In pharma risk analysis deals with biologics so all suggestions and concerns from the team are used to create the animal study. For example we recently were working on a drug and we feared it would have a certain side affect so during the animal study we paid closed attention to check for the side effect and it did appear so formulation had to go back and try again. I think it is important to make sure everyone is involved in risk analysis and that it is done early on in the products life.