Regulatory considerations for vaccine development: talk 2 – clinical regulatory considerations 1

Published on November 30, 2015   33 min

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Other Talks in the Series: Vaccines

My name is Lewis Schrager, I'm Vice President of Scientific Affairs for Aeras. I will be discussing Regulatory Considerations for Vaccine Development. This is talk 2 of a series of vaccine development talks. Talk 1 was given by Dr. Norman Baylor, with a concentration on chemical manufacturing and control issues, as well as pre-clinical regulatory issues. My talk, talk 2, will focus on clinical regulatory considerations.
I need to let you know that the perspectives that I'll provide in this presentation are my own, and are not intended to represent those of the US Food and Drug Administration. I do not work for the US Food and Drug Administration, but in years past I had, I want to make that perfectly clear.
The outline of the talk, in general, will be as follows. We'll start off by talking about investigational new drug regulations or IND regulations. Then we'll talk about the three pathways that are available to attain biological licenses, they are called biological license application or BLA pathways: the traditional pathway, the accelerated approval pathway, and the animal rule. We'll talk about programs that could accelerate the clinical testing, that is, the IND phase and review the BLA phase of these processes. And these accelerated clinical testing and review processes are fast track designation, breakthrough designation, and priority review. We'll touch upon the package insert, just to familiarize it with yourself, given that it's the critical regulatory work product of vaccine development. We'll focus on safety and efficacy concepts as vaccines are tested, and give you the regulator's perspective on these issues. And then we'll touch on a couple of other issues that are important when considering vaccine regulation, one being adaptive trial design, another being developing vaccines for global infectious diseases, and some of the regulatory incentives that entail.

Regulatory considerations for vaccine development: talk 2 – clinical regulatory considerations 1

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