Biomedical Engineering and Bioengineering Commons^™

After The License Approval: How Analytics Can Keep You In The Market, Robert Sitrin

Vaccine Technology III

Getting a BLA approved for a new vaccine can be a daunting task, but keeping the market supplied after licensure of a successful vaccine can be an even bigger challenge. Analytics can play an important role in keeping product supplied to the marketplace, especially during the critical launch phase The talk will describe the application of analytical comparability to GARDASIL®, Merck’s novel new vaccine to prevent cervical cancer, in order to bridge product produced by a launch facility to that produced by a scale-up facility without the need for a clinical trial. This effort assured a smooth transition of supply …