QDIS Blog

There was no love for Advancis from the FDA in this article on Feb 14 when the FDA gave them a refusal to file letter. This is the second one now in the last few weeks.

FDA deny drug application from Advancis - Washington Business Journal: :

What is very interesting to me is that Advancis does not have a press release on this on their website. The last press release they have is dated Jan, 12 2007. This day and age, it is amazing to me that companies don’t react quickly to these sorts of situations. It’s been two weeks since this happened with no word from the company on their website. I understand that time is needed to form a response but something should be immediately announced.

Their Amoxicillin PULSYS once daily dosing is the product concerned and according to the company they were surprised just like Pharmacyclics that I posted about previously at the FDA’s response. The FDA, according to the company, is concerned about how they plan to scale up their manufacturing process to make bulk quantities. Previously, the company had failed some phase III clinical trials which had to be repeated and then had to re-file the NDA in Dec 2006.

I’m wondering if this means the companies are not really listening to the FDA or if the FDA is changing their mind midstream. While this may not seem to be much of difference it could have major implications for other companies getting ready to file NDAs. If the FDA is starting to crack down and not even accept applications, then the industry needs to be much more careful about how they prepare their filings. If on the other hand, these two companies just weren’t really listening and picking up on the nuances from the FDA then it may not have much of an effect on other companies.

I do know from personal experience that you have to be very careful in the questions you ask the FDA. Many times at end of phase x meetings, you submit questions in writing ahead of time and depending on exactly how those questions are worded, you may get different answers. I know of some companies that will only ask yes or no questions and try to word the question so as to get the answer they desire instead of asking questions to really learn what the FDA thinking is on a given set of circumstances. I have always felt this was a mistake. Early on, it is vitally important to ask open ended questions before too much time and money is spent going down a regulatory or development route that may lead to failure at a late stage when it is very costly.

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I’ve been meaning to comment on this article for quite some time. The LA Times is reporting that a virus may be responsible for Mad Cow disease (aka bovine spongiform encephalopathy or BSE).

Virus may be the cause of mad cow - Los Angeles Times:

For a long time, scientists have thought prions, misshaped proteins were the cause but according to these new results from Lead author Dr. Laura Manuelidis of Yale University, the prions occur late in the development of the disease in mice. It remains to be proven that these isolated virus particles cause the disease but work is underway to prove just that. They did stimulate the product of the prions fivefold and this did not increase the level of infection. If this does prove to be the case, it is certainly a major turn of events for Mad Cow disease. Other scientists are highly skeptical of this idea.

I personally have always had some doubts about prions being the cause but am really not an expert on the subject. A virus seems to me to be much reasonable explanation. It is curious is to why no one had seen these sorts of particles in previous research. It will be interesting to see if they can prove that these viruses actually cause the disease.

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Earlier this month, DrugResearcher.com had an article on revamping at major pharmaceutical companies.

Roche revamps R&D for speed:

An import part of the article is in the last paragraph. GlaxoSmithkline reorganized their research into seven Centres of Excellence for Drug Discovery years ago and I don’t know that it has increased their overall productivity. It may gets more drugs into development, but the more important issue of making sure the ones that do go into development have the greatest possible probability of success.

I’ve seen this before and I don’t have much faith in these “reorganizations”. Inevitably, these sorts of moves don’t make major contributions to the bottom line and sometimes actually make matters worse. I personally think that the culture and huge bureaucracies are more to blame for the lack of research results. That isn’t to say re-orgs can’t make thing better, that can be. I just think too many times they don’t pay off.

I’ve also said that just moving the bottlenecks of development from one place to another is not the answer. The bottlenecks need to be removed from the system entirely, rather than just moved from place to place without increasing the overall output.

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