Avelient BioPharm Blog

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“Approvable” Removed from the FDA Lexicon

One of my first assignments in the pharmaceutical industry was as project manager for a product registration tracking system at one of the big drug companies. The system held the registration status of all of the company’s products worldwide - whether the product was submitted for approval in a given country, approved for marketing, actively being sold in the country, withdrawn from the market, etc.

There was one registration status in the database that was specific to the FDA and struck me as somewhat odd: “approvable”. At first, I wondered if “approvable” was even a real word. Looking it up in the dictionary, I found that it meant “capable of being approved.” So, I asked myself the following question: if a drug is capable of being approved, why wouldn’t the FDA just approve it? I found solace in the fact that I was not the only one confused by this term - much of the industry was also puzzled as to its meaning.

On August 11, 2008, a new FDA policy went into effect that removed the term “approvable” from the FDA drug review process. The remainder of this article reviews the changes and the impact to the industry. Continue reading this entry »

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Little Exercise, Big Benefit

About four weeks ago, around the time the elliptical machine in my basement decided to break, I resolved it was time for me to (begrudgingly) start running again. In the four weeks since, I have built myself up from a labored breathing after only eight tenths of a mile to a more modest pant after running nearly three. Make no mistake: I hate running. I hate thinking about it, I hate warming up for it, and I really hate actually doing it. It’s only afterward, when I realize the benefit of the exercise, that I can actually feel good that I did it. And before any jogging advocates email me and indicate how I can improve my stride and build enough endurance to really make the experience more pleasurable, I implore you to reconsider; I am and always will be squarely in the “hate” camp.

That said, no other exercise gets me into shape more quickly. It gives me reason to hate it even more. Continue reading this entry »

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ROXRO Pharma: How to Score Big as the (Really) Little Guy

Last week I attended a Pharmaceutical Executive web conference called “A Better Way to Conduct Alliance Management”.  The conference was somewhat interesting, but in reality, it was more of an hour long advertisement for Intralinks, the conference sponsor.  However, one of the speakers at the conference intrigued me: Gayle Mills, Executive Vice President of Business Operations at ROXRO Pharma. Gayle’s role at the conference was to discuss alliance management from the perspective of a small company.  ROXRO’s lead compound, ROX-888, has completed Phase III trials for the treatment of acute pain, including post-operative pain. ROXRO expects to file a New Drug Application with the FDA this year for approval to market ROX-888. 

The kicker is that ROXRO has only six employees. Six employees?!?!  Did I hear that correctly? How does a company with six employees get a drug through Phase III trials and on the doorstep of marketing approval?  Doesn’t it take a small army of people to get a drug to market in the United States of America?  I decided to dig a little deeper and find out how they do it. Continue reading this entry »

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Pharmaceutical start-ups: Phytomedics

I read today about a really interesting pharmaceutical company that, though it’s considered a start-up, has spent the last 12 years researching and developing new drugs and methodologies that will allow for more rapid and safer development of drug products: Phytomedics. Their focus is on botanical drugs, which, in theory, could provide many of the benefits of drugs in today’s market, but at less risk and less cost.

According to the FDA, in order to be considered a “botanical” product, a drug must have the following characteristics: Continue reading this entry »

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The Agonist/Antagonist Duel for Enhanced Pharmaceuticals

This is the first posting from Scott Alexander. For more information about Scott, click the Author link on this page.

One of the persistent challenges of the Pharmaceutical industry has been maintaining the safety and efficacy of drug products in patients over time. In other words, when a patient starts taking the drug, the patient is able to take a lower, safer dose of the product in order to treat the symptoms. However, over time, the patient becomes desensitized or builds tolerance to the drug such that he/she must take higher, less safe doses of the product in order get the desired effect. Eventually, the dosing may reach dangerous levels causing serious, or even fatal, side effects. The crux of the problem is that the pharmaceutical industry does not really have a handle on how target drug-receptors are activated or de-activated in the body in order to achieve the desired result. As a result, desensitization is viewed as an unavoidable side effect.

Continue reading this entry »

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A Perspective on Clinical Statistics: Getting Beyond the Sizzle

Today’s blog comes to us from Georgette Asherman, founder of Direct Effects. She was one of the first writers in the early days of our blog, providing us with the article, “Sample Size Calculations: Thinking About Effect Size.” She has been a professional statistician in pharmaceuticals, consumer products, business services and public policy for over 10 years. She has been associated with organizations such as Unilever, Bristol-Myers Squibb, Chase Manhattan Credit Card Services, and the New Jersey Department of Health. In recent years she has developed an interest in quantitative aspects of modern biological sciences. She has worked in clinical and non-clinical biostatistics, chemistry data analysis and instrument capability studies.

She holds an M.S. in Statistics from Rutgers University and a B.A. from Cornell University. She is a member of the American Statistical Association and the New York Area SAS Users Group. Continue reading this entry »

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8 Drugs your Doctor Won’t Take?

I was flipping through my June Men’s Health magazine when I came across an article entitled, “8 Drugs Doctors Would Never Take,” written by Morgan Lord. Unfortunately, it’s unclear to me how Lord compiled this list, or weighted the pharmaceuticals that are on it, though I don’t disagree that some of the drugs he lists, if not taken carefully, can be harmful. Continue reading this entry »

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Pharmaceutical Start-ups: WellGen

On April 7th, I had the opportunity to attend the biannual Pharm Fest at Montclair State University. It was a well-organized and interesting event, with several seminars of interest. I wish I could write a full-fledged article on each of the panelists I heard from during that seminar, because I believe they’re all working on something of merit. Today, however, I’d like to focus on WellGen, a company represented by Dr. Kathleen Mullinix that works with nutrigenomics.

Nutrigenomics, according to the Wellgen web site, is the study of how foods and their bioactives, components we more commonly know as vitamins and minerals, interact with genes in the human body to affect health. The concept is that the more we know about this interaction, the better able we’ll be to create customized regiments in human eating habits to promote optimal health based on gene makeup. Continue reading this entry »

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$10,000 Health Challenge to Big Pharma

The other day I was forwarded a link by a friend of mine to a personal health newsletter called “NaturalNews.com.” This was actually for a technology consulting position that I had been forwarded, but in doing my due diligence, I investigated the web site to find out more about the company. I found an article posted on June 20th by Mike Adams challenging big Pharma to a fitness test between him and someone using big Pharma’s big drugs on a preventative basis. The winner gets $10,000 and the loser…well…has to write the check.

The premise of the challenge is that Mike Adams wants to prove that taking medications, on a preventative basis, really does not lead to optimal health. In theory, this is a great challenge to Pharmaceuticals, though I don’t think he will get much response from the major players in the industry. One of the innate problems in his campaign is the qualification that his challenger must be taking 10 different types of drugs, and must have been doing so on a preventative basis for a year. Continue reading this entry »

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Back to Virtuality

It’s been a while since I last wrote on the blog, and for those of you that follow regularly, I apologize. We’ve had a lot going on in our company, and if you haven’t already heard, we re-designed our web site (go to www.avelient.com to see the new site) and released our first major product, a development platform for small town business alliances, called HOLMES. I encourage you to check out the changes that have been made when you get a chance!

But this week, we return to blogging with another entry into the virtual world of Second Life. I was excited last Wednesday evening, June 11th, to be able to attend a talk hosted by Simon Bignell, a lecturer at the University of Derby in the United Kingdom. Using his Second Life alter ego, Milton Broome, Simon gave us about an hour of his time as he told us about the research that’s being done in virtual worlds on Autism spectrum disorder and Asperger’s (to keep tabs on what Milton is up to, check out his web site). Continue reading this entry »