Sonia Appel
Founder & Principal Consultant Alismere
Sonia Appel has led biotech technical operations for over 20 years, from early pharmaceutical development to commercial molecular diagnostics. She has run multiple scale-up and portfolio expansion projects, successful CMC programs, and placed small molecules and ADCs in the clinic. She is the founder of alismereTM life sciences, a consulting firm partnering with biotech technical operations C-level to create frameworks and develop strategies that drive the execution of technical programs of any complexity.
Seminars
Join this closing discussion session with leaders in ADC CMC and supply chain field to break down the key learnings from the two day’s presentations and discussion. With your fellow speakers and attendees, discuss and debate the opportunities in ADC manufacturing speed to the clinic, navigating supply and quality across outsourcing partners, optimized lyophilization in DP manufacturing and beyond.
As more companies emerge and pivot to enter the field of ADC development, understanding analytical and CMC principles, requirements, and timelines is vital to advance to IND and stay competitive in a busy biopharma ecosystem.
Designed for ADC biotech C-level, CMC, analytical and quality leaders currently in discovery stage, don’t miss this workshop to learn the CMC roadmap and accelerate your ADC development from gene to IND.
Workshop highlights include:
- Outlining and optimizing the CMC timeline to achieve clinical supply readiness and enable patient dosing immediately upon IND allowed-toproceed
- Navigating the process development activities and delving into cell line development, biologic design, linkerpayload and conjugation
- Detailing the core principles of analytical development and specifications
