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 Addressing Challenges in Antimicrobial Resistance
Antimicrobial resistance (AMR) is a serious public health threat and a high priority for NIH. NIH/NIAID is committed to address AMR as reflected in our 2014 report on the current status and future directions of our AMR research portfolio. Two areas of critical need are: 1) addressing key bottlenecks that hinder the development of new antibacterial drug, which are needed to replenish a dwindling drug pipeline and 2) the development of rapid diagnostics to enable more focused, streamlined development and rational use of such therapeutics. These two topics are interrelated, sharing similar regulatory and commercialization challenges.
The two workshops described below underscore the importance of considering these topics as parts of a comprehensive strategy to address AMR; however, participants are free to register for one or both of the workshops.
Registration for attendance in person closed on Thursday Sept. 18th at 5pm EDT

Overcoming Bottlenecks in Antibacterial Product Development

September 22-23, 2014
Draft Agenda
The August 2012 workshop sponsored by DMID and entitled “Bridging the Gap – Overcoming Bottlenecks in the Development of Therapeutics for Infectious Diseases” was a resounding success that generated excitement from all stakeholders including the USG, industry and academia.  The participants were in agreement that the conversation should continue and that additional workshops should address specific topics within the original scope.
DMID plans to capitalize on the momentum built from the initial workshop by sponsoring a second workshop that will focus on the challenges in developing antibacterial products, with an eye toward finding ways to overcome those bottlenecks.
The specific objectives of this second workshop are to:
  • Identify the current state of the antibacterial pipeline from the perspective of all stakeholders.
  • Leverage the collective experience of all participants to identify and collaboratively discuss solutions to the many challenges in antibacterial development.
  • Brainstorm on innovative ways to approach antibacterial product development and consider how to leverage existing resources to help advance these new ideas


Coordinated Development of Diagnostics and Therapeutics

September 23-24, 2014

Draft Agenda

This workshop will bring together key leaders in therapeutics and diagnostics development, along with clinicians and representatives of regulatory and reimbursement agencies, to discuss challenges and opportunities surrounding the potential impact of rapid diagnostics on the development and use of therapeutics for infectious disease.  The aim is to identify strategies that could enable a more coordinated development of diagnostic and therapeutic products, in order to target bacterial pathogens and/or drug resistance phenotypes and to reduce the empiric use of antibacterial treatment.  


Topic areas include: 
  1. Diagnostic product use scenarios – what are the settings in which rapid diagnostics would best support therapeutic use / development? (e.g., narrow-spectrum therapeutic treatment of high-risk pathogens, patient enrollment, i.e., “enrichment”, for clinical trials, clinical laboratory pathogen screening/ environmental surveillance), what are key scientific and clinical challenges?
  2. Stakeholder relationships – are developer partnerships feasible or necessary? what are the potential benefits and challenges of creating strategic relationships between developers and/or other stakeholders? (e.g., benefits may include more focused product development, more efficient clinical trials, incentives for commercialization and reimbursement; difficulties may include data sharing, intellectual property, and commercial impact on existing Rx products)
  3. Regulatory path – how do the risk/benefit considerations for regulatory approval impact the product development path for different types of diagnostic products?  (e.g., licensure of a “companion Dx” for therapeutic use vs. creation of diagnostic tests for patient “enrichment” during clinical trial enrollment)



For information on the "Overcoming Bottlenecks in Antibacterial Product Development Workshop", please contact:

Dr. Jane Knisely (, Dr. Rosemarie Aurigemma (, and Dr. Tina Guina (


For information on the "Coordinated Development of Diagnostics and Therapeutics Workshop, please contact:

Dr. Ann Eakin ( and
Dr. Randall Kincaid (



Workshops will be held at 5601 Fishers Lane, Rockville, MD 20852.
There is no fee to attend the workshops but registration is required. Currently only webinar attendance is available. If you would be interested in attending the meeting via webinar, please go to the registration form. Webinar registration is now open. 
Parking and Metro Access
Local participants can park at 5635 Fishers Lane, Rockville, MD 20852 (3 min walk from the meeting site).  Reimbursement for parking will be available at the registration desk.  The meeting site can also be accessed using the Metro. The Twinbrook stop on the Red Line is a 10 min walk from the meeting site.
Closest Lodging 
Hilton Washington DC/Rockville (10 minute walk from meeting site)
1750 Rockville Pike
Rockville, MD  20852
Building Access: Domestic and International Participants
Domestic participants will need a government issued ID (i.e. driver license or government-issued PIV card) to enter the building.
International participants will need to bring their passport and also must complete a form, which is required by US Government security standards in order to gain access to the building. If you are an International participant, please contact us as soon as possible to get the form since this information is needed no later than September 8, 2014.

Last Updated September 04, 2014

Last Reviewed September 04, 2014