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The US Food and Drug Administration (FDA) sent a warning letter on July 29 to Novartis admonishing the company for placing a Facebook Share widget on a website promoting the use of Tasigna a treatment for chronic myeloid leukemia. An excerpt from the warning letter is as follows:

"This website contains a “Facebook Share” social media widget1 that generates Novartis-created information for Tasigna that can be shared with Facebook users (i.e., “shared content”). The shared content is misleading because it makes representations about the efficacy of Tasigna but fails to communicate any risk information associated with the use of this drug. In addition, the shared content inadequately communicates Tasigna’s FDA-approved indication and implies superiority over other products".

Further according to the agency

“Facebook Share is a way for users of Facebook to share articles, pages, video, or flash content of a site with other Facebook users. Over two billion pieces of content are shared each week through Facebook. With two clicks, visitors to a website can share any page of that website through Facebook by generating a link to the page, along with a thumbnail image and a brief description (i.e., “shared content”) that will appear on the users’ profiles and, depending on privacy settings, in the home page stream of all of the users’ friends. Each time a link is shared by one user, potentially hundreds of new people may see and/or click through on the link.”

Novartis removed the widget as instructed in the letter by the agency. However, millions of people likely clicked the widget and received inappropriate information about Tasigna. The placement of a share widget on the Tasigna website is shocking because Novartis is not a newcomer to social media and the agency is in the process of formulating guidelines for the use of social media for promotional purposes. The recent Novartis brouhaha suggests that once again a big  pharma company is playing the tried and tested cat and mouse game with the agency to see how far they can push the limits before getting “spanked.” 

Perhaps big pharma companies that are interested in using social media for promotional purposes ought to study Novo Nordisk’s Race for the Cure Twitter campaign that is being used  to promote its insulin products. Unlike Novartis, Novo was very careful to work within established regulatory guidelines that guide print and broadcast media to create the Twitter campaign. To date, FDA has not sent Novo any warning letters about the campaign which appears to be wildly successful.

Hat tip to Ed at the Pharmalot Blog

Until next time…

Good Luck and Good Tweeting!!!!!

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Genzyme announced in a Securities and Exchange Commission filing on Monday that it inked a "fill and finish manufacturing services" deal with Hospira for several of its top selling drugs including Cerezyme (Gaucher disease), Fabrazyme (Fabry disease, Myozyme (Pompe disease) and Thyrogen (thryroid cancer). The move follows a series of highly publicized manufacturing problems at the company’s Allston Landing, MA biomanufacturing facility in 2009.

Beginning in March, Genzyme received a warning letter from the US Food and Drug Administration (FDA) detailing "significant objectionable conditions" at the Allston facility. The agency identified deviation and violations of current Good Manufacturing Practice (GMP) in four areas including: 1) maintenance of equipment, 2) computerized systems, 3) production controls and 4) the failure to follow procedures aimed at preventing microbiological contamination.

In June, Genzyme shut down the biomanufacturing plant to clean up viral contamination that had been slowing down production of Cerezyme and Fabrazyme. The virus, Vesivirus 2117, is known to interfere with the growth of Chinese hamster ovary (CHO) cells and is believed to have been introduced through a cell culture nutrient. The virus doesn’t infect humans, but the shutdown cost the company millions in revenue and caused shortages of Cerezyme and Fabrazyme. Production restarted at the plant in September.

Meanwhile, in November, the Food and Drug Administration said it found tiny particles of steel, rubber and fiber in finished vials of Cerezyme, Fabrazyme, Myozyme, Aldurazyme (mucopolysaccharidosis I) and Thyrogen. These and other violations are outlined in a 483 that was issued by FDA following inspection of the troubled facility.

The deal with Hospira, which makes drug and medication delivery systems,calls for the initial term to expire on Dec. 31, 2015. There are options for a two-year extension. The financial terms of the agreement were not disclosed. The deal is still subject to regulatory approval for manufacturing the products.

While GMP deviations and warning letters are common place at many biotechnology companies, Genzyme’s ongoing manufacturing problems had potentially grave medical implications. This is because, unlike most of its competitors, Genzyme focuses almost exclusively on the development of orphan drugs. Orphan drugs are used to treat diseases like Gaucher, Fabry and Pompe disease which are rare, afflict relatively small numbers of patient and usually result from genetic mutations. Generally speaking, there is usually only a single manufacturer of orphan drugs. Consequently, manufacturing problems can result in drug shortages which may inhibit access to these life saving drugs. As corny as it may sound, patients with orphan diseases have literally placed their lives in the hands of the drug companies that manufacture these orphan drugs.

Until last year, Genzyme had an outstanding and impeccable reputation and was regularly lauded by the orphan drug community. Unfortunately, its management team lost sight of its original to commitment to quality—a sign that changes may be necessary in the executive suite. Hopefully, the new fill and finish deal with Hospira will eliminate many of the company’s manufacturing problems and Genzyme can restore confidence in its brand!

Until next time....

Good Luck and Good Manufacturing !!!

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There is a perception out there that cover letters are old school and that they are no longer necessary when applying for a job. I suspect that this is largely a result of the notion held by many online job applicants that software programs rather than humans evaluate the suitability of prospective job candidates. While this may be true, it never hurts to differentiate yourself from the thousands of others who applied for the same position and didn’t include a cover letter. Further, adding a cover letters allows you to pepper your job application with key words that you may not have been able to squeeze into your resume and may give you a leg up on the competition!

Writing in this Sunday’s New York Times, Phyllis Korkki offers insights and tips on writing cover letters that could mean the difference between employment and not. The take home message—cover letters are not expendable.

Until next time…

Good Luck and Good Job Hunting!!!!!!!!!!

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In an attempt to assuage the jitters and financial concerns of investors who own stock in pharmaceutical, biotechnology and medical device companies, the US Food and Drug Administration announced yesterday that it will be change the format of the letter received by companies whose products are not ready for approval.

In the old days (at least until yesterday), when the agency determined that drugs were not suitable for sale, it would send companies a so-called non-approval letter. This letter was designed to inform drug and device makers that their products had issues that needed to be resolved before the agency will approve them. Apparently, (at least according to drug and device manufacturers), receipt of non-approval letters by companies signaled to investors that the product in question would never, under any circumstances, be approved by FDA. This urban legend was born because most companies that receive non-approvable letters decide against investing more time and money into products that FDA has deemed “unapprovable” i.e. there isn’t enough of a financial inducement or upside to continue further development.

Now, when new products are not up to snuff, companies will receive something called a “complete response letter.” According to the agency, the new letters will describe what is missing from a new drug or device application and, when, appropriate, offer advice on how to fix or address the problem(s). However, because contents of FDA letters are not released to the public, investors may now be less informed about the prospects of a new drug than in the past when the agency was able to send “approvable” or “non-approval” letters to companies.  “While this new plan may provide more detailed information to a company regarding issues that need to be addressed, investors will likely be kept in the dark on the true status of a drug’s approvability” said a pharmaceutical analyst after learning about the format changes. He went on to say “Investors will no longer know whether a drug is truly dead in the eyes of FDA.”

In my opinion, this is another example of FDA cow towing to the whims and wishes of industry. Whether you call it, a “non-approvable” or “complete response letter”, it still means the same thing—the drug or device is not ready for prime time! I don’t think that the change in semantics will do anything to assuage concerns of jittery investors. What it WILL do is force investors to rely solely on the honesty of the management teams that receives these letters—Oy!

I think that FDA ought to stick to the business of evaluating the safety and efficacy of drugs and be less concerned with the political and economic needs of the drug and device industries. Finally, it would be prudent for FDA to allow appropriately trained professionals to provide psychotherapy to all of the frightened and jittery investors out there!!

Until next time…

Good Luck and Good Job Hunting!!!!!!!

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The regulatory problems at Wyeth continue. The US Food and Drug Agency announced that it issued an approvable letter for Tygacil (Wyeth’s tetracycline-like antibiotic) to treat community acquired pneumonia (CAP). Apparently, FDA regulators want more data on the effectiveness and safety of Tygacil in severe cases of CAP and additional information on possible liver toxicity.

Tygacil, an intravenously administered antibiotic, won FDA approval in 2005 to treat adults with complicated intra-abdominal infections and complicated skin and skin-structure infections. Tygacil had about $138 million in sales last year; falling far short of the projected $500-$800 million in annual sales that it was expected to yield when it was first brought to market. If Wyeth gains approval for CAP, expect Tygacil sales to soar.

In other regulatory news, FDA granted Wyeth “fast-track approval” for a new version of its market-leading pediatric pneumococcal vaccine called Prevnar. The new 13-valent formulation will provide protection against 13 different pneumococcal serotypes. The older version only provided protection against 7 serotypes. Wyeth hopes to complete its filing for pediatric use of the new Prevnar vaccine in early 2009. Prevnar is Wyeth’s second-leading product with sales of about $2.5 billion in 2007.  

The new Prevnar vaccine will likely go head-to-head with GlaxoSmithKline’s new 10-valent pneumococcal vaccine  called Synflorix^Tm which is in late stage clinical development and is currently being reviewed for marketing approval in the EU. Unlike Wyeth’s vaccine, Synflorix^Tm  was found to be effective in protecting against otitis media (ear infections) caused by Haemophilus influenzae.

Until next time,

Good Luck and Good Job Hunting (avoid Collegeville, PA)!!!!!!!!

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It seems like nothing is going right for Merck these days. On Monday, the US Food and Drug Administration (FDA) issued a “not approvable”–aka a rejection letter–for Merck’s new cholesterol drug called Cordaptive or MK-0524A. The highly-touted drug, which Merck executives hoped would replace Merck’s blockbuster cholesterol drug, Zocor (which lost patent protection a couple of years ago), can both lower LDL (bad) and raise HDL (good) cholesterol. Although experts believe that these properties should benefit people with high cholesterol, the results from recent clinical trials suggest that drugs that raise LDL and lower HDL cholesterol may have safety problems.

Cordaptive consists of an extended-release form of niacin (a B vitamin) and another agent that inhibits a niacin side effect called flushing — redness, burning and tingling of the face. Niacin has been used to control cholesterol for decades. Abbott Laboratories already sells an extended-release form of niacin called Niaspan.

Despite positive results from recent clinical trials and pending approval by the European Union, the agency rejected Merck’s NDA. Regulators also rejected Cordaptive as a brand name. It is likely that FDA is scrutinizing and proceeding cautiously with new cholesterol medications because of the recent flap over Zetia and Vytorin (which are co-marketed and sold by Merck and Schering Plough). As you may recall, both companies have been accused of trying to protect sales of the two drugs by delaying results of a study that showed Vytorin worked no better than Zocor, which is much cheaper.  Merck’s stock price dropped about 5% yesterday after the company announced that it received a not approvable letter from FDA.

Although MK-0524A may ultimately reach the US market, I wouldn’t count on it anytime soon. Merck has seriously tarnished its reputation with FDA because of the Vioxx, Vytorin and Singular controversies. The old adage, “You reap what you sow” is particularly apt in this instance. Look for more “asset reallocation” moves in Rahway.

Until next time…

Good Luck and Good Job Hunting!!!!!!!!

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I am sitting in Newark Airport waiting for my flight to San Diego which, not surprisingly, has been delayed for about 2 hours.  As you might have guessed from the title of this post, I am on my way to the 2008 FASEB Career Development Symposium which is run every year at the annual FASEB meeting. 

As we have done in the past, my colleagues Eric Celidonio and Joe Tringali, and I  will be presenting seminars and resume writing workshops for graduate students and postdocs.  Our goal, as always is to offer these folks some advice and tips on how to find a job after they complete their training.  Unfortunately, the job market for PhDs has been depressed for the past 8 years or so.  There once was a time, circa 1994-2000, when finding a job for alife sciences or chemistry PhDs was a snap.  In those days, many jobs were left unfilled. Ironically, it  has been scientific advances and technological innovations that have made it more difficult for PhDs to find jobs over the past decade or so.

Anyway, if you are attending FASEB this year, please stop by.  Also, tell all your friends!  We like when it is busy.

Until next time....

Good Luck and Good Job Hunting!!!!!!!!!!

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I wanted to follow up my post last week–Part 2: Ask the Recruiter--Job Searching –with a short post about writing cover letters.  As I mentioned in my post last week, the purpose of a cover letter is to summarize your background and skill sets so that a hiring manager (who reads the letter) can quickly determine whether you are qualified for the job for which you applied. In addition to mentioning your background and skill sets, it is vital that cover letters be customized to include buzz words and job qualifications found in the ad that induced you to apply for the job. By showing the hiring manager that you meet all the job requirements and possess the requisite skills listed in the job ad, it makes its easier to determine whether you are qualified for the job. Writing a strong, customized cover letter rather then sending out a form cover letter can make the difference between getting a job interview or not.

Rather then try and describe how to craft a  strong cover letter, I  highly recommend that you take a look at the following cover letter example that came to me by way of the Monster Career Newsletter.  Although most of the articles in the newsletter are geared for Monster users, this is  that provided insight into crafting a winning cover letter.

Please let me know whether you found the article useful or helpful!

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