If we have this new database and all of the adverse events are outsourced? Why is the safety deparmtent still hiring? What do they do if they dont look at safety data or adverse events or even process AEs? Seriously, why are there hundreds of directosr and executive directors in safety if they don't do anything? We don't need them and they add NO value to the teams. They are dead weight
Why is there a safety biostats department? Why isn't regulary biostats enough? Why is there a safety epidmeliogy deparment? Why isn't epidmeiology enough? Why Why Why must Paul have his own company within a companY?
Safety may the most important department in any biopharma company. They bring balance, expertise and sanity to the runaway amibition of (often incompetent) developments leads, marketeers, and other forces within a company. Most are academics at heart, with a genuine heart to 'do the right thing for patients'. When safety goes astray, bad things happen. Viva la safety!
you can dance if you want to the night is young and so am I. but if your friends don't want to dance well, they're no friends of mine.
There isnt a good reason for more headcount when they don't do anything. The real reason for the head count going up and the outsourcing going up is so they can all be VPs. It isnt enough to have eds reporting to eds, paul wants all the safety leads to be VPs and GSO EDs. It's rather crazy but Roger doens't have the experience to know any better. Remember he was a reseracher at merk
Why is there a safety biostats department? Why isn't regulary biostats enough? There is no safety biostats department. There are 2 or 3 people in biostats (part of development) that do safety analysis. But it is not a department at all. Why is there a safety epidmeliogy deparment? Why isn't epidmeiology enough? There is no safety epidemiology department. There ised to be one in the past, but it was merged with the development epidemiology. Why Why Why must Paul have his own company within a companY? And why are you such a missinformed asshole?
Paul runs a company within a company. Look at the redundant headcount. You are a lying piece of crap. Everyone knows all the work is outsourced and he has his own redundant teams like biostats running unvalidated analyses. Trolls like you should just shut up before everyone starts asking questions and you are out the door.
He has a napoleanoic complex. Did you hear him at the odac? I am in charge of regualtory..... I am in charge of safety.... What a question, wait I have David Chang here, a physician here to answer questions. Seriously what a complete joke. Might as well put Stuttering Sean up there and not answer questions. Paul is the Palin of the pharmaceutical industry. Drive a porsche, park with porsches. Ride bikes with Kevin. He da' man.
How many safety functions doing the same thing does one need? Safety TAs, Safety GSOs, Internaiontal safety, Safety scientists, Safety reviewers. That's a lot of MDs when one good one will do. Seriously folks, it is beyond ridiculous. These are the stupidest people and for their fearless leader to brag about the international expansion is shameful. Lets not forget that cases are processed by CROs and safety data reviewed by developement
1. CROs that process cases help a little. They don't do aggregate analysis and they don't understand the benefit side of the risk:benefit equation that defines a drug. 2. Development doesn't even begin to understand the safety reg environment and what is required to maintain compliance. They are biased toward benefit, too much and judgement is clouded. 3. The amount of work required to maintain line of sight on #1 & #2 is very time consuming, and almost always underestimated by those who aren't safety professionals. The entire industry (and the public) is focused on safety. This has to be done right and requires a dedicated, focused group.
Hey r*****. What does safety do? Safety is supposed to process AEs. The CROs do that. Safety is supposed to review data. Clinical does that. Safety has no idea about the safety reg environement. What a load of crap. You have to be a doctor first to review safety data and the safety department has few if any licensed physicians. most are rejects from honduras or some eastern euoropean country. in fact are there any US licenseds MDs in safety anymore aside from those sent from clinical to clean up the deparment. What work is being done if #1 and 2 are not being done. Go away troll and confess your department is full of idiots who know nothing and who do nothing.
We should outsource safety to an independent third party and save a billion a year on Paul's overhead.
Boy are you misguided. We need quality not quantity. If a safety person is working in oncology then the person should know what adjuvant means. These r*****s don't review data and don't have medical licenses. They don't to anything but hold up development beacuse their leader want them to be go against development.
"...beacuse their leader want them to be go against development." Really? Must be another development lead from Amgen trolling the boards...
