Christopher Spedaliere

Company: Merck & Co.

Job title: Senior Scientist Regulatory CMC

Seminars:

Roundtable Discussion: Reducing Chromatography Dependence Through Smarter Upstream Control 9:45 am

Hear how optimized reaction parameters, buffer systems, and TFF design can reduce or eliminate chromatography steps See case examples where simpler ADCs are purified without added unit operations Evaluate when chromatography remains essential for complex formats and DARspecific separationRead more

day: Day One

Balancing Early Development Flexibility With Regulatory Expectations for ADC Process Development 11:30 am

Understanding what must be locked down before pivotal trials and BLA submissions Exploring what is considered acceptable early-phase deferrals and how to justify them Understanding what the “must-do” aspects of process development are and what can be deferred for IND approval, in order to improve costs and speed of early developmentRead more

day: Day One