Plenary Session 8 - The Wonders and Woes of Biological Platforms

The need for efficiency and standardization has driven industry and regulators alike to establish the concept of platforms. Based on prior knowledge and clinical needs, a platform approach is tailored to molecular classes, manufacturing and analytical processes, drug delivery and regulatory practices. Common technology, like expression systems, single-use processes, and analytical method instrumentation, can drive adoption of platforms within a company and across industry with significant benefits of speed to development, capital equipment usage, and expedited documentation.

The use of platforms may, however, result in some drawbacks. The strict adherence to a platform can blind both industry and regulators to innovation. Company platforms may remain unaltered despite the efforts of venders, new developments, and startup companies to introduce improvements and advanced technologies. Regulatory authorities become comfortable with established standards putting added pressure on the introduction of new technologies.

This session will dive into regulatory science, the process of discovery and implementation of risk-based science to drive regulation towards enhanced product and analytical development, and lifecycle management. Talks will derive from institutions engaged in the development of novel technology platforms and regulatory paradigms as well as industry and regulatory efforts in this field. Discussion will follow, probing opportunities and hurdles, with the hope of seeing value in and a pathway towards modern biologicals development, regulation, and commercial practices.




Additional Panelist:

Philip Krause, Independent Consultant