as 80 percent.

Despite the rising incidence of TB worldwide, no new drugs for treating drug-sensitive TB and only one new drug for treating multidrug-resistant TB have been introduced to the market in the past 40 years.  

Founding a Public-Private Partnership to Advance the Development of New TB Drugs

In 2000, with support from the National Institute of Allergy and Infectious Diseases (NIAID), we joined the Rockefeller Foundation, the Bill and Melinda Gates Foundation, the World Health Organization, and others in founding a global organization to advance the development of new TB drugs.

The Global Alliance for TB Drug Development, or TB Alliance, is a not-for-profit, product development partnership. Together, the partners aim to find and develop drugs that will shorten treatment for TB, make treatment affordable, and provide patients with drug resistant TB with new options and new hope. Today, the TB Alliance manages the largest pipeline of new TB drugs in history.

Delivering Project Management, Research Consultation, and Regulatory Services

Since its inception, our experts have delivered support to the TB Alliance in several critical areas— including integrated planning, study design, implementation, and monitoring for its lead compound PA-824 and other similar projects. We coordinate clinical, nonclinical, and manufacturing studies, and provide expert assistance with statistical analysis and medical writing. Our experts serve as research consultants and source and coordinate additional research expertise from around the world.

We also provide extensive regulatory support, conducting regulatory due diligence and helping manage communications with the U.S. Food and Drug Administration (FDA)—including authorship and assembling of investigational new drug (IND) and orphan drug applications, and other submissions

Managing Development of a Compound that May Help Treat Multidrug Resistant TB

In 2001, we undertook a key role in developing a compound known as PA-824, which showed promise as a treatment for TB infection. Since then, our experts have coordinated the initial due diligence and early studies on the compound and supported a global program for development of PA-824 that includes 26 institutions in nine countries.

In 2005 we helped draft and supported the filing of an IND application with the FDA, and subsequently supported the advancement of PA-824 through Phase I and II trials. In 2007, a 14-day efficacy study was conducted with tuberculosis patients in South Africa and by 2010 studies were initiated with PA-824 in combination with other drugs, which is the standard for TB treatment.

In 2014, PA-824 became known by the name pretomanid. That year we supported the planning of a Phase III clinical trial of an advanced combination regimen that includes pretomanid, moxifloxacin and pyrazinamide. Known as PaMZ, this is the first-ever drug regimen designed to treat both drug-sensitive and some forms of multidrug resistant TB.

In 2015, PA-824 moved into Phase III trials, and we continue to support the TB Alliance, serving as the regulatory contact with the FDA.  The trial—named Shortening Treatments by Advancing Novel Drugs or STAND—spans more than 50 study sites across Africa, Asia, Eastern Europe, and Latin America. Not only is this study a major milestone in the development of a potential regimen for MDR-TB, it could also help open a regulatory pathway for new combination trials.

Continued Dedication to a Shared Mission

We are proud to continue our service to the TB Alliance, supporting five of its ongoing drug development programs, including pretomanid. Our ongoing work has the potential to extend beyond the fight against tuberculosis to advance global efforts to combat antibiotic and antimicrobial resistance of other bacteria.

The challenges of developing new affordable medicines for the world's poorest populations are significant. But we believe that, by working creatively in partnership with international public and private entities, we can overcome these challenges and, in time, bring badly needed medicines through the drug development pipeline.

Share

Clients

  • Global Alliance for TB Drug Development

Our Experts

Doris Rouse
Doris J. Rouse Vice President, Global Health Technologies
Anthony Hickey Distinguished Fellow, Aerosol and Nanomaterials Engineering

Practice Areas

Global Health Public Health and Well-Being

Services

Regulatory Consulting and Support for Medical Products Quality Assurance and Regulatory Compliance

Interview with TB Alliance Experts

Learn More

Visit the TB Alliance online

Read our report on the economics of TB Drug Development

RTI Logo
Partner With Us
  • US Government
  • Commercial
  • Foundations & Associations
  • Multilateral Donors
  • Universities
  • Suppliers
Site
  • Privacy Policy
  • Security Policy
  • Site Map
  • Terms of Use
  • Accessibility
  • Contact Us
Contact Us
Facebook Icon Twitter Icon Instagram Icon YouTube Icon Linkedin Icon
delivering the promise of science
for global good
RTI Health Solutions RTI Innovation Advisors RTI Health Advance

© 2022 RTI International. RTI International is a trade name of Research Triangle Institute. RTI and the RTI logo are U.S. registered trademarks of Research Triangle Institute.