Advances in delivery technologies are rapidly expanding what’s possible across genetic medicines and complex therapeutics, but translating these innovations into clinical reality depends on more than promising science. Chemistry, manufacturing, and control (CMC) considerations often become the defining factor in whether a program progresses smoothly or encounters delays.
This panel brings together experts across formulation, platform development, and delivery strategy to discuss how real-world CMC decisions are made for complex systems. Through practical examples and candid discussion, panelists will explore challenges such as scalability, analytical method development, control strategies, and defining product-specific critical quality attributes.
Topics will include:
- Aligning early development with realistic timelines and manufacturing constraints
- Establishing robust analytical methods and demonstrating product quality
- Managing impurities and ensuring consistency across scale
- Designing risk-based control strategies from clinical to commercial stages
- Navigating the interface between formulation, delivery modality, and final drug product
Featuring:
- Lora Landis (Genetic Medicines / CMC / Polymers)
- Ashley Tong (Platform / Genetic Medicines)
- Markrete Krikorian (Delivery / CMC / N=1 Therapy)
Whether you work in research, development, or manufacturing, this session will provide practical insights into how CMC strategy shapes the path from innovation to clinic.
Speakers
Advances in delivery technologies are rapidly expanding what’s possible across genetic medicines and complex therapeutics, but translating these innovations into clinical reality depends on more than promising science. Chemistry, manufacturing, and control (CMC) considerations often become the defining factor in whether a program progresses smoothly or encounters delays.
This panel brings together experts across formulation, platform development, and delivery strategy to discuss how real-world CMC decisions are made for complex systems. Through practical examples and candid discussion, panelists will explore challenges such as scalability, analytical method development, control strategies, and defining product-specific critical quality attributes.
Topics will include:
- Aligning early development with realistic timelines and manufacturing constraints
- Establishing robust analytical methods and demonstrating product quality
- Managing impurities and ensuring consistency across scale
- Designing risk-based control strategies from clinical to commercial stages
- Navigating the interface between formulation, delivery modality, and final drug product
Featuring:
- Lora Landis (Genetic Medicines / CMC / Polymers)
- Ashley Tong (Platform / Genetic Medicines)
- Markrete Krikorian (Delivery / CMC / N=1 Therapy)
Whether you work in research, development, or manufacturing, this session will provide practical insights into how CMC strategy shapes the path from innovation to clinic.
Speakers