Let's look back the past half dozen regulatory heads. Have any had any pharma reg experience. Frightening to say but None. Would FDA hate AMgen if we had a reasonable experienced reghead?
The better question to be asked is whether Amgen should have hired someone fired from lilly to be SVP of RegSafety?
Your answer may depend on whether you measure success by the ability to obtain approval for dangerous drugs that ought not to ever have been approved or, instead, by "doing the right thing."
Everyone at amgen knows the answer to this question. The glaxo marketers want weak regsafety folk so that they can find no safety issues and avoid FDA. It's a sinister strategy to hire or assign unqualified people for leaders hip positions.
Whats so hard about regulatory. All you do is suck up to the fda and kick down to the team and don't let marketing say anything. Even a caveman could do it. Wait, cavemen are doing it in TO
Guess out of the last 5 regualtory heads, how many had industry regulatory experience? You can include our current as he hasn;t.
With so many regulatory failures, it's no wonder why dmab sales continue to be weak. Goldman is making millions shorting our stock down to the low 50s. Sick. Why can't we get Blankfein to run our company? We need the McKinsey consultants to step up and recommend to Kevin to hire some competent people.
Its not just Regulatory Affairs. One would think Amgen would want an endocrinologist or rheumatologist in Clinical Defelopment leading the bone programs - not a nephrologist!
