SCPDG September 10, 2026, Meeting

Presented by

Yan-Bo Yang, Ph.D.

President/CEO

BioPharmaDev, Inc., Corona, CA

Abstract: Many pharmaceutical companies face severe delays or costly setbacks during drug development, often incurring multi-million-dollar losses and losing years of critical time. These failure modes typically stem from key systemic and strategic gaps: the lack of comprehensive know-how planning, an ill-defined regulatory submission pathway, suboptimal submission data quality, disconnected workflows across development phases, inconsistent or poorly characterized active pharmaceutical ingredients (APIs), and a limited understanding of evolving regulatory requirements and agency expectations.

This presentation addresses these critical shortfalls through real-world case studies and actionable industry insights. The session will explore the core pillars of Chemistry, Manufacturing, and Controls (CMC), emphasizing strategic best practices across raw material qualification, analytical method development and validation, specification setting, cleaning validation, study quality management, extractables and leachables (E&L) evaluations, and regulatory inspection readiness. Additionally, the presentation will offer practical guidance on what studies to execute and how to implement them across different stages of drug development, striking an optimal balance between business priorities, technical rigor, and regulatory compliance.

Agenda: This is a hybrid event. On-Site check-in and Networking from 4:00-4:30PM PT. Zoom login will open at 4:15PM PT. Presentations and Discussion will be from 4:30-5:30PM PT. There is no charge for on-site or virtual attendance.

Important Notes: You must register to receive an emailed Zoom link for virtual attendance. You will receive the Zoom link after registration closes.