More VC Casualties

Ron Z

Guest
Heard from a ROC friend that the VP of Reg, Mike S., got booted into touch before Chritsmas. Why the shake up? New coach in town or what?

Seriously, what is happening up in ROC?
 






Heard from a ROC friend that the VP of Reg, Mike S., got booted into touch before Chritsmas. Why the shake up? New coach in town or what?

Seriously, what is happening up in ROC?

Isn't Vision Care doing OK? New products this year? Biotrue a success story? If not who are the VPs and Directors is in charge of Vision Care research at B+L? If regulatory can not get a product approved by the FDA you have to look at the failures early in the development of the product.
 






Mike was walked out the door - and is taking the fall for years of bungled product issues.

Funny to watch the JNJ team come in and replace the B&L people, and now the Schering people / brent's friends are replacing the JNJ people -and performance continues to drop. I think things would be much better for VC if they threw out the current team and got some of the orignial folks back and gave them the proper resources to do their jobs. In fact, its probably the only chance B&L VC has because the current team doesnt have a clue - not one. They will just keep replacing people to cover for their own issues - and Brent isn't strong enough - or close enough - to the business to tell.
 












Mike was walked out the door - and is taking the fall for years of bungled product issues.

Funny to watch the JNJ team come in and replace the B&L people, and now the Schering people / brent's friends are replacing the JNJ people -and performance continues to drop. I think things would be much better for VC if they threw out the current team and got some of the orignial folks back and gave them the proper resources to do their jobs. In fact, its probably the only chance B&L VC has because the current team doesnt have a clue - not one. They will just keep replacing people to cover for their own issues - and Brent isn't strong enough - or close enough - to the business to tell.

Recruit former B+L folks that knew Vision Care or hire new people in the Vision Care business. The management of Vision Care by Pharma VPs and Directors does not work. They do not know the business and really are not interested in Vision Care because their future career goals are to have a job that is 100% Pharma not Vision Care.
 












Not only have there been no new real product launches in a decade, existing products - with marginal performance attributes, have not been approved for launch in other countries - for example, Japan - the worlds second largets contact lens market.

This had nothing to do with Mike - but he paid the price...
 






Not only have there been no new real product launches in a decade, existing products - with marginal performance attributes, have not been approved for launch in other countries - for example, Japan - the worlds second largets contact lens market.

This had nothing to do with Mike - but he paid the price...

The Directors and VPs (Preclinical, Clinical) that put the submission package together for US, Japan are primarily responsible. Regulatory can help with the process but ultimately it is the scientists in R&D that generate the reports that are reviewed by the regulatory agencies.

Poor science and or poor products = not approved.
 






The organization of Vision Care research is flawed. Resources should be shifted from people generating data that can not be used for regulatory submissions to making sure that 100% of peoples time is spent generating data that can be used for regulatory submissions.

There are so many scientists in R&D and they are spending so much time on unproductive activities.
 






The organization of Vision Care research is flawed. Resources should be shifted from people generating data that can not be used for regulatory submissions to making sure that 100% of peoples time is spent generating data that can be used for regulatory submissions.

There are so many scientists in R&D and they are spending so much time on unproductive activities.

Their football pool has been quite active in the last few months. We are now itching for the basketball pools to be well underway.
 












If only a small percentage of the Scientist in R&D work on the studies and reports needed for generating the regulatory submissions it is not a surprise that the regulatory submissions are going down in flames.

Reorganizing R&D to get more of the scientists responsible for generating studies and reports for the FDA would be a good first step to getting regulatory success in product submissions.
 






If only a small percentage of the Scientist in R&D work on the studies and reports needed for generating the regulatory submissions it is not a surprise that the regulatory submissions are going down in flames.

Reorganizing R&D to get more of the scientists responsible for generating studies and reports for the FDA would be a good first step to getting regulatory success in product submissions.


Agreed, now is a good time to reorganize and change the reporting structure of the scientists in R&D so that a larger percentage of them have accountability to generating the reports necessary for the regulatory submissions.