Supporting the Development of Biologics Through the IND Enabling Studies and Clinical Phases
Recorded: November 2024
This webinar will discuss how Pharmaron’s global teams are dedicated to advancing the development of biological drugs from discovery to commercial supply. With established capabilities in microbial, mammalian, and viral expression systems, we will outline the journey and key milestones required to move from discovery to candidate selection effectively. We will also detail the steps needed to complete the IND enabling phase of product development and prepare for BLA and MAA submissions to achieve successful regulatory approval.
Agenda
1. Introduction to Biologics
- An Introduction to Biologics and discussion on the desire for speed to Phase 1 Clinical Dosing and Proof of Concept
2. Key Principles and Approaches
- Key Principles and Approaches that Pharmaron apply to support Drug Development through the IND-enabling stages
3. Case Studies
- Case Studies to bring to life the approaches and scientific excellence to balance time and cost without impacting quality
4. Strategies for Regulatory Approval
- Strategies for the onward journey of the product toward BLA and MAA submission for regulatory approval
6. Summary