Avelient BioPharm Blog

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AIDS Cure on the Horizon?

One of the most powerful scenes for me in the movie Philadelphia was the moment in which Tom Hanks’ character, Andrew Beckett, introduces himself to Denzel Washington’s Joe Miller.  They exchange a handshake at one point in the scene, and Beckett reveals to Miller that he has AIDS.  When Miller reacts to the revelation by immediately backing away and becoming visibly uncomfortable, while looking, desperately, for some way to clean what he believes is a now tainted hand, it served as a stark reminder to me of how prominent this disease once was in the psyche of the American public.  I think there was a lot of fear, and a lot of unknowns about the disease: how it was spread, who was susceptible, and what it could do to you.

Since those days of uncertainty, the disease has ravaged millions, though in its wake followed a continually growing understanding of the virus and how it works.  Continue reading this entry »

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Obesity and Our Bacterial Friends

One of the persistent arguments in today’s world is whether obesity is in our genes or something that can be controlled by diet and exercise (and a good night’s sleep and low stress and …).  On my way drive home from work last week, I heard a very interesting story on NPR about research on the effect of gut bacteria on weight gain/loss.

Studies compared mice born and kept in a sterile environment with no bacteria in their gut against mice born and kept in a non-sterile environment.  Both sets of mice were fed the same amount of food.  The bacteria-free mice stayed skinny while the mice with gut bacteria gained weight.  The reason is that the bacteria in the intestines of the mice raised in a non-sterile environment were able to break down the food and turn it into calories, while the food passed right through the intestines of the bacteria-free mice undigested.

These findings beg the question: can we manipulate the bacteria in our intestines in order to control weight gain or loss?  For more information on the research and its implications, check out the printed article on the NPR website here.

Are your Political Views Biologically Programmed?

I was sitting down for a drink the other day with a longtime friend when the topic of politics came up for discussion.  Growing up in Massachusetts, I rarely encountered somebody of a conservative mindset, let alone someone who would admit to being so in such a heavily democratic state, so I had always assumed she was a democrat.  Much to my surprise, she wasn’t, and staunchly so.  She had grown up in the same type of environment I had, and she had been exposed to the same propaganda, and I thought had pretty much the same views that I had when it came to how an ideal world should work.

I think the surprise must have registered pretty immediately on my face, because she seemed almost apologetic after that; not apologetic for her views as a republican, but for the shock she had just imparted on me. For me it was just more of a surprise that my assumption was incorrect. Continue reading this entry »

Checking in on the Status of Electronic Application Submissions

A few years ago, I was the project manager for a system that tracked the status of drug products worldwide for a large pharmaceutical company (e.g. whether a product was submitted for approval, approved, actively marketed, withdrawn, etc.).  Back then, health authorities, such as the FDA in the US and the EMEA in the European Union, were in the early stages of moving from paper submissions for marketing applications to electronic submissions that conformed to the electronic Common Technical Document (eCTD) specifications.  I thought now would be a good time to check in and see where things stand with the move to electronic submission.  Continue reading this entry »

Brain Drain, Smoking, and Jenny McCarthy

The past few weeks have been rough.  I have a lot of project work going on, and I find myself staying up later and later to try to keep up with it all.  I guess it’s one of the consequences of trying to build a new company, grow a family, and keep in shape.  There just isn’t time to stare blankly into space for a few minutes and recharge the batteries.

I’ve considered trying to make a habit of drinking a glass of wine every night after dinner, but I just can’t get into it.  It is, believe it or not, because of my doctor that I’m even trying; my cholesterol is great (well, my good cholesterol is *too* low), but he feels that one glass of red wine per day is good for the heart and strikes a balance that may have escaped over the course of a hectic day.  What’s not to like about that kind of advice? Continue reading this entry »

Compassionate Use for Investigational Drugs

In the Avelient BioPharm Blog article “A Brief FDA History Lesson“, Mariano Di Fabio provided some background on the events that lead to the establishment of the FDA’s current clinical trial framework, and he questioned if this framework should be changed so that experimental drugs could be released for use by terminally ill patients.  Mariano is not alone in his call. 

In today’s healthcare environment, with the internet and media coverage providing early stage insight into developmental pipelines, more and more physicians and patients are calling for access to drugs before they are approved for marketing.  However, it’s not always the FDA that stands in the way.  The drug companies also have to agree to provide their developmental products for special access. For various reasons, they are not always willing to do it.  Continue reading this entry »

Loosing Sleep over Economic Crisis

It seems almost every conversation these days starts with people lamenting over the state of their stock portfolios.  No matter what you’ve invested in, no matter how secure you believe your investments to be, you get weak in the knees when going to check on the current state of your 401k, or 503b, or 529 plan, or some other plan for saving money for the future.

Unfortunately, the Pharmaceutical and Biotechnology industries have not been immune to the collapse.  Since this all began a couple of weeks ago, it seems that many companies have seen a downward trend in their publicly traded stocks.  Continue reading this entry »

Latest Tactics to Stifle Generic Competition

In the last half of this decade, it is estimated that $100 billion worth of brand name drugs have lost (or will lose) patent exclusivity. Each year, generic drugs take more and more of the market share from brand-name drug manufacturers.  In fact, the percentage of drug prescriptions dispensed for generics increased from 47% to 63% between 1999 and 2007.  It seems like a losing battle for the brand-name manufacturers, so as the old saying goes… if you can’t beat ‘em, join ‘em.  The big pharmas are starting to take their slice out of the generic industry. Continue reading this entry »

Pharmaceutical Profile: Sequenom

I was reading my monthly copy of Pharmaceutical Executive magazine when I came across Joanna Breitstein’s excellent article profiling the latest trend in the pharmaceutical arena: big deals that are safe bets.  In her article, “Place your Bets,” Breitstein characterizes Roche’s bid to acquire Genentech as a reflection of the cautious approach to deal-making that big Pharma is using these days, and indicates that with patent expiration on the heels of many blockbuster drugs, especially Pfizer’s Lipitor, there is a strong demand for small company buyout targets with promising products in their pipeline.

Sequenom is one such company on the list that I found particularly interesting.  Continue reading this entry »

Bridion and the Tale of Two Agencies

Once upon a time, there was a promising new drug named Bridion.  It was touted by its manufacturer as the first major pharmaceutical advance in the field of anesthesia in two decades.  The drug was submitted to two powerful health authorities for marketing approval.  Authorization looked like a foregone conclusion as advisory committees for both agencies gave the drug sterling reviews.  Financial houses hopped on board and predicted $1 billion in annual sales for Bridion.  One agency completed its analysis and determined that the product had proven acceptable safety and efficacy in clinical trials and granted approval.  But just days later, unexpectedly, the second agency decided not to accept the unanimous recommendation from its advisory committee and rejected poor Bridion. Continue reading this entry »