Welcome to the CMC Strategy Forum North America

The Forum will bring together industry, regulatory, and academic professionals to discuss key emerging CMC issues that affect biotechnology. The topic for 2026 is "Advancing Biomanufacturing and Global Regulatory Modernization". The two-day program features speaker presentations, panel discussions, and networking opportunities that give you the opportunity to engage with fellow attendees in meaningful discussions on the latest CMC updates and issues in biotechnology.

View the scientific program below or click this link to open the scientific program in a new tab. View the full Forum abstract below.

Advancing Biomanufacturing and Global Regulatory Modernization

The 2026 CMC Strategy Forum North America will bring together global experts from regulatory authorities, industry, and academia to discuss advances in biomanufacturing, regulatory modernization, and global regulatory convergence. The two-day interactive program will feature presentations, panels, and networking opportunities designed to promote open dialogue and collaboration across the biopharmaceutical community. The Forum will focus on CMC and regulatory modernization, global harmonization, and science- and risk-based approaches to ensure the reliable supply of quality medicine. Key topics will include phase-appropriate development strategies, emerging manufacturing approaches, and the supporting and evolving regulatory and quality frameworks. A dedicated session on global convergence will highlight experiences from international collaborative initiatives, with a focus on strengthening reliance, work-sharing, and regulatory alignment to accelerate global access to biologic therapies.

Participants will better understand how traditional quality guidelines are being applied within flexible, data-driven, and risk-based CMC frameworks to support innovation and lifecycle agility.

"It is a privilege to present at the CMC Strategy Forum and to exchange insights with professionals from across the biopharmaceutical industry and regulatory agencies." 
—Xiaoqing Hua, CMC Strategy Forum North America 2025 Attendee
"This highly focused conference helped me to learn a lot from great speakers and engaging audiences on novel modality development, control strategy, and regulatory considerations."
—Fang Zhang, CMC Strategy Forum North America 2025 Attendee

Past Event Videos

  • Addressing Convergence at CMC Strategy Forum North America and WCBP

  • Evolution and Impact of the CMC Strategy Forum

  • Why You Should Attend CMC Fora

  • Attending These Conferences Helps Your Career

  • Why is CASSS the Best Place for Global CMC Discussions?

  • Best-Kept Secret in Biotech

  • Witnessing Global Regulators Collaborating

  • Inspiring the Biopharma Community