Jumpstarting Your Biological & Biosimilar Development: Bringing Cell & Gene Therapies to Agency Submission
April 25, 2019 @ 11:00 am - 12:00 pm
Preclinical safety testing is an integral part of ensuring the successful development of biosimilars & biologics, but how do you navigate this process for these similar but unique products? What special endpoints do you need to consider when developing innovative cell and gene therapies? While biologics follow a process similar to the pharmaceutical IND process, there are key differences.
In this hour-long webinar, Michael Dellogono, Ph.D., will discuss the essentials for developing an effective Preclinical Program to bring biologics to agency submission including, vaccines, cell therapies, and gene therapies; while also touching on how to avoid repetitive testing for biosimilars.
During this presentation he will review:
- Preclinical considerations for vaccines, cell therapies, and gene therapies
- The expectations & requirements the FDA has when reviewing biologics for approval
- The array of preclinical testing & studies required for successful biologics development
- Steps to establish biosimilarity between your product and the reference
- Avoiding common errors/oversights in biosimilar submissions