Posted on Mon, Jul 26, 2010 @ 01:47 PM
Could the recent FDA approval of a generic version of Lovenox (enoxaparin) be the beginning of approvals of other complex molecules? We recall that the Biologics Price Competition and 
Innovation Act of 2009 found its way into the Health reform bill. The Biologics Act provides a pathway for biosimilars, however, grants biologics innovator companies 12-years patent exclusivity (http://tiny.cc/ymnj1). While biologics currently reside outside the current generics approval processes, it seems that “complex molecules” like enoxaparin do not. The developers of the generic enoxaparin, Sandoz, division of Novartis, are hoping to win approval next for a generic version of the “complex mixture” Copaxone for the treatment of multiple sclerosis. For more details on FDA’s position visit: http://tiny.cc/fvvve. For more information regarding Sanofi’s position, read their July 23 statement here: http://tiny.cc/zgib3.
--John Kouten
Posted on Wed, May 26, 2010 @ 11:05 AM
Personalized medicine has been a hot topic in life sciences for a while now. With
the clearly changing landscape in healthcare, and increased pressure on drug developers to maximize their returns and minimize costs, personalized medicine is more important now than ever before, and it is becoming a reality.
It is estimated that the majority of cancer drugs fail to deliver the outcomes for which they are prescribed. The promise that personalized medicine offers to patients is the potential to identify which individuals will respond to a particular drug. Think about the cost savings implications if the practice of personalized medicine can become standard operating procedure across all therapeutic areas.
There are also enormous potential benefits to full implementation of personalized medicine in clinical research and drug development. Consider the impact on clinical trial design, cost and success vs. failure rates for clinical research programs of drugs in development if the trial sponsors can screen and identify those patients most likely to respond to a potential new therapeutic at enrollment, and which patients should be excluded from the trial.
What is also very intriguing is to consider how many drugs that have "failed" using traditional clinical research models that could find new life in the era of personalized medicine. Drugs that showed promise but ultimately failed due to the inherent shortcomings of current clinical development protocols could be resurrected and ultimatley brought to market if found to be effective in specific patient populations identified using personalized medicine. Unmet needs in under served patient populations could be addressed, and investments in new therapeutic options could be justified as money well spent, rather than written off.
This is an area of great interest to me. I recently published an article in the Life Sciences Supplement to NJBIZ that explored some of these issues, and I look forward to what the future has in store.
Click here to download a copy of my article, entitled "Personalized medicine offers opportunity" published in the 2010 Life Sciences Supplement to NJBIZ.
--David Avitabile
Posted on Thu, Feb 04, 2010 @ 03:34 PM
Nearly three months have now passed since the FDA's Division for Drug Marketing Advertising and Communications (DDMAC) held its hearing entitled “Promotion of FDA-Regulated Medical Products Using the Internet and Social Media Tools.” So far the response from DDMAC and direction provided to industry can be measured by the almost deafening sound of crickets coming from the direction of Washington DC.
Hopefully, before we're too far along into 2010, DDMAC will provide constructive guidance to industry on the use of social media to communicate with patients. They certainly had plenty of feedback from interested parties during those hearings.
--David Avitabile
Posted on Fri, Dec 04, 2009 @ 11:14 AM
The In Vivo Blog has a very interesting discussion about a recent Pink Sheet/CMS Summit Panel discussion that suggested that the FDA may be practicing "stealth" comparative effectiveness through an increasingly greater focus on superiority data (rather than, I presume, non-inferiority data). Read it here at In Vivo.
The blog raises a number of interesting points, not the least of which is the question that is on many people's minds, including physicians, patients and industry: "is the FDA becoming too conservative?"
I believe that this question needs to be considered as part of the overall discussion, debate and analysis of issues such as the decline in new molecular entities, fewer first action FDA approvals, and fewer treatment options available for patients who need them.
A decline in R&D productivity has contributed to these issues to be sure, but I don't believe that industry is to blame for all of it. Open and honest discussion and debate is in the best interests of everybody, especially patients.
--David Avitabile