PBSS San Diego: IND Filing for Antibody-Based Therapeutics

Join Attentive Science in San Diego for PBSS on Dec 4

Main Topic::

Preclinical Development and IND Filing for Antibody-Based Therapeutics: Nuts, Bolts and Best Practices

About the Main Topic::

Commercial clinical pipeline of mAbs has vastly increased in recent years; the mAbs based therapeutics in development has been growing at an incredible pace. The investigational new drug application (IND) application is an important step to achieve in mAb based therapeutics, 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 mAb based therapeutics. In this workshop, we will cover the best practices for a successful IND package of mAbs. Our highly experienced speakers will discuss the preclinical studies for mAb based therapeutics IND packages. This workshop will be suitable for novice drug developers and small molecule drug development experts who are interested in mAb therapeutic development.

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

FDA’s perspective by an FDA reviewer: the Do's and Don'ts in an IND