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Despite a lull in layoffs over the past summer, this fall is shaping up to another bad one for pharmaceutical employees. Late last week Novartis announced that it was laying off about 2,000 employees. Prior to the Novartis announcement, Amgen, AstraZeneca, and Merck have all disclosed plans to eliminate thousands of jobs on a worldwide basis.  To add insult to injury, Sanofi Aventis told its employees today that the company would be shifting operations from New Jersey to Massachusetts and that hundred of employees would be losing their jobs. While a Sanofi spokesperson refused to specify the exact number of employees who may lose their jobs, estimates are in the hundreds, mainly in R&D and sales in the oncology and cardiovascular areas.

The announcement was not unexpected because several weeks ago the company announced that it would cut another $2.9 billion in costs to offset pending generic encroachment on its top selling medications Plavix and Avapro. Further, consolidation of Sanofi’s R&D operations and its early development work to the Boston area is mainly a result of its acquisition of Genzyme earlier this year. To that end, later-stage development work will remain at Sanofi’s headquarters in Bridgewater, NJ while pharmaceutical R&D, Sanofi Pasteur biologics and global oncology has already been moved to Massachusetts. At present, Sanofi employs about 3,000 people in New Jersey and 5,000 in Massachusetts (including Genzyme employees).

Interestingly, while job cuts are taking place in western markets, hiring is brisk in emerging like China and India. For example, several months ago Pfizer announced that it was closing down its antibiotic discovery program in the US and moving it to China. Likewise, Novartis plans on sending some medicinal chemistry and regulatory work overseas to India. If the downsizing and outsourcing trends continue at their current pace, it will become increasingly difficult for most Americans to find pharmaceutical R&D jobs in the US. Can anybody still wonder why we may be losing ground to countries like India and China?

Until next time...

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

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Several years ago RNAi was hot and it was touted as a technology that would revolutionize modern pharmaceutical science. I never thought RNAi had much promise beyond being a research tool but what do I know? 

With this in mind, I felt exonerated today after reading that Roche had divested all of its RNAi assets to a small Madison, WI drug discovery company called Arrowhead Research. In exchange for the assets, Roche acquired an equity position in the company.  About a year ago Roche formally announced that it was exiting the RNAi business, but until now was unable to find a buyer. 

According to a press release, Arrowhead now owns the Roche Madison Inc facility (formerly the Mirus R&D facility in Madison, WI), which employs a team of 40 scientists. Arrowhead also gets licenses from several leading firms, including Tekmira Pharmaceuticals for RNAi drug delivery technology and Alnylam for RNAi intellectual property and short interfering RNA structures. Arrowhead was already in the RNAi delivery space.

Previously, Roche spent roughly a half-billion dollars to amass its position in RNAi, including $331 million paid to Alnylam Pharmaceuticals in 2007 for access to RNAi technology and $125 million for the purchase of Mirus Bio in 2008. Arrowhead, in contrast, is paying Roche no money for these and other assets; instead it is giving the Swiss firm an ownership stake of slightly under 10%.

Many other big pharma companies have also abandoned their efforts in the RNAi space. While RNAi works in the lab as a research tool, the inability to successfully deliver it to internal cellular targets has prevent companies from commercializing it. I hate to say it, but “I told you so.”

Until next time....

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

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I started my career as a PC guy and have since become an enthusiastic Apple fan.  After purchasing my first iPod five or so years, I was immediately convinced that Apple got it. I now own an iPhone and an Ipod and if I could afford it would junk my PCs in favor of Apple computers. 

Admittedly, I was not a Steve Jobs fan—not because I didn’t like but because I did not really know much about him. I just thought his company’s products rock. After his passing last week, my wife happened to hear on NPR snippets of his commencement address at Stanford University in 2005. She came and immediately said I should listen to it! And, I finally did! It was one of the most insightful, passionate and prosaic speeches that I have ever heard. 

I heartily recommend that those of you who may be at a crossroads in their lives or suffering the financial impact of the recession listen to his speech. Steve Jobs got it and it may help you get it too!   

Until next time....

Good Luck and Good Karma!

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By now, most BioJobBlog readers have heard that China is poised to become a world leader in the life sciences. As some of you may already know, over 80 per cent of the worlds active pharmaceutical ingredients (APIs) that are used to produce FDA-approved medicines are synthesized in China and exported to manufacturing facilities throughout the world. Further, not a day goes bye without a press release about a new partnership forged between multinational life sciences companies and a Chinese partner. Finally, the Chinese government is heavily investing in the life science industry in an attempt to manufacture medicines for internal use and to export. 

Therefore, it should come as no surprise that Chinese life sciences companies are hiring. One such company is ShangPharma Corporation. ShangPharma was established in 2002 and has locations in Chengdu and Shanghai, China. It is one of China’s largest contract research organizations and employs over 1,600 persons. The company offers discovery and preclinical development services in both chemistry and biology including API and biologics manufacturing. 

The company is currently looking for a person with a PhD or Masters degree with expertise in CNS and/or cognitive subhuman primates (cymologous and/or rhesus monkeys) models. This is a Group Leader position and the ideal candidate will have a background in pharmacology and neurosurgery. Strong communication skills and the ability to speak and write reports in English are required. Please click here for more information or to apply for the position.

While working in China may not be the first choice for most Americans, it may be ideal for foreign students who trained in the US and have a good command of the English language. Whether you are Chinese or American, a sobering fact to remember is that almost 300,000 American pharmaceutical employees have lost their jobs since 2001; making this one of the worst life sciences job markets in history!

Until next time...

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

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Crowdsourcing—using the collective talent of the Internet to solve problems—has been increasingly used to solve problems and find solutions in the computer software and electronics industry. Over the past few years, several forward-thinking life scientists had proposed the idea that crowdsourcing could possibly be used to solve the molecular structure of proteins that could be used as drug targets. To bring this possibility to reality, in 2008 a team of scientists at the University of Washington created an online, interactive, protein-folding game call Foldit that showcased the principle and properties of protein biochemistry. The thought was that Foldit and its worldwide cadre of users could be used to solve the molecular structure of certain proteins. Since 2008, over 100,000 have downloaded Foldit software and turned into a large, worldwide, multiplayer competition.

Earlier this week a group of scientists reported in the journal Nature Structure & Molecular Biology that Foldit users helped them to determine the molecular structure of a simian HIV protease that had baffled scientists for 15 years. The actual three dimensional structure of the protein that was predicted by Foldit was confirmed by X-ray crystallography. According to the paper’s authors (that included the Foldit players who helped solve the protein’s structure),

“Although much attention has recently been given to the potential of crowdsourcing and game playing, this is the first instance that we are aware of in which online gamers solved a longstanding scientific problem. These results indicate the potential for integrating video games into the real-world scientific process: the ingenuity of game players is a formidable force that, if properly directed, can be used to solve a wide range of scientific problems.”

Crowdsourcing is a new concept that is beginning to be embraced by the life sciences community including academics as well as industrial scientists. To learn more about crowdsourcing and its use in drug discovery and design, please read an article that I wrote for LifeScienceLeader this past July.

Until next time...

Good Luck and Good Gaming!!!!!!!!! 

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Mark Senak, author of the outstanding EyeonFDA blog, tweeted today, that Eli Lilly & Co had launched a YouTube Channel. According to a post on the company’s blog Lilly Pad, its new channel dubbed the “Lilly Health Channel” will “videos on health and wellness, employee and community outreach efforts, health innovation, Lilly programs and other non-product-branded initiatives.”

While the announcement of a launch of another pharma-sponsored YouTube channel is no longer new or novel, Eli Lilly has been trying to transform itself into a modern, social media and crowdsourcing-focused pharmaceutical company. For example, Lilly is one of only a handful of big pharma companies that sponsors its own corporate blog. Moreover, the company is a leader in using so-called crowdsourcing to discover and develop potential new drugs. It has spun off at least two ventures that utilize a crowdsourcing approach to new drug discovery. Finally, unlike most other big pharma CEOs, its chief executive John Lechleiter has been outspoken about the lack of innovation and available workforce talent in the US life sciences industry. 

Is Lilly truly the pharmaceutical company of the future? That remains to be seen! 

Until next time... 

Good Luck and Good Viewing!!!!

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For the past several days, the rumor mill has been rampant with suggestions that UK-based Shire may acquire Cubist, a publicly traded Massachusetts-based biotechnology company that sells Cubicin, an antibiotic indicated for the treatment of certain infections caused by methicillin-resistant Staphylococcus aureus (MRSA).

Rumor has it that Shire approached Cubist about a month ago with a $44.5-a-share proposal ($2.0 billion) and the pair have been in talks about a deal ever since. Last week, Shire announced that it had entered into a deal to acquire private-held Advanced BioHealing for $750 million. Connecticut-based Advanced BioHealing markets and develops products to enhance wound healing and treat diabetic foot infections in patients with diabetes. Shire’s acquisition of both companies would provide it with a substantial US presence in the antibacterial treatment and diabetes markets.

While Cubist may be a good “fit” for Shire, it is not clear whether or not the company will prevail in its takeover bid. Last month, Cubist settled a patent dispute Teva Pharmaceuticals over Cubicin, which lessened the threat of generic competition by the Israeli drug maker. This sparked speculation among a number of Wall Street analysts that other pharmaceutical companies including AstraZeneca and Johnson & Johnson who are themselves facing generic competition, may consider acquiring Cubist in an attempt to add new antibiotics to their antibacterial portfolios. 

This is not the first time that analysts have speculated that Cubicin may be ripe for acquisition. Almost two years ago, word-on-the-street had it that Novartis may acquire the company. Nevertheless, Cubist is one of the few remaining publicly-traded biotechnology companies that specialize in new antibacterial drug discovery. Its potential acquisition by a big pharma company may signal the end of innovative drug discovery in the antibiotics discovery space. Here’s hoping that Cubist remains independent!

Until next time...

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

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The loss of patent protection and a decline in revenues for a number of blockbuster brand name antibiotics has caused many big pharmaceutical companies to exit the antibacterial drug discovery market. The three remaining big pharma companies still actively engaged in antibacterial research are GlaxoSmithKline, AstraZeneca and Novartis (all European owned companies).

A new report by UK-based Datamonitor entitled “Forecast Insight: Antibacterials” predicts that antibiotic sales revenues will decline from $19.6 billion in 2009 to about $16.4 billion in 2019. Not surprisingly, the report blames the projected decline on generic competition and the lack of new antibiotic launches over the past 10 years.

At present, the top seven antibiotic markets in the world include the US, Japan, France, Germany, Italy, Spain and the UK. According to Datamonitor’s analyses, total sales in these markets have fallen by about 1.6 percent annually since 2005 and will continue to decline by almost 2.0 percent a year through 2019. In 2009, three antibiotics had sales of about or more than $1.0 billion; Johnson & Johnson’s Levaquin (market leader), and Pfizer’s Zosyn, and Zyvox. Interestingly, Pfizer recently decided to shut down its US-based antibacterial drug discovery program and move it to China and Johnson & Johnson recently announced that it was getting out of the antibiotic discovery business. 

Big pharma’s decision to abandon antibiotic research could not have come at a worse time. The incidence of antibiotic resistance among both Gram positive and Gram negative bacteria is rising at unprecedented rates. And while safe and effective treatments for Gram positive infections including MRSA (methicillin-resistant Staphylococcus aureus) still exist, the number of treatment options to treat Gram negative infections caused by Acinetobacter spp, Pseudomonas aeruginosa and enteric bacteria is severely limited. The recent description and rapid spread of a beta-lactamase enzyme called NDM-1 that inactivates the antibiotic carbapenem—the last safe and effective antibiotic to universally treat infections caused by Gram negative bacteria —is extremely troubling and worrisome.

While much of the focus over the last decade was on MRSA, infections caused by untreatable, multiple drug resistant Gram negative bacteria will pose the greatest public health threat over the next 10 years. Unfortunately, it is much harder to develop new antibiotic treatments for Gram negative infections as compared with ones caused by Gram positive bacteria. Further, at present, most of the companies that remain in the antibiotic space continue to focus on new treatment for MRSA and related bacteria. Consequently, new treatments for Gram negative infections may be more than a decade away!

Finally, like MRSA, most infections caused by multiple drug resistant Gram negative bacteria are nosocomial in nature (although the incidence of community acquired infections is also on the rise). This means that the most likely place to become infected with these bacteria is institutionalized healthcare settings including hospitals and nursing homes.

In the past, we have relied on pharmaceutical and biotechnology companies to discover new antibiotic treatments. The decision of many of these companies to leave the antibacterial space for purely financial reasons is unfortunate and regrettable. However, the growing incidence of antibiotic resistance among both Gram positive and Gram negative bacteria suggests that new antibiotics are necessary and that alternate approaches to new antibiotic drug discovery must be implemented. Whether this is through public/private partnerships or strictly through government programs is irrelevant. The bottom line is that we need new antibiotics; and if they are not discovered soon, many patients will die from previously treatable bacterial infections!

Until next time...

Good Luck and Good Job Hunting (start an antibiotic drug discovery company)

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There has been some buzz on LinkedIn and Facebook about an article that appeared in the March 3, 2011 issue of Nature Magazine. The article entitled “Traditional Drug-Discovery Model Ripe for Reform” and basically chronicles the decline in emphasis being placed by most companies on traditional in-house drug discovery as a source for new candidate molecules. Also, it points out that most big pharma companies now agree that they are not good at drug discovery but excel in clinical development and marketing of new medicines. Industry’s new view of itself is supported by the fact that over 200,000 pharmaceutical and biotechnology workers—roughly 50% were discovery scientists—have their lost jobs in the past three years or so. This begs the question “who is going to discover the new molecular entities that large drug companies are going clinically evaluate and ultimately market? According to the article, academic researchers are likely to play a pivotal role in this newly emerging drug discovery paradigm. 

The new model proposed in the article goes something like this. First, all intellectual property rights for certain compounds will be lifted or removed. Compounds of interest would subsequently be evaluated in small clinical trials for safety and possible efficacy. And, interested drug makers would only compete with one another on specific molecules after they were deemed safe and potentially effective. Up until this point, all data on prospective drug candidates would be openly published and freely available to interested parties.

Proponents of the model contend that the approach would allow drug targets to be more quickly validated and developed less expensively because there would less duplication of research activities. Further, it would reduce the exposure of patients to experimental molecules that have already deemed to be ineffective. Interestingly, the new model would rely exclusively on academic scientists who would be supported by a global initiative that cost about $325 million per years— with half coming from the pharmaceutical industry and half from the public. Finally, drug candidates identified in the initial screening process would be available to companies that participate in the initiative (presumably to the company that invested the most?)

While the proposed model is clearly “wishful thinking” on behalf of academics who are struggling to win grant support, it is deeply flaw and was obviously proposed by academic scientists who lack a clear understanding of the industrial drug development process. First, intellectual property (IP) and patents are the life blood of the industry and are in fact what allows drug companies to prevent competition in certain therapeutic areas maximize their return on investment on the drugs that they develop. Therefore, it is highly  unlikely that any drug maker would agree to lift or suspend IP around a novel new molecule. Second, must academic scientists are not qualified nor trained to engage in industrial drug development. Unlike academic science, industrial research is highly regulated and must be performed according the regulations and guidelines established by various regulatory agencies like the US Food and Drug Administration. If the research is not conducted in a regulatory compliant manner, then the prospective new drug will not be able to win regulatory approval. Third, eliminating IP would prevent university tech transfer offices—which exist almost entirely to manage a university’s IP—from negotiating lucrative licensing deals with interested companies or other parties. This, in turn, would reduce the contribution of funds by technology transfer offices that is used to run many academic research centers. Finally, the model is based upon the assumption that academic scientists (unlike drug companies) willfully and freely share information with one another for the “common good.” However, based on my experiences as an academic for over 20 years, most scientists don’t subscribe to the level of altruism and philanthropy attributed to them in the article. In fact the ego-involvement and competition amongst academics is so fierce, that  many academic refuse to share important new information or breakthroughs with their colleagues until grants are funded or the data are published in peer reviewed journals. Put simply, most academics are trained to work by themselves in their own laboratories and are neither interactive nor collaborative by nature.

There is no question that the old industrial drug discovery model is in transition and a new one will ultimately emerge. However, the role of academics in the new model is likely going to be less than proposed in present article. Too many systemic changes would be required for this model to be effective. That said, providing graduate students and postdocs with training in regulatory affairs and new drug development could be a step in the right direction! Nevertheless, a better solution to the problem may be a greater role for government in new drug discovery and development. To that end, the UK Medical Research Council has established the Developmental Pathway Funding Scheme that supports the development of promising basic science research into new drugs and medical devices. Also, Francis Collins, the current head of the National Institutes of Health has proposed the creation of a National Center for Advancing Translational Sciences to transform basic science into prospective new drugs and treatments.

Despite the good intentions of the article, the path forward for academic scientists is not going to be easy. To make matters worse, it is becoming increasingly difficult for PhD-trained scientists to find jobs. That said, if you are truly interested in industrial drug discovery and development I highly recommend that you take some regulatory affairs course or enroll in a certificate or MS degree program in biotechnology that teaches the business side of the life sciences industry.

Until next time...

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

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The Japanese drug maker Eisai, Co announced that it will cut at least 900 jobs over the next five years to improve operating margins to offset the impending lost of patent protection for Aricept its blockbuster Alzheimer’s  disease treatment. The company did not specify where the cuts would take place.

In other news, based Eli Lilly & Co announced plans to outsource its R&D bioanalytical functions to Advion Biosciences a contract research organization that is building new laboratories Lilly’s home town of Indianapolis, Indiana. Ithaca NY-based Advion is building a 22,000 sq ft facility that will focus on ADME and toxicology experiments that are required for new molecules to enter human clinical testing.

Advion offers a range of Good Laboratory Practice-compliant and discovery bioanalytical services, including liquid chromatography-tandem mass spectrometry (LC/MS/MS) for determining small-molecule drugs, macromolecule therapies and biomarkers; immunoassay services; ADME (absorption, distribution, metabolism, and excretion) screening; cytochrome P450 inhibition and induction study support; metabolism profiling; metabolite identification; sample management; and sample storage.

According to a press release:

 “Lilly will transition its own drug discovery bioanalytical capabilities to Advion and will offer employees affected by the move the opportunity to join Advion. The new laboratory is expected to be fully operational by the end of May 2011.”

This is another example of big pharmaceutical companies exiting the R&D space. Because of the rampant downsizing and outsourcing of R&D functions to CROs, now could be one of the better times in years to start a biotech company. Big pharma is relying on starts up companies and academic laboratories to be the major source of new molecules that they develop. That said, the age of big “in-house” drug discovery operations at big pharmaceutical companies is drawing to an end. 

Until next time...

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

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Despite assertions to the contrary, scientists are pretty much like most other people. They eat, sleep, work, party and for the most part are social creatures. Therefore, it should come as no surprise that scientists are also susceptible to hype and succumb to research “fads.” In my former life as an academician, these fads were not so obvious and, for the most part, they unobtrusively helped to advance scientific research. However, after I abandoned academia for the private sector, these fads became blatantly obvious to me.  And, for the most part, were primarily driven by potential profits rather than advancing scientific knowledge for the common good.

First, there was combinatorial chemistry in the mid-1990s. Honestly, I never understood the hubris of the pioneers in this field who thought that by randomly mixing chemicals in a laboratory they could outdo nature when it came to creating new drugs. Nevertheless, the combinatorial chemistry fad over time resulted in high throughput screening, laboratory automation and sophisticated assay development technologies which serve as the foundation for modern drug discovery and development.

Next, there was the Human Genome Project that was supposed to provide drug developers with a plethora of previously undiscovered, potential new drug targets. While sequencing the human genome did provide scientists with a treasure trove of new biological targets, drug makers quickly ascertained that progress in drug discovery was not being hindered by the lack of targets but by a dearth of new drug candidates! Ironically, the lack of drug candidates resulted mainly from abandoning natural product drug discovery in favor of combinatorial chemistry. Like combinatorial chemistry, sequencing the human genome helped to improve DNA sequencing technology, sequence analysis and ushered in the fields of genomics and bioinformatics.

After the human genome was sequenced, scientists began to focus on the fields of computational biology and molecular modeling to help to discover and develop new drugs. While computational biology and molecular modeling yield some small successes, its use in drug discovery and development was limited. Ultimately, these fields morphed into something called translational science or medicine; a discipline that I don’t fully understand.

Finally, in the early 2000s, RNA interference (RNAi) became the technology du jour. RNAi was a powerful laboratory-based discipline that was sexy enough to garner its creators a Nobel Prize. Because of this, many drug companies had high hopes for RNAi and quickly jumped on the RNAi bandwagon. Billions of dollars were invested in the technology with the hope that RNAi would speed new drug discovery and also yield new drug candidates. At the outset, it was clear to many industry experts that RNAi molecules would be difficult to develop as new drug candidates. This is because RNAi molecules are difficult to deliver to cell-based targets and have short biological half lives. Despite these obvious shortcomings, many venture capitalists and large drug companies adopted a “damn the torpedoes, full-speed ahead” attitude and invested countless dollars and hours into RNAi research.  A doubter from the beginning (and pretty vocal about it too), I was not surprised to read an article in today’s Science Times entitled “Drugmakers’ Fever for the Power of RNA Interference Has Cooled” which describes the likely demise of RNAi as a source of new drug candidates.

Today, the new fad appears to be personalized medicine. While I don’t think that personalized medicine is yet “ready for prime time” I believe that it will become a commercial and medical reality in the next 10 to 20 years. Yet, despite lessons learned from past research fads, personalized medicine is being over hyped and oversold by the scientific and medical communities as well as the lay press.

Fads come and go in science as they do in real life. After all, we scientists are humans! That said, scientists are obliged to “go where the data takes you rather than where you (financially or intellectually) want it to go.  If scientists fail to live by this credo, countless research hours will be spent on ideas that cost a lot but yield little.

Until next time..

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

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Aptuit, a drug discovery and development company announced that it will be cutting 340 jobs in Scotland over the next year. The company cited the worldwide economic downturn as the culprit. Likewise, the Austrian vaccine maker Intercell announced that it would be laying off an unspecified number of employees and dramatically cutting R&D expenses (by 40%) after it killed development of its enterotoxigenic Escherichia coli vaccine patch. The company pulled the plug on the vaccine after it failed to reduce the incidence of diarrhea in a randomized and placebo-controlled Phase III study involving 2036 participants.

On the bright side, PPD, a global contract research organization, announced that it plans to invest $28 million to expand its Lab Services Division in Henrico County, Virginia and add 190 new jobs over the next three years. 

Until next time...

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

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I read a post today on Yahoo News entitled “Warning on New Superbugs from S. Asia.” While I initially thought that this article may contain some important news on the real and growing of multiple drug resistant bacterial pathogens, I sadly learned that it was nothing more than an sensationalistic attempt to promote the discovery of a new metallo-beta-lactamase gene bla(NDM-1) in an Indian isolate of Klebsiella pneumoniae, a Gram negative bacterium. The work was performed by a group at Cardiff University in Wales and published almost a year ago in the journal Antimicrobial Agents and Chemotherapy.

There is no question that morbidity and mortality from Gram negative infections is rising and will certainly continue to increase in the future. This is because most of the work in antibacterial drug discovery in the last decade was focused on Gram positive bacteria including methicillin resistant Staphylococcus aureus (MRSA) and vancomycin resistant enterococci (VRE). Although new antibiotics have reached the market for these organisms, they are used judiciously, and mainly as a last resort, because of fears of emerging resistance to them among Gram positive clinical isolates. Unfortunately, developing new antibiotics against Gram negative pathogens as compared with Gram positive bacteria is much more difficult. To that end, no antibiotics of note have been discovered in recent years to treat multiple drug resistant strains of Gram negative bacteria. 

While identification of the bla (NDM-1) gene may be scientifically and biologically interesting, it will likely have little effect on the clinical treatment of Gram negative infections. This is because many Gram negative isolates are already resistant to most beta-lactam antibiotics and consequently these antibiotics are used only sparingly to treat many Gram negative infections. Regardless of the implications of the discovery of the NDM-1, what I find most troubling about the article is its title. It leads uninformed persons to believe that the world is in grave danger and that a pandemic of multiple drug resistant strains of Gram negative bacteria may be imminent.  While infections caused by multiple drug resistance strains of Gram negative bacteria are clearly on the rise, strains carrying the NDM-1 gene will not decimate the world population any time soon! In fact, the authors suggest that these strains may cause some problems in India which “already has high levels of antibiotic resistance.”

There is no doubt that informing people about the growing incidence of multiple drug resistant bacteria is a good thing. Maybe, if enough people get frightened they may be able to induce big pharmaceutical companies—many of which abandoned antibiotic drug discovery and development in the late 90s—to reinvigorate their programs. That said, it is not clear why this story got elevated to a lead story on Yahoo News since the discovery was made almost a year ago—maybe today is a slow news day? Nevertheless, the impending doom and sensationalistic tone of the article suggests that reporters who cover the life sciences need some training in microbiology. This is necessary to insure that the stories that they write about antibiotics are kept in the appropriate context and historical perspective. That said, don’t be surprised today if the sales of antibacterial products increase and the stock prices of biotechnology companies involved in antibacterial drug discovery and development spike!

Until next time...

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

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Yesterday, I posted a piece on "hit'  throughput screening (see below).  At the time, I learned about  'hit" throughput screening, I mentioned that  I had never heard of "hit" throughput screening but I did know about high throughput screening.  As it turns out, there was a problem in translation and in fact, there is no such thing as hit throughput screening and it is actually high throughput screening.  Mea Culpa!  I apologize for the error and in the future I will be assiduous in my fact checking before I post (a lesson that the boneheads in the Obama administration learned the hard way in the recent Sherrod brouhaha)

The Growth of High Throughput Screening

No; this isn’t a typo! My colleagues at Meet the Boss sent me a press release today about efforts underway at Pfizer and GlaxoSmithKline to redefine HTS to mean “hit” throughput screening rather than high throughput screening. As many of you may know, high throughput screening which began in the mid 1990s was supposed to revolutionize drug discovery and development—it did not! Nevertheless, after almost 15 years of refinement it appears that the technology may be paying off and can be used as an adjunctive tool to expedite and lower the cost of small molecule and protein-based drug discovery. While I don’t know much about this emerging technology, the press release presented below suggests that a meeting about HTS may be in the works. 

It is understood that huge amounts of money have been invested into drug discovery and the biggest problem faced by the industry is investing in drugs which may not make it onto the market. Europe has always been seen to trail behind the US when discussing drug discovery within the pharmaceutical industry, but with the biotechnology revolution they have begun to catch and becoming a driving force within the global industry.

The NGP EU committee has been celebrating the success of their pioneering roles in genome sequencing and the development of proteomic. Pfizer has recently announced to the NGP Drug Discovery committee that they plan to roll out a hit identification and screening file strategy. The process will offer a new flexible strategy for hit identification while sculpting a more reliable and efficient screening process. 

High throughput screening (HTS) has grown rapidly over the last ten years and Pfizer themselves noted the huge advances in both detection technology and laboratory automation. Pfizer believe that not only big Pharma but also smaller companies can implement HTS as well. By implementing HTS,  it can remove the indecision over which compunds will be profiles, many smaller companies agonize over the costs of conventional profiling sometimes only choosing between 10 and 20 compounds, this already removes other possibilities before true research can really begin. Pfizer among other members of the NGP EU Drug Discovery committee wish to discuss how they wish to implement large scale profiling at a lower cost, while maintaining the incredible biological, technological, and scientific advancements they are already demonstrating globally.

GSK have also joined Pfizer recently in encouraging the implementation of HTS. “We are now at a stage where we can exploit the benefits of cutting edge technology for increased quality, performance and capabilities. We also have the option to supply the same number of compounds, with the same level of quality at an affordable price”. 

Key to discussions will be representatives from AstraZeneca - Goran Wennberg, VP Discovery Information, Bayer Schering Pharma - Andreas Busch, Head of Global Drug Discovery & Member of the Board , Novartis - Olivier Grenet , Group Head of Genome Biology ,GlaxoSmithKline - Tino Rossi, VP of PreClinical Drug Discovery & Enabling Technologies and Pfizer - John Mathias, Head of High Through Put Screening all determined to firmly place Europe as the Drug Discovery capital.

The discovery and implementation of HTS not only offers an opportunity to smaller Pharma companies but also the consumer, if research and quality is increased and cost decreased this in turn will be passed onto the consumer.

Stay tuned for more details.

Until next time...

Good Luck and Good Job Hunting

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

The annual event started seven years ago is sponsored by the National Human Genome Research Institute of the National Institutes of Health. To learn more about the activities that are planned for this year's celebration, please click here.  And this year, you can become a fan of the day on Facebook!

Have a great day celebrating, but please remember to clone responsibly!!!!!!

Until next time...

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

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For the past decade or more multiple drug resistant strains of bacteria such as methicillin resistant Staphylococcus aureus (MRSA), enterococci and other Gram positive cocci have been highlighted and showcased in the medical and lay press. While the incidence of infections caused by MRSA and other Gram positive cocci has steadily risen, antibacterial drug discovery experts have long known that the greatest disease threat in the future will be from emerging multiple antibiotic resistant strains of Gram negative bacteria including Acinetobacter baumannii, Klebsiella pneumoniae, Serratia marcescens and Pseudomonas aeruginosa.

Last Spring, in an interview that I conducted with Barry Eisenstein, MD, Senior Vice President of Scientific Affairs at Cubist Pharmaceuticals and an antibacterial drug discovery expert, he indicated that there are currently no drugs in development to treat infections caused by antibiotic resistant Gram negative bacteria. He warned that this, coupled with the loss of interest in antibiotic development by large pharmaceutical companies, will cause infections caused by multiple drug resistant Gram negative bacteria to become a serious unmet medical need in the not so distant future. The appearance of an article in the New York Times this past Saturday chronicling the rise of infections caused by antibiotic resistant Gram negative bacterial suggests that the not so distant future may have already arrived! For the record: would newspaper and television reporters please refrain from identifying bacteria as “germs.” It is an anachronistic term which was coined in the 19^th century before bacteria and viruses were conclusively identified as the cause of most infectious diseases.

Despite the media hype about antibiotic resistant Gram positive bacteria, a variety of new drugs have been developed to treat infections caused by these bacteria. Interestingly, because of greater public awareness about MRSA infections and improved hospital infection control and surveillance programs, the incidence of disease caused by MRSA and other Gram positive bacteria is finally beginning to wane. Unfortunately, the same is not true for infections caused by antibiotic resistance Gram negative bacteria.

For those of you who may not know, the cell wall architecture of Gram negative bacteria (and a multitude of antibiotic resistance mechanisms) makes it much more difficult and costly to develop new antibiotics to treat Gram negative infections. Consequently, research in this area has been largely ignored for the past 15 years or so. This means that in the future the morbidity and mortality associated with infections caused by antibiotic resistant Gram negative bacteria is certain to rise. With this in mind, persons at the greatest risk of developing these infections include patients in hospitals and long term care facilities and individuals receiving implantable medical devices.

Because most large pharmaceutical companies abandoned antibiotic drug discovery in the mid to late 1990s, it is unlikely that new Gram negative antibiotics will come from the pharmaceutical sector. While there are several small biopharmaceutical start ups working on antibiotics for Gram negative bacteria (KaloBios Pharmaceuticals, Calixa Therapeutics and Novexel) the increasing regulatory scrutiny and rising development costs suggests that these companies may have trouble bringing new antibiotics to market. Sadly, this places the onus of new Gram negative antibiotic discovery squarely on the shoulders of the US government. To that end, as much as it pains me to say this, it will likely take the death of government official or family member before sufficient resources are allocated to address this rapidly growing unmet medical need. Maybe the Obama Administration ought to think about allocating stimulus monies to begin to address the problem!

Until next time...

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

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A rare or orphan disease is defined in the US as one that affects fewer than 200,000 at any given time. It is estimated that there are 6000 to 8000 rare diseases in the world today. Because the number of patients afflicted with orphan diseases is so small, drug companies have historically been reluctant to invest money to discover and develop new treatments for them. The dearth of treatments for rare diseases induced Congress to pass the Orphan Drug Act in 1983 which provided market exclusivity, tax breaks and incentives and regulatory help for companies to development new drugs for orphan disease indications.

While many current blockbuster drugs including recombinant human insulin, growth hormone and erythropoietin originally garnered regulatory approval after receiving orphan status in the late 1980s, most big pharma and biotechnology companies (except Genzyme) largely abandoned orphan drug development until recently. The renewed interest in orphan drug development has been primarily driven by the demise of big pharma’s blockbuster business model that began in the early 2000s. The search for new, non-blockbuster drugs and fresh markets is what induced Pfizer, the world’s largest pharmaceutical company, to recently inked a multimillion dollar deal with Protalix Biotherapeutics, a small biopharmaceutical company developing a new treatment for Gaucher disease—an orphan indication.

Because of renewed interest and the ever increasing need for new orphan drugs, the FDA’s Office of Orphan Products Development is offering an Orphan Drug Designation Workshop that will provide a unique opportunity for all potential drug sponsors—including biotechnology companies, pharmaceutical firms and academic institutions—to learn about the application process for orphan drug designation.

The National Organization for Rare Disorders (NORD) is a co-sponsor of the workshops, which will take place on February 25-26 at Keck Graduate Institute and August 3-4 at the University of Minnesota.

Participants are encouraged to bring specific product proposals for at least one candidate orphan drug that holds promise for the treatment of a rare disease. A significant portion of the workshop will be dedicated to preparing applications, including one-on-one guidance sessions with FDA staff members. FDA will keep product and disease information confidential.

Final applications can be submitted to the FDA at the close of each workshop. For information or to register:

FDA Workshop Brochure
Registration for the February Workshop

Finally, February 28^th is Rare Disease Day. The event is sponsored by the EURODIS a European advocacy group that promotes awareness and research for rare diseases. NORD and Discovery Health are also sponsoring the day.

Until next time....

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

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I was introduced to single malt Scotch whisky about six years ago after my in-laws returned from a distillery tour of Scotland. Never a scotch drinker, after sampling a variety of brands, I decided that Islay single malts, most notably Lagavulin and Caol Ila, were my favorites. Over the past few years, several of my friends and I have been searching for the ultimate single malt.I thought that the Macallan 30 year old that my father-in-law received for his 90th birthday was pretty special.

Imagine my surprise after learning that a team of New Zealand scientists recovered five crates of 100 year old Mackinlay’s whisky from the ice below an Antarctic hut once used by the famed polar explorer Ernest Shackleton. While Mackinlay is a blend whisky and not a single malt, its age alone is extraordinary and impressive! Although some of the bottles had cracked because of the ice, the team who found them - restorers working on the hut - said they were sure the crates contained intact bottles "given liquid can be heard when the crates are moved".

Whyte & Mackay, which owns the McKinlay brand and supplied the whisky for Shackleton, launched the bid to recover the bottles for samples to test and decide whether to relaunch the defunct spirit. The drinks group's master blender Richard Paterson described the find as "a gift from the heavens for whisky lovers". He added,

"If the contents can be confirmed, safely extracted and analyzed, the original blend may be able to be replicated"

"Given the original recipe no longer exists, this may open a door into history."

Shackleton's expedition ran short of supplies on its long ski trek to the South Pole from the northern Antarctic coast in 1907-1909 and turned back about 100 miles short of its goal.

His loss—our gain!

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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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The drug maker Eli Lilly and Co quietly launched a new website today for a program dubbed Lilly Phenotypic Drug Discovery Initiative or PD². According to the company, “The PD² initiative is a unique opportunity for investigators from external institutions to submit proprietary compounds for potential screening in Lilly's phenotypic assay panel. This highly collaborative process is enabled by a web-based application that facilitates efficient transfer of information between Lilly and the investigator. The PD² screening panel is currently comprised of five modules which are relevant to therapeutic areas of long-term strategic interest, including oncology, neurological disorders, and metabolic diseases. This panel may change over time to reflect additional research interests.”

Company officials believe that program will allow it to evaluate and possibly license treatments from biotech companies and academic institutions "that are never fully evaluated as potential drug candidates." The launch of the PD² website—perhaps the first of its kind—clearly sends a signal that pharmaceutical companies are reducing their reliance on internal discovery programs to identify prospective new molecular entities and are eager to enter into licensing deals to find and acquire them. 

Membership in the PD² requires that a legal representative from the investigator's academic institution or biotech company executes a Material Transfer Agreement (MTA). Once the MTA is reviewed and approved by Lilly officials, the institution can create an account. Until that time, use of the site is limited to browsing only. I have no doubt that technology transfer offices at most major universities will be signing up for membership in short order.

I think the PD² initiative is an innovative and timely one given the massive reductions in R&D jobs that have taken place at many pharma companies over the past two years. Expect other pharma companies to follow Lilly’s lead.

Until next time....

Good Luck and Good Job Hunting!!!!!

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

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

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

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

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

Happy Birthday DNA!

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Targanta Therapeutics, a Cambridge, MA-based biopharmaceutical company, announced that it will lay off 85 of its 115 employees or almost 75% of its workforce. The news follows the FDA’s rejection of its application for oritavancin, an antibiotic it is developing to treat infections caused by methicillin-resistant Staphylococcus aureus (MRSA) and other antibiotic resistant bacteria. The agency wants Targanta to conduct another Phase III clinical trial to further assess of oritavancin’s safety and efficacy.

The company estimates that the new clinical trial will cost about $20 million. Targanta CEO Mark Leuchtenberger said “We are no longer a pre-commercial company. We are back to being a Phase three company, and that requires us to right-size and to streamline our operations.”

Things are not going well for companies in the antibacterial drug discovery and development space. Late last month, FDA rejected Swiss-based Arpida’s NDA for iclaprim an antibiotic it was developing to treat complicated skin and soft infections caused by MRSA. Shortly after receiving the news, Arpida layed off roughly 72% of its employees and is down to about 30 employees like Targanta.

It is unfortunate that big pharma decided to abandon antibacterial discovery and development research about eight years ago. Consequently, development of  new, much-needed antibiotics has been relegated to financially-strapped, small biopharmaceutical companies whose likelihood of success is questionable.

Until next time…

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

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New Jersey-based Pharmacopeia, the first-ever combinatorial chemistry company, announced that it had agreed to be purchased by Ligand Pharmaceuticals in a stock deal worth about $70 million. Onetime a leader in combinatorial chemistry and high throughput screening, Pharmacopeia has struggled of late after it jettisoned its profitable molecular modeling division several years ago. While the company was able to advance several of its lead compounds into early phase clinical testing, its  longtime business model, predicated on multiple, small discovery deals with large pharmaceutical companies, was unable to provide enough capital to continue to sustain operations.

Pharmacopeia was established in 1993 after its founders licensed from Columbia University several of the first issued combinatorial chemistry patents. The company was a pioneer in combinatorial chemistry (and subsequently high throughput screening) and was the first to publicly tout the virtues of combinatorial chemistry in drug discovery. By the mid-1990s, many pharmaceutical companies had embraced combinatorial chemistry as the “next big thing” and began eliminating traditional natural product and medicinal chemistry jobs. The industry’s love affair with combinatorial chemistry grew so strong that many companies (most notably Merck), completely eliminated their natural products discovery departments in the late 1990s. Unfortunately, the role of combinatorial chemistry in drug discovery never lived up to its promised potential and was largely abandoned in the early 2000s. Although combinatorial chemistry is now part of the modern day drug discovery paradigm, this onetime “shining star” has largely been relegated to a minor supporting role.

I first became acquainted with Pharmacopeia in 1994 after I took a job with Transcell Technologies, a now-defunct biotechnology company that was co-located with Pharmacopeia in a research facility in Monmouth Junction, NJ. While Transcell and Pharmacopeia shared a cafeteria and some common laboratory equipment, Pharmacopeia employees were strictly forbidden to talk with Transcell employees— lest they inadvertently divulge proprietary combinatorial chemistry concepts that might jeopardize the company’s future. Coincidentally, a guy who lived two doors down from my family and me turned out to be Pharmacopeia’s in-house intellectual property attorney. Although, Ron and I became good friends, he was also extremely tight-lipped about the “goings-on” at Pharmacopeia. Privately-held Pharmacopeia went public in 1995 and at one time, its market capitalization was almost $1.0 billion.

By any reckoning, a 15-year run is outstanding for a biopharmaceutical company. However, as the old adage goes, “All good things must come to an end.” At present, it is not clear, whether or not California-based Ligand will relocate the company or cut jobs. Nevertheless, Pharmacopeia’s impending demise sends a clear signal that the golden age of combinatorial chemistry has ended!

Until next time….

Good Luck and Good Job Hunting!!!

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In addition to being used to speed drug review, the new fees will support post-market surveillance and post-market evaluation of drug safety. Further, for the first time, drug manufacturerers have agreed to provide user fees to support FDA review of direct to consumer advertising (DTC). At present, FDA has no authority over DTC ads prior to drug launch; companies submit copies of broadcast and print ads when they begin running. FDA is seeking the authority to review DTC ads before they can be aired or printed.

Increases in user fees suggest that the agency ought to be looking for a few "good women and men" to review regulatory submissions and institute its new focus on drug safety and surveillance.

Until next time......

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

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