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ElMaestro ★★★ Denmark, 2011-01-02 01:22 (5642 d 21:15 ago) Posting: # 6379 Views: 13,729 |
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Dear all, I will remember 2010 for a lot of interesting events; I had the pleasure and privilege to be involved in a lot of activities with different companies -generic and originator- and different products, product classes and formulation principles. In several cases (and I do mean in different companies) I have been involved with dossiers that are not in any way supportive of a marketing authorisation (e.g. due to CI's well outside acceptance region, wrong endpoints, wrong designs etc) and where the only sensible thing is to retract the dossier. Sometimes this is painfully clear very early. But in reality I see these dossiers pushed forward to the bitter end with numerous rounds of deficiency letters and responses that don't move much. And here's the schism: The guys who work on these projects often know quite early that the dossier has zero chance, but they also know that the decision to euthanise the project is taken by a guy way up the corporate ladder who does not get into boring details such as the scientific arguments on which regulators are basing their negative decision, and that guy is going to ask a simple yet extremely important question before trashing the dossier: "Have you folks done everything you can to save the product?". People on the projects can get fired if they don't answer yes. And therefore people on the projects who know that question is coming feel they are forced to carry on way, way beyond reason. As a result I think a lot of time and resources are going wasted. Not only within companies but as a consequence also within agencies. Observe along these lines also that CMDh in Europe recently decided that referrals can only take place if the RMS is positive. A strong signal in my opinion. On one hand I think it is really sad occasionally to see things carried forth to a bitter end in cash-burn mode when the end could be reached sooner and cheaper. On the other hand, I also understand¹ why management would like to know if everything has been done etc. Do you agree about this schism? If yes, how could this issue be addressed? Let me hear some thoughts, please. Happy new year. EM. ¹: In this regard please don't assume that I agree when I say I understand. Please also don't assume that I disagree. |
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Helmut ★★★   Vienna, Austria, 2011-01-02 01:52 (5642 d 20:45 ago) @ ElMaestro Posting: # 6380 Views: 12,068 |
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My capt’n! Sad story, but I don’t see a schism here (who’s left?), but a rapid decline in business practice.¹ I recommend this nice article² as a sort of Vademecum. What do you think about radically advancing our consultancy rates and closing this forum ASAP? ¹ Do you know the Peter Principle? ² People are more likely to take advice when they have to pay for it. Employees ‘are for free’ and therefore not listened to. — Dif-tor heh smusma 🖖🏼 Довге життя Україна! ![[image]](https://static.bebac.at/pics/Blue_and_yellow_ribbon_UA.png) Helmut Schütz ![[image]](https://static.bebac.at/img/CC by.png) The quality of responses received is directly proportional to the quality of the question asked. 🚮 Science Quotes |
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ElMaestro ★★★ Denmark, 2011-01-07 15:38 (5637 d 07:00 ago) @ Helmut Posting: # 6403 Views: 12,024 |
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Dear HS, ❝ What do you think about radically advancing our consultancy rates and closing this forum ASAP? I like the idea of higher fees. But I think it might be too early to close the forum as I may have ID'ed some new land we need to conquer. "Get a pack of our new LungBuster Cigars - Guaranteed to kill you just as slowly as all the others do!" © ElMaestro 2011. I will sell the rights to that slogan for 10.000 Euros. I will furthermore design a regulatory pathway for qualification of the claim for 20.000 Euros. EM. |
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Helmut ★★★ Vienna, Austria, 2011-01-07 16:51 (5637 d 05:46 ago) @ ElMaestro Posting: # 6404 Views: 12,105 |
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Dear ElMaestro! ❝ […] as I may have ID'ed some new land we need to conquer. Unbelievable. "Substantially equivalent"! Let's see whether I have some pre-2007 packs of Camels which may act as a reference. Then let's set up a proper in-vivo protocol: nicotine (challenging half-life, might miss Cmax easily), tar (lung biopsies?), PD surrogate carboxyhaemoglobin? ❝ "Get a pack of our new LungBuster Cigars - Guaranteed to kill you just as slowly as all the others do!" Nice slogan.  — Dif-tor heh smusma 🖖🏼 Довге життя Україна! Helmut Schütz The quality of responses received is directly proportional to the quality of the question asked. 🚮 Science Quotes |
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d_labes ★★★ Berlin, Germany, 2011-01-07 17:00 (5637 d 05:37 ago) @ ElMaestro Posting: # 6405 Views: 12,007 |
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My dear Pirate! First I had thought this must be a joke  , but it seems authentic! That reminds me strongly on the old days of Prohibition.Hopefully the Seven seas are not under the FDA jurisdiction  .BTW Concerning the Subject: I had thought Grass was already prohibited in "HohesA"? Greetings. The Last Smoker in Berlin (smiley just stolen from Helmut) |
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Helmut ★★★ Vienna, Austria, 2011-01-07 17:39 (5637 d 04:58 ago) @ d_labes Posting: # 6406 Views: 15,162 |
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Dear D. Labes! ❝ That reminds me strongly on the old days of Prohibition. Ha! What do you expect from a country where the majority believes in conspiracy theories, UFOs, and intelligent design and where hypocrisy is considered a serious hobby. Everything is connected: have you ever heard about the Bureau of Alcohol, Tobacco, Firearms and Explosives‽ ![[image]](https://upload.wikimedia.org/wikipedia/commons/thumb/5/54/US-DrugEnforcementAdministration-Seal.svg/200px-US-DrugEnforcementAdministration-Seal.svg.png) Reminds me on experiences we had with the DEA. About 10 years ago we wanted to import 100 mg (!!) of a certified analytical reference standard of d-amphetamine (which is a Schedule II drug). Took us half a year, lots of paperwork going to and fro, and finally we received a certificate on laid paper with an embossed seal (gold foil stamping, etc.). Not the fancy logo DEA uses today, but the unavoidable eagle crowned with a lot of vine leaves and a nicely arranged bunch of grapes at the bottom.  Got it framed and had it on our lab's wall for a good while. ❝ The Last Smoker in Berlin The Last Smoker in Vienna. Smiley released for official use. — Dif-tor heh smusma 🖖🏼 Довге життя Україна! Helmut Schütz The quality of responses received is directly proportional to the quality of the question asked. 🚮 Science Quotes |
Ing. Helmut Schütz
