Ahmed Bassyouni
Principal Consultant Bassyouni Consulting
Regulatory CMC leader with over twenty-five years of experience in the biotech industry. Expert in the development and execution of regulatory strategy and submissions for all stages of development including marketing applications for ADC, biologic and chemical molecules. Highly experienced in leading global health authority meetings. Regulatory CMC leader for global registration of Kadcyla.
Seminars
Monday 8th March 2027
Unlocking the Regulatory Process from First-in-Human to Biologics Licence Application Submissions
1:30 pm
- Addressing the key requirements for early-stage ADC drug development
- Unlocking attributes necessary for late-stage ADC drug development
- Leveraging health authority interactions to derisk decisions and acceleration to clinic
Monday 8th March 2027
Group Discussion: Unlocking Faster ADC Development Through Smarter Regulatory CMC
2:00 pm
- Exploring how early CMC strategies can help streamline development timelines and reduce regulatory delays
- Discussing the strategies for building robust CMC packages that support faster progression into and through the clinic
- Achieving best practices for process development, analytical control strategies, and comparability planning to facilitate regulatory interactions and accelerate time to market
