The 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