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Antibody Preclinical Development & IND Filing: Nuts, Bolts, Best Practices and Regulatory Strategies
The investigational new drug application (IND) application is an important step in a drug development program, and understanding the requirements for a successful IND filing is utmost 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 (antibodies, antibody-drug conjugates and multispecific antibodies). In this workshop, our highly experienced speakers from industry and the FDA will discuss the necessary preclinical studies for an antibody candidate and the best practices and regulatory strategies for a successful IND package of an antibody candidate.
Outline:
- Overview of antibody-based therapeutics: structure, generation, design, and optimization
- Overview of preclinical development and IND filing requirements for antibody-based therapeutics
- Non-clinical pharmacology considerations antibodies and in vivo disease modeling
- Pharmacokinetic/Pharmacodynamic and bioanalytical considerations for successful IND filings
- Human dose projection through clinpharm quantitative modeling
- Preclinical toxicology studies
- IND-enabling CMC activities
- Clinical Development Plan
- Regulatory strategies and interactions with FDA: Industry perspective & how to prepare for FDA meetings
- The regulatory perspective: the do’s and don’ts and avoiding a clinical hold
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