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The Pharmalot blog today reported that pharma and biotech downsizing, restructuring and outsourcing have resulted in 38 manufacturing facilities in 2011. While this may not sound like a lot given the ongoing tough economy, the post reports that 65 facilities were closed in 2010. According to some estimates, these closures have resulted in the loss of roughly 18,000 life sciences manufacturing jobs in the past two years. Sadly, pharmaceutical manufacturing, like almost all other manufacturing jobs in the US are being lost at an unprecedented rate. Further, many of these manufacturing jobs are being outsourced to multinational CMOs or to manufacturing facilities being built by pharma companies in emerging markets like Latin America, Eastern Europe and Asia.

Not surprisingly, most of the 2011 closures were in the Northeast (8) resulting in the loss of roughly 1,400 jobs. And, not surprisingly again, one of the hardest hit states was New Jersey; home to almost all of the major pharmaceutical companies in the world. The next region that was hit hard is the Mid-Atlantic (7) with notable closures in Maryland (Shire Pharmaceuticals) and North Carolina (DSM Pharmaceutical Products).

Interestingly, while plant closures are on the rise, there is new manufacturing facility construction that may help to offset the losses. However, unlike the past, many of the new facilities are being financed by academic institutions and not-for-profits rather than life sciences companies. According to the post, roughly 106 new North American (not only the US) are underway and represent an investment value of $4.3 billion. The new Shire facility being constructed in Lexington, MA and the International Vaccine Center (InterVac) in Saskatoon, Saskatchewan were cited as examples.

Despite the constructions of several new manufacturing facilities in North America, it is obvious that most major life sciences companies are looking South and East for future pharmaceutical and biomanufacturing capabilities. The bottom line is that labor and the cost of goods are cheaper in these markets and in contrast with the past, there are skilled workforces in place to manufacture life sciences products according to American, European and Japanese Current Good Manufacturing Practices. 

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While China and India have gotten the most attention as emerging pharmaceutical markets, Latin American markets most notably Mexico and Brazil (okay, it is a South American country but it can be included in Latin America) have been quietly expanding as rapidly as the Indian and Chinese markets. To wit, Denmark-based, Novo Nordisk—the world’s largest insulin maker—recently announced that it will be beefing up its medical consultant (aka sales reps) presence in Latin America over the next two to three years. During this period, the company expects to increase its current headcount of 300 to 800 employees.

Novo currently holds a 50 percent share of the Latin American insulin market. The company currently generates annual sales in Latin America of approximately $360 million. But, its main rivals Sanofi Aventis and Eli Lilly & Co, which sell faster-acting insulins, are beginning to cut into Novo’s market share.  The solution: add more sales reps in the region. While this may be great news for Latin American sales reps, it is not good news for American sales reps. Unless, of course, these reps speak Spanish and are willing to relocate!

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During the Bush Administration I, along with many others, was a harsh critic of the US Food and Drug Administration (FDA). The criticisms that I levied against the agency were mainly based on its inability to adequately maintain the safety of the American drug and food supply and Bush’s repeated attempts to politicize the organization and render it useless. That said, it is amazing how much has and will change at the agency during the Obama Administration. To wit, Margaret Hamburg, the current FDA Commissioner yesterday announced plans that would dramatically transform the agency and largely change the way it does business.

In an unusually rare special report entitled “Pathway to Global Product Safety and Quality” Hamburg points out the monitoring problems currently facing the agency and proposes a four-point plan on how to fix them. To understand the importance of this document it is necessary to point out some little know facts about the American food and drug supply.

First, almost two-thirds of all fruits and vegetables and nearly 75 percent of all seafood consumed by Americans is imported. This year the number of these types of food shipments is expected to grow to 24 million through 300 or more ports. A little as a decade ago, the agency was responsible for overseeing and policing six million shipments annually. Second, it is estimated that over 80 percent of the active pharmaceutical ingredients (APIs) found in approved drugs are made in manufacturing plants found mainly in China, India and Latin America. Because of funding and “manpower” shortages, most of these API manufacturing facilities are rarely inspected for regulatory compliance. According to the report, many kinds of antibiotics, oncology drug and other medications are no longer produced in the US or in many cases anywhere in the Western world. Finally, roughly 50 percent of all approved medical devices sold in the US are made in foreign production facilities.

In 2008, government officials determined that the agency would need approximately 13 years to inspect all foreign drug manufacturing plants, 27 years to check every foreign medical device production facility and a whopping 1,900 years to check every foreign food production plant! This is because FDA has only several hundred inspectors who are empowered to perform these inspections. Consequently, only a fraction of the food and APIs imported to the US are inspected. For example, less than one pound in a million of imported seafood gets as much as a “visual inspection” to determine whether or not it is fit for American consumption. This led the report’s authors to contend that “the safety of America’s food and medical products remain under serious threat.”

Yet, despite this ongoing threat, Republican lawmakers last week voted to cut the agency’s budget rather than increase it to perform the necessary number of food and drug inspections. Further, the same lawmakers oppose any corporate or consumer fees, whether voluntary or forced, to help to underwrite the inspections calling them an unacceptable tax. This has forced the agency to enlist the help of regulators in other nations to create a global coalition or network to perform the required inspections to insure the regulatory compliance and safety of foods, drugs and devices imported into the US. While the FDA has limited cooperation agreements with regulators in Europe and other Western countries, it just recently stationed its own inspectors in emerging markets like China, India and Central America. In theory this should work. However, in the past, some of the governments of these countries have refused to fully cooperation with FDA. Further, and perhaps more problematic, is that regulatory agencies in some other countries are largely corrupt or nonexistent. Finally, some outspoken former FDA employees and critics contend that improvements in the communication between FDA in Washington and its field offices in US states may be necessary before the agency can effectively enlist the cooperation of foreign regulators.

There is no doubt that contaminated foods, counterfeit medical devices and tainted drugs are increasingly finding their way into the US. It is FDA’s legislated responsibility to insure that all foods and drugs sold in the US are safe and effective for all Americans. Republican lawmaker’s refusal to increase FDA’s budget to allow the agency to fulfill its mandate is unconscionable and indefensible. The safety and health of all Americans is critically important for the well being of the nation and ought to take precedent over budget shortfalls and a looming US trade deficit.

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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.

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The Pharmalot Blog reported today that a survey conducted by the outsourcing firm Challenger, Gray & Christmas shows that only 200 pharmaceutical employees lost jobs in August. This compared with the 2,023 jobs lost in July, 830 in June and the 6,943 in May. According to the post, this year’s job loss tally is 37,265 as compared with 53,004 in 2009.  Since 2007, it has been estimated that over 180,000 life sciences employees have lost their jobs.

While the slowing layoffs are encouraging, there are no signs that companies are going to be hiring in 2011 (unless you are willing to relocate to Asia). Further, while layoffs are slowing a big pharma companies, the number of scientists losing their jobs at biotechnology companies because of insufficient capital or merger and acquisition activities remains steady and will likely increase if Sanofi-Aventis purchases Genzyme and other biotechnology companies are purchased. For example, Pfizer announced today that it was purchasing FoldRx for an undisclosed amount. FoldRx’s pipeline contains preclinical and clinical candidates for investigational new drugs that treat diseases caused by protein misfolding. The acquisition is consistent with Pfizer’s intention to move into the orphan drug market.

From an historical perspective, the early 2000s was the golden age for life sciences employees in most Western countries. Unfortunately, the golden age has ended for Western employees and it appears that a new era for pharmaceutical and biotechnology employees is beginning in the Asia, South America and Africa!

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A survey involving 2000 members of the public and 2500 scientists conducted by the Pew Research Center for the People & the Press and the American Association for the Advancement of Science (AAAS) revealed that almost two-thirds of Americans hold scientists and engineers (and their contributions to society) in high regard. However, in marked contrast, 85% of the scientists surveyed said that public ignorance of science was a major problem. And, not surprisingly a majority of the scientists surveyed feel that American media coverage of science is “fair or poor.”

While the reasons for this disconnect in opinions aren’t readily apparent, perhaps some insights into the public’s understanding of scientific concepts like evolution and climate might be informative. For example, almost 35% of Americans believe that “humans existed in their current form since the beginning of time” whereas only 2% of scientists hold this belief. Further, only about 50 percent of Americans agree that humans are behind climate change and a whopping11 percent believe that there isn’t global warming at all. These beliefs trouble many scientists because there is no credible scientific evidence to refute the theory of evolution and there is incontrovertible data which shows that humans are a major contributor to global warming. So, what’s the deal with Americans?

There is little doubt that American science education is lacking. For the most part, this deficiency has been blamed on poorly trained and uninformed primary and secondary school science teachers. While this may be partly true, scientists and engineers also bear much of the responsibility.  According to the report, only 3 percent of the scientists surveyed said that they “often” spoke to reporters and the media. In other words, a majority of scientists don’t feel that it’s important to engage the public in fundamental discussion about evolution and climate change.  A facile and convenient way for scientists to eschew any responsibility for the problem is to label the American public as “ignorant about science” and not do anything about it. If scientists truly want to improve the public understanding of science, it will be necessary to roll up our sleeves and do some work to better inform and educate them!  New social media tools like blogs, videos, podcasts and social networking sites like BioCrowd represent ideal vehicles to begin to make headway against this vexing problem! 

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Good Luck and Good Teaching!!!!!!!

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