Action Plan — The Focus Areas:
III. Research (Issue C)

C.	Issue: Special efforts are needed to translate research findings into medically useful products for human and agricultural/veterinary use, such as novel antimicrobial therapeutics, diagnostic tests, vaccines and other tools for preventing AR emergence and spread.
	1.	Goal: Address the governmental role in translating novel ideas into new clinically relevant products, focusing on gaps not filled by pharmaceutical industry and other nongovernment groups.
		a.	Action Items
			74.	Explore the need to encourage preclinical studies on the toxicology, pharmacokinetics, and pharmacodynamics of novel therapeutic agents for the treatment of multidrug-resistant pathogens and facilitate the transition of potential products from preclinical to clinical studies leading to development by industry of novel therapeutic agents. Coordinator: NIH Collaborators: DoD, DVA, FDA, USDA Timeline: Begin within one to two years
			75.	TOP PRIORITY ACTION ITEM — In consultation with academia and the private sector, identify and conduct human clinical studies addressing AR issues of public health significance that are unlikely to be studied in the private sector, such as:
					Novel therapies;
					Existing antimicrobials administered in treatment regimens and combinations that may not be included in approved indications and dosing schedules; and
					Other products and practices relevant to the control and treatment of antimicrobial-resistant pathogens including devices, diagnostics, antimicrobial soaps, disinfectants, etc.
				Coordinator: NIH Collaborators: CDC, DVA, DoD, FDA Timeline: Begin within one to two years
	2.	Goal: Develop rapid, inexpensive, point-of-care diagnostic methods to facilitate appropriate use of antimicrobials.
		a.	Action Item
			76.	TOP PRIORITY ACTION ITEM — Identify, develop, test, and evaluate new rapid diagnostic methods for human and veterinary uses with partners including academia and the private sector. Such methods should be accurate, affordable, and easily implemented in routine clinical settings and may include:
					Tests for resistance genes that are associated with drug resistance, including nonculture specimens;
					Rapid point-of-care diagnostics for patients with viral respiratory infections and clinical syndromes such as otitis media, sinusitis, and pneumonia; and
					Rapid methods for detecting drug resistance among fungi, parasites, viruses, and mycobacteria.
			Coordinators: NIH, FDA Collaborators: DoD, USDA, CDC, AHRQ, DVA Timeline: Initiated
	3.	Goal: Develop new products and strategies to prevent and treat colonization and infection with resistant organisms in patients, prevent transmission of resistant infections in the community, and prevent AR emergence.
		a.	Action Items
			77.	TOP PRIORITY ACTION ITEM — Encourage basic and clinical research in support of the development and appropriate use of vaccines in human and veterinary medicine in partnership with academia and the private sector. Vaccines are needed to:
					Prevent viral infections that predispose patients to and are difficult to differentiate from bacterial infection and are presumptively treated with antibacterial agents (e.g., influenza virus);
					Prevent colonization, infection, and transmission of resistant organisms such as enterococci and staphylococci; and
					Prevent common bacterial infections (such as S. pneumoniae, nontypable Haemophilus influenzae) to reduce antibacterial use.
			Coordinators: NIH, FDA Collaborators: CDC, DoD, DVA, USDA Timeline: Initiated
			78.	Encourage basic and clinical research in support of novel approaches to preventing or treating infections with resistant organisms that occur in humans and animals by partnering with academia and the private sector. Novel approaches may include:
					Bacteriophage therapy;
					Active (vaccine) and passive (antibody, hyperimmune globulin) immunization;
					Host-derived antimicrobial agents;
					Nonantibiotic antimicrobials and nonchemical approaches with broad or nonspecific anti-infective activities (e.g., defending and nonspecific immunostimulants, such as defensins, ribozymes, etc.); and
					Microbial ecology (probiotics, direct fed microbials, etc.).
			Coordinator: NIH Collaborators: DoD, DVA, FDA, USDA, CDC Timeline: Initiated

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