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The Philadelphia Inquirer reported today that Pennsylvania state legislators, spearheading efforts to retain jobs in the state after the $68 billion Pfizer-Wyeth merger closes next month, said they were fairly confident many positions would remain at Wyeth's regional operations in Collegeville, Great Valley and other sites. Wyeth employs about 4,500 people in the region - about 3,600 in Collegeville and 900 in Great Valley and elsewhere.

One legislator told the Inquirer that "Representatives of both Pfizer and Wyeth have continued to assure us that we should not worry and they have continued to listen to the case that we have made for as many jobs as possible remaining in Pennsylvania." Pfizer, which plans to cut about 20,000 of the combined companies' 130,000 jobs, would not comment yesterday on the statement or the job situation in Pennsylvania. Gee, what a surprise!

If I were a betting man, I would say that there will be massive layoffs in Pennsylvania and elsewhere after the deal closes. Don’t be surprised if Wyeth’s Madison, NJ headquarters and its research facilities in Princeton NJ are first to get the ax. Finally, I am now firmly convinced that you can never trust a thing that a politician says.

Until next time...

Good Luck and Good Job Hunting!!!

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The New York Times that W. Scott Harkonen, MD the former chief executive of InterMune, a Brisbane, CA biopharmaceutical company, was convicted yesterday for issuing what federal prosecutors called a misleading press release that contributed to off-label sales of the company’s drug Actimmune.

Actimmune is bioengineered form of interferon gamma approved in 2000 to treat children and adults with chronic granulomatous disease (CGD) and severe, malignant osteopetrosis—two relatively rare genetic diseases. But the main sales of the drug, which peaked at $141million in 2003, came from an unapproved use: treating idiopathic pulmonary fibrosis, a scarring of the lungs that can be fatal. While licensed physicians in the US can prescribe approved drugs for off label, it is illegal for drug makers to promote the use of prescription drugs to treat indications for which the drug didn’t receive approval.

According to the Times article, InterMune conducted a large clinical trial testing Actimmune as a treatment for the lung disease. The drug did not achieve the clinical endpoints of the trial, which was to improve lung function of patients receiving Actimmune as compared with patients receiving a placebo. However, a review of the statistical analyses of the trial revealed that if only the patients in the trial with mild or moderate disease were considered, those who got the drug lived longer than those who received the placebo .The company highlighted the “survival benefit” of patients treated with Actimmune in a news release, issued in August 2002.  Following the press release, sales of Actimmune (which costs about $50,000 per year) peak at $141 million in 2003—the drug was mainly being used to treat idiopathic pulmonary fibrosis an indication for which the drug hadn’t received regulatory approval. Because of this, federal prosecutors contended that the news release was part of a scheme to induce off-label sales of Actimmune. Interestingly, in 2007, a second large clinical trial of Actimmune found that the drug didn’t prolong the lives of patients with pulmonary fibrosis.

The InterMune case isn’t unique in the life sciences industry. Time and time again companies are charged with off-label promotional activities and typically these cases are settled before they go to trial. To that end, the InterMune case is an exception but Harkonen’s conviction sends a warn drug company executives that the US government takes off label promotion seriously and it will no longer be tolerated.

While it can be argued that off label drug use can benefit patients and ought to be allowed, off label promotion of previously approved drugs allows drug companies to benefit financially without investing in expensive clinical trials to win regulatory approval for the off label indication. In other words, off label promotion of prescription drugs can be a financial windfall for companies and induce them to place profits ahead of patient safety and drug efficacy. This is why promotion of off label use of prescription drugs is illegal and a prosecutable crime. 

It is important to remember that prescription drugs are required to undergo a rigorous regulatory review to insure that they are safe and efficacious. While the use of approved drugs to treat off label indications may benefit some patients, the drugs in question must be rigorously tested for safety and efficacy to treat the indication before they are used to in large numbers of patients. And, as we have seen in recent years, even drugs that have gone through clinical testing and garnered regulatory approval may not be as effective or safe when used to treat billions of patients!

Until next time...

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

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A spokesperson at the US Food and Drug Administration (FDA) announced today that it decided to delay its decision whether or not to approve GlaxoSmithKline’s (GSK) anti-cervical cancer vaccine Cervarix. The agency was scheduled to announce its ruling Tuesday on whether to approve Cervarix, but a GSK spokeswoman said the review will continue. An agency spokesperson failed to disclose any reasons for the delay because FDA doesn’t comment on ongoing product reviews. This is the second regulatory delay for Cervarix in the past two years.

The delay comes as something of a surprise because earlier this Earlier this month, an outside panel of health experts voted that Cervarix appears safe and effective for girls and women ages 10 to 25. The FDA is not required to follow the group's advice, though it usually does. Cervarix already is approved in nearly 100 other countries, but has been delayed in the U.S. since 2007, when the FDA said it needed additional safety data.

An approval from FDA would allow London-based GSK to compete against Merck's blockbuster vaccine Gardasil, which has been on the US market following its approval in 2006. Based on all available published reports, Cervarix has a similar safety profile and efficacy profile as compared with Gardasil.

One of the issues with Cervarix may be the adjuvant use to formulate the vaccine to bolster anti-HPV immunity. While Merck's Gardasil uses an aluminum salt adjuvant, Cervarix uses a novel adjuvant known as AS04. The agency’s lack of familiarity with AS04 and possible concerns about its safety may be what is delaying the Cervarix decision. 

Stay tuned for further details!

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Fierce biotech reported today that word on the street is that the Swiss drug maker Novartis may tender an offer to acquire London-based AstraZeneca.

On the surface, the deal doesn’t make much business sense. However, Astra Zeneca’s purchase of the Maryland-based vaccine manufacturer MedImmune two years ago might make the company more attractive to Novartis which has a strong biotechnology pipeline and is looking to improve the competitiveness of its vaccine division.

AstraZeneca stock share price is soaring as a result of the rumors.

Stay tuned for the latest developments!

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There has been a growing reliance on the use of online tools to teach science to primary, secondary and college students. This makes sense because anybody who has pursued a science career will tell you that using web-based programs, applications and searches is absolutely essential when conducting scientific research. To that end, Amber Johnson at onlinecourses.org sent me an article that details some really cool educational add-on tools that are available for the Firefox browser.

I highly recommend that science educators at all levels check out the post and evaluate some of these interesting tools!

Until next time...

Good Luck and Good Teaching!!!!!!!!

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While pharmaceutical and biotechnology companies have been reluctant to use social media, Bio-Rad, Applied BioSystems and other life sciences reagent and instrumentation companies have jumped on the YouTube video train with reckless abandon.

A quick perusal of the molecular biology-related videos on YouTube reveals several scintillating titles like “Do the Double Helix,” “DNA Replication Rap,” and my personal favorite from Bio-Rad, “The PCR Song” (see video below)

Until next time....

Good Luck and Good Watching !!!! 

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The Belgian chemical manufacturer Solvay announced today that it had agreed to sell its pharmaceutical business unit to Abbott Pharmaceuticals for $6.6 billion. By purchasing Solvay, Abbott gains access to emerging markets in Eastern Europe and Asia along with new therapeutic areas, including hormone therapies and vaccines. Solvay's flu vaccine Influvac will give Abbott an entrant in the burgeoning vaccines market, which is currently dominated by European pharmaceutical giants like GlaxoSmithKline and Novartis.

Abbott already holds U.S. marketing rights for Solvay's Trilipix and TriCor, drugs which raise "good" HDL cholesterol while reducing triglycerides and "bad" LDL cholesterol.

Solvay's other top-selling drugs include the Parkinson's disease treatment Duodopa and hormone therapy drugs AndroGel and Duphaston. It is not clear whether or not the Solvay purchase will affect ongoing pharmaceutical operations or staffing decision in the US. However, I suspect that there will be management changes and layoffs in Europe.

In other news, Johnson & Johnson bought an 18 percent stake in Dutch biotechnology company Crucell NV, which is trying to develop a universal flu vaccine, while competitor Merck acquired the rights to sell Australia-based CSL Ltd.'s Afluria flu vaccine in the U.S.

The Solvay deal is the latest in a string of mergers and acquisitions, as cash-rich pharmaceutical companies race to acquire new products amid looming patent expiry on blockbuster drugs. Earlier this year Swiss drugmaker Roche acquired Genentech following similar deals uniting Pfizer Inc. and Wyeth, and Merck & Co. Inc. with Schering-Plough.

Expect more M&A activity in the life sciences sector before year’s end.

Until next time...

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

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NextLevel Pharma has organized several life sciences meetings that may be of interest to BioJobBlog readers. These include: a webinar entitled “Safety Biomarkers in Drug Development” on October 14 and 21, 2009; a conference, “Best Practices in Phase IV Clinical and Observational Research” December 3-4, 2009 in Prague, Czech Republic and “Advancing Biologics from the Lab to the Clinic", January 11-12, 2010 in Brussels, Belgium.

Each of these offerings offers ideas and insights into important issues that are emerging in the life sciences industry. Check it out!

Until next time....

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

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The competition for National Institutes of Health (NIH) grant funding has been intensifying over the past five years or more. In the past, NIH had gone to extraordinary lengths to insure that senior investigators didn’t lose their funding so as to not hinder the progress of long standing research programs. However, in recent years, NIH funding managers have eschewed the unwritten policy of preferentially funding established investigators in favor of younger ones!  According to an article in today’s New York Times, NIH grant managers are increasingly ignoring the advice of study sections and funding scientists whose projects receive less favorable reviews than those denied money. Many of the favored funding recipients are “new investigators,” or scientists who had never before received a grant from NIH. Further, in 2007, the last year for which figures are available, “19 percent of the grants awarded to individual scientists were made as exceptions, or given outside of rankings by scientific reviewers, according to a report by the Government Accountability Office. Nearly all of the increase in exceptions in 2007 went to new investigators, with the young scientists’ share rising from 20 percent of all exceptions in 2003 to half in 2007.”

Not surprisingly, many senior investigators are calling “foul” despite the fact that the median age at which scientists win their first NIH grant has risen steadily, to 41 years, from 35 in 1980. While all meritorious grant proposals ought to be funded, the reality is that there simply isn’t enough money to around. As a former tenure track faculty member, I believe that new investigators deserve something of a handicap or edge when it comes to competing for their first grants. After all, how can an overwhelmed, newly minted faculty member be expected to successfully compete with established investigators who have mastered their jobs and more importantly, the art of grant writing? Sadly, the old practice of preferentially funding established investigators over new ones tended to stifle innovation and reward scientists who liked to play it safe!

We live in an increasingly competitive world where innovation is at a premium. American scientists and granting agencies must abandon their old practices if they want to remain competitive on the world stage. To that end, funding some young, innovative investigators over a few established faculty members who have enjoyed long successful scientific careers doesn’t seem like a bad investment to me! After all isn’t all about retun on investment these days?

Until next time...

Good Luck and Good Job Hunting!!!!

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Last week, I took a group of Seattle researchers to task about issuing a press release about isolating methicillin resistant Staphylococcus aureus (MRSA) from sand samples taken from public beaches in Washington State. Their findings were neither remarkable nor news worthy and likely did more harm than good. Sadly, another article about MRSA—designed to alarm rather than inform and educate the American public—appeared in today’s Science section of the NY Times.

The article, “Ties to Pets Has Germ Jumping To and Fro” in which the word “germ” appeared several times, reports on the possible transmission of MRSA between humans and their pets, most notably dogs and cats. Much of the article focuses on the “strong link between animal to human transmission,” offers several frightening examples of serious zoonotic cases that have been recently reported and suggests that cats are eight times more likely than other pets to transmit MRSA to their owners. After reading the first part of the article, readers would rightfully believe that we are in the midst of a massive zoonotic MRSA epidemic with family pets at its epicenter.  However, on the second page of the article the author mentions an epidemiological survey study conducted by Dr. J. Scott Weese, a veterinarian from the University of Guelph in Ontario Canada which showed  that only “two to three percent of pets carry MRSA on their fur or skin or in their saliva.” Further, the study suggests that healthy animals that are transiently colonized by MRSA eliminate them “in a manner of weeks.” Compare the 2 to 3 per cent carrier rate in pets with an almost 70% human carriage rate of MRSA. While I am a PhD-trained infectious disease microbiologist, I don’t think it requires a PhD to quickly realize that pets really aren’t a major source or cause of MRSA infections for humans. That said, raising awareness among veterinarians about MRSA might aid in the development of appropriate disease surveillance, diagnostic testing, andinfection control to lessen the impact of MRSA on smallanimals.

I have no doubt that many people will look at and possibly treat their pets differently after reading the Times article. Further, many will unnecessarily spend money to have their pets tested for the presence or absence of MRSA. While informing the American public that pets (like humans) might unknowingly transmit MRSA is a good thing, turning the rare transmission of MRSA from animals to humans into a major epidemiological brou-ha-ha is misleading, scientifically disingenuous and reckless. Good journalism should inform and educate, not alarm and frighten people by presenting misleading and wrong-headed information. 

Until next time....

Good Luck and Good petting your pets (it will do more good than harm)

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Mark Senak at the EyeonFDA blog reported yesterday that the US Food and Drug Administration (FDA) is seeking public input on the use of social media in the pharmaceutical, biotechnology and medical devices/diagnostic industry. Meetings to solicit input will be held in Washington DC on November 12 and 13^th.  This will be the first opportunity for industry representatives and the public to begin a discussion with FDA on the policies that will guide the use of social media in the life sciences industry.

According to EyeonFDA, on Monday, the agency will publish a notice in the Federal Register announcing this historic event (see excerpt below)

Questions have arisen regarding the application of the prescription drug and device advertising and labeling provisions, regulations, and policies of promotion on the Internet, especially with regard to the use of emerging technologies such as blogs, microblogs, podcasts, social networks and online communities, video sharing, widgets, and wikis. This section briefly discusses the issues the agency has identified as most frequently raised by regulated companies and other interested parties. It should be noted that although a question may raise a particular issue, that does not necessarily mean that the agency will issue guidance or a regulation on that issue. The agency invites comment at the public hearing on the general concept of Internet promotion, positive or negative; on any aspect of Internet promotion that is of interest to the presenter; and on the topics outlined in the following paragraphs. We are specifically interested in data and research on the use of social media tools in promotion, including data from companies on their own experiences, the extent to which health care professionals and consumers are using and are influenced by various social media tools, and the impact of Internet and social media promotion on the public health.

For the past year or more, many bloggers and other social media enthusiasts have taken FDA to task for not taking action on the topic. Finally, the agency realized that something had to be done given the growing use and popularity of social media tools and strategies in other less regulated industries. Earlier this week, in an unexpected move, FDA launched its first Twitter feed. Perhaps this was a hint that FDA is beginning to emerge from the dark ages into the digital world of Web 2.0 and social media.

Hat tip to Mark!

Until next time...

Good Luck and Good Twittering !!!!!!!

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I previously posted an article on BioJobBlog about biomedical and scientific search engines. One of them called Novoseek, which is mainly geared for life scientists, has recently launched a new set of features known as  My Novoseek

My Novoseek allows users to create a personal account to store and manage indiviudal Novoseek searches. Its functionalities include:

• Search history
• Saved searches
• Search labeling and indexing
• New publication alerts
• Account filtering and management

These newly introduced features improve Novoseek’s search capabilities, content management and convenience. For example, saving searches and creating alerts offers users a facile and convenient way to be alerted when new papers are published in your areas of interest. Also, Novoseek’s indexing and content management features makes creating and labeling collections of papers really easy. Finally, the ability to customize and manage account settings and view search histories makes searching for new information easier, less time consuming and prevents search redundancy.

While I haven’t spent much time evaluating other biomedical search engines, my experience with Novoseek has positive and I recommend that you check it out. Also, unlike other biomedical search engines, Novoseek has a distinctive social media bent and is using it to constantly add new features to meet new and exisitng user demands. To that end, Novoseek maintains its own blog to keep user abreast of happenings in the biomedical search engine world and can be found on Facebook and Twitter.

Signing up for Novoseek is easy, requires only three steps and only takes five minutes or less.

Please visit the Novoseek website and let me know what you think.

Until next time...

Good Luck and Good Searching!!!!!

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Last week, in a post about the antibacterial properties of cinnamon oil, I mentioned a concoction consisting of cinnamon bark, lemon oil and eucalyptus called “thieves oil” that was used by grave robbers in the Middle Ages to prevent bacterial infections from routinely handling dead bodies. Interestingly, my local New York NBC affiliate filmed a video with an infectious disease physician who demonstrates how to make and use thieves oil. 

Check it out!

Until next time....

Good Luck and Remember to wash your hands!!!!

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By now, most of you have heard or read how vital networking is to either advance your career or find a job. Like it or not, learning to network is another skill that everyone must master (including scientists) to insure a successful career trajectory. Not surprisingly, most scientists are notoriously poor at networking—mostly because they haven’t been taught to network or perhaps more egregiously they have been told that it isn’t worthwhile or necessary to find a job. For example, in 1974, during a seminar  series required of all incoming graduate students in the Department of Bacteriology at the University of Wisconsin, a very famous and influential microbiologist sanguinely quipped: “your science should speak for itself and that’s all that matters!” In other words, if we graduate students do “good science” then others will recognize it and we shouldn’t have difficulty finding a job upon completion of our training. How wrong he was—it took me over five years (and two post docs) before landing a faculty position at the University Of Miami Shcool Of Medicine in 1987!

Unfortunately, this “networking isn’t necessary” attitude is still pervasive among life sciences faculty members in many graduate departments throughout the US; despite an acknowledgement that there continue to be dwindling numbers of job opportunities for PhD scientists. Nevertheless, in the real world—especially during  tough economic times—networking is a vital component of all job searches. That said, you never know who you may meet when networking at a conference, a seminar or even at a social event who might be helpful in your job search. However, before you begin networking, it is vitally important to understand networking rules and basics.  To that end, I found an informative article that showcases 13 common networking mistakes and blunders to avoid making. I highly recommend that you read this article before your next (or first) networking event!

Until next time,

Good Luck and Good Networking!!!!!

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Mark Senak who runs the EyeonFDA blog reported yesterday that the US Food and Drug Administration (FDA) had launched a Twitter account. As Mark aptly points out, FDA’s unexpected leap into social media is ironic given that the agency has been steadfastly reluctant to craft any guidance whatsoever on the use of Web 2.0  technology or social media by drug and device manufacturers. Maybe, the agency was tired of being overshadowed by the Centers for Disease Control in Atlanta, GA whose rapid adoption and use of social media for public health and related issues has been outstanding. 

For those of you FDA aficionados, FDA can be found on Twitter at @FDA_Drug_Info. Despite its very recent launch, the agency already has over 1,700 followers. Not surprisingly, FDA_Drug_Info is following only six individuals and is largely a one-way informational channel. Maybe somebody ought to tell the agency that social media, most notably Twitter, is suppose to be interactive and conversational? Also, couldn’t FDA staffers come up with a better Twitter handle? I mean the use of underlines to separate words in FDA_Drug_Info is so ......Web 1.0!!!! Finally, most of the information tweeted by the agency has to do with drug approvals, workshop announcements, safety warnings, etc. Maybe somebody also should tell them that most life sciences companies block Twitter and other forms of social media. Nevertheless, based on some recent tweets, it appears that the agency is targeting healthcare providers and consumers as their main audiences.

Despite FDA’s Twitter presence, I wouldn’t expect any Web 2.0 guidance or a drug and device social media policy any time soon. I say this because the agency yet to craft guidance on website design and Google Ads—two very ancient internet tools!!!! Maybe they ought to appoint a social media czar at the agency?

Until next time....

Good Luck and Good Tweeting!!!!

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The 2009 Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) is currently taking place in San Francisco. For those of you who may not know ICAAC, is an annual meeting mainly attended by infectious disease physicians and researchers where the latest and most cutting edge research on infectious agents is reported. Things must have been a little slow at this year’s meeting (except for H1N1 of course) which led the newswires to pick up a story about the isolation of methicillin resistant Staphylococcus aureus  (MRSA) at public beaches in Washington State. While MRSA infections are certainly a public health concern, particularly among infants, older adults and immunocompromised individuals finding MRSA at public beaches isn’t particularly surprising nor newsworthy.

S. aureus is an opportunistic pathogen that isn't particularly virulent and is incapable of causing disease unless it is accidentally introduced into a wound, surgical incision or similar environment. In humans, the bacterium colonizes mainly the nasal passages, but it may be regularly found in most other anatomical locales, including the skin, oral cavity and gastrointestinal tract. Epidemiological studies have demonstrated that over 70% of people transiently carry S. aureus in their nasal passages at one time or another in their lives. This means that S. aureus is very common and ubiquitous in human populations. Consequently, I wasn’t surprised when I learned that Seattle researchers had isolated S. aureus at public beaches in Washington State. Nor was I shocked to learn that some of the isolates were MRSA strains!  After all, the incidence of methicillin-resistant S. aureus has been steadily increasing in the US and elsewhere for the past 20 years. And, healthy people who carry MRSA (and regularly shed it from their bodies) do like to go to beach and lay in the sand when the weather is warm. That said, I would have flabbergasted if the researchers didn't isolate MRSA from the beach sand samples that they surveyed. As an aside, I want to let my readers know that I isolated S. aureus from a soil sample while an undergraduate microbiology  major at Cornell University. Finally, while some MRSA infections can be fatal, those that are diagnosed correctly and early are usually easy to eliminate with conventional antibiotic regimens.

Because the work mentioned in the ICAAC press release hasn’t been published, it is  difficult to evaluate the results and implications of the study's findings.  Nevertheless, I don’t think it was prudent for the scientists who conducted the research to issue a press release about finding MRSA at public beaches—especially when the American public is already jittery about infectious agents like H1N1. If the authors’ intent was to make a big splash (pun intended) by mentioning the “dreaded MRSA” in their press release, they were successful—the story is all over the news. However, in my opinion, we are obliged as scientists to accurately inform the lay public about important scientific and public health issues—not play into its worse fears and misconceptions about them.

Until next time...

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

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Eli Lilly & Co announced today that it is eliminating another 5,500 jobs or roughly 14% of its global workforce over the next two years. This would reduce to size of Lilly’s worldwide workforce from 40,500 to 35,000 by 2011. In addition to the job cuts, the company is reorganizing itself into 5 business units and hopes to save about $1.0 billion in annual costs.

These newly announced job cuts come after the company eliminated 4,000 sales representative jobs this past August and restructured its sale force. Also, prior to the recent cuts, Lilly launched the Lilly Phenotypic Drug Discovery Initiative or PD² a new program to ostensibly strengthen relationships with academic institutions to speed drug discovery and thereby reduce its reliance on internal drug discovery efforts to keep its pipeline full.

Unlike other major pharmaceutical companies that conducted massive layoffs over the past two years, Lilly was content, until the past few months, to lay off small numbers of employees and offer others retirement packages. Unfortunately, the loss of patent protection on several of its blockbuster drugs coupled with generic encroachment on several brands and impending health care reform, forced Lilly to take more draconian action.

Layoffs have been something of rarity in the life sciences sector over the past eight months or so, but this is usually the time that marks the beginning of the corporate “layoff season.” Don’t be surprised if other large life sciences companies announce similar layoffs in the coming months. Luckily, the economy seems to be improving and there are signs that hiring is beginning to ramp up in the pharmaceutical, biotechnology and devices industries.

Speaking of pink slips, those of you who have been downsized or find yourself out of a life sciences job may be interested in a new organization called Pink Slip mixers. According to a description on the group’s website:

“Our Pink Slip Mixers are about hundreds of professional, mid- to upper-level executives who are (might be) victims of the "economic downturn" of 2008. Our parties are about banding together, networking and bonding with the recently "Pinked". We will share our experiences of why we were let off, what companies are hiring, and the "buzz words" that specific hiring managers want to hear. Aside from the usual imbibing, commiseration and fun that every pink slip party brings, headhunters, direct-hire companies, and recruiting firms will also on-hand to learn a little bit more about what you do. Maybe you'll meet a new contact, or find a new job!” 

Sounds like these mixers might be good networking opportunities and a place to kick back and commiserate with others who are no longer gainfully employed. I am planning to attend a Pink Slip Mixer when one is organized in the NYC metropolitan area. Like many of you, I lost my full time contract copywriting job over a year ago!

Until next time...

Good Luck and Good Job Hunting!!!!

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The U.S. Food and Drug Administration’s (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted that clinical data support both the efficacy and safety of Cervarix®, GlaxoSmithKline (GSK) cervical cancer vaccine.

In a press release, the company announced that “Cervarix was shown to be highly effective and well tolerated in girls and young women for the prevention of cervical pre-cancers and cervical cancer related to human papillomavirus (HPV) types 16 and 18, the two most common virus types that cause cervical cancer. The committee also discussed data demonstrating the efficacy of  Cervarix against additional cancer-causing virus types.”

The Committee’s favorable recommendation, although not binding, will be considered by the FDA in its final review of the Biologics License Application (BLA) for the candidate vaccine.

In March 2009, GSK submitted final data from its Phase III pivotal study (HPV-008), the single largest efficacy trial of a cervical cancer vaccine to date. The file included data from clinical trials in more than 30 countries involving nearly 30,000 participants receiving Cervarix, which reflect an ethnically and racially diverse population and a broad range of women. It also included a thorough safety assessment relevant to 10-25 year old girls and young women.

Cervarix® has been approved in nearly 100 countries around the world, including the 27 member states of the European Union (EU), Australia, Brazil, South Korea, Mexico and Taiwan. Licensing applications have been submitted in more than 20 additional countries, including Japan and the United States. GSK also received World Health Organization (WHO) prequalification in July 2009.

The likely approval will provide girls and women with an alternative to Merck’s cervical cancer vaccine Gardasil which has been on the market for almost two years. Gardasil has recently come under fire by religious and anti-vaccine groups and sales have been lackluster lately. It will be interesting what effect if any Cervarix will have on the US anti-HPV/cervical cancer market. That said, I doubt whether Merck executives will be sleeping as well as they have been prior to today’s advisory panel recommendation!

For a great comparison of the two vaccines check out an article in today's New York Time business section.

Until next time...

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

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There are many natural products from animals, plants, fungi and bacteria that possess antibacterial properties. This makes complete sense from an evolutionary standpoint. Therefore, it should comes as no surprise that spices like cinnamon and natural products like honey possess inherent antibacterial properties. Nevertheless, despite my over 30 years as a card-carrying bacteriologist, I always pleased and pleasantly surprised when I learn that a common substance like cinnamon oil has potent antibacterial activity against antibiotic-resistant bacterial pathogens.

A recent study showed that a cinnamon oil solution was capable of killing a variety of nosocomial bacterial pathogens including Streptococcus pneumoniae and methicillin-resistant Staphylococcus aureus (MRSA). Moreover, the cinnamon oil appeared to be as effective as several antiseptics and disinfectants widely used in many hospitals. And, this isn’t the first report on the antibacterial effects of cinnamon oil. In a 2008 study, French researchers showed cinnamon oil solutions of 10% or less were effective against S. aureus, Escherichia coli and several antibiotic resistant strains of bacteria.  Further, there is a precedent for the use of cinnamon-derived products as an antiseptic. In the Middle Ages thieves who stole jewelry from dead bodies and used “thieves oil”—a concoction consisting of cinnamon bark, lemon oil and eucalyptus—rarely got ill. Finally, cinnamon oil when topically applied to the skin is generally safe. However, in some people it can cause an allergic reaction.

This is good news for a country that has grown increasingly obsessed with chemically-based antibacterial soaps and sanitizers whose overuse may actually be selecting for the emergence of strains of multiple antibiotic resistant bacteria. Nevertheless, the use of natural antiseptics like cinnamon and other plant oils as sanitizers may help to reduce the growing incidence of  drug resistance among nosocomial bacterial pathogens.

Until next time....

Good Luck and Remember to Wash Your Hands (with plain soap, not antibacterial-containing products!)

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As an iPhone user, I am constantly amazed at the applications that are developed for it. I recently downloaded a flashlight app that converts my iPhone into a flash light in case of a power outage or finding myself in the dark like I did two summers ago at Moosehead Lake in Maine. Just when I thought iphone apps couldn’t get cooler, I learned about a new app called “Outbreaks By Me.” It was developed by researchers at Children's Hospital Boston in collaboration with the MIT Media Lab, enables users to track and report outbreaks of infectious diseases, such as H1N1 (swine flu), on the ground in real time. The application can be downloaded from iTunes.

According to a press release “the application builds upon the mission and proven capability of HealthMap, an online resource that collects, filters, maps and disseminates information about emerging infectious diseases, and provides a new, contextualized view of a user's specific location – pinpointing outbreaks that have been reported in the vicinity of the user and offering the opportunity to search for additional outbreak information by location or disease.” An additional feature of Outbreaks Near Me is the ability to set alerts that will notify users via text or by e-mail when new outbreaks are reported in their proximity, or if users enter a new area of activity. It also offers an option for users to submit an outbreak report which will allow people in cities and countries around the world to interact with the HealthMap team and participate in the public health surveillance process.

What will iPhone app developers think of next— an app for swine flu vaccination?   Now that would be way cool!

Until next time....

Good Luck and Good Swine Flu Hunting!!!!!!!

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Since the beginning of the pandemic last spring, BioCrowd founder and virologist extraordinaire Vincent Racaniello has been vigilantly writing at his at his Virology Blog about HIN1 pathogenesis, epidemiology, immune responses and vaccines.  When not blogging about HIN1, Vincent also writes about other viral diseases and does a weekly virology podcast called This Week in Virology (TWIV).

In a very short time, Professor Racaniello has amassed a huge collection of original articles that could be compiled into a virology textbook with a title like “Everything you ever wanted to know about H1N1.” And, not surprisingly, his Herculean efforts have not gone unnoticed: today his Virology Blog was recognized and listed as a legitimate source of H1N1 information by the New York Times. 

For those of you who haven’t been overwhelmed by the unrelenting swine flu media frenzy and are seeking sound information about the H1N1 epidemic, I highly recommend that you check out Vincent’s blog. Also, you can talk with Vincent at BioCrowd when he is not too busy blogging, podcasting or conducting laboratory research.

Until next time...

Good Luck and Remember to Wash Your Hands !!!!!

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It should come as no surprise to most BioJobBlog readers that scientists are not known for their writing or literary skills. And, for the most part, graduate students in the life sciences receive little or no instruction or training in scientific writing. This wasn’t always the case. When I entered graduate school at the University Of Wisconsin way back in 1974, Joe Wilson, Chairman of the Department of Bacteriology at the time, insisted that all incoming graduate students take a semester-long course in scientific writing. Most of my peers thought it was a colossal waste of time but by the end of the semester we all knew how, in theory, to write a scientific paper, understood the peer review process and if nothing else could write something that resembled a scientific manuscript when asked to do so. I personally learned a lot during the course and thought it was extremely useful. 

I currently work as a freelance science/medical writer and I think the course has served me well throughout my career. In fact, while a tenure-track Assistant Professor at the University of Miami School of Medicine, many of my colleagues would give me their RO1 applications to review for content, grammar and editing before submitting them to NIH. As the former Chairman of my department said to me after I asked him what he thought after reading my first grant application, “It is extremely well written from a literary standpoint”. Not exactly what I wanted to hear but maybe that explains why I am a science writer and no longer an academic. So it goes....!

The reason that I am rambling on about scientists and their poor writing skills is that things haven’t gotten much better over the 35 year since I took that mandatory writing course as first semester graduate student at UW. Based on my observations, graduate students are only asked to do original writing when preparing their theses and in some instances when writing manuscripts (which are usually re-written by their mentors).  What is even more troubling is that science undergraduate students do virtually no writing at all! How then do we expect graduate students and postdocs to successfully write grant application and manuscripts if they receive no formal training in science writing?

To that end, I came across an interesting, albeit humorous, post from Dr. Isis, who according to her bio is “a physiologist at a major research university working on some terribly impressive stuff. She blogs about balancing her research career with the demands of raising small children, how to succeed as a woman in academia, and anything else she finds interesting.” Like me, Dr. Isis, doesn’t think that scientists spend enough time teaching other scientists how to write. In the post she offers some ideas, tips and solution to this increasingly vexing problem! 

Basic Writing Resources for Basic Scientists

Dr. Isis does hot science. Hot, hot, caliente science. I feel like we have already established that, though.

Learning to do hot science has not been a trivial thing, but learning to write in the scientific arena was orders of magnitude harder. It's still something that does not come easy for me and that I have had to practice to improve. I learned the first time I received my first crapvalanche of papers from a group of students that I am not the only one who has had trouble translating the suckquake of writing I learned in high school and as an undergraduate into successful scientific writing.

I wonder if scientific writing is something that we don't spend enough time teaching pre-graduate school level students.  I know that in science courses I've taught that have required papers, the most formal instruction time I have been able to devote to writing is showing them this: 

Video 1: Strong Bad teaches us how to write a successful paper. Strong Bad is full of wisdom and has taught me about 90% of the awesome stuff I know. I'd encourage you to check him out here.

But, I digress. This long, overly drawn-out, unnecessary introduction had tweo purposes -- 1) to give me an excuse to use Strong Bad in a blog. I <3 Strong Bad. 2) to point the following resource out to you.

This weekend someone showed me "Ask Betty: Grammar in College Writing." Ask Betty is run by the Department of English at the University of Washington and has all sorts of great information. It has a list of common editing symbols for those of us who edits papers and a lesson on common grammatical mistakes for those of us who are writing papers. I think this site could potentially be a fantastic resource for those of use who speak English as a second language. There's a Q&A page with examples of phrases and discussion of whether they are well-written. There is also a resource page with links to external writing resources.

Addendum: While Dr. Isis offers a good self-help solution to the problem, perhaps it might be more useful if graduate students and postdocs are required to take formal science writing courses as part of their graduate training. Technology has advanced considerably since 1974 and students no longer have to take time out from their busy schedules to attend a bricks and mortar class like I did. The course could be offered online and students could complete it at their own speed. The growing number of foreign graduate students and postdoctoral fellows, whose primary language isn’t English, suggests that a course like this may be in the best interests of American science.

Until next time....

Good Luck and Good Job Hunting!!!!

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Sepracor shareholders may be able to sleep better at night without the aid of the company’s top selling insomnia drug Lunesta after agreeing to be purchased on Thursday by Dainippon Sunmitomo Pharma of Japan. Dainippon will pay $2.6 billion for the rights to Lunesta and other drugs in Sepracor’s pipeline. 

This is the third deal in the last two year involving the purchase of American pharmaceutical companies by Japanese drug makers seeking to aggressively expand their reach into the US drug markets. Last year, Takeda Pharmaceutical purchased Cambridge, MA-based Millenium Pharmaceuticals for $8.8 billion and Eisai brought MGI Pharma of Minnesota for $3.9 billion. 

Sepracor, a specialty pharmaceutical company founded in 1984 focused on strategy of developing single isomers or chiral drugs and active metabolites of top selling drugs with the goal of developing a pipeline of proprietary pharmaceutical products. The company’s most successful product is Lunesta, a prescription sleep aid that had sales of almost $500 million in 2008.

Last January, the company layed off 20% of its workforce (350 sales reps, plus 410 contract sales reps) as Lunesta sales slumped because of competition from generic versions of Ambien and branded Ambien CR and revenue losses from its Xopenex COPD franchise. It isn’t clear whether or not more Sepracor will shed more jobs after the Dainippon deal closes sometime next year. 

Stay tuned for updates!

Until next time...

Good Luck and Good Job Hunting!!!!

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There was another article in today’s New York Times lamenting the marketing practices utilized by drug companies to inform physicians about their products. While these practices may be troubling to legislators and the American public, everybody who works in the life sciences industry including regulatory agencies like the US Food and Drug Administration (FDA) understands the “rules of the game” and how it is played. However,

over the past three years, there has been a full frontal assault on direct-to-consumer advertising and marketing and sales practices used by drug makers to hawk their products to physicians and the American public. This has largely been an over reaction to the lack of regulatory oversight of drug manufacturers during the Bush administration. The new regulations have severely limited what sales representatives can offer physicians e.g. gifts and free lunches and dinners, for more face time to sell their products. Consequently, the only means left available to drug makers to reach large numbers of physicians is marketing through medical education.

This is how it works. Companies annually budget monies to pay highly recognized physicians aka key opinion leaders (KOLs) to give lectures to physicians that might influence their prescribing habits. These lectures often take the form of informational seminars that focus on treatment options for certain therapeutic indications which often times subliminally highlight the advantages of the sponsor’s product over its competitors. Not surprisingly, the effectiveness and success of these programs is usually directly proportional to the sums of money invested in them. For example, in 2004, Forrest Laboratories (the subject of the NY Times article) planned on spending “$34.7 million to pay 2000 physicians to deliver 15,000 marketing lectures about Lexapro (an antidepressant) to their peers in one year.” The investment appears to have paid off; sales Lexapro reached $2.3 billion in 2008 even though a lower cost generic version of the drug is available. And, while the Forrest investment in medical education may appear to be a large one, it pales in comparison to the sums invested in medical education programs by much larger companies like Pfizer, Merck and others.

While certain members of Congress may be “shocked and outraged,” these practices are sanctioned by FDA. And, as long as drug makers are compliant and adhere to the rules they shouldn’t be faulted or penalized for their efforts. The point that I am trying to make is that drug makers, like all other for-profit entities, must maximize sales to generate sufficient profits remain in business. Therefore, it should come as no surprise to legislators or the American public for that matter, that drug makers use all legally available means to maximize the sale of their products. If Congress doesn’t like what drug makers are doing, then they ought to stop complaining and legislate changes to the rules. Put simply, it’s time for Congress to “put up or shut up.”

Until next time...

Good Luck and Good Job Hunting!!!!

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Amber Johnson of Accredited College Online thought that BioJobBlog readers might be interested in an article that she authored entitled “10 Big Ways that the Recession is Hitting Higher Ed.”  It is an informative piece that might be of interest to high school and undergraduate students and parents who have kids in college.

10 Big Ways the Recession is Hitting Higher Ed

From elementary to college, schools around the nation have felt the recession in many different ways. As the economy sinks, the educational demands rise. Teachers are holding on to dear life for their jobs, students are struggling to pay for college and the states are running out of school funding. But even with all of these economic woes, there are still people eager to teach and happy to learn.

1. Budget Cuts. Since the beginning of the fiscal year, the U.S. has suffered a 5 percent drop (about $4 billion) from the amount of money state governments apportioned for higher education, according to a U.S. News & World Report article. This is directly affecting universities across the country, who’ve seen larger class sizes, less professors and counselors, as well as canceled courses, which experts say could "threaten the quality of education."
2. Spike in Tuition. College tuition has been an inevitable hurdle for many students and families for years, but in this recession, it stings that much more. Since 1982, college tuition and fees have increased 439 percent, which is about three times higher than the increase in family incomes, according to an ABC news report. In some cases, tuition increases are the school’s response to more financial aid requests, but these scholarships may not be enough to cover soaring prices.
3. Decline in Aid. Many states are cutting college financial aid programs when students need it most. An increase in unemployment and financial losses has caused 620,000 more students to apply for federal aid in the first quarter compared to last year. An Associated Press article reports that without financial assistance, students may be forced to drop out, transfer or be laden with debt.
4. Decline in Endowments. A major factor in these educational downturns is the decline in college endowments. Big and small donors simply aren’t giving back right now, which has caused hiring freezes, cutbacks on financial aid and halted construction projects, according to a Wall Street Journal article.
5. Graduate in Three Years.Graduating in three years is a surefire way to slash college costs. American colleges are now starting to offer three-year college degrees, which is the normal time frame for many British and Canadian students. It’s an upcoming trend, according to CBS MoneyWatch, that could make "elite education" more affordable.
6. More Kids Are Going Public. According to a CBS News report, private school enrollments have declined as many students make the switch from private to public schools. While some continue to pay top dollar for private school tuition payments, others have had to transfer to less prestigious schools to save money.
7. Arts Programs Suffer. With devastating budget cuts on the agenda, college art departments are the first area to be altered. According to a New York Times article, students can expect to see fewer teachers, programs and courses in the arts when they return to campus in the fall. While some colleges are phasing out programs altogether, others, like Louisiana State University, are holding off on new computers, production technology and traveling for conferences to lessen their demand for funding.
8. Growth and Decline of Majors. For college students, choosing the right major during the recession may secure a stable career in the future. Certain industries, such as journalism, entertainment and finance should be avoided, according to a report by College Finance 101, because they have seen the most turmoil during the recession.
9. Higher Community College Enrollment. With the recession at its peak, many college students have opted for the more affordable institutions — community colleges, according to The Chronicle of Higher Education. However, this influx of students has caused some community colleges to turn them away, claiming there’s not enough room, teachers and accommodations at these campuses.
10. Distance Learning is More Desirable. A big thing hitting the economy is online education. Whether people have lost a job, are fearful of losing one or want a degree, online colleges have open seats. A CNN report, titled "Riding out the recession in a virtual classroom," touches on the idea of investing in education during troubled times to have a back-up plan and find the right career path for you.

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