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Earlier this week Roche Holding AG announced that it would pay $230 million to acquire the San Diego, CA-based biopharmaceutical company Anadys. The reason for the acquisition is to bolster Roche’s standing in the hepatitis C market which is projected to grow to as much as $15 billion annually by 2019.

Anadys has a fairly large experimental pipeline of hepatitis C drugs, the most advanced candidate being setrobuivr that is being clinically tested in combination with the generic antiviral drug ribavirin and Pegasys (PEGylated α-interferon) as a hepatitis C treatment.

The Anadys deal comes on the heels of an agreement last week between Roche and Merck & Co to jointly market hepatitis C treatments in the US. Merck recently won approval last May for Victrelis (boceprevir) the first new hepatitis C treatment in over a decade. Also, late last month Vertex Pharmaceuticals received approval for a new hepatitis C drug called Incivek (telaprevir). Anadys is also conducting early clinical trials on ANA773 as a possible treatment for hepatitis C infection, cancer and other chronic diseases.

In other news, GlaxoSmithKline (GSK) is rumored to be contemplating purchasing Maryland-based Human Genome Sciences (HGS), which recently received US approval for Benlysta a novel monoclonal antibody treatment for the autoimmune disease systemic lupus erythematous. 

Benlysta was the first new drug to be approved to treat lupus in over 50 years. GSK is HGS’s commercialization partner for Benlysta which is expected to be a blockbuster drug. The reason for the takeover rumors is likely HGS’s stock price which has fallen from 52-week high of $30 to its current value of $15 per share. 

Until next time...

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

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The clinical trial phase of the drug development process is labor intensive, costly and usually takes the largest amount of time to complete. In the past, most human clinical trials for new molecular entities discovered by American scientists were conducted in the US. However, growing healthcare costs and shortages of “treatment-naive” trial participants have forced drug makers to take the effort global. To that end, many companies now routinely conduct Phase I (safety) and Phase II (proof of principle) trials in Eastern Europe, Latin America and Asia. Moreover, a growing number of pharmaceutical companies are beginning to conduct pivotal Phase III trials in which a majority of participants come from outside of the US.

Last year, a report from the inspector general of the Department of Health and Human Services revealed that in 2008 a whopping 78 percent of all subjects participating in trials to support drug applications submitted to the US Food and Drug Administration were enrolled in foreign sites. Likewise, in Europe, approximately 61 percent of patients in human trials submitted to the European Medicines Agency (EMA) from 2005-2009 were from developing countries. Additionally, 11 percent of the participants were enrolled in studies conducted in Eastern Europe. Poland and Hungary appear to have benefited the most from this trend; the number of Poles involved in trials rose fivefold over the period while Hungary was up almost fourfold.

According to a recent article from Reuters, ClinicalTrials.gov—a public website managed by the National Institutes of Health that tracks current US clinical trials—lists roughly 106,000 human clinical trials that are underway around the world. Approximately 50 percent of these trials are being conducted in the US. Interestingly, at present, only 43 percent of all pivotal Phase III trials are being conducted in the US.  Not surprisingly, China is the beneficiary of the trend and is experiencing exponential growth in the number of clinical trials conducted within its borders. To date, over 2,700 clinical trials have been performed in China and that number is likely to drastically increase over the next five years as Chinese medical and healthcare infrastructure continue to improve.

While outsourcing human clinical trials may be favorable to drug makers, the trend is beginning to anger many American physicians who previously benefited from managing US-based clinical trials. These physicians blame their misfortune on the life sciences industry’s endless pursuit to lower costs and the increasing regulatory bureaucracy and red tape surrounding clinical trial procedures in the US.

In addition to physician anger, outsourcing human clinical trials poses several other problems. First, there is a question of ethics. For example, is it right to test an expensive new drug in a country where locals may never be able to afford it if approved? And, are foreign patients always adequately informed or educated about the potential risks and side effects associated with experimental medicines? Second, can ethnic differences between patients contribute to differences in drug effectiveness and safety? In other words, will Caucasian patients respond to a new drug in the same ways as Asian patients? Finally, in the absence of rigorous regulatory inspections can Good Clinical Practices be routinely maintained across all global clinical trial sites? To that end, as pointed out in the Reuters article from 2005 to 2009 EMA inspectors only conducted 44 good clinical practice inspections (outside of the US and Europe) from a total of 44,034 clinical sites. Meanwhile, during the same period, the US FDA inspected only 0.7 percent of foreign clinical trial sites as compared with 1.9 percent of domestic sites.

Like it or not, outsourcing of human clinical trials in emerging markets is a trend that is likely here to stay. Hopefully, in the future, regulatory agencies will be able to better oversee foreign human clinical trials to insure that the drugs that they approve continue to be safe and efficacious.

Until next time...

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

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A collaborative research team led by scientists at the candy maker (M&Ms, Snickers, Milky Way) Mars, the U.S. Department of Agriculture—Agricultural Research Service (USDA-ARS) and IBM—announced this morning that they have successfully completed a preliminary cacao genome sequence, a map of the crop that supplies the majority of the world's cocoa for the manufacture of chocolate and other food products. The Mars group announcement upstaged a second research group—a consortium composed of Hershey, Pennsylvania State University and the French government—that was working furiously to complete its version of the cocoa sequence. BioJobBlog covered the initial announcement about the sequencing project made by the Mars group back in 2008.

While the race to sequence the cocoa genome was not as intense and bitter as the one between Celera and the Human Genome Project to sequence the human genome, the competition between the Mars and Hershey to be the first to announce the completed genome had similar trappings. Initially, there had been discussions between the two groups to work collaboratively on the cocoa genome. But after some deliberation the Mars team decided to “go it alone.”

At present, about 70 percent of the world crop is grown in West Africa by millions of small growers. With the cocoa sequence in hand, scientists believe that they can use molecular biology to improve yields and create cocoa varieties that are more resistant to diseases. For example, a fungal disease known as witches’ broom almost decimated the entire Brazilian cocoa group several years ago. Improving yields and making cocoa more resistant to infection may help to bring the cost of cocoa-based products like chocolate in the future. Another benefit may be improving the taste or increasing the amount of anti-aging flavonoids found in chocolate.

The cocoa genome contains about 420 million base pairs as compared with the human genome which contains roughly 3 billion base pairs. The Mars group edged out the Hershey-led group because it started earlier and mainly relied on fast, second generation DNA sequencers made by Illumina and 454. While Mars can claim victory because it finished first, the Hershey-derived sequence will be valuable to corroborate Mars’ preliminary sequence. Like everything else in science, research results must be independently confirmed before they are accepted by the wider scientific community.

Hat tip to Mars and Hershey for insuring future of the world’s chocolate supply!

Until next time...

Good Luck and Good Eating (Neuhaus chocolate rocks)

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

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

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

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

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

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

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

Hat tip to Ed at the Pharmalot blog!

Until next time...

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

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

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

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

Until next time....

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

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Back in the late 1990s, applying for jobs online was all the rage! The technology was new and fresh and applying for jobs online was fast and easy. Companies raced to build corporate websites for prospective job applicants, major job boards like Monster and Careerbuilder were launched and human resources professionals though they were ushering in a “new era of employee recruitment and retention.” While applying for jobs online once seemed like a panacea for both job seekers and corporate employers, it never has lived up to all the fanfare and hype!

There is no question that applying for jobs online is quick, easy and most importantly emotionally gratifying. Paradoxically, these are the very qualities that have almost rendered the practice useless when it comes to finding a new job. Before applying for jobs online became de rigueur, large numbers of qualified, prospective employees were hired into new jobs. Unfortunately, these days’ most corporate websites and job boards are swamped by unqualified applicants who submit their resumes when ever and where ever they can! This has prompted many companies and job board site to automate their applicant screening processes—which, in many cases, fail to discriminate between qualified and unqualified job applicants. Frequently, because of the sheer volume of applicants, many companies no longer acknowledge receipt of job applications. While this practice is unprofessional in my opinion, it sends a subliminal—if not obvious message—to applicants that the likelihood of winning the job is remote. It is not uncommon for job applicants to never hear from a company after they have hit the send button to submit a job application.

So, if applying for jobs online isn’t the answer, what should jobseekers do to find gainful employment? Like it or not, the best way to find a new job is through networking. The advent of social networking sites like Facebook, Linked In and BioCrowd makes networking less daunting than it used to be. However, it is important to note, that online networking alone won’t be sufficient! Unfortunately, (for some of you anyway), interacting with people in real life will be required! The best way to begin networking is to use Google (or your favorite search engine) to identify companies or institutions that are looking for applicants with your skills and qualifications. Next, work hard to find a contact at a company who is willing to support your application or at least, forward it to an appropriate hiring manager. If you don’t know anybody at the company ask friends or relatives if they do. If this doesn’t work, post a notice on Facebook or Linked In asking if anybody in your network can provide a contact name or phone number of a hiring manager at the company you are interested in. If this also proves to be unsuccessful, you can run at Internet search on a particular advertised position or go to a company website to find the name of a hiring manager. However, to avert an avalanche of inquiries about online job postings, many companies no longer list the names of hiring managers on their websites. If all else fails, you can always put in a call into human resources and ask for more information about a job with the hope of getting the hiring manager’s name.

Once you obtain the name of a hiring manager, send an e-mail message indicating your interesting the position along with an attached resume/curriculum vitae. One note of caution; managers are usually inundated with e-mail messages (many which remain unanswered) and often have their spam filters set on high. Consequently, it may be prudent to also send a hiring manager an old fashioned cover letter and curriculum vitae authority using traditional or overnight mail delivery.

While networking to get an employee referral for a job remains the best way to get your “foot-in-the-door” at most companies, the referral channels, like almost all others, are also extremely clogged. This may require a direct phone call to a hiring manager to inquire about whether or not to apply for a job or to check on the progress of an application. That said, use this approach wisely—some managers may think that this shows initiative (and will pull your resume from the resume heap) while others may be offended or annoyed by your boldness. Nevertheless, once you make the call, DO NOT call back unless you are advised to do so. If the company is interested in you as a job candidate, they will contact you after they have had sufficient time to review your application.

While companies continue to advertise positions, the best way to land a new job is through word of mouth. This is because many companies don’t advertise all open positions and some companies run ads even though they are not hiring. Nevertheless, building a solid network of contacts and friends (both online and in real life) is critical for successful job searches.

In today’s difficult economy it may be prudent to employ a multifaceted job search strategy that includes a mix of networking, job boards and online applications. Also, it is important to cast as wide a job net as possible and not limit your search to a specific job type—especially if you have skills  and qualifications that cut across disciplines. Finally, I always tell prospective job candidates that looking for a new job must be a “full time endeavor.” Devoting less than a full time effort to your job search will likely yield disappointing results!

Until next time….

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

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In his book, “Free: The Future of a Radical Price” Chris Anderson, editor of Wired Magazine, asserts that the cost of DNA sequencing falls 50% each year. To that end, in February, a company called Complete Genomics based in Mountain View, California, announced it will read entire human genomes at $5000 a shot, starting in June this year. This will cost less than one-tenth of what companies charge today for genome sequencing. 

If you believe Anderson, in five years sequencing a human genome will be under $100. Based on these calculations, the window of opportunity for companies that sequence genomic DNA to make a profit is closing rapidly. So, if you were considering getting into the DNA sequencing biz, the right time may be now—before it is no longer a profitable biz model.

Until next time...

Good Luck and Good Sequencing!!!!!!!!!!!
 

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National DNA Day is a unique day when students, teachers and the public can learn more about genetics and genomics! The day commemorates the completion of the Human Genome Project in April 2003, and the discovery of DNA's double helix by Watson, Crick and Rosalind Franklin.

National DNA Day is usually observed on April 25 (it was created by the US Congress seven years ago), but this year the National Human Genome Research Institute (NHGRI) will hold most of its activities on Friday, April 24 to accommodate classroom schedules. Building upon the popularity of the online chatroom and ambassador programs, NHGRI and its DNA Day partners this year have expanded their outreach efforts even further by creating National DNA Day social networking pages on Facebook and Twitter.

National DNA Day is much more than a time to honor historical achievements. It's a day filled with opportunities for students, teachers and the public to learn how the exciting field of genome research affects our lives. NHGRI researchers, called DNA Day Ambassadors, are visiting dozens of high schools throughout the nation during April to give presentations and field questions from students. This year, NHGRI is particularly focusing on the southwest region of the United States, sending DNA Day ambassadors to high schools in Utah, Colorado, Arizona, New Mexico and Texas.

No matter where they live, students and teachers can participate in National DNA Day through a live, moderated online chat with NHGRI researchers, which will be open for questions Friday, April 24, from 8 a.m. to 6 p.m. Eastern. NHGRI experts will be available to answer questions on a wide range of topics, including basic science, clinical research, genomics careers and the ethical, legal and social implications of genome research. For those unable to participate in the live event, a transcript of the chat will be available on the DNA Day Web site at National DNA Day Online Chatroom.

You can also participate online on Facebook and @dnaday on Twitter

Happy Birthday DNA!

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That methicillin resistant Staphylococcus aureus (MRSA) is in the news again is not surprising. However, to my knowledge, Nicholas Kristof‘s article in today’s New York Times may be the first Op-Ed piece written by a non-scientist about the growing threat and seriousness of MRSA infections. Mr. Kristof apparently became aware of MRSA when he was contacted by Tom Anderson, MD, a Camden, Indiana physician who was experiencing “phenomenal levels of MRSA infections" in his community.

Beginning in the early 1990s, Dr Anderson noticed a rapidly rising incidence in the number of community acquired skin infections caused by MRSA among his patients. Most of Dr Anderson’s patients were swine farmers—the predominant industry in Camden. At first puzzled by the growing incidences of MRSA outbreaks, Dr. Anderson began to suspect that his patient’s pigs may be the source of growing number of cases of MRSA skin infections. He was reluctant to alert public health officials about his suspicions because any hint livestock-related health issues might jeopardize the livelihood of many of his neighbors and friends. By last fall, however, Camden’s MRSA epidemic had grown so large that Dr. Anderson could no longer remain silent. Rather than alert the authorities himself, he decided to invite Mr. Kristof, an investigative reporter, to visit him in Camden and break the story. Unfortunately, before Mr. Kristof could visit, Dr. Anderson died abruptly at age 54. There was no autopsy, but a blood test suggested he may have died from a heart attack or aneurysm. And—this is where the story gets interesting—a recent Dutch study has linked porcine MRSA isolates to a case of human endocarditis. Dr. Anderson had himself suffered at least three bouts of MRSA infections.

In another Dutch study conducted in 2004, MRSA strain ST398 (which caused the endocarditis in the more recent study) was isolated from three family members, three farm workers and 8 of 10 pigs from a single farm. Since then, strain ST398 has spread rapidly through the Netherlands — especially in swine-producing areas— and pig farmers there are 760 times more likely than the general population to carry MRSA. More recently, a study conducted by public health officials in Ontario, Canada showed that 20% of pig farmers were colonized by strains of MRSA genetically identical to those isolated from European pigs. Finally, a 2008 study conducted in Iowa, reported that strain ST398 was isolated from 45 percent of pig farmers and 49 percent of hogs that were tested. Together, these studies suggest that colonization of swine by MRSA and pig farmers is very common and that swine (and possibly other agricultural animals) could become an important reservoir for strains of MRSA.

While not conclusive, most infectious diseases experts believe that the emergence of MRSA and antibiotic resistant bacteria can be directly linked to the widespread and rampant use of antibiotics as growth enhancers in livestock feed. Despite the alarming emergence of multiple antibiotic resistance bacteria, livestock producers in the US and elsewhere continue to add antibiotics to livestock feeds. This led Mr. Kristof to lament that “we as a nation have moved to a model of agriculture that produces cheap bacon but risks the health of all of us.” Not surprisingly, as is frequently the case, big business has chosen to place profits before the health and safety of society.

Until next time...

Good Luck and Good Reading (look for Mr. Kristof’s Sunday column on the emergence of antibiotic resistant "superbugs")

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A panel of eight judges at the Wharton School of Business at the University of Pennsylvania was asked to identify the top 20 life-altering technologies that were developed over the last 30 years. The survey was sponsored by Knowledge@ Wharton, U Penn’s business publication and the PBS’s “Nightly Business Report.” 

Not surprisingly, the Internet was voted the top innovation followed by computers, mobile phones and e-mail. Interestingly, DNA sequencing and testing was listed as number 5—one of five technologies from the life sciences and medical sectors—the others being MRI, laparoscopy, genetically-modified plants, biofuels and anti-retroviral (HIV) drugs. Finally, Internet social networking, a recent innovation, made a surprise appearance on the list at number 20!. The entire list is as follows:

1. Internet, broadband, WWW (browser and html)
2. PC/laptop computers
3. Mobile phones
4. E-mail
5. DNA testing and sequencing/Human genome mapping
6. Magnetic Resonance Imaging (MRI)
7. Microprocessors
8. Fiber optics
9. Office software (spreadsheets, word processors)
10. Non-invasive laser/robotic surgery (laparoscopy)
11. Open source software and services (e.g., Linux, Wikipedia)
12. Light emitting diodes
13. Liquid crystal display (LCD)
14. GPS systems
15. Online shopping/ecommerce/auctions (e.g., eBay)
16. Media file compression (jpeg, mpeg, mp3)
17. Microfinance
18. Photovoltaic Solar Energy
19. Large scale wind turbines
20. Social networking via the Internet
21. Graphic user interface (GUI)
22. Digital photography/videography
23. RFID and applications (e.g., EZ Pass)
24. Genetically modified plants
25. Bio fuels
26. Bar codes and scanners
27. ATMs
28. Stents
29. SRAM flash memory
30. Anti retroviral treatment for AIDS

If your favorite technology wasn’t listed in the Top 30, please let me know and we can add it to the list!

Until next time...

Good Luck and Good Job Hunting (try social networks)!!!!!!!

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The consolidation trend in the US life sciences industry continues. Carlsbad, CA-based Invitrogen, a provider of cells, molecular and biochemical probes and reagents used in life sciences research,announced on Thursday that it will acquire (merge) with automated DNA sequencer manufacturer Applied Biosystems (ABS).  Invitrogen will pay $6.7 billion in cash and stock to buy ABS which is an independent unit of Applera Corporation.

As most of you know, ABS supplied hundreds of automated DNA sequencing machines ($300,000 per machine) that were used to sequence the human genome. The advent of automated DNA sequencers in the mid to late 1990s helped (along with Craig Venter) to speed up efforts to complete the Human Genome project which officially began in 1990. The first draft of the human genome was published in 2001. Unfortunately for ABS, it was unable to refocus and adjust to changing business conditions after the government-sponsored human genome project ended in the early 2000s.  Attempts to reinvent the company included moving into commercial businesses like selling equipment to test food for pathogens or DNA from crime scenes.

The deal, if approved by regulators, would create a giant supplier of machines and materials used by academic and pharmaceutical industry research laboratories, with about $3.5 billion in annual sales. Although the deal makes sense from a business perspective, it is likely that there will be a “reallocation of corporate resources” once the merger is approved by European and US regulators.

Until next time….

Good Luck and Good Job Hunting (try Carlsbad, it is a great place)!!!!!!!!

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