Just discovered the “PCR Song,” which predates the Agilent video…with a “we are the world” theme.  

High school biotech students are also flooding YouTube with Biotech rap  new dance forms…and this rather creative DNA Replication Song.  

Lots of fun (but hope they didn’t submit these as their senior projects….)

Kudos to Agilent Technologies for being a bit zany in its advertising. A new “music video” brings Barry White sound to the Mass Spec crowd (courtesy of Agilent Technologies)….and hat tip to Chris Truelove, Pharma Blogs in Review.

AMS

How will FDA’s commitment to Quality by Design (QbD) influence the drug approval process? It’s a matter of debate, but Russ Somma, founder of SommaTech, a respected drug development consulting company, shares some keen insight with PharmExecBlog. FDA’s decision to do away with “approvable” and “nonapprovable” letters for new drug applications will no doubt cause confusion and hardships in the short term, Somma says, but the move is in the spirit of QbD–putting the onus on the drug manufacturer to build efficacy and safety into a product from day one–and is therefore consistent with FDA’s recent quality- and science-based initiatives.

PWT

We received an office visit today from Dr. Prabir Basu, executive director of the National Institute for Pharmaceutical Technology and Education, or NIPTE. (He’s also head of Purdue University’s Pharmaceutical Technology Education Center.) NIPTE, in case you haven’t heard, is a not-for-profit consortium of 11 universities whose mission is to further scientific education and training in the pharmaceutical industry. More accurately, NIPTE hopes to bring about a paradigm shift in the way that pharmaceutical products are developed and manufactured and how pharmaceutical workers are educated and trained, in line with FDA’s Critical Path initiative.

Pharmaceutical education and pharmaceutical manufacturing are in crisis, says Basu. “We need more science,” he says. By that, he means we need better integration of the various scientific disciplines that, collectively, are needed to move the industry forward. Basu cites the experience of a friend from industry who had to hire a chemist, analyst and engineer to do the job of one person, since none of the three could perform the multiple functions required of the position. To that end, NIPTE is completing work on two manifestos, a Technology Roadmap and Education Roadmap, that will lay out a course for overhauling pharmaceutical science education. Look for excerpts of the two on PharmaManufacturing.com in the coming months.

How is it that 11 different institutions, with input from FDA and industry, have gotten together on the same page to produce these roadmaps? “Fear of extinction,” says Basu. Pharmaceutical manufacturers are losing their competitive edge, and pharmaceutical science programs are losing their relevance, top professors are retiring or leaving their posts, and few universities have sufficient funding to lure qualified new faculty to their pharmaceutical science and engineering or physical pharmacy programs.

We interviewed Dr Basu earlier in the year at the 2008 IFPAC meeting, and we’ll have more such discussions and more information on NIPTE as we launch our PharmaQbD.com web site this October.

PWT

The story, click here for our version (one of thousands circulating) —-which explains the Valentine’s Day inspections at Ranbaxy’s U.S. headquarters last year—  has been generating a lot of buzz this week. Also mentioned in the allegations is Parexel Consulting, the consulting arm of contract manufacturer Parexel, which had a huge presence at DIA this year. Both deny any wrongdoing.

 Here’s how Indian television news covered the story earlier this week. 

Michele’s video report from Interphex China in Dalian is finally up on our site and you’ll find it here.   Also, Paul Thomas has rejoined our editorial team, after a few years in pharmaceutical PR, conference development and CME. 

Paul had become our resident authority in RFID for track and trace applications.  Now that e-pedigrees are back in the news, in earnest, stay tuned for some meaty reporting on the topic.

We’re glad he’s back, and he’ll soon be contributing to this blog, so look out for his byline.

AMS

LabJabPharma.com, a new forum, aims to do for R&D what Cafe Pharma does for sales.  There are other more formal forums, like the AAAS career forum that are currently very active, but this one is focused on pharma and appears to be modelled after Cafe Pharma.

Since it’s so new, it’s a “clean slate” right now. But why not take a few minutes to write in some night when issues at work become frustrating and some peer advice would be useful and get a discussion started?  You’ll find it here.

I’m curious to know whether pharma’s scientists would choose to express themselves, when communicating anonymously online, like some of their counterparts in sales? (As in “$%^& that $%^&*@# technician who destroyed my $%^&*@# assay…” Somehow I doubt it.  But who knows…maybe some of the worst, most prolific ranters on Cafe Pharma aren’t sales people)

 Haven’t had much time for TV lately, so I was very late in discovering that the brilliant comedienne Tracey Ullman is back and in rare form in her satirical show, “State of the Union,” in which she skewers everyone from A. Huffington and Andy Rooney to Beckham to Hollywood’s A list.  Her aim is deadly.  (Consider this example—-at 9 minutes it’s a very long clip—-skip the beginning, but please do watch the second skit, starting from about 1:52)

Among her characters is Padma, a pharmacist working in Tennessee, who breaks out into Bollywood-style song when reciting the potentially negative side effects of drugs.   If any of you have missed this inspired and politically incorrect silliness, here is one sampling from You Tube (one of several posted on YT). 

“Not Invented Here” syndrome is a factor in many businesses today. It usually means reluctance to use technology that was developed elsewhere.  However, according to some sources, the drug industry has turned the phrase on its head, depending almost exclusively on innovations that were developed elsewhere (including NIH)

In a letter to the Wall Street Journal recently, Harvard Medical School professor (and former NEJM Editor) Dr. Marcia Angell responded critically to Ben Zycher’s editorial on the industry’s importance to drug development, stating that the industry lacks scientific creativity when it comes to drug development. 

An excerpt:

The problem with . . . publicly-funded innovation handed off to the drug companies — is that the industry expects to be rewarded as though it were the source of innovation, pricing drugs as high as the traffic will bear and doing everything possible to extend its exclusive marketing rights. The only really innovative thing about this industry today is the claims of its apologists.

For more, read on.  

How about the ingenuity and cost involved in taking a laboratory concept and processes that produce micrograms of product and transforming them into safe, large-scale manufacturing processes? Is the industry over-compensated for that?

What do you think?

George Laszlo has been keeping tabs on the technology offerings in his blog.  For access to this very handy list, a work-in-progress, read on.  Also note posts on open-source code (technology is ready, but is the industry ready for it, he asks) and the changing role of the Pharma CIO.