can anyone help me to develop a project plan by using speed to market concept in pharmaceutical product / vaccine development Saving Changes...
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Sergio Luis ConteHelping to create solutions for everyone| Worldwide based OrganizationsBuenos Aires, Argentina
In my country (Argentina) I have to follow an standard project life cycle in order to get the product approved by the goverment authority. So, while you could accelerate some steps you are constrained to that life cycle.
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1 reply by Mathivanan Balakrishnan
Jan 19, 2016 1:46 AM
Mathivanan Balakrishnan
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Hi Sergio Luis,
Thanks for your reply
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James DeinerProject Manager| Janssen R&DPipersville, Pa, United States
Mathivanan,
I think "speed to market" can be applied at various levels in Pharma development, and I'm wondering which you are interested in.
At the highest level, your product development team might choose an overall development strategy that is quicker, by choosing certain indications, target populations, pivotal trials, etc.
Next, in your protocol you might choose an adaptive trial design, which would build in certain early decision points and quick responses to interim analyzes results, so that you are able to modify your approach so you do not waste time and effort on less than promising doses, etc. Also, the overall duration of your trial will depend upon the number of subjects, sites, countries in your trial, so your team will want to weigh the size/duration of your trial with the risks of not meeting your endpoint or slow enrollment, etc.
Then you might be more "ruthless" in developing the schedule for your trial. Often we've found that the various functions involved in clinical development build "fluff" into their estimates so that their individual functions are not late. But the accumulated fluff can extend your duration. Get your whole team focused on minimizing the overall project critical path, and then managing to that; not sub-optimizing by focusing on individual functions.
Finally, you most likely can't (and shouldn't) try to accelerate every single project schedule. So in your overall portfolio, you want to focus on your highest priority projects and accelerate those, possibly at the expense of lower priority or lower value projects.
In my country (Argentina) I have to follow an standard project life cycle in order to get the product approved by the goverment authority. So, while you could accelerate some steps you are constrained to that life cycle.
Hi Sergio Luis,
Thanks for your reply Saving Changes...
Hello James Deiner,
Thanks for your reply. Yeah, I completely agree with your points but i could not able to find any concept model of template to find where we can speed up the process in the whole development cycle of the new product Saving Changes...
