Program Director/Principal Investigator (Last, First, Middle): Gurvich, Vadim J. PROJECT SUMMARY The FDA White Paper, published in March 2004 (Innovation or Stagnation: Challenge and Opportunity on the Critical Path to New Medical Products) emphasizes that the applied sciences required for medical product development has not kept pace with tremendous advances in basic sciences. In this comprehensive document, the FDA has identified that at least part of the answer lies in expanded research in pharmaceutical product development and manufacturing science and technology also termed as ?Industrialization?. The main barriers to progress in development of robust manufacturing science lie in the limited fundamental understanding of the complex materials and processes with which the industry must work and with the development, design, scale- up and operation of pharmaceutical processes. To build that understanding and to develop the basic tools needed to substantially advance these domains, the need for a systematic program of research and education has to be established. The research needs to address areas such as the evaluation and incorporation of pharmaceutical materials and components into drug products that are capable of reliable performance based on desired QTPP?s, characterization and measurement of pharmaceutical material properties, the prediction of properties, systematic methodology for identifying and optimizing formulation design that can select from existing components to develop formulations meeting a suite of desired product attributes, systematic methodology for selecting the most appropriate drug product form given the characteristics of the active ingredient and the desired administration profile, the ability to design innovative platform technologies that allow for significant variation in dosing with minor modification of the basic platform formulation and its associated manufacturing technologies, predictive models and design spaces for a suite of high priority unit operations used in active pharmaceutical ingredients and key dosage form production, adapting multivariable control system design approaches as well as optimal control methods for complex process operations, sensor network deployment, trend monitoring, and innovations in manufacturing beyond the conversion to continuous processing such as microprocessing. OMB No. 0925-0001/0002 (Rev. 03/16 Approved Through 10/31/2018) Page Continuation Format Page
Gurvich, Vadim J. PROJECT NARRATIVE The strategic goal of this program is to improve the overall pharmaceutical manufacturing, quality of pharmaceutical products, and the knowledge base by providing scientific support to the US Food and Drug Administration?s Critical Path Manufacturing Sector Initiative. The National Institute for Pharmaceutical Technology and Education is contributing to this goal by developing innovative manufacturing science that improves reliability, safety and quality of drugs and significantly increases efficiency of the process of translating novel drug and dosage form design discoveries into approved marketed therapies. OMB No. 0925-0001/0002 (Rev. 03/16 Approved Through 10/31/2018) Page Continuation Format Page
