Overview
Innovations in the development of advanced therapies have yielded new and dynamic solutions for the prevention and treatment of diseases where none existed previously. However, compared to traditional small molecules, advanced therapies present unique CMC challenges that may complicate development. Effective CMC strategies are crucial to the successful development and lifecycle management of these products. Leveraging advances in technology as well as accelerations in development due to the pandemic will enable us to bring even more products to market.
The DIA Advanced Therapies: Innovations in CMC conference will explore common CMC challenges posed by the development of these increasingly complex products. The use of multi-stakeholder perspectives and relevant case studies will provide solutions to enable regulatory compliance, shorter review timelines, and support post-approval maintenance.
Featured
Who should attend?
- CMC Regulatory Affairs
- CMC Writing
- Quality Assurance/Quality Control
- Regulatory Compliance
- Development and Manufacturing
- CMC Project Management
- Rare, Orphan Diseases
- CMC Lifecycle Management
- Biotechnology
Program Committee
-
Kirsten Messmer, PhD, RAC • Senior Research Analyst
POLITICO's AgencyIQ, United States -
Judy Chou, PhD • President and CEO
AltruBio, Inc., United States -
Eliana Clark, PhD • Senior Vice President Technical Operations and Quality
Intellia Therapeutics, Inc., United States -
M. Scott Furness, PhD • Deputy Director, Office of New Drug Products, OPQ, CDER
FDA, United States -
Anthony Bevivino, PhD • Associate Principal Scientist
Merck & Co., Inc., United States -
Sofia Buch, PhD, MSc • Vice President for Cell Therapy CMC
Novo Nordisk A/S, Denmark -
Mia Kiistala • Owner, Principal Consultant
Aurora CMC Consulting, Finland -
Cynthia Schnedar, JD • Principal, Regulatory Compliance
Greenleaf Health Inc., United States -
Cortney Lawrence, PhD • Research Scientist, Global Regulatory Affairs CMC Biotechnology
Eli Lilly and Company, United States
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