An issue as complex as antimicrobial resistance requires a comprehensive approach that draws upon not only federal agencies and academic researchers, but also industry, healthcare providers, and individual citizens to advance basic and applied research as well as to support public health efforts.
Antibacterial Resistance Leadership Group (ARLG)
NIAID launched the Antibacterial Resistance Leadership Group (ARLG) in 2013, a major new clinical effort to address antibacterial resistance (AR). Studies conducted by the ARLG may include clinical testing of new drugs to treat multidrug-resistant Gram-negative bacteria, evaluating diagnostic devices in clinical settings, evaluating the effectiveness of new antibacterial stewardship programs, and optimizing treatment regimens to reduce the emergence of resistance. The ARLG is drawing on the creativity of the global research community by inviting concept submissions to identify and address AR priorities.
Trans Atlantic Task Force on Antimicrobial Resistance (TATFAR)
TATFAR was created in 2009 with the goal of improving cooperation between the United States and the European Union (EU) in three key areas: 1) appropriate therapeutic use of antimicrobial drugs in medical and veterinary communities; 2) prevention of healthcare and community-associated drug-resistant infections; and 3) strategies for improving the pipeline of new antimicrobial drugs. The outcomes of the task force include recommendations for areas of future cooperation between the EU and the United States presented at the EU-U.S. Summit and published in 2011. NIAID collaborated with the European Commission’s Directorate General for Research and Innovation to organize the 2011 TATFAR workshop on the Challenges and Solutions for the Development of New Diagnostic Tests to Combat Antimicrobial Resistance. U.S. representatives to TATFAR include the U.S. Department of Health and Human Services (co-chair), NIH (NIAID), CDC, FDA and BARDA. View the TATFAR website for the 2011 recommendations report, 2014 TATFAR progress report, and related TATFAR documents.
NIAID supports a variety of Public-Private Partnerships, which are collaborations between public institutions (governmental and academic) and non-governmental agencies (such as large pharmaceutical and small biotechnology companies), that will accelerate research and development of new drugs targeting infectious diseases. Some examples are
- The Lilly TB Drug Discovery Initiative: a multidisciplinary partnership to accelerate the discovery and development of new drugs to fight TB.
- The Global Alliance for TB Drug Development (TB Alliance): a non-profit organization dedicated to the development of new drug regimens for the treatment of drug-resistant and drug sensitive-TB.
- Medicines for Malaria Venture (MMV): a non-profit organization developing new drugs for malaria.
- PATH: an international nonprofit organization whose Drug Development program is working to develop and ensure availability and accessibility of safe and effective new medicines for diseases disproportionately affecting people in developing countries.
- Drugs for Neglected Diseases initiative (DNDi): a non-profit organization developing new treatments for neglected diseases, such as sleeping sickness (human African trypanosomiasis), Chagas’ disease, leishmaniasis, filariasis, other helminth infections, malaria, and pediatric HIV.
Workshops on New Approaches To Prevent and Treat Infectious Diseases
NIAID is committed to discovering new ways to treat and prevent infectious diseases while minimizing the development of antimicrobial resistance. As part of a comprehensive strategy to address antimicrobial resistance, NIAID convenes meetings bringing together representatives from academic institutions, biotech and pharmaceutical companies, non-profit organizations, and other government agencies. Examples include
- Pharmacokinetics-Pharmacodynamics (PK-PD) for Development of Therapeutics against Bacterial Pathogens (2017): In 2017, NIAID hosted a workshop on "Pharmacokinetics-Pharmacodynamics (PK-PD) for Development of Therapeutics against Bacterial Pathogens." The goal of this workshop was to discuss details and critical parameters of various PK-PD methods and identify best practices and approaches for linking to human PK data and drug efficacy analyses. The use of PK-PD analyses to identify efficacious dose regimens may allow more rapid progress to pivotal clinical efficacy studies, which is of significant utility in development of antibacterial drugs. Attendees included experts from academia, industry and government agencies, including FDA.
- Challenges in the Discovery of Gram-negative Antibacterials (2017): NIAID and the Pew Charitable Trusts Antibiotics Innovation Program co-sponsored a workshop focused on antibiotic discovery for gram-negative bacteria, including finding and designing molecules that get into and stay inside these organisms. Additional information about the meeting is available here. Related to this topic, NIAID released a funding opportunity in 2016 to advance therapeutic discovery for gram-negative bacteria.
- Bacteriophage Therapy Workshops (2015 and 2017): In 2015, NIAID co-sponsored a workshop on “Bacteriophage Therapy: An Alternative Strategy to Combat Drug Resistance.” This workshop brought together members of the medical, academic, and commercial sectors, along with representatives of regulatory agencies, to discuss the potential of bacteriophages and related products for therapy and prevention of infectious disease. The goals of the workshop were to provide background on the historical and current uses of phage products in medicine and to identify key challenges and opportunities for development of phage-related products, particularly as they relate to strategies to mitigate antibacterial drug resistance. Additional information can be found here. In 2017, NIAID and FDA co-sponsored a workshop on "Bacteriophage Therapy: Scientific and Regulatory Issues." The workshop discussed different models for use of phage therapy, as well as medical indications, to address drug-resistant infections.
- The Role of the Microbiota Workshop (2015): In 2015, NIAID sponsored the “Role of the Microbiota in Infectious Diseases” workshop to foster further collaboration between those performing basic research characterizing the microbiota/microbiome and the infectious disease research community; identify new and unique strategies for improving the translational pipeline of microbiome-infectious disease research; and discuss key challenges and opportunities for the development of microbiome-based products designed to mitigate infectious diseases.
- Development of New Antibacterial Products: Charting a Course for the Future (2014): NIH and FDA hosted this workshop to explore key issues and challenges related to antibacterial product development and discuss the development of streamlined regulatory pathways for bringing new antibacterial drugs to market.
- Overcoming Bottlenecks Workshops (2012 and 2014): In 2012, NIAID sponsored a workshop entitled “Bridging the Gap – Overcoming Bottlenecks in the Development of Therapeutics for Infectious Diseases.” The workshop brought together leaders in the field of therapeutics to review the current state of product development research, encourage collaboration between seasoned and new investigators, and discuss innovative ways to address product development bottlenecks. Building on the momentum from this workshop, NIAID convened a second meeting in September 2014 entitled, “Overcoming Bottlenecks in Antibacterial Product Development.” This workshop focused on the challenges of developing antibacterial products, with an eye toward finding ways to overcome those bottlenecks.
- Coordinated Development of Diagnostics and Therapeutics Workshop (2014): Immediately following the 2014 Bottlenecks workshop, NIAID sponsored a meeting in collaboration with FDA to explore the challenges, opportunities, and potential impact of rapid diagnostics on the development and use of therapeutics for infectious disease. The aim was to identify strategies to advance the development of rapid diagnostics to enable more focused, streamlined development and rational use of such therapeutics. The topics discussed at both workshops are interrelated, sharing similar regulatory and commercialization challenges. The two meetings, held back-to-back, capitalized on the linked discussion and brought stakeholders together to address these critical areas of need.
- Staphylococcal Vaccine Workshops (2010 and 2013): NIAID co-sponsored these workshops with CDC and FDA. At the 2010 meeting, workshop participants discussed state-of-the-art approaches to developing a vaccine to prevent Staphylococcal infection, obstacles to developing these vaccines, and strategies for determining vaccine effectiveness. In 2013, participants discussed recent developments in staphylococcal vaccine design and mechanisms to overcome staphylococcal vaccine research challenges. (View the 2013 meeting summary.) Staphylococcal vaccines could prevent MRSA infections and reduce the spread of antimicrobial resistance.
- Critical Path for Infectious Disease Therapeutic Targeting Host Pathways (2009): This workshop explored how to treat infectious diseases by targeting host pathways rather than the microbes themselves. NIAID is committed to supporting research on host-targeted interventions to treat infectious diseases. As an alternative to conventional antimicrobial drugs, this novel therapeutic approach could become a powerful new tool in the fight against drug resistance.