mation technology would be made scientifically robust through agency-wide adoption of a regulatory science discipline.

Goodman outlined the following areas of scientific emphasis and the vision of success for each:

  • Transform product development—Given calls for a paradigm shift in drug development, Goodman predicted that the process will be radically different upon successful implementation of regulatory science at FDA. He described the ideal process as agile and adaptive to new information, with the ability to consolidate clinical and biological information and identify population subgroups that can uniquely benefit from new drugs, with the ultimate goal of delivering products to patients efficiently and safely. Personalized medicine, diagnostics, biomarkers, innovative clinical trial designs, and combination interventions can all benefit from this change.

  • Identify unmet public health needs—The ability to respond rapidly to a pandemic with prepared countermeasures is crucial to the safety and security of the nation and to the national and global public health. Sound science, technology, and methods are essential for the development of products to respond to global diseases, emerging infectious disease threats, and bioterrorism; vaccines; and diagnostics. An ideal regulatory system will be able to identify innovative products with the potential to address unmet medical needs and provide countermeasures for public health and stability.

  • Focus on regenerative medicine—Stem cells, engineered tissues, and combination products are areas of rapidly emerging technology; however, FDA’s intervention will be necessary to bridge the gap between innovation and the market. Despite limited resources, stated Goodman, FDA recognizes the importance of regenerative medicine and has made an effort to interact with the development community and NIH to consider standards and models in this area. The hope is that such medicines will be successfully developed to treat serious diseases, replace damaged organs and tissues, and create new treatments for diabetes and cardiac and neurogenerative diseases.

  • Modernize predictive science—As with regenerative medicine, FDA has the potential to improve predictive science and translate advances in life science and engineering into practice. With a sound science base and the right resources, the agency can modernize in vitro toxicology and product characterization, rapidly detect pathogens and contaminants in food and medical products, and assess environmental and chemical hazards.



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