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Until recently, there was little or no mention of business activity within the emerging Chinese life sciences industry. However, as the Chinese middle class continues to grow, the need and demand for pharmaceutical and biotechnology drugs (including vaccines and other biologics continues) to grow at a frenetic pace. Further, a growing abundance of US-trained scientists has allowed the Chinese life science industry to develop much more quickly than anticipated. Also, many major pharmaceutical companies like Merck, Roche and Novartis have invested hundreds of millions of dollars in China and have already established world class Chinese R&D facilities. Finally, unlike in most Western countries, the Chinese government controls roughly 80% of the pharmaceutical and biologics manufacturing that takes place in China. Together, this suggests that China has quietly established itself as a life sciences power to be reckoned with! To that end, there were two reports that came across the transom this morning that piqued my interest. 

The first report was about a company called Lotus Pharmaceuticals, Inc.

"Lotus Pharmaceuticals, Inc., a growing developer and producer of prescription drugs and licensed national seller of pharmaceutical products in the People's Republic of China ("PRC"), reported the groundbreaking ceremony on March 9 to construct a new building complex on the grounds of its production facility in Beijing.

Officials of Beijing municipal and Chaoyang district governments, officers of the China State Food & Drug, and representatives of both state-owned and private pharmaceutical companies attended the ceremony. CEO, Zhongyi Liu, welcomed the guests. "After a year of planning, we are pleased to start the construction of the new building complex and expect to finish the construction by July, interior decoration by September and GMP certification by December of this year," he said. "This is a new page for Lotus' development and it will provide important impetus to profitable growth, which is anticipated to reach $150 million in annual sales during the first year after the facility, is fully operational."

The second reported on plans to build a venture-back, “private” contract manufacturing facility that specializes in biomanufacturing in metropolitan Beijing.

"AutekBio, Inc., SUMA Ventures and Beijing E-Town Harvest International Capital Management Corporation, a venture capital group from Beijing Municipal Government announced a joint investment of more than US$100m to develop a new contract manufacturing organization (CMO) for biopharmaceutical industry in China. This joint effort led by AutekBio represents strong interests from both private investment sector and government to establish world quality capability and capacity in biopharmaceutical manufacturing in China.

The new joint venture will build up a world class R&D and manufacturing center in southern Beijing to service international biologic developments, with combined volumes of bioreactors up to 20,000 liters in multiple production lines (trains). The firm will also benefit from financial, regulatory and other supports from the Chinese government for the biotech industry." 

It is becoming increasingly apparent that China has clearly set its sights on establishing itself as player on the global life sciences stage. After spending a week in China during the country’s preparation for the Beijing Games, I discovered that China can achieve any goal that it sets for itself in very short order.  

Until next time...  

Good Luck and Good Job Hunting (try China)!!!!!! 

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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 loss of over 200,000 pharmaceutical jobs over the past three years has been mainly driven by the anticipated loss of revenue from blockbuster drugs that will lose patent protection by 2013. While drug makers frequently cite blockbuster patent expiry as the reason for the need to downsize, they rarely provide the business and economic metrics, numbers and statistics that have influenced their decisions. 

Patricia Van Arnum, Senior Editor of Pharmaceutical Technology wrote a fascinating article in this month’s issue of Pharmaceutical Technology Europe that skillfully outlined the economic forces that are driving branded pharmaceutical companies to downsize and reorganize. According to the article, in October 2009 the pharmaceutical intelligence firm IMS estimated that the global pharmaceutical market is expected to growth 4-6% in 2010 and reach $825 billion. Market growth at an annual rate of 4-7% is expected to continue through 2013 and the size of global pharmaceutical market is projected to exceed $975 billion. The US pharmaceutical market, the largest in the world, is expected to drive much of this growth. However, the growth of the American market is only expected to be 3.5% in 2010. In market contrast, China’s pharmaceutical market is expected to increase by a staggering 20% per year and contribute 21% to the overall growth of the global pharmaceutical market by 2013. 

While prospects for the US market are better than originally anticipated, the loss of nearly $137 billion in revenues in 2013— because of patent expiry of blockbuster products—coupled with fewer new drug approvals are the factors that will limit the growth of the global pharmaceutical market to single digits through 2013 and likely beyond. Some of the drugs slated to lose patent protection by 2013 include Lipitor (atorvastatin) by Pfizer, Plavix (clopidogrel) by Sanofi-Aventis and Bristol-Myers Squibb and Seretide/Advair (salmeterol and fluticasone) by GlaxoSmithKline. Lipitor, Plavix and Seretide were the number one-, two- and foruth best-selling drugs in 2008 with global sales of $13.7 billion, $8.6 billion and $7.7 billion respectively.

The increasing growth of the generic pharmaceutical industry is best reflected in the concomitant growth of merchant active pharmaceutical ingredient (API) manufacturing industry. In the API world, there are two types of manufacturers; the so-called captive API producers or companies that exclusively manufacture APIs for finished, branded products and merchant manufacturers which are third party providers of APIs. Over the past four years or so, the growth of the merchant API market for generic products has substantially outpaced the growth of the API for innovator products. For example, from 2004-2008 the merchant market for generics grew at an average annual rate of 9.1% from $12 billion in 2004 to $17 billion in 2008 according to a recent report by the Chemical Pharmaceutical Association (CPA). In contrast, the CPA determined that the merchant market for innovator/branded APIs only increased at an average annual rate of 4.4% from $16 billion in 2004 to $19 billion in 2008. Looking ahead, the worldwide market for merchant APIs is projected to grow at an average annual growth rate of 6.8% through 2013 to about $50 billion. During this period, growth of innovator APIs is expected to be about 1.8% whereas the growth of generic API is expected to be a robust 11.4%.

The US is currently the largest market for generic APIs and consumed roughly 22.9% of the total global demand for generic APIs in 2008. China, which is the second largest consumer of generic APIs, consumed 19.2%. While the US is expected to remain the largest consumer of both innovator and generic APIs, China is projected to become the largest consumer of generic APIs in 2013 capturing a 26% share of the total generic API market (the US will be number 2 with 20.5% market share).

According to industry analysts, China, India, Latin America and Central and Eastern Europe (most notably Russia), represent attractive growth opportunities for generic APIs. India and China now account for roughly 25% of the global generic market and demand in these countries is expected to remain strong for the foreseeable future as the middle class continues to emerge. To that end, China is projected to have the highest average annual growth rate at 18.4% and India’s market will grow by 14% through 2013. Similar growth is expected for the Eastern European, Russian and Brazilian generic API markets.

While the economic size of emerging generic markets is still small compared with those of the US, Western Europe and Japan, it signals that generic drugs will likely drive the future growth of the pharmaceutical industry. The lack of innovation and rising costs of branded, prescription drugs in developed nations is the main driving force behind the rapid emergence of the generic drug industry. That said, is it any wonder why Pfizer is thinking about entering the generic pharmaceutical business and that Western drug companies are shedding scientists and sales people in the US and Europe and growing the sizes of their R&D and sales force staffs in Asia, Eastern Europe and Latin America? Honestly, if I had any money left to invest, I would seriously be considering traded generic pharmaceutical manufacturers—their future success is almost guaranteed!

Until next time...

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

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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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Pfizer today announced that it’s looking to increase its sales force in China to 3,200 by the end of next year, up from about 2,300. The company expects to have sales representatives in about 250 Chinese cities by the end of 2011. It presently has a sales presence in about 185 cities. Previously, Pfizer it will cut nearly 20,000 jobs as part of the Wyeth merger. Over the pass several years more than 50,000 US pharma sales reps have lost their jobs.

Eli Lilly said last fall that it would continue to hire in China, even as it cuts jobs in the U.S. and other developed markets. Novartis is also making a big push into China, hiring hundreds of workers and spending $1 billion to expand a research center in Shanghai.

With business tough in developed markets, drug makers are counting on the developing world for growth and are expanding into biotechnology and generic drug manufacturing.

Like it or not, the emerging markets in China, India, Brazil and elsewhere represent a substantial upside whereas markets in the developing world are becoming less profitable. Drug companies, like most other large multinational companies, always will follow the profit stream not matter where it takes them or at what cost to the folks at home.

Until next time...

 Good Luck and Good Job Hunting (Try China, I hear they are looking for sales reps)

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The rancorous debate over a regulatory approval pathway for follow-on biologics (aka biosimilars) continues to rage on in the US Congress. Despite recommendations from the Federal Trade Commission that a data exclusivity period for follow-on biologics isn't necessary and a seven year compromise offered by President Obama,the pharmaceutical and biotechnology lobbies continue to press Congress for a 12 to 14 year period of data exclusivity in any legislation for follow-on biologics. 

In a well-balanced article in today’s New York Times, Andrew Pollack diligently put forth the arguments against follow-on biologics that innovator companies have been espousing for the past decade. These include: complexity of the manufacturing processes for biotechnology drugs, potential tolerability and safety issues and perhaps, most importantly, an anticipated loss of profits that innovator companies claim “would stifle American innovation” in the life sciences. Until recently, these arguments were successfully used to hinder any substantive debates on follow-on biologics legislation. However, it  has become increasingly apparent that the American healthcare system can no longer sustain the high costs and lack of access to potentially life-saving branded biotechnology drugs. For those of you who may not know, a regulatory approval pathway for biosimilars already exists in Europe and it has been used to approve eight products since its inception in 2004.  Biosimilars are also available in Australia and have been sold for many years in less-regulated markets including India, China and elsewhere. Japan recently approved legislation for approval of biosimilars and Canada is close to finalizing its regulatory guidelines for these products.

American innovator companies recognizing the inevitability of follow-on biologics, no longer oppose legislation for approval of these molecules. Instead, these companies and their supporters have tenaciously latched on to the data exclusivity argument, presumably in a last ditch effort to preserve their profits from multibillion dollar biotechnology drug franchises that may be lost when follow-on biologics legislation is enacted.  And, for the most part, their uncompromising insistence on an excessively long data exclusivity period appears to be taking hold with members of Congress. At last count, there were more Congressional sponsors of legislation favoring a 12 to 14 year data exclusivity period than there was for those who support a 5 year data exclusively period. The five year data exclusivity period was proposed by follow-on biologics proponents because it is identical to the period required for generic versions of small molecule drugs enacted in the Hatch Waxman Act.

I have been following the follow-on biologic debate for the past eight years and, to date, I know of no scientific claims or relevant safety concerns which argue that 12 to 14 years of data exclusivity is warranted for follow-on products.  For example, no untoward safety or tolerability problems have been reported for any of the eight biosimilar products that were approved and sold in Europe for the past three years. Further, European healthcare agencies and physicians haven’t readily embraced biosimilars despite an almost 25%-30% reduction in price. The one exception is Germany (the largest generic market in Europe), where biosimilar versions of erythropoietin (Eprex) have captured 30% of the anemia market. This, in turn, has  forced some innovator companies to lower prices on their branded products.

Based on the European experience, it is likely that follow-on biologics won’t catch on quickly in the US and it may take years for them to erode the market share garnered by innovator brands.  Also, contrary to earlier assertions, it is becoming increasingly apparent that only large, well capitalized companies with sophisticated regulatory, marketing and distribution capabilities will be able to compete in the US follow-on biologics market. To that end, companies like Sandoz (Novartis) and Merck—one of the companies that originally opposed follow-on biologics legislation—will likely dominant the US follow-on biologics market.

Ironically, the biggest losers in the follow-on biologics debate will likely be the innovator companies—but not for the reasons they once cited to prevent regulatory approval of these molecules. By spending hundreds of millions of dollars lobbying against follow-on biologics legislation—rather than investing to develop their own lower cost, generic versions of blockbuster biotechnology products—innovator companies have unwittingly provided foreign follow-on biologics manufacturers with a competitive advantage when follow-on biologics are finally approved for sale in the US. Companies like Sandoz, Teva and several Indian biosimilar companies— with products already on the market in Europe, India and China—have been developing biosimilar molecules for the past fiver years or more. Their scientific and regulatory experiences with these products suggests that they will be poised to dominate the US market after legislation permitting approval and sale of follow-on biologics is finally completed. Surprisingly, Merck is the only major pharmaceutical company to publicly announce its intention to compete in the follow-on biologics market. The Merck announcement was made last fall—almost three years after Sandoz won European approval for Omnitrope, its first biosimilar product!

Until next time...

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

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China's Beijing Genomics Institute in Shenzhen announced that it has mapped the entire genetic code for the giant panda using DNA sequencing and analysis equipment from San Diego-based Illumina. The project began in mid 2008 and was completed by Jan.2009.

The panda at the center of this discovery is Jingjing, who lives in China's Chengdu Panda Breeding Research Center and was the mascot for the 2008 Beijing Olympics. The genetic information from Jingjing is expected to be complemented in the future with genetic information from other pandas.

Scientists hope to use the data from the sequencing project to better understand panda biology and reproduction. Giant pandas are difficult to breed in captivity and are currently on the endangered species list.

In China, the panda's genome sequencing was ranked by the Chinese government as one of the top 10 technology achievements of the year, right up there with the nation's space shuttle and the completion of the Tibetan railway.

Until next time...

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

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From time to time, I come across some interesting facts and statistics that are worth noting. This month’s issue of Pharmaceutical Technology Europe offered several things that were blog-worthy. Here they are: 

• IMS Health has readjusted the growth of the pharmaceutical industry in 2009 from 4.5-5.5% to 2.5-3.6% with sales expected to exceed $820 billion
• The size of the US pharmaceutical market is expected to contract by 1-2% in 2009
• Emerging markets like China, India and Brazil are expected to contribute to more than half of the global market growth in 2009 and sustain an average growth rate of 40% by 2013
• The size of the Middle East pharmaceutical market is predicted to exceed $18 billion by 2014

As one industry analyst put it “This high level of growth in emerging markets, combined with the contraction of the US market and ongoing low single-digit growth in other developed markets, is driving the pharmaceutical market to a new world order.” If I had money, I would be investing in generic pharmaceutical companies and follow-on biologic manufacturers!

Until next time...

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

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The New York Times reported today that the Wuhan Zoo in Central China has taken to feeding its two 3-year-old pandas homemade chicken soup to reduce stress and provide them with a “nutritional boost.” Xiwang and Weiwei needed a boost after China’s weeklong National Day celebration. As many as 30,000 visitors swarmed the zoo this past Wednesday and over 1000 people packed into panda enclosure to see them. This caused the pandas to pace restlessly and zoo officials decided that it would be good to give them some chicken soup because they were “fatigued and had a bit of a shock.” Their normal diet consists mainly of bamboo, milk and buns.

The pandas apparently love chicken zoo and according to the zoo “They drink it like they drink their milk.” That said who can resist a steaming hot bowl of mom’s chicken soup when feeling ill or when things just aren’t going well? Personally, I like matzo balls in my chicken soup—but that is a different story!

Until next time….

Good Luck and Have a Cup of Chicken Soup on Me!!!!!

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The Pharmalot blog reported today that Merck received approval from the US Food and Drug Administration to use Gardasil to prevent vaginal and vulval cancer in addition to cervical cancer.

Of late, Gardasil has been a lightening rod for controversy—mostly because of Merck’s unrelenting marketing campaigns (and the behind-the-scenes lobbying for the vaccine to be placed on the US mandatory vaccination list)  coupled with the Christian right’s moral machinations about premarital sex and sexually transmitted diseases in general. Also, let’s not forget the brouhaha surrounding FDA’s decision to delay approval of GlaxoSmithKline’s competing cervical cancer vaccine called Cervarix. Finally, about a month ago, there was study published in the New England Journal of Medicine questioning the cost effectiveness of Gardasil vaccination of women after the age of 18.

Regardless of your moral, ethical or business concerns about Gardasil, the bottom line is this: girls/women vaccinated with Gardasil are much less likely to develop cervical cancer as compared with those who are not vaccinated.

As I have mentioned before, all approved and marketed drugs have side effects and possible safety/tolerability issues. More importantly, the decision to approve a particular drug is always based on a careful risks/benefits assessment by government healthcare regulators. Whether or not a person uses a drug or vaccine is ultimately a personal choice. With the exception of mandatory childhood vaccines (children can be exempted for moral or religious reasons), every American has the right to decide whether or not to use a medication or undergo a treatment recommend by a healthcare professional. Based on everything that I have read about Gardasil, it appears to be a safe and effective vaccine to prevent cervical cancer. When FDA finally approves Cervarix (probably sometime in late 2009), it will offer women who may have concerns about Gardasil with an alternate vaccine to protect them against developing cervical cancer.

The funny thing about the Gardasil firestorm is that cervical cancer isn’t a major healthcare problem in the US. This is because a majority of American women undergo annual routine gynecological examinations (that include pap smears, the current gold standard for cervical cancer detection). In contrast, cervical cancer is a major healthcare problem and economic concern in Asia, most notably in China and India. This begs the question—why are Merck and GSK so intent on selling their cervical cancer vaccines in the US? Put simply, there is still much more money to be made in the US than in Asia. Look for approval of Gardasil and Cervarix in China and India when the middle class of both countries reach a critical mass.

Until next time…

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

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Somebody once said “Jews know two things—suffering and where to find good Chinese food”. Since I am Jewish, it is not surprising that I have experienced a fair amount of suffering throughout my life and, wherever I go, I seem to know where to find “good” Chinese food.  That said, my interest was piqued when I found a post in Yahoo Science News entitled “Study finds Chinese food good for your heart”. Given my lifelong fondness and penchant for Chinese cuisine, I thought that all of that eating that I had done had finally paid off. Unfortunately, after reading the subtitle of the article; “Chinese red yeast rice reduces repeat heart attacks/mortality rates” I realized that my joy and optimism were somewhat premature.

According to the report, researchers at Jefferson Medical College found that a partially purified extract of Chinese red yeast rice, Xuezhikang (XZK), reduced the risk of repeat heart attacks by 45%, revascularization (bypass surgery/angioplasty), cardiovascular mortality and total mortality by one-third and cancer mortality by two-thirds. The multicenter, randomized, double-blind clinical study was conducted on about 5,000 heart attack patients, ranging in age from 18-70 during a five-year period at over 60 hospitals in the People's Republic of China. Study participants were given 300-milligram XZK capsules or a placebo and tracked over a five-year period. The XZK extract used in the study contained a combination of lovastatin, lovastatin hydroxyl acid, ergosterol and several uncharacterized components.

Based on study results, the study’s authors believe that XZK may offer therapeutic benefits to people at risk of heart attack and cardiovascular disease. However, they cautioned that the active pharmacologic ingredient (API) of the red yeast rice is unknown and it isn’t clear how XZK works to fight cardiovascular disease.

Chinese medicine practitioners have long touted the benefits of red yeast rice for heart patients. Nevertheless, this is the first controlled clinical study of red yeast rice that tends to substantiate these claims. According to the study authors it is important to note that “the commercially available over-the-counter supplement found in your average health food store is not what was studied here. Those over-the-counter supplements are not regulated (by the US Food and Drug Administration), so exact amounts of active ingredient are unknown and their efficacy has not been studied yet.”

It is unfortunate that I didn’t know about the benefits of red yeast rice during my recent trip to China. I certainly would have gone out of my way to try some. That said, given the plethora of exotic foods that I tasted in China, maybe I ate some XZK without knowing it!

Until next time

Good Luck and Good Eating (Chinese of course)……

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Genzyme announced today that it plans to build a research and development center in Beijing as part of its continued global expansion. When completed, the 200,000 square-foot facility (which is expected to cost $90 million to build) will be able to accommodate 350 employees.  The company, which wants to establish a long-term presence in China, expects the facility to open in 2010.

Genzyme said it already has 25 employees working in offices in Beijing and Shanghai and has a pilot program for its cell therapy MACI at Beijing Wujing Hospital. Like other American biotechnology companies, Genzyme see a bright future in China. 

And since I am talking about China, I would be remiss if I didn’t mention that I will be in China in about three weeks to visit my friend who is an executive chef and will be managing food operations at the Beijing Olympics in August, 2008. I plan on visiting Beijing and Shanghai, so if you live in either of these cities and want to get together to chat about biotechnology, blogging or anything else, please feel free to drop me a line.

Until next time….

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

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Who can resist those adorable black and white Giant Pandas? Late last week, the International Giant Panda Genome Project was launched by Beijing Genomic Institute-Shenzhen, China. The goal of this project is to finish the sequencing and assembling of the draft sequence within six months. 

According to the news release:” The giant panda is a much loved animal all over the world and is considered a symbol of China, as illustrated by its being one of the mascots for the upcoming Olympics in Beijing. The excitement surrounding the launch of this ambitious project, however, has been built around how this new genomic information will have extensive impact in numerous scientific areas -- from ecology to evolution to sequencing technology. Such data will aid in understanding the genetic and biological underpinnings of this unique species, especially with regard to its very specific niche in the environment and the molecular mechanisms of its evolution.”

“Of special interest is that these data will be extremely useful for protecting and monitoring this endangered species and will provide information on the impact of captive breeding. In addition, it will have considerable use in controlling diseases that could devastate these fragile populations.” For those of you who don’t know, breeding pandas is not an easy thing. In fact, according to a guy I used to work with, who is a panda breeding expert, it is more art than science. However, it may not be as arcane as he makes it out to be considering that he had a sweet consulting gig for panda breeding with the Chinese government.

The giant panda project (GPP) will be conducted by Chinese scientists as well as scientist from other countries including, Canada, Wales, Denmark and the United States! It is truly an international collaboration!

Long live the pandas!

Until next time…

Good Luck and Good Job Hunting (try GPP- China)!!!!!!

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For the past year or more, the US media has been vociferously bashing tainted imported Chinese goods any time it can. The tainted products have ranged from toys to dog food and most recently to Baxter’s heparin which has been associated with illnesses and deaths in this country.  

I suspect that this recent spate of China bashing has more to do with political and future economic issues than the safety and well being of the American public. Nevertheless, according to US Food and Drug Administration Current Good Manufacturing Practices (CGMP) regulations, companies that hold the licenses to manufacture pharmaceutical and biotechnology products assume full responsibility for the quality and safety of their products. To accomplish this, companies are required to test all raw materials, excipients and APIs (regardless of their source) before they are assembled to make a finish pharmaceutical or biotechnology product. The results of these tests must be carefully analyzed and compared with the product quality specifications established by the company and approved by FDA. If the test results for product ingredients are outside of the normal range of established specifications, then the company is obliged to reject the materials and not used them to manufacture product. To that end, there was clearly, something was wrong with quality testing at the Baxter heparin manufacturing facility because the adulterated heparin API should have been detected long, before it was used to manufacture the final product. Although the Chinese heparin may have adulterated, the onus was on Baxter (the company that holds the product license) and not the Chinese government to insure its final product met quality standards and was safe for public use.

Outsourcing is a fact of life in almost every sector of the American economy. Pharmaceutical and biotechnology companies import the materials they use in their products from all over the world. It is FDA’s job to insure that American companies remain CGMP compliant so that they produce safe and effective medications. To blame America’s regulatory shortcomings on foreign manufacturers and their governments is dangerous and naïve-not to mention chauvinistic.

Until next time…

Good Luck and Good Job Hunting (try Shanghai)!!!!!!!!!!

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