The session will discuss the current challenges of static and unstructured PDF-based CMC regulatory submissions for drug applications and the modernization efforts of utilizing structured data for regulatory CMC submissions. The session will address actionable steps companies can take to enable digital transformation to streamline and improve the current process of preparing regulatory CMC submissions. Specifically, the session will provide insights on how industry can incorporate advanced technologies to prepare for emerging global regulatory requirements that will change the CMC regulatory submission and review paradigm. Ultimately, companies will need to modify their internal processes to ensure compliance with new regulatory requirements, but there is less clarity across industry on the roadmap for implementation and how to best navigate a stepwise approach towards modernization. The session will also include a Regulator's perspective to the challenges of PDF-based submissions and the need of digitization, digitalization and automation to readily capture information and effectively utilize modern knowledge management tools. Recently, FDA's Office of Digital Transformation (ODT) has rolled out a series of action plans for technology and data modernization. The session will give an overview of FDA's digital transformation history including some CMC-specific initiatives such as the Knowledge-Aided Assessment and Structured Application (KASA) and Pharmaceutical Quality/Chemistry, Manufacturing, and Controls (PQ/CMC) initiatives to modernize the CMC submission and review process. Together, industry and regulators can leverage technology to collaboratively build towards a future vision of enhanced efficiency, reduced filing timelines, and improved speed to market for critical therapeutics.
13:45 - 14:10: Unleashing the Power of Data Standardization for Optimized CMC Regulatory Information Management and Submissions by Marquerita Algorri and Sheetal Gaiki 14:10 - 14:25: Balancing Data and Narrative with the Use of the Overall Control Strategy by Ciby Abraham, Ph.D. 14:25 - 14:40: Regulatory Consideration on Digital Transformation of the CMC Submission and Review Process by Maotang Zhou, Ph.D. 14:40 - 15:15: Question and Answer/Panel Discussion moderated by Nina Cauchon