The purpose of this Request for Information (RFI) is to solicit informal input from the public and private sectors (e.g. industry, academia, Federally Funded Research and Development Centers (FFRDCs), government laboratories, physician and pharmacist societies, patient-focused research foundations and advocacy groups, and other health care providers) to obtain external input into developing an annual list of regulatory science initiatives specific for antimicrobial products. This input will help the Office of Antimicrobial Products develop the FY2019 Regulatory Science Initiatives.

This RFI seeks research ideas to identify research areas where regulatory science can support new antibacterial drug development in general, by creating new drug development tools or standards for use by industry or other stakeholders, to meet patient needs.

Background

Antibacterial drug resistance is a major threat to public health. FDA’s roles in combatting antibacterial drug resistance include: (1) facilitate the development of new antibacterial drugs to treat patients and

2. advance the science of clinical trial design. The design and conduct of clinical trials to evaluate new antibacterial drugs in patients with serious bacterial infections is challenging. There is a need to immediately begin antibacterial drug treatment. There is often a delay in availability of information regarding the identification and antibacterial susceptibility of the causal pathogen, when isolated. Innovative scientific approaches can help facilitate new drug development as part of efforts to combat antibacterial drug resistance.

Input from internal CDER discussions and from a variety of external stakeholders was taken into consideration in helping the Office of Antimicrobial Products develop the priorities list in previous years. The priorities, external collaborations (e.g., contracts), and information on the public workshops can be found on the on the Office of Antimicrobial Products webpage at: www.fda.gov/OAPresearch.

Information Requested

FDA is interested in research to advance regulatory science to facilitate the development new antibacterial therapies for the treatment of serious bacterial disease, FDA is exploring approaches to help stimulate development programs for antibacterial drugs where limited resources or a lack of incentives is preventing the development of new antibacterial drugs.

Specifically, FDA is interested in research in the following areas:

1. Evaluate potential innovations in clinical trial design for new antibacterial drugs such as enrollment strategies, data collection streamlining, drug development tools,clinical endpoints, and new statistical analytic approaches
2. Advance the science of in-vitro, animal model, and/or pharmacokinetic studies to facilitate antibacterial drug development, including studies focused on drug development for special populations such as patients with unmet need, children and patients with renal or hepatic dysfunction
3. Evaluate the use of rapid diagnostic tests in clinical trials for new antibacterial drugs to enrich enrollment of patients with the condition of interest
4. Advance the science of antibacterial drug susceptibility evaluation
5. Evaluate potential endpoints in clinical trials in the area of unmet medical need

Suggestions for other areas of research are encouraged.

Please note that research proposals should be broadly applicable to antibacterial drug development and not for a specific drug product. For example, recent public discussions have highlighted the need for the d evelopment of a patient reported outcome (PRO) tool for use in clinical trials of new drugs for the treatment of non-cystic fibrosis bronchiectasis.

Responses to RFI

Please include the following information in your response: Introduction/Background:

• Existing institutional expertise, capabilities, and leadership in the field.
• Existing scientific infrastructures supporting research and development activities
• Existing programs that successfully interact with government agencies, international organizations, public or private partners, and other groups (e.g. trade orpatient-advocacy groups).

Research Opportunities:

• Include specific examples of research completed in the area
• Include scientific work conducted to support your proposal
• Include new ideas or approaches for the four specific areas listed above to advance the field