The Carnage Continues: GlaxoSmithKline to Slash an Additional 4,000 Jobs

GlaxoSmithKline (GSK) Britain’s largest pharmaceutical company today announced it plans on slashing 4,000 jobs over the coming months. The bulk of the cuts will be in America and Europe, and are part of the company’s efforts to shift resources away from low-growth territories into parts of the world with greater scope to expand sales, most notably Asia. GSK’s currently employs 99,000 workers worldwide. The reduction in headcount will be combined with a drive to make the company’s research and development more cost-efficient. 

While the job losses will not be as severe as those announced last week by its rival Astra Zeneca, they will provide further depressing news for a sector that is fighting to contain costs as it reduces its reliance on big-selling blockbuster drugs, many of whose patents will expire in the next two to three years.

The pipeline of new drugs at GSK is much deeper than at many of its rivals, say industry analysts. The company’s roster of planned launches includes Menhibrix, a vaccine to combat meningitis, and Benlysta (belimumab), a novel, monoclonal antibody treatment for systemic lupus erythematosus that it is co-developing with Maryland-based, Human Genome Sciences. In total, the group has more than 30 products in the advanced stages of development and testing.

While GSK continues to develop new drugs, it has increasingly been turning to emerging markets to find and sustain corporate growth. This has meant that thousands of jobs have already been sacrificed in the West, although the company is adding staff elsewhere. For example, it recently cut 2,000 sales jobs in America but added 1,500 staff in China. Also, GSK’s vaccine division has suffered a few regulatory setbacks with its pneumococcal vaccine Synflorix and its cervical cancer vaccine Cervarix. The loss of market share in these areas has put additional financial pressure on the company.

Like many of its competitors, GSK is looking to other divisions of the company to cover projected losses in the pharmaceutical sector. Recently, GSK has shifted a lot of its attention to its consumer products division, which owns brands such as Lucozade and Ribena soft drinks, Aquafresh and Sensodyne toothpaste, and over-the-counter medicines such as Panadol painkillers and Alli, a weight-loss pill. Analysts predict the division will have raised its annual sales 18% to £4.7 billion. A deal signed last year to increase sales of Lucozade in China has provided the blueprint for how the company would like to develop the consumer healthcare side of its business.

Similarly, last week, Sanofi-Aventis, a French rival, announced a joint venture with Minsheng Pharmaceutical Group, a Chinese company, to sell vitamin pills and nutritional supplements. Also, Pfizer recently announced it would bid for the possibility of purchasing the financially-troubled German generics manufacturer Ratiopharm; signaling the possibility that the world's largest branded pharmaceutical manager may be toying with the idea of getting into the generics business.

Late last year I predicted that more pharmaceutical company employees would loss their jobs. Sadly, this prediction has come true. That said, I am surprised at the scope and size of the layoffs that have already taken place in 2010. I suspect that more layoffs are likely in the near future if the economy doesn’t turn around anytime soon.

Hat tip to Ed at the Pharmalot blog!

Until next time...

Good Luck and Good Job Hunting (try medical devices or biotech)!!!!!!!!

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What Do a New Award Winning Book and BioCrowd Have in Common?

Vincent Racaniello, virologist extraordinaire and a BioCrowd co-founder is slated to appear on ABC World News this evening to discuss Rebecca Sloot’s new book entitled The Immortal Life of Henrietta Lacks. The book details the life of little-known Henrietta Lack whose cancerous cervical cells (subsequently called HeLa cells by the scientists who managed to cultivate and immortalize them in the laboratory), revolutionized the field of virology and changed the way viral vaccines are manufactured.

Rebecca Skloot, the author, is an award-winning science writer, and a contributing editor at Popular Science magazine; she's worked as a correspondent for the NPR show RadioLab, and PBS Nova ScienceNOW. Her writing appears in The New York Times Magazine, O: The Oprah Magazine, Discover and others. The “Immortal Life of Henrietta Lack” is her first book.

So, why is Vincent being featured on tonight’s newscast about the HeLa book? For those of you who don’t know, Vincent has spent almost 30 years unraveling the molecular mechanisms by which the polio virus causes disease. And, as many of you may know, HeLa cells are the cell line of choice to cultivate polio virus in the laboratory. In addition to cloning the polio virus receptor in HeLa cells, members of Vincent’s laboratory have elucidated the genes and their proteins responsible for the neurotrophic effects of the virus that can lead to paralysis from polio infections. Further, for those of you who may not know, Vincent, while a postdoctoral fellow in David Baltimore's laboratory, was the first to demonstrate that transfection of HeLa cells with cDNA made from polio virus genomic RNA (using the newly discovered HIV reverse transcriptase enzyme that resulted in Baltimore winning the 1975 Nobel Prize in Physiology or Medicine) yielded infectious polio virions.

While Vincent’s findings greatly aided research to elucidate the underlying pathogenic mechanisms of the polio virus, it transformed and revolutionized the entire field of RNA virology. Prior to Vincent’s discovery, it was impossible to study the molecular biology of RNA viruses using recombinant methods because unlike DNA, there are no known RNA restriction enzymes. The ability to transcribe viral RNA into cDNA molecules that yield infection RNA viral particles permitted researchers to dissect RNA virus genomes (using recombinant DNA technology) to determine contribution of individual genes to viral pathogenesis.

Vincent, one of only a handful of virus pioneers, is now applying his considerable pioneering talents to social media because he believes that Web 2.0 tools like blogs, podcasts, videos and social networking sites can be successfully used for science education and improving the public understanding of the life sciences.

Until next time...

Good Luck and Good Viewing (ABC World News Tonight)!!!!!!

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BioCrowd Featured on BIO's 'I Am Biotech' Website

I Am Biotech, the Biotechnology Industry Organization’s (BIO) outreach program is trying to promote the use of social media to spread the word about the importance of biotechnology and how it has changed the world for many individuals.

BioCrowd was invited to contribute to the social media section of the website. Like us, I Am Biotech believes that social media has an important role in promoting a better public understanding of biotechnology and other aspects of the life sciences industry.

Please check us out and learn more about the value of becoming a member of the BioCrowd by clicking here.

Until next time

Good Luck and Good Surfing!!!!!!!!!!!

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BioJobBlogger's True Identity is Revealed!

When I first started writing BioJobBlog back in 2007, I didn’t see any reason to hide my identity. However, as many inexperienced and naive bloggers ultimately learn, whatever you say can and will be used against you at some point. To that end, I was contacted by two lawyers during my first year of operation and decided to go uncover so that I could continue to work in the life sciences industry.

Over the past two years, I believe that I have become less inflammatory, vitriolic and pedantic and matured as a writer to the point where I don’t have to worry as much about getting fired or sued as I have in the past. Also, it helps that I am gainfully employed as a freelance writer and the people who pay me know that I write BioJobBlog (and probably don't read it)! Finally, and perhaps most importantly, marketing and SEO experts have repeatedly told me that anonymously-penned blogs have substantially less traffic then blogs where the author is identified and assumes responsibility for what he/she says (not that I am trying to increase traffic to my blog or anything)

I am sure many of you have been losing sleep at night trying to figure out who I am. Of course, people who have been reading BioJobBlog from the beginning (thank you loyal readers) already know my true identity (mainly because I told you who I was). But, for those of you who don’t and desperately need to know please click here.

Once you find out who I am, it may explain things....or not!

Until next time,

Good Luck and Good Reading !!!!!!!

 

More Regulatory Woes for New Antibiotic

Theravance Inc. announced Thursday US Food and Drug Administration (FDA) regulators are not satisfied with new data on its infection drug candidate telavancin (Vibativ), and indicated that further clinical studies may be required to win marketing approval.

Approval of Vibativ has been held up for three years, as the Food and Drug Administration asked the company for more data about the drug, and about studies Theravance has conducted in support of its application to the FDA. Theravance said Thursday the FDA told it the data so far is not enough to prove Vibativ works.

The agency will not begin a formal review of the drug until it says it is satisfied with the data.

Vibativ, or telavancin, is an injection intended to treat complicated or drug-resistant infections like methicillin-resistant Staphylococcus aureus (MRSA). Theravance submitted an NDA to FDA for review in December 2006.

According to Theravance, the FDA did not say Theravance would have to run a new clinical trial to gain approval, but it suggested a design for such a study. Company representative said that they do not know what the FDA wants and said the agency did not provide any suggestions about the goals of the proposed study, how many patients should be included, or even how many studies might be required ( I guess it may be time for a meeting to discuss these issues?).

In response to the FDA’s previous requests for more data on telavancin, Theravance said it combined data from two late stage trials of Vibativ, with the goal of making the data more comparable. It said the FDA told it that the data is equal to only one study. Two late-stage trials are often required to win approval.

Theravance said it has tested Vibativ on about 1,500 patients and said its studies are the largest that have been submitted in support of a new drug of its type.

Regulatory concerns about Vibativ include a risk of birth defects when it is used in pregnant women, manufacturing issues, and questions about data comparing the drug to vancomycin, which is the most powerful antibiotic currently on the market.

While getting new antibiotics are the market are important, clinical studies must be carefully designed with appropriate endpoint to address potential safety and efficacy issues. Although Theravance believes that it has done that, the agency, as always, will be the final arbiter of a decision on telavancin.

Until next time...

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

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Got Biology? This List Does!

Have you ever found yourself in a situation where you needed important biological, genetic or other life sciences information quickly? Sure, you can Google the topic but it takes time to wade through all of the search results until you find the right one!

Carol Brown from Onlineuniversities.com sent me a list of the “100 Best Reference Sites for Science Students.” The list contains information for chemistry, environmental science and even geology.  I extracted the life sciences websites from the list and posted them below.  

  1. Biology Online: On this site you can post questions in a forum, look things up in a bio dictionary, and read all kinds of informative articles and tutorials.
  2. Everything Bio: Check out this resource to find a glossary, textbooks, images and a range of other online biology tools.
  3. Life Science Dictionary: Try out this dictionary to look up life science terms and identify their meanings.
  4. Molecular Biology Glossary: Students of molecular biology will appreciate this valuable research tool.
  5. National Biological Information Infrastructure: Want to know and read about the research being done in the life sciences? Check out this site.
  6. Biology Reference: You can look up loads of helpful biology terms in this online encyclopedia.
  7. Biology Nation: From finding the best biology grad programs for looking up biology terminology, this site is a one-stop resource.
  8. Dictionary of Cell and Molecular Biology: Search through this online dictionary to refresh your memory on the parts of the cell.
  9. BioScience: With a dictionary, encyclopedia, links, software, and custom search tools, you’ll find more reference material than you could ever need on this site.
  10. All Experts: Biology: Have a biology question you just can’t seem to find the 
  11. Amino Acids Repository: Use this site as a reference on amino acid properties alone and in proteins.
  12. Table of Standard Genetic Code: This site is a great reference when trying to remember which part of DNA goes where.
  13. Talking Glossary of Genetic Terms: Don’t know how to say a particular term? No worries, this glossary will tell you and more.
  14. Human Genome Acronym List: Don’t have a clue what the ASHG is? This site can help you look it up.
  15. Genetics Resources on the Web: Search through this site for the best genetics resources the web has to offer.
  16. National Human Genome Research Institute: This site offers a number of helpful educational resources for students young and old.
  17. Genetics Virtual Library: Search by organism or topic to find the genetic information you need to do your homework.
  18. Genetics Home Reference: Those studying genetic disorders will appreciate this quick online reference for conditions.
  19. GeneTests: Even if you’re not in medicine, you’ll be able to find interesting and compelling information on this site.
  20. Gene Cards: You’ll find a collection of concise information on just about every gene out there on this site.

While I can’t vouch for the quality of the  list, it looks to be pretty informative.

Until next time...

Good Luck and Good Studying!!!!!!

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How Social Media May Be Influencing Human Clinical Trials and Access to Potentially Life-Saving Investigational New Drugs

It’s no secret that pharmaceutical and biotechnology companies are “not in love” with social media. However, whether life sciences company like it or not, social media is beginning to affect human clinical testing with an increasing number of patients demanding access to unapproved experimental drugs to treat life-threatening illnesses. 

In a recent article that appeared in the January 15, 2010 issue of Genetic Engineering and Biotechnology News entitled “Expanded Access to Investigational New Drugs”, Natalie Douglas, CEO of UK-based Idis Pharma wrote:

"...the trend toward greater transparency of drug development pipelines and the accessibility of powerful social media tools, have led us to a more informed empowered and vocal population of patients. This, in turn, has led to increased demands for access to unapproved drugs that are in various stages of human clinical testing. “Patients can easily access information about investigational drugs via the Internet and are leveraging social media tools such as YouTube, Twitter and blog to influence companies to garner access to them” Douglas added.

This can place enormous pressure on the companies that are testing investigational new drugs because the safety and efficacy of the drug candidates has yet to be determined. Understandably, companies are loath to provide patients who don’t meet clinical trial inclusion requirements access to experimental drugs with unknown safety and efficacy characteristics. Nonetheless, if requests for access to investigational drugs are denied, social media tools can easily be used to quickly and widely publicize the denial. According to Douglas, aggressive use of social media tools by patients seeking access to investigational drugs has helped their stories make national news. This can create gargantuan regulatory and public relations problems for companies with drugs in clinical development and put them at the center of an ethical and moral firestorm—despite their best intentions to develop new drugs that eventually may help millions of patients suffering from various diseases and conditions.

Many patient advocacy groups, consumers and shareholders understand the almost limitless reach of social media and its ability to influence public opinion, discussions and trends. Whether or not drug makers are willing to use social media, many have yet to understand that they are already part of the social media conversation that is taking place daily. And, as all social media enthusiasts have realized, if you are not part of the conversation then you don’t know what is being said about you on the Internet. More importantly perhaps, is that by choosing not to participate in the conversation, companies have lost all ability to influence and manage what is being said. In other words, life sciences companies that steadfastly choose not to use social media may, paradoxically, be setting themselves up for public relations and regulatory headaches that could have easily been avoided.

While the social media frenzy may be beginning to wane, there is no question that it has changed the way people interact and influenced the way business is transacted online and in real life. Companies that insist on clinging to past business practices that are exclusive, non-interactive and designed to promote opacity are likely to lose customers and market share as 21st century technology continues to unfold.

Hat tip to Natalie!

Until next time...

Good Luck and Good Tweeting!

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Is the Economy Really Improving? Astra Zeneca to Cut 8,000 Jobs

AstraZeneca PLC said today it , or 12 percent of its work force, by 2014 to cut costs as it reported disappointing fourth quarter earnings. The job cuts will be made across all regions and divisions and were necessary because some of the company’s major products including the child asthma medication Pulmicort, which made sales of $1.3 billion in 2009, and breast cancer treatment Arimidex, with $1.92 billion in sales will be losing patent protection in the near future.

CEO David Brennan said the company was extending a cost-cutting program it launched in 2007, which had saved the company $1.6 billion annually at the end of 2009.Extending the program out to 2014 will cost another $2 billion, with expected benefits of $1.9 billion a year by 2014, he said.

Around 12,600 jobs having already been eliminated under the program, although Brennan suggested that the net figure was closer to 4,600 after new roles were created by the company, which employs around 63,000 people worldwide.

The new round of cuts will be global, including sales and marketing, business infrastructure, research and development and the supply chain. The company’s research & development division will lose about 1,800 jobs and according to Brennan there may be some closures of research and development sites or facilities as part of the restructuring. The company is reported to be waiting for regulatory approval of five new products.

Despite claims that the US economy is improving, big pharma continues to downsize its R&D workforce. Call me crazy, but aren’t these the same companies that argue that healthcare reform will stifle innovation and hinder new drug discovery? This begs the question: how do you discover new and novel medicines and treatments if the people who discover and develop drugs no longer work at your company? There is always outsourcing and M&A I suppose.

Until next time...

Good Luck and Good Job Hunting

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Merger Aftermath: Pfizer Refocuses

While I never was involved in a corporate acquisition or merger, I have many friends who have lived through them and based on their experiences it is a never a “pretty sight.” Merger aftermaths usually feature massive layoffs, executive management disputes and turf wars and corporate culture clashes tha occur when two workforces are forced to merge as one. However, sometimes mergers may be a good thing for struggling companies. To that end, Pfizer may actually benefit from it $68 billion acquisition of Wyeth late last year.

The acquisition will cost at least 20,000 employees their jobs—not a good thing in a national economy where unemployment is well over 10 percent (despite claims to the contrary). However, this merger is strikingly different than Pfizer’s questionable past mergers and acquisitions which were primarily engineered to procure one or two drugs that had blockbuster potential e.g. Lipitor and Celebrex. This time around, Pfizer’s management team is actually re-evaluating its entire drug development portfolio and attempting to expand the company’s pipeline to include vaccines, therapeutic proteins and other biologics. As I previously noted, most major pharmaceutical companies believe that biologics will be the major driver of pharmaceutical markets in the not so distant future.

According to a post on PharmaLive, Pfizer announced that it will discontinue research and development on roughly 100 experimental new drug candidates. Pfizer officials revealed that the company will continue with 500 research projects in six areas of: 1) Alzheimer’s disease, 2) diabetes, 3) pain, 4) cancer and 5) mental illness (including schizophrenia).

Of the 500 projects, 30 drugs are being tested for cancer indications, 10 for Alzheimer’s disease, eight for pain and 11 for inflammation. Further,133 are in various stages of human clinical testing, including several that are awaiting regulatory approval in the US and elsewhere. 

On the biologics front, Pfizer has six vaccines and 27 biopharmaceutical drugs in development. Prior to the Wyeth acquisition, the company only had one vaccine and 16 new biologics that it was testing. Like most other pharmaceutical companies, Pfizer wants to be a major player in the biopharmaceutical and biologics markets by 2015.

Only time will tell!

Until next time,

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

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Improving Science Literacy and American Innovation

Politicians, educators and business leaders love to complain about the America’s dwindling competitiveness in math and science and the growing lack of innovation that seems to be pervasive among many American high school and college-aged students. This is the same mantra that I have been hearing for the past 20 years. Unfortunately, while the powers at be like to complain about these things, no government agencies, educational groups or private sector businesses seem to be able to come up with approaches or solutions to these problems (talk about lack of innovation!). 

Luckily, as Thomas Friedman pointed out in an Op-ED in this past Sunday’s New York Times, there are individuals and not-for-profit entities that have come up with two possible approaches to improve science and math preparedness and American innovation. 

The first of these novel ideas is called National Lab Day (NLD). It was introduced last November by a coalition of educators and scientific and engineering associations. NLD’s goal is to inspire future scientists, engineers and innovators by pairing experienced scientists and engineers with students in grades K-12 to work on hands-on science project around the US. Participating organizations that have pledged support for NLB include pledged support for National Lab Day are the John D. and Catherine T. MacArthur Foundation, the National Science Teachers Association, the National Science Foundation, the Bill and Melinda Gates Foundation, the Jack D. Hidary Foundation, the American Chemistry Society, the National Institutes of Health; and the Business Roundtable.

Conspicuously absent from the list are large organizations like the American Association for the Advancement of Science, the Federation of American Societies for Experimental Medicine, the American Society of Microbiology and others. Moreover, no academic institutions or research foundations or life sciences companies have offered to participate. See what I mean about lots of complaining and no action? To learn more about the program or offer support visit NationalLabDay.org

Another program that Friedman mentioned was the Network for Teaching Entrepreneurship or NFTE. NFTE works with middle and high school teachers to help them teach entrepreneurship. The centerpiece of the program is a national contest for start-ups with 24,000 low-income students participating. Each student has to invent a product or service, write up a business plan and then implement it.

While the scope of NFTE is limited to only low income students, I learned first hand what an important skill entrepreneurship is on the world stage. In the early 2000s while working as a management consultant, I was invited to dinner by the CEO of an Australian life sciences company. During dinner, I candidly asked her why an Australian biotech company was interested in hiring an American as a management consultant. She told me that while Australians do great science they are awful when it comes to translating the science into a viable business. “We simply don’t have the entrepreneurial understanding and spirit that most of you Americans seem to have. Our society doesn’t focus on individualism and innovation, we like to maintain the status quo” she said. After the meeting, I realized that we Americans take our entrepreneurial skills for granted and if we can no longer excel in this area than the US is truly doomed.

Finally, since this post is about science literacy and improving the public understanding of science, I wanted to mention a cool website called Sense About Science that you ought to check out. Although it is a UK-based organization, what it is trying to promote has global relevance. According to the website:

“Sense About Science is an independent charitable trust promoting good science and evidence in public debates. We do this by promoting respect for evidence and by urging scientists to engage actively with a wide range of groups, particularly when debates are controversial or difficult.

We work with scientists to

  • respond to inaccuracies in public claims about science, medicine, and technology
  • promote the benefits of scientific research to the public
  • help those who need expert help contact scientists about issues of importance
  • brief non-specialists on scientific developments and practices

Sense About Science is governed by a Board of Trustees and run by a small office staff. We are supported by an Advisory Council and over 2,000 scientists and other specialists, ranging from Nobel Laureates to postdoctoral fellows, who are signed up to our database, Evidence Base. We also work with younger scientists in our VoYS (Voice of Young Science) programme, which you can read more about here.”

Until next time....

Good Luck and Good Learning!!!!!!!!

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BioCareer Advice: Putting It All Together for a Successful Job Interview

I previously have written about various aspects of the interviewing process in the life sciences industry. While I had written on various aspects of interviewing, I never assembled all of the pieces into a single post to give job seekers a complete view of the entire process. To that end, I came across a great post authored by Megan Driscoll, Founder and President of PharmaLogics Recruiting, a life sciences recruiting and placement firm.

It is a multi-part piece. That said, please click here to read the entire post. Megan offers an outstanding roadmap of what bioscientists ought to expect as they wind their way from the interview process to the offer stage of the job search process.

Hat tip to Megan

Until next time...

Good Luck and Good Job Hunting!!!!!

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Shuffling of Executives at Novartis: Vasella is Out as CEO

The Pharmalot blog authored by the intrepid Ed Silverman today reported that Dan Vasella is out as CEO at Novartis and there has been an executive shake up at the company. According to the post, Vasella is reliquishing his post a CEO but retaining his chairman title For a complete run down and a glimpse at the new Novartis org chart read Ed's post

Vasella has come under fire (literally and figuratively) over the past year or so.  Industry insiders and Novartis shareholders contended that he couldn't manage the day-to-day operations of companies and succeed as Chairman. Also, Vasella was the victim of  unwarranted, vicious attacks by animal rights activists who publicly denounced him and set his home on fire!

Vasella, one of the few physicians to head a pharmaceutical company, held the top position since 1996 following the merger of Sandoz and Ciba-Geigy to form Novartis. The company has expanded in to new therapeutic areas and markets and performed well under Vasella's stewardship. However, many industry experts contend that ten years is the optimum tenure for most life sciences CEOs. What's four years in the scheme of things?

Until next time....

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

Social Media, Life Sciences Companies and Medical Product Promotion

Mark Senak, who authors the Eye on FDA blog, today posted a brilliant article on the paradoxical relationship between social media, medical product manufacturers and FDA regulators. While an increasing number of patients, consumers and healthcare stake holders rely on social media and related technologies to garner information about medicines and potential treatments, the companies that produce the drugs, diagnostics and devices steadfastly refuse to participate in any meaningful conversations aimed at developing regulatory guidelines to guide the use of social media as a promotional vehicle. Mark was spot on when he said:

 “There is a great public hunger and consumption of Internet material on healthcare in general, and for people to get their information not necessarily from large institutions, but from other people whom they trust.  That used to be family and friends with whom they spoke. Today, it is increasingly expanded to people they meet in disease-specific social networks on-line. Medical product manufacturers, in fact, are the real experts on the products that they produce - having invested millions of dollars and effort in testing and researching them.  The information they ought to be able to find its way to the patients who seek it.”

Despite FDA’s attempt to begin a discussion by holding public hearings on November 12-13 in Washington to gather feedback and input on the use of social media and the Internet for medical product promotion, a majority of drug and devices manufacturers have clearly signaled an unwillingness to participate. Although I didn’t attend the hearings, Mark noted that “only a few companies participated; most of the time was taken up by secondary and even tertiary stakeholders like communications firms and bloggers.” The question that was on everyone’s mind in attendance was “where are the pharma companies?” Surely, they have a major role to play in the discussion since the regulations that are crafted will guide the use of social media for promotional purposes in the future. Despite the stakes, Mark aptly noted:

“One would hope that they were, and are, biding their time to carefully measure a response and would be entering their comments into the docket, being kept open by FDA until February 28.  But so far, there are only 22 documents that have been entered into the docket - none appearing to be from a medical product manufacturer.”

So, what gives? As I previously mentioned, life sciences companies are extremely parochial and not given to change; especially regulatory change! However, the current discussions surrounding social media, which is only about 5 years old, gives medical product manufacturers an opportunity to be part of a discussion that will likely shape the regulations that guide their promotional activities well into the 21st century. Their almost collective reluctance to actively participate in these discussions reinforces the notion that drug and devices manufacturers are out of touch with their stakeholders and prefer to be reactive rather than proactive! At the end of the day, the quality of a relationship between a patient (consumer) and a drug or device manufacturer will ultimately determine the success or failure of the products that they produce.

For updates on social media and the life sciences industry please visit the #FDSM website.

Hat tip to Mark!

Until next time...

Good Luck and Good Tweeting!

 

Comedy as an Alternate Career Choice for Life Scientists?

Let’s face it; scientists aren’t generally regarded as being funny. While I have met several very funny researchers during my almost 35 year career, the vast majority of my colleagues have been mostly serious and, at times, difficult to amuse; especially when things weren't going so well in the lab.

I consider myself to be a funny guy. And, hanging out and playing softball with Larry David, co-creator of Seinfeld and star of Curb Your Enthusiasm, for three years while a postdoc at Columbia Medical School convinced me that I have some talent. However, while I have often fantasized about a career in comedy, I never had the courage to turn in my lab coat and give it a try. The same can't be said about Tim Lee; a card-carrying PhD-trained biologist who after realizing laboratory research wasn’t for him decided to embark on a career as stand up comedian.

While Powerpoint presentations (modeled after scientific seminars) serve as the centerpieces of his stand up routines, Tim is also exploring other comedic vehicles to help him continue to make a living as a stand up comic. As he told BioCrowd co-founder Vincent Racaniello and I in a recent podcast that we did with Tim before a mid-week stand up gig in San Francisco, 'you gotta lead with your strengths."

Tim has been working as a comedian for the past seven years and, much to his surprise and pleasure, is "making more than he would have if he had chosen to do a postdoc after completing his PhD degree." Tim's star is rising and was recently featured in a New York Times article entitled “Did You Hear the One about the Former Scientist.”

Vincent and I had a wonderful discussion with Tim about his difficult decision to abandon science and what it feels like to embark on a new career (that you didn’t spend 10 years training for!) He still takes science seriously and frequently peruses journal articles and other scientific sources for material. And, for the record both Vincent and I thought Tim was pretty, pretty good (as Larry David would say) at what he does!.

To listen to the podcast and to see a video of one of Tim’s stand up routines visit BioCrowd!

Until next time...

Good Luck and Good Job Hunting (the comedy clubs can use a few more good scientists)

 

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A Common Thread: Pompe Disease, Genzyme and Hollywood

Harrison Ford’s new movie “Extraordinary Measures” (also starring Brendan Fraser) is loosely based on John Crowley’s ongoing crusade to find a cure for Pompe Disease a genetically inherited illness that afflicts two of his three children.The film chronicles the 'extraordinary measures' taken by Crowley to find a treatment for the so-called orphan disease that affects the lives of about 40,000 persons worldwide. While I haven’t seen the film, it bears a striking resemble to the 1992 film “Lorenzo’s Oil” which chronicled the struggles of two parents to find a “cure” for their son’s adrenoleukodystrophy an another orphan disease.

Crowley’s story began about 12 years ago when his oldest child was diagnosed with Pompe Disease. For those of you who may not know, Pompe Disease is a progressive, multisystemic, debilitating, and often fatal neuromuscular disorder. The disease is linked to an inherited deficiency of the lysosomal enzyme acid alpha-glucosidase (GAA), which is responsible for the breakdown of glycogen inside the cells. The result is intralysosomal accumulation of glycogen, primarily in muscle cells, that leads to a progressive loss of muscle function and ultimately death. At the time of the diagnosis, Crowley, a Princeton, NJ resident, was working as a marketer for Bristol Myers Squibb. He quickly learned that there was no effective treatment for Pompe Disease and that his daughter may not live beyond early childhood. Further, because the disease afflicted so few individuals, no pharmaceutical or biotechnology companies were working on treatments for Pompe Disease. 

To stave off the likelihood of his daughter’s death, in 2000, Crowley raided his 401k plan and mortgaged his home to start a company called Novazyme that focused exclusively on developing treatments for Pompe Disease. Having no time to waste, Crowley and the Novazyme team worked feverishly to develop an alglucosidase alfa enzyme replacement therapy for Pompe. By 2001, the Novazyme team had identified a likely treatment and Crowley sold his company to Genzyme. As a senior vice president at Genzyme, he oversaw clinical development of the product which is now called Myozyme and is the first FDA-approved treatment for Pompe Disease. Crowley left Genzyme in 2004 and is currently CEO of Amicus Therapeutics a 100 person company focused on developing new treatments for Pompe Disease and other orphan indications.

At present, there are no other treatments besides Myozyme for Pompe Disease. This is because Pompe Disease is designated as an orphan indication and Genzyme received seven years of market exclusivity for Myozyme as stipulated in the Orphan Drug Act. Myozyme received FDA approval in 2006.

While Genzyme has been the only player in the Pompe Disease market for the past four years, manufacturing and scale up problems threaten to jeopardize the Myozyme franchise. Genzyme’s highly publicized problems at its Allston, MA-manufacturing facility have been well documented and Genzyme’s management team is taking bold steps to correct them (including hiring a new senior vice president for global product quality) and entering into an agreement with Hospira Worldwide Inc to provide fill and finish manufacturing services.

But perhaps more troubling, were the problems that the company experienced when attempting to scale up Myozyme production from the 160L to 200L bioreactor scale to meet growing demand for the drug.  FDA informed Genzyme that that Myozyme® (alglucosidase alfa) produced at the 160L bioreactor scale and Myozyme produced at the 2000L scale should be classified as two different products because of differences in the carbohydrate structures of the molecules. And, the company would have to file a new biologics application (BLA) for the 2000L product to garner regulatory approval.

Currently, Genzyme has U.S. approval to sell Myozyme manufactured at the 160L scale, and the company has been seeking clearance from the FDA for Myozyme produced at the 2000L scale (now marketed as Lumizyme). Lumizyme has already been approved in more than 40 countries. However, manufacturing problems and violations at the Allston facility forced FDA to delay a decision on the approvability of Lumizyme this past March. Earlier this week, Genzyme announced that FDA will issue a new decision on Lumizyme in June.

While originally spurned by large drug companies, orphan drug development is becoming much more attractive because of the lack of new blockbuster drugs in most company’s development pipeline. According to a recent report, the number of orphan product designations in the US more than doubled in the last decade rising from 208 in the 2000-02 periods to 425 in 2006-08. More recently, Pfizer, the world’s largest pharmaceutical company announced that it agreed to pay at least $60 million for rights to Protalix Biotherapeutics Inc.'s new treatment (taliglucerase alfa) for Gaucher’s Disease another orphan indication. This suggests that Pfizer has made a decision to directly compete with Genzyme, the world leader in orphan drug development.

Don’t be surprised when other large pharmaceutical and biotechnology companies announce plans to compete in the orphan drug market...there is money to be made!

Until next time...

Good Luck and Good Job Hunting!!!

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Salmonella, Turtles and Frogs...Oh My!

As many BioJobBlog readers may know by now, my PhD thesis focused on elucidating the underlying pathogenic mechanisms that contributed to the pathogenesis of Salmonella gastroenteritis. Salmonella gastroenteritis, which is primarily a food-borne illness, occurs in approximately 1.4 million Americans each year. Most people who develop Salmonella gastroenteritis recover without treatment within four to seven days. However, some people develop diarrhea so severe they are hospitalized and can become critically ill. According to a former lab mate, who accidentally infected himself, Salmonella gastroenteritis is much worse than the mild form of the disease described in many microbiology textbooks!

While I haven’t performed any research in this field for about 30 years, I still consider myself to be a Salmonella expert (go figure). Therefore, it should come as no surprise that a newspaper article entitled “Salmonella outbreak linked to pet frogs”— that appeared in the Salt Lake Tribune several weeks ago—caught my eye.

According to the article, a 31-state Salmonella outbreak (which was first detected in Utah was linked to pet frogs. The U.S. Centers for Disease Control and Prevention (CDC) in Atlanta started a national investigation to find the source of the outbreak this past summer, after five Utahans were infected by the strain of S. typhimurium a common cause of gastroenteritis (I knew getting a PhD would useful one day). In all, 85 people across several states developed gastroenteritis and nearly two-thirds had had some contact with frogs. Most of the patients were children and among those whose outcomes are known, almost a third required hospitalization. None died.

The source of the outbreak was eventually linked back to a single frog breeder in California that distributed the African dwarf frogs thought to be responsible for the multi-state outbreak. According to CDC officials, the bacteria were likely spread through contact with the tanks' water, not the frogs themselves. Of those who supplied information to the CDC, 30 percent said they cleaned the frog's aquarium in the kitchen sink and 35 percent used the bathroom basin.

While this last bit of information wasn’t remarkable, I finally—after almost 30 years as card carrying microbiologist—realized how the urban legend about Salmonella and turtles got started! Like many kids, I had a pet turtle. I remember my parents cautioning me about handling the turtle because I would get sick (of course I handled the turtle and never got sick). Later on, as a microbiology undergraduate student, I learned about the relationship between Salmonella and turtles and that turtle had been associated with Salmonella gastroenteritis outbreaks in the past. An interesting but inconsequential fact because I no longer owned a pet turtle.

Early on as a graduate student, I learned that it takes a minimum of about 108 salmonellae to cause gastroenteritis. At the time, I wasn’t thinking much about turtles and failed to realize that the large dose required for infection pretty much ruled out the likelihood that picking up a turtle would almost certainly result in Salmonella gastroenteritis. Although reptiles and amphibians harbor Salmonella in their gastrointestinal tracts, a child would have to suck on an infected turtle (or eat its poop) to get a large enough inoculum to initiate an infection—now this is where the PhD training become evident. However, if parents clean their children’s infected tanks in kitchen or bathroom sinks and then fail to wash their hands or the sinks with disinfectant, the number of salmonellae present in these environments would be sufficient to cause disease if infected food or water was ingested. And, this is what likely happened in the frog outbreak; based on the epidemiological data presented by CDC investigators

So, what is the lesson of this story? While it is true that turtles and frogs may carry Salmonella (in a separate study 21 percent of frogs from 16 retailers tested positive) the likelihood of developing gastroenteritis after touching or briefly handling frogs or turtles is extremely low. However, it is not a good idea to handle them for long periods of time without washing your hands before your next meal or cleaning their tanks in areas where food is prepared or people brush their teeth! Food borne illnesses are easy to prevent if appropriate personal hygiene is practiced and foods are prepared and cooked according to recommended standards. 

Finally, it took a long time, but I can now feel comfortable around turtles. This is probably a good thing—my friend Pete is a turtle fanatic and he constantly wants me to pick up his pets!

Until next time...

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

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The Job Slog: Several Challenging Interview Questions that Mid Career Bioprofessionals May Have to Answer

There is no question that job opportunities for recent life sciences undergraduates, graduate students and postdoctoral fellows are becoming increasingly difficult to find. While this is troubling, older, mid-career bioprofessionals who may be looking for new jobs and challenges are having a rougher go of it. This is because older employees generally cost more to hire and many employers mistakenly believe that seasoned employees make lack the drive and technological skills as compared with younger, less experienced jobseekers.

Whether or not these assumptions are true, the interview questions that older job candidates may be asked are likely to be different than those offered up to younger prospective employees. To that end, there was an informative “how to” blog post written by Shelbi Walker of Back to Work, Inc that offers older professionals some responses that older job candidate can use to answer challenging questions that they may encounter during a face-to-face job interview.

I listed some sample questions and acceptable possible responses to them below:

1.  You appear to be overqualified for this position. Won't you get bored?

Suggested Responses:

“You are an excellent company. You deserve excellence in employees."

“Experience is a great premium today.”

“There is a greater return on your money if I hit the ground running. Less training time.” 

“I always like for additional work to do to prevent from getting bored.”           

2.  This company is on the fast track. Do you think that you can keep up?

Suggested Responses:

“I have stayed on top of the latest development in our industry and am computer literate." (Use this opportunity to showcase any training classes or courses you have taken.)

Also, consider hitting this question head-on by stating politely that you have not noticed any slowdown in attitude or energy. 

3.  This isn’t exactly the type of job you have done in the past. Can you tell us how you will transfer your skills?

Suggested Responses:

"I have viewed your website and read everything about your company.” (Then, draw some analogy to a previous area of expertise, and relate it to the new company's product or service).

4.  I noticed that you have been out of work for over six months. Can you explain this break in employment?

Suggested Responses:

"I explored some other options but they weren’t for me.  I feel that I have many more years of productivity left to work in this industry."

“I am looking for something different. I am fortunate to be in a position to take time to make sure this job is right for both of us. "

"I used this time to brush up (or learn) a new skill, and now I am ready to contribute my knowledge and expertise to an exciting company like yours."

5Why do you think you are qualified for this job? I don't see where you have experience that would match our business needs

Suggested Responses:

"My excitement at learning new things never diminishes. With my work experience, I know I will be a quick learner." Take this opportunity to point out any skills you have added to your repertoire. Identify a skill you have, and align it to something you would need to do on the new job.

6.  Your resume indicates you have worked at a lot of different places. Can you comment on that?

Suggested Responses:

“Each of those positions broadened my knowledge and skill base."

“It does appear that way, but, in the last 10 years, the economy has been such that mergers have forced a number of us to realize our potential in various environments." (Always turn a perceived negative into a real positive!)

7.   You were with your last company for 19 years. Can you change the way you did things?

Suggested Responses:

"I am looking for change!"

"My last company underwent many changes during that time, and I enjoyed trying new things and ideas." (Give examples whenever possible.)

8.  I see you have been a consultant. Does that just mean you were out of work?

Suggested Responses:

" My old company brought me back on contract to complete several projects, which I did — and now I want to see if there is something more exciting out there. "

“ I understand lots of people are calling themselves consultants while they look for a new position. " (Laugh — sometimes, it's OK to insert a little bit of levity.)

9.  What salary are you looking for (the implication that is may be too high because you have been in the workforce so long)

Suggested Responses:

Never respond with a specific dollar amount. Affirm that you have vast skills and experience. Indicate that you are either willing to start over to show them what you bring to the table or deserving of top dollar.

Alternatively, ask the interviewer what dollar amount is allocated for the position in this year's budget. And, finally ask the interviewer whether or not they are offering you the job since you are discussing salary requirements!

While I can’t guarantee that you will be asked any or all of these questions at your next job interview, they are food for thought!

Until next time...

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

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Issues Surrounding the Use of Social Media in the Life Sciences Industry are Still Alive and Well

Despite rumors of impending demise and premature death, the issues surrounding the use of social media in the life sciences industry are still alive and relevant. To that end, the Business Development Institute is sponsoring a “Healthcare Social Communications Leadership Forum Breakfasts on February 4, 2010 at New York University in Manhattan. The conference is limited to 75 attendees. While there are seats still available they are rapidly disappearing. 

Some of the topics to be discussed include:

  • How to connect with consumers who are already using the internet for healthcare information?
  • What are the case studies of leading brands that use internet based social strategies to achieve communications objectives?
  • What are examples of social communities that demonstrate how leading healthcare brands interact, educate and provide value to consumers online?
  • How to deal with regulatory and legal issues when planning and implementing social and internet based strategies
  • Why real-time social media tools, such as Twitter, are gaining momentum and what's the business case to use them
  • How to sell projects and prove ROI to senior management
  • What are the tools, technologies, and best practices for monitoring and measuring internet based programs?

Scheduled presenters and panelists are:

  1. Michael Fleming, Senior Director, Social Media, GlaxoSmithKline
  2. Robert Halper, Director of Video Communication, Johnson & Johnson
  3. Lance Hill, CEO, Within3
  4. Ray Kerins, Vice President / Worldwide Communications, Pfizer Inc.
  5. Marc Monseau, Director, Corporate Communications & Social Media, Johnson & Johnson
  6. Rodney Spady, Head of Global Interactive Marketing and Web Officer, OTC Global Marketing, Novartis Consumer Health, Inc.

For more information, including registration, please click here to visit the event website. Use promo code BIOC before February 3rd for a discounted rate of $175.

See you at the meeting!

Until next time...

Good Luck and Good Job Social Networking!!!!!!

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US Pharma Layoffs Continue as Companies Increase the Size of Asian Operations

Pfizer today announced that it’s looking to increase its sales force in China to 3,200 by the end of next year, up from about 2,300. The company expects to have sales representatives in about 250 Chinese cities by the end of 2011. It presently has a sales presence in about 185 cities. Previously, Pfizer it will cut nearly 20,000 jobs as part of the Wyeth merger. Over the pass several years more than 50,000 US pharma sales reps have lost their jobs.

Eli Lilly said last fall that it would continue to hire in China, even as it cuts jobs in the U.S. and other developed markets. Novartis is also making a big push into China, hiring hundreds of workers and spending $1 billion to expand a research center in Shanghai.

With business tough in developed markets, drug makers are counting on the developing world for growth and are expanding into biotechnology and generic drug manufacturing.

Like it or not, the emerging markets in China, India, Brazil and elsewhere represent a substantial upside whereas markets in the developing world are becoming less profitable. Drug companies, like most other large multinational companies, always will follow the profit stream not matter where it takes them or at what cost to the folks at home.

Until next time...

 Good Luck and Good Job Hunting (Try China, I hear they are looking for sales reps)

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Is Pfizer Positioning Itself to Enter the Generic Pharmaceuticals Market?

Pfizer is one of three companies vying for the opportunity to . Teva Pharmaceutical Industries Ltd, the Swedish private equity fund EQT and Pfizer are the three finalists to purchase Ratiopharm GmbH which is valued at about €2.8-3 billion. The finalists will make their bids in early February. France’s Sanofi-Aventis SA Euronext and China’s Sinopharm Group Co. Ltd. withdrew from the tender in December

Ratiopharm is a private company owned by the Merckle family. Ludwig Merckle put the company up for sale last year, after his late father Adolf Merckle committed suicide in early 2009 after losing control over his business empire to lenders. If Teva acquires Ratiopharm, it will win a major foothold in the German healthcare market, considered a large and growing market. Teva, the world’s largest generic drug company, is currently not a big player in the German market.

 The rising development and retail costs of name brand prescription drugs and the future possibility of price controls in the US is forcing pharmaceutical companies to reconsider the value of generic drugs. Currently, generic prescriptions are rapidly outpacing those for branded products and the size of the US and international markets for both small and large molecule drugs (biosimilars) growing daily. Previously, most innovator companies didn’t think the profit margins nor returns on investment were sufficient to add generic molecules to their product portfolios. However, a few large pharmaceutical companies have already entered the generics fracas; most notably Sandoz (a division of Novartis) which manufactures both generic small molecule and biosimilar biotechnology products and more recently established Merck BioVentures which aims to compete in the follow-on biologics market. 

Many experts believe that it is only a mater of time before most big pharma companies like Pfizer realize that they have to be in both the branded and generic sides of the business. Don’t be surprised over the coming months if other pharma companies consider doing deals to acquire generic drug manufacturers. Diversification will be the mantra of the next decade or so!

Until next time...

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

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Does Direct-to-Consumer Television Advertising Really Work?--You Betcha!

Last week, the market-analyst firm Manhattan Research released a list of the top branded pharma Web sites based on traffic generated from direct-to-consumer (DTC) television ads. The firm tracked about 250 different product sites and asked 6,575 consumers which websites they visited in the past 12 months. Consumers were asked to recall the reason they visited the site, whether they are taking the product, think they need the product, and the actions they took after they visited the site. The following list represents the top ten product websites that were more likely to have website traffic driven by DTC television ads. However, it is important to note that the rankings are not based on the volume of traffic but the percentage of traffic generated in response to integrated DTC advertising campaigns.  

  1. NuvaRing—Merck (formerly Schering Plough formerly Organon)
  2. Latisse—Allergan
  3. Cialis—Lilly
  4. Boniva—Roche
  5. Abilify—Bristol Myers Squibb
  6. Gardasil—Merck
  7. Yaz— Bayer
  8. Viagra—Pfizer
  9. Levitra—Eli Lilly
  10. Lunesta—Sepracor

Interestingly, of the top ten products on the list about 70% of them have to do with sex or woen's reproductive health. The exceptions include Abilify (depression and bipolar disease), Lunesta (insomnia) and Latisse (eyelash growth). Pfizer, Levitra and Cialis are treatments for ED, Gardasil is an anti-cervical cancer vaccine, Boniva is used to treat osteoporosis (post menopausal women) whereas Yaz and NuvaRing are both used for birth control.

I thought the results of the survey where interesting because many experts say the effectiveness of DTC television advertising may be waning with the growing use of online resources. While the results of this survey are not conclusive, it suggests that DTC television advertising won’t be going away anytime soon. And that the growing use of televisions as web portals may actually increase not diminish industry’s reliance on DTC television ads to sell its product and treatments—oy! 

Hat tip to George Koroneos at the PharmaExec.com blog.

Until next time...

Good Luck and Good Watching!!!!!!!!!

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Medical Marijuana Use Is Legal in New Jersey

At long last, marijuana for medical use is legal in New Jersey. As one of his more courageous acts while in office, outgoing Governor John Corzine signed the act into law late yesterday making New Jersey the fourteenth state to legalize medical pot. Four more states and the District of Columbia are expected to follow suit by year's end.

Many things are driving this sea change. The federal government last year announced that it would no longer prosecute medical marijuana smokers in states where it is legal, while the National Institutes of Health has begun funding research on medicinal use in a reversal of a long-standing policy.

Gallup Polls show a solid majority of Americans sympathetic to therapeutic marijuana use.

Unlike California's medical marijuana law which allows the use, possession, and cultivation of marijuana by anyone who possess a "written or oral recommendation" from their physician that he or she "would benefit from medical marijuana," New Jersey's version requires patient identification cards and state-monitored dispensaries -- easing fears that medical use will fuel illegal sales and teenage substance abuse.

While cannabis preparations have been used to relieve nausea and pain since ancient times, research involving medical uses of marijuana was under funded and in many instances discouraged according to an article in today’s New York Times. But over the last 15 years, research on the body's cannabinoid receptors has begun to decipher the chemistry and biology of the positive effects of cannabinoids especially in the areas of glaucoma and chemotherapy induced nausea and vomiting experienced by patients being treated for cancer. More recently, clinical trials have shown that these benefits outweigh the concerns about addiction, heart and respiratory diseases, cancers, and psychoses -- at least, with short-term use.

Marinol, a synthetic cannabinoid pill, is approved by the Food and Drug Administration for treating AIDS-related wasting and chemotherapy-related nausea. But many patients say choking down a slow-acting pill simply doesn't provide the convenient and immediate relief of inhaling marijuana smoke. A new drug, Sativex, made by GW Pharmaceuticals, may renew the debate. A cannabinoid-based oral spray, Sativex is approved in Canada for treating pain in multiple sclerosis and advanced cancer. The company is now completing the clinical testing needed for approval in Europe and the United States.

While I don’t endorse or use illegal drugs (any more), there is no question that medical marijuana helps patients deal with chronic and, in some instances, severely debilitating conditions that impact the overall quality of their lives. I have long contended that just because a substance is deemed illegal it doesn’t negate potential medically-beneficial properties. An example of legal drugs that don’t have any therapeutic benefits and cause much more morbidity and mortality than marijuana are cigarettes and alcohol. Need I say more?

All I gotta say is that we have come a long way since I saw the film Refer Madness while growing up and coming of age in the late 60s. For those of you who haven’t seen the film it is funny whether you are straight or high! object width="445" height="364">

 

 

 

 

I guess the nation—well NJ anyway—is finally going to pot!

Until next time...

Good Luck and Good Toking (only for medicinal purposes of course)!!!!!!!!!!!

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Standing Out in the Crowd: Tips on How to Best Compete for a Job Interview

I previously posted several articles on interviewing tips. This presupposes that many of my readers have made the first cut and have been invited to participate in a phone or face-to-face onsite job interview. Unfortunately, this isn’t any easy thing to do in today’s current employment market. Nevertheless, there are a variety of things that job seekers can do to help their application standout from the hundreds (thousands) of other applications submitted by others competing for the same position. To that end, I found an article that first appeared on the JobsJournal.com website that offers basic tips on how to design a resume (and accompanying cover letter) to distinguish individual jobseekers from their competition.

While the information contained in the article isn’t “game changing” it does offer fresh insights into how job candidates must position themselves to be noticed in today’s fierce and highly competitive job market.

Until next time...

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

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The Saga Continues: Will Genzyme Soon Be Up for Sale?

While Genzyme has begun to address its manufacturing woes and its CEO and top leadership have managed to keep their jobs, the specter of a possible forced sale of the company has emerged. This is because Carl Icahn, the billionaire, activist investor with a history of forcing the sale of financially-challenged and underperforming public biopharmaceutical companies like ImClone and MedImmune, owns 1 percent of the outstanding shares of Genzyme.

Speculation is rife that Icahn and Ralph Whitworth, a founder of Relational Investors which owns 4 percent of Genzyme’s stock, may force the company to put itself up for sale. While many experts contend that this may not be in the best financial interests of Icahn and Whitworth (or other institutional investors), the threat may allow both men to get themselves or their representatives on Genzyme’s board. This would allow them to control the direction of the company and better position the company (the fifth largest biotechnology company in the world) for future sale. Henri Termeer, Genzyme’s embattle CEO, said he has had no contact with Icahn.

Investors have not been pleased with Genzyme’s current management team’s decision to plow profits from its orphan disease business into R&D activities that have been unsuccessful. According to a recent Citigroup financial report, the company may have squandered over $1.0 billion (throughout its history) by investing into unprofitable, non-core research areas including kidney disease diagnostics and surgical products. Conventional wisdom suggests that if Icahn and Whitworth gain control of the Genzyme board that they could sell off Genzyme’s unprofitable kidney disease and surgical lines which would allow management to focus on orphan diseases drug development and allow the company to fix its recent highly publicized manufacturing problems.  Relational’s Whitworth hinted that this is one scenario that he may be interested in pursuing. To date, Icahn has been uncharacteristically mute on a possible takeover attempt.

Stayed tuned for more details.

Until next time....

Good Luck and Good Job Hunting!!!!!! (try Genzyme, they are probably looking for a few good biomanufacturing executives and managers)  

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Healthcare Reform: Obama Pushes for Shorter Data Exclusivity Period for Biosimilars

Many progressives and left-leaning individuals (like me) voted for President Obama because he presented himself as somebody who will stand up for what he believes. Until recently, I, along with others, have been deeply disappointed in his performance and it was no longer clear to me what he truly believes in. However, his recent stand on healthcare reform (sadly without a public option), his performance at the global warming summit and most recently his quick response and unequivocal support for Haitian earthquake victims suggest to me that we are finally beginning to see what President Obama believes and what he is made up. To that end, Obama has turned up the heat to reduce the proposed 12 period of data exclusivity for biosimilars (aka follow-on biologics) in the bill that was passed by both the US House and Senate. Both the President and Rep. Henry Waxman, D-CA (of Hatch-Waxman fame) are trying to reduce the 12 year exclusivity 10 years or less. Obama previously went on record saying that he favored a 7 year exclusivity period for biosimilars.

Not surprisingly, the move has met with fierce opposition from the pharmaceutical and biotechnology industries that argue the longer period is needed to encourage investment and R&D required to produce biopharmaceutical products. Lobbying by both sides has dramatically increased as healthcare reform is pretty much a done deal. However, brand companies have spent many millions more than generic manufacturers to lobby Congress on the 12 year period.

It is about time that an American President is willing to do what is in the best interest of the American public instead of what lobbyists and special interests are demanding. And, to those companies that steadfastly hold to the notion that biopharmaceuticals take an inordinately long time to bring to market I ask: “What’s in your pipeline?”

Until next time...

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

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Tips for a Successful Phone Interview

Life sciences employers ranging from academic institution to private sector companies are increasingly turning to telephone interviews as an initial means to screen prospective job candidates. While in many instances these interviews are perfunctory, they are conducted for two main reasons. First, the employer wants to verify that the information presented by the candidate in his/her curriculum vitae is correct and accurate. Second, and perhaps more importantly, to determine whether or not a candidate has sufficient oral communications skills that warrant the cost necessary to bring a candidate in for a face-to-face on site interview. 

The use of telephone interviews has become increasingly popular because of the escalating costs associated with bringing candidates in for onsite interviews and a growing number of foreign born applicants applying for life sciences jobs. Put simply, a prospective employer can easily determine an applicant’s command of the English language and his/her immigration status in a telephone interview. Both immigration status (permanent resident or citizenship) and outstanding command of the English language have become of paramount importance to most life sciences employers over the past five years or so. However, it is important to note, that individual employers place different emphasis on the qualifications and skills of applicants for different job opportunities within an organization.

Like it or not, you may find yourself in the position of having to participate in a telephone interview before a decision is made on whether or not you may be invited to visit for an onsite interview. To that end, Pete Kistler, CEO of Brand-Yourself.com, recently posted a great piece that describes how to best prepare for a phone interview. He offers seven easy-to-follow tips that are likely to increase the probability of a visit for an onsite interview.

1. Use a landline. You don’t want to risk having problems with cell phone service. It is irritating for employers to conduct interviews if the call breaks up frequently or is dropped completely. If you don’t have a land line at home, just make sure you are in an area with as much cell phone service as possible. Do what you can so the process runs as smooth as possible.

2. Keep your materials handy. In fact, lay everything out in front of you. This includes your resume, notes about your career objective (even if it isn’t included in your original cover letter it’s a good idea to have this out depending on the questions he will ask you), a pen and pad of paper for note-taking and anything else you think may be helpful during your interview. Because you won’t have to schlep into an office, you can have anything out in front of you to aid with your success.

3. Steer clear of distractions. Find a quiet place to interview and stay there! There shouldn’t be any noise in the background to distract you or your potential employer. However, it is understandable that this can be tricky if you have young children at home who need your attention. When you set up your interview appointment, try to schedule it for as precise a time or window as possible. That way, you are able to avoid possible distractions (ex.: your phone interview is between 4 and 4:30, so no one can have company over during that time, the kids are fed and occupied or a sitter will watch them, if need be.)

4. Speak slowly and clearly. When you speak to people face-to-face, you are able to understand what they are saying more clearly because you can see their mouth move. So in a way, you are reading their lips! Neither you nor your potential employer will be able to do this over the phone of course, so speak clearly and a little bit more slowly than you would if you were talking to this person in person. If you can’t hear him, drop hints that he isn’t speaking clearly or loud enough by politely asking him to repeat himself. If this makes you uncomfortable at all you can always blame it on your phone: “I’m really sorry, it’s hard to hear you, the volume on my phone just won’t go up!”

5. Remember – you can’t be seen. That means that anything you say cannot be interpreted by your body language. Beware of jokes or sarcastic remarks that would have been harmless had he seen your facial expression. Maintain your professionalism; stay on target with the interview topics and focus on the key information about you that will get you hired.

6. No eating, drinking or chewing gum! This is self-explanatory. But, we humans are creatures of habit and might pop a potato chip in our mouths at just the wrong moment. However, when I say no eating or drinking I mean during the phone interview. You should eat beforehand to get your brain going so you can focus.

7. Prepare questions ahead of time. Just like in a personal interview, prepare a few questions to ask your potential employer at the end of your phone interview. Some examples are:

“What is the start date for the opportunity?”

“What software/equipment would I be using?”

Remember – do not ask about salary or benefits until the employer has brought it up.

Fortunately, it can be less intimidating interviewing over the phone with these telephone interview tips and you may even feel more confident that you’ll do well. Great! As long as you are fully prepared and take the necessary precautions, there is no reason why you shouldn’t have a successful phone interview.

Until next time....

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

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Study Finds that Funding for Life Sciences Research Continues to Wane

Ed Silverman, over at the newly reinvigorated Pharmalot Blog, today reported that a recent study publicized in the Journal of the American Medical Association showed that, after a decade of doubling, the rate of increase in biomedical research funding slowed from 2003 to 2007, and after adjusted for inflation, the absolute level of funding from the National Institutes of Health and industry appears to have decreased by 2 percent. The NIH remains the largest federal contributor to biomedicalresearch, accounting for 84% of total federal funding in 2007 

Further, the report indicated that research funding provided by pharmaceutical and biotechnology companies and medical devices and diagnostics manufacturers rose from $40 billion in 2003 to $58.6 billion in 2007; an increase (adjusted for inflation) of roughly 25 percent. Most of the funding came from large pharmaceutical companies. Interestingly, however, the sector of the life sciences industry that exhibited the greatest increase in growth over the same period was diagnostic and device makers (59 percent), followed by biotechnology (41 per cent) and lastly, pharmaceutical companies (25 per cent).

While the results of the study are not surprising, it is clear that the life science sector is beginning to focus more on device and diagnostics than on small molecules and even biotechnology products. Further, reductions in federal funding are forcing researchers to increasingly rely on grants and contracts from private sector companies. This suggests that an ever expanding percentage of the research conducted at many academic institutions will be financed and underwritten by for profit companies. Although more product-focused academic research is not necessarily a bad idea, it does call into question the direction and possible breadth of academic research and the availability and sharing of important scientific information, data sets and discoveries. 

Until next time...

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

 

Update: Tracking Pfizer's Job Cuts and Other Layoffs

It is getting difficult to keep track of the job cuts that are happening almost daily at Pfizer. A quick perusal of the job cuts to date indicate that the company has eliminated about 1200 jobs in the past week; 680 in Pennsylvania, 400 in New Jersey and 116 in Rockland County, NY (where I grew up!). While there is currently a lull in activity, I suspect additional job cuts will be forthcoming in the near future.

Merck earlier announced that it was slashing about 500 jobs in New Jersey which continues the ongoing carnage that the NJ pharmaceutical workforce had to endure over the past three years.

Meanwhile, in New England, Charles River Laboratories International announced that it is suspending operations at its Shrewsbury, MA facility by the middle of this year. Approximately 300 workers will be losing their jobs at the facility that focused on preclinical drug development.

Despite claims that the US economy is improving, life sciences layoffs are continuing and job growth is much slower than expected. While some economists aren’t that surprised, I would be nervous and exploring my options if I was employed at a life sciences company!

Until next time...

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

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Website to Track FDA Progress on Regulations for Social Media and the Life Sciences Industry

As Jonathan Richman, author of the Dose of Digital blog focused on pharmaceutical marketing aptly put it, its time to “stop talking about social media.” “To recap, in 2009 we demanded the FDA call a hearing to discuss social media…and they did! We wrote and read hundreds, if not thousands, of articles on social media. We transformed (read: hijacked) every digital marketing conference into a social media conference. We launched a ton of social media programs even if they represent a conservative start.”

While I am still an ardent social media enthusiast and supporter, I agree with Jonathan that it may be time to sit back, relax and reflect a little bit until FDA enlightens us with their first round of guidance on social media and the life sciences industry. Having said that, I am certain that the agency’s first iteration will provide us bloggers with sufficient fodder to write about and ignite round 2 of the discussion. In the meantime, @Skypen of Ignite Health graciously created a website called Everything About the FDA, Internet & Social Media that provides updates, commentary and even tweets (#FDASM) about FDA progress or lack thereof.

I think that social media has a role to play in the life sciences industry. However, the role has yet to be defined mostly because of the lack of regulatory guidance in the area.

Until next time...

Good Luck and Good Tweeting!!!!!!!!!

 

Bioscientists and the MBA Degree

I am frequently asked by graduate students and postdoctoral fellows who are having trouble finding a research and development job, whether or not it makes sense to go to business school to get an Masters of Business Administration) MBA degree to enhance their business acumen. While I don’t think it would hurt (especially if you are interested in business), I also don’t think most scientists benefit from enrolling traditional MBA degree programs. With this in mind, some forward-looking academic institutions have launched joint PhD-MBA programs which allow students enrolled in these programs to graduate with PhD and MBA degrees at the end of their graduate training.

The joint programs typically take less time than it would to earn each of the degrees individually and mainly cater to scientists who have decided to eschew academic science careers in favor of life sciences management jobs. While these programs are relatively new and continue to evolve, growing numbers of would-be scientists who are also interested in business are taking advantage of them.

One of these students, Kristy Houck graduated with a PhD in pharmacology and a MBA from the Pennsylvania State College of Medicine joint program almost two years ago. “I loved science, but knew that I didn’t want to perform bench work for the rest of my life. This opened a world of career opportunities for me” said Houck. “Previous graduates of the program have quickly risen to management level positions because they are recognized as business-savvy scientists” she added.

Other academic institutions are closely watching these programs to determine whether or not graduates of the joint PhD-MBA programs have better employment outcomes as compared with person who go through traditional PhD and MBA graduate programs. I listed the institutions that currently offer the joint program in the table below. Check it out!

Academic institutions that offer joint PhD/MBA program in the life sciences

 

Name of Institution                                                   Website

Dartmouth

http://su.pr/2udGyO

Pennsylvania State University (Dept. of Pharmacology)

http://su.pr/21CRWm

San Diego State University

http://su.pr/2hqX8y

University of Connecticut

http://su.pr/4LQ6Dt

University of Florida

http://su.pr/2ltSSj

Vanderbilt University

http://su.pr/9Ze6Uf

Wake Forest University

http://su.pr/As4gip

Until next time....

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

 

More Pharmaceutical Industry Carnage: Pfizer Cuts 680 Jobs in Pennsylvania; More Likely

Just when you thought that holding on to a job couldn’t get any worse, Pfizer formally announced yesterday that it would be eliminating 680 jobs from a combined workforce of 4,500 at two former Wyeth facilities in Pennsylvania. According to a company spokesperson, 450 of the layoffs would come from Collegeville and 230 from Great Valley. They will take effect March 12. Persons affected by the layoffs will each qualify for a separation package that will include severance payments, continued medical benefits, and help finding a new job via outplacement services.

While some layoffs were expected, they were much greater than some state legislators were led to believe in earlier discussions with Pfizer. And this isn’t likely to be the end of corporate reorganization at Pfizer PA-based facilities. This is because Pfizer is shutting down the Great Valley facility. There is speculation that after this round of layoffs that the 670 remaining Great Valley employees will be transferred to the Collegeville site or other Pfizer locations. And, it is likely that more Pfizer employees will lose their jobs because Pfizer previously announced that it intended to eliminate as many as 15% or 20,000 jobs after its $68 billion acquisition of Wyeth.

Over the past several months, Pfizer, Eli Lilly, AstraZeneca, Johnson & Johnson and GlaxoSmithKline have announced more than 40,000 job cuts which have devastated the pharmaceutical workforces in Pennsylvania, New Jersey and Delaware. 

Until next time...

Good Luck and hmmmmmm...are there any pharmaceutical jobs left to hunt for?

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Nagging Concerns Persist About Continuing Medical Education

As part of their licensure requirements, all physicians and other healthcare providers (HCPs) in the US must participate in continuing medical education (CME). CME requirements are established on a state-by-state basis HCPs who fail to meet annual quotas face reprimand, censure and possibly loss of their medical licenses. As you may imagine, CME is a big business and, not surprisingly, there is no dearth of CME content developers and providers. Unfortunately, CME course development costs are high and, despite state mandated licensure requirements, no one seems to want to sponsor or underwrite the CME development programs except drug and devices companies. Obviously, this creates the potential for monumental conflicts of interest mainly because physicians and other HCPs are drug and device company primary customers.

While I don’t profess to be an expert on CME rules and regulation, I know that the rules and regulations that guide CME content development have become increasingly restrictive over the past few years. In the past, drug and devices manufacturers were able to identify relevant product-related topics within certain therapeutic areas, engage a CME provider to create a curriculum and then offer a product-focused program to physicians. Today, drug companies aren’t allowed to create CME program built around specific products. Instead, CME developers compete for grant monies from drug and device manufacturers and are asked to create CME around relevant issues in certain therapeutic areas. Of course, most of the companies that award the grants have products in those therapeutic areas; but i digress. Companies that award the grants cannot participate or influence the content that appears in the CME programs. Of course this is impossible!

For example, several years ago I was working at an agency that received a “grant” from a client that was developing a new treatment for a virus-associated metabolic syndrome. While we weren’t allowed to highlight or suggest specific treatment options we did receive in direct and subliminal guidance (through various company channels) regarding messaging around content development. To that end, while the company wasn’t directly involved in content development, its medical affairs and marketing departments were “aware” of the content that we were developing. While this was appropriate and well within regulatory guidelines, it is not difficult to see that potential conflicts of interest and bias may have existed in this instance.

Over the last year or so, questionable medical writing practices and conflict of interest concerns about CME course development have come under intense scrutiny in the US Congress. Consequently, there have been ongoing and repeated calls to prohibit industry participation in CME content development. While this may be a great idea, if drug companies no longer are allowed underwrite or sponsor CME course development, there isn’t likely to be any CME in the future. And, if there is no CME, physicians and other HCPs won’t be able meet state-mandated CME requirements to maintain their licenses to practice? What a conundrum!

One solution to the problem is to require state governments, the American Medical Association, university medical schools, hospitals and other organizations (insurance companies?) to underwrite CME development costs! After all, these are the entities that require CME for HCPs to retain their licenses. While this is a perfectly logical solution to a vexing problem, don’t expect any of them to step up to the plate anytime soon. The bottom line: drug companies support and underwrite CME because they recognize that it is a viable marketing vehicle—albeit a subtle one—that is certain to improve product awareness and ultimately sales. For example, if Pfizer sponsors a CME program on erectile dysfunction at a high end resort in some exotic locale and, its logo or mention of a grant to develop the curriculum is acknowledged, it is not unreasonable to assume that physicians attending the course may possibly choose to prescribe Viagra over a competitor’s product. To make matters worse, CME sponsors often time help to defer costs of hotel accommodations, provide support for meals, and even sponsor receptions for physicians who attend CME training programs.

I suspect that some of you may be wondering why I am ranting and raving about CME today. Well, there was an article in today’s New York Times about Stanford Medical School receiving an unrestricted, three-year $3.0 million grant from Pfizer to develop unspecified new CME curricula for physicians. Philip Pizzo, MD, dean of Stanford’s medical school lauds this as the beginning of a new age in CME and suggests that Pfizer will have no say on how the grant monies will be spent. 

Dr. Pizzo contends that the “no-strings-attached” provisions of the grant will insure that the new curricula will be devoid of drug industry influence that has permeated CME courses in the past. Stanford plans to set up “unbiased programs” of postgraduate education on the Stanford campus rather than the industry-selected topics of the past that have been presented to rooms full of doctors at hotels and resorts.” While the new grant sounds promising, I wonder whether or not Stanford is going to disclose the amount of research funding it annually receives from Pfizer. Further, will faculty members who receive or previously have received research monies from Pfizer be prohibited from contributing to content development?  The point I want to make is that, despite Stanford’s good intentions and assertions to the contrary, there is no way to insure that there will be no bias or conflicts of interest in the new curriculum that is developed. 

Finally, I don’t think that there is any question that CME is essential to insure that Americans receive the latest and best possible medical treatments that are available. However, to insure farness and no bias, drug makers and device manufacturers should not be allowed to underwrite or participate in CME content development. This activity should be in the purview of not-for-profit entities (that don’t receive drug industry money) and state government agencies. Like it or not, we live in a quid pro quo society and drug and devices companies (like all “for profit” companies) don’t make investments unless there is an anticipated or guaranteed return on the investment!

Until next time...

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

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Interviewing Myths and Urban Legends

It seems that every day there is a post to a career development site about interviewing protocols, procedures, behaviors and tips. While it is difficult to generalize about what to expect at an interview, many career counselors and employment experts agree that there are several basic interviewing hints and tips that can be useful. To that end, I came across a post published at Yahoo Hot Jobs that I thought was worth a read.

Most of the hints and recommendations are things that I cover in my lecture entitled “Interviewing Tips.”

It is always a good thing to learn that you are giving the appropriate advice to people who are relying on you for help!!!!! 

I highly recommend that you read the piece and follow as many of the author’s recommendations as possible at your next interview. Yes, there are jobs still out there ....they are just more difficult to find.

Until next time...

Good Luck and Good Interviewing (I hope)

Happy New Year: Merck and Pfizer Announce 900 Job Cuts

Just when you thought things couldn’t get much worse for New Jersey, Merck and Pfizer today disclosed that it will eliminate 900 more jobs in NJ. While the job cuts were expected, it is still bad news for New Jersey’s life sciences workforce.

Based on information provided by the New Jersey Department of Labor website Pfizer will eliminate 400 jobs from Monmouth Junction, NJ where Wyeth previously maintained research offices. Similarly, Merck plans on cutting 500 jobs in Kenilworth, NJ where Schering Plough’s maintained its former headquarters. While it isn’t clear what types of jobs will be affected, cuts are expected in both R&D and sales continuing an ongoing trend that began almost three years ago. In case you haven’t been paying attention, most major American pharmaceutical companies have been eliminating R&D jobs in the US and either outsourcing those activities or building new research facilities in India, China, Brazil and Eastern Europe where there are lost cost, highly trained pharmaceutical scientists.

Until next time...

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

 

The "Skinny" on the Emergence of Antibiotic Resistant Strains of Bacteria

For many years, I taught medical students that the emergence of antibiotic resistant strains of bacteria primarily resulted from the overuse and misuse of antibiotics by physicians. While this seemed to make sense, I started chatting in the late 1990s with Steve Projan— a well known and highly respect maven on bacterial antibiotic resistance—who told me that the physician story was an urban legend and that the main reason for the emergence of antibiotic resistance was directly related to the use of antibiotics as growth enhancers in livestock feed. Not surprisingly, shortly after my conversations with Dr. Projan, papers began appearing in the literature that corroborated the claims.

Despite a growing body of convincing scientific evidence, the Bush administration did nothing to regulate or reduce the use of antibiotics in live stocks feeds in the US for almost a decade. Last year it is estimated that 35 million pounds of antibiotics were used in the US. Interestingly, 70% were used in cows, chickens and pigs. It is important to point out that the US isn’t the only culprit; recent estimates suggest that 50% of the global antibiotic supply is used by the livestock industry. Recognizing a growing problem, the European Union and other developed countries (not the US) have adopted strong limits on the use of antibiotics for livestock purposes.

Thankfully, the pressure against the use of antibiotics in agriculture and livestock production is rising. The World Health Organization concluded this year that surging antibiotic resistance is one of the leading threats to human health, and the White House last month said the problem is "urgent." Also this year, the three federal agencies tasked with protecting public health — the Food and Drug Administration (FDA), CDC and U.S. Department of Agriculture — declared drug-resistant diseases stemming from antibiotic use in animals a "serious emerging concern." And, this past summer, FDA deputy commissioner Dr. Joshua Sharfstein told Congress that farmers need to stop feeding antibiotics to healthy farm animals.

Pharmaceutical companies and agricultural lobbyists argue that antibiotics keep animals healthy and meat costs low, and have successfully help to defeat a series of proposed limits on their use. To that end, in 2009, drug makers spent $135 million and agribusiness companies another $70 million, lobbying against new limits on the use of antibiotics as livestock growth enhancers. FDA official say that without new laws the agency’s options are fairly limited. Ironically, the agency approved antibiotic use in animals in 1951, before concerns about drug resistance were recognized. And, the only way to withdraw that approval is through a drug-by-drug process that can take years of study, review and comment.

Previous attempts by FDA to limit antibiotic usage have consistently met with limited success. For example, in 1977 the agency proposed a ban on penicillin and tetracycline in animal feed, but it was defeated after criticism from interest groups. In 2000 FDA ordered the antibiotic Baytril (used in the poultry industry) off the market. Five years later, after a series of failed judicial appeals, poultry farmers finally stopped using the drug as a growth enhancer. Finally, in 2008 the FDA issued its second limit on an antibiotic used in cows, pigs and chickens, citing "the importance of cephalosporin drugs for treating disease in humans." But the Bush Administration — in an FDA note in the federal register — reversed that decision five days before it was going to take effect after receiving several hundred letters from drug companies and farm animal trade groups.

Luckily, we now have a President who believes in regulation of big business to protect the health and welfare of Americans and is smart enough to make the scientific connections between emerging antibiotic resistance in animals and human. Maybe some real change will be coming soon....one can only hope!!!!!!!!!!

Hat tip to Ed at the Pharmalot Blog

Until next time...

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

 

Genzyme Announces It Will Outsource Fill and Finish Operations for Cerezyme, Fabrazyme, Myozyme and Thyrogen

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

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

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

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

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

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

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

Until next time....

Good Luck and Good Manufacturing !!!

 

Novartis Offers $38.5 Billion to Purchase Alcon and Position Itself as a World Leader in the Eye Care Market

Novartis AG today announced it plans to take over Alcon Inc. by paying $38.5 billion for the 77 percent stake it does not already own in a deal that would make it one of the biggest players in the global market for eye-care products.

The Swiss pharmaceutical and generics giant had already purchased 25 percent of Alcon from Nestle in April 2008 for $11 billion, with the option of buying the food and drinks company's remaining stake at a later date. With the acquisition of Alcon, Novartis will control about 70% of the world’s vision market (it already owns the Ciba Vision brand). Alcon is based in Huenenberg, Switzerland, and has its U.S. headquarters in Fort Worth, Texas. The company employs some 15,000 people worldwide and specializes in surgical equipment and devices, contacts lens solutions and other consumer eye-care products.

Daniel Vasella, MD, Novartis’ Chairman and CEO, said "This is the right time to simplify Alcon's ownership to eliminate uncertainties for employees and shareholders." He added "It will also allow us to strengthen innovation power by combining R&D efforts and grow our global market presence thanks to our complementary product portfolios."

If I were a betting man, I would say that Novartis is the pharmaceutical company to watch over the next decade. Like Johnson and Johnson, the company has diversified its business to include consumer goods, vaccines and perhaps most importantly generic pharmaceuticals via its Sandoz division. One area that Novartis hasn’t fully embraced to date is devices. However, as we enter the age of personalized medicine, don’t be surprised if the company acquires or invests in a variety of medical devices and diagnostic companies!

Until next time...

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

 

Is a Bioscience Career Worth the Aggravation?

While this isn’t a new topic, I wanted to raise the question again because I recently received a message  from a reader that greatly troubled me. The person who posted the comment has a PhD degree in biomedical engineering and is extremely angry with the existing system because of the lack of employment opportunities in her field. Put simply, she is so frustrated with the system that she no longer believes that it is ethical to advise young people to pursue careers in the life sciences. I know that she isn’t alone and that many of you share her anger and frustration with the lies (as she put it) about employment opportunities for life sciences PhD candidates and postdoctoral fellows

From time to time, I am invited by graduate students and postdoctoral fellows to talk about alternative careers in the life sciences. I try to remain upbeat and positive during my presentation but generally I can’t control myself by the Q&A session. Invariably, I rant and rave about how dysfunctional academia has become. Interestingly, I recently was uninvited by my former graduate department where I was slated to present a seminar on alternate career choices for life scientists. As the tenured faculty member (you know how I feel about tenure) who would have sponsored my visit told me “the seminars that we offer our students are scientific in nature and much different than many of the topics that I discuss on my very interesting blog.” Consequently, he informed me that I was no longer invited to give my talk (I was previously invited by the Department Chair who happened to be a former colleague of mine who decided to move to another institution before my visit). In an e-mail response to his un-invitation, I told him that I wanted to visit the Department and give the talk because I believe that my graduate education is what enabled me to maneuver the minefield that ultimately became my career path. Also, I told him that I wanted to share my insights and career experiences with current graduate students and postdoctoral fellows because I thought that many may benefit from them. Not surprisingly, I never heard back from him. 

The point that I am trying to make is that my message about alternative careers for PhD students is diametrically opposed to the mission of most PhD programs; which is to prepare 100% of their students for academic careers. Unfortunately, as I have stated many times in the past, only about 10% of those who receive life sciences PhD degrees land academic appointments. What are the remaining 90% of the folks who toiled long and hard for their PhD degrees suppose to do with their lives? In the past, as many as 50% or more of these students were able to garner jobs as research scientists at biotechnology and pharmaceutical companies or with government agencies like the CDC, FDA, EPA and others. Unfortunately, the pharmaceutical industry has laid off over 200,000 employees in the past 3 years, funding for biotech companies has hit an all time low and we are experiencing the worst recession in almost 70 years which is causing government agencies to stop hiring! This begs the question: what are graduate students pursuing PhD degrees and postdoctoral fellows suppose to do to put food on the table to feed their families and themselves? 

While I don’t have an easy answer to that question, I can tell you that getting angry and frustrated or dropping out of the system isn’t going to change anything. I will also tell you that the system isn’t going to change by itself! To that end, it may make sense for all of you angry and frustrated graduate students and postdoctoral fellows to band together and tell your advisors and mentors that “you are mad as hell and not going to take it anymore.” To show them that you are serious, I highly recommend that your offer them a plan to address your concerns about finding gainful employment (not decade long postdoctoral fellowships) following completion of your PhD degrees. For example, you may suggest that they add alternate career certificate and degree programs to their existing curricula. Or, if new programs are too costly, suggest that they offer courses that showcase alternate career options like entrepreneurship, science writing or medical communications. Finally, at the very list, insist that they work with local companies and organization to create sponsored internship opportunities and get them to commit to supporting annual career development symposia or job fairs for graduate students and postdocs.

For the past decade or more, I have struggled to convince many of my academic colleagues to consider any and all of the above suggestions. Unfortunately, my pleas for creation of new courses and programs have fallen upon deaf ears! Given my current lack of success, I suspect that it is going to take more than one person (me) to induce the academic establishment to consider systemic change. That said anybody who may be interested in joining the “cause” to improve employment opportunities for PhD life scientists, please feel free to contact me!

Until next time...

Good Luck and Good Organizing!!!!!

 

Reinvigorating Your Job Search for the New Year

The holiday season is officially over and its time to face the prospects of a new year! The good news is that the economy is recovering and new job opportunities are beginning to appear at an increasing rate. To that end, it may be a good time to re-evaluate your career options and fine tune every element of your ongoing job search. The most obvious activities include updating your resume (assuming that things have changed since 2009), resuming your networking activities and looking online for new job prospects. However, Phyllis Korkki, a New York Times career columnist, offers some other hints that may help to improve your 2010 job search and hopefully land a new one!

 Until next time...

Good Luck and Good Job Searching!!!!!!!!!!!