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Earlier this week Roche Holding AG announced that it would pay $230 million to acquire the San Diego, CA-based biopharmaceutical company Anadys. The reason for the acquisition is to bolster Roche’s standing in the hepatitis C market which is projected to grow to as much as $15 billion annually by 2019.

Anadys has a fairly large experimental pipeline of hepatitis C drugs, the most advanced candidate being setrobuivr that is being clinically tested in combination with the generic antiviral drug ribavirin and Pegasys (PEGylated α-interferon) as a hepatitis C treatment.

The Anadys deal comes on the heels of an agreement last week between Roche and Merck & Co to jointly market hepatitis C treatments in the US. Merck recently won approval last May for Victrelis (boceprevir) the first new hepatitis C treatment in over a decade. Also, late last month Vertex Pharmaceuticals received approval for a new hepatitis C drug called Incivek (telaprevir). Anadys is also conducting early clinical trials on ANA773 as a possible treatment for hepatitis C infection, cancer and other chronic diseases.

In other news, GlaxoSmithKline (GSK) is rumored to be contemplating purchasing Maryland-based Human Genome Sciences (HGS), which recently received US approval for Benlysta a novel monoclonal antibody treatment for the autoimmune disease systemic lupus erythematous. 

Benlysta was the first new drug to be approved to treat lupus in over 50 years. GSK is HGS’s commercialization partner for Benlysta which is expected to be a blockbuster drug. The reason for the takeover rumors is likely HGS’s stock price which has fallen from 52-week high of $30 to its current value of $15 per share. 

Until next time...

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

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Not too long ago, the mere mention of the word “vaccine” caused most big pharma executives to break out into a cold sweat. Once derided as low margin products and potential market busters—once most populations are immunized the incidence of disease declines and the market begins to falter—vaccines, primarily pediatric ones, have made a huge comeback over the last five years. 

One of the main reasons for the resurgence of the vaccine industry, was passage of US legislation that better-defined the legal obligations of vaccine makers and inclusion in the legislation of provisions that cap the size of awards made to persons claiming injury after vaccination. Another factor that contributed to the growing popularity of vaccines was emergence of the middle class in vast and concomitant improves in the healthcare systems of emerging markets that include South America, Asia and Africa. Unlike the mature vaccine markets in the US, Europe and Japan (because of low birthrates), the Asian, Latin American and African markets are poised for explosive growth over the next two decades.

In a recent article entitled “Vaccines-The Sustainable Blockbuster Business” Frost and Sullivan’s Senior Healthcare Analyst Barath Shankar Subramanian provides some interesting and insightful factoids about the vaccine industry. They are:

Pediatric vaccines are leading adult vaccines and represent the fastest growing segment of the global vaccine market

Europe is the world’s leading vaccine producer with over 90% of total production

The top five vaccine manufacturers (all big pharma companies) produce more than four-fifths of global vaccine revenues while other manufacturers (approximately 40) account for only one-fifth.

The North American market accounts for over 50 percent of the total spend on vaccines

North America and Europe supply only 14 percent of the world’s vaccine demand; the rest is met by suppliers in developing markets

Government investment, not-for-profit spending and industry alliances/ partnerships, in addition to private R&D spending, are helping to drive the current resurgence of the global vaccine industry

At present, there no fewer than 80 new candidates in late stage clinical development. Further, almost 40 per cent of the new vaccine candidates are for indications that currently have no vaccines on the market.  Finally, improvements in vaccine delivery are helping to drive the improved uptake of vaccines. For example, aerosols, transdermal skin patches, oral drops and even pills—all designed to eliminate needles and improve patient compliance and overcome cold chain supply issues are currently being developed.

From a business perspective—as far as sustainable markets go—the pediatric segment of the vaccine market is a clear winner. Currently, the leading global causes of vaccine-preventable, deaths for children under five include: pneumococcal disease, rotavirus, measles, Hemophilus influenzae b (Hib) infections, pertussis and tetanus. To that end, it is likely that governments in emerging markets will continue to add existing and new vaccines to government-mandated immunization programs. This is almost certain to propel the vaccine market to new heights over the next 10 years or more.

Until next time...

Good Luck and Good Job Hunting (think biologics!)

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The Pharmalot Blog today reported that the Japanese drug maker Shionogi Pharmaceuticals is testing  a novel approach to hiring new pharmaceutical sales reps. 

According to the post, Shionogi has eight open positions to fill in the US which in of itself is interesting considering that as many as 80,000 pharma sales reps may have lost their jobs over the past three years or so. But, after a little digging, Ed Silverman, who writes the Pharmalot blog discovered something a little different about the ads for the jobs.

 “The ads state expressly that anyone with a background in pharma sales is not wanted for the jobs, which pay around $40,000-plus, not counting a bonus of $17,000 to $19,000 and the usual frills, such as the use of a company car. You do, however, need a bachelor’s degree - no major is specified - and must be outgoing, upbeat and comfortable speaking with others (see a job description here).”

Ed posits that by eschewing reps with prior experience the company will spend a lot less money and are likely to be more “trainable” than experienced, higher priced reps who may have developed “bad habits.” And, according to Ed, some those bad habits may include those who may be “inclined to look for off-label marketing violations that could be the stuff of whistleblower lawsuits or those who are primed to seek opportunities to sue for overtime pay.” 

Oh that Ed, what a kidder!

Until next time....

Good Luck and Good Job Hunting!!!!

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Mark Senak, author of the EyeonFDA blog and a feisty social media advocate and enthusiast today reported that the long awaited FDA guidelines for the use of social media by life sciences companies might not be completed until 2012. 

Mark, who is attending the Food and Drug Law Institute Advertising and Promotion Conference being held in Washington, D.C. (#FDLIAP), based his timeline on remarks made by during presentations by a couple of FDA employees from the Division of Drug Marketing, Advertising and Communications (DDMAC). According to Mark:

“A process begun in 2009 may see a milestone in 2010 with issuance of draft guidance, followed by commentary and revision and the issuance of a final of what will be much guidance, apparently.  A three year "event.”

Further, Mark offered this assessment:

“The Internet and social media landscape moves at the speed of light.  Consider that Twitter only came into existence three years ago.  The development of each new platform introduces new questions into the equation.  Consider the frequency and with what depth and breadth consumers consult the Internet and social media for health care information, and we have a priority that demands something faster than a three year event.”

While I agree with Mark that FDA should act faster to develop guidelines for the use of social media for promotional and non-promotional purposes, the existing guidelines for print and broadcast media are sufficient for companies (which abide by DDMAC regulations) to launch successful social media campaigns. A great example of this is Novo Nordisk’s novel Twitter campaign entitled “Race with Insulin” in which professional race car driver Charlie Kimball tweets about his use of Novo’s insulin products.  Novo contends that the campaign helps to dispel the notion that persons with type I diabetes are limited in what they can do personally and professionally (it also helps to sell more insulin!)

Some industry insiders and bloggers think that Novo’s Twitter campaign may be inappropriate and ill-advised. Like it or not, the Race with Insulin Twitter campaign is compliant with existing DDMAC regulations and no different than many other direct-to-consumer advertising campaigns that use paid company spokespersons. Personally, I think that criticism of the campaign is nothing more than “sour grapes,” i.e. Novo figured it out before other pharma marketers did!

The lack of FDA guidance on the use of social media will certainly hinder and perhaps deter other pharma companies from leveraging the true power of social media. However, the old adage “where there is a will, there is way” is particularly apt for those companies that are seriously considering social media in the absence of any notable regulatory guidance on the subject.

Until next time....

Good Luck and Good Tweeting!!!!!!!!!!!!!

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Several years ago a television show appeared on the BBC entitled “Secret Diary of a Call Girl” which follows the life of a seemingly ordinary, but struggling, student named Hannah aka Belle de Jour who, unbeknownst to family and friends, secretly moonlights as a prostitute to make ends meet. The BBC series (which starred the British actress Billie Piper) was based on an anonymously written blog (later books) that began appearing in 2003.

Last November, the author behind the blog and bestselling books revealed herself to be none other than Brooke Magnanti, PhD a researcher in developmental neurotoxicology and cancer epidemiology at a hospital in Bristol, England. And, while a doctoral student in 2003, actually worked as a prostitute (£300 per hour) for an escort service to help pay rent and make ends meet when writing her PhD thesis. At the time, she was already an experienced science blogger and began writing about her experiences on a blog entitled 'Belle de Jour: Diary of a London Call Girl' which was later adapted into the books and the television series. 

Magnanti said she was working on a doctoral study for the department of forensic pathology of Sheffield University in 2003 when she began her secret life. "I was getting ready to submit my thesis. I saved up a bit of money. I thought, I'll just move to London, because that's where the jobs are, and I'll see what happens. She added "I couldn't find a professional job in my chosen field because I didn't have my PhD yet. I didn't have a lot of spare time on my hands because I was still making corrections and preparing for the defense and I got through my savings a lot faster than I thought I would"

Dr. Magnanti has no regrets about the 14 months she spent working as a high priced call girl. "I've felt worse about my writing than I ever have about sex for money," she said. "I did have another job at one point, as a computer programmer, but I kept up with my other work because it was so much more enjoyable" she added. Interestingly, Magnanti has kept her day job as a researcher and writes in her spare time.

While this alternate career option may not appeal to most, it certainly was a creative choice that demonstrated at least one scientist’s commitment to “doing whatever it takes” to pursue a scientific career!

Until next time...

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

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A team of researchers at the University of Wisconsin-Madison (my alma mater) genetically engineered a strain of Streptomyces platensis to overproduce the antibiotics platensimycin and platencin. They accomplished this by deleting a regulatory gene (ptmR1, whichencodes a putative GntR-like transcriptional regulator) in the antibiotic synthetic pathway that controls production. The newly engineered strain has been reported to overproduce platensimycin and platencin with yieldsof 323 ± 29 mg/L and 255 ± 30 mg/L, respectively. This represents a 100-fold increase in the yields observed with corresponding S. platensis wild type strains.

Platensimycin is the first of a new class of natural product antibiotics (with a novel mode of action) to be discovered in the past 40 years.  It exhibits strong, broad-spectrum Gram-positive antibacterial activity by selectively inhibiting cellular lipid biosynthesis. Treatment with platensimycin eradicates Staphylococcus aureus infection in mice. Because of its unique mode of action, platensimycin shows no cross-resistance to other key antibiotic-resistant strains tested, including methicillin-resistant S. aureus, vancomycin-intermediate S. aureus and vancomycin-resistant enterococci.

Platencin, also a natural product, is chemically and biologically related but different from platensimycin. Like platensimycin, it exhibits a broad-spectrum Gram-positive antibacterial activity through inhibition of fatty acid biosynthesis. And, it doesn’t exhibit cross-resistance to methicillin-resistant Staphylococcus aureus, vancomycin-intermediate S. aureus, and vancomycin-resistant Enterococci. Moreover, platencin shows potent in vivo efficacy without any observed toxicity.

Both antibiotics show promise for commercialization. While we need new antibiotics, both platensimycin and platencin target only Gram positive bacteria. Infections caused by multiple drug resistant Gram negative bacteria are threatening to overtake those caused by Gram positive in the very near future. At present, to the best of my knowledge, there are no new antibiotics in the pipeline directed against multiple drug resistant Gram negative strains.

Until next time...

Good Luck and Good Antibiotic Hunting!!!!!!!!

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In the February issue of Genetic Engineering and Biotechnology News, J. Leslie Glick a former CEO of Genex and veteran of the biotechnology industry put forward a novel solution to financial crisis that is currently gripping the life sciences industry and the rest of the US economy. Dr. Glick proposed that the US government ought to consider injecting taxpayer monies into venture capital firms (VC) which, he believes, would foster creation of new companies, create more jobs, stimulate the ailing economy and also provide the government with an outstanding return on its investment.

According to Dr. Glick, “historical results reported by the National Venture Capital Association for the 20 year period ending December 31, 2007, show an annualized return of 16.7% to investors in some 1,860 U.S. venture capital and private equity partnerships. If the U.S. government had made annual investments of $10 billion in VC firms throughout the U.S. during that 20year period, the $200 billion total investment would have yielded a total return of almost $1.5 trillion.” Further, he asserts that according to the  International Trade Administration of the Department of Commerce, from 1970 to 2000, U.S. VC firms invested over $270 billion in more than 16,000 companies. In 2000, the surviving VC-backed companies employed 7.6 million people, representing 5.9% of all U.S. jobs, and generated sales of $1.3 trillion, accounting for 13.1% of the U.S. GDP.

This financial upside sound enticing but who is going to keep track of the money and keep an eye on how and what the VCs are investing in? Dr. Glick proposes creation of a non-partisan funding mechanism, possibly overseen by an independent panel of business people that would disburse $10 to $25 billion annually of taxpayer’s dollars to vetted and certified VC firms. Because of its investment, the US government would become a limited partner in these firms and could direct them to invest in technologies that would help to reduce health care costs, develop energy alternatives or improve food production capacity. While this proposal is unprecedented and controversial, we are living in extremely uncertain financial times that may necessitate innovative and out-of-the-box solutions to restore normalcy to the US economy. That said, all proposals—no mater how unconventional or outrageous—ought to be carefully evaluated and vetted to determine whether or not they have merit to help overcome our deepening recession.

Kudos to Dr. Glick!

Until next time,

Good Luck and Good Investing!!!!!!

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According to a press release by IMS, a company that tracks pharmaceutical sales, growth of the US pharmaceutical market shrank from 8% in 2006 to a meager 3.8% in 2007–the slowest growth rate since 1961. Total U.S. prescription sales in 2007 only reached $286.5 billion. The 2007 slowdown in sales was attributed to:

• Loss of patent exclusivity for branded products
• Fewer new drug approvals
• Effect of Medicare Part D on annual growth
• Renewed focus on safety issues by US Food and Drug Administration

Industry officials place the blame for the slow down on FDA because fewer newer drugs were approved in 2007 as compared with years past. However, I believe that the slow down has more to do with:

• Higher prices of branded medications as compared with generic drugs
• Lack of public confidence in the pharmaceutical industry
• Increased scrutiny by regulators on direct to consumer advertising and continuing medical education (CME)
• Fewer and less innovative drugs in company pipelines

Bashing FDA is easy. The willingness of the pharmaceutical industry to assume ownership of some of its own shortcomings and missteps is substantially more difficult to do!

Until next time….

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

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