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Yesterday, after giving a talk on social media to a great NYC-based PR firm called Ricochet,I decided to take an uptown trip to visit Professor Vincent Racaniello at Columbia University Medical School to talk about the new applications that we plan to introduce to BioCrowd.

When I arrived at Professor Racaniello’s office, which has an outstanding view of the Hudson River and George Washington Bridge, he was in the middle of taping this week’s This Week in Virology (TWiV) podcast with co-hosts Dick Despommier and Alan Dove. Much to my surprise, Vincent invited me to join the conversation although I am a bacteriologist not a virologist. The podcast was devoted mainly to answering questions that listeners had submitted to the show. One listener alerted us to a post at Newsweek Online entitled “Fight Flu and Falsehoods” while we didn’t agree with the author’s assertion that “that hand washing doesn’t affect the transmissibility of influenza”—it does reduce infections rates of other viruses, bacteria and parasites, so it is a good idea to continue to wash your hands—accompanying the article was an outstanding online quiz that assesses how much you really know about influenza and other viruses. 

I think it would be fun for BioJobBlog readers to take the quiz, report scores and then tabulate the results.

To take the quiz, click here and to report your score click here!  I will tabulate the results and share them in a later post if enough BioJobBlog readers and their friends take!

Until next time

Good Luck and More Luck On the Quiz!!!

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There was an interesting article in the New York Times this past week entitled“Do Women Need Such Big Flu Shot.” The gist of the article was that we would have more doses of influenza 2009 H1N1 vaccine if we accounted for the biological differences between the immune responses in men and women follow influenza vaccination (the article cites a study that contends that less vaccine is need to elicit an protective response in women as compared with men.

I was going to write a post about the article but I got distracted and thought I would revisit it when I had more time. Much to my surprise, Vincent Racaniello, a Bio-Crowd founder, virologist extraordinaire and host of the popular TWiV podcast series, had already “scooped” me. Professor Racaniello graciously allowed me to crib his entire post and let BioJobBlog readers decide for themselves whether or not there are real differences in the male and female immune responses to influenza vaccines or the results obtained by the scientists who conducted the study may be explain by strain to strain variation among influenza A isolates? Read Professor Racaniello’s post below and let me know what YOU think!

Do women need the same amount of influenza vaccine as men?

by Vincent Racaniello

“Do Women Need Such Big Flu Shots?” suggests that we would have more doses of influenza 2009 H1N1 vaccine if we accounted for the biological differences between men and women. The idea is that women generate a stronger antibody response than men, and therefore require less vaccine. Does this idea have scientific support?

The opinion is based in part on a study carried out in 2004-05, in which adults were immunized with full (15 micrograms) or half-doses of trivalent inactivated influenza vaccine. This vaccine, made by Aventis Pasteur, contains influenza H3N2, H1N1, and B strains. Serum samples obtained before immunization and 21 days later were assayed for antibody response to each strain of influenza by hemagglutination-inhibtion. I’ve taken the data on geometric mean serum HI titers according to age, sex, and dose and plotted them on a graph:

Based on the results the authors conclude that “Significantly higher geometric mean titer responses in women were identified for all ages, regardless of dose or influenza strain. Half-dose vaccination may be an effective strategy for healthy adults younger than 50 years in the setting of an influenza vaccine shortage.” But are these immune responses protective?

HI titers of 1:40 or more (which would be reported as 40 or higher in the graph) are believed to indicate levels of antibody that would protect against infection with influenza virus. By this criteria, the full and half dose of vaccine would provide protection agains the influenza H3N2 and B viruses in both men and women. The results confirm that females respond more strongly to the same dose of vaccine than men. But look at the results with the H1N1 strain – in all subjects, no matter the dose of vaccine or gender, the antibody response would not be sufficient to protect against infection. Furthermore, the response is only slightly better than in women.

In interpret these observations to mean that the antibody response to inactivated influenza virus vaccine is not universally more robust in women compared with men – it appears to depend on the virus strain. Clearly clinical studies are required to address this question. Even after spending millions of dollars to decide whether to give women less influenza vaccine, a new strain of influenza virus might come along that induces no better antibody response in women than in men.

My conclusion is that it would not be possible to determine conclusively that women could receive half the amount of inactivated influenza virus vaccine as men. I would rather spend money on developing new ways to produce as much influenza vaccine as needed as quickly as possible – such as by making virus-like particles in plants.

Engler RJ, Nelson MR, Klote MM, VanRaden MJ, Huang CY, Cox NJ, Klimov A, Keitel WA, Nichol KL, Carr WW, Treanor JJ, & Walter Reed Health Care System Influenza Vaccine Consortium (2008). Half- vs full-dose trivalent inactivated influenza vaccine (2004-2005): age, dose, and sex effects on immune responses. Archives of internal medicine, 168 (22), 2405-14 PMID: 19064822

 Until next time...

Good Luck and Good Reading!!!!!

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The New York Times reported today that AstraZeneca has agreed to pay $520 million to settle two federal investigations and two whistle blower lawsuits over the sale, marketing and off-label promotion of its blockbuster antipsychotic drug Seroquel. Despite this settlement, UK-based AstraZeneca still must contend with 14,444 civil lawsuits filed by many patients who developed diabetes and other health related conditions because of misleading marketing that failed to adequately disclose that the drug caused abnormal weight gain.                     

AstraZeneca joins a growing list of pharmaceutical companies that have been penalized for off label promotion and misleading advertising. Earlier this year Eli Lilly & Co paid $1.4 billion over its marketing of another antipsychotic drug Zyprexa and Pfizer announced that it would pay $2.3 billion including a record-breaking criminal fine of $1.195 billion mostly for its painkiller Bextra which was withdrawn from the market.

Despite the size of the fines and settlement figures for these recent cases, they are a drop in the bucket when compared with the amount of money generated by illicit marketing and advertising. For example, the $520 million that AstraZeneca has agreed to pay to settle the Seroquel case pales in comparison to the $17 billion that the drug has generated in US sales since 2004. The same was true for Zyprexa and Bextra.

While these settlements cannot repair much of the damage that has been done to unknowing patients, it signals that the US government is beginning to live up to its pledge to provide safe and efficacious medicines to the American public.

Until next time...

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

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I was sitting around minding my own business (well sort of) and I received the following e-mail message. People must be reading BioJobBlog or something!

In the middle of the worst national job market since the early 1980's, Roche Pharma Research in Nutley, New Jersey is hiring. Specifically, this world class R&D center is seeking to hire 40 scientists to strengthen its research efforts to develop drugs to combat inflammatory diseases like arthritis and asthma.

In addition to Inflammation, Nutley continues to be the headquarters for Roche's Oncology Disease Biology Area, as well as RNA Therapeutics (an emerging area in understanding how genes are turned on and off in cells).

Focusing on drug discovery and non-clinical development, the site has a long tradition of discovering innovative new medicines.

Marcie Geremakis of Roche HR is available to discuss the efforts to recruit the new scientists and why Nutley is an outstanding environment for scientists.  A number of scientists are available to discuss the following:

• Roche's cutting edge scientific approaches to drug discovery focused on meeting the demands of the emerging need for personalized healthcare.

• Roche's intent to provide its scientists with the environment necessary to push forward novel ideas while challenging old paradigms.
• The ability to use state-of-the-art technology and collaborate with Roche's world class scientists across the globe engaged in biomarker discovery, novel biologics platforms, RNAi and diagnostics.

With well over 100 projects in research and more than 60 New Molecular Entities in development, Roche’s pipeline is among the best in the pharmaceuticals industry.

Please call me at 212-468-4306 or e-mail me at jillian.chertok@mslworldwide.com if you would like any additional information, or are interested in scheduling a time to speak with Marcie or one of the scientists at Roche. 

I must disclose that I have no financial arrangement with this agency nor have I ever done business with them before.  But, I figured if there are jobs to be had in this economy I ought to pass them on to folks who are looking.

Until next time...

Good Luck and Good Job Hunting!!!!!

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I received a call today from GDS International, a UK-based b2b publishing company, alerting me to its annual, event called the Next Generation Pharmaceutical Summit (NGP) currently taking place at the Ritz Carlton on Amelia Island in FL. This invitation only event is supposed to bring pharmaceutical and life sciences executives to discuss problems facing the industry and what thing ought to be implemented to insure continued progress and growth.   This is the news coming out of the conference attended by over 50 pharmaceutical and biotechnology executives

Big Pharma concludes that M&A is not the New R&D

With large firms seeking synergies to drive down R&D costs, M&A deals can aid in the transfer of technical knowledge, scalability and reduce time to market. However, previous M&A periods have not alleviated the productivity crisis. “While short term gains emerge from these deals, in the mid to long term, R&D innovation, organic growth, and internal drivers are still key facet’s behind creating a successful company and providing an organization with sustainability.” So says, an executive committee composed of  50 pharmaceutical executives including Jeffery Nye, Chief Medical Officer at Johnson & Johnson, Reinilde Heyrman—VP of Clinical  Development at Daiichi Sankyo, Oscar Laskin—VP of Early Development at Celgene are leading the debate, joined by Ann Wang—VP of Clinical Operations at Human Genome Sciences. These sentiments confirm the notion that the pharmaceutical and biotechnology industries are in transition and suggest that life sciences companies still face many serious challenges in the not too distant future.

While increasing mergers and acquisitions isn’t likely to reinvigorate R&D, newly emerging economic pressures have recently triggered another wave of M&A activity in both sectors. But is this the solution for long-term sustainable growth?  “The willingness for the industry to unite in such a way clearly demonstrates long-term strategies for improved business processes so long-term investment in R&D can be secured” said Drew Contessa the NPG director.

The NPG will reconvene in April 2010 to review recommendations and actionable items.

The realization that M&A is not a solution to correct waning productivity in R&D was a long time coming. It cost about 150,000 pharmaceutical employees their jobs over the past three years. The idea that companies are beginning to recognize that buying or merging with another company is not a panacea or long term fix is a good thing. 

Hopefully, the life sciences industry can learn from its past mistakes.

Until next time....

Good Luck and Good Job Hunting!!!!!! 

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For the past several weeks, the EyeonFDA blog has been reporting on the possible regulatory impact of Google’s Sidewiki on life sciences companies. For those of you who may not be familiar with Sidewiki  (released in late September) it is a new feature of the Google toolbar which can turn a static web 1.0 website into an interactive web 2.0 experience by allowing website visitors to leave comments behind.

When you use side-wiki, you have the ability to leave your comments and associate them with a website whether or not the website owner has enabled commenting.  Since the comments are maintained by Google, there is no direct relationship with the website.  Basically, anybody who visits a website that has Sidewiki enabled can say or comment on whatever they like and immortalize it (until Google removes it) for the entire world to see. Apparently, this doesn’t sit well with many website owners and Google purportedly recently release code to disable Sidewiki at websites that don’t want to support it. However, it isn’t clear how robust the anti-sidewiki code is!

While I haven’t formulated an opinion on Side Wiki yet (mostly because it isn’t that interesting to me), it does represent a regulatory dilemma for life sciences companies with marketed drugs and devices. According to today’s EyeonFDA post “If someone writes of an adverse event on a Sidewiki, or promotes an off-label use, it is now on the company's home page.  Is the company under a duty to monitor and correct such misinformation or if they do, do they incur liability for doing so?  It is a conundrum - and there is no insight apparent from the FDA on the matter.” Further, most life sciences companies have yet to craft a legal or regulatory policy for Sidewiki usage. 

EyeonFDA has been assiduously monitoring life sciences company websites for the appearance of Sidewiki. To date EyeonFDA has found it on the following company websites:

1. Abbott
2. Amgen
3. AstraZeneca
4. Bayer
5. Baxter
6. Bristol-Myers Squibb
7. GSK
8. Johnson & Johnson
9. Lilly
10. Novartis
11. Novo Nordisk
12. Pfizer
13. Roche
14. Sanofi-Aventis
15. Takeda

While Google would like everyone to believe that Sidewiki is taking the Internet by storm and spreading like the H1N1 virus, a show of hands at yesterdays e-Patient Connections 2009 meeting in Philly, which was attended by many computer geeks and social media enthusiasts, revealed that about4 out of about 150 had heard of it! Nevertheless, it is out there and life sciences companies would be well advised to formulate internal legal and regulatory guidelines despite the fact that FDA hasn’t issued any guidance on its use.

P.S. Shortly after I posted this, @pharmaguy alerted me to an article that appeared on the today's online PharmaExec.com entitled "SideWiki: What's Pharma To Do"?

Until next time...

Good Luck and Good Commenting

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e-Patients Connections 2009 (#epatcon) was held this past Monday and Tuesday at the Park Hyatt hotel in Philadelphia, PA. BioCrowd was one of several co-sponsors of the event. The theme of the conference, organized by Kevin Kruse a veteran medical communication and training expert, who now runs Kru Research, was to “reach, engage and educate empowered digital health consumers.” And, boy, did it deliver! While this was Kru Research’s first official conference, it was well organized, extremely interactive and the quality of the speakers was second to none! Topics that were featured included social media and the life sciences industry, technological advances in e-based healthcare delivery, the relationship between the news media and healthcare information and the continuing evolution of online and e-based healthcare communities.

Conference attendees included representatives from the life sciences industry, medical communications experts, advertising and marketing professionals and a multitude of social media enthusiasts and consultants who kept the Twitter screen humming throughout the meeting (a big shout out to the “troublemaking table”). And, surprisingly, there was a representative from the Division of Drug Marketing and Advertising and Communications (DDMAC) at the US Food and Drug Administration, who I believe, was one of the most sought after individuals at the meeting. CNN reporter Elizabeth Cohen who writes the Empowered Patient and racecar driver Charles Kimball, a type I diabetic and company spokesperson for Novo Nordisk also gave talks.

My favorite talks were those presented by online patient community organizers including Tricia Geoghegan of Ortho-McNeil-Janssen Pharmaceuticals who created the Facebook ADHD Allies community, Lisa Tate of WomenHeart and Robert Schumm of Bayer Consumer Care who created Facebook Strong@ Heart and Rachel Lewinson of the Juvenile Diabetes Research Organization and Susan Harrow Rago of Novo Nordisk who created Juvenation.org a website dedicated to those with Type I diabetes. These communities are outstanding examples of how partnerships between pharmaceutical companies and advocacy groups can help to better educate the public and heighten awareness about potentially life-altering diseases. Another example of a great online community and healthcare portal is Insomnia 123.com. This website was conceived and constructed by Christine Macadams and her partners’ one of whom is a practicing physician. Unlike the other online communities, which are sponsored and mainly supported by consumer healthcare division of large pharmaceutical companies, Insomnia 123.com was exclusively created by a group of concerned individuals who wanted to better educate and improve the lives of people with insomnia—a largely unreported and self-medicated condition.

On the technical side, the talks presented by Lee Segal of Klick, Kevin Durr of Avantera , Ian Kelly of Red Nucleus and Scott Ballenger of ListenLogic were illuminating and extremely informative. Some of the innovations taking place in digital media are exciting and almost overwhelming at times (even for a social media enthusiast like me). I think the company to watch is ListenLogic which uses semantic search engines to collect real time data and “chatter” on the web. This technology may provide a cost-effective solution to assuage the concerns of many life sciences companies that claim that collecting and analyzing overwhelming amounts of data is one of the main reasons why they are reluctant to entry the social media space.

Marc Monseau of Johnson and Johnson gave an illuminating talk on his experiences as a corporate blogger and Twitter user and described some of the challenges that had to be overcome before his company was able to break the “social media barrier.” Janice McCallum, an economist by training and a healthcare communications and media expert gave an informative talk about the growing role and impact of patient-generated healthcare content on patient awareness and education.

Finally, the novel and innovative Pecha Kucha sessions were outstanding and extremely well done! While all were expertly crafted, Dr. Val’s and Jonathan Richman’s Pecha Kucha were memorable. Dr. Val’s, which was extremely powerful and moving, was performed entirely in verse and Jonathan’s was—well, one of Jonathan’s always entertaining and informative presentations.

In summary, the “e-Patient Connections 2009” was a resounding success and in my opinion reached its goal to “reach engage and educate empowered digital health consumers.” That said, I can’t wait for “e-Patient Connections 2010” meeting!!!

Hat tip to @ellenhoenig and @eileenobrien for inviting me to my first tweetup (great fun) and finally meeting @janice McCallum, @christianeTrue, @stevewoodruff and Silja aka @whydotpharma! 

Until next time...

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

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Cliff Mintz, BioCrowd co-founder and the mastermind behind BioJobBlog, is featured today in an online article at the Science Careers website entitled “Life After Rejection.” The piece was expertly crafted by Siri Carpenter, PhD a free lance science writer based in Madison, Wisconsin— coincidentally, the institution that awarded me my PhD. 

Being denied tenure as an Assistant Professor of Microbiology and Immunology was one of the most devastating events in my professional life. It literally took me over 10 year to come to terms with the implications of the decision. But, I am here to tell you (and in the article) that there IS life after being denied tenure; and in many ways, it is quite liberating. My tenure denial empowered me to explore careers that were previously closed to me as an academician and perhaps, more importantly, to find out who I am and what I really wanted to do with the rest of my life!

Don't get me wrong; it still bugs me that I wasn’t awarded tenure—mostly because being refused tenure implies that you “weren’t smart enough” to make it in academia. Not surprisingly, the “not-being-smart-enough label” doesn’t do much for a person’s self esteem and, many who are denied tenure (including me) tend to view themselves as abject failures in the eyes of their colleagues and friends.

However, looking back, being denied tenure was probably one of the best things that had ever happened to me. Truth be told, I would have been a lousy academic. I am too social and entrepreneurial to have flourished in a system that is rigid, parochial and not conducive to change.  That said, if I sound bitter and a bit envious of those who were granted tenure, you are correct!  After all, who wouldn’t be envious of  people who come and go as they please, don’t have to answer to a boss and are guaranteed a job for life; regardless of their social skills, academic performance or contribution to education?

The point that I want to make is that being denied tenure is an emotionally devastating and traumatic event that nobody ought to experience. However,  if  you should to find yourself in the uncomfortable position of being denied tenure, please remember to continue to believe in yourself, don't give up and, as corny as it may sound, "follow the advice of your heart" when making your next career move!

Until next time....

Good Luck and Good Job Hunting!!!!!

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Late last week, the US Food and Drug Administration (FDA) approved GlaxoSmithKline’s cervical cancer vaccine Cervarix for use in girls and women ages 10 to 25 and also approved Gardasil —Merck’s cervical cancer vaccine previously approved in 2006 for use in girls and women—for boys and men ages 9 to 26. For those of you who may not know, over 99% of human cervical cancers are caused by infections with cancer-causing strains of the human papilloma virus (HPV) which also causes venereal warts. Vaccination with Cervarix protects against cervical cancer by inducing immunity against HPV 16 and 18 (which cause most cervical cancers in developed nations) whereas Gardasil affords protection against HPV 16 and 18 as well as HPV 6 and 11, strains that cause venereal warts (which don’t lead to cancer).

Despite FDA’s approval to vaccinate boys with Gardasil to prevent HPV infections, the Centers for Disease Control’s Advisory Committee on Immunization Practices (ACIP)— which guides national policy on use of vaccines—decided yesterday to recommend the use of the vaccine in girls and women but didn’t fully endorse its use in males. Typically, ACIP recommendations are adopted by professional medical associations and set the standards of practice for physicians. Also, its recommendations play a major role in determining whether or not insurers and third party payors will reimburse patients who are vaccinated. The new recommendations mean, in effect, that physicians and clinics may now administer the vaccine at their discretion to boys and men ages 9 to 26, but they are not expected to offer it. In contrast, vaccination of girls and women ages 10 to 25 will be strongly recommended, readily available and reimbursable. This means that parents may consider the vaccine as an option for their sons, but some health insurers may choose not to cover the shots—an option which is sure to severely limit the numbers of boys and men who are vaccinated with Gardasil.

The ACIP committee decided not to include Gardasil immunization for boys and men on its recommended list because several members, most notably a medical economist, questioned whether vaccinating boys would be cost effective in the long run. At the heart of the debate was whether or not it was appropriate and cost-effective to vaccinate boys for a problem (venereal warts) that can be embarrassing and uncomfortable but is not life-threatening. For those of you who may not know, Gardasil immunization is expensive and requires a series of three injections that cost $130 each ($390 total).  Cervarix, which also requires a series of three injections, is planned to be offered for $385.

Last year in the United States, about 37 percent of girls ages 13 to 17 started the Gardasil vaccine series, a national immunization survey showed, and about half of them completed it. Not a great track record for a vaccine demonstrated to prevent cervical cancer and dramatically reduce the transmission of venereal warts. Nevertheless, yesterday’s decision to recommend vaccination for girls and women but not boys and men makes no sense to me from a public health perspective and it almost smacks of gender bias. Let me explain.

Like all other sexually transmitted diseases (STDs), HPV is transmitted from men to women and visa versa. Based on years of epidemiological studies, the only effective way to reduce the overall incidence of STDs is to implement strategies that prevent infections in both females and males. While boys and men can’t develop cervical cancer, they do contract venereal warts and perhaps, more importantly, can serve as carriers or reservoirs of HPV infection in the population. In other words, infected males (who may or may not show symptoms of HPV infection) still possess the potential to transmit it to sexually-active, unvaccinated girls and women. Consequently, while the incidence of HPV infections may begin to decrease among women after immunization, it will never be completely eliminated and the possibility of developing cervical cancer will continue to be a public health concern.

While the ACIP’s understanding of the transmission of STDs is tragically flawed, its willingness to publicly disclose cost effectiveness as a reason to not endorse HPV vaccination for males is even more egregious! The agency’s decision begs the question: Which is more costly; 10,000 American women developing cervical cancer each year (and countless others going for unnecessary cervical biopsies because of “bad” Pap smears) or a heads up to insurance companies that they ought to cover the costs of male HPV immunizations? 

The ACIP’s reluctance to recommend male HPV vaccination based on economic and health care cost concerns rather than on public health implications is yet another example of how broken the US healthcare system is and how drastically it needs to be reformed. Allowing 3,700 women to die each year in the US from cervical cancer when there is a safe and effective way to prevent these deaths is, in my opinion, unconscionable!

Until next time...

Good Luck and Good Job Hunting!!!!!

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Whenever I do resume critiquing at scientific meetings, someone always asks about how to negotiate a job offer.  Most of the people that ask the question aren't even close to receiving a job offer and I do my best to deflect the question.  However, at a recent meeting, I spent 30 minutes with a PhD student who had received an offer advising him on how to get a better deal from his prospective new employer.  This got me thinking and I invited Joe Tringali, a veteran recruiter with lots of negotiating experience to write a blog post about strategies and things to consider when negotiating a job offer.

The "Dos" and "Don'ts" of Negotiating a Job Offer

by Joe Tringali

Invariably, the topic of salary negotiations in the interview process makes its way to the surface and, as a seasoned professional recruiter, I have a few thoughts that I would like to share with jobseekers.  During the course of my almost 30 year career, I have work as a traditional “headhunter” and also as on onsite contract recruiter for pharmaceutical and biotechnology companies, shifting gears and mindset as warranted by the particular client and the task at hand. In other words, I have been on both sides of the negotiating table either on behalf of a job candidate or a client company.

Fundamentally, job seekers need to understand the “economics” surrounding their search; who—the candidate or employer—has the most leverage in the relationship? Is there more demand than there is supply for a candidate with a specific set of skills or is there an excess of talent allowing an employer to choose the absolute best candidate for job. That said, consider the following:

A candidate who has received an offer can always try to negotiate to see how far they can push  the employer. As a rule of thumb, the initial offer that is proffered is usually not the best offer and if you aren’t satisfied with it, try and negotiate for a better deal.  If you ask and you don’t get what you want, the initial offer will likely still stand but you won’t have any regrets or say to yourself “I should have asked” if you eventually accept the offer. On the other hand, if the offer IS negotiable, it’s most likely only negotiable within a finite range. To that end, you must “come to the table” knowing your worth and what the compensation and benefits standards are for comparable positions in the industry. Rest assured that the prospective employer is at least as prepared as you are (usually more so) when it comes to negotiating offers. After all, most companies have dedicated compensation departments that spend a good portion of their workweek establishing fair compensation ranges. This doesn’t mean that you shouldn’t ask and attempt to negotiate, but simply that you must temper your expectations and not “expect the world.” Typically, employers are limited with what is negotiable in an offer. Things that are typically not negotiable are base salaries and healthcare and financial benefits. Other things like vacation time, sign on bonuses, relocation costs etc are. The reasons why base salary and benefits are not negotiable are because companies try to maintain internal equity among its employees.

When to negotiate? The obvious answer is to negotiate from a position of strength—when a formal offer has been extended (but never before). The offer signals that a company “wants you” and the candidate ought to consider the offer as it stands. Assuming the offer is fair (and the candidate SHOULD know his/her worth as part of the search process), accept it and move on with your career. Should you feel it isn’t quite up to par based on your understanding of your skills and marketplace demand, you might consider a conversation that sounds something like the following:

“I’m thrilled to receive the offer and am trying to find a way to make this work for both parties. My understanding of the market ( from online research, university career services, friends with similar experience, in similar roles, in similar geography,  is that an offer of 2k more might be more in line. IF there is any way you can bump the offer up by 2K, I will accept it and start on XXX date”

In other words, you are offering something back (acceptance/start date) in exchange for a possibly bump in the offer (most companies want you to start sooner rather than later). The worst case is that the employer comes back and says they cannot do any more with regard to compensation. Depending upon your assessment of the situation, you might then try to negotiate additional vacation days or an increase in relocation costs to offset the $2K that you need to feel comfortable to accept the offer. If the answer is still no, the original offer stands until you either accept or reject it—the decision is yours. Generally speaking, most offers are fair and in the range you might expect given your background and years of experience in the industry. But, only you can determine whether or not an offer is right for you. Ultimately, that decision ought to be based on compensation requirements, job responsibilities, geography, and whether or not an offer will meet your needs at this particular time in your life.

Until next time...

Good Luck and Good Job Hunting!!!!!

Joe Tringali is a Principal with Tringali & Associates, Inc., a recruitment consulting practice based in Manchester, New Hampshire. He has over 30 years of progressive experience in the field of Human Resources and is particularly well-qualified in the design and implementation of creative staffing programs and executive search practices within the Life Sciences. Some his clients include Pfizer, Eisai Pharmaceuticals, Millennium Pharmaceuticals, Biogen Idec, Genzyme , TKT/Shire , Harvard University and Infinity Pharmaceuticals.

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I regularly watch Real Time with Bill Maher and generally agree with many of the political views and ideas that he espouses. In fact, I am a fan! However, his rant two weeks ago about the H1N1 vaccines, and vaccination in general, showed me that while politically astute and incisive he has absolutely no understanding about science and modern medicine (see video below). Making matters worst, his guest, former conservative senator Bill Frist, a surgeon by training, was ill prepared to correct and refute some of Maher’s outrageous assertions regarding the differences between the two currently available H1N1 vaccines and the basic principles of vaccinology.

Maher is quick to tell people that they are stupid when they don’t agree with his ideas or political views. And, he rightfully criticized George W. Bush for routinely making decisions about important issues based on “his gut feelings” rather than facts. Ironically, this is exactly what Bill Maher does when he talks to his guests about medicine and food. Maher, who may be a vegetarian and is clearly anti-traditional medicine,  is quick to point out that Westernized medicine and food production is profit driven and consequently, any information or advice offered by the US government is little more than a ploy to keep people sick and fat. In other words, don’t trust anything that the government tells you if you believe otherwise or you heard it from a celebrity. 

I suspect that science wasn’t Bill’s “cup of tea” (he frequently calls the tea baggers who don’t trust anything that the Obama administration tells them idiots and morons) and may have never taken anything he learned about science seriously. If he had, he might have learned how vaccines work and realized that modern vaccines (the first vaccines were produced in the 1780s) protect over 95% of people who receive them from devastating childhood diseases and even cervical cancer. Instead, he cites bogus and scientifically refuted claims about vaccine safety including mercury poisoning, links to autism and the miniscule possibility of developing Guerin-Barr Syndrome (which was first observed in large number of patients following vaccination with the 1976 Swine Flu vaccine). Shockingly, despite incontrovertible evidence to the contrary he continues to spew misinformation and flat-out wrong claims about vaccines. Ironically, his wrong-headed vaccine tirades are remarkably similar to those of the Birthers —people who refuse to believe that President Obama is an American despite incontrovertible evidence to the contrary—and racists who contend that Obama is a Muslim—two groups that he is quick to bash and dismiss as crazies and morons. In other words, Maher believes that he is right even though he is clearly misinformed or wrong!

Originally, I was going to write this post after Maher’s “Real Time” tirade about vaccines almost two weeks ago on Real Time. However, I relented but couldn’t help myself after reading an article in today’s Scientist Times about a pregnant woman who lost her second child after she contracted the flu. As many of you may know, pregnant women are very susceptible to influenza which could have serous consequences for the mother and baby. This is an exchange the woman had with a physical therapist with whom she was working to regain muscle control after being hospitalized (and near death) for almost 4 months:

“Have you ever read the labels?” she (the physical therapist asked). “They’re so full of toxins.”

Asked if she realized that a shot, had it existed in June, might have saved her client and her baby, she frowned and went back to her clipboard.

Are you kidding me—full of toxins? This is exactly what Maher was trying to imply during his anti-vaccine rant on Real Time. Unfortunately, millions of people listen to him and celebrities like Oprah, Dr. Phil and Maher and many believe (and blindly follow) their recommendations and advice. While this may not be a problem when talking about hair color, books to read or weight loss it is extremely troubling and dangerous when it comes to scientific and medical advice. The problem is that a vast majority of Americans are scientifically illiterate and are either incapable or unwilling to analyze and evaluate scientific or medical information on their own. This forces many people to rely on the Internet, government agencies and sometimes healthcare professionals to do their medical and scientific thinking for them. And when things go wrong, or not as advertised, they are quick to accuse the government or the healthcare industry of withholding information and engaging in nefarious conspiracies. This is exacerbated by the fact that science and medical reporting in the US is grossly inadequate, often wrong and frequently designed to be as sensationalistic as possible. Is it any wonder why the American public is often confused and misinformed about science and medicine?

My scientific training has taught me to analyze and evaluate all available data before I draw any conclusions on a topic. And, as an infectious disease expert I believe that childhood vaccines are unequivocally safe and effective. To that end, they have substantially reduced the morbidity and mortality associated with mumps, measles, diphtheria, whooping cough, pneumonia, tetanus, almost eradicated polio and eliminated smallpox from the planet. There is no doubt that there are risks associated with vaccination and that a small number of those vaccinated may experience some side effects or serious adverse events. But, the small risks associated with modern vaccines don’t outweigh the benefits and positive effects on billions of people who may have lost their lives if they hadn’t been developed in the first place. I wonder whether or not an anti-vaccine movement would exist today if smallpox and polio were still causing as much death, disfigurement and paralysis as they had prior to development of the smallpox and polio vaccines in the mid 20^th century.

In closing, as an American, I believe that everybody is entitled to their opinions and the right to freely express them. However, I implore Bill Maher get the FACTS right before summarily bashing a topic and making recommendations to the millions of people who watch Real Time and believe what he says. Otherwise, he is no smarter or better than the ignorant, close-minded, right wingers who he regularly trashes on his show.

Until next time...

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

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The Pharmalot Blog reported today that AstraZeneca offered all of it sales representatives—numbering 5,000-6,000—a buyout option. However, AstraZeneca prefers to avoid the term buyout and instead instructed its reps to ’self identify’ whether or not they want a package to leave the company. According to the post, an AstraZeneca spokesman declined to discuss how many reps it would like to shed, but did provide this statement:

“AstraZeneca is making changes to our sales force, which will be managed first by looking at vacancies and offering field sales employees the opportunity to self-identify whether they are interested in leaving the company. We will know the full scope of the changes in the coming weeks.”

Like many other pharma companies, AstraZeneca will lose $11.1 billion in patented-protected revenue by the end of 2012 and face stiff generic competition.

Pharma sales reps, like R&D scientists, have been facing tough times over the past three years or so. In the late 1990s, pharma companies hired massive numbers of reps, only to realize several years later, that increasing the number of reps didn’t necessarily translate into increase drug sales. The economic downturn, coupled with projected loss of revenues due to patent expiry of blockbuster drugs over the next few years, provided pharma with an opportunity to downsize. Finally, the growing use of web-based strategies to educate physicians, contract sales forces and a diminishing number of products led to the demise of the pharma rep as we know it.

My recommendation to downsized reps is to get some biotechnology training or device/diagnostic training and to try and leverage previous experience into sales jobs at biotechnology and devices companies. Both industries have enormous growth potential and the transition from pharma to them shouldn’t be all that onerous.

Until next time...

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

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Advances made in DNA sequencing technology and genomic analysis has lowered the cost of sequencing a genome from millions of dollars a decade ago to less than $500 today. And, because of this, there are a growing number of companies that are willing to quickly and cheaply sequence and analyze your DNA. While this may be medically beneficial and appealing to some, it may not be for everyone. Moreover, and perhaps more importantly, who will control access to and insure the privacy of your genetic information if you choose to have your genome sequenced and analyzed. 

Alan McHughen, PhD, a molecular biologist and Professor of Botany and Plant Sciences at the University of California-Riverside, who has previously written about privacy and access to personal genomic data, wrote an article for BioJobBlog that explores the ramifications and possibility of DNA identity theft in the future. Also, he has written a book 'Pandora's Picnic Basket; The Potential and Hazards of Genetically Modified Foods' to refute the myths and explore the genuine risks of genetic modification technology

Genetic Privacy

By Alan McHughen

For just $399 (plus shipping and handling), the scientists at 23and me.com will scan your complete genome. The DNA analysis reports on 118 different medical and health dispositions, your maternal and paternal ethnic ancestry, and a curious bunch of genetic trivia concerning your persona (is your earwax sticky or flaky?). All you do is pay the money and spit into a collection tube; they extract your DNA from the spit and look for half a million single nucleotide polymorphisms (SNPs) scattered throughout your genome, including many in or near genes associated with particular traits. Other companies offer similar services. For example, Decodeme.com charges $985, but catalogs twice as many SNPs, and you collect your DNA with a cheek swab.

Alternatively, if you don’t need the complete genome scan but are curious about specific medical conditions or family lineage, you can get less expensive gene tests from an increasing number of companies willing to take your money and DNA sample in exchange for the genetic information their scientists reveal. If heart disease runs in your family, you may either relieve or exacerbate your anxieties by shelling out $200 to have a cardio scan for relevant genetic predispositions. Or, for as little as $99, a man can have his Y chromosome probed to confirm his place in the family patrilineage, and possibly connect to ancient and famous princes or pirates.

These genetic information services, with prices now well into recreational and hobby budget range, provide the most personal, private — and unchangeable— information possible about you. The sinister side of this fascinating field is all too often overlooked—it can reveal your most intimate genetic details to strangers and nosy neighbors. While the various testing labs assure confidentiality, there is little to no control over personal genetic information. In the US, anything you discard is salvageable by anyone else, and your trash can become another’s treasure if it carries blood, saliva, hair, semen or any other DNA-laden bodily secretions.

While we worry about identity theft, personal financial or other private information, our uniquely personal information is up for grabs. The Genetic Information Nondiscrimination Act (GINA) of 2008 offers some protection, but it is limited to employment and medical insurance issues. GINA does not protect your genetic information from being abused by life insurers. Or nosey neighbors. 

Genetic privacy raises a whole spectrum of social, ethical, legal and medical issues. Suppose your neighbor salvages your trash and has your DNA analyzed. This local gossip then shares the juicy news that you have a “higher than average predisposition” to, say, alcoholism. Soon, everyone in the community shuns you as a latent alcoholic, and you have no idea why. The community knows more about your genetic makeup than you do. And, because they don’t know how to interpret statistical language such as “a higher than average predisposition”, those conditions may easily be exaggerated into probabilities, if not certainties.

If people have a right to know their own genetic information, they have the obverse right to NOT know. People can choose to remain ignorant about their genetic makeup. Consider, for example, Huntington’s disease (HD). This death sentence is one of the few health conditions almost due to genetics, and the DNA assay has been available for years. Curiously, most people at risk, i.e., those with HD in their direct lineage, choose NOT to take the test; they prefer not to know until (or if) symptoms appear. What happens when the local busybody lets the cat out of the bag on HD? Word will get around and the at-risk person will inevitably find out, if only by the ‘different’ treatment by neighbors, thus obliterating the exercise of their right to remain ignorant. Whether the test result is positive or negative on HD is immaterial at this point, the rights will have been violated. The DNA test for HD is currently more elaborate than the simple SNP analysis, but because SNPs associated with HD are being reported, it’s only a matter of time before they come generally available.

Perhaps you’ve suspected the woman down the street had a child from an adulterous one night stand a few years ago, and the cuckold husband remains a doting, if clueless, dad. Now, with just $89 (including overnight FedEx delivery!) and a little misdemeanor creativity, well within the standard ethical bounds of busybodies, you can satisfy your suspicions with a surreptitious and discrete paternity test. And, to provoke some real excitement in your sleepy small town, show the results to the husband.

A few minutes of thought and discussion generates many other issues and examples of the precarious security of personal genetic information and identity, and the potentially dire consequences of genetic information getting out. Society is yet to discuss the privacy issues surrounding genetic identity as vigorously as we have with personal financial or medical records. It’s getting late. Do you know where your DNA is?

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The fourth quarter is over, earnings are being announced and new budgets for the upcoming fiscal year are being evaluated and tweaked. This means that we have officially entered layoff and closure season. Isn’t it great that big companies wait until right before the holiday season to let employees know whether or not they will have a job next year?

That said, two companies, Bristol Myers Squibb (BMS) and Pfizer/Wyeth are the first to kickoff the 2009-2010 season.

BMS announced that it will lay off 25% of its Abilify sales force. This comes only six months after the drugmaker extended its contract with Otsuka Pharmaceutical to market the anti-psychotic and depression drug. Abilify is BMS’s second best selling medication after Plavix that is co-marketed with Sanofi-Aventis. Otsuka developed the drug and BMS markets and distributes it in the US and several European counties.

Abilify loses patent protection in 2012 and faces stiff generic competition in the anti-psychotic and depression markets. A BMS spokesperson declined to say exactly how many reps would be losing their jobs. However, according to a post on the sorely missed and recently resurrected Pharmalot blog there is speculation that Otsuka may hire some of the layed off BMS reps.

In other news, Pfizer/Wyeth announced that it will be closing its facility in Bridgewater, NJ but expanding operations at its Peapack-Gladstone, NJ location. The Bridgewater facility employs 300 people, 100 of which are involved in technology.  The company announced yesterday that it wouldn't be shutting down Wyeth's Collegeville, PA headquarters.

Over 120,000 employees have been laid off by pharma companies in the past three years, many of whom lived and worked in New Jersey.  Unemployment in NJ is hovering around 10%.

Stay tuned for more updates.

Hat tip to Ed at Pharmalot

Until next time...

Good Luck and Good Job Hunting!!!!!

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Without fanfare, GlaxoSmithKline (GSK) quietly announced today that the US Food and Drug Administration (FDA) granted approval for CERVARIX® [Human papillomavirus bivalent (types 16 and 18) vaccine, recombinant] for the prevention of cervical pre-cancers and cervical cancer associated with oncogenic human papillomavirus (HPV) types 16 and 18 for use in girls and young women (aged 10-25).

It has taken GSK over three years to garner US regulatory approval for CERVARIX® which has been approved and used in over 100 other countries in the world. Early "unspecified concerns" delayed approval and, as recently as two weeks, FDA delayed a decision despite recommendations from an advisory panel to approve the vaccine. Coincidentally, a week before the agency was expected to announce approval for the vaccine, a British girl died after she was vaccinated with Cervarix. While FDA spokespersons claimed that the girl’s death following vaccination had nothing to do with the delaying a decision on Cervarix, many industry pundits believe that the FDA was reluctant to approve the vaccine in light of the sensational media coverage in the UK surrounding the incident. After an autopsy was performed on the girl, British authorities announced that a massive cardiac tumor that had infiltrated one of her lungs, not Cervarix was responsible for her death.

Today’s approval of Cervarix provides American consumers with an alterative to Gardasil, Merck’s cervical cancer vaccine that was approved about two years ago. That said, the ability to protect girls and young women from the possibility of developing cervical cancer is more important than which of the two vaccines is used to induce immunity. I plan on immunizing my daughter when she is old enough!

Until next time...

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

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In a previous blog post, I suggested that there was much speculation about whether or not there would be substantial job losses at the various Wyeth sites throughout Pennsylvania after the Wyeth-Pfizer merger closes. As you may recall, company representatives were assuring Pennsylvania legislators that major job cuts and site closure weren’t likely. 

Yesterday, Bernard Poussot, president of Wyeth Pharmaceuticals, sent a message telling employees the company’s Collegeville Headquarters, which employs about 4,000 people, would remain open after the deal closes on October 15, 2009. The fate of employees at other Pennsylvania-based Wyeth facilities remains uncertain.

While this may be good news for some employees at the Collegeville site, it is likely that a substantial number of jobs will be shed after the deal closes. Previously, Pfizer suggested that the combined company intends to shed about 20,000 jobs. I guess the good news is that all 4000 Wyeth employees won’t be losing their jobs!

Until next time...

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

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I don’t want to brag but I have been touting career options in health informatics and health information technology (HIT) for the past year or so. Today, I came across a post by CareerBuilders declaring health informatics and HIT are the hottest new career trends to hit the market in recent years. 

As the drive towards digitizing medical and healthcare records continue, there will be literally thousands of job opportunities for people with the right skill sets. Getting a nursing degree is one of the steps to achieve a great career in health informatics!

Health informatics will put technology in place that provides hospitals and other health-care providers with access to an electronic network of vital patient information such as like medical histories and prescriptions. The information age finally meets healthcare administration.

The facts
The health informatics initiative won’t succeed unless employees — that’s you! — bring the specialized skills needed to build and expand the network. All other pieces are in place:

• The American Recovery and Reinvestment Act of 2009 includes $20.6 billion to help providers drive adoption and development of the IT infrastructure needed
• The U.S. Bureau of Labor Statistics (BLS) projects health information management employment to grow nearly 18 percent by 2016
• The BLS projects a need for more than 6,000 new professionals each year through 2014 — but only 2,600 graduates have entered the field this past year 

Your opportunity
To succeed, health informatics (HIM) will demand a wide variety of specialized positions across IT and health care. It will engage conventional experience from both areas — such as registered nurses and LPNs/LVNs, or IT implementation specialists and IT project managers — if you’re looking for a new twist on your current career.

But new positions will also thrive in this hybrid field. Look for new HIM job titles in your next job search, like health IT professionals, HIM coders, HIM medical records professionals and various health informatics specialists, including trainers, researchers and analysts.

Get online to check out the job titles mentioned above and listed below for related descriptions, and see if you might need any additional training to meet requirements: 

Nursing
- Telemedicine clinical professionals

- Chief nursing information officers

- Clinical IT liaisons 

Again, getting a nursing degree is one of the steps to achieve a successful career in health informatics

Health-care administration
- Medical and health services managers

- Document scanners

- Data entry clerks

- File clerks

IT specialists
- Senior programmers

- Senior clinical analysts

- Database analysts

- Developers

- Business analysts

- Software engineers

- Data integration specialists

Not too shabby of a list! In a previous blog post I identified a variety of training options for people interested in pursuing careers in health informatics and HIT. Check it out!

Until next time....

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

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An annual survey conducted by Science magazine and the American Association has identified the 2008 top twenty life sciences employers in the world. The rankings were based on a company’s leadership, stability, social responsibility and treatment of its employees. Six of the top 10— Genentech, Gilead Sciences, Genzyme Corp., Schering-Plough Corp., Gilead Sciences are based in the US whereas the remaining four—Boehringer Ingelheim, Roche Pharmaceuticals, EMD Serono, and Millennium are headquartered outside of the US. For the first time, eight of the top 20 are located outside the United States.

In case you were wondering, Genentech was ranked number 1. This is the fifth time out of the past 6 years that the San-Francisco based company made it to the number one slot (it fell to second last year). Another notable is Massachusetts-based Genzyme which made it to the number 3 spot (out of 575 companies) for the second consecutive year. Surprisingly, Monsanto, the company that makes genetically modified seed crops, was number 2—this despite all of the negative press about genetically modified foods. Let see whether or not Genentech can retain its number 1 ranking after the Roche takeover of the company is completed.

Until next time....

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

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According to a report yesterday, Roche is reducing headcount at San Francisco-based Genentech by merging the information technology departments of its pharmaceutical and diagnostics divisions. The company didn’t disclose how many people would be losing jobs as a result of the consolidation.

The company previously merged all of its human resources functions and roughly 20% of HR personnel lost their jobs—although most were able to find new jobs within Roche.

A Roche spokeswoman added that the company will continue unifying its communication processes in an attempt to further reduce the size of its workforce.

Expect more announcements from Roche in the coming months.

Until next time...

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

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I have refrained from commenting on healthcare reform until now because there wasn’t much I could add to the debate. That said, while reading an article in a local paper on bacterial antibiotic resistance and how to minimize it, the author—an infectious disease doc—offered a telling statistic that identified the root problem with our current healthcare system. According to the article, 65% of the time, physicians will prescribe antibiotics to patients suffering from upper respiratory tract infections who demand them, whether or not they are warranted. In marked contrast, 12% of patients with upper respiratory tract infections who don’t ask for antibiotics receive antibiotic prescriptions. The bottom line: physicians give patients the drugs and treatment they demand because they are afraid of losing them as customers knowing full well the patients will go to another physician who will give them what they want! After all, physicians are in business and to stay in business they need to make enough money to cover their overhead and make a profit. However, over prescribing antibiotics is one of the main reasons why we are in the midst of an epidemic of infections caused by multiple drug resistant bacteria. In my opinion, business outcomes should never supersede or trump medical or public health outcomes.

Don’t get me wrong, I am an entrepreneur and believe that people with good ideas ought to be rewarded for their efforts and make as much money as they can. However, in my opinion, for profit business practices and healthcare haven’t historically worked well for the American healthcare system. Removing profit incentives from healthcare would be an important first step to begin to repair our broken healthcare system. Can anybody say public option?

Until next time...

Good Luck and Support the Public Option!!!!

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The answer to this question is not yet! However, the The Wall Street Journal recently reported that 64% of U.S. physicians are using smart phones (up 50% from two years ago) and increasingly are relying on them to find medical information, manage patients and transmitting clinical data. To that end, a post at the Medical Translation Insights blog discusses the changing role of smart phones in healthcare and the regulatory challenges they may face if classified as medical devices.

 When Cell Phones Become Medical Devices

The definition of "medical device" is shifting, quickly and dramatically.  The revised MDD now includes stand-alone software in the definition. In other words,if software has a medical purpose, it probably can/must be CE marked. And smart phones are quickly becoming the conduit of choice for collecting and researching, disseminating, and evaluating clinical data.

As Bob on Medical Device Software points out, its unique user interface, display, and broadband capabilities make the Apple iPhone a particularly attractive platform for medical applications. For example, the AirStrip OBSERVER suite of applications is custom-designed for the iPhone, makes some components available for download at the Apple App Store, and received FDA clearance for some modalities.

While most medical apps fall into the reference category, applications are getting more sophisticated and are taking advantage of the devices networking abilities. A trio of applications developed by researchers at the University of Utah aptly demonstrate these advances. Another factor is the appeal and widespread use of these devices. The Wall Street Journal reports [login required] today that 64% of U.S. physicians are using smart phones.

There are several big questions and unknowns hanging over these developments: First and foremost, there is the question of data security. As quoted in the same WSJ article, Deborah Peel of Patient Privacy Rights worries that "the vast majority of health information technology has not been designed to ensure that patients control access to that data and use of that data". So, paradoxically, the more ways that doctors can access patients' records, the more their confidentiality is threatened.

Second, what is the quality threshold for smart phone applications? Just because something is on the iPhone doesn't mean it's necessarily a quality application

Regulators around the world are bound to tackle these questions. FDA, for instance, is already looking at this issue and sooner or later will regulate certain phones. It's certainly not the end of the world to be classified as a medical device, but verification and validation of these applications won't be easy.

 As these applications get developed and become part of a networked medical device, language will also become an issue again. Translation service providers will need to become familiar with smart phone development and localization issues and support consistently translated content across multiple platforms and media.

Until next time...

Good Luck and Good Job Hunting

ForeignExchange Translations provides specialized language services to pharmaceutical and medical device companies

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In a previous post I lauded health information technology (HIT) aka health informatics as a possible new career choice for scientists with life sciences PhD degrees who also have a proclivity for software development and data base management. Shortly after I posted the piece, I happened to read an article in a local publication about a NJ-based company called the MISI Company that is at the forefront of the HIT field and developing software to help digitize American healthcare records. 

I invited Dave Roth, an MISI executive, to share his views on the future of HIT and what ought to be done to insure that e-medical records are appropriately and successfully created. BTW, for my bioinformatics and genomics friends, MISI is looking to hire a few talented men and women who are interested in HIT careers.

HIT: The Other Missing Link

by Dave Roth

Health information technology (HIT) is hot. There’s every reason to believe that HIT will play a major role in the reforms envisioned for our health care system. From President Obama announcing $5B in grants to aid medical research, to bioinformaticists developing tools for predicting genetic predisposition to diseases, to software developers working on electronic medical records (EMR) systems, HIT is a burgeoning field. What concerns people like me – read: people who are users of technology rather than the developers of it – is that all this HIT talk seems to have very little mention of us in it.

Not long ago, I wrote an article called The Missing Link in Healthcare IT: The Consumer. In it I pointed out that none of the current government definitions being proposed for "meaningful use" of electronic medical record (EMR) systems define meaningful from the healthcare consumer's perspective. I also noted that whatever rules the government establishes for receiving stimulus money for the development of HIT solutions, none of them will exclude technologists from collaborating with consumers in the development of their solutions. I posited that technologists would be doing us all a favor if they would stop to consider for a moment how their systems will affect the consumer’s experience of health care services.

I was encouraged when David Goldhill, in his cover story in the September 2009 issue of Atlantic Monthly, How American Health Care Killed My Father, wrote, “[A] guiding principle of any reform should be to put the consumer, not the insurer or the government, at the center of the system.” Goldhill’s prescription for a better health care system begins with advocating for the consumers of services and focusing on how to get the best outcomes for those consumers at a reasonable cost. He was channeling the views of many people, such as Harvard Business School professor Regina Herzlinger, who believe consumer-driven health care is the only reform that will truly be meaningful.

The growing visibility of the consumer in this debate has gotten me to thinking there is real opportunity in the HIT job market for another missing link: Consumer-centric Health IT Developers. It is a rare developer who brings to his/her craft an appreciation of the importance of understanding who you are developing for. Rarer still is the developer who is aware of and employs tools and techniques for capturing end-users’ feedback during the development process. More often than not, user-centered design (UCD) is considered a luxury that burns up time and precious dollars. This misconception is largely the result of development teams typically waiting until they are too far into the development cycle before engaging with those who will be using their creation. Inevitably, problems are discovered with the usability or utility of the system that will hinder adoption. But the problems are discovered too late to be fixed by the target launch date and/or within budget. Users/Consumers become the enemy in this scenario.

There is another way. HIT technologists should understand how and why to engage their target audience at the beginning of the development process, long before anything is actually developed. They should begin by understanding who they are developing for, what these people are looking to accomplish, and how they can best help them accomplish it. Using such techniques has been shown to actually reduce downstream development work and increase adoption. I believe technologists schooled in the techniques of consumer-centered design will be central to any successful, long-term health care reform.

Dave is Vice President and  heads MISI Company's Experience Design (XD) group - a group of strategists, experience architects, visual designers and technologists whose mission is to help ensure the success of every interaction between a business and its target audience. His career spans 30 years and includes award-winning work in documentary and corporate film/video, print advertising, and interactive software application development for computers and the Internet. Dave is a Stanford University grad, a SF 49ers fan and a member of the Single Malt Scotch Whiskey Society.

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I came across a recent post on Adage.com entitled “Pharma Drops Search Advertising After FDA Warning” that revealed that paid search ads by pharmaceutical companies dropped a 84% between March 26 of this year and the end of June. As you may recall, March 26 was when 14 companies received warning letters from the US Food and Drug Administration (FDA) indicating that they had violated marketing guidelines for search ad advertising. The letters stated that sponsored-link advertisements for specific drugs were misleading due to the exclusion of risk information associated with the use of the drug -- even though the regulatory agency's guidelines are for print and broadcast, not online or social media. Pharma companies that believed they were in compliance with the unwritten "one-click rule"— taking the consumer from the ad to a site that offered fair balance and the risk information by clicking on the ad. What? Did I read that correctly; the words “unwritten and FDA” in the same sentence? This is very surprising since anybody who has worked with the agency is well aware of the “if it isn’t written it didn’t happen” principle. But I digress....

The post went on to say that pharmaceutical companies are “fearful of running afoul” of the agency again. Say what? The words “pharma and fearful” used in the same sentence? The point that I am trying to make is that pharma chose to keep things vague about web-based advertising to see how far they can push the envelope with FDA instead of taking the proverbial “bull by the horns” and directly asking FDA for guidance on web 2.0 technologies and their uses. Wouldn’t it be in everyone’s best interest if companies took a more active role to help craft new rules on the use of new media technologies rather then rely on and wait for FDA to do it for them? While the old “cat and mouse” game worked for old media, it is no longer tenable when it comes to Web 2.0 and related technologies.

The FDA is holding public hearings next month to begin the process of establishing internet advertising guidelines and the use of social media in the life science industry. This offers drug and devices companies an opportunity to show FDA that they no longer want to be part of the problem but part of the solution.  I have always subscribed to the notion that “you don’t get if you don’t ask!”

Until next time...

Good Luck and Good Surfing (on the Internet that is)

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For the first time in history, more people are searching the Internet for health information than asking doctors. Web 2.0 and social media tools are allowing people to discover new ways to connect, learn and engage one other in search of healthcare and drug information.

e-Patient Connections 2009 which will be held in Philadelphia, PA on  October 26 and 27 will feature a number of leading authorities on social media and digital health  Some of the featured speakers include Wired Magazine’s Thomas Goetz, Jay
Bernhardt of the CDC, and Lee Aase of the Mayo Clinic. The conference also offers case studies, 1:1 coaching sessions with industry experts and the latest products from digital health companies.

BioJobBlog readers can use the discount code kru500 to save $500 off the current price.

See you there!

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The bad news is that the US unemployment rate is close to 10 percent. The good news is that the government is looking for scientists at FDA, NIH, USDA, CDC, EPA and other agencies. For those of you who haven’t applied for a government job, the process can be daunting and overwhelming. To alleviate some of the pain, Cyndi Fischer, MSA at the BioCareer Center has written a post on the salient features of filling out a job application for a government job!

Capturing Your Worth in a Government Job Application 

You’d like to consider government employment but are not sure where to start. You know the government has a generous compensation and benefit plan, can offer long term employment stability, and in most cases its employees do not need to seek research grants or funding to continue their rewarding scientific work. Sounds like a dream, so why haven’t you applied? Perhaps you’ve heard that it’s hard to get a government job, that the hiring process is mysterious, slow and a confusing maze of information. While some of those concerns are valid some of the time, government employment has such positive benefits it is indeed a career path you don’t want to overlook. The most important thing to remember about applying for a government position is that all the items that appear to be drawbacks to you in the application phase, are really set in place to ensure that the most qualified candidate, hopefully you, will get the job!

So what do you need to know to ensure that you have the best shot at being considered for a coveted research position within the government? First you must apply to a vacancy announcement published by the government in order to be considered, and subsequently offered employment. Almost all government entities now use an automated system to post vacancy announcements and receive applications. The most widely used website to post vacancy announcements is USAJOBS.opm.gov. Once you have established an account on the site and placed your resume in the space available, you are ready to apply for any vacancy announcement you would like. Be keenly aware though, this is where attention to detail separates the candidates to be interviewed from the resumes in the scrap pile. The government hiring system revolves around merit. Specifically, the candidate who has the most knowledge, skills and abilities (KSA) to be successful in the vacant position should be offered the job, as the desired KSA’s for an opening are derived from the position description itself. Your role is to ensure that you capture your KSA’s as accurately as possible so that you are considered for the positions you are most qualified to hold.

If KSA’s are the key to government employment, how do you ensure you include everything that needs to be considered? In many cases this will be easy to discern as the vacancy announcement will list specific KSA questions prompting your response. If there are questions that seek specific answers, it is a requirement that you answer them or your application will not even be considered. In the event there are not specific questions presented, you must ensure you cover the likely KSA’s for that position within the body of your resume. Knowing what the KSA’s are for the position being advertised is one

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There was an interesting post today at the Seattle, WA-based  Xconomy.com website about the salaries of people who work in the biotechnology industry. The post mainly focused on the salaries of biotech workers in the Pacific Northwest and based on results of a local survey the median salary is roughly around $60,000 per year. While this pales in comparison to the $81,499 reported earlier this spring from a group sponsored by the Pharmaceutical Research and Manufacturers Association (PhRMA), it is important to note that “real salary” data are difficult to obtain and much of what is released is based on salary figures that don’t include bonuses and other benefits. Further differences survey methodologies may also account for the seemingly disparate results. Nevertheless, salaries in biotech are generally better than those offered in other science-related industries and, not surprisingly, are highly dependent on degree requirements and job duties and responsibilities.

The bottom line: in my opinion, a job in biotech is a good career choice because of the projected upward growth for the industry. More importantly, pharma is continuing to abandon its reliance on small molecules and increasingly embracing biotechnology and its products as the future of the life sciences and healthcare industries. If I was undergraduate life sciences major today, I would be looking to the biotech and medical devices/devices industry, not pharma, for future long term employment!!! And, contrary to popular belief, a PhD degree is no longer a requirement for many biotechnology jobs.

Until next time...

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

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My son, who is a 9^th grader, was recently asked to write an essay for his social studies class about the application of Machiavellian principles to modern day rulers and governments. One of Machiavelli’s ideas that he chose to write about was the notion that a good ruler or government must do it’s very best to insure the safety and health of its subjects or constituents. While this may seem altruistic or philanthropic don’t be fooled—workers who are afraid, unhealthy or regularly ill aren’t productive and can threaten the economic well-being and stability of a society. In any event, he asked me to help with a modern day example of how safety can be reconciled with the Machiavellian principle; “the end justifies the means.” As an infectious disease professional, I quickly realized that mandatory vaccination of newborns and school-aged children against viral and bacterial diseases is a great example.

Prior to the development and subsequent worldwide use of childhood vaccines, epidemics and pandemics of smallpox, measles, polio, diphtheria and other serious diseases routinely ravaged the planet with impunity. During the recurring outbreaks, large numbers of people became ill, and while some sustained life-long debilitating injuries, many others suffered long, painful and excruciating deaths. The recognition that often devastating and regularly occurring outbreaks and epidemics could threaten the well being— and possibly destabilize monarchies and democratically elected governments—  led to the development of  20^th century vaccines against many bacterial and viral childhood diseases. However, it is important to note, while most vaccines are safe and offer protection for many individuals (typically 90% or higher), a small percentage (usually 1% to 5%) of those vaccinated, may experience side effects ranging from mild to severe and possibly life threatening. I believe that vaccination is a polemic for the “ends justify the means” principle because while some vaccinated individual may suffer serious side effects or death greater numbers will benefit from the protection and safety afforded by most vaccines. In other words, governments must be willing to risk harm and possibly death to some of its citizens to insure the productivity, well being and ultimately the safety of the majority.

Despite the medical and health benefits of vaccines, the anti-vaccine movement in the US has steadily been gaining strength of late. Vaccine opponents’ fears have been stoked and promulgated by bogus clinical data offered by fraudulent scientists (which have subsequently been discredited and refuted) and media outlets seeking sensational stories to sell magazines and newspapers. Last week, a 14 year old British girl died shortly after being vaccinated with Cervarix, GlaxoSmithKline’s (GSK) cervical cancer vaccine. This story was quickly pounced upon by the British tabloids and widely circulated.  In the end, the safety of the Cervarix—a vaccine administered to 1.8 million girls without a single death similar to the one that had occurred—became suspect. Almost immediately, anti-vaccine advocates publicized this unfortunate incident as another other reason why parents shouldn’t vaccinate their children. The girl’s death prompted UK officials to immediately suspend all nationwide Cervarix vaccinations; even though an autopsy hadn’t been performed to determine the actual cause of the girl’s death. After an autopsy was finally performed, British health officials announced that the girl had a large cardiac tumor that had infiltrated one of her lungs and that it was likely cancer not Cervarix that caused her death. Unfortunately, the media’s feeding frenzy fanned by the anti-vaccine lobby’s loud voice may have cost GSK US FDA approval of  Cervarix—a product approved and safely used in over 100 countries! 

About three weeks prior to the British girl’s death, an FDA advisory committee unanimously recommended approval of Cervarix. Generally, the agency follows recommendations of its advisory committees. Ironically, the girl’s death occurred several day’s prior to an FDA decision on whether or not to approve Cervarix. Much to the surprise of many industry experts, this past Tuesday, FDA delayed its decision on Cervarix’s approval. FDA spokespeople claimed that the girl’s death had no bearing on its decision to delay Cervarix’s approval (if you believe that, would any of you be interested in some land in Florida?).

It is no secret that GSK has struggled to get Cervarix approved in the US —a decision on its approval has been delayed three times over the past several years. In the interim, the company has managed to successfully address all of the agency’s concerns over Cervarix’s safety and efficacy.

FDA’s decision to delay Cervarix’s approval is great news and something of a victory for Merck, the manufacturer of Gardasil— the ONLY cervical cancer vaccine approved in the US and Cervarix’s main competitor. Failure of Cervarix to win FDA approval will undoubtedly help Merck to bolster Gardasil sales and help it maintain its stranglehold on the US anti-cervical cancer market for the foreseeable future!

Until next time...

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

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Allergan, the maker of Botox and Latisse sued the US Food and Drug Administration (FDA) in federal court yesterday because it believes that regulations banning off label promotion of prescription drugs violates the company’s right to freedom of speech and impedes its ability to provide physicians with information regarding patient safety.

The company contends in a lawsuit filed Thursday that it should be able to educate doctors about the risks and benefits of using treatments for unapproved uses. Botox is approved for several uses by the Food and Drug Administration. In addition to its use as a wrinkle treatment, it is approved for eye muscle disorders and excessive underarm sweating. But physicians often use it for unapproved, or off-label, indications including muscle-spasm conditions.

The impetus for the lawsuit is an FDA requirement that the company provide new risk information education to physicians on Botox as a therapeutic treatment. According to an Allergan spokesperson, "Our reason for seeking action now relates to the fact that we have recently been required by FDA to initiate a REMS (Risk and Mitigation) program for Botox to ensure that physicians are equipped to evaluate the risks and benefits of treatment." In April, health officials warned doctors and patients about potentially deadly risks of using Botox and similar drugs for unapproved uses to treat certain types of muscle spasms. The drugs carried risks of rare botulism symptoms, particularly when given to children to help relax uncontrollable muscle movements.

Allergan estimates that 20% of Botox usage is off-label for unapproved indications. Because of this, the company believes that it is important to “proactively provide comprehensive information to physicians about these off-label uses, such as dosing guidelines, patient selection criteria and proper injection technique to ensure that physicians are equipped to treat patients as safely and successfully as possible. And, “without judicial relief, Allergan is unable to engage in a truthful and relevant information exchange with the medical community for fear of prosecution." 

It sounds to me like the lawsuit is more about increasing the annual sales of Botox for a growing number of unapproved indications rather than ensuring patient safety. These types of lawsuits have becoming increasingly popular because of previous legal precedent that extends an individual’s right to freedom of speech to corporations and other entities. However, more importantly, if Allergan is successful, it could signal the end of the regulations and ban on off label promotion of prescription drugs and devices. Is eliminating a few wrinkles from aging baby boomers (like me) worth all the trouble?

Until next time...

Good Luck and Good Job Hunting (hmm...maybe if I look younger I might be able to find a job?)

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