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

Connect with Abzena’s Sr. Director, Scientific Project Leader of Analytical, Dr Eric Miller and Director of Business Development, Dr Elonne Petrin at the upcoming PBSS workshop on Dec. 4th at The Alexandria at Torrey Pines.  The event will be focused on preclinical development and IND filing strategies for ADCs.  Abzena is a sponsor for the event, so please feel free to swing by our tabletop to discuss your antibody-based development program with Eric and Elonne.

Workshop summary:

Commercial clinical pipelines 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 of utmost importance 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

For more information or to register Click Here!