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Home Funding News

Industry Day for Advancing Medical Countermeasure Regulatory Science

by Global Biodefense Staff
March 11, 2013

FDA - Advancing Regulatory ScienceThe U.S. Food and Drug Administration will host an Industry Day March 25, 2013 to discuss a Broad Agency Announcement (BAA) for state of the art advancements in technology, materials, processes, methods, devices, and techniques in pharmaceutical regulatory science. 

Proposals will be solicited under the BAA that focus on one or more of the following areas of interest:

Medical Countermeasures for Bioterror Threats
Develop, characterize, and qualify animal models for medical countermeasure development
Identify and evaluate methods to improve availability and reuse of personal protective equipment 
Continued development of electronic data standards and report forms to facilitate rapid assessment of the safety and efficacy of deployed medical countermeasures 
Develop and evaluate high throughput, sensitive, specific, cost-effective methods to detect threat agents, diagnose the disease or condition, and perform broad-based pathogen detection
Improve knowledge of natural history of pathophysiology of human diseases or conditions caused by Chemical, Biological, Radiological and Nuclear (CBRN) agents 
Identify and develop biomarkers that enhance the understanding of the mechanism of action of MCMs, and provide measures of MCM product efficacy 
Determine pathogenesis in relevant nonclinical models and evaluate for predictive value to human condition
General Topics
Develop better models of human adverse responses
Identify and evaluate biomarkers and endpoints for clinical and non-clinical evaluations
Improved computational methods and in silico modeling
Develop and refine clinical trial designs, endpoints and analysis methods
Develop quantitative models and measures of disease progression
Leverage existing clinical trial datasets to identify potential trial endpoints, relationships between clinical parameters and outcomes, clinical utility of biomarkers
Identify and qualify new and improved biomarkers and study endpoints
Develop and evaluate novel approaches for biomarker identification, including ‘omics, systems biology and high throughput methods
Enable development of novel and improved manufacturing methods
Investigate feasibility and value of emerging and improved analytical technologies for evaluating product quality such as Nuclear Magnetic Resonance, mass spec, near infrared or Ramen spectroscopy 
Evaluate applicability of various analytical technologies for determination of the “similarity” of biosimilars to their reference products
Improve methods and tools to detect and measure the properties of engineered nanomaterials and complex dosage forms such as transdermal patches, inhalation delivery systems, and targeted drug delivery systems
Develop sensitive, rapid, high-throughput methods to detect, identify, and enumerate microbial contaminants and validate their utility in assessing product sterility
Develop new approaches such as in vitro and in vivo methods to identify measurable product characteristics
Develop new ways to evaluate gene therapy and antisense therapy products developed in this period of fast-paced scientific progress
Explore the role of wireless and mobile application in new medical therapies and diagnostics
Refine methods for analysis of post-market data, including data mining of spontaneous reports and analysis of electronic health records from accessible large healthcare databases
Harmonize microbiological and chemical analytical methods development and validation across the Foods Program to enhance detection and removal of unsafe contaminants from the food and feed supply

Anticipated funding for the program may range from $200,000 to $6,000,000 dollars subject to congressional appropriations. 

The FDA BAA Industry Day will be held March 25, 2013 in Silver Spring, Md. Pre-registration is required. Further details are available under FDABAA-12-00118. The BAA response date is May 22, 2013

Tags: Animal ModelsBAABiomarkersChemical DetectionEventsNanotech

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