Mark Brunswick

Mark Brunswick, a former FDA reviewer and current head of regulatory affairs at Arena Pharmaceuticals Inc., explained that some "FDA speak" is caused by the fact that the agency may be reviewing an application that is similar to yours, and they may have seen problems with it that they'd like you to avoid, but they can't tell you because of confidentiality conflicts.
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Brunswick noted that it's also important to bring the right people to the meeting, adding that regulatory professionals are preferred because CEOs tend to have "selective hearing."He also said patient advocacy representatives can be an important ally - especially in today's safety-conscious environment - because they can "sway agency opinion by saying 'we are prepared to accept this safety risk.'"
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Yet Brunswick cautioned that the risk of bringing an expert to an FDA meeting is that "you don't know what they are going to say" and "it's very hard to kick them under the table and tell them to shut up" without the reviewers noticing.

Use Your Time Wisely

One mistake often made by young biotechs is to start off a meeting by giving the FDA a standard corporate presentation, Brunswick said."For the most part, they don't care" about your business objectives, so skip ahead to the data in question, he advised.
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The level of communication a company has with the agency may depend, at least to some extent, on the review team, Brunswick said.Some teams stay in constant contact and others just "send the final letter when they are done," he said.

Mark Mark Brunswick, Ph.D., Director, Regulatory Affairs, Elan Pharmaceuticals

Mark BrunswickDirector, Regulatory Affairs, Elan Pharmaceuticals

Mark BrunswickDirector, Regulatory Affairs, Elan Pharmaceuticals

Mark Brunswick, Senior Director, Head of Regulatory Affairs, Arena Pharmaceuticals