CaSSS Northeast Regional Forum 2021

CaSSS Northeast Regional Forum 2021

Date: March 23, 2021, 11 a.m. EDT

Location: Virtual

The 2021 CaSSS Northeast Regional Forum - titled "CMC ASAP: Accelerated and Streamlined CMC Development for Emerging and Rare Diseases" - is co-chaired by Chi-Ting Huang, CTH Consulting and Jennifer Schlegel, Magenta Therapeutics.

CMC development is often rate limiting for initiation of first in human studies, continuation to late stage development, and ultimately commercialization. The challenge is particularly acute for emerging and rare disease indications. Developing efficient and streamlined CMC strategies are imperative to quickly delivering therapeutics and diagnostics to patients while maintaining patient critical safety and quality standards.Planned Topics:

• Strategies for rapid development across CMC functions
• Robust and efficient assay development throughout product lifecycle
• Leveraging past-experience to optimize process development strategies (e.g., process analytical tools)
• Regulatory-CMC considerations for accelerated development
• Diagnostic kit development

Biologics Consulting consultants will be attending this virtual event.

2021-03-23 The 2021 CaSSS Northeast Regional Forum - titled "CMC ASAP: Accelerated and Streamlined CMC Development for Emerging and Rare Diseases" - is co-chaired by Chi-Ting Huang, CTH Consulting and Jennifer Schlegel, Magenta Therapeutics. CMC development is often rate limiting for initiation of first in human studies, continuation to late stage development, and ultimately commercialization. The challenge is particularly acute for emerging and rare disease indications. Developing efficient and streamlined CMC strategies are imperative to quickly delivering therapeutics and diagnostics to patients while maintaining patient critical safety and quality standards.Planned Topics: • Strategies for rapid development across CMC functions • Robust and efficient assay development throughout product lifecycle • Leveraging past-experience to optimize process development strategies (e.g., process analytical tools) • Regulatory-CMC considerations for accelerated development • Diagnostic kit development Biologics Consulting consultants will be attending this virtual event. America/New_York CaSSS Northeast Regional Forum 2021 Virtual