Speakers: Tracy Chen, Bert Ho, Kathleen Meyer, Peter Staehr

Details: Webcast Available

Investigational new drug (IND) application is an important milestone that marks the entry of a molecule into clinical development. Knowing the objectives, expectations, and processes of assembling and filing an IND is the key to not only a successful filing but also a promising clinical development path forward. Often, there are cases where too many nice-to-have studies crowd in the package but critical studies/issues are not addressed, and this can lead to significant delays in clinical development.  Additionally, the regulatory environment is changing as rapidly as the industry. Therefore, keeping up to date on the regulatory requirements and the industry’s best practices in different aspects including non-clinical safety, PK, CMC, and clinical plan is paramount.

In this workshop, our speakers highly experienced with IND filings will discuss systemically the preclinical studies required for small molecule IND filings and the nuts, bolts, and best practices for putting together a high-quality IND package, as well as how to interact with various regulatory agencies. Below are the topics to be covered:

• Overview of preclinical development and IND/CTA filing
• Preclinical studies required for IND filing: Safety, DMPK & CMC
• Clinical Development plans
• Interfacing with regulatory agencies including FDA