Thursday 18th September - Main Conference Day Three - ET (Eastern Time, GMT-05:00)
This talk will focus on the steps and procedures necessary to produce a drug product, starting with a biologic drug substance. This is the final step in drug manufacture and the only set of procedures that must be done aseptically. The typical testing procedures for drug product will also be discussed.
- Frank Riske, Ph.D. - Founder and Principal Consultant, Deep Dive Biotech Consulting
- Shahid Uddin - Senior Director, Formulation Development and Laboratory Operations, CMC, Immunocore
- Shahid Uddin - Senior Director, Formulation Development and Laboratory Operations, CMC, Immunocore
- Laurence Whitty-Léveillé, Ph.D - Associate Principal Scientist, Merck & Co., Inc.
Patient convenience and the need for self-administration are fueling the demand for prefilled syringes and autoinjectors for biologics, requiring specialized formulation and fill finish capabilities.
- Samir Mitragotri - Hiller Professor of Bioengineering, John A. Paulson School of Engineering & Applied Sciences, Wyss Institute, Harvard University
- Christina Vessely - Principal Consultant, CMC Analytical and Formulation Development, Biologics Consulting
Subcutaneous delivery of biologics via self-dosing devices is increasingly essential for chronic disease management, yet development remains slow and costly—often requiring years and tens of millions of dollars due to formulation redevelopment and complex clinical trials. A key barrier is the disconnect between drug and device development, regulated under separate frameworks (21 CFR 210/211 vs. 820). This talk introduces an integrated approach for drug and device development from project inception to commercial launch and provide effective toolboxes along the development phases.
- Yu (Eunice) Tang - Executive Director, PharmDev and Manufacturing, Syndax Pharmaceuticals, Inc