Science Events in Seattle
Stay up-to-date with all of the life science events taking place in the Seattle area with the Science in Seattle events calendar! From academia to industry and biotech to pharma, our events calendar is your complete source for life science conferences, symposiums, networking, and workshops in Seattle. We even cover science pub nights and science fundraisers!
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Preclinical Development and IND Filing for Antibody Therapeutics: the Nuts, Bolts, and Best Practices
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, and CMC (Chemistry, Manufacturing, Control)
Clinical development plans
Regulatory strategies and agency interactions
FDA’s perspective
