Cannabis Derived Pharmaceuticals The Next Frontier?

Posted in BioBusiness

I wrote an article on the emerging medical marijuana and cannabis-derived pharmaceuticals market for Life Science Leader.

Please click here to view!

It was a very interesting article to research and fun to write Please let me know your thoughts and feedback!!!

 

Until next time….

Good Luck and Good Job Hunting (not when you are high of course)

Sanofi Aventis Announces New Layoffs

Posted in BioJobBuzz

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!!!!!!!

 

So Much for The Promise of RNAi!!!

Posted in BioBusiness

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!!!!!!!!

 

Life and Career Advice From Steve Jobs

Posted in Career Advice

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!

Looking for a Job in the Life Science Industry? Try China!

Posted in BioJobBuzz

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!!!!!!

 

Crowdsourcing Comes of Age For Molecular Modeling and Drug Discovery

Posted in Social Media

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!!!!!!!!! 

 

Pharma and Social Media: Lilly Launches A YouTube Channel

Posted in Social Media

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!!!!

 

The Rumor Mill: Is Cubist Really In Play?

Posted in BioBusiness

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!!!!!!!!

 

Antibiotic Revenues and Antibacterial Drug Discovery Research Are Declining

Posted in BioBusiness

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)

 

A New Role for Academic Scientists in New Drug Discovery and Development?

Posted in BioBusiness

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!!!!!!!!!!