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Regulatory affairs professionals (RAP) are by far some of the most important employees at pharmaceutical, biotechnology and medical devices companies. Without RAPs, the requisite regulatory documents would not be filed and new drugs and devices would not be approved for marketing and sale.

Unlike other life sciences disciplines, a career in regulatory affairs is highly industry- specific and rarely taught at most academic institutions. In other words, if you are considering a career in regulatory affairs, don’t expect to get the training that you need in a PhD or postdoctoral training program; you will have to get it elsewhere!

A recent report compiled by the Regulatory Affairs Professionals Society (RAPS) entitled the “2010 Scope of Practice & Compensation Report for the Regulatory Profession” highlights the growing value and importance of regulatory affairs personnel in the life science industry. The report was compiled from the results of a survey of over 3000 regulatory affairs employees in 55 different countries.

The results show regulatory professionals are taking on a wider range of responsibilities, including becoming increasingly involved in critical business functions. Despite the economic downturn since the previous survey in 2008, overall compensation continued on an upward trend, although it grew at a slightly slower pace. The report also points to the continuing globalization of the profession, increased involvement with multiple product types and 6% higher compensation for professionals with Regulatory Affairs Certification (RAC).

Other important findings included in RAPS’ report include:

• US respondents with the RAC credential reported average total compensation that was 6% higher than their peers without the RAC. Forty-four percent of all survey respondents are RAC certified.
• The percentage of RACs is especially high in Canada (54%) and the US (47.2%). A little more than 21% of European-based respondents reported having the RAC.
• Overall, about 34% of respondents said they were involved in comparative effectiveness research and reimbursement, up from 23% in 2008.
• Half of all senior-level respondents reported being involved in government affairs.
• About 70% of respondents said their work is either global in nature or focused on multiple regions of the world.
• More than 68% reported involvement with multiple product types, a 6.3% increase from 2008.
• Overall, just 5.7% reported working with biosimilars, a product category that was added to the survey for the first time, but 22% of respondents from Asia and Latin America reported involvement with biosimilars.
• Nearly all respondents have a university degree; many have advanced degrees. The percentage of respondents whose highest degree earned is a master’s is up to 37.5%, a 17.2% increase from 2008. The percentage of respondents with MBAs and postgraduate certificates also increased.
• Respondents reported significant professional experience outside regulatory, an indication that many have transitioned into regulatory from another, related field. Most have educational backgrounds in life sciences, clinical sciences or engineering.

If this sounds like a career option for you, I highly recommend that you visit the RAPS website. If you already have a PhD, masters’ degree or even a bachelor’s degree, getting RAC certification will certainly increase the likelihood of landing a regulatory affairs job in the life sciences industry. One caveat: the RAPS courses are not inexpensive and may require a substantial amount of time in order to pass the RAC examination.

If the RAC route doesn’t seem realistic or reasonable, try getting an entry-level job with the US Food and Drug Administration. Being an ex-agency employee will guarantee employment in the life sciences industry until you retire!

Until next time....

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

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Despite a court ruling last week that dismissed the bogus link between vaccination and autism, I continue to receive comments from so-called “non-vaccinators” about a post that I published last week about New Jersey’s dismal vaccinations rates. Most of the comments are anecdotal and suggest that childhood vaccination was the likely culprit for their children’s autism, brain damage or other ailments. While I feel their pain, the notion that children should not continue to be vaccinated is misguided and has serious negative public health implications.

There is ample public health and scientific information that suggests that childhood vaccination has worked well to reduce the incidence of morbidity and mortality in Western nations. Ironically, if it wasn’t for mandatory childhood vaccinations, the death and lasting physical or neurological damage caused by many preventable diseases like smallpox, measles, mumps, diphtheria and whooping cough would be much higher. Unfortunately, we Americans have been lead to believe —intentionally or not—that there should be no side effects associated with drugs, vaccines and other medicines. The bottom line is that all drugs, vaccines and medicines have side effects; some more serious or noticeable than others! Further, the decision to develop new drugs and vaccines is always based on a risk to benefit ratio. Pharmaceutical and biotechnology companies will only develop products to address unmet medical needs when the benefits of these products clearly outweigh the potential risks. However, in some cases, most notably cancer drugs, the risk to benefit ratio becomes less obvious. There is no question that most cancer drugs have serious and potential life threatening side effects. Nevertheless, the benefit—survival and not death—far outweighs potential downstream risks!

Like it or not, the medical benefits of vaccination far outweigh the risks associated with them. As many of you may know, there is currently a whooping cough epidemic in California. California health officials assert that the epidemic likely started among unvaccinated individuals and then spread to the larger population. The observation that many of the patients with whooping cough were previously vaccinated against the disease in childhood suggests that either their immunity to whooping has declined over the years or that the causative bacterium, Bordetella pertussis has become more virulent. 

The former hypothesis is more likely than the later mainly because Bordetella infections were almost non-existent until increased immigration and the non-vaccination movement began in earnest about 15 years ago! Students of infectious diseases will tell you that virulence of infectious agents tends to increase as they are passed from one infected individual to the next. Consequently, the lack of any significant B pertussis outbreaks (until very recently) suggests that changes in the underlying virulence mechanism of the bacterium are not responsible for the current outbreaks.

Again, as a parent, I understand the pain and suffering of those whose children may have experienced debilitating effects coincident with childhood vaccination regimens. However, as more parents continue to eschew vaccination against childhood disease, the incidence of death and children with serious life long debilitating effects associated with many common childhood diseases is certain to rise. With this in mind, I will continue to write and post articles that support childhood vaccinations. I will gladly stop posting these articles when someone can provide me with scientifically accurate and valid data that suggest that vaccination does more harm than good!

Until next time...

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

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Those of you who may be old enough to recognize the slogan “We’ve come a long way baby” ought to consider reading the list below about the things that the majority of today’s 18 year olds (college freshman) have never done. The reason why I think that the list is important is because we educators (most of whom are baby boomers and increasingly Gen Xers) grew up in a different world than the Millennials aka Gen Y. 

Like it or not, these differences must be taken into consideration when devising strategies on how to teach these students! What may have worked for you or me, may no longer be the best way to teach this and future generations of students.

The article was sent to me by a representative at matchacollege.com.

10 Things the Class of 2014 Hasn’t Experienced

Below is a list of the 10 things the class of 2014 hasn’t experienced, or more accurately, the 10 things a majority of 18-year-olds haven’t experienced firsthand.

1. A world without the internet
   Not only do new college students not know a world without the internet, but many also haven’t endured the screaming modem connecting through a telephone landline. A dropped connection or the fear of it limited your enjoyment and inhibited you from accomplishing much. But as the internet has evolved, connections have become faster and almost everything has become available with the click of a mouse. Teenagers are able to sign up for SATs, apply for college, apply for financial aid, select their classes, find a dorm, find a roommate and join a club all before they set foot on campus. The legwork that came with making such a life transition two decades ago has been eliminated.
2. Consistent email correspondences
   It’s tragically unhip to use an email for anything other than formal correspondence. It has become an archaic form of internet communication and it has been supplanted by social networking sites. Email is rarely used to facilitate conversations by young people because it’s too slow and too impersonal. Instead, it’s used for formal messages with bosses and professors, and as a tool for signing up for websites.
3. Life without cell phones
   College freshmen now are connected to their friends every minute of every day thanks to their smartphones. They can maintain constant contact with each other by texting and Facebooking – the latter of which has made high school reunions less anticipated because graduates from the last several years already know what their classmates are doing with their lives. Many college students have never used a payphone, which was the main communication device to use when you were out and about in years past, though you couldn’t make the call if you didn’t remember the number.
4. Cameras with film
   The class of 2014 will be taking plenty of pictures in the coming years, capturing the memorable and not-so-memorable moments that occur during college. But before the advent of Facebook, when picture-taking was less of a priority to young people, a camera was only as good as the film that accompanied it. There was no immediate gratification after taking a round of photos because you couldn’t upload them onto your computer. Instead, you dropped the roll off at the drugstore and waited until the photos were developed – it was the only way you would see the photos.
5. Using a paper map
   Now, commuters are less likely to get lost with the presence of a GPS. The only time a paper map is unfolded, trial and error is used or verbal directions are requested during a trip is when the GPS hasn’t been updated in a while, and it steers you to an empty field. So when students from the class of 2014 embark on their first college roadtrips, the absence of wrong turns and unexpected detours will result in more time to have fun.
6. Driving manual transmission cars
   Although cars with manual transmissions are still manufactured, few young people bother to learn how to drive them. The phase-out began a couple of decades ago, but for a while, many parents took it upon themselves to teach their kids how to drive a stick shift because it was still considered a useful skill. Cars with manual transmissions are usually cheaper, and car enthusiasts will tell you they’re more fun to drive. But driving has become a chore, and young and old people alike prefer to keep it as easy as possible.
7. Thumbing through an encyclopedia, dictionary or thesaurus
   The time-consuming activity of thumbing through an encyclopedia, dictionary or thesaurus made research papers a dreaded part of the college experience during the pre-internet era. It was a given that you would spend hours upon hours in the library, and if you didn’t, your GPA would suffer. For home use, Encyclopedia Britannica and Webster’s Dictionary were reliable options. Now, definitions can be easily found by googling the term, and Wikipedia has become an informal source of information despite its inaccuracy. Library time is spent surfing the internet, unless a professor gives an assignment that requires for certain books to be cited.
8. Returning videotapes
   Through the ’80s and ’90s, college students would spend late nights perusing the aisles of video stores, looking for the latest and greatest hits to view during their downtime. It was imperative they returned the videotapes in a timely manner; otherwise they would face late fees, which would put a dent their nearly empty bank accounts. And, of course, the tapes had to be rewound. Students today use torrents and sites like Netflix, and they never have to leave their dorm suites.
9. Cash only
   No longer are trips to the ATM a necessary weekly occurrence. There are very few situations in which cash is needed, so few people carry bills in their wallets. Everyone with a bank account owns a debit card, so wads of cash aren’t needed by college students for activities like barhopping. Instead, they use their debit cards for everything, including bar tabs, which grow as more beer and shots are downed, causing future meals to be sacrificed due to the limited funds that remain.
10. Reliance on a wristwatch
    Cell phones have ensured that people no longer uses wristwatches for time-telling purposes. Watches are no different than any piece of jewelry – they’re aesthetically-pleasing items that are worn fashionably. But it doesn’t seem to be a trend for 18-year-olds to own one, and with their cell phones always in their palms, they always know the time.

Until next time...

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

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Over 70 percent of hiring managers and HR professionals routinely use Google to find out more about prospective job candidates. While many jobseekers know this and do everything possible to expunge deleterious and compromising information from a Google search on their names, some don’t know that Facebook profiles are a routine target of all Google searches. Consequently, hiring managers may have access to some personal information (including photos) that may jeopardize a job candidate’s prospects.  

Today, German government officials proposed a new law that would place restrictions on employers who want to use Facebook profiles to recruit and vet job candidates. The bill would allow hiring managers to search for publicly accessible information about prospective employees on the Web and to view pages on job networking sites like LinkedIn, BioCrowd and Xing.  But it would not allow employers to access or use information about job candidates on purely social networks like Facebook. The proposed law would also prohibit companies from secretly videotaping employees except in certain areas as long as they disclosed the fact.

The idea of crafting legislation to limit company access to personal information of job candidates found on social networks like Facebook, Ning and others reveals the underlying paradox of the social media phenomenon. That is that people publicly, voluntarily and willingly offer private and intimate information about themselves as part of their right to freedom of expression and then that information can be used against them! In other words, the transparency and inherent freedom of expression offered by social media can in reality hinder, restrict or inhibit the professional and social opportunities of those who use it. I highly doubt that legislation similar to the proposed German law would ever see the light of day in the US.

For now, I highly recommend that jobseekers continue to routinely Google themselves to see what information is “out there” about them. Also, continue to limit access to personal profiles on Facebook and any other “purely social” online networking sites that you may belong too. Both activities will help to insure that the photo of you in a compromising position or with a beer bong in your hand won’t eliminate you as a prospective job candidate.

Until next time....

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

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As predicted by many industry insiders and Wall Street analysts, the Genzyme board may be  holding out for at least a $75 per share offer from Sanofi-Aventis.  Previously, Sanofi-Aventis offered Genzyme $69 per share despite clear signals from Genzyme's board and its shareholder that the proffered offer was inadequate.

The Genzyme board is likely under extreme pressure to hold out for the $75 per share price because that is the price being sought by its powerful and influential minority shareholders Carl Icahn and Ralph Whitworth.

Carl Icahn, no stranger to corporate buyouts, is a master at getting the price that he wants for the companies that he sells. He previously sold ImClone to Eli Lilly for $70 per share after Jim Cornelius, Bristol-Myers Squibb’s former CEO, refused to offer more than $64 per share of ImClone stock.

Conventional wisdom suggests that Sanofi will likely buy Genzyme for at least $75 per share if not more!

Stay tuned for updates!

Until next time..

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

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There is no question that losing a job or facing the prospect of long term unemployment can have severe emotional and psychological consequences. Sadly, I came across a post today on PharmaLive’s Daily Advantage that describes how an ex-Pfizer employee stabbed his wife two times in the chest November, 2009, 10 months after he lost his job as a research biochemist.

The employee had worked as a biochemist at Pfizer Inc. for 11 years, first in Ann Arbor, Mich., and more recently in Groton. He became increasingly ill, suffering from major depression with psychotic features and obsessive compulsive disorder after he was laid off from his position in January 2009. At his trial he found not guilty by reason of insanity and was committed to Connecticut psychiatric facility for a period not to exceed 10 years.

While this may be an extreme case, the emotional and psychological effects of unemployment can be devastating to even seemingly emotionally-well equipped persons. If you happened to be unemployed, and are feeling “out of sorts” I highly recommend that you seek out friends, clergy or mental health professionals who you can talk to! Your mental health is just as important as your physical health when it comes to job searching or life!

Until next time...

Good Luck and Good Job Hunting

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When it comes to job searching, the curriculum vitae (CV) or resume is the most important document that a jobseeker must create. Despite the importance of this document, many jobseekers, especially graduate students and postdoctoral fellows, fail to give them much thought or put much time into creating them. In today’s economy, typos, poor grammar and too much information are certain to cause most hiring managers to take a pass on you as a job candidate. However, as Caroline Potter of Yahoo HotJobs describes in her article entitled “The Biggest Resume Mistakes You Can Make” there are more critical issues that must be considered and addressed when crafting a successful CV or resume. 

In the article Ms Potter asserts that “The biggest flaw for a resume (CV) is when it fails to showcase a person’s accomplishments, contributions, and results and instead spouts a job description of each position he’s held.”

To learn more about the things that you ought to avoid when crafting your resume, click here.

Until next time...

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

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There was an extremely troubling article in today’s New Jersey Trenton Times that indicated that a New Jersey’s childhood vaccination rates ranked 42nd in 2009—45^th in 2008—in the nation. The ranking were based on annual vaccination statistic compiled by the Centers for Disease Control in Atlanta, GA.

The lead-in paragraph to the article elegantly captured the irony of the dubious statistic:

“One of the most affluent (and most populous states) states in the country, home to more than a few giants in the pharmaceutical industry also has one of the lowest rates of immunizing babies and toddlers in the nation.”

New Jersey’s vaccination rates among infants and toddlers for childhood diseases— mumps, measles, diphtheria, Pertussis (whooping cough), hepatitis B and rubella—was roughly 64 percent in 2009. This was significantly lower than the national average of 71 percent and the lowest in the Northeast. For example, in Pennsylvania and New York, two of the states bordering New Jersey, the vaccination rates in 2009 were 72 and 71 present respectively.

The reasons given for the low rate are plausible but, in most cases, incomprehensible from an infectious diseases and public health perspectives. It has been postulated that low-income and immigrant communities lack health insurance and access to medical information about mandatory childhood vaccination regimens. While it is facile to blame low income and immigrant populations for New Jersey's  egregiously low vaccination rate, the problem may actually lie with more affluent and educated NJ citizens who have medical insurance (help to pay the salaries of medical billing workers) and understand the public health implications of mandatory childhood immunizations. 

According to the article, parents and even some health care professionals are backing away from mandatory vaccination because they “don’t like seeing kids cry” after sometimes receiving up to four vaccinations during a single office visit! Say what????? I accompanied my three children for most of their childhood immunizations, and while some tears may have been shed, they recovered quickly and are now protected against a variety of potentially life-threatening diseases.  Apparently, some parents and health care professionals are willing to jeopardize the public health of a nation because the “shots hurt.” To that I say; get over it—like it or not, life can be painful and no matter how hard you may try you cannot shield your kids from it!

The fallacious and recently publicly discredited link between childhood vaccination and autism, coupled with the growing public distrust of the pharmaceutical companies that manufacture the vaccines may be more plausible explanations for New Jersey’s declining immunization rates in NJ. This suggests that vaccine manufacturers and public health officials ought to work closely together to be educate the American public about the benefits and potential risks associated with childhood vaccination.

Finally, as some of you may know, many states like New Jersey have religious exemptions that allow children to skip mandatory childhood immunizations. Interestingly and troublingly these children are allowed to attend public schools despite the fact that they haven’t been vaccinated. Again, I say what??? Increasingly, these unvaccinated students have been implicated as the reservoirs for the pertussis outbreaks that are currently ravaging school aged children and older adults throughout the US. It is my belief that children who fail to receive the appropriate immunizations because of religious reason should not be allowed to attend public school. This is because, unlike many of the low income and immigrant families who may be unaware or cannot afford to immunize their children because they lack health insurance, many of the folks claiming religious exemptions have health insurance and are living above the poverty level. Consequently, if these parents choose to not immunize their children (and fail to meet mandated public health requirements for entry into public schools), then they ought to be financially responsible for their child’s education.

Paradoxically, the plummeting vaccination rates in New Jersey and elsewhere are being driven by a small but extremely vocal segment of the American public. Unfortunately, this anti-vaccine sentiment in America is unlikely to abate until an increasing number of children begin to die from easily preventable childhood diseases. As far as I am concerned, the benefits of childhood vaccines far outweigh their risks and help to maintain the public health of all Americans.

Until next time...

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

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Unlike PhD-trained scientists, physicians and other healthcare professionals must be licensed to practice medicine and are annually required to participate in continuing medical education courses (CME), seminars and lectures. CME training is required by medical licensing agencies to insure that healthcare practitioners are update to date with the latest clinical practices and informed about medical development within their respective fields. 

While all medical licensing agents require CME training, they do not fund or provide any of the content or learning materials required to implement that training. Historically, pharmaceutical, biotechnology and medical devices/diagnostic companies have underwritten the development for most CME courseware. Critics of this practice suggest that this represents clear conflict of interest concerns. And, in recent years, regulatory authorities like the US Food and Drug Administration, the American Medical Association and others have begun to agree with these suppositions. Consequently, the regulations that guide CME writing have drastically changed in recent years causing confusion among CME training providers and writers.

Despite growing concerns about the regulatory aspects of CME, there is still a high demand for persons who develop and write CME materials. While CME training is primarily geared towards physicians and other healthcare professionals, most of the content and training materials are prepared by PhD-trained scientists. Although a PhD in the life sciences is not an absolute requirement, many CME providers are beginning to hire persons with advanced degrees as developers and writers. Unfortunately, becoming a CME writing professional is not as easy as it sounds and requires some additional training beyond the PhD to break into the field. 

To that end, I recently became aware of a company called InQuill Medical Communications that offers training to life scientists interested in pursuing careers in CME writing. In addition to their courseware, InQuill offers a paid internship program to selected program graduate. The company is run by Johanna Lackner Marx who has over 15 years of experience in medical writing and developing and writing CME materials.

For more information about their training programs and some free information about careers in CME, please click here.

In the spirit of full disclosure, BioJobBlog is affiliated with InQuill. However, despite my over ten years of experience as a medical and science writer, I have had limited success in landing CME writing gigs because of my lack of formal writing and regulatory training in this area. That said those of you who may be interested in pursuing a career as a CME writer may benefit from the InQuill program!

Until next time...

Good Luck and Good Job Hunting!!!!!

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There was an illuminating review today in the New York Times of a new book entitled “Higher Education? How Colleges are Wasting Our Money and Failing Our Kids-and What We Can Do About it.” Its authors are two longtime faculty members Andrew Hacker (tenured professor) and Claudia Dreifus (a freelance writer and adjunct instructor).

While I haven’t read the book, some of the problems with higher education asserted by the authors (and mentioned in the review) are consistent with my observations and experience. For example the review mentions that:

“Mr. Hacker and Ms. Dreifus list a host of crimes, or at least flaws in the system, some in the control of universities and others built into the external political, cultural or economic environment, or indeed into human nature. These include the narrow self-interestedness of academic departments; the greed of faculty members and administrators alike; the near-universal hypertrophy of “the athletics incubus”; unfunded government mandates; lifetime employment for pampered professors (thanks to the combination of tenure and Congressional abolition of mandatory retirement); and the demands of students and their parents for frivolous extras (driving what the authors call “the amenities arms race”).

The authors raise interesting questions about tenure and its alternatives. Like many critics of tenure, though, they have a keen eye for abuses of power but are remarkably sanguine about the capacity of the First Amendment to shield scholars from pressure exerted by those with the power to fire them.

The authors’ deepest scorn is reserved for the claim that good teaching depends on research, and their most extreme proposal is that universities drastically reduce the amount of research they support, by “spinning off” medical schools and research centers, discontinuing paid sabbaticals and abolishing the current system of promotion and tenure, a system that tends to reward research productivity more than effective teaching.”

While I tend agree that the emphasis on research, the pressure to publish and obtain extramural funding has had a negative impact on teaching, I disagree that teaching isn’t positively impacted by faculty members who are actively involved in scholarly research-what a conundrum!

Nevertheless, this book written by two long-time academicians provides compelling arguments for abolition of tenure and the need to improve teaching at the undergraduate and graduate levels.

Until next time...

Good Luck and Good Job Hunting (try teaching)!!!!!!!!!!

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As many of you know, I am a big Salmonella fan (not really that strange for a microbiologist who did his PhD thesis on Salmonella gastroenteritis). However, this notorious food-borne pathogen has once again made its way into the US food supply chain. 

This time, an Iowa-based egg producer, Wright County Egg, is at fault. This outbreak which began in May and sickened hundreds of American has resulted in the recall of over 380 million eggs! Ironically, the outbreak started just weeks before new government safety rule went into effect to reduce the risk of Salmonella infection of eggs. Public health officials believe that this is the largest outbreak of salmonellosis of poultry-related products in recent years.

Like most other nationwide Salmonella outbreaks, this one is a result of poor sanitary conditions and inadequate quality control at the production facility. Wright County Egg had repeatedly been cited for violating US Food and Drug Administration regulations. Yet, the company was allowed to continue operations without fixing the problems identified by FDA inspectors and regulators.

For those of you who may not know, chickens are frequently infected by Salmonella spp and can be found in the feces from infected animals. Chickens are not the cleanest of animals and fecal contamination is expected and common at most egg laying and processing facilities. If adequate health, sanitary and quality control procedures are assiduously adhered to at these production facilities, the likelihood of Salmonella infection of poultry products is very low. Conversely, the incidence of infections is sure to increase if these rules and regulations are not adhered to.

Once again we are in the midst of another major “food poisoning” outbreak, because a company cut corners to reduce costs and failed to adhere to federally mandated Good Manufacturing Practices for foods and related products.

As Woody Allen quipped in the closing moments of his film “Annie Hall”....”Most of us need the eggs.” Truer words were never spoken!

Until next time....

Good Luck and Good Job Hunting (try microbiology)

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 The folks over at Sologig.com, a website that freelancers, contractors and independent use to secure jobs provided a great tip for those of you out there who may be underemployed. Sorry graduate students and postdocs this doesn’t apply to overworked and poorly paid employees working on an advanced degree! Anyway, the advice was spot on and worth sharing!  

Are You Underemployed?

Sologig.com

If you're underemployed, you're either working part-time but really desire full-time employment, or you've accepted a full-time position that you're over-qualified for.  Here are some tips to help you break out of the underemployment cycle:

1. Embrace your underemployment: if you're working a part-time job, use your free time to volunteer at local organizations so you can explore other interests that you might want to transform in to full-time work.
2. Go above and beyond: if you're in a job that's "too easy," try reaching out to colleagues in other departments to see if they need help.  The more you learn, the more of an asset you will become to your company.
3. Do your job really well: even with mundane tasks, it's still important and necessary to get the job done.  It will also demonstrate your integrity to those around you.

I have embraced points #2 and #3 during several of my contracting gigs. While it didn’t lead to full time employment (not for me), it did help me to establish new relationships and contacts that have paid off in the future!

Hat tip to Sologig!

Until next time...

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

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Mark Senak, a pharmaceutical social media advocate and the author of the EyeonFDA blog, today reported that the Swiss pharmaceutical giant Roche published on its website a document entitled Social Media Principles. The document outlines Roche’s rules and regulations guiding the company’s use and commitment to social media.

In an accompanying statement, Roche officially affirmed the role of social media as part of its Communication Policy.

Roche actively uses Social Media to communicate with its stakeholders. As committed in our Communication Policy we want to be a transparent company and thus welcome this new form of communication.

Further, while the company recognizes the use and benefits of social media, it acknowledged the regulatory risks associated with the new medium

Roche recognizes the ubiquity and benefits of social media and welcomes its use - however, we also acknowledge that certain risks are associated with these new channels. We have therefore developed this guideline to help our employees use these new platforms in a responsible way.

Finally and perhaps most importantly, Roche appointed Sabine Kostevc as Head of
Corporate Internet and Social Media. 

Contact

Sabine Kostevc

Head of Corporate Internet and Social Media

• http://twitter.com/skoko
• global.social_media @roche.com
• Media Team

She may be the first communication executive to hold an official title that has the phrase ‘social media” associated it. Surprisingly, this may be the biggest development of all; mainly because once one pharmaceutical company does something new, they all similar to follow!

Roche’s willingness to publicly commit to the use of social media is a bold and calculated move by a company that recognizes its power and the major role it will likely play in the future of the pharmaceutical industry. Further, it suggests that Roche, unlike most of its competitors, it willing to take a proactive role in helping to shape the social media regulatory guidelines being developed by the US Food and Drug Administration. Finally, Roche executives realize that increased transparency and open communications with its stakeholder may help to improve the public image of big pharma companies and perhaps rekindle the innovation that has been sorely lacking in the industry.

The bottom line: Rather than remaining part of the problem, Roche has boldly proclaimed that it wants to be part of the solution!

Hat tip to Mark and Roche!

Until next time...

Good Luck and Good Tweeting err Facebooking err Blogging!!!!!!!!!!!

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Let me say at the outset of this post that I have a PhD in Bacteriology and admittedly less than objective when it comes to the topic of microbiology education and improving the public understanding of science. However, in today’s New York Times Science Times section there were no fewer than five articles that required some knowledge of microbiology to understand the implications about what was written.

1. Vaccination is Steady, but Pertussis is Surging
2. Really? The Claim: More Sugar Leads to More Cavities
3. Steep Drop Seen in Circumcisions in the U.S.
4. Patterns: Medicare Coverage Drives Antibiotic Use
5. Vital Signs: Nipple Piercings Add to Risk of Abscesses

While it doesn’t require a PhD to decipher the information in this article a basic understanding of microbiology would allow readers to understand the significance and future implications of the material that was presented. For example, in the article about nipple piercings; anybody who has taken an introductory microbiology class knows that bacteria like Staphylococcus aureus and Streptococcus pyogenes can cause pus-laden infections and if left untreated can result in potentially life-threatening abscess formation. Sugar and cavities? Microbiology 101 students all know that bacteria like S. mutans (that live in everyone’s mouths) ferment sugars and produce lactic acid that degrades tooth enamel and can cause cavities. And, most entry level microbiology students understand that the overuse of conventional antibiotics is largely responsible for the emergence of multiple drug resistant bacteria like multiple drug resistant S. aureus MRSA) and vancomycin resistant enterococci (VRE).

The point that I am trying to make is that bacteria are all around us; some do good things like fix nitrogen to improve crop yields and produce oxygen during photosynthesis while others cause devastating acute and chronic infections. Nevertheless, the lay public is largely ignorant about the microbes on and around them. Most of my friends, many of whom have advanced degrees in their fields, don’t know the difference between a virus and a bacterium and believe that it is okay to treat a cold with antibiotics! How can people modify their behaviors to effectuate change to improve their lives if they lack a rudimentary understanding of the factors responsible for conditions that afflict them?

Don’t get me wrong—we don’t need more PhD microbiologists. However, requiring all high school biology students and maybe biology degree students to have a firm understanding of the fundamental principles of microbiology would be a great start toward improving the lives of many Americans!

Until next time...

Good Luck and Good Job Hunting!!!!

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I read a fascinating article today posted on MedEdNews Insider Blog about the formation of a new agency called Rx Entertainment that helps to match celebrities with direct-to-consumer advertising campaigns created by pharmaceutical companies. Admittedly, I hadn’t thought much about the matching process, but in the past I have posted a few rants about direct-to-consumer advertising (DTC), Brooke Shields hawking Latisse for Allergan and the Robert Jarvik Lipitor brouhaha.

So, the post about an entertainment agency that helps to match celebrities with DTC prescription drug advertising campaigns piqued my interest. The blog post was actually an interview that was conducted by the blogger with the founder of Entertainment Rx (I love the name)! The interviewer asked the Rx Entertainment founder for examples of her agency’s matching maker prowess.  The list (see below) is very impressive:

1. Claire Danes and Brooke Shields for Latisse
2. Food Network’s Ellie Krieger for Centecor in the area of arthritis
3. Gretchen Wilson for LapBand
4. Jennifer Lopez for childhood vaccines
5. Vanessa Williams and Virginia Madsen for Botox
6. Sally Field for Boniva
7. Jim Belushi, Bruce Jenner, Danica Patrick, and Patty Loveless for COPD
8. Keri Russell on a campaign for Sanofi-Aventis  on the Sounds of Pertussis vaccine campaign
9. Angelica Huston to help launch the well-known Merck Manual
10. Elisabeth Hasselbeck and Marg Helgenberger for a fundraiser sponsored by P&G  where all the proceeds went to breast cancer research
11. Robert DeNiro to help launch a nicotine patch. He was premiering one of his films in NY and a fundraiser for cancer research was tied to the event.
12. Dara Torres worked with Centecor, and The National Psoriasis Foundation on a public service campaign to raise awareness for psoriasis
13. Hector Elizondo on a campaign for CaringforAlz; campaign focused on the caregivers of Alzheimers patients (Hector’s mother suffered from the condition).  This was a national campaign supported by the Exelon brand team at Novartis.

According to the post, Rx Entertain manages the negotiation process between the celebs and pharmaceutical/biotechnology from beginning to end. There was no mention of the salaries paid to the celebrities for their participation in the DTC ads.  However the Rx Entertainment founder did offer several bits of cautionary advice:

The celebrity spokesperson ought to have a legitimate tie to the disease and that A-list celebrities may not always be the most appropriate spokespeople because of the baggage (scheduling issues, entourage and additional difficulties) they may bring to the campaign. 

That said who knew that B-list celebs had good shots at potential careers in the pharmaceutical and biotechnology industries? Talk about alternate career paths!

Until next time....

Good Luck and Good Job Hunting (ever consider acting????) !!!!!!!

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Most working people are taught at an early age that the only worthwhile types of employment are permanent jobs. Temporary or part-time jobs are viewed as stop gap measures or a way to make some extra cash en route to a professional career. While this may be true when the job market is good, it isn’t necessarily the cases when looking for a job during recessionary times. 

Like most of you, I knew nothing about the contract, freelance or temporary job market until I found myself unemployed and needing cash to put food on the table. I entered the temporary job market about five or six years ago and I have never left! With this in mind, Phyllis Korrki who writes the Career Corner for the New York Times Sunday Business section wrote a great article on the temporary job market entitled "Finding a Bridge Over the Void.”

It is well written piece and worth a read if you cannot find work in your intended career but need a job. I highly recommend that those of you with five or more years of postdoctoral experience (and no end in sight) read this! It will help to ease some of your stress and emotional issues around not be able to find a permanent position!

Until next time...

Good Luck and Good Job Hunting!!!!!

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Despite the brouhaha surrounding the publication of an article about new South Asian strains of antibiotic resistant bacteria that carry the NDM-1 gene, some good may actually come from it. The Pharmalot Blog reported today that an article entitled “Are You Ready for a World without Antibiotics” appeared in the UK’s Guardian newspaper just two days after the first report about NDM-1.

While the Guardian piece is a little heavy handed in parts, it does a good job accurately portraying the growing lack of antibiotics left in the armamentarium to treat infections caused by many drug resistant Gram positive and Gram negative bacterial pathogens. As I have noted numerous times before, large pharma, for the most part, quietly exited antibiotic drug discovery and development in the late 1990s. 

Only a handful of biotechnology companies are developing new drugs to combat infections caused by antibiotic resistant bacteria. Unfortunately, many of these companies have hit regulatory snags for these drugs and the likelihood of approval is questionable. And if something isn’t done soon e.g. government funded initiatives, people may begin to succumb to bacterial infections at rates that haven’t been seen since the pre-antibiotic era which ended in the 1940s.

Until next time...

Good Luck and Good Job Hunting!!!!!

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As I noted in a post a couple of days ago, the media frenzy surrounding the identification of a new beta lactamase and erythromycin inactivating enzyme in strains of Klebsiella pneumoniae and Escherichia coli was neither noteworthy nor anything to get all worked up about. For whatever reason, the media reported results of an almost year old research study. If the results of this study had serious public health implications why did it take media outlets so long to report it to the lay public? I suspect that the report was a cleverly crafted promotional campaign underwritten by pharmaceutical companies that are trying to boost sales of their antibiotics. To that end, the Pharmalot Blog reported yesterday about potential conflicts of interests for several of the study’s authors.

According to the Pharmalot post, “The study in The Lancet was funded by the European Union, as well as Wyeth and the Wellcome Trust charity, both of which are involved in producing antibiotics for treating such cases, CNN-IBN reports. Karthikeyan Kumaraswamy, the scientist who headed the study, received a travel grant from Wyeth. And David Livermore, another co-author, received conference support from numerous drugmakers and also holds stock in AstraZeneca, Merck, Pfizer and GlaxoSmithKline, the report continues.”

These revelations caused spokespersons from the Indian government to issue the following statement:

“This news has created a misconception and a feeling that the point of origin of the bacteria is in India. We have got the matter examined. We have come to a conclusion that this is not the right statement. After seeing the research paper, I strongly refute that hospitals in India are the source of the strain and strongly condemn naming the bacteria after New Delhi,” Director General of Health Services RK Srivastav tells CNN-IBN. “Intellectual scientific freedom is all very good but there is a conflict of interest in this research. Researchers like these are examined separately according to the code of ethics.”

Back in the day, it was commonplace to assign the city or country of origin to bacterial isolates. And, I see no reason why this should not continue. While I disagree with the Indian government’s claim that the NDM-1 strain designation will interfere with tourism in that country, I still contend that elevation of the study results to the international stage was premature and largely irresponsible. The fact that several of the study’s co-authors were or are funded by pharmaceutical companies and own stock in these companies suggest that the media frenzy may have been “stoked” for personal and corporate gains.

Hat tip to Ed at Pharmalot!

Until next time...

Good Luck and Good Job Hunting (try clinical microbiology)

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Because I was traveling for the past couple of weeks, I missed an article entitled “Unnatural Science” by Virginia Heffernan that originally appeared in the July 31 edition of the New York Times Magazine. After returning home this past Sunday, I had the opportunity to read it and what a read it was!

 It was an apt and brilliantly written piece about the often venomous and offensive blogging that has gone on for several years at ScienceBlogs: a science blogging collective overseen by the Seed Media Group. Interestingly, BioJobBlog was approached about a year ago by the Seed Media Group to consider blogging under the ScienceBlogs umbrella. For those of you who may not know, the bloggers who write for ScienceBlogs get paid based on the amount of site traffic that their blogs generate. While the sums of money that are paid are nominal, graduate students and postdocs, and even Assistant Professors can blog to their hearts content and make a couple of hundred dollars each month while waiting for the results from experiments that may be incubating. However, after reviewing the content and quality of some of the so-called blogs at ScienceBlogs, I respectfully declined Seed Media’s offer to come aboard.

Unbeknownst to me, a couple of months ago a group of 20 or more bloggers “angrily parted ways with ScienceBlogs because is started running Food Frontiers a nutrition blog that PepsiCo paid to have on the site” wrote Ms Heffernan. Also, she noted, “In farewell posts the bloggers charged that the advertorial was deceptive and undermined the purpose of the collective.” According to the article, Seed Media Group quickly removed the “tainted blog.” Unfortunately, the damage had been done and the action wasn’t sufficient to prevent other bloggers from leaving.

Unfortunately, my past experiences and “run ins” with several ScienceBlogs bloggers (“On Becoming a Domestic and Laboratory Goddess” and GrrlScientist, on Living the Scientific Life (Scientist, Interrupted) were extremely unpleasant, humiliating and unprofessional. After reading Ms Heffernan’s piece on the often caustic, offensive and inappropriate remarks made by many of the bloggers who write for ScienceBlogs I felt vindicated in my assessment of the quality and veracity of the writing at the collective. To that end, she wrote “And while I found interesting stuff here and there, I also discovered that ScienceBlogs has become preoccupied with trivia, name-calling and saber rattling. Maybe that’s why the ScienceBlogs ship started to sink.”

 While I think ScienceBlogs is a great idea and has merit, the people who run the site have failed to realize that they cannot allow scientists to say and publish whatever they want. Unfortunately, many of these well-educated and supposedly erudite scientists have inadequate social skills, over-sized egos and the notion that the freedom of speech gives them permission to say whatever they like no matter how offensive or odious it may be.

However, what I think is even more egregious than the offensive comments and slurs against people was the holier-than-thou attitude adopted by many of the bloggers who left Science Blogs because the Food Frontier Blog was sponsored by PepsiCo. After all, how could ScienceBlogs management allow a corporate entity to sponsor a blog and possibly denigrate and call into question the science discussed by other bloggers? To that end, I bet many of the defecting bloggers wouldn’t scoff at the opportunity to get research grant monies from a company interested in their research. In fact, it would be interesting to see how many of the bloggers at ScienceBlogs have research contracts and agreements with pharmaceutical, biotechnology and medical devices companies.

I actually feel bad for the Seed Media Group because the company is run by a bunch of good guys who are trying to do the right thing. That is, discussing and promoting science in the blogosphere with the hope of improving the public understanding of science and technology. Maybe it was time for the bloggers who left to go. There will be other bloggers to take their places. For the foreseeable future, BioJobBlog will remain independent.  However, if ScienceBlogs wants to make me an offer I can’t refuse; than I am all ears!

Until next time...

Good Luck and Good Blogging!!!!!!!!!

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Despite assertions by its CEO that there isn’t enough scientific talent in the US, Eli Lilly announced that it will lay off a couple of thousand employees within the next 90 days. Most of the cuts will take place in Indianapolis at four different sites where the company currently employees about 13,000 workers. According to an article in today’s Indianapolis Star

“The struggling Indianapolis company, which has been cutting thousands of jobs in recent months, told the state on Monday that its downsizing is not temporary, but for the long haul.

The reductions in force at the Indianapolis sites of employment are expected to be permanent," wrote Kay Jackson, Lilly's senior director of human resources, in a letter to the Indiana Department of Workforce Development. She added that the cuts, when added up, are not expected to be more than 33 percent of the head count at any one site, or more than 500 workers at any site."

Like most of its rival big pharma companies, Lilly has cut the number of full-time equivalent workers by about 2,100 worldwide since last September. That's when it announced it would cut a total of 5,500 workers worldwide by 2011 to save $1 billion in annual costs. The reason for the cuts; an expected steep falloff in revenues over the next few years when the patents on Lilly's blockbuster drugs begin to expire and face low-priced generic competition  

John C. Lechleiter, Ph.D, Lilly’s CEO, contends that the lack of innovation and new product development at most American pharmaceutical companies can be explained by a dearth of qualified and adequately trained American scientists. Maybe this is why most pharma R&D job are currently being outsourced to China, India, Brazil and Eastern Europe? Alternatively, it may be cheaper to employ US-trained foreign nationals in these places rather than high priced American scientists who perform similar jobs in the US.  

Until next time...

Good Luck and Good Job Hunting (forget Indiana-not there is anything wrong with it)

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I read a post today on Yahoo News entitled “Warning on New Superbugs from S. Asia.” While I initially thought that this article may contain some important news on the real and growing of multiple drug resistant bacterial pathogens, I sadly learned that it was nothing more than an sensationalistic attempt to promote the discovery of a new metallo-beta-lactamase gene bla(NDM-1) in an Indian isolate of Klebsiella pneumoniae, a Gram negative bacterium. The work was performed by a group at Cardiff University in Wales and published almost a year ago in the journal Antimicrobial Agents and Chemotherapy.

There is no question that morbidity and mortality from Gram negative infections is rising and will certainly continue to increase in the future. This is because most of the work in antibacterial drug discovery in the last decade was focused on Gram positive bacteria including methicillin resistant Staphylococcus aureus (MRSA) and vancomycin resistant enterococci (VRE). Although new antibiotics have reached the market for these organisms, they are used judiciously, and mainly as a last resort, because of fears of emerging resistance to them among Gram positive clinical isolates. Unfortunately, developing new antibiotics against Gram negative pathogens as compared with Gram positive bacteria is much more difficult. To that end, no antibiotics of note have been discovered in recent years to treat multiple drug resistant strains of Gram negative bacteria. 

While identification of the bla (NDM-1) gene may be scientifically and biologically interesting, it will likely have little effect on the clinical treatment of Gram negative infections. This is because many Gram negative isolates are already resistant to most beta-lactam antibiotics and consequently these antibiotics are used only sparingly to treat many Gram negative infections. Regardless of the implications of the discovery of the NDM-1, what I find most troubling about the article is its title. It leads uninformed persons to believe that the world is in grave danger and that a pandemic of multiple drug resistant strains of Gram negative bacteria may be imminent.  While infections caused by multiple drug resistance strains of Gram negative bacteria are clearly on the rise, strains carrying the NDM-1 gene will not decimate the world population any time soon! In fact, the authors suggest that these strains may cause some problems in India which “already has high levels of antibiotic resistance.”

There is no doubt that informing people about the growing incidence of multiple drug resistant bacteria is a good thing. Maybe, if enough people get frightened they may be able to induce big pharmaceutical companies—many of which abandoned antibiotic drug discovery and development in the late 90s—to reinvigorate their programs. That said, it is not clear why this story got elevated to a lead story on Yahoo News since the discovery was made almost a year ago—maybe today is a slow news day? Nevertheless, the impending doom and sensationalistic tone of the article suggests that reporters who cover the life sciences need some training in microbiology. This is necessary to insure that the stories that they write about antibiotics are kept in the appropriate context and historical perspective. That said, don’t be surprised today if the sales of antibacterial products increase and the stock prices of biotechnology companies involved in antibacterial drug discovery and development spike!

Until next time...

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

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A recent study conducted by University of California San Diego Extension ranks careers in the health and life sciences fields at the top for recent college graduates. Sandy Bloom of GreatDegree.com recently wrote an article (see below) that provides insights and tips on how recent college graduate may be able to “snag” one of these up and coming hot jobs!

Hot Careers for College Graduates in 2010

By Sandy Bloom

For college graduates, landing a first job can be daunting, especially in hard economic times. But a recent report released by UC San Diego Extension, “Hot Careers for College Graduates in 2010,” shows that for certain career paths, finding a job may be easier than you think.

Nearly half of the top careers listed in the study stem from the health and bio fields, including the areas of health information technology and health law.

After earning a health degree or online biology degree, you can soon be working in one of these hot jobs, too.  Here’s how:

Health Information Technology

The report ranks careers in health information technology at the top because physicians and hospitals must update their medical records systems to be completely electronic in the coming years. Health information technicians are responsible for organizing these medical records, ensuring the records are accurate and complete, and updating the patients’ files electronically. According to the Department of Labor, employment of medical records and health information technicians is expected to increase by 20 percent over the next eight years.

Those looking to work in this high-demand profession should earn an associate’s degree with coursework in health information. Most employers prefer hiring credentialed medical record and health information technicians who have passed a credentialing exam. Experienced medical records and health information technicians advance their careers by earning bachelor’s or master’s degrees in biology, math, chemistry, health, and computer science.

Clinical Trials Design and Management For Oncology

The second ranked “hottest” career is clinical trial managers, specifically for cancer drugs. According to the report, “as the population ages, diseases are becoming more prevalent” and cures for those diseases are in demand. Clinical trial managers must oversee researchers who dedicate years to researching and testing before getting experimental drugs approved and brought to the market.

To become a clinical trial manager, you should earn a bachelor’s degree in chemistry, biology, or another life science. Then, receive a post-baccalaureate certificate to be certified by the Academy of Clinical Research Professions. Those working toward this in-demand career should partake in observation study courses or internships to observe a clinical trial in progress. Lastly, sign up to take online computer science courses to become familiar with Clinical Trial Management Systems.

Geriatric Health Care

According to last census in 2000, some 14 million seniors ages 65 and older report some level of disability that needs extra care. That means there is a huge demand for elder care professionals such as nurses, doctors, and nursing care professionals specializing in geriatric health care. In addition, because of the increasing incidence of mental illness among the aging, there is also a high demand for psychology professionals trained to treat older patients.

Training to be a nurse, a doctor, or psychiatrist or psychologist requires a bachelor’s degree in science as well as completion of board exams and residencies.

Occupational Health and Safety

Occupational Health and Safety Specialists (OHSS) analyze work environments to prevent injury by studying trends or patterns of injury and illness. They then suggest policy changes and develop and implement programs to improve conditions or practices that are dangerous. Environmental health and safety officers, ergonomists, health physicists, and industrial hygienists all perform this type of work.

To become an occupational health and safety specialist, you should earn a bachelor’s degree in a science or engineering discipline or a Master’s degree in science or in public health. All specialists must be trained on the law and inspection procedures through classroom and on-the-job training.

Other careers to consider include synthetic biology, regenerative medicine, stem cell research and medical devices including molecular diagnostics.

Hat tip to GreatDegree.com

Until next time...

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

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For the past few years, CEOs have been taking a lot of heat; and in many cases rightfully so. However, from time to time some of these “captains of industry” say things that may be useful to ambitious young executives, employees and would-be entrepreneurs. 

The folks over at BestCollegesOnline sent me a link to a post entitled “The 30 Best CEO Interviews You Should Watch on YouTube.” While I haven’t seen any of the videos (I don’t have the luxury of time to do so), viewing some of them may be worth it!

Check them out and let me know if find a good one.

Until next time...

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

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

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

Further according to the agency

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

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

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

Hat tip to Ed at the Pharmalot Blog

Until next time…

Good Luck and Good Tweeting!!!!!

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According to a post today on the Pharmalot Blog,

“After what appeared to be a slowdown in layoffs taking place in the pharmaceutical industry, job cuts are accelerating again, according to the latest monthly tally from Challenger, Gray & Christmas. There were 2,023 jobs lost in pharma in July, a notable uptick from the 830 lost in June. Overall, the industry has shed 37,010 jobs this year. “

While I think the massive layoffs that occurred in past three years are unlikely in the future, pharma companies will continue to downsize as patent expiry of blockbusters continue and M&A activity in the biotechnology sector rises.

Until next time,

Good Luck and Good Job Hunting!!!

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Can things get any worse at Genzyme? First there were the manufacturing problems that result in plummeting stock share prices and a proxy battle by Carl Icahn and company. Next up was a $175 million consent decree judgment levied by the US Food and Drug Administration for the manufacturing problems. Then came the $18 billion takeover bid from Sanofi Aventis. Now, patients affected by shortages of the drugs Fabrazyme three patients have petitioned the US Department of Health and Human Services (HHS) to disregard Genzyme’s patent for the medicine to overcome the drug shortages.

Because of the manufacturing problems, Genzyme rationed its supplies of Fabrazyme to one-third of the normal dose for Fabry disease patients. Some of these patients reported increased pain and no newly diagnosed patients could receive the drug. Meanwhile, Shire Pharmaceuticals has been trying to obtain FDA approval of its Fabry disease treatment, Replagal which is approved in Europe.

The patients who petitioned HHS contend that HHS can override the patents because the National Institutes of Health paid for research at the Mount Sinai School of Medicine, which exclusively licensed Fabrazyme to Genzyme. The goal of the action is to induce another company to produce the drug in case Genzyme is unable to deliver adequate quantities to new and existing patients. Provisions in the Bayh-Dole Act suggest that this action may not be unreasonable if ‘a licensee cannot reasonably meet the public health and safety needs of the American public.’

Stay tuned for the next installment of the continuing Genzyme saga!

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Anybody who has lost a job or been unable to find one for an extended period knows how troubling and painful it can be. While things may look bleak, my colleagues over at Online Degree Programs sent me a blog post that some of you may find useful. 

Some of the suggestions are really good whereas others; not so much. Nevertheless, the worse thing to do is sit around and do nothing.

The best approach is to keep yourself occupied, continue looking for work and think strategically about your next career move.

Until next time…

Good Luck and Good Job Hunting!!!

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