The Biotechnology Industry Keeps on Getting Smaller: Celgene Buys Abraxis Biosciences for $2.9 Billion

The recession is clearly taking its toll on the biotechnology industry and continues to force it to consolidate. Today, Celgene announced that it would purchase Los Angeles, CA-based Abraxis Biosciences, Inc for $2.9 billion in cash and stock to expand its cancer drug pipeline. The company hopes to "re-energize" sales of Abraxis' only approved drug, the breast cancer treatment Abraxane, and also win approval for Abraxane as a treatment for skin, lung, and pancreatic cancer.  Sales of Abraxane began to tank after Astra Zeneca terminated a marketing agreement with Abraxis in 2008. Abraxane is an injectable medicine that is approved to treat breast cancer in patients who have failed all other treatment options.

New Jersey-based Celgene, the maker of Revlimid (multiple myeloma, and one type of the bone barrow disease myelodysplastic syndrome) and Vidazas (acute myeloid leukemia and five types of myelodysplastic syndrome) expects to seek approval of Abraxane as a treatment for lung cancer early next year. Celegene also sells Thalomid, a modified version of thalidomide, to treat mutliple myeloma and certain forms of leprosy.

Abraxis Biosciences employs about 900 people. While no layoffs or job cuts were announced, don’t be surprised when they happen shortly after the deal closes later this year.

Until next time...

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

 

The Secret Life of Bees Revealed

When I was an undergraduate pre-vet student at Cornell, I took a course called “Introduction to Bee Keeping.” In Cornell parlance this was a so-called gut course: one that you took because it was easy to get an A grade. The course was taught by a professional beekeeper named Roger Morse who kept his bees in Ithaca during the Spring/Summer in Florida during the winter. At that time, price of honey had nearly tripled (it was during the counterculture days) and beekeepers were living large. As is often the case, this “gut course” was one of the most fascinating and best courses that I took at Cornell and it provided me with a life long appreciation and respect for honey bees.

The reason for this soliloquy is that in today’s New York Times there was an article that described how the German government is using honeybees to assess the levels of air pollution in and around several major municipal airports. This is accomplished by analyzing the honey produced by bees maintained in hives near the airport for environmental toxicants like hydrocarbons and heavy metals. Honey produced by the airport bees is compared to honey produced by bees in hives in less industrial areas as a means of comparison. Preliminary data suggest that the airport honey “was comparable to honey produced in areas without any industrial activity.” However a German official indicated that “a much larger data sampling over more time is needed for a definitive conclusion but preliminary results are promising.”

The bees are maintained by local bee keepers and the honey (once deemed environmentally sound) is given away as gifts to airport travelers. While biomonitoring using bees doesn’t replace traditional methods of analyses for environmental pollutants German officials contend that “it’s a very clear message for the public because it is easy to understand.”

Jamie Ellis, assistant professor of entomology at the Honey Bee Research and Extension Laboratory, University of Florida in Gainesville said “We all believe it can be done, but translating the results into real-world solutions or answers may be a little premature.” Still, similar work with insects to gauge water quality has long been successful. Who knows; maybe honey bees can be used as modern day biological sentinels of pollution similar to canaries in coal mine that were used to detect toxic gases. 

Regardless of their use, honey bees are still fascinating and cool in my book. And, because of the beekeeping course that I took 36 ago, I can confidently tell my children that the insects that are bothering them are not bees but wasps!!!!!!!!

Until next time...

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

 

BioJobBlog Teams with Career Management Source to add a Career Center to Promote Real Time Life Science Jobs

BioJobBlog and Career Management Source, a producer of online applications for streamlining job searching and hiring, have teamed to create BioCareers, a life sciences job board and career center. For job candidates, BioCareers offers real time job listings, application tracking, and e-mail job alerts. Employers can post jobs, advertise jobs, search resume databases and have jobs listed on other jobs like Job Job-Job Health and Twitter jobs. 

The search engine that powers BioCareers automatically pulls life sciences jobs in real time and updates job searches when positions are filled or new ones become available. Candidates can search for jobs by location or job title. One of the nicer features of BioCareers is candidate e-mail alerts when new jobs are posted or added in real time by the search engine.

I have been looking for a dedicated life sciences jobs search engine and career management solution for the past 10 years. I stumbled upon the Career Management Source platform quite by accident but I am glad that I did. And, the best part of the deal was that I didn’t have to do any of the work—the design, setup and implementation was completed by Career Management Source representatives.

You can test the BioCareers search engine capabilities by conducting a job search using the widget found in the BioJobBlog sidebar (look left). If you are interested in viewing and checking out the BioCareers website please click here.

For those of you, who may be interested in adding a career center to your blog or website, please visit www.JobJobHealth.com or e-mail Career Management Source or call 888-865-8914.

Until next time..

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

 

Summertime Blues

Summer has finally arrived and everyone I know is kicking back, looking forward to their previously planned vacations and enjoying their four day (summer hours) work week. While many folks still have jobs, the unemployment rates are not dropping as quickly as anticipated and large numbers of layed-off and right-sized former life sciences employees are still without jobs. 

I recently checked the BioJobBlog archives and quickly realized that I have written close to 100 posts on how to craft an industrial strength resume, conduct a job search, prepare for a phone or face-to-face job interview, network and negotiate a job offer. To that end, I thought it might be informative and constructive to resurrect some of these older posts and re-assemble them into a thread that describes each step of the job hunting process. Also, as many of you may know, I was recently sued by an odious individual for invasion of privacy and defamation because I exposed her alleged illegal dog breeding and puppy mill ring. 

Consequently, much of my free time over the next two weeks will be spent on the case. That said, I will begin posting daily job hunting tips and advice on July 5, 2010.

I hope that my readers find this series useful. Also, I would like to hear from those of you who despise and abhor persons who mistreat and abuse animals and are willing to help me put my accuser out of business for good!!!!!!!!

Until next time...

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

 

Pharmaceutical Markets: Sex, Drugs (Quality of Life) and Rock n' Roll

The Internet and print media were buzzing this past week about the decision by a US Food and Drug Administration (FDA) panel of expert medical reviewers to not recommend approval of Boehringer Ingelheim flibanserin; a new medication to treat female sexual dysfunction or perhaps more apt lack of sexual interest.

Flibanserin was originally developed as an antidepressant but while it failed to treat depression women who participated in clinical trials reported increased sexual interest. The lack of drugs to treat female sexual dysfunction propelled Boehringer to continue to develop flibanserin to treat low libido in women. Previously, drug makers attempted to develop Viagra-like drugs and testosterone patches (testosterone increases sexual desire) to increase female libido—neither worked (without substantial side effects) to warrant approval. The FDA panel decided to not recommend flibanserin for approval because its modest effects on heightening female sexual desire did not outweigh side effects like dizziness and nausea.

A 2005 article in Nature Reviews Drug Discovery suggested that the size of the female sexual dysfunction market in the US could exceed $4 billion annually with only about 15 per cent of patients receiving treatment. Not surprisingly, many pharmaceutical companies have invested billions to develop new drugs to treat this indication.

There is no question that quality of life drugs like Viagra, Latisse and Botox generate billions of dollars in sales each year. While these drugs may help small numbers of patients who truly suffer from serious medical conditions, they are mainly used for so-called recreational purposes (sexual performance and beauty enhancement) by a majority of “patients.” That said, pharmaceutical companies have the right to develop whatever drugs or treatments that they choose. However, I contend that there are more serious medical conditions out there than failure to achieve orgasm or the need to not apply mascara on a daily basis.

Hat tip to Ed at Pharmalot for some outstanding investigative reporting!

Until next time...

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

 

Lilly and Walmart to Sell Co-Branded Insulin?

The once venerable drugmarker Eli Lilly & Co yesterday announced that it would co-brand its Humulin insulin product with Walmart one of the world’s largest retailers starting in mid September. According to a Lilly spokesperson the product will be sold in U.S. Wal-Mart pharmacies.

Humulin, with $1 billion in worldwide sales for Lilly last year, will be Lilly’s first co-branded product with a retail pharmacy and will replace Wal-Mart’s current Relion insulin brand. The Lilly-Walmart deal is indicative of the massive changes that are taking place in the pharmaceutical industry as generic products begin to encroach on blockbuster brand name product franchises. 

The move will undoubtedly expand the product lifecycle of Lilly’s Humulin brand given Walmart’s vast distribution channels and its gargantuan customer base.

Until next time...

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

 

Post Merger: Are Things Getting Any Better at Pfizer?

Pfizer’s acquisition of Wyeth was supposed to provide the company with expertise—that was sorely lacking—in biologics and biotechnology products. While it is too early to ascertain whether or not the Wyeth acquisition will “bear fruit”, today’s announcement that Pfizer is suspending all clinical trials of tanezumab, a monoclonal antibody treatment for osteoarthritis, suggests that the company may need more help than expected to develop new biological products. According to a statement, Pfizer’s immediate worldwide suspension of the clinical trials followed a small number of reports of tanezumab patients experience worsening of osteoarthritis leading to joint replacement.

Things have not gone well for Pfizer lately. Earlier this year the company abandoned late stage clinical development of an Alzheimer drug called dimebon that it had licensed from a smaller specialty pharmaceutical company. Also in 2010, Pfizer halted clinical development of Sutent for breast and liver cancer after it failed to meet principal goals in two Phase III trials. Finally, several years ago, the company killed late stage clinical development of a highly touted new cholesterol drug torcetrapib (Lipitor’ successor) after it failed to meet clinical endpoints in a pivotal Phase III trial.

Not surprisingly, Wall Street analysts are not particularly enthusiastic about Pfizer’s future. Many consider Pfizer to have one of the worst pipelines among major pharmaceutical companies. Also, many believe that productivity at the company is lacking in almost all therapeutic areas. In defense of the productivity of Pfizer R&D scientists (those who still have jobs), it is extremely difficult to remain productive or focused when major acquisitions e.g. Warner Lambert, Pharmacia and Wyeth occur every few years. As I have stated numerous times before, bigger isn’t always necessarily better. Here’s hoping that the Wyeth acquisition can rescue Pfizer from its current “death spiral” and return some value to its shareholders.

Until next time...

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

 

Pharma and Philanthropy?

Pharmaceutical and biotechnology companies like to distinguish themselves from companies that manufacture consumer products because their products have the potential to save the lives of patients suffering from a plethora of illnesses. While a life-saving cancer treatment may inherently be more valuable than a pair of snow tires, the goal of the companies that manufacture them is to sell enough products to remain profitable. To that end, pharmaceutical and biotechnology companies have an edge over consumer products companies because drug makers can use altruism and philanthropy to market their drugs. In fact, many drug manufacturers play up their commitments to altruism and philanthropy to justify high drug prices because of the enormous costs associated with drug discovery and development. This tactic begs the question: “Just how philanthropic are drug makers?”

To answer this question The Access to Medicine Foundation created the Access to Medicine Index .which provides a benchmark on the access to medicine policies and practices of the largest global pharmaceutical companies.The index is designed to offer stakeholder and prospective investor ways to compare pharma’s social responsibility records by measuring 106 indicators that examine activities across seven criteria such as philanthropy, patents, pricing and management (see more here)

The 2010 index (only the second of its kind) ranked 26 pharmaceutical companies on their efforts to provide access to medicines, vaccines and diagnostic tests to people living in 88 countries. The companies included 20 originator (branded) companies – those who primarily market patented drugs they have developed – andsix companies whose primary business is the production and sale of generic medicines. The results are shown below:

Branded Pharmaceutical Companies

  1. GlaxoSmithKline
  2. Merck
  3. Novartis
  4. Gilead Sciences
  5. Sanofi-Aventis
  6. Roche
  7. AstraZeneca
  8. Novo Nordisk
  9. Johnson & Johnson
  10. Abbott Labs
  11. Pfizer
  12. Boehringer Ingelheim
  13. Eli Lilly
  14. Bayer
  15. Bristol-Myers Squibb
  16. Eisai
  17. Merck KGA
  18. Takeda Pharmaceuticals
  19. Astellas Pharma
  20. Daiichi Sankyo

Generic Manufacturers

  1. Ranbaxy Laboratories Limited
  2. Cipla Limited
  3. Dr. Reddy’s Laboratories
  4. Mylan, Inc
  5. Sun Pharmaceuticals
  6. Teva Pharmaceuticals Ltd.

While the lists may seem impressive, Index founder Wim Leereveld cautions: “…the industry as a whole still has a long way to go.”

Ed Silverman, who runs the Pharmalot Blog, offered his insights about the list and the foundation’s findings: “The report, of course, will be used to defuse critics, such as non-governmental organizations and activist groups, who say not enough is done to make meds accessible in poor countries. The arguments often center on compulsory licensing and free-trade agreements, as well as intellectual property disputes, pricing and donations. Pharma, you may recall, has been on the defensive ever since they fought South Africa over HIV meds, and is now ramping up operations in so-called emerging markets, many of which are low-margin operations where incomes are lower. “

I don’t fault drug makers for aggressively marketing their products to generate revenues to insure profits and growth. After all, business is business. However, I think that it is disingenuous to use altruism and philanthropy as a means to market and sell high priced drugs. Ironically, this practice tends to limit the access of poor and disenfranchised patients who might benefit the most from these medicines.

Hat tip to Ed at Pharmalot

Until next time...

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

 

Need a Quick Business Tune Up: Stanford's Summer Institute for Entrepreneurship Can Help!

The Stanford Summer Institute for Summer Entrepreneurship was started several years ago and was “designed for currently enrolled, non-business graduate students.” According to the program’s website, “The business world is in need of young visionaries with backgrounds in humanities, science, and engineering. The Stanford Graduate School of Business Summer Institute for Entrepreneurship offers current graduate students the unique opportunity to build the analytical and practical skills critical to launching a successful business.” That’s right, all you would-be entrepreneurs who want to start your won biotech company ought to check it out!

The program has been wildly successful since its inception. The 2010 class is completely full and applications for the 2011 session will be available this September. For a program overview, check out this video

Please contact Aimee Slobin for more information. Also, you can download a program brochure by clicking here.

Until next time...

Good Luck and Good Job Hunting!!!!

 

Life Sciences Job Update: Which Ones are Hot!!!

While the layoffs at pharma and biotech companies continue, the good news is that fewer jobs are being lost in 2010 as compared with 2009. Despite the massive loss of R&D and sales and marketing jobs, many life sciences companies are beginning to hire again. In general, job opportunities at emerging growth public biotech and venture-backed start-ups appear to be growing while those at big pharma and big biotech are stagnant or shrinking. Specifically companies are looking to hire:

  1. Clinical affairs managers and executives
  2. Regulatory affairs personnel and executives
  3. Commercial and operational expertise at all levels
  4. Business development executives
  5. Chief financial officers
  6. Investor relations and corporate communications professionals
  7. CEOs (venture capital investors are beginning to part with their capital again)
  8. Board of directors candidates (especially those with specific functional expertise in clinical development, regulatory affairs or commercialization)

A quick perusal of the list indicates that most of these jobs are not traditional science-related jobs and many may require additional training and expertise; especially in business. That said, now may be a good time to re-evaluate whether or not a MBA may be in your future.

Until next time....

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

 

Biocareers: Some Advice for Would Be Entrepreneurs

More and more people are losing their corporate jobs because of the recession. The bleak job market coupled with diminishing opportunities for older, seasoned employees is forcing many to consider starting their own businesses to join the ranks of the self employed. However, before you take the leap, I highly recommend that you read Phyllis Korkki’s article in this Sunday’s New York Times entitled “Taking the Leap To Self Employment.

As a person who successfully made the leap, she offers amazing insights into what it really takes to be successful as an entrepreneur or small business owner. Most importantly, would be entrepreneurs must possess three important characteristics: motivation, drive and passion. If you lack any of the three, chances are that you are not cut out to be self employed or entrepreneurial enough to start your own company. Also, she aptly points out that one of the major drawbacks of self employment is loneliness. I cannot stress enough that this is the major complaint of most self employed persons that I know. 

While nobody wants to admit it, humans are social animals who need to interact with one another to fulfill the evolutionary need to be “social.” Luckily, the advent of social media has helped to overcome the daily loneliness experienced by many entrepreneurs and self employed persons. That said, before you make the leap, please read the article—it will help to determine whether or not self employment is right for you!

Until next time...

Good Luck and Good Job Hunting

 

Another Setback for Merck

Earlier this month, Merck BioVentures, the company’s new division focused on developing follow-on biologics aka biosimilars announced that it was scuttling plans to develop MK-2578, a PEGylated version of erythropoietin (EPO); its first follow-on biologics candidate (someone should have mentioned to Merck that PEG-EPO is NOT a follow-on product but actually a NME that would require full regulatory approval).  In yet another setback, this past week the US Food and Drug Administration (FDA) postponed a decision to broaden usage of its Gardasil human papillomavirus (HPV) vaccine to women between the ages of 27 and 45.

The company had submitted new data to agency and had hoped to hear by the end of June about the new indication for Gardasil; FDA will likely delay a response until the end of 2010. Gardasil is already approved to protect against some strains of the human papillomavirus, which can lead to cervical cancer, in girls and women ages 9 to 26. It is also approved to prevent genital warts in males of the same age. Merck has aggressively been trying to expand the indications for the vaccine to bolster sales. Gardasil revenue in 2009 was $1.1 billion, down from $1.4 billion in 2008 and $1.48 billion in 2007.

Decreasing sales have been attributed to high cost of the vaccine and concerns over side effects after vaccination. Also, some parents’ worry that Gardasil vaccination may suggest to teenagers that premarital sex is okay. Interestingly, while cervical cancer remains a risk among HPV-infected girls and women, a recent study found that only 34 percent of teenage girls ages 13 to 17 received Merck’s Gardasil human papillomavirus vaccine. Finally, sales of Cervarix, a competing HPV vaccine developed by GlaxoSmithKline, are beginning to cut into Gardasil market share.

Until next time...

Good Luck and Good Job Hunting!!!

 

YouTube and Pharma: An Update

There is no question that video is taking the Internet by storm and is quickly replacing the written word as a means of communication. Despite the obvious business opportunities offered by videos, most big pharma companies have failed to jump on the video bandwagon. As always, there are exceptions to the status quo and a handful of life sciences companies most notably Johnson & Johnson, have been experimenting with video over the past few years.

According to Mark Senak, the unofficial life sciences company video archivist and author of the always insightful EyeonFDA blog, there are presently about 15 companies that have channels on YouTube; the largest video sharing website on the Internet. Previously, Mark was able to find 10 or so active companies on the YouTube website. Despite this modest increase, Mark notes that most pharma YouTube channels are not regularly maintained and suffer from lack of original content. 

There is no question that video is expensive to make if it is done commercially. However, Ken Grant at Analtech, a small chromatography company in Delaware, who has successfully used video to drive and improve business outcomes, contends that a low cost Flip video camera or equivalent is sufficient to get the job done! 

I suspect that big pharma may be waiting for FDA to weigh in on the use of social media for promotional purposes before it allocates any resources for video production. However, as I have stated many times before, social media can be used in many other ways (besides for promotional purposes) to meet business objectives and maintain corporate brand integrity. Until pharma marketers and brand managers recognize this, social media and pharma will be a moot point.

Until next time...

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

 

Social Media for Life Scientists: Videos, Wikis and Blogs...Oh My!

Mary Canady who writes the Comprendia Blog and helps to manage the San Diego Biotechnology Network has crafted a number of useful social media lists for scientists and others who work in the life sciences industry. 

Videos are de rigueur and you can find a plethora of science video websites on Mary’s comprehensive list (almost, she forgot BioCrowd). 

Many life sciences and technology companies are experimenting with social media; primarily by writing corporate blogs. Check out Mary’s list of corporate life sciences bloggers to find out what they are thinking and blogging about. 

Finally, wikis are growing in influence and importance in the life sciences. There are a number of well crafted sciences wikis out there that may be useful. Click here to see the list.

Hat tip to Mary!

Until next time...

Good Luck and Good Job Hunting!!!!!

 

New Directions: Pfizer Creates an Orphan Drug Division

Pfizer today announced plans to set up a Rare Diseases Research Unit that will target the more-than-6000 global orphan diseases. For those of you who may not know, orphan diseases are classified by the US Food and Drug Administration as those that afflict 200,000 persons or less.

According to a press release, Pfizer’s new division will “pursue treatments across all therapeutic areas and modalities and will serve as the focal point for the company’s existing research on rare diseases”. It also intends to “work closely with patient advocacy groups, like the National Organization for Rare Diseases, as it develops and advances the unit’s research strategy. It will be lead by Edward Mascioli, most recently the head of Dapis Capital, a private equity firm. Previously he was vice president of clinical affairs at Peptimmune and senior medical director at Paraxel.

Pfizer’s decision to enter the orphan drug market signals that no markets are too small for big pharmaceutical companies to consider in an era where blockbuster drugs are few and far between. Nevertheless, it is noteworthy that orphan drugs (which are generally biologics) offer drug maker several perks including: seven years of market exclusivity, tax breaks and credits, reduced clinical trials costs and expedited regulatory review. More importantly, perhaps, orphan drugs are highly priced and can yield impressive returns even though they are used to treat small patient populations. For example, several of Genzyme’s drugs such as Myozyme and Cerezyme—both designated as orphan drugs—have already reached over $1.0 billion in annual sales. 

While sales of orphan drugs may never reach those of Plavix, Lipitor, Epogen and other multibillion dollar blockbusters, garnering US regulatory approval for four or more (which cost much less than $1.5 billion to develop) will likely provide a substantial ROI to companies that develop them. Also, developing drugs that improve the quality of life for patients with no other treatment options will undoubtedly go a long way to improve tarnished reputation of the pharmaceutical industry.

Until next time...

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

 

Sanofi Aventis to Reduce Sales and Marketing Workforce to Cut Costs

The expanding European financial crisis is forcing drug makers to continue to explore ways in which to cut costs. Faced with budget deficits amid a global economic crisis, European countries such as Germany, France and Greece have cut or plan to cut their health-care spending. Greece last month ordered drugmakers, including France’s largest drug maker Sanofi-Aventis, to cut prices by 3 percent to 27 percent to help rescue its economy. 

Not surprisingly, Sanofi Aventis responded by announcing new job cuts and more stringent cost control measures. Yesterday, Sanofi’s Chief Financial Officer announced at an analyst meeting in Los Angeles that “We are restructuring. We are changing our marketing model. We are merging sales forces, we are reducing sales forces, having a multiproduct sales force. We will continue to do that.” Most of the job cuts and cost saving measures will come at the expense of sales and marketing personnel. The size of pharmaceutical R&D and sales and marketing workforces have been devastated over the past three years with over 200,000 employees losing their jobs.

Sanofi-Aventis Chief Executive Officer Chris Viehbacher, who joined the company in 2008, shut or sold plants and canceled the least promising research projects in a bid to trim 2 billion euros ($2.46 billion) in costs. These actions, coupled with the most recent restructuring efforts were enacted to ensure 2013 earnings are at least equal to 2008 profit. Like most other big pharma companies, Sanofi has been looking to emerging markets and consumer products for new income as competition from generic drugs hurts sales. The anti-clotting drug Plavix which is Sanofi’s largest selling drug generating over $4.0 billion annually will lose patent protection in 2011-2012. Bristol Myers Squibb, Sanofi’s marketing partner for Plavix in the US, also exceeded $4.0 billion in sales last year.

Sanofi also announced today that it acquired the assets of Montreal-based Canderm Pharma, Inc a consumer products company for $1.9 billion signaling its intention to aggressively enter the North American consumer healthcare products markets.

Until next time...

Good Luck and Good Job Hunting

 

Situation Not Improving at Johnson & Johnson's McNeil Consumer Healthcare Unit

Johnson & Johnson’s McNeil Consumer Healthcare, already under Congressional investigation for selling allegedly tainted Tylenol, announced late Tuesday that it was recalling other products made in the Puerto Rico manufacturing facility in question.

According to an article in today’s New York Times, “McNeil Consumer Healthcare, the Johnson & Johnson unit, said that it was recalling four lots of certain Benadryl allergy tablets and one lot of Extra Strength Tylenol gel pills. McNeil did not respond to a reporter’s query about how many bottles those lots amounted to.”

Since last November, McNeil has recalled about 11.7 million bottles of various Motrin products and about 6.3 million bottles of Tylenol Arthritis Pain caplets made at the Puerto Rico plant in question. The company began the product recall after receiving numerous consumer complaints about a moldy odor emanating from some of its products.

Company representatives contend that the moldy smell was caused by contamination from a chemical byproduct of a substance used to treat wooden transport pallets. Further, McNeil suggested that the risk of serious medical problems was remote and people should not stop using the products (yeah right).

The current recall just adds to McNeil’s growing manufacturing problems. The company is already under scrutiny by the House Committee on Oversight and Government Reform over a recall last April of an estimated 136 million bottles of liquid pediatric Tylenol, Motrin, Benadryl and Zyrtec.

I suspect that more problems will be uncovered as the FDA and Congressional investigations continue. Serious manufacturing and quality problems can almost always be avoided or minimized when company executives and management makes a bona fide commitment to quality systems. Clearly, the heads of McNeil Consumer Healthcare might benefit from remedial current good manufacturing practices (cGMP) training.

Until next time...

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

 

Eight Common Mistakes Made During Job Interviews

Now that the economy is improving and the job market is loosening up a bit, the likelihood of a face-to-face job interview is increasing. The folks over at Best Online Colleges recently sent me a post about common mistakes made during job interviews and how to avoid them. While some of the proffered suggestions and tips overlap with some of my own, there are several that are new and novel and worth considering. 

Like most other things in life, practicing your interviewing skills will improve your performance and increase the probability of receiving a job offer. That said, take a look the list and see whether or not you can avoid these oft time embarrassing mistakes during your next face-to-face.

  1. Forgetting the name of your interviewer
    Often times, a company will give you the name of your interviewer when it contacts you to set up an interview. In these cases, not knowing their name as you set foot in their office is inexcusable. If first impressions are everything, then you’ve scored a zero before the process has even started. Be sure to memorize their name as soon as you get it, and if you forget, look for clues in their office – like a nameplate.
  2. Succumbing to your nerves
    Remember that you aren’t facing a firing squad – your life isn’t at stake, so don’t act like it. What’s the worst that could happen? You won’t get the job you already didn’t have? Don’t work yourself into a panic. Vomiting on your interviewer’s desk, sweating like an NBA basketball player or shaking like you’re sitting in a 727 that’s hitting turbulence are way worse than a couple of stutters. Clear your mind beforehand and keep things in perspective.
  3. Relaxing too much
    If you have too much perspective – or just nerves of steel – don’t make it apparent by propping your feet up on your interviewer’s desk, for example. Don’t make inappropriate jokes or inane comments. Unless instructed otherwise, you should act formally and business-like. Your behavior should be 100 percent professional. More likely than not, they’ll judge you based on how you act during that short period of time.
  4. Divulging too much
    In the haste to appear as open as possible, many interviewees tend to give too much information. But honesty isn’t always the best policy. Your prospective employer doesn’t need to know about the three-month-long coke binder you went on after freshman year. They don’t want to hear about how your previous boss did his best to imitate Bill Lumbergh. Only disclose what they need to hear related to your performance as an employee.
  5. Coming empty-handed and empty-minded
    Don’t give your interviewer the impression that you didn’t take any time to prepare before meeting with them. They’ve done their homework and they expect you to do yours. It’s essential that you study the company. How’s it performing? What’s its mission? How does the position for which you’re applying fit into the grand scheme of things? Be sure to bring additional copies of your resume, a list of your professional references, the job posting (if possible), and a pen and notepad.
  6. Transforming into a phony salesman
    No interviewer likes a phony – unless of course your prospective job title is “phony salesman.” But in most cases, acting overly-enthusiastic can be off-putting. They know you really want the job. You don’t have to pretend it’s the best job in the history of jobs. And don’t exaggerate your abilities. If you try too hard to say what your interviewer wants to hear, they’ll know.
  7. Cell interruption
    There’s nothing ruder than a noisy cell phone chiming in during an exchange with your interviewer. Silence your phone before entering the building. Mom’s “Good Luck <3" text message will still be there after the interview and the sentiment will remain the same.
  8. Succumbing to your ADD
    The worst is when an interviewer gives a long-winded information-filled speech and you’ve only managed to absorb the first sentence. Take a deep breath, slow your racing mind and give them your full attention. You don’t want to respond with a blank stare when they ask if you have any questions.

Hat tip to Best Online Colleges!

Until next time...

Good Luck and Good Job Hunting!!!!!

 

Finally Some Good News for Genzyme

After weeks of bad press regarding manufacturing problems and a narrowly-averted proxy contest, Genzyme today announced that its experimental drug for multiple sclerosis, alemtuzumab, received fast track approval status from the US Food and Drug Administration (FDA).

Alemtuzumab (marketed as Campath, MabCampath or Campath-1H) is a monoclonal antibody used in the treatment of chronic lymphocytic leukemia (CLL), cutaneous T-cell lymphoma (CTCL) and T-cell lymphoma. Alemtuzumab targets CD52, a protein present on the surface of mature lymphocytes, but not on the stem cells from which these lymphocytes are derived.

For those of you who may not know, FDA grants fast track status to experimental drug candidates that are designed to treat serious diseases, and may be superior to current treatments. Fast track status includes an expedited review and additional collaboration between Genzyme and the and the agency and allows Genzyme to submit portions of the alemtuzumab BLA as they are completed, rather than waiting to submit the completed application when testing is finished.

Until next time..

Good Luck and Good Job Hunting!!!

 

FDA Begins Reining In Genetic Testing Companies: It's About Time!

The US Food and Drug Administration (FDA) announced on Friday that it will begin monitoring and investigating the services offered by consumer-focused, personal genomic testing companies. In warning letters to five companies, the agency notified company executives that their tests are considered medical devices and therefore must be federally approved as safe and effective. None of the companies have submitted their products for approval, according to the FDA. Further, the agency contends that personal genomic tests as medical devices must be “analytically and clinically accurate so that individuals are not misled by incorrect test results or unsupported clinical interpretations." Previously, the agency hadn’t definitively classified the tests as medical devices. However, the agency has become increasingly concerned that results from the tests may ultimately be used for diagnostics and prognostic purposes by various entities including insurance companies and employers.

The companies that received letters on Friday included California-based 23 and Me (backed by Google Health), Navigenics and Illumina and Knome of Cambridge, Mass.; and deCode Genetics of Lake Barrington, Ill. The FDA sent a similar letter in May to Pathway Genomics of San Diego, after Pathway announced it intended to sell its tests through Walgreens drugstores. Many industry insiders believe that the proposed Pathway Genomic-Walgreens was the proverbial “straw that broke the camel’s back” which prematurely forced the agency to take regulatory action.

The letters deal with specific tests marketed by: 23andMe Inc., deCODE Genetics, Illumina, Navigenics and Knome Inc. FDA asks each of the companies to contact the agency to make arrangements for submitting their tests for review. 23andMe and Navigenics and DeCode Genetics, sell tests that scan a person’s DNA, looking at genetic variations that can suggest whether a person is at a higher or lower risk of getting certain diseases like cancer or diabetes. Illumina sells DNA chips that are used by some companies to do the DNA scans whereas Knome offers consumers a complete sequence of their DNA, which can be used to glean disease risk information. While 23 and Me is pushing back, deCode Genetics CEO stated that the company will work with the agency to legitimize its tests as part of “standard medical care.” Knome, whose whole genomic sequencing platform will ultimately supplant the services offered by 23 and Me, Navigenics and Pathway Genomics, has also expressed a willingness to work with the agency.

Despite the existence of theGenetic Information Nondiscrimination Act (GINA) enacted in May 2008—which ostensibly would shield patients from potential “genetic discrimination”—many privacy and medical information advocates fear that loopholes will allow insurance companies and prospective employers to abuse the results from personal genomic analyses. To that end, GINA does not cover life, individual disability insurance, or long-term care insurance, and the potential for genetic discrimination still exists in these areas. For example, a person at genetic risk for developing Alzheimer’s could be denied long-term healthcare insurance because Alzheimer’s patients have been known to live for long periods of time, and their care is costly.

Another legitimate concern raised by some people is ownership of the results of personal genomic analyses. Surprisingly, at present, it isn’t clear who owns or ultimately controls a person’s genetic information data after it is generated. For example, it is likely (but not certain) that a consumer who purchases whole genome sequencing services from a personal genomics company owns and controls his/her sequence data. Ownership and control of the information isn’t likely to be straightforward or easily defined until rules and regulations are crafted to clarify how genomic information is owned, stored, and accessed by individuals and third parties.

While companies like 23 and Me and their ilk aren’t pleased that FDA has finally classified their tests as medical devices, they had to know that regulatory oversight of the personal genomic testing business was inevitable. This is because the results from personal genomic tests have been and will continue to be used by various and sundry entities a diagnostic and prognostic tools.

It is obvious to almost everyone in the life sciences industry that there are huge sums of money to be made in the personal genomic testing space. Consequently, the last thing that personal genomics company executives wanted was regulatory oversight by FDA (it tends to interfere with business and profit margins). However, we all have experienced first hand what happens when companies are allowed to operate in the absence regulatory oversight.

Hat tip to FDA for finally taking a stand on this important issue!

Until next time...

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

 

Millennials vs. Baby Boomers: Adapting the Workplace to Accommodate Both

The differences between the Millennial (born 1980ish-2000) and Baby Boomers (born 1947-1966) generations are noticeable and stark. To that end, the differences between these two generational groups have been the subject of many articles and many talk radio shows (my friend  fellow boomer and host of the always amusing The Recruiting Animal Show loves the get me “going” on the topic).

Before I legitimately entered the Web 2.0 world several years ago, I thought the planet was in serious jeopardy (how boomer-centric of me!). While Millennials aka GenY have their own problems —just like me and my fellow boomers —I believe that their sense of community, connectivity and transparency, may, in the end, save a world that is being run into the ground. That said there is an interesting article in the Sunday New York Times business section written by Michael Costonis and Rob Salkowitz that clearly delineates the differences between Millennials and status-quo boomers; and why it is important for boomers to co-exist rather than resist Millennial trends in the workplace. The authors describe Millennials this way:

“Young workers grew up in a digital culture distinguished by near-immediate sharing of information. They tend to be collaborative and team-oriented, even when they aren’t technology experts. They grew up multitasking and don’t see the sharp delineations between “work” and “leisure” that previous generations did. Millennials often prize freedom, innovation and speed over security and stability. They seek flexibility in work schedules and work locations.

Most of all, young workers take access to technology for granted — as a way to get information, keep track of friends, schedule activities and do their work. And, of course, this access has now gone mobile, via wireless connections and smartphones.

Newer technology also creates a more networked and less hierarchical workplace. Work is distributed across more people in more places, with virtual teams communicating more or less instantly.”

Not a bad set of characteristics and skill sets, if leveraged correctly, may actually improve workplace efficiency and productivity and possibly reduce costs!

We boomers like to think of ourselves as agents of change. While this may have been true in the ‘60s and ‘70s, it is no longer the case—once a group becomes the so-called establishment there is no impetus or inducement to change the status quo. And, as many boomers have learned, change can be difficult and nobody really likes it! 

With this in mind, it makes sense for boomers to tap into their inner, ancient desires for change and accommodate, rather than resist, workplace changes being insisted upon by millennial hires. After all, they will be running the world in the next decade or so and if we aging boomers want to be taken care of and treated well, then a little support and understand may go a long way! And, as we used to say back in the tumultuous ‘60s: “Try it; you’ll like it!”

Until next time...

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

Addendum: I was taken to task by a GenXer who claimed that, in typically Baby-boomer style I tried to butt in on GenX by asserting that the Boomer generation extended until 1966. While some experts claim that GenX may have begun as early as 1961 others do not and contend that it began in earnest in the West in 1966.  In any event, Baby Boomers and GenXers are aging and will ultimately have to cede control to the Millennials.  But hey, why not split a few hairs (even if many of us have few hairs left to do that!)

Lilly CEO: "US is Losing it Edge in Life Sciences Innovation"

John Lechleiter, PhD, chairman and CEO of Eli Lilly & Co. today told members of the Detroit Economic Club that the US is losing its competitive edge and that “evidence is mounting for an innovation crisis in the life sciences

Lechleiter blamed the crisis on US tax and immigration policies over the last 10 years that have reduced research and investment funding and driven away foreign-born, U.S.-trained scientists.

He also attributed the problem to the US Food and Drug Administration’s new emphasis on drug safety.  “The FDA approved 92 drugs the last five years. That is the lowest of any five-year period,” he said. “We lose patent protections (on brand name drugs) and that is $100 billion less revenue for the industry and less for research and development” said Lechleiter. Further, he said that “American drug companies still spend 40 percent more on research in development in the U.S. than in other parts of the world.”

To avert the crisis, Lechleiter suggested the following: 

  1. Increase and improve education for students in math and science
  2. Change immigration laws to allow more H1-B visas for scientists and ease the process that allows immigrants to gain green cards to work in the U.S. The last time the H1-B visa cap was raised was in 1990
  3. Increase federal funding for pharmaceutical and basic science research, which has declined over the last five years
  4. Change tax policies to provide more incentives for research and development. The U.S. lags behind the rest of the world in offering R&D tax credits, he said. Moreover, the U.S. should not tax foreign subsidiaries of U.S. corporations

Lechleiter, who was trained as a chemist, is the only CEO of a major pharmaceutical company who holds a PhD degree. Therefore, his ideas resonate more for me than those of his business-only CEO counterparts. To that end, his suggestions regarding improving math and science education, immigration reform (which I have long contended is killing US competitiveness) and increasing federal funding for research make sense. However, the notion that US tax laws and lack of corporate tax incentives is stifling American innovation and competitiveness is pure hogwash.

While corporate tax rates may be higher in the US than elsewhere, there are so many loop holes that most corporations pay less than their share fair. Further, let’s not forget that the personal income tax rate is much higher in the rest of the developed world than it is in the US. It is just so “American” to not want to pay taxes and then demand and expect government services at no cost to the taxpayer (at least in Europe they pay high taxes and get good services).  And, let's not forget that despite their heavy tax burden it was American corporations not foreign ones that caused the recent global recession.

That said, I gotta give John some credit for his suggestions; three out of four (or a .750 average) isn’t bad in baseball or the pharmaceutical industry!

Hat tip to Ed at Pharmalot

Until next time...

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

 

Why Pharma May Never Be Good At Social Media

Johnson & Johnson is arguably one of the world leaders in bringing social media to the pharmaceutical industry. Marc Monseau and his dedicated team oversee a network of blogs, video channels and Twitter feeds while some of J&J’s brand companies even sponsor patient advocacy communities like ADHD Moms and ADHD Allies. However, the company’s recent handling of manufacturing problems and recall of Tylenol and other pediatric medicines seemingly flies in the face of openness and transparency; two of the underlying tenets and guiding principles of social media.

In an article in today’s New York Times, Natasha Singer reports that “a Congressional investigation into a recent recall of children’s Tylenol and other pediatric medicines has been stymied by the manufacturer, Johnson & Johnson, raising the prospect that new measures — like issuing of subpoenas to compel cooperation — could be invoked.”

McNeil Consumer Healthcare, the unit that manufacturers Tylenol and other over-the-counter medications, is no stranger to scrutiny by the US Food and Drug Administration (FDA). It is currently being investigated for a pattern of violations in manufacturing practice and quality control issues that have led to recalls of several medications. Last month, the agency suggested that it was considering criminal penalties or other actions against McNeil executives.

According to the times article, the House committee opened its investigation in early May shortly after McNeil announced a voluntary recall of liquid pediatric Tylenol, Motrin, Benadryl and Zyrtec. FDA investigators uncovered evidence that the products, made at a company plant in Fort Washington, Pa., may have included metal particles, or too much of the active drug ingredient, or inactive ingredients that did not meet testing standards.”

Manufacturing problems are not uncommon in the pharmaceutical industry and it isn’t clear what J&J has to lose by not fully cooperating with FDA officials. In fact, failure to cooperate could lead to harsher penalties and larger fines. However, I suspect that McNeil hasn’t been forthcoming because of allegations of a so-called “phantom recall” that took place last year, where J&J contractors secretly removed alleged defective products from store shelves.” Nevertheless, ongoing media coverage of the recall and the circumstances behind it are beginning to cast a very negative light on McNeil products and the J&J brand.

Pharmaceutical social media advocates contend that one of the reasons why pharma companies ought to use social media tools is information dissemination and so-called damage or crisis control. While I haven’t been assiduously screening all of the J&J social media channels, it seems like now would be an ideal time to begin to leverage them. 

It is unfortunate that an innovative and progressive pharmaceutical company like J&J has come under fire. However, product quality and safety is of paramount importance to consumers. And companies that cannot ensure those product attributes must move quickly and decisively to reinstate them. To that end, J&J ought to fully cooperate with FDA regulators, fix its Tylenol problems and then use its abundant social media channels to reinstate public confidence in McNeil Consumer Healthcare and the J&J brand! After all, isn’t that what social media is all about?

Until next time...

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

 

The Dark Underside of New Jersey Dog Breeders: Donna Roberts Sues BioJobBlogger

After several years of taking Donna Roberts to task for fraud and the  illegal sale of dogs, she has finally decided to sue me.  While I haven't seen the lawsuit yet, I suspect it will accuse me of libel, slander etc.

Others have warned me that I will be sued and they were right.  To that end, I want everybody who has been cheated or ripped off by Donna and her crew to contact me.  It's time to send a message to the authorities that these people need to be stopped.

Until next time...

Good Luck and Good Job Hunting !!!!!

Genzyme v. Icahn: Is Carl's Bark Worst than His Bite?

Genzyme announced yesterday that it had reached an agreement with Carl Icahn to settle their very public and bitter proxy battle. As you may recall, Icahn, who controls approximately 4.9% of shares in Genzyme, sought to replace Henri A. Termeer, Genzyme’s embattled long-time CEO and three other company directors.

Under the terms of the agreement, Icahn will withdraw his slate of four nominees for the Genzyme board of directors and vote his shares in favor of two company nominees. Also, the Genzyme board will appoint two Icahn nominees Steven Burakoff, MD and Eric Ende, MD to serve as directors immediately following the company June 16, 2010 annual shareholders meeting. Dr. Burakoff is Professor of Medicine, Hematology and Medical Oncology at the Mount Sinai School of Medicine and Director of the Tisch Cancer Institute at the Mount Sinai Medical Center. Dr. Ende, a participant in the Icahn funds’ proxy solicitation, is a former biotechnology analyst with Merrill Lynch & Co. Inc.

This isn’t the first time that Icahn has threatened a proxy fight to get his nominees elected to the board of directors at companies where he controls a small but significant amount of outstanding shares of stock.  Previously, he attempted to wrest control of the Biogen and ImClone and Enzon Pharmaceuticals board of directors. While his attempt to commandeer the Biogen board failed, he was successful at ImClone, the maker of the anti-colon cancer drug Erbitux that he sold to Eli Lilly in 2008 for ca. $6.1 billion. In Enzon’s case, the CEO resigned about six months after accommodating Icahn’s demands.

It is patently obvious that biotechnology company executives don’t want Icahn to gain control of their companies. This is because once Icahn gains control of the companies he sells them to the highest bidder. While this may make sense to a financial guy like Carl, it doesn’t sit well with company executives who understand that they will likely lose their jobs once a company is sold! 

Although Carl’s public proxy contest strategy usually gets him most of what he wants, I am not sure that it is in the best interests of company stock price and shareholder. Publicly airing a company’s dirty laundry tends to reduce shareholder confidence and may push its stock price lower than necessary. I think that it may be in a company’s best interest to quietly negotiate with Icahn behind the scenes rather than take the fight to the public. In the end, Icahn invariably wins and the management team that is under fire may look less competent or weaker than it actually is. Biogen ultimately won but Enzon and Genzyme lost the public opinion battle.

Until next time...

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

 

Of Women, Men and Testosterone

I came of age in the late 60s and early 70s and the women’s movement was in full swing. Other men and I worked hard to ensure that future generations of women were treated equally and have the same rights and opportunities as their male counterparts. However, some of the earlier and more radical members of the moment believed that society should be genderless and that there were no differences between the sexes. While that notion was intellectually, emotionally and psychologically appealing, nobody can deny that there aren’t obvious, anatomical, hormonal and genetic differences between human males and females. Therefore, it should come as no surprise that women behave differently than men and visa versa (of course in biology there are always exceptions).

Over the years, researchers have determined that differences in female and male behavior can be attributed to a variety of things including physiological environmental, enculturative factors. Like it or not, behavioral differences between men and women have been ascribed to hormonal differences and fluctuations. For example, it is commonly accepted that higher levels of testosterone in men are thought to be responsible for male aggressive behavior whereas in women small amounts of testosterone enhance female libido. With this in mind, a new study published last week in PNAS suggests that testosterone may also play a role in a woman’s ability to trust or distrust others: most notably men.

The study was conducted by a group of Dutch researchers at the Utrecht University. Twenty-four women participated in the double-blind study over two days. On the first day, half of the women were given a dose of testosterone under their tongue, while the other received a placebo; the treatments were switched on the second day so that each participant experienced both treatments. 

After the testosterone treatment, the researchers administered a facial trustworthiness task, in which each subject was shown a series of human faces and asked to assess how trustworthy the person in the image is. Economic exchange tasks, which are usually employed in similar experiments, were not used because of the possible confounding effects of testosterone on risk-taking and reward-seeking behavior. By administering mood tests and asking participants to guess which treatment they had received on either day, the researchers reduced the likelihood that either subjective preconceptions or mood changes may have affected the outcome.

The results of the study showed that women who received testosterone were less trusting than those who received the placebo. Moreover, the study revealed that “naturally distrustful” women were affected less by testosterone as compared with “more trusting” females where hormone-induced effects were the greatest. These findings led the researchers to postulate that the trust-reducing effect of testosterone may be adaptive and especially advantageous for less-socially aware women. For example, when competition is high and resources scarce, highly trusting women may be at greater risk for being cheated or taken advantage of and might benefit from a little jolt of testosterone-induced distrustfulness.

Interesting, female levels of testosterone have been observed to peak right around ovulation. Evolutionarily, it makes complete sense that a woman’s libido (remember testosterone stimulates this) would be highest at the time that she is most likely to conceive. However, the results from the Dutch study suggest that testosterone-induced distrustfulness may actually push potential mates away (and possibly explain why there are so many discerning women out there). 

This led Nicholas Wade, the New York Times reporter who wrote a piece on the study to quip: “So guys, you knew women were complex, but it is even worse than you thought: at the moment you are most desired, you are least trusted.” Women—go figure!

Until next time.....

Good Luck and Good Hunting (for the few cavemen who still exist)

 

Pharma Edges Closer to Using Social Media for Non-Promotional Purposes

Pharmaceutical giant GlaxoSmithKline (GSK) and MedTrust Online, an online oncology information site announced the development of CancerTrials App, the first free geo-locating oncology clinical trials application for the Apple iPhone and iPad platforms.

According to a press release, oncologists can easily find and share information about experimental therapies in clinical trials with their patients. CancerTrials App provides a quick search menu based on 12 common cancers and more advanced features that refine searches based on criteria such as gender, age, trial status and more. Once relevant clinical trials are found, results can be mapped relative to the location of the iPhone or iPad running the application. These features should help oncologists connect patients to appropriate regional and local clinical trials for which they may be eligible. Obviously, the app will help to bolster clinical trial enrollment in the oncology space.

While not a full blow geo-based social media platform like FourSquare,the Cancer Trials app is a step in the right direction and demonstrates the power of mobile medical applications and the potential of social media to improve clinical drug development. 

CancerTrials App for the iPhone and iPad is the first release of the application that connects to MedTrust Online's proprietary databases of oncology information. Other apps for RIM's BlackBerry and Google's Android operating systems will be released over the next several months.

Hat tip to GSK which has boldly gone where no other pharma company has gone before!

Until next time....

Good Luck and Good Job Hunting!!!!!

 

Why Layoffs Won't Help Big Pharma

For the past three years, I assiduously have attempted to track all of the major layoffs announced by big pharma and biotechnology companies. Quite honestly, it has been hard to stay on top of these almost weekly announcements. To date, over 200,000 life sciences employees have lost their jobs. And, I don’t think that job layoffs will abate for a year or more.

While pharma layoffs make sense in the short term—most notably to insure that stock share prices remain as inflated as possible—they are not going to solve pharma’s lack of innovation and the rising attrition rates for new molecular entities. On paper, outsourcing R&D make perfect fiscal and scientific sense. After all, there are literal thousands of US-trained scientists all over the world these days; mainly in China, India and Eastern Europe and it is much more cost effective to do research in these regions. However, in my opinion, outsourcing R&D, like layoffs, is a short term strategy that will likely backfire and not deliver the anticipated ROI. For example, many US technology companies that outsourced sizable portions of their operations in the early 2000 are now beginning to bring them back to the US as Asian labor costs continue to rise and product quality declines. This begs the question: what should big pharma companies do to regain their edge to bring new medicines to market?

Allan Haberman, of Haberman Associates, wrote a compelling post several months ago on his blog the Biopharmconsortium Blog where he offers some insights and strategies that may help big pharma out of its current lack of innovation and new product development.  Until that happens, I will continue to track pharma and biotech company layoffs as they are announced.

Until next time....

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

 

Tracking Pharma Job Cuts

There are rumors that companies are hiring again and that pharmaceutical jobs may begin to make a comeback over the next six months to a year. This  may be a real possibility based on a new report released yesterday the outplacement firm Challenger, Gray and Christmas, Inc.

According to the report , 51,034 pharmaceutical employees lost their jobs by the end of May 2009. In contrast, by the end of May this year, only 34,157 pharma employees received pink slips. This represents a 33% reduction in the number of people being layed off as compared with the same time period last year. 

These data can be interpreted in a couple of different ways. First, fewer pharmaceutical employees are getting layed off which means that the economy may be getting better and the job market may be improving. Second, pharma companies can no longer continue to layoff employees at 2009 rates without impacting their with day-to-day operations.

Personally, as a half-empty kind of guy, I think the later hypothesis is more likely! Only time will tell whether or not the economy has truly turned a corner and when we can expect pharma companies to begin hiring en masse again.

Hat tip to Ed at Pharmalot.

Until next time...

Good Luck and Good Job Hunting???

 

Social Media and Pharma: Adverse Events Reporting Revisited

Last week I attended the Advanced Learning Institute’s conference on social media and pharma. During several question and answer periods, I raised the idea about using social medial tools to improve adverse effects (AE) reporting and post marketing drug surveillance activities. While there was a lot of head nodding suggesting that many of the conference attendees agreed with the points I was making, the conversation about social media and AE reporting was extremely muted. I suspect that most pharmaceutical and biotechnology companies don’t want to discuss the topic until the US Food and Drug Administration issues its mythical regulatory guidance on the use of social media for promotional and other purposes some time next year (?).

John Mack aka Pharmaguy is an ardent supporter (like me) of the use of social media for AE reporting. John was at the meeting and he mentioned that the next day he would be giving a talk on that topic to the World Drug Safety Congress in Washington, DC. Conveniently, he posted a copy of the talk to Slideshare and his blog, Pharma Marketing Blog before his talk.

John’s ideas and insights into the use of social media tools for AE reporting are spot on (and consistent with mine of course!). I highly recommend that those of you who are interested in learning more about this topic take a look at the presentation; it is very informative and quite well done.

It is anybody’s guess at this point whether or not pharma will embrace social media and use it for more than promotional and marketing purposes. However, there is a growing body of evidence which suggests that pharma is beginning to realize that they can no longer fight the pressure from its stakeholders to embrace social media.

Stay tuned for late-breaking social media and pharma news!

Until next time...

Good Luck and Good Tweeting, Blogging, Videoing etc!

 

Social Media, Clinical Trial Recruitment and Mobile Healthcare Apps

About a year ago I posted an article to BioJobBlog that suggested that social media can be leveraged to improve clinical trial recruitment to test investigational new drug candidates. Yesterday, Mark Senak, author of the EyeonFDA posted an article which suggested that the use of video on YouTube and other video-viewing sites makes complete sense to recruit prospective participants for human clinical trials. Here are some of Mark’s thoughts on the topic:

“The reasons I think video is a good way to expose people to learning about clinical trials are multiple. First, it allows me as a prospective clinical trial participant to learn about a clinical trial when I want to learn about it and where I want to learn about it - a hallmark of social media.  Second, it is private - I can learn from a video that can be developed to address a wide range of issues - issues that I might not be so comfortable addressing with a live person.  Thirdly, and perhaps most importantly, I learn about the clinical trials perhaps from someone on a video who is very much like me.  He can be someone with my condition - someone who has gone through a trial, and talk about how his concerns were addressed, what his fears were and what the benefits of participation were.  That, I think, is a much more convincing way to learn about a trial than an ad in a newspaper or even a discussion with a clinical person.  Video can't replace the medical professional, but it sure can get my interest and perhaps trust to make recruitment much easier.”

While the industry’s use of social media for this purpose is not quite there yet, there are some signs that pharmaceutical and biotechnology companies may be trending in that direction. First, a growing number of clinical research organizations (CROs) which help companies plan and manage clinical studies are already using social media tools to recruit prospective clinical trials participants. Second, as Mark reported yesterday, Pfizer launched a YouTube channel called PfizerClinicalTeam last July which presumably would bolster clinical trial recruitment. Unfortunately, as Mark pointed, its most recent video was posted in April, 2010, regarding a new study on schizophrenia. Don’t be surprised if other companies launch social media-focused clinical trials recruitment campaigns in the not too distant future. Like Mark, I believe that social media tools are ideal for this purpose!

In other news, Pfizer, a late entrant to the fledgling pharmaceutical social media space, is showing signs that it is beginning to embrace the social media web. Yesterday, Pfizer and Epocrates announced a collaboration to create an application for the iPhone that gives healthcare providers mobile access to the Pfizer Medical Information Group to obtain medical and science information about Pfizer products or to report adverse events. According to Pfizer, it is creating the app to: “enable easy, direct access to its Medical Information services, via the Epocrates channel, in an effort to enhance the safe and effective use of its medicines, and help improve the quality of patient care.”

Direct access to medical information via mobile devices is growing in popularity among physicians and other healthcare providers because it enables them to get answers on the go without wasting time to fire up a laptop or find a tethered computer to use outside of the clinic.

Despite assertions to the contrary by most pharmaceutical and biotechnology companies, social media tools are ideal vehicles for adverse event reporting and post market drug surveillance activities. Pfizer’s creation of a mobile medical information app coupled with the launch last week of a joint US Food and Drug Administration (FDA) and National Institutes of Health drug safety portal called Safety Reporting Portal (original eh?) suggest that the use of social media tools for online adverse event reporting and drug safety purposes is not too far off. Let’s see what develops over the next year or so after FDA issues regulatory guidance on the use of social media in the life sciences industry.

Until next time...

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

 

Pfizer Employees Evicted From Office Space in Connecticut

The fallout from Pfizer’s purchase of Wyeth last year continues to slog on. Today, Pfizer told 500 scientists who reside in one of three of the company’s office towers in New London, CT that they will be relocated within the next month.

An e-mail message sent to the 500 affected scientists explained that “a business entity with an immediate need for office space has expressed interest in the New London property.” While a Pfizer spokesperson refused the identify the prospective new renter, sources familiar with the situation believe that Electric Boat in Groton, a division of General Dynamics,  which previously expressed a need for 50,000 square feet to house a growing engineering department is the likely new client.

The move shouldn’t come as a surprise to the New London scientists because Pfizer announced last year that it would close the 700,000 square-foot former worldwide R&D headquarters by the end of 2011. Most of the company’s 1,400 drug-development employees in New London will move across the Thames River to the company’s research site in Groton. Nevertheless, the indignity of being evicted and forced to relocate by a bunch of engineers must really smart—not that there is anything wrong with engineers!

Until next time...

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

 

What's Up With Follow-on Biologics aka Biosimilars?

The conversation about follow-on biologics became extremely muted after passage of the US Healthcare Reform Act which included a 12 year period of data exclusivity for innovator company products. This provision inhibits biosimilar manufacturers from introducing generic versions of branded biologics for 12 years from the date the US Food and Drug Administration granted a license for the branded product. While this may effectively limit activity in the follow-on biologics space in the US, it didn’t stop Merck from launching its BioVentures Division (dedicated to follow-on biologics development) almost two years ago.

At the time of the announcement Merck executives in charge of the BioVentures Division divulged that its first product would be a PEGylated version of Amgen’s anemia drug Epogen (EPO). Unfortunately, a PEGylated version of EPO doesn’t qualify as a follow-on biologics because PEGylated proteins are considered new molecular entities (NMEs) by regulatory agencies. Nevertheless, Merck also said it would develop other follow-on products and that its efforts would be based primarily on the proprietary humanized yeast biomanufacturing platform it acquired after purchasing Glycofi, a New Hampshire-based biopharmaceutical company that developed the technology. Interestingly, two weeks ago Merck announced that it was abandoning the PEGylated-EPO product that it mentioned two years ago at the BioVentures kick off press conference.

It isn’t clear whether or not Merck jettisoned the project because of patent infringement litigation, regulatory concerns or possibly because of the increasingly fierce competition in the EPO space. Another possibility is that pharmaceutical companies have finally realized that biologically-active proteins are costly to manufacture and have limited therapeutic applicability as compared with monoclonal antibodies (MAbs) which are taking the biopharmaceutical industry by storm. At last count, there were over 300 MAbs in various phases of pre-clinical development with and about 125 in late stage clinical development. Last week, Teva and Lonza announced plans to develop a biosimilar version of Roche’s anti-inflammatory and cancer MAb Rituxan (rituximab)—kicking off a new era in the biosimilar industry.

For those of you who are unfamiliar with or remain interested in the follow-on biologics debate, I came across a nice PowerPoint presentation given by Teruhide Yamaguchi at the Division of Biological Chemistry and Biologicals at the National Institutes of Health.


Quality Safety and Efficacy of Follow-on Biologics

Until next time...

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