Virtual Event
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Preclinical Development and IND Filing for Antibody Therapeutics: the Nuts, Bolts and Best Practices
October 14, 2025 @ 8:45 am - 5:30 pm
Virtual Event
The investigational new drug application (IND) is an important step to achieve in antibody-based therapeutics, and understanding the requirements for a successful IND filing is important to ensure fast and efficient development. While the principles and basics are similar across different modalities for an IND filing such as safety studies, there are important aspects that need to be considered for antibody-based therapeutics. In this workshop, we will cover the best practices for a successful IND package of an antibody candidate. Our highly experienced speakers will discuss the preclinical studies for antibody-based therapeutics IND packages.
Topics to be covered:
- Overview of preclinical development and IND filing –requirements for antibody-based therapeutics
- Required preclinical studies for
- Safety assessment
- Pharmacology
- Pharmacokinetics
- CMC (Chemistry, Manufacturing, Control)
- Clinical development plans
- Regulatory strategies and agency interactions
- FDA’s perspective
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