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Antimicrobial Resistance Interagency Task Force
2007 Annual Report (Released June 2008)

Action Items 80—82

Focus Area IV: Product Development

** TOP PRIORITY **

Action Item #80: Identify Ways (e.g., Financial and/or Other Incentives or Investments) To Promote the Development and/or Appropriate Use of Priority AR Products, such as Novel Compounds and Approaches, for Human And Veterinary Medicine for Which Market Incentives Are Inadequate.

Project Title: Evolution of HIV drug resistance mutations in animal models

• Agency: CDC
• Description: The DHAP Laboratory Branch focuses on the development of improved diagnostics for HIV drug resistance surveillance, laboratory investigations on the clinical implications of drug resistant HIV, and studies in monkey models of drug resistance emergence and evolution during chemoprophylaxis and microbicide interventions. Studies also address the development of improved diagnostics for HIV drug resistance surveillance.
• Results: HIVResNet has developed laboratory guidelines on HIV drug resistance using dried blood spot samples. In the process of developing laboratory networks at different levels to meet the need of HIV drug resistance surveillance and monitoring around t

Project Title: Collaborations to facilitate vaccine development

• Agency: FDA
• Description: Collaborations to facilitate vaccine development.
• Results: Participated in and supported international efforts to develop improved vaccines and drugs to prevent multi-drug resistant TB. For example, scientists from the LMDCI have participated in a project (funded by the Biotechnology Engagement Program) that is focused on developing a new class of drugs against TB. This research is being conducted in collaboration with Russian scientists and chemists fromt he Southern Research Institute and investigators at the Albert Einstein College of Medicine, the Aeras Global Tuberculosis Foundation, and NIH in evaluating the safety and effectiveness of new TB vaccines.

Project Title: Support partnerships to promote development of priority AR products

• Agency: NIH
• Description: NIAID brings together leading scientists to share capabilities and expertise in new drug discovery
• Results: NIAID, Eli Lilly and Company, the Infectious Disease Research Institute, and others have begun a not-for-profit partnership announced in June 2007 to promote discovery of new TB drugs especially for resistant cases (www3.niaid.nih.gov/topics/tuberculosis/Research/lilly.htm/).

Project Title: Inclusion of many aspects of AR as Biodefence

• Agency: NIH
• Description: Study of the spread of antibiotic resistance, mechanisms of resistance and development of strategies to recover use of existing antibiotics
• Results: Example of recent award include: Microbiotix Inc. "Bacterial DNA helicases: Targets for novel antibiotics."

Action Item #82: Continue Ongoing Approaches that Streamline the Regulatory Process, Including Clinical Trials and Enhanced Pre-Clinical Studies (e.g., Use of Pharmacokinetics and Pharmacodynamics Data) To Help Bring AR Products (Including Drugs, Vaccines, Diagnostics and Devices) To Market as Efficiently and As Rapidly as Possible, While Still Assuring Their Safety and Efficacy.

Project Title: Meningitis Vaccine Project (MVP)

• Agency: FDA
• Description: MVP is a combined WHO Program for Appropriate Technology in Health (PATH) project to develop affordable meningococcal conjugate vaccines for Africa.
• Results: CBER-PATH Cooperative Research and Development (CRADA) resulted in development of novel efficient conguation technology and tech transfer to Serum Institute of India. Vaccine currently in phase 2-3 trials in Africa. Additional CBER research supporting immunologic assays to evaluate vaccine efficacy. This consortium of public, private, and non-profit organizations, and a philathropic organization (the Gate Foundation) will develop a vaccine that is critically needed in Africa.

Project Title: Regulatory requirements – industry and scientific community

• Agency: FDA
• Description: Clarify FDA regulatory requirements to both industry and the scientific community.
• Results: 1)Presented regulatory requirements for tests used in AR initiaties to the Professional IVD Roundtable twice yearly. Discussed obstacles/issues that might exist in technology transfer; 2)CDRH assisted device manufacturers in the most efficient way to get an alternative method for detecting vancomycin resistance in S. aureus to market; 3)preliminary stages of esubmission for AST devices to promote a faster more efficient means of presenting data for a 510(k) review process; 4) 4/10/06 FDA published guidance document to ensure the safe & effective use of in vitro diagnostics for detecting novel influenza A; 5) 2/3/06 FDA cleared new assay submitted by CDC for the detecting human infection with H5 Avaian Flu virus; 6) other approvals:10/18/06 MASTALEX-MRSA rapid test for confirming Methicillin Resistant Staph aureus;12/12/06, Smart GBS Dx System rapid DNA test for detecting Group B strep in pregnant women; 2/14/07 ImmunoCard STAT EHEC rapid test for detecting Shiga toxins 1 & 2 produced by E.coli in stool to aid in the diagnosis of diseases caused by enterohemorrhagic E.coli (EHEC).

Project Title: HIV Drug Resistance Genotype Assay Guidance

• Agency: FDA
• Description: Revised guidance on HIV Drug Resistance Genotype Assays. Significantly reduces the extent of studies required for clearance.
• Results: Published now.

Project Title: TB meeting with EMEA

• Agency: FDA
• Description: A working group with representatives from FDA and EMEA met to discuss strategies for developing drugs for TB, a disease in for which resistance is a significant problem.
• Results: Meeting was held in early Spring 2008.

Project Title: Guidance to Industry: Use of Noninferiority Studies to Support Approval

• Agency: FDA
• Description: This guidance made recommendations on the appropriate use of noninferority studies to approve antimicrobial drugs, with an emphasis on acute bacterial sinusitiis, acute otis media, and acute bacterial exacerbations of chronic bronchitis, indications for which overuse of antibiotics is common.
• Results: Draft guidance published 10/12/2007.

Project Title: Guidance to industry: Acute Bacterial Sinusitis - Developing Antimicrobial Drugs for Treatment

• Agency: FDA
• Description: This document provided guidance on the development of drugs for ABS, a less serious, self-limited infection. Emphasis was placed on the importance of conducting meaningful clinical trials that adequately support approval. Overuse of antibiotics in infections such as these leads to the development of resistance.
• Results: Draft guidance published 10/29/2007.

Project Title: Guidance to Industry: Acute Bacterial Otitis Media - Developing Antimicrobial Drugs for Treatment

• Agency: FDA
• Description: This document provided guidance on the development of drugs for acute bacterial otitis media, a less serious, self-limited infection. Emphasis was placed on the importance of conducting meaningful clinical trials that adequately support approval. Overuse of antibiotics in infections such as these leads to the development of resistance.
• Results: Draft guidance published 1/17/2008.

Project Title: Guidance to Industry: Malaria - Developing Drug and Nonvaccine Biologics for Treatment and Prevention

• Agency: FDA
• Description: This document provided guidance for the development of drugs for malaria, a disease for which the development of resistance is a major concern.
• Results: Draft guidance published 6/2007.

Project Title: Advisory Committee Meeting: Developing therapies for the treatment and/or prevention of disease caused by Shiga toxin-producing bacteria.

• Agency: FDA
• Description: Meeting to dicuss challenging clinical development issues for a bacteri8al disease that occurs in sporadic outbreaks and is particularly difficult to study.
• Results: Meeting held on 4/12/2007.

<— Previous Section: Action Items 73–79

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