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According to a post at the Pharmalot blog, a contractor who worked for Novartis was charged with running a prostitution ring from his desk at the drug maker’s facility in Hanover, NJ. Luckily (for Novartis anyway) the actual ’services’ were provided at a veterinarian clinic several miles away. Novartis noted in a statement that was sent to Pharmalot that the alleged pimp “is employed by Kelly Temp Services, a company contracted to provide services to Novartis. However, he no longer works there, and the drug maker maintains that it holds employees and contractors to the highest ethical standards. Novartis also wants us to know it is cooperating with authorities, whose investigation is ongoing.”

There were a few amusing comments posted at Pharmalot.  For example: one reader commented: “No doubt Novartis was impressed with his organization and managerial skills. A career in conference and events management beckons.” Another reader quipped; “Can anyone say - multi-tasking?” Finally, my personal favorite was from a guy with the nick “jobseeker” who boldly stated; “I’m looking for employment. What position did he hold?”

Hat tip to Ed at Pharmalot!

Until next time…

Good Luck and Good Job Hunting (I hear that there is a contractor opening at Novartis)!!!!!!!!

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Bristol-Myers Squibb announced earlier today that its Board of Directors approved a deal to purchase ImClone for $4.5 billion. BMS already owns about 17% of ImClone’s shares and is ImClone’s US marketing partner for Erbitux, a monoclonal antibody treatment for colorectal and head and neck cancers. BMS bought Kosan Biosciences earlier this year for $195 million.

The ImClone offer comes after an announcement late last week from CEO Jim Cornelius who said that there will likely be more job cuts at BMS to keep pace with the company “productivity transformation initiative.”  Earlier this year, BMS sold ConvaTec, its wound care and medical device subsidiary for $6.5 billion which will likely provide BMS with the monies necessary to complete the ImClone purchase.

The acquisition makes sense for BMS because of its campaign to re-invent itself as a “next generation biopharma company.” Currently, BMS’s biotechnology roster consists of only two drugs: Erbitux (which was developed by ImClone and licensed by BMS) and Orencia a treatment for rheumatoid arthritis. That said, BMS has several monoclonal antibodies and other biotechnology drugs in its pipeline. I think that the purchase of ImClone makes BMS more attractive as a takeover target for Sanofi-Aventis or another major pharmaceutical company itching to get into the biotechnology frenzy.

BMS’s purchase of ImClone closes the book on a steamy and oft times nefarious drug development saga that I assume both companies would like to forget. As you may recall, in 2001, Peter Dolan, then CEO of BMS, cut a questionable licensing deal (and made a $2.0 billion investment in ImClone) for marketing rights to Erbitux. At that time, Sam Waksal, one of ImClone’s founders, was CEO of the company.  Shortly after the deal, BMS researchers discovered that the clinical trials data that were used to convince BMS that Erbitux was a treatment for colorectal cancer were flawed.  Because of this, BMS was forced to invest hundreds of millions of dollar and spend several more years before it would ultimately win regulatory approval for Erbitux.  Meanwhile, before the deal was finalized, Waksal, seeing a huge financial upside, engaged in insider trading of ImClone’s stock. Later, he disclosed that he needed the money to cover the enormous debt that he incurred because of his high profile NYC lifestyle. Ultimately, Waksal and his close friend Martha Stewart plead guilty to insider trading of ImClone stock and spent several years in prison.

Ironically, the acquisition of ImClone by BMS is something of a vindication for former CEO Peter Dolan. At the time that Dolan cut the deal with ImClone, many Wall Street analysts and industry insider thought that Dolan paid an excessive amount for Erbitux which was clinically unproven. Ultimately, Dolan was ousted as CEO after it was learned that he cut an illegal deal with Apotex, a Canadian generics manufacturer, to delay release of generic versions of its anti-clotting drug Plavix (co-marketed with Sanofi-Aventis) after expiry of Plavix patents in 2010.

The BMS-ImClone deal is one of several big M &A deals that have recently taken place as a result of financially-troubling times. Don’t expect consolidation in the pharma and biotechnology industries to subside any time soon!

Until next time….

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

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After beating Wall Street expectations and disclosing positive results from an osteoporosis (densomab) clinical trial, Amgen was ordered by the US Food and Drug Administration (FDA) yesterday to change the labels for its EPO drugs (Epogen and Aranesp) that will likely further restrict their use in treating patients with cancer.

The label changes ordered by FDA represent the first time that the agency has invoked its power to change prescribing information for drugs that it previously approved. In the past, FDA could only negotiate with drug manufacturers about changes to labels and prescribing information. In my opinion, it’s about time that FDA has been empowered to unilaterally order these types of changes. I have long contended that negotiations between the agency and drug makers about labeling and prescribing information is not in the best interests of Americans who use prescription drugs. To that end, it was negotiations between FDA and Merck about whether the serious cardiovascular risks associated Vioxx should appear on the Vioxx label (they didn’t) that lead to the misuse, safety problems and ultimate recall of the drug.

While the ordered label changes are not good news for Amgen and its partner Johnson and Johnson which sells Procrit (EPO manufactured by Amgen and sold by J&J), they are in the best interests of all Americans who use these drugs to treat anemia caused by cancer chemotherapy and kidney disease.

Until next time….

Good Luck and Good Job Hunting (avoid A Thousand Oaks, CA)!!!!!!!!!!

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It was only a matter of time after J & J launched its health channel on YouTube two weeks ago, that other pharma companies would begin to post videos on video-sharing sites. As a general rule, nobody in pharma wants to be first but after the first company takes the plunge, nobody wants to be left out or behind. Therefore, it came as no surprise when late last week, GlaxoSmithKline (which has a tendency to be second-to-market with competing products), launched a beta version of it so-called GSKCIC channel on You\Tube.

 According to a post on the Pharmalot blog, so far there are only two videos on the channel. One describes the company ongoing commitment and fight against disease in the developing world (ironically, the video ends prematurely).The second, which is full length, features CEO Andrew Witty telling us about his career at GSK (which began in 1985 as a management trainee) and how GSK is looking for a few good employees who “like a good challenge.” Curiously, the day after the Witty video appeared on YouTube, GSK announced that it was laying off about 90 workers or 10% of its work force at its manufacturing plant in Zebulon, North Carolina. A company spokesperson said that more cuts are expected at the North Carolina facility.

Maybe someone at GSK ought to tell its CEO that the company isn’t hiring at the moment?????????

Hat tip to Ed at Pharmalot!

Until next time….

Good Luck and Good Job Hunting!!!!

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Earlier this week, Roche announced that it wanted to buy the remaining portion of Genentech that it doesn’t already own. On Friday, one of Europe’s largest pharmaceutical companies, Sanofi-Aventis, announced that it was buying the UK-based vaccine manufacturer Acambis for $547 billion.

Like Roche and Genentech, Sanofi-Aventis was already partnered with Acambis and by purchasing Acambis, Sanofi gains a smallpox vaccine that was contracted by the US government for $425 million. Sanofi is the world’s largest manufacturer of influenza vaccines and last month announced plans to open a $157 million manufacturing facility in France, citing projections that demand for vaccines will double by 2016. In case you didn’t know, vaccines, once the scourge of the pharmaceutical industry, are now the hottest”pharmaceutical” products on the market!

Because of growing demand and lucrative margins for biologics and biotechnology products, many big pharma companies are attempting (through acquisitions and mergers) to quickly enter the biologics and biotechnology markets. These days, small molecules are passé and biotech is the next big thing (where have all the pharma execs been for the past 20 years).  

Europe has long wanted to dominate the biotechnology market. This has not been possible because of the US’s large lead in the space. However, all this can change because of a weak dollar and a surging Euro! Rather than attempt to create their own biotechnology companies, large cash-rich, European pharma companies can simply buy profitable US biotechnology companies with strong product pipelines.

I suspect that the weak dollar and failing US economy contributed to Roche’s decision to buy Genentech and Teva to buy Barr Pharmaceuticals last week. I would not be surprised if there are more acquisitions of American biotechnology and pharma companies in the very near future. I think that it may be time for Amgen and Bristol-Myers Squibb employees to begin to brush up on their French or German.

Until next time….

Good Luck and Good Job Hunting (in Europe)!!!!!!!!

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Despite an increase in profits, BMS announced today that it will continue with its Productivity Transformation Initiative (PTI) that was instituted last fall. According to the PTI, BMS must save $1.0 billion over the next 2 years. Of course, the only way to accomplish this is by laying off employees whose jobs are not directly related to the process of transforming BMS into a “ next generation biopharma company” (Would somebody please write me and explain what that means)???? I suspect that BMS employees will be receiving “pink slips” after Labor Day.

This has been a devastating week for the NJ-based pharmaceutical industry. First, Teva announced last week that it will buy Montvale NJ-based Barr Pharmaceuticals and then earlier this week Roche issued a press release indicating that it will move its corporate headquarters from Nutley NJ to South San Francisco (Genentech’s headquarters) by 2010. The impending layoffs at BMS coupled with job freezes and downsizing at other NJ pharma companies like Schering Plough and Merck may signal the beginning of the end of New Jersey’s status as the “nation’s medicine chest.”

Until next time….

Good Luck and Good Job Hunting (forget New Jersey)!

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Who doesn’t like to gossip? The intrigue…the drama….the sheer joy of it! But, can gossiping hurt your career?  Based on my experiences and numerous job losses, the answer to that question is a resounding yes!!! 

That said, others may feel otherwise about workplace gossip.  After all, doesn’t everybody gossip? And, why would a little gossip hurt one’s career? I found an interesting article on the effects of workplace gossiping and how to safely indulge and manage the impulse when it strikes you at work

Until next time….

Good Luck and Good Job Hunting (a good friend of mine heard a rumor…..)!!!!!!!!

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A post at the Pharmalot blog said that the US FDA and the Centers for Disease Control issued a statement today indicating, that after reviewing side effect reports, Merck’s anti-HPV (cervical cancer) vaccine Gardasil is safe and effective, and its benefits continue to outweigh its risks.

According to the statement, the joint agency review determined that 94 percent of  all side effects reported after Gardasil vaccination were not serious. The most commonly reported adverse events fainting, pain at the injection site, headache, nausea and fever. Fainting is common after injections and vaccinations, especially in adolescents, the agencies noted.

Although there have been 20 reported deaths following vaccination, there was no common pattern or tend that would suggest they were caused by the vaccine itself. The statement went on to say that in cases where autopsy, death certificate and medical records were available, the cause of death was explained by factors other than the vaccine.

The statement was likely issued in response to highly publicized and widely circulated adverse events reports issued by the ultraconservative Judicial Watch which is morally opposed to HPV vaccination. It is extremely unfortunate that a small but vocal group of conservative Christians are willing to risk the health of their daughters because they are morally opposed to premarital sex and birth control. 

Until next time….

Good Luck and Good Job Hunting!!!

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On the heels of yesterday’s announcement that it wants to buy Genentech, Roche, in a surprise move, announced today that it will move its Nutley, NJ-based US corporate headquarters to California. According to a report, research and development activities in oncology and metabolism at the Nutley site will be expanded. However, the company will consolidate all Nutley-based finance and information-technology operations and close manufacturing facilities on the site by 2010. It is not clear how many of Roche’s 3,240 New Jersey employees will be affected by the proposed move to South San Francisco. Suffice it to say, more than a few Roche employees are likely to lose their jobs after the company’s headquarters heads west.

Once dubbed the”nation's medicine chest”, New Jersey has steadily been losing pharmaceutical jobs since 1990 when 20% of all US pharmaceutical jobs were in NJ—at present 13.7% of  American pharmaceutical jobs reside in NJ. It has been a long, slow burn for the pharmaceutical and biotechnology workforce in the Garden State.

The Roche announcement comes as several other New Jersey drug makers, including Schering-Plough and Johnson & Johnson's Ortho Biotech unit, have been laying off workers because of the economic downturn and tough times in the industry. It also comes several days after Barr Pharmaceuticals, headquartered in Montvale, announced that it is being acquired for $7.5 billion by Israeli generics giant Teva.  

The growing scarcity of pharmaceutical and biotechnology jobs coupled with the highest property taxes in the US may cause a mass migration from the state. Not that there is anything wrong with that!!!!!!

Until next time….

Good Luck and Good Job Hunting!!!!!

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At lunch the other day, I was telling a bunch of people about how brilliant Roche’s biotechnology strategy has been for the past 20 years or so. All of this changed for me on Monday, when Roche announced that it wanted to buy the remaining shares of Genentech that it already doesn’t own for $ 43.7 billion —Roche currently owns 56% of Genentech’s stock. More importantly, Roche doesn’t have control of Genentech’s board of directors nor does it influence corporate strategy or product development.

Unlike many other pharma companies who have historically purchased  biotechnology companies and then integrated them into existing corporate structures, Roche previously opted to buy controlling interests in companies and then allowed them to continue to operate independently with little corporate input or guidance. Unlike pharma culture, which is very structured and inherently conservative, the most successful biotechnology companies have been built on cultures that promote creativity and “thinking outside the box”.   If Roche buys Genentech and attempts to integrate it into the existing Roche family of companies, I suspect that all of this will change dramatically.

For the past 30 years or so, Genentech has been one of the brightest stars in the biotechnology universe.  Genentech’s management team worked long and hard to implement and maintain a vision that was formulated way back in the late 1970s when the company was first formed. Even though it is the world’s largest and most financially successful biotechnology company, Genentech has steadfastly resisted the temptation to go “corporate” and has worked diligently to maintain its “biotechnology identity” —symbolized by innovation, creativity and employee-centric policies.

I have no doubt that if the Roche-Genentech deal is approved, there will be a mass exodus of talent from the company. Based on my experience, a publicly-treaded biotechnology employee’s greatest fear is the dreaded corporate takeover! I have yet to meet a biotechnology company employee who is willing to sacrifice freedom and creativity (despite a possible financial upside) for more structure, discipline and an endless plethora of rules! 

In my opinion, the deal makes sense for Roche—competition in the cancer space is intense and they want to hedge their future success on Genentech’s oncology franchise. In the best case scenario, Roche will buy Genentech but allow it to operate as a wholly owned subsidiary with an independent management team that spends as little time in Basel as possible. I think the old adage “If it ain’t broke, don’t fix it” is particularly apt here!

Until next time….

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

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Teva and Barr Pharmaceuticals announced today that they have signed a definitive agreement under which Teva will acquire Barr, the fourth largest generic drug company worldwide. Teva the world’s largest generic manufacturer will acquire Barr for $7.5 billion.

As I mentioned yesterday about a possible deal between Teva and Barr, the acquisition is pivotal strategic move for Teva. It provides Teva with a stronger presence in the US generic markets and it elevates Teva as a force to be reckoned with in the biosimilar/follow-on biologics race in Europe and ultimately in America.

I guess when the Israelis say they are going to do something, they do it!

Hat tip to Ed at Pharmalot for the heads up!

Until next time….

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

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A post today on the Pharmalot blog suggests that Israeli generic manufacturer Teva is in talks to acquire US-based Barr Pharmaceuticals for  $7.0 -7.5$ billion. Barr’s present market cap is approximately $5.0 billion.

The acquisition would make sense for Teva to broaden its reach into the generic and branded generic markets in the US. Also, Barr recently acquired PLIVA which has active research programs on biosimilars and is currently selling its version of EPO in Croatia and other parts of Eastern Europe.

Teva has been trying to get into the biosimilar/follow-on biologics market for the past eight years or so. The company previously bought several early stage biogenerics manufacturers but have yet to advance their plans to formally enter the biosimilar/follow-on biologics market. This may be the opportunity that Teva has been looking for!

Check back for updates.

Until next time…

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

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Like my kids frequently say when I mutter something obvious…”Like..DUH.! According to an article in today’s New York Times, “American medical care may be the most expensive in the world, but that does not mean it is worth every penny. A study to be released Thursday highlights the stark contrast between what the United States spends on its health system and the quality of care it delivers, especially when compared with many other industrialized nations.” No surprises here—the US spends more per capital on healthcare than all other industrialized nations but a greater percentage of the US population is without adequate healthcare.

One of the things that irritate me the most is that many Americans still believe that US healthcare is second to none. True, Americans have greater access to experimental and new cutting-edge treatments than others in the world, but when it comes to preventing or prophylatically delaying the onset of chronic diseases like diabetes, high blood pressure, obesity etc, the American healthcare system is grossly deficient.  

Healthcare insiders and third party payors have known that the system has been failing for past 20 years. Unfortunately, the healthcare and drug maker company lobbies have effectively blocked and prevented any changes to correct the glaring deficiencies of the American healthcare system. Anytime, anybody utters the phrase “nationalized healthcare” a collective shudder is exhibited by most Americans. The truth is that Medicare, a government-run healthcare insurer, is responsible for covering almost 60% of all medicals claims that are filed annually in the US. This means that healthcare benefits supplied to a majority of Americans are under the auspices of a nationalized healthcare program. Why not go all the way and cover the medical costs of all Americans?????

Politicians can no longer deny that it’s time for a change—the health of America depends on it!

Until next time…

Good Luck and Good Job Hunting

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I became a medical/science writer after a rather circuitous, unconventional and sometimes, checkered career. Along the way, I learned a few things that I thought would be important to share with other PhDs who are seeking to change careers, t broaden their horizons and or simply to bring home a paycheck! I am sure that I missed a few things but here are my top 10 reasons to consider a career in medical/science writing:

10. Academic and industrial jobs are scare 
9.   No postdoctoral training is required
8.   Previous industrial experience is not a prerequisite for employment
7.   No laboratory work must be done to publish
6.   Starting salaries range from $40-$50 per hour or $75-90K annually 
5    There is a growing need for therapeutic area content experts
4.   Assignments change regularly and there is an enormous of amount of flexibility in when    and how you work 
3    Although a writer doesn’t perform any laboratory work, there is an opportunity to utilize the scientific skill sets (data analysis, thinking and problem solving) that you learned during your graduate training
2.   Even when times get tough, writers are always in high demand because publishing is the life blood of science
1.  You enjoy writing, thinking creatively and working with an eclectic bunch of people who are not scientists!

Until next time..... 

Good Luck and Good Writing!!!!!!!!

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Yesterday Pfizer announced that it would layoff 275 employees at its manufacturing facility in Kalamazoo County in Michigan. Not to be out done by big pharma, generics manufacturer Perrigo Co. said today that it is going to create 400 new jobs in the western Michigan town of Allegan. According to published reports, Perrigo plans to invest $10.5 million in its Allegan, MI headquarters and manufacturing facility in an expansion that is projected to generate 99 new jobs within a year and 400 others over five years. A Michigan Economic Development Corp’s analysis suggests that the Perrigo expansion could generate up to 1,039 jobs in Michigan by 2020

A Perrigo spokesperson said that as it has done with past jobs cuts in Kalamazoo, the company will recruit the Pfizer personnel losing their jobs. This is good news for the folks who were laid off by Pfizer yesterday. However, when you do the math (275-99), the will be a net loss of 176 pharmaceutical jobs in Western Michigan by year’s end. Although Perrigo said that another 300 jobs will be created over the next five years, I wouldn’t count on many jobs being added until the US economy finds its way out of its current recession.

Hat tip to Pharmalot for the heads up!

Until next ….

Good Luck and Good Job Hunting (Michigan may be better than I thought)!!!!!

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Pfizer is at it again. The company announced today that it will cut 275 jobs from its manufacturing operations in Kalamazoo County before the end of the year. The cut will reduce the company’s total employee roster to about 2,500 at the Portage, MI site.

Pfizer has been steadily streamlining and downsizing operations in Michigan ever since it inherited several Michigan-based sites after it acquired Pharmacia in 2002.

Not surprisingly, a company spokesman said “We operate in a highly competitive and constantly changing environment, and we have to adapt to that.'' Easy for him to say—he still has a job. 

The announcement comes on the heels of a rumor circulating last week that some Pfizer employees at its Croton R&D facility may lose their jobs next fall.

Until next time….

Good Luck and Good Job Hunting (avoid Michigan)!!!!!!!!!!

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First, King Pharmaceuticals posted a non-branded high blood pressure video on YouTube in early 2007. Next, Novartis added a 60-second commercial (as part of its Fluflix campaign) asking people to submit videos about what it's like to have the flu. Earlier this year, Insmed upped the ante by posting a video lobbying for new legislation for the approval of follow-on biologics in the US. However, these pharma assaults on YouTube pale in comparison to the launch of Johnson & Johnson’s health channel on YouTube earlier this week.

The channel currently showcases a small selection of health information videos created by NBC News chief medical editor Nancy Snyderman while she worked J&J. Video sites, like YouTube and Vimeo, offer pharma companies a place to feature expensive off media advertising assets (that are currently collecting dust) and to post ads for new drugs and products that are ready for launch.  J &J is the first pharma company to recognize that it can leverage the current social media craze to increase its visibility, sell more drugs and bolster its stock price!

While companies could host videos on their own websites,YouTube’s massive traffic of more than 80 million users offers companies a much larger and diverse audience. And unlike blogs or forums, pharma companies have complete control over the content of the videos that they post on video websites. Moreover, they don't have to worry about negative comments being left after a post (YouTube comments can be turned off), and they can brand and edit video content to target a particular demographic or audience. Finally, videos can be changed or removed by companies as needed.

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Richmond Va-based INSMED, a US-based follow-on biologics manufacturer, posted a press release on its website entitled: “Insmed Announces First Human Bioequivalence Data for a Follow-on Biologic by a U.S. Company” that reports on the results from a Phase I clinical trial that demonstrated that it lead product INS-19 was bioequivalent to Amgen’s Neupogen^(R) (recombinant G-CSF) in stimulating human white blood cell production. 

, Dr. Geoffrey Allan, President and CEO of Insmed said  "These results are very exciting, as they represent Insmed's ability to replicate a protein product, to bring that product rapidly through the clinic and to demonstrate clear bioequivalence to the innovator drug," said "To our knowledge, we are the first U.S. company to report human bioequivalence data for a follow-on biologic product, validating the idea that follow-on biologics can be a scientific reality in the U.S. and that Insmed is well positioned to be a leader in the field. “ The company has requested a meeting with FDA to discuss the design of a Phase III human clinical trial for INS-19.

I am not sure why INSMED is so excited about its results. Sandoz essentially accomplished the same feat with Omnitrope, its biosimilar version of recombinant human growth hormone (HGH)and it took a law suit and a loophole in the approval process for growth hormones for FDA to allow it to be sold in the US. In my opinion, until legislation is passed that provides a clearly defined legal pathway for approval of follow-on biologics I suspect that INS-19 will suffer the same fate (or perhaps worse) than Omnitrope. Bioequivalence is only legal defined for and relevant for approval of small molecule NOT BIOLOGICS when seeking expedited approval for generic versions of branded products. That said, I want to tip my hat to INSMED for its willingness to take a lead role in the fight to get follow-on biologics approved in the US. Finally, there is nothing like an edgy press release and a few bloggers to bring an issue that is rapidly losing momentum back to the forefront.

Kudos to INSMED!!!!!!

Until next time….

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

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The social development of the web 2.0 has largely bypassed science. Hugely popular websites such as Facebook, MySpace, Twitter, Digg, Delicious and the like have millions of members and generate huge amounts of traffic. But those who use these sites come from all walks of life. None are devoted solely to science.

With this in mind, it would seem that social networking sites that cater to scientists would have special value and appeal. A few have been launched —but there is certainly room for improvement.

This fall, Vincent Racaniello at the College of Physicians and Surgeons at Columbia University and I will launch BioCrowd.com, a new social network designed by scientists (Vincent and me) for bioscientists (and others in the life sciences) who wish to connect with others to advance, promote or shape their careers.

Please visit the home page to sign up to be notified when we launch. BioCrowd will combine the interactivity of sites like Facebook and the networking capabilities of LinkedIn to help to advance your career in the biosciences.

Be part of  "The BioCrowd" !!!!!!!!

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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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One of the more awkward things in any employee’s career is asking a boss or supervisor for a raise. There is no right or easy way to successfully accomplish this often gut-wrenching task. That said, I came across a post that provides some insights into the process and offers some tips on how to optimize negotiations to get the raise that you think you deserve!

Of course, this post is only relevant for those of us who still have jobs! Nevertheless, some of the tips offered in the article will come in handy when negotiating a new compensation package for your next job.

Until next time….

Good Luck and Good Job Hunting!!!!!

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Siemens, the German conglomerate that manufactures everything from locomotives to medical imaging devices, officially announced on Tuesday that it will be sacking 4% of it workforce or 16,750 employees. Although the company didn’t specify where all of the cut would be taking place—it is a global workforce reduction—a company spokesperson did indicate that 1,500 administrative jobs in its healthcare division would be eliminated and most of those jobs are in the US. Many of these cuts will likely take place in the tri-state area (New York, New Jersey and Pennsylvania)—not welcome news for the already battered pharmaceutical and biotechnology industries in the region.

While the cuts seem pretty substantial to most people (especially those Siemens employees who are losing their jobs) one company executive quipped “If you have 400,000 people on your payroll, cutting 17,000 is not that big a deal” — only if you aren’t one of the people who is losing a job.

Until next time….

Good Luck and Good Job Hunting!!!!!

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The old adage “When it rains, it pours” is particular apt for the bad news that has plagued the once venerable Merck & Co for the past five years. First, there was the Vioxx scandal, followed in short order by the Vytorin and Singulair messes and now it appears that the company’s new anti-cervical cancer vaccine, Gardasil, may have —pardon the expression — a few “warts” on it. 

Last night on my local nightly news, there was a brief report about emerging safety issues with Gardasil. According to the report, adverse events ranging from “massive wart outbreaks to seizures and paralysis” have been reported for the anti-HPV vaccine. Since its approval in 2006, over 8,000 adverse event reports (the total number of people vaccinated was not disclosed) and 18 alleged deaths have been reported for Gardasil (although none of the deaths has been directly linked to Gardasil vaccination). This news comes on the heels of a recent Wall Street analyst’s report indicating that sales of Gardasil are much lower than expected. It appears that the vaccine, once considered by Merck insiders as the new blockbuster that could save the flagging drug maker, may, after all, be relegated to specialty drug status.

As many of you may know, GlaxoSmithKline (GSK) is seeking US approval for its anti-cervical cancer vaccine called Cervarix. Although Merck beat GSK to market, Cervarix has undergone more clinical testing and allegedly may have a better safety and tolerability profile than Gardasil (only the regulatory agencies know for sure). Nevertheless, it is not clear whether GSK will benefit or be injured by the negative publicity that Gardasil is receiving. As I mentioned in a previous post, the US Food and Drug Administration (FDA) recently delayed Cervarix’s approval pending submission of additional data that the agency requested from GSK.

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Monoclonal antibodies (MAbs) directed against vascular endothelial growth factor (VEGF) receptors on cancer cells, have been found to slow the growth of a variety of cancers including colorectal, breast and lung.  While a number of blockbuster biotechnology products( based on these MAbs (Avastin by Genentech/Roche and Eribitux by Bristol-Myers Squibb/ImClone/Merck KGA) have been approved to treat a variety of different cancers their effectiveness as cancer treatments has been the subject of intense debate since their approvals.

Although numerous human clinical trials have shown that VEGF inhibitors slow the growth and development of tumors, they, as a class, don’t seem to significantly increase the survival time for most cancer patients. Further, Avastin and Erbitux are generally not used as stand alone treatments but are used in combination with more tradition anti-cancer chemotherapies. The high costs of these drugs, (Avastin’s worldwide sales hit $ 3.5 billion last year) and their variable effectiveness have caused many to question the usefulness of this class of drugs to treat cancer patients.

The well-publicized use of these drugs as cancer treatments coupled with anecdotal evidence about their effectiveness has put practicing oncologists between a rock and a hard place when it comes to treating patietns with cancer. In an article in Sunday’s New York Times one prominent oncologist said that depsite the controversy,  “I still use Avastin routinely. It’s not a slam dunk and, in fact, the incremental benefit may be more modest than we want to admit.” Others are more sanguine about VEGF inhibitors as cancer treatments “Even when these drugs ‘work,’ what kind of impact are you talking about?” said Fran Visco, president of the National Breast Cancer Coalition. But we market them and give them to everybody.”  

Nevertheless, most oncologists find it difficult to withhold Avastin or Erbitux from cancer patients seeking hope. As one oncologist put it “ When I am not sitting in front of a patient, I think about whether drugs like Avastin are worth it to society. But when facing a seriously ill patient, who, based on clinical trial results, might benefit — even if only a little — from Avastin, I think about the patient’s needs.” 

Regardless of their therapeutic value, the main issue with this class of anti-cancer drugs is cost. Avastin treatment costs patients about $4000-$9000 per month— Eribitux treatment is even more costly! While Medicare and most private insurers cover 80% of the cost, patients can be responsible for 20% or more of treatmetn costs.  As posited in the Times article “If Avastin were inexpensive or if it cured cancer or even held it at bay, as the drug Gleevec does for blood cancer, few might care.”

Are anti-VEGF drugs real cancer treatments or expensive red herrings? Clearly, the jury is still out on that one. That said, I think that only cancer patients can truly provide an accurate response to that question!

Until next time…

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

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According to apost at Pharmalot, rumor has it that Pfizer will lay off a number of chemists at its main R&D facility in Groton, Connecticut as early as next Fall The rumor supposedly began at an R&D blog run by a former Pfizer employee (always a reliable source for inside information). 

M y colleague Ed Silverman who runs Pharmalot contacted Pfizer about the rumor and received this response “A leading R&D organization must evolve, continue to build on its strengths, capture competitive advantage wherever possible and be realistic about what it will take to return Pfizer to growth. What I can assure you is that if and when there are organizational changes, those decisions are never taken lightly. Our guiding principle is that colleagues hear about important Pfizer news from company leadership first and are treated with the utmost respect.” In other words, Pfizer will likely be laying off more employees in the very near future.

Hat tip to Ed!

Until next time…

Good Luck, Good Job Hunting and Happy 4^th of July!!!!!

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Everybody who works for a living has to learn how to deal with annoying co-workers who, either directly or indirectly, may have an effect on your career trajectory. Managing difficult co-workers is essential if you want to learn how to adroitly deal with workplace politics. I came across a well-crafted post that identifies 6 unique, annoying co-worker personality types and offers advice on how to effectively leverage these troublesome personalities to your benefit.

1. The Naysayer. This office dweller delights in shooting down ideas. Even during "blue sky" brainstorming sessions, where all suggestions are to be contemplated with an open mind, the Naysayer immediately pooh-poohs any proposal that challenges the status quo.

The right approach: Because great solutions often rise from diverse opinions, withhold comment -- and judgment -- until the appropriate time. Moreover, be tactful and constructive when delivering criticism or alternative viewpoints.

2. The Spotlight Stealer. There is definitely an "I" in "team" according to this glory seeker, who tries to take full credit for collaborative efforts and impress higher-ups. This overly ambitious corporate climber never heard a good idea he wouldn't pass off as his own.

The right approach: Win over the boss and colleagues by being a team player. When receiving kudos, for instance, publicly thank everyone who helped you. "I couldn't have done it without ..." is a savvy phrase to remember.

3. The Buzzwordsmith. Whether speaking or writing, the Buzzwordsmith sacrifices clarity in favor of showcasing an expansive vocabulary of clichéd business terms. This ineffective communicator loves to "utilize" -- never just "use" -- industry-specific jargon and obscure acronyms that muddle messages. Favorite buzzwords include "synergistic," "actionable," "monetize," and "paradigm shift."

The right approach: Be succinct. Focus on clarity and minimize misunderstandings by favoring direct, concrete statements. If you're unsure whether the person you are communicating with will understand your message, rephrase it, using "plain English."

4. The Inconsiderate Emailer. Addicted to the "reply all" function, this "cc" supporter clogs colleagues' already-overflowing inboxes with unnecessary messages. This person also marks less-than-critical emails as "high priority" and sends enormous attachments that crash unwitting recipients' computers.

The right approach: Break the habit of using email as your default mode of communication, as many conversations are better suited for quick phone calls or in-person discussions. The benefit? The less email you send, the less you're likely to receive.

5. The Interrupter. The Interrupter has little regard for others' peace, quiet or concentration. When this person is not entering your work area to request immediate help, the Interrupter is in meetings loudly tapping on a laptop, fielding calls on a cell phone, or initiating off-topic side conversations.

The right approach: Don't let competing demands and tight deadlines trump basic common courtesy. Simply put, mind your manners to build healthy relationships at work.

6. The Stick in the Mud. This person is all business all of the time. Disapproving of any attempt at levity, the constant killjoy doesn't have fun at work and doesn't think anyone else should either.

The right approach: Have a sense of humor and don't be afraid to laugh at yourself once in awhile. A good laugh can help you build rapport, boost morale, and deflate tension when working under stressful situations.

Do you recognize any of your co-workers who fit the bill? Or, perhaps more worrisome, do you fit into any of these categories. Food for thought……..

Until next time…

Good Luck and Good Job Hunting (remember those workplace politics)!!!!!!!!

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