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RegisterA corporate schism [Off Topic]
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.
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.
Complete thread:
- A corporate schismElMaestro 2011-01-02 00:22
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- Corporates' evolution Helmut 2011-01-02 00:52
- Where the grass is greener the lungs are black? ElMaestro 2011-01-07 14:38
- Wow! Helmut 2011-01-07 15:51
- Where the grass is greener the lungs are black? d_labes 2011-01-07 16:00
- Prohibition Helmut 2011-01-07 16:39
- Where the grass is greener the lungs are black? ElMaestro 2011-01-07 14:38
- Corporates' evolution Helmut 2011-01-02 00:52
Ing. Helmut Schütz