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Sandoz, the generics division of Novartis, is currently the world leader in the biosimilar market. In fact, if it was not for Sandoz, the biosimilar industry may never have gotten started in the first place! As some of you may know, Sandoz sued FDA (and won) to gain approval of its biosimilar human growth hormone. While FDA contends that Omnitrope is not really a biosimilar (it was approved as a “drug” rather than a biologic) most analysts agree that it was the first biosimilar product ever approved and sold in the US. 

As part of its global biosimilar strategy, Sandoz today announced that it had initiated Phase III clinical trails for US approval of biosimilar version of recombinant human granulocyte-colony stimulating factor(G-CSF) or filgrastim (Amgen’s Neupogen®) and another for global launch of PEG-filgrastim (Amgen’s Neulasta®); a PEGylated form of G-CSF.

The filgrastim study is designed to evaluate the efficacy and safety of Sandoz's biosimilar filgrastim versus Neupogen® in breast cancer patients eligible for myelosuppressive chemotherapy treatment. These trials expected to support extension of commercialization to the US, the largest global market for biologics. The pegfilgrastim study, which is being conducted in breast cancer patients undergoing myelosuppressive chemotherapy treatment, represents the next major step in the Sandoz global biosimilar development program. Previously, Sandoz announced that it had initiated late stage clinical trials for a biosimilar version of Roche’s monoclonal antibody cancer treatment Rituxan®). Finally, Sandoz has eight to ten different biosimilar molecules at various stages of development in its pipeline.

Sandoz currently markets and sells three biosimilars: filgrastim (Zario®), somatropin (Omnitrope®) and epoetin alfa (Binocrit®) in countries across Europe and elsewhere. As mentioned above Omnitrope is also sold in the US. However, because FDA has yet to craft a regulatory approval pathway for biosimilars (despite legislation mandating their approval) it is illegal to sell biosimilars (with the exception of Omnitrope) in the US.

Once vilified and staunchly opposed by most major pharmaceutical and biotechnology companies, the biosimilar business has been picking up steam in the past few years. To that end, companies like Merck, Pfizer, Teva and more recently Amgen and Biogen (all of whom lobbied against an approval pathway for biosimilars in the US) announced plans to compete on the global biosimilar market.

The decision of these companies to enter the biosimilar market is largely a result of downward pricing pressures on pharmaceutical and biotechnology drugs and near-empty drug pipelines at most major life sciences companies. Nevertheless, it is still not clear whether or not a robust biosimilar market truly exists. To wit, biosimilars have been in the market in the EU for the past fiver years and have not gained much traction there. However, the real biosimilar markets probably exist in China, Brazil and other emerging countries where there are large populations and emerging middle classes but drug prices are under tight government regulation. Because of this, the uptake of biosimilars in these markets will likely be greater than in Europe and the US.

Until next time...

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

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Asia’s largest drug maker, Takeda, today announced that it will eliminate 2,800 jobs or about 9% of its workforce in the US and Europe. The job cuts, planned over the next four years, are intended to better integrate NycoMed, the Swiss company purchased by Takeda for $12 billion last September.

Most of the positions affected by the downsizing are in the US and Europe and will help the company save $1.7 billion over the next year or so.The plan includes the elimination of 2,100 jobs mainly in Europe and 700 in the U.S. across research, commercial, operations and administrative functions. Takeda currently has about 30,000 employees worldwide with operations in 42 countries.

The reason for the downsizing is slumping US sales of the company’s top selling drug Actos (diabetes) that will lose patent protection this August and face stiff generic competition. Like other pharmaceutical companies, Takeda is abandoning the US and European markets in favor emerging markets in China, India, Brazil and the Middle East.

Until next time...

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

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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. 

Until next time...

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

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The recent E. coli 0104:H4 outbreak of gastroenteritis in Europe that sickened thousands and killed over 20 people was one of the largest foodborne disease outbreaks in the world (for the latest updates check out this article). This prompted my colleagues over at Onlinecertificateprograms.org to post an article entitled “10 Worst Food Contamination Outbreaks” that outlines the most serious foodborne illness to afflict the US.

Some of you may remember some of the more highly publicized ones including the “Jack in the Box” and “Sizzler” E. coli outbreaks in 1993 and 2000 respectively. While E. coli is still on everyone’s mind, the other usual suspects including Salmonella, Listeria and botulism are also featured!

 Here is the list! 

1. Washington Packing Corporation, Botulism (1963): After two women died from botulism due to eating a bad can of A&P tuna packed by the Washington Packing Corporation, health authorities began investigating the company's foods, eventually discovering that the bad tuna had been shipped and stocked in major population centers throughout the Midwest. Wary consumers immediately stopped purchasing tuna, causing the then $277 million industry to suffer a 35% decrease in sales. The families of the two women were paid $226,500 by Washington, which was shut down after the incident.
2. Skewer Inn Restaurant, Botulism (1983): Botulism struck again 20 years after Washington, resulting in one death. The oversight occurred at Peoria, Illinois' Skewer Inn, a popular restaurant located in the constantly-busy Northwoods Mall. Each victim ate beef patty-melts containing contaminated onions, later experiencing symptoms such as blurred vision, slurred speech, trouble breathing and paralysis. Overall, 28 people were hospitalized, 12 of whom required ventilatory support for varying periods of time.
3. Jalisco Cheese, Listeria (1985): The deadliest food contamination outbreak in US history was caused by listeria, a bacteria found in sewage, soil, stream water and plants that manifests through fever, aches and diarrhea. Many of the 142 Southern Californians who fell ill from Jalisco's Mexican-style soft cheese suffered dire consequences — 48 died including 19 stillbirths and 10 infants. When an investigation was completed, the bacteria were traced back to poorly pasteurized milk used to make the cheese at an Artesia plant.
4. Hillfarm Dairy, Salmonella (1985): Consumers would've been best-advised to avoid dairy products altogether in 1985. The Hillfarm Dairy debacle wasn't as severe as the Jalisco debacle, but it was far more widespread, as 16,284 cases of food poisoning due to salmonella were confirmed and possibly 200,000 cases altogether existed in the Midwest. Two deaths resulted, and as many as 12 may have occurred due to two batches of tainted milk produced in Melrose Park, Ill.
5. Jack in the Box, E. coli (1993): Highly publicized and nearly catastrophic for Jack in the Box, the 1993 E. coli outbreak in the Pacific Northwest could've been prevented if the fast food chain had selected better meat, or at least cooked the contaminated meat at the right temperature. According to reports at the time, the patties eaten by the victims contained fecal matter and weren't cooked at 155 degrees Fahrenheit as mandated by Washington state law. Four children died and more than 700 others became sick, prompting the USDA to enforce stricter regulations, and Jack in the Box to overhaul its food safety procedures.
6. Sizzler, E. coli (2000): One of the nation's largest steakhouse franchises experienced a crisis in 2000 when an E. coli O157:H7 outbreak in Milwaukee, Wis., originating from two restaurants in the area, sickened 65 people and killed a three-year-old girl. Health officials discovered that raw meat shipped from the Excel meat packing facility in Colorado came into contact with food eaten by the victims. According to Sizzler, it required all of its restaurants to cook beef entrees at the 160-degree temperature recommended by the US Food and Drug Administration.
7. Pilgrim's Pride, Listeria (2002): At the time, it spurred the largest meat recall in US history. The listeria outbreak of fall 2002 ended with 46 illnesses, three miscarriages and the deaths of seven people, causing Pilgrim's Pride, then the second-largest poultry company in the US, to suspend operations at its Franconia, Pa. plant. From there, products were shipped to grocery stores, food service institutions and restaurants around the country, specifically affecting Connecticut, Delaware, Maryland, Michigan, New Jersey, New York, Ohio and Pennsylvania.
8. Chi-Chi's restaurant, Hepatitis A (2003): Typically a problem suffered by residents of developing countries where personal hygiene standards are poor, a hepatitis A outbreak is a problem most Americans don't worry about facing. Thanks to a batch of green onions used in food at Chi-Chi's Mexican restaurant in Beaver, Pa., more than 660 people fell ill and four people died in the nation's worst outbreak of the infectious disease. Almost all of the victims contracted it by eating mild salsa and cheese dip, which contained raw onions that were traced to Mexico.
9. Natural Selection Foods, E. coli (2006): Veggie eaters across America halted their consumption of spinach in late 2006, as reports surfaced that certain helpings were contaminated with E. coli O157:H7. In early fall, 199 people were infected in 26 states — 31 of whom suffered kidney failure — and three people died. At fault was a farm in San Benito County, Calif., where CDC investigators suspected irrigation that was possibly contaminated from cattle feces, originating from nearby Paicines Ranch, came into contact with spinach fields.
10. Peppers and Tomatoes, Salmonellosis (2008): Jalapeno peppers, serrano peppers and tomatoes contributed to the 2008 United States salmonellosis outbreak, which proved difficult for the CDC to trace. Ultimately, investigators discovered the strain in irrigation water and serrano peppers originating from a packing facility in Nuevo Leon, Mexico and grower in Tamaulipas, Mexico. It infected 1,442 people in 42 states, with the most incidences occurring in Texas (384). At least one death was attributed to the outbreak.

Until next time...

 Good Luck and Good Eating!!!!!!!!

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A massive foodborne outbreak of enterohemorrhagic E. coli (EHEC; typically E. coli 0157:H7) has caused16 deaths and sickened over 470 persons in Northern Europe. The source of the outbreak is thought to be fecally-contaminated raw vegetables including cucumbers, tomatoes and leaf lettuce. The source of the outbreak is still uncertain. German public health officials initially pointed to several cucumbers from Spain as the culprits. But, while these products were contaminated with EHEC, it appears that a different EHEC is responsible for the German outbreak.

Most of the sickened individuals are in Northern Germany although public health officials fear that the outbreak may spread. To that end, the outbreak appears to have worsened over the last 24 hours, with nearly 100 more people suffering from severe and potentially fatal symptoms. Typically, there are only 50 to 60 cases of EHEC infections per year in Germany.

Fecal contamination of the raw vegetables is the likely cause of this massive outbreak because E. coli is found in large quantities in the digestive systems of humans, cows and other mammals. Enteropathogenic strains of E. coli have been responsible for a large number of food contamination outbreaks in a wide range of countries. In most cases, the disease caused by these organisms is characterized by severe abdominal pains, diarrhea and generalized malaise. However, EHEC can cause more severe symptoms, ranging from bloody diarrhea to the rare hemolytic uremic syndrome which can lead to kidney failure, seizures, strokes, comas and death. The uremic syndrome is caused by secretion of a potent and sometime lethal enterotoxin manufactured by EHEC.

Unlike Salmonella gastroenteritis, where large number of organisms must be ingested to cause disease, EHEC infections can be caused by far fewer bacteria following ingestion of contaminated foodstuffs. In this regard, infections caused by EHEC are similar to those caused by Shigella spp which can be caused by between 1 to 10 ingested bacteria.

Let’s hope that the source of the outbreak is quickly identified before more people get sick or die.

Until next time...

Good Luck and Wash All Raw Vegetables Before Eating!!!!!!

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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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The Pharmalot Blog today reported that Abbott will be cutting about 3,000 jobs. The downsizing comes about a year after Abbott purchased Solvay Pharmaceuticals for about 6.2 billion but failed last month to find a buyer for the Solvay vaccine unit (which was expected to fetch about $600 million). 

According to the post, most of the jobs will be eliminated in R&D, manufacturing and commercial operations mainly at former Solvay Pharmaceutical sites in the Netherlands and Germany. Also, Solvay’s current US headquarters in Marietta Georgia will be closed in the near future.

Abbott has approximately 90,000 employees worldwide. While the recession may be officially over the job cuts continue and unemployment continues to rise.

Until next time...

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

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One economic downturn and it seems as though the pharmaceutical world has been turned upside down! Who would have thought a few years ago that emerging pharmaceutical markets in India and Asia will outpace the US and Western European markets in the very near future (I did but nobody listens to me). To that end, Ranbaxy Laboratories will hire nearly 1,500 marketing executives, expanding its sales team by at least 50%, to spur sales and regain its rank as India’s top drug maker. The recruitment push is among the biggest by an Indian drug maker in recent years.  Ironically, pharma sales reps are still being regularly layed off in the US.

The company plans to hire mostly medical representatives, regional managers and area managers by July to boost sales in the rural markets.  According to a Ranbaxy hiring manager “Ranbaxy is looking at new rural markets and deeper penetration in interior markets.”

Ranbaxy is owned by Japan’s Daiichi Sankyo which employs over 12,000 people in 46 countries.

Industry analysts suggest that Ranbaxy’s aggressive hiring push is a sign that the company is focusing on internal markets which are poised for exponential growth in the next few years. Also, Ranbaxy has had its share of legal and regulatory disputes over patents and generics drugs in the US and Western Europe signaling that the company may be pursuing those markets less aggressively than in the past.

Until next time…

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

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As reported in the March issue of Pharmaceutical Technology Europe, figures published by the European Medicines Agency (EMA) showed that the approval rate for new drugs (branded, generics, biosimilars and orphan) increased between 2007 and 2009; however most of the approvals were for generic drugs not new ones.

According to the published figures there were 58 new drug approvals in 2007, 66 in 2008 and 117 in 2009. However, the number of approvals for branded products decreased during this period; 35 in 2009 compared with 41 in 2008 and 59 in 2007. On the other hand, the approval rate for generics skyrocketed with more than 50 in 2009 as compared with 4 in 2008 and 5 in 2007.

Interestingly, biosimilar products didn’t fare as well as small molecule generic drugs with the number of applications and approvals decreasing during the period. For example, in 2007 10 new biosimilar applications were filed as compared with 3 in 2008 and 1 in 2009. Likewise, the number of approved biosimilar products decreased with 5 in 2007, 6 in 2008 and 0 in 2009. This trend suggests that biosimilars, mainly therapeutic proteins are not faring well in the European market. However, this is likely to change as patents begin to expire for monoclonal antibody-based drugs which are increasingly becoming the new drugs of choice for many indications including oncology, inflammation and metabolic diseases. Nevertheless, there is a growing emphasis and trend on developing generic medications as compared with new ones. Expect this trend to continue as patent expiry for many small and large molecule continues to draw near.

Until next time…

Good Luck and Good Job Hunting!!!!!

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Earlier this week, an article appeared in the NY Times Business section heralding the entry of several large pharmaceutical companies into the branded generics industry. For those of you who may not know, generic drugs are lower cost versions of brand name prescription drugs that have lost patent protection. Generic prescription drugs are usually much cheaper than their brand name counterparts but generally deliver the same therapeutic effects as the branded product. In most cases, so-called “commodity generic drugs” are not branded and sold to consumers by their chemical names. A good example of a commodity generic drug is the anti-depressant sertraline HCl; which Pfizer sells under the brand name Zoloft. Pfizer still manufactures and sells Zoloft but Zoloft lost patent protection several years ago and a generic version of the active ingredient, sertraline HCl, is now available to consumers. Because sertraline HCl is much cheaper than Zoloft, pharmacists almost always substitute prescriptions for Zoloft with sertraline HCl. This is perfectly acceptable because sertraline HCl was approved by the US Food and Drug administration with an AB rating which means that sertraline HCl is biologically equivalent to Zoloft.

Unlike commoditized (no-name) generics, branded generics are off-patent prescription drugs that are sold to consumers—as the name implies—under a brand name. Typically, because these products are “branded” and actively marketed by manufacturers they are sold at higher prices than equivalent no-name generics. This is because consumers are generally willing to pay more for drugs that are manufactured by well known and trusted companies as compared with no-name generics which are usually produced by lesser known or unidentified manufacturers.

Branded generics are not a new or novel concept. They were previously championed by a number of generics manufacturers, most notably Barr Laboratories, which was recently purchased by the Israeli generics giant TEVA. In the past, when pharma embraced the blockbuster drug business model, drug manufacturers built in revenues— that eventually would be lost through patent expiry—into the price of their top selling drugs. This allows drug companies to maximize ROI early in a drug’s life cycle years before patent expiry Studies have shown that branded prescription drugs can lose as much as 90% of their original value two years after the introduction of generic equivalents. Consequently, because of drastically diminishing financial returns after patent expiry, it didn’t make economic sense to continue to promote and support a brand that was facing generic competition. Put simply, the company made its money on the drug and it is time to move on. 

However, the emergence in recent years of an affluent middle class in developing markets like China, India, Brazil, Eastern Europe and elsewhere is causing branded pharmaceutical companies to reconsider their generics strategy. In these markets, many people frequently pay out of pocket for their medicines but cannot afford to pay for the expensive brand name drugs. Also, in some emerging markets, where the threat of low quality or counterfeit prescription drugs may be high, consumers who can afford to purchase medicines are willing to pay more for drugs manufactured by well known and respected companies. Finally, IMS Health estimates that close to $89 billion in US drug sales alone will be lost to generic competition over the next five years or so.

In the absence of any new blockbuster drugs on the horizon, many big pharma companies have been scrambling to acquire or enter into relationship with established regional generic manufacturers. For example, GlaxoSmithKline recently bought a stake in Aspen a South African generics manufacturer and entered into an agreement with India-based Dr. Reddy’s laboratory to sell generic products in Asia and other emerging markets. Likewise, in the last year, Pfizer created an off-patent generics division (products are sold under Greenstone label which is a wholly owned subsidiary of Pfizer) and signed agreements with three Indian companies to sell their products in the US and other markets. These deals added about 200 products to Pfizer’s new generics portfolio. Further, Pfizer recently announced that the Greenstone brand has become the world’s seventh largest generics seller. In addition, Pfizer is expected to make a formal bid to purchase the financially-troubled German generics manufacturer Ratiopharm; one of Germany’s largest purveyor of generic drugs.

Not to be outdone by the competition, the French drug maker Sanofi-Aventis recently purchased Brazil-based Medley, a dominant player in the South American branded generics industry and Laboratorios Kendrik, a Mexican generics producer. Last year, the company also purchased Zentiva, a leading Czech generic manufacturer signally the company’s intention to move into financially-lucrative Eastern European markets.

Watson, one of the largest American generics manufacturers (which primarily operates in the US) recently purchased Arrow, a generic producer that operates in 20 different countries. Finally, Novartis, recognizing a business opportunity before most of its competitors, entered the generic market in 2003 following creation of Sandoz, a division of Novartis that manufactures and sells small molecule generic drugs and branded biosimilar products. Recently, Novartis purchased the German branded generics manufacturer Hexal, making it the world’s second largest generic drug manufacturer after Teva.

The entry of pharmaceutical companies into the generics business is allowing these companies to pursue a two-tiered business strategy in certain markets which is designed to preserve the long term value of their branded franchises. For example, companies can continue to sell their expensive name-brand drugs to the wealthy (or those that can afford them) and concurrently sell the more moderately priced branded generics which includes and over the counter products to the broader market. 

While some may lament the end of the blockbuster drug era, rising healthcare costs and generic competition is forcing big pharma to continue to explore novel and innovative strategies to reinvent itself.

Until next time...

Good Luck and Good Job Hunting (try the generic industry; business is booming)

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The increasing costs of conducting human clinical trials and the requirement for more stringent safety data for new molecular entities is forcing a growing number of pharmaceutical and biotechnology companies to outsource clinical development of new drugs to Central and Eastern Europe and Asia, most notably India. If your company is considering this option, you may be interested in attending an upcoming conference and workshop sponsored by Next Level Pharma. 

 “Clinical Outsourcing Alliances in Central & Eastern Europe” is a one day conference that will be held on October 8, 2009 in Boston, MA. Company representatives from American and European life science companies and clinical research organization will present talks on the “nuts and bolts” of setting up and conducting human clinical trials in Europe.

A half-day workshop entitled “Clinical Outsource Alliances in India” is being offered on day 2 of the conference. The workshop is intended to introduce American clinical trial sponsors interested in conducting human clinical trials in India to prospective Indian CROs. Presentations from American pharmaceutical executives and Indian CRO representatives will describe the realities of running clinical trials in India and allow attendees to identify potential clinical development partners.

Don’t miss this opportunity to learn the “ins” and “outs of outsourcing foreign clinical drug development.

Until next time...

Good Luck and Good Job Hunting!!!!!

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Previously, the US Congress proposed legislation to create a regulatory approval process to allow the Food and Drug Administration (FDA) to approve generic versions of blockbuster biotechnology drugs known as follow-on biologics (FOBs). While a regulatory pathway exists for approval of generic versions of small molecule drugs (as outlined in the Hatch-Waxman Act) there is no legally-approved regulatory pathway to bring FOBs to market in the US. In contrast with the US, the European Union crafted legislation five years ago that allows biosimilars —the name given to FOBs in Europe—to be approved and sold in EU member states. Since 2004, the European Medicines Agency (EMEA), the EU regulatory body, has approved the sale of six biosimilar drugs with many more in the queue awaiting regulatory review.

The debate over FOB legislation started in the US about 10 years ago when patent expiry of many  multi-billion blockbuster biotechnology drugs was fast approaching. From the beginning, many so-called innovator companies (the companies that produced the original branded biotechnology drugs) and the trade associations that represent them on Capital Hill, the Biotechnology Industry Organization (BIO) and the Pharmaceutical Manufacturing Association (PhRMA), aggressively lobbied against any form of FOB legislation. However, late last year, several senators introduced legislation that would permit FDA to approve generic versions of many blockbuster biopharmaceutical products following patent expiry. The proposed legislation stipulated that FOB manufacturers would have to wait 12 years —after patent expiry of previously approved biotechnology drugs—before generic versions of those drugs could be sold in the US. That legislation, which unabashedly favored innovator drug manufacturers, passed the Senate health committee but died without being voted on. The new measure, introduced Thursday, cuts by more than half — to 5 years, from 12 — the time allowed before cheaper versions of biotechnology drugs could compete with the originals. A similar bill was introduced two weeks ago in the House by Representative Henry A. Waxman, Democrat of California and chairman of the Energy and Commerce Committee.

While the proposed reduction in the so-called “FOB waiting period” is commendable, I don’t think that any waiting period is necessary before FOBs can be sold in the US. It is difficult to understand why innovator companies require an additional patent protection—beyond the 20 years already afforded to them under US patent law—to continue to sell their blockbuster products! To that end, Jeff Joseph, a spokesman for the BIO said that the FOB waiting period reduction, “.... Would jeopardize patient safety and undermine our ability to develop future cures and therapies.” I believe that the FOB waiting period being championed by innovators companies is nothing more a thinly veiled attempt by them to continue to maintain monopolistic control over lucrative multibillion dollar biopharmaceutical drug franchises. Biotech executives have vowed to vigorously fight the new legislation, saying it could result in unsafe medicines, fewer cures and fewer jobs in biotechnology centers like Boston, California and elsewhere. Interestingly, similar arguments were put forward by the pharmaceutical industry before the Hatch-Waxman act was passed by Congress in 1984..

Despite the claims that FOBs will stifle innovation and may jeopardize the safety of Americans, the current high costs and lack of access to affordable healthcare will almost certainly leave Congress no choice but to pass legislation that permits the marketing and sale of FOBs in the US. While FOB legislation is a likely fait accompli, US drug manufacturers remain steadfastly opposed to any FOB legislation. I believe that innovator company opposition to FOB legislation is really a “red herring” that serves to detract attention away from the real issue that the drug industry is deathly afraid of federal regulation of drug prices. Interestingly, the US is one of the only countries in the world where drug prices are not regulated or controlled by the government. This permits drug manufacturers to set prices based exclusively on “what price the US market will bear.” In other words, they can charge as much as they want for their drugs, as long as third party payors, insurance companies and Medicare and Medicaid agree to continue to cover the costs of the drugs that they manufacture (it should come as no surprise to anyone that the American pharmaceutical and biotechnology markets are the largest and most financially lucrative in the world).

I have no doubt that innovator companies will continue to fight hard and as long as possible prevent adoption of legislation regulating the approval of FOBs. After all, there are huge sums of money and corporate profits at stake. Like it or not, FOBs will ultimately be sold in the US—the current costs of drug and healthcare are simply too high to sustain. Despite a fierce decade-long struggle, most American drug makers will privately concede that sale of FOBs in the US is inevitable. Nevertheless, innovator companies will likely not publicly endorse FOB legislation until the US government provides them with assurances that it will not seek to regulate American drug prices for the foreseeable future.

Until next time...

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

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Pfizer announced today that it will eliminate almost 1,000 jobs in France through layoffs or voluntary departures. Gerard Bouquet, vice-president of Pfizer France, announced that "This new organization will take effect from Dec. 1, 2009 and there will be no forced layoffs before that date.” The cuts will affect Pfizer’s sales force and at it Paris-based headquarters.

Today’s announcement comes just a few days after Rod MacKenzie, Pfizer’s worldwide head of discovery research told reporters “Given the complexity of the changes within research, I have concluded that we will not be able to provide that clarity [for the layoffs] or communicate them by the end of the year." While it appears that there may some confusion regarding American workers, this is clearly not the case for Pfizer’s European employees.

Until next time…

Good Luck and Good Job Hunting

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We in America have grown accustomed to the constant barrage of direct-to-consumer (DTC) advertising of prescription drugs provided to us daily by pharmaceutical and biotechnology companies. That said, some of you may be surprised to learn that DTC advertising of prescription drugs is only permitted in two countries in the world: New Zealand and the US.

According to William Burns, an executive at Roche Pharmaceuticals, “Direct-to-consumer promotion was the single worst decision for the industry." He added, "When industry says we're spending all the money on R&D but actually it's spending it on TV advertising to preserve margins, it doesn't get much credibility." It may not provide much credibility to the industry but is sure does help sales.  reported that a total of $4.2 billion was spent on DTC drug ads in the U.S. in 2005, up 330 percent from 1996.

Apparently Mr. Burns is not alone in his opinion. Angus Russell, chief executive of Britain's Shire Pharmaceuticals also condemned DTC.  As many of you know, I ‘m not a big fan of DTC nor am I flag-waving American but I find it rather curious that after almost 12 years of DTC advertising that European pharma executives are suddenly speaking out against the practice. Could this be little more than a ploy to get the European Commission to re-examine and possibly loosen it restrictions on the way prescription drugs are promoted in the EU? Quite coincidentally, the European Commission is in the process of drawing up legislation that would allow a degree of information to be disseminated about medicines by their makers, although advertising pharmaceuticals would remain banned. The legislation was initially expected to be unveiled by the European Union's executive arm last week but has been delayed.

Drug makers have long campaigned against rules that prevent them from talking directly to consumers in Europe, despite a wealth of often unreliable information being available on the Internet. I think this statement by Mr. Burns sums up the situation "You've got the two extremes on the planet, where we (drug makers) are given access to the public in America, which is too much, and in Europe we're not given access to information" (sounds like sour grapes to me).

Maybe a compromise between the two extremes would be a solution acceptable to both American and European regulators? 

Until next time…

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

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Pharmaceutical Technology Europe published a list last month called the Pharma Exec 50 for 2008. To qualify for the list, companies had to have more than $510 billion in sales.  Unlike other lists of this ilk, it is easy to read, visually appealing and mentions each company’s top selling drugs and their annual R &D spending.  It is definitely worth a read by people who need or like to stay abreast of the life sciences industry. And for a change, the list was compiled by a European rather than an American publication. Not that there is anything wrong with that!

Good Luck and Good Job Hunting!!!!

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Astra Zeneca and Sanofi-Aventis announced job cuts today that will take place in the UK and Germany.

AstraZeneca says it plans to cut more than 300 jobs at its research and development hub at Alderley Park near Wilmslow England, 60 more than unions had feared.

The company, one of the biggest employers in Cheshire, said last week that it was examining its global R&D structure, prompting trade unions to claim that 244 jobs were likely to go at Alderley Park - its largest site for research - which employs more than 3,500. The majority of those affected at Alderley Park work on R&D into respiratory conditions, while there will be a smaller number of job losses from the cardio-vascular team.

Sanofi Aventis plans to eliminate 380 sales and marketing jobs in Germany, one-fifth of the total, because of difficult market conditions, a company spokesperson said. Sanofi Aventis currently employs 1,900 sales and marketing personnel in Germany. The company has 10,000 employees in the country.

The cuts will be made through a voluntary departure plan and retirements, the spokesperson said, citing difficulties in obtaining reimbursements, competition from generic drugs, and falling prices as reasons for the cuts.

The spokesman declined to comment on German press reports which said Sanofi Aventis's sales in Germany fell 8 per cent last year.

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