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Last week, the US Food and Drug Administration issued a press release lauding its approval of 35 new prescription medications in FY2001. According to the release 2011 was a banner year for drug approvals; being only surpassed in FY2009 when 37 new medicines garnered regulatory approval.

FDA detailed its accomplishments in a report entitled “FY2011, Innovative Drug Approvals” which touted faster approval times in the United States as compared with the FDA’s counterparts around the globe. Twenty-four of the 35 approvals occurred in the United States before any other country in the world and also before the European Union, continuing a trend of the United States leading the world in first approval of new medicines. 

Among this year’s highlights:

1. Two of the drugs – one for melanoma and one for lung cancer – are breakthroughs in personalized medicine. Each was approved with a diagnostic test that helps identify patients for whom the drug is most likely to bring benefits;
2. Seven of the new medicines provide major advances in cancer treatment;
3. Almost half of the drugs were judged to be significant therapeutic advances over existing therapies for heart attack, stroke and kidney transplant rejection;
4. Ten are for rare or “orphan” diseases, which frequently lack any therapy because of the small number of patients with the condition, such as a treatment for hereditary angioedema;
5. Almost half (16) were approved under “priority review,” in which the FDA has a six month goal to complete its review for safety and effectiveness;
6. Two-thirds of the new approvals were completed in a single review cycle, meaning sufficient evidence was provided by the manufacturer so that the FDA could move the application through the review process without requesting major new information;
7. Three were approved using “accelerated approval,” a program under which the FDA approves safe and effective medically important new drugs quickly, and relies on subsequent post-market studies to confirm clinical benefit. For example, Corifact, the first treatment approved for a rare blood clotting disorder, was approved under this program
8. Thirty-four of 35 were approved on or before the review time targets agreed to with industry under The Prescription Drug User Fee Act  (PDUFA), including three cancer drugs that FDA approved in less than six months.

PDUFA was established by Congress in 1992 to ensure that the FDA had the necessary resources for the safe and timely review of new drugs and for increased drug safety efforts. The current legislative authority for PDUFA expires on Sept. 30, 2012. 

Maybe the agency can keep its streak alive before  PDUFA expires next year!

Until next time...

Good Luck and Good Job Hunting!!!!!

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Vincent, Michael, and Stanley recorded episode #8 of the podcast This Week in Microbiology live at the 2011 ASM General Meeting in New Orleans, with guests Andreas Baümler, Nicole Dubilier, and Paul Rainey. 

They spoke about how pathogens benefit from disease, symbioses between chemosynthetic bacteria and marine invertebrates, and repetitive sequences in bacteria.

Hosts: Vincent Racaniello, Michael Schmidt, Stan Maloy, Andreas Baümler, Nicole Dubilier, and Paul Rainey.

Right click download TWiM #8  (60 MB, .mp3, 86.5 minutes).

Links for this episode:

• Salmonella invasion from the gut lumen into tissues (PLoS Pathogens)
• Symbiotic diversity in marine animals (Nature Rev Micro)
• REPINs, a new family of mobile DNA bacteria (PLoS Genetics, In Press)
• Letters read on TWiM #8

Subscribe to TWiM (free) on iTunes, Zune Marketplace, via RSS feed, by email or listen on your mobile device with the Microbeworld app.

Send your microbiology questions and comments (email or mp3 file) to twim@twiv.tv , or call them in to 908-312-0760. You can also post articles that you would like us to discuss at microbeworld.org and tag them with twim.

 Until next time...

Good Luck and Good Listening!!!!!!!

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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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The NY Times today reported that a 15-year veteran chemist at the US Food and Drug Administration (FDA) has been charged with using confidential and proprietary information about pending drug applications to buy and sell pharmaceutical and biotechnology company stock.

According to a criminal complaint filed by the US Justice Department, Cheng Yi Liang, 57 and his son Andrew made millions trading stocks on inside information since 2007. The criminal lawsuit alleges that the Liangs traded stocks in five pharmaceutical and biotechnology companies that had drug applications under review at the agency. Cheng Yi Liang’s job gave him access to a password protected-database that tracked the progress of new drug applications. Some of the companies leveraged by the Liangs included Vanda Pharmaceuticals, Clinical Data, Momenta Pharmaceuticals, Middlebrook Pharmaceuticals and Progenics. The Securities and Exchange Commission (SEC) simultaneously filed a civil securities fraud lawsuit against Cheng Yi Liang. 

The elder Liang is accused in the criminal complaint of “of using the FDA database to get an early look at F.D.A. decisions on companies developing drugs and then working with his son to trade on that knowledge, buying stock ahead of good news and selling it before bad news was announced. Both complaints assert that the defendants made just under $2.3 million in direct profits and avoided an additional $1.3 million in losses”. Further, the S.E.C. complaint accused FDA employee Liang of illegally trading ahead of more than two dozen F.D.A. announcements involving drug applications by 19 companies.

The case is noteworthy because, according to the Times article “it is uncommon for insider-trading investigations to involve FDA, despite the significant amount of market-moving information that passes through the agency each year. The agency maintains a rigorous ethics code and imposes significant restrictions on stock ownership and trading by its employees.”  The good news is that insider trading at FDA is rare and that a majority of its employee maintain ethical and moral standards that are consistent with the mission of the agency which is to supply the American public with safe and efficacious medicines. However, while the Liangs got caught, it does not mean that other less-than- scrupulous employees at FDA have also not benefited from less sophisticated insider trading schemes than those employed by the defendants. After all, FDA employees are human like the rest of us and the temptation to “get rich quickly” can be overwhelming especially during hard financial times.

Until next time...

Good Luck and Good Job Hunting (try FDA, there is at least one open position that needs to be filled)

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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 $789 billion American Recovery and Reinvestment Act that was passed in 2009 included funding for the Health Information Technology for Economic and Clinical Health (HITECH) act to promote the adoption of electronic health record (EHR) technology in health. Beginning next year, doctors and eligible medical providers can receive Medicaid incentive payments over a five-year period if they adopt a certified EHR technology platform and adopt so-called "five goals" established by the Centers for Medicare and Medicaid Services

The act is expected to create more than 50,000 new health information technology (HIT) jobs. With many hospitals and physicians making the transition from paper charts to electronic medical records, there is a growing demand for specialists trained in the latest medical record technology. Recognizing the surging demand for HIT workers many universities including two- and four- year colleges and for profit institutions like DeVry University have created HIT certificate and degree programs.

There is no question that HIT professionals will be in high demand over the next decade or so. That said, if you have an interest in biology or medicine and like IT, HIT may be a good career choice for you! Don’t wait; act now.

Until next time...

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

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The era of blockbuster drugs was officially declared over several years ago by many pharmaceutical analysts and pundits. Nevertheless, as the old adage goes “it’s difficult to treat old dogs’ new tricks!” After all, the blockbuster drug model has been the major driver of pharmaceutical and biotechnology markets for close to 50 years. Consequently, big pharma and biotech companies haven’t truly abandoned the possibility of finding potential new blockbusters. And, it appears that the blockbuster heir apparent may be drugs to treat rare aka orphan disease indications. 

At first blush, this strategy may not make a lot of sense. This is because rare diseases afflict only small numbers of patients (at least in the US and other Western nations). However, what may be considered a rare disease in Europe or the US may actually be less rare in countries with large populations like China and India. Further, while current rare diseases patient populations may be small, the cost of the drugs developed to treat them is extremely high. In some instances, the annual cost per patient can exceed several hundred thousand dollars. If you do the math, it becomes apparent that developing rare disease treatments or so-called niche busters can actually be very big business. 

The rare diseases business model has been perfected by Genzyme and many big pharma companies are trying to emulate it. To that end, big pharma’s push into rare diseases continues to gather momentum. So far this year Sanofi-Aventis has made an $18.5bn move for Genzyme, while Pfizer and GlaxoSmithKline have both created rare disease business units.

According to Glaxo’s estimates, 7,000 rare diseases have been identified and collectively this affects 6-8% of the world’s population; in the US and Europe alone rare diseases affect 25 million people. In addition mortality rates are very high, often at a very young age, and less than 10% of these diseases are treated with approved drugs.

To date, over 7,000 rare diseases have been identified. Companies involved in the new rare diseases treatment race have whittled the list down to roughly 200-250 disorders that represent a clear path for clinical, regulatory and commercial success. The criteria used to select these indications include identifying rare disorders with: 1) a relatively high prevalence rate, 20 an early age of onset, 3) a large unmet medical need and 3) a known molecular target. The indications have been broadly classified into four distinct groups:  metabolic disorders, autoimmune/inflammation, central nervous system and blood disorders.

While Genzyme identified, developed and commercialized its rare diseases treatments, it is likely that big pharma companies like Pfizer, Glaxo, and Merck will either in-license potential new treatments or acquire companies with platform technologies or drugs in various stages of clinical development. For example, Merck’s acquisition of Glycofi several years ago has allowed the company to enter into the rare diseases and biosimilar markets.

One of the major problems with extant rare diseases treatment is their excessive and oppressive costs. One can only hope that the increased competition in the rare diseases space will help to lower drug prices and make them more affordable for patients who suffer from these devastating and life-threatening disorders.

For more insights in to the orphan drug disease market, check out an article that I wrote for Life Science Leader this month

Until next time...

Good Luck and Good Job Hunting!!!!!

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We are now three years into one of the worst economic downturns in the history of the US. While the job market will eventually recover, don’t expect things to be the “way they were” before the recession. In other words, the job market has undergone a paradigm shift and new job seeking rules have replaced the old ones.

To that end, I recently found an article written by Liz Wogemuth of US News and World report entitled “5 Strategies for Surviving the ‘New Normal’ Job Market.” The post is well crafted and offer fresh insights into the new rules and behaviors that ought to help guide job seekers for the foreseeable future.

They are: 

1.  Be patient

These days, companies are slower to invest and slower to hire. Even rockstar employees will have to work harder to convince companies to bankroll ambitious projects. "For those people who do have the big idea, [return on investment] is going to be absolutely critical," says Brad Karsh, president of JB Training Solutions, a management and business skills training firm. Given their extreme uncertainty about the near future, companies will likely be more amenable to making an investment that pays off in seven months than one that pays off in seven years.

Most companies are also no longer doling out annual raises or annual promotions, which mean workers, need to be patient about advancement in earnings and position. One thing that's slowing down the process: Upper executives aren't moving around as much as they used to. "It used to be you'd lose 25 percent of your [vice presidents] every year, let's say, because they'd go to other companies or start their own," Karsh says. "Well, more people are like, 'I don't want to leave.'" Even top employees are turning down offers from outside companies because they fear taking a risk on a new employer in such an uncertain economy, Karsh says.

Workers who are on the market should be prepared for a longer interview process. Companies are increasingly asking candidates to interview with multiple people at the company and asking them to return for multiple rounds of interviews. "One thing I tell people is, 'don’t take this personally,'" Karsh says. "It's just a function of the economy." Even though the process can be grueling and frustrating, it's critical that job seekers stay fresh and enthusiastic--still smiling and prepared with questions at the eighth interview. Some may be frustrated with companies that can't make a decision, perhaps feeling that the company is giving them the runaround. Employers need to be forthright with candidates about their plans, capabilities, and timetable, Karsh says.

2.  In your job search, take the time to tailor

Some job seekers are applying to hundreds of jobs, but if inundated hiring managers can't easily spot the relevance of your experience to the position they're filling, they'll breeze right past. Career expert Ellen Gordon Reeves often speaks to groups of job seekers and says she is still finding that many people are not presenting themselves well--making no effort to tailor their resumes and cover letters to the jobs they are applying to. "Everybody fears rejection, so they don't really pitch themselves," Reeves says. Her advice: Put yourself in the hiring manager's shoes. Imagine what you would think of your resume if you were hiring for this position. Would the job experience listed look relevant to you? If not, spend some time recasting your work history and your skills. "Write for the job you want, not the jobs you've had," Reeves says. If you're doing this well, with your resume and cover letter, it should take at least a day (if not more) to apply for a single position. But it's so much more effective than blindly submitting your resume that it's worth the time it takes.

3.  Leverage your relationships to find openings 

Unfortunately, many job openings are impossible to find with your computer. Companies are skipping posting openings online so they can fill positions without scavenging through the onslaught of (often ill-matched) resumes. A new survey from ExecuNet found that companies and executive search firms are posting fewer executive position openings online this year. Firms said that only 22 percent of positions paying $200,000 or more are being posted on job boards or websites, compared with 30 percent in 2008 and 24 percent last year. In a different survey of recruiters, 92 percent reported that they believe in a "hidden market" for executive positions. Recruiters are relying more on their networks, as well as searching internal databases and doing their own research.

4.  Look to add value constantly 

As an employee, whether you're bringing in new money or you're saving money, you need to be adding value monetarily, Karsh says. "If you work in sales and you can say, 'I increased my client list by 25 percent, I increased my sales by 50 percent,' that's the sort of thing that employers are looking for right now--anything that can affect the bottom line," Karsh says. "If you're not in sales, you can affect it by saving the company money." Find savings opportunities by refining a process, or even suggesting a cheaper way to, say, buy or use office supplies. One tip: Put your suggestions in an E-mail so you are sure to get credit for them. 

5.  Find fresh advice 

There are a lot of people in the world offering career advice better suited for the job market of the previous decade. In this markedly different economy, old advice may very well cause damage. Sometimes the changes are minor, but they can make you look out of touch. For example, adding the line "References available upon request" can make your resume or cover letter look out of date. "It goes without saying that your references are available upon request," says management consultant and U.S. News contributor Alison Green. "It would be really odd if they were not."

Until next time....

Good Luck and Good Job Hunting!!!!

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There was an extremely troubling article in today’s New Jersey Trenton Times that indicated that a New Jersey’s childhood vaccination rates ranked 42nd in 2009—45^th in 2008—in the nation. The ranking were based on annual vaccination statistic compiled by the Centers for Disease Control in Atlanta, GA.

The lead-in paragraph to the article elegantly captured the irony of the dubious statistic:

“One of the most affluent (and most populous states) states in the country, home to more than a few giants in the pharmaceutical industry also has one of the lowest rates of immunizing babies and toddlers in the nation.”

New Jersey’s vaccination rates among infants and toddlers for childhood diseases— mumps, measles, diphtheria, Pertussis (whooping cough), hepatitis B and rubella—was roughly 64 percent in 2009. This was significantly lower than the national average of 71 percent and the lowest in the Northeast. For example, in Pennsylvania and New York, two of the states bordering New Jersey, the vaccination rates in 2009 were 72 and 71 present respectively.

The reasons given for the low rate are plausible but, in most cases, incomprehensible from an infectious diseases and public health perspectives. It has been postulated that low-income and immigrant communities lack health insurance and access to medical information about mandatory childhood vaccination regimens. While it is facile to blame low income and immigrant populations for New Jersey's  egregiously low vaccination rate, the problem may actually lie with more affluent and educated NJ citizens who have medical insurance (help to pay the salaries of medical billing workers) and understand the public health implications of mandatory childhood immunizations. 

According to the article, parents and even some health care professionals are backing away from mandatory vaccination because they “don’t like seeing kids cry” after sometimes receiving up to four vaccinations during a single office visit! Say what????? I accompanied my three children for most of their childhood immunizations, and while some tears may have been shed, they recovered quickly and are now protected against a variety of potentially life-threatening diseases.  Apparently, some parents and health care professionals are willing to jeopardize the public health of a nation because the “shots hurt.” To that I say; get over it—like it or not, life can be painful and no matter how hard you may try you cannot shield your kids from it!

The fallacious and recently publicly discredited link between childhood vaccination and autism, coupled with the growing public distrust of the pharmaceutical companies that manufacture the vaccines may be more plausible explanations for New Jersey’s declining immunization rates in NJ. This suggests that vaccine manufacturers and public health officials ought to work closely together to be educate the American public about the benefits and potential risks associated with childhood vaccination.

Finally, as some of you may know, many states like New Jersey have religious exemptions that allow children to skip mandatory childhood immunizations. Interestingly and troublingly these children are allowed to attend public schools despite the fact that they haven’t been vaccinated. Again, I say what??? Increasingly, these unvaccinated students have been implicated as the reservoirs for the pertussis outbreaks that are currently ravaging school aged children and older adults throughout the US. It is my belief that children who fail to receive the appropriate immunizations because of religious reason should not be allowed to attend public school. This is because, unlike many of the low income and immigrant families who may be unaware or cannot afford to immunize their children because they lack health insurance, many of the folks claiming religious exemptions have health insurance and are living above the poverty level. Consequently, if these parents choose to not immunize their children (and fail to meet mandated public health requirements for entry into public schools), then they ought to be financially responsible for their child’s education.

Paradoxically, the plummeting vaccination rates in New Jersey and elsewhere are being driven by a small but extremely vocal segment of the American public. Unfortunately, this anti-vaccine sentiment in America is unlikely to abate until an increasing number of children begin to die from easily preventable childhood diseases. As far as I am concerned, the benefits of childhood vaccines far outweigh their risks and help to maintain the public health of all Americans.

Until next time...

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

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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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As you may know, BioJobBlogger was recently sued for defamation, invasion of privacy and punitive damages by Donna Roberts and Dawn Abrams two so called dog breeder.

To that end, a group of concerned dog advocates and friends have created a website called Stop Puppy Fraud to help to raise awareness about fraudulent dog breeders and to help raise money to defray legal expenses.

P.S. The dog in the pic is Moose-- a two to five year old mixed breed dog (misrepresented as a 9 month old Havanese purebred) rescued from Abrams and Roberts.

Thankfully, he is in much better shape today than in the pic (taken less than a week after we purchased him from Dawn Abrams) with bilateral ear infections, a fulminant urinary tract infection that prevented him from urinating and necrotic gums and rotting front teeth that were ultimately saved by a veterinary dental expert).

Until next time...

Good Luck and Help Save the Puppies!!!!!!

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Pfizer today announced plans to set up a Rare Diseases Research Unit that will target the more-than-6000 global orphan diseases. For those of you who may not know, orphan diseases are classified by the US Food and Drug Administration as those that afflict 200,000 persons or less.

According to a press release, Pfizer’s new division will “pursue treatments across all therapeutic areas and modalities and will serve as the focal point for the company’s existing research on rare diseases”. It also intends to “work closely with patient advocacy groups, like the National Organization for Rare Diseases, as it develops and advances the unit’s research strategy. It will be lead by Edward Mascioli, most recently the head of Dapis Capital, a private equity firm. Previously he was vice president of clinical affairs at Peptimmune and senior medical director at Paraxel.

Pfizer’s decision to enter the orphan drug market signals that no markets are too small for big pharmaceutical companies to consider in an era where blockbuster drugs are few and far between. Nevertheless, it is noteworthy that orphan drugs (which are generally biologics) offer drug maker several perks including: seven years of market exclusivity, tax breaks and credits, reduced clinical trials costs and expedited regulatory review. More importantly, perhaps, orphan drugs are highly priced and can yield impressive returns even though they are used to treat small patient populations. For example, several of Genzyme’s drugs such as Myozyme and Cerezyme—both designated as orphan drugs—have already reached over $1.0 billion in annual sales. 

While sales of orphan drugs may never reach those of Plavix, Lipitor, Epogen and other multibillion dollar blockbusters, garnering US regulatory approval for four or more (which cost much less than $1.5 billion to develop) will likely provide a substantial ROI to companies that develop them. Also, developing drugs that improve the quality of life for patients with no other treatment options will undoubtedly go a long way to improve tarnished reputation of the pharmaceutical industry.

Until next time...

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

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Because I subscribe to transparency, full disclosure and the notion that most stories have two sides, I felt that it was only appropriate to post a comment sent to me by a an ardent Donna Roberts supporter who believes that she and her ring of dog-grifting associates are innocent and have been unduly harmed and wronged by my blog posts.  

From: notifications@lexblog.com <notifications@lexblog.com>
Subject: [Bio Job Blog] New Comment Posted to 'Donna Roberts Responds: I am Innocent of All Charges--The Rest of the World is Guilty'
To: cmintz@bioinsights.com
Date: Monday, May 3, 2010, 1:40 PM

An unapproved comment has been posted on your blog Bio Job Blog, for entry
#267937 (Donna Roberts Responds: I am Innocent of All Charges--The Rest of
the World is Guilty). You need to approve this comment before it will
appear on your site.

IP Address: 68.39.22.204
Name: Edward
Email Address: njlaw4u@yahoo.com
URL:
Comments:

Mr. Mintz,
   I have read all your posts and I have read all the comments posted.    I
have yet to read Mrs. Roberts threaten you, she is just trying to correct
the lies you have been spreading about her and her family.  She is a mother
protecting her children and grandchildren. It is you sir that has
threatened them and have exposed the children of this family to possible
harm by posting addresses.  Several sex offenders live in their area and
you just pointed out targets for them, shame on you.  If you have a problem
with Donna Roberts then attack Donna Roberts do not involve innocent
children.  If you had a problem with Dawn Abrams then take her to court, if
she sold you sick dogs that would be the legal thing to do but she didn't
sell you sick dogs and she didn't jump when you threatened her so you are
mad.  Mr. Mintz call it what you want, harassing this family will only end
you up in court.  This family has endured everything you have thrown at
them, every agency you have called on them and every person you have
poisoned by your blog.    I say it's enough, you are not going to stop this
family from having their dogs and rightfully so. This is America, home of
the FREE.  They are not hurting anyone, all the pups are sold with the
backing of the NJ Lemon Law for Animals and in my opinion, knowing that
their every move is being watched and monitored by you this would be the
safest place to buy a puppy from because God Forbid they sell any pup with
a problem, you would have it all over. So I am sure they are being extra
careful. I also did some checking, Mrs. Roberts is truthful.  No complaints
have been lodged against any of her children or her grandchildren. I called
the Burlington Consumer Affairs Dept and they have no complaints for any of
them except for Donna Roberts made by Barbara Harra and Laurie Pallantee in
2007. That was 3 years ago and nothing since, does that sould like a
horrible puppymill breeder. My God Man, LET IT GO !!!!!!

BioJobBlogger Response:  I won't let it go because of all of  the dogs Donna and her gang have harmed or mistreated and the pain that they have wrought on innocent and unsuspecting persons who simply wanted to buy a healthy and loving pet!

Until next time...

Good Luck and Good Dog Grifter Hunting!!!!!!!!

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Despite a down economy, it appears that business for the dog grifting team of Donna Roberts aka Marcie Duben (and many other false identities) and Dawn Abrams is booming. The reason that  I know this is that over the past week or so I have received several message regarding from BioJobBlog readers about bogus dog transactions.

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Despite court rulings, statewide investigations and public humiliation, Dawn Abrams and Donna Roberts continue to scam would be dog owners who want to buy puppies and give them good homes. 

A would be client sent me an e-mail message claiming that he was duped by the dynamic duo of sleaze because he didn’t research them in advance. Like me, he believed that these people were legitimate before it was too late. 

According to his message, these brazen and seemingly unrelenting grifters are currently doing business as:

Havanese Puppies Ready to Go (Danalyn, Medford/Vincentown)

537 Oakshade Rd., Vincentown, NJ 08008

609-346-6571

The Vincentown address is where Dawn Roberts lives in a run down farm house with 6 children. Apparently, Donna Roberts is using one of her tried and true aliases Marie Dueben (who I think is the name of one of her ex-husband’s wives). The person who wrote to me contends that these odious individuals are also doing business as My Cute Muppets on the Puppyfind website.

Despite repeated unsuccessful attempts to shut Dawn and Donna down, these amoral and unethical scumbags continue to dupe innocent, unsuspecting would-be dog owners. It is a shame that these jerks are not big enough criminals to make it onto the New Jersey State radar of people to put away. But, as I always say, what goes around comes around.

And I hope that Dawn and Donna’s days of reckoning comes around sooner rather than later.

Until next time…

Keep the faith; there is justice in the world! 

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Roche disclosed in a regulatory filing that it will plans to eliminate 500 positions in New Jersey by the end of this month, related to last year's acquisition of Genentech Inc., and plans to cut another 100 jobs in the state by June. While the cuts were expected after Roche acquired Genentech last year and announced it would move its US headquarters from Nutley, NJ to South San Francisco, it wasn’t clear how extensive the job loses would be. The company is closing down all manufacturing operations at the aging Nutley site.

This is more bad news for the State of New Jersey which has borne the brunt of the pharma downsizing trend that began in earnest about 4 years ago. As many of you may know, New Jersey has the highest concentration of pharmaceutical employees in the US. The loss of pharmaceutical jobs coupled with an enormous budget deficit suggests that it will be many years before New Jersey is able to recover from the economic downturn.

Roche, which had 2009 revenue of about $45.9 billion, employs more than 80,000 people worldwide.

Until next time…

Good Luck and Good Job Hunting (forget New Jersey)

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

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

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

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

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

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

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

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

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

Until next time...

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

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As many of you may recall, in 2001, Sam Waksal, founder and former CEO of the biotechnology company ImClone was convicted (along with his good friend Martha Stewart) for fraud and insider trading of ImClone stock. Waksal, who was released from prison in late 2008 and lived in a half way house for several months had kept a relatively low profile until earlier this month. Rumor has it that Sam along with Richard Mulligan, PhD a Harvard professor and former ImClone director and Dr. Larry Witte, a current executive vice president in the ImClone division of Eli Lilly are attempting raise about $50 million for the privately-held new venture called Kadmon. Other reports indicate that Waksal and other members of the Kadmon team are putting up $50 million as well. 

According to insider reports the company will ostensibly focus on cancer and infectious disease targets and—taking a page out of the Cubist, Celgene and Sepracor play books—re-purpose once promising drug candidates discarded by other companies. To that end, according an article in TheStreet, the company's drug research programs include a "statin inhibitor for influenza" from a "leading Ivy League university" along with a variety of monoclonal antibodies for use as targeted cancer treatments, similar to Erbitux. Kadmon is also eyeing several existing cancer-focused drug companies, one of which already has a marketed product, as acquisition targets, according to the prospectus. For those of you who may be wondering about whether or not Waksal can legally start another biotechnology company, an agreement with the Securities and Exchange Commission bars Waksal from serving as an officer in a publicly traded company, but as previously mentioned, Kadmon is a private venture.

Whether you like Waksal or not, his track record in the biotechnology industry speaks for itself. Unlike the vast majority of his rivals, Waksal shepherded a molecule from discovery through commercialization. That molecule, a monoclonal antibody called Erbitux, became a multibillion dollar a year treatment for certain forms of colorectal cancer. More importantly, Waksal was one of the first to recognize that humanized monoclonal antibodies directed against certain cellular receptors could be used to treat a variety of oncology indications—a concept that is driving a large portion of discovery and product development in the oncology space. For those of you who may not know, Eli Lilly purchased ImClone two years ago for $7.0 billion dollars after a very public and acrimonious fight over the sale price of ImClone erupted between Carl Icahn, ImClone’s Chairman, and Jim Cornelius, CEO of Bristol-Myers Squibb (BMS). ImClone and BMS co-marketed Eribitux prior to the sale.

Waksal has been in and around the biotechnology industry for over 30 years and many consider him to be one of the early industry pioneers. Unfortunately, despite his dubious past, Waksal represents a dying breed of visionaries whose entrepreneurial spirit and unorthodox approach to new drug development is largely responsible the biotechnology industry’s current largess. Like other ex-felons Waksal did his time and like all Americans he is entitled to a second chance.

Let’s hope that Sam learned a few things during his incarceration and is smarter and wiser for his second and possibly final act. I wish Waksal success in his new venture and I hope that he and his team still possess the insight, creativity and tenacity required to discover and develop innovative oncology and infectious diseases drugs.

Until next time....

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

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There was a very disturbing article on the front page of today’s New York Time about an increasingly popular practice of debarking dogs by people who live in urban areas like New York City. Debarking is accomplished by severing a dog’s vocal cords. The practice may be more widespread than reported because of nuisance pet policies imposed on apartment owners by co-op boards in the city. According to the article, the surgery usually leaves the animal with something between a wheeze and a squeak in lieu of a bark.               

While I am not a card-carrying animal rights activist and find excessive barking annoying, I am a dog owner and a biologist who strongly believes in evolution. And, as far as I am concerned, if dogs weren’t meant to bark they wouldn’t! Taking away a dog’s only means of verbal communication (one of my dogs “whines” when she needs to go out and the doggy door is shut) is, in my opinion, detrimental to a dog’s physical and behavioral well being. As one animal behaviorist said in the article:

“Dogs are usually barking because of some frustration. It’s frustrating to be a sheepdog with no sheep. What I’d be concerned about is, if you are debarking a dog and it has an underlying happiness.”

Proponents of the procedure say that it is a harmless procedure and dogs that have been debarked don’t act any differently than they did before the operation. Luckily, many younger veterinarians have deemed that the surgery unnecessary and unethical and refuse to perform it.

My first experience with debarking was after I inadvertently purchased my two dogs from the daughter of a notorious and nefarious New Jersey-based puppy mill breeder. I learned that it is not uncommon among puppy mill owners, to silence their dogs to prevent detection by authorities by shoving metal rebar down their throats. The repeated assaults on a dog’s vocal cords caused scarring and sometimes rupture which, in turn, renders the animal unable to bark. Imagine my outrage when I read that some veterinarians knowingly and willingly perform this surgery because pet owners requested that it be done!

I think the practice of debarking is repugnant, reprehensible and not justified in any circumstances. If your dog has a barking problem, hire an animal behaviorist or call Cesar Milan, aka the Dog Whisperer. It is likely there is an underlying behavioral problem or cause of the problem that can be fixed by behavior modification or pharmacological interventions. Debarking surgery is a convenient and facile solution for pet owners who say they love their dogs but are unwilling to spend the time and effort required to solve the problems. 

In conclusion, if dogs weren’t meant to bark then they would not have when they first appeared on the planet!!!

Until next time...

Good Luck and Don't Forget to Hug Your Puppy Today!!!!

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Theravance Inc. announced Thursday US Food and Drug Administration (FDA) regulators are not satisfied with new data on its infection drug candidate telavancin (Vibativ), and indicated that further clinical studies may be required to win marketing approval.

Approval of Vibativ has been held up for three years, as the Food and Drug Administration asked the company for more data about the drug, and about studies Theravance has conducted in support of its application to the FDA. Theravance said Thursday the FDA told it the data so far is not enough to prove Vibativ works.

The agency will not begin a formal review of the drug until it says it is satisfied with the data.

Vibativ, or telavancin, is an injection intended to treat complicated or drug-resistant infections like methicillin-resistant Staphylococcus aureus (MRSA). Theravance submitted an NDA to FDA for review in December 2006.

According to Theravance, the FDA did not say Theravance would have to run a new clinical trial to gain approval, but it suggested a design for such a study. Company representative said that they do not know what the FDA wants and said the agency did not provide any suggestions about the goals of the proposed study, how many patients should be included, or even how many studies might be required ( I guess it may be time for a meeting to discuss these issues?).

In response to the FDA’s previous requests for more data on telavancin, Theravance said it combined data from two late stage trials of Vibativ, with the goal of making the data more comparable. It said the FDA told it that the data is equal to only one study. Two late-stage trials are often required to win approval.

Theravance said it has tested Vibativ on about 1,500 patients and said its studies are the largest that have been submitted in support of a new drug of its type.

Regulatory concerns about Vibativ include a risk of birth defects when it is used in pregnant women, manufacturing issues, and questions about data comparing the drug to vancomycin, which is the most powerful antibiotic currently on the market.

While getting new antibiotics are the market are important, clinical studies must be carefully designed with appropriate endpoint to address potential safety and efficacy issues. Although Theravance believes that it has done that, the agency, as always, will be the final arbiter of a decision on telavancin.

Until next time...

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

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It’s no secret that pharmaceutical and biotechnology companies are “not in love” with social media. However, whether life sciences company like it or not, social media is beginning to affect human clinical testing with an increasing number of patients demanding access to unapproved experimental drugs to treat life-threatening illnesses. 

In a recent article that appeared in the January 15, 2010 issue of Genetic Engineering and Biotechnology News entitled “Expanded Access to Investigational New Drugs”, Natalie Douglas, CEO of UK-based Idis Pharma wrote:

"...the trend toward greater transparency of drug development pipelines and the accessibility of powerful social media tools, have led us to a more informed empowered and vocal population of patients. This, in turn, has led to increased demands for access to unapproved drugs that are in various stages of human clinical testing. “Patients can easily access information about investigational drugs via the Internet and are leveraging social media tools such as YouTube, Twitter and blog to influence companies to garner access to them” Douglas added.

This can place enormous pressure on the companies that are testing investigational new drugs because the safety and efficacy of the drug candidates has yet to be determined. Understandably, companies are loath to provide patients who don’t meet clinical trial inclusion requirements access to experimental drugs with unknown safety and efficacy characteristics. Nonetheless, if requests for access to investigational drugs are denied, social media tools can easily be used to quickly and widely publicize the denial. According to Douglas, aggressive use of social media tools by patients seeking access to investigational drugs has helped their stories make national news. This can create gargantuan regulatory and public relations problems for companies with drugs in clinical development and put them at the center of an ethical and moral firestorm—despite their best intentions to develop new drugs that eventually may help millions of patients suffering from various diseases and conditions.

Many patient advocacy groups, consumers and shareholders understand the almost limitless reach of social media and its ability to influence public opinion, discussions and trends. Whether or not drug makers are willing to use social media, many have yet to understand that they are already part of the social media conversation that is taking place daily. And, as all social media enthusiasts have realized, if you are not part of the conversation then you don’t know what is being said about you on the Internet. More importantly perhaps, is that by choosing not to participate in the conversation, companies have lost all ability to influence and manage what is being said. In other words, life sciences companies that steadfastly choose not to use social media may, paradoxically, be setting themselves up for public relations and regulatory headaches that could have easily been avoided.

While the social media frenzy may be beginning to wane, there is no question that it has changed the way people interact and influenced the way business is transacted online and in real life. Companies that insist on clinging to past business practices that are exclusive, non-interactive and designed to promote opacity are likely to lose customers and market share as 21^st century technology continues to unfold.

Hat tip to Natalie!

Until next time...

Good Luck and Good Tweeting!

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At long last, marijuana for medical use is legal in New Jersey. As one of his more courageous acts while in office, outgoing Governor John Corzine signed the act into law late yesterday making New Jersey the fourteenth state to legalize medical pot. Four more states and the District of Columbia are expected to follow suit by year's end.

Many things are driving this sea change. The federal government last year announced that it would no longer prosecute medical marijuana smokers in states where it is legal, while the National Institutes of Health has begun funding research on medicinal use in a reversal of a long-standing policy.

Gallup Polls show a solid majority of Americans sympathetic to therapeutic marijuana use.

Unlike California's medical marijuana law which allows the use, possession, and cultivation of marijuana by anyone who possess a "written or oral recommendation" from their physician that he or she "would benefit from medical marijuana," New Jersey's version requires patient identification cards and state-monitored dispensaries -- easing fears that medical use will fuel illegal sales and teenage substance abuse.

While cannabis preparations have been used to relieve nausea and pain since ancient times, research involving medical uses of marijuana was under funded and in many instances discouraged according to an article in today’s New York Times. But over the last 15 years, research on the body's cannabinoid receptors has begun to decipher the chemistry and biology of the positive effects of cannabinoids especially in the areas of glaucoma and chemotherapy induced nausea and vomiting experienced by patients being treated for cancer. More recently, clinical trials have shown that these benefits outweigh the concerns about addiction, heart and respiratory diseases, cancers, and psychoses -- at least, with short-term use.

Marinol, a synthetic cannabinoid pill, is approved by the Food and Drug Administration for treating AIDS-related wasting and chemotherapy-related nausea. But many patients say choking down a slow-acting pill simply doesn't provide the convenient and immediate relief of inhaling marijuana smoke. A new drug, Sativex, made by GW Pharmaceuticals, may renew the debate. A cannabinoid-based oral spray, Sativex is approved in Canada for treating pain in multiple sclerosis and advanced cancer. The company is now completing the clinical testing needed for approval in Europe and the United States.

While I don’t endorse or use illegal drugs (any more), there is no question that medical marijuana helps patients deal with chronic and, in some instances, severely debilitating conditions that impact the overall quality of their lives. I have long contended that just because a substance is deemed illegal it doesn’t negate potential medically-beneficial properties. An example of legal drugs that don’t have any therapeutic benefits and cause much more morbidity and mortality than marijuana are cigarettes and alcohol. Need I say more?

All I gotta say is that we have come a long way since I saw the film Refer Madness while growing up and coming of age in the late 60s. For those of you who haven’t seen the film it is funny whether you are straight or high! object width="445" height="364">

I guess the nation—well NJ anyway—is finally going to pot!

Until next time...

Good Luck and Good Toking (only for medicinal purposes of course)!!!!!!!!!!!

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It is getting difficult to keep track of the job cuts that are happening almost daily at Pfizer. A quick perusal of the job cuts to date indicate that the company has eliminated about 1200 jobs in the past week; 680 in Pennsylvania, 400 in New Jersey and 116 in Rockland County, NY (where I grew up!). While there is currently a lull in activity, I suspect additional job cuts will be forthcoming in the near future.

Merck earlier announced that it was slashing about 500 jobs in New Jersey which continues the ongoing carnage that the NJ pharmaceutical workforce had to endure over the past three years.

Meanwhile, in New England, Charles River Laboratories International announced that it is suspending operations at its Shrewsbury, MA facility by the middle of this year. Approximately 300 workers will be losing their jobs at the facility that focused on preclinical drug development.

Despite claims that the US economy is improving, life sciences layoffs are continuing and job growth is much slower than expected. While some economists aren’t that surprised, I would be nervous and exploring my options if I was employed at a life sciences company!

Until next time...

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

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Governor Deval Patrick and the Massachusetts Life Sciences Center announced today that the Center’s Board of Directors has awarded $25 million in Tax Incentives to twenty-eight life sciences companies. The companies receiving tax incentive awards have committed to creating a combined 918 new jobs in the Commonwealth over the coming year. The companies that received awards include many of state’s largest biotechnology companies e.g. Biogen, Genzyme, Sepracor and Cubist, as well as some smaller private and public ones (see below) 

1. Alnylam Pharmaceuticals, Inc. (Cambridge) — $300,000
2. Biogen Idec MA, Inc. (Cambridge) — $1,500,000
3. Constellation Pharmaceuticals, Inc. (Cambridge) — $513,252
4. Cubist Pharmaceuticals, Inc. (Lexington) — $1,740,000
5. Dyax Corporation (Cambridge) — $100,000
6. Facet Solutions (Hopkinton) — $300,000
7. FoldRx Pharmaceuticals, Inc. (Cambridge) — $510,000
8. Genzyme Corporation (Cambridge/Framingham) — $6,000,000
9. GTC Biotherapeutics, Inc. (Framingham) — $300,000
10. Hologic, Inc. (Bedford) — $220,000
11. Infinity Pharmaceuticals, Inc. (Cambridge) — $540,000
12. InfraReDx, Inc. (Burlington) — $630,000
13. Interlace Medical, Inc. (Framingham) — $300,000
14. Lightlab Imaging, Inc. (Westford) — $188,951
15. Merrimack Pharmaceuticals, Inc. (Cambridge) — $1,500,000
16. Morgan Advanced Ceramics, Inc. (New Bedford) — $570,000
17. NeuroMetrix, Inc. (Waltham) — $300,000
18. Nova Biomedical Corporation (Waltham) — $300,000
19. OmniGuide, Inc. (Cambridge) — $540,000
20. Organogenesis (Canton) — $245,240
21. Pharmasphere, LLC (Worcester) — $360,000
22. Sepracor, Inc. (Marlboro) — $750,000
23. Shire Human Genetic Therapies, Inc. (Lexington) — $6,277,057
24. STD Med, Inc. (Stoughton) — $121,000
25. Still River Systems, Inc. (Littleton) — $300,000
26. TEI Biosciences, Inc. (South Boston) — $27,000
27. Tolerx, Inc. (Cambridge) — $300,000
28. Zoll Medical Corporation (Chelmsford) — $267,500

While the tax breaks are a great way to insure that the 28 companies that received them will remain and continue to do business in Massachusetts, creation of only 918 new jobs in exchange for $25 million in tax incentives doesn’t seem fair to me! I guess beggars (state governments) can be chooser in the current economic climate.

Until next time...

Good Luck and Good Job Hunting (try MA, there may be one or two opportunities there)

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Johnson & Johnson announced today it would eliminate as many as 8,200 jobs, or 7% of its work force, to help the company cope with what it expects will be a slow economic recovery amid damped demand for drugs, medical devices and consumer products. J&J employs about 117, 000 workers globally. While the job cuts will be global, many losing their jobs will be outside of the US. 

J & J joins a growing list of pharmaceutical and life sciences companies that have announced new layoffs. Pfizer Inc., the world’s biggest drugmaker, plans to fire 19,000 workers following its acquisition of Wyeth and had already cut 10,000 positions since 2007. J&J began firing as many as 4,400 employees from its pharmaceutical and stent divisions in late 2007. Finally, Merck recently announced that it will be eliminating 16,000 workers after its merger with Schering Plough closes later this year.

J&J’s announcement is more bad news for New Jersey which is still reeling from the earlier loss of tens of thousands of pharmaceutical and life sciences jobs.

Until next time...

Good Luck and Good Job Hunting (forget New Jersey)

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I was sitting around minding my own business (well sort of) and I received the following e-mail message. People must be reading BioJobBlog or something!

In the middle of the worst national job market since the early 1980's, Roche Pharma Research in Nutley, New Jersey is hiring. Specifically, this world class R&D center is seeking to hire 40 scientists to strengthen its research efforts to develop drugs to combat inflammatory diseases like arthritis and asthma.

In addition to Inflammation, Nutley continues to be the headquarters for Roche's Oncology Disease Biology Area, as well as RNA Therapeutics (an emerging area in understanding how genes are turned on and off in cells).

Focusing on drug discovery and non-clinical development, the site has a long tradition of discovering innovative new medicines.

Marcie Geremakis of Roche HR is available to discuss the efforts to recruit the new scientists and why Nutley is an outstanding environment for scientists.  A number of scientists are available to discuss the following:

• Roche's cutting edge scientific approaches to drug discovery focused on meeting the demands of the emerging need for personalized healthcare.

• Roche's intent to provide its scientists with the environment necessary to push forward novel ideas while challenging old paradigms.
• The ability to use state-of-the-art technology and collaborate with Roche's world class scientists across the globe engaged in biomarker discovery, novel biologics platforms, RNAi and diagnostics.

With well over 100 projects in research and more than 60 New Molecular Entities in development, Roche’s pipeline is among the best in the pharmaceuticals industry.

Please call me at 212-468-4306 or e-mail me at jillian.chertok@mslworldwide.com if you would like any additional information, or are interested in scheduling a time to speak with Marcie or one of the scientists at Roche. 

I must disclose that I have no financial arrangement with this agency nor have I ever done business with them before.  But, I figured if there are jobs to be had in this economy I ought to pass them on to folks who are looking.

Until next time...

Good Luck and Good Job Hunting!!!!!

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The fourth quarter is over, earnings are being announced and new budgets for the upcoming fiscal year are being evaluated and tweaked. This means that we have officially entered layoff and closure season. Isn’t it great that big companies wait until right before the holiday season to let employees know whether or not they will have a job next year?

That said, two companies, Bristol Myers Squibb (BMS) and Pfizer/Wyeth are the first to kickoff the 2009-2010 season.

BMS announced that it will lay off 25% of its Abilify sales force. This comes only six months after the drugmaker extended its contract with Otsuka Pharmaceutical to market the anti-psychotic and depression drug. Abilify is BMS’s second best selling medication after Plavix that is co-marketed with Sanofi-Aventis. Otsuka developed the drug and BMS markets and distributes it in the US and several European counties.

Abilify loses patent protection in 2012 and faces stiff generic competition in the anti-psychotic and depression markets. A BMS spokesperson declined to say exactly how many reps would be losing their jobs. However, according to a post on the sorely missed and recently resurrected Pharmalot blog there is speculation that Otsuka may hire some of the layed off BMS reps.

In other news, Pfizer/Wyeth announced that it will be closing its facility in Bridgewater, NJ but expanding operations at its Peapack-Gladstone, NJ location. The Bridgewater facility employs 300 people, 100 of which are involved in technology.  The company announced yesterday that it wouldn't be shutting down Wyeth's Collegeville, PA headquarters.

Over 120,000 employees have been laid off by pharma companies in the past three years, many of whom lived and worked in New Jersey.  Unemployment in NJ is hovering around 10%.

Stay tuned for more updates.

Hat tip to Ed at Pharmalot

Until next time...

Good Luck and Good Job Hunting!!!!!

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In a previous post I lauded health information technology (HIT) aka health informatics as a possible new career choice for scientists with life sciences PhD degrees who also have a proclivity for software development and data base management. Shortly after I posted the piece, I happened to read an article in a local publication about a NJ-based company called the MISI Company that is at the forefront of the HIT field and developing software to help digitize American healthcare records. 

I invited Dave Roth, an MISI executive, to share his views on the future of HIT and what ought to be done to insure that e-medical records are appropriately and successfully created. BTW, for my bioinformatics and genomics friends, MISI is looking to hire a few talented men and women who are interested in HIT careers.

HIT: The Other Missing Link

by Dave Roth

Health information technology (HIT) is hot. There’s every reason to believe that HIT will play a major role in the reforms envisioned for our health care system. From President Obama announcing $5B in grants to aid medical research, to bioinformaticists developing tools for predicting genetic predisposition to diseases, to software developers working on electronic medical records (EMR) systems, HIT is a burgeoning field. What concerns people like me – read: people who are users of technology rather than the developers of it – is that all this HIT talk seems to have very little mention of us in it.

Not long ago, I wrote an article called The Missing Link in Healthcare IT: The Consumer. In it I pointed out that none of the current government definitions being proposed for "meaningful use" of electronic medical record (EMR) systems define meaningful from the healthcare consumer's perspective. I also noted that whatever rules the government establishes for receiving stimulus money for the development of HIT solutions, none of them will exclude technologists from collaborating with consumers in the development of their solutions. I posited that technologists would be doing us all a favor if they would stop to consider for a moment how their systems will affect the consumer’s experience of health care services.

I was encouraged when David Goldhill, in his cover story in the September 2009 issue of Atlantic Monthly, How American Health Care Killed My Father, wrote, “[A] guiding principle of any reform should be to put the consumer, not the insurer or the government, at the center of the system.” Goldhill’s prescription for a better health care system begins with advocating for the consumers of services and focusing on how to get the best outcomes for those consumers at a reasonable cost. He was channeling the views of many people, such as Harvard Business School professor Regina Herzlinger, who believe consumer-driven health care is the only reform that will truly be meaningful.

The growing visibility of the consumer in this debate has gotten me to thinking there is real opportunity in the HIT job market for another missing link: Consumer-centric Health IT Developers. It is a rare developer who brings to his/her craft an appreciation of the importance of understanding who you are developing for. Rarer still is the developer who is aware of and employs tools and techniques for capturing end-users’ feedback during the development process. More often than not, user-centered design (UCD) is considered a luxury that burns up time and precious dollars. This misconception is largely the result of development teams typically waiting until they are too far into the development cycle before engaging with those who will be using their creation. Inevitably, problems are discovered with the usability or utility of the system that will hinder adoption. But the problems are discovered too late to be fixed by the target launch date and/or within budget. Users/Consumers become the enemy in this scenario.

There is another way. HIT technologists should understand how and why to engage their target audience at the beginning of the development process, long before anything is actually developed. They should begin by understanding who they are developing for, what these people are looking to accomplish, and how they can best help them accomplish it. Using such techniques has been shown to actually reduce downstream development work and increase adoption. I believe technologists schooled in the techniques of consumer-centered design will be central to any successful, long-term health care reform.

Dave is Vice President and  heads MISI Company's Experience Design (XD) group - a group of strategists, experience architects, visual designers and technologists whose mission is to help ensure the success of every interaction between a business and its target audience. His career spans 30 years and includes award-winning work in documentary and corporate film/video, print advertising, and interactive software application development for computers and the Internet. Dave is a Stanford University grad, a SF 49ers fan and a member of the Single Malt Scotch Whiskey Society.

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The Philadelphia Inquirer reported today that Pennsylvania state legislators, spearheading efforts to retain jobs in the state after the $68 billion Pfizer-Wyeth merger closes next month, said they were fairly confident many positions would remain at Wyeth's regional operations in Collegeville, Great Valley and other sites. Wyeth employs about 4,500 people in the region - about 3,600 in Collegeville and 900 in Great Valley and elsewhere.

One legislator told the Inquirer that "Representatives of both Pfizer and Wyeth have continued to assure us that we should not worry and they have continued to listen to the case that we have made for as many jobs as possible remaining in Pennsylvania." Pfizer, which plans to cut about 20,000 of the combined companies' 130,000 jobs, would not comment yesterday on the statement or the job situation in Pennsylvania. Gee, what a surprise!

If I were a betting man, I would say that there will be massive layoffs in Pennsylvania and elsewhere after the deal closes. Don’t be surprised if Wyeth’s Madison, NJ headquarters and its research facilities in Princeton NJ are first to get the ax. Finally, I am now firmly convinced that you can never trust a thing that a politician says.

Until next time...

Good Luck and Good Job Hunting!!!

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According to a recent report issued by the Pharmaceutical Manufacturers of America (PhRMA), a record 861 new cancer treatments are being developed by pharmaceutical and biotechnology companies. Many of these treatments, which include vaccines and immunomodulators, are in clinical development or awaiting regulatory approval.

The breakdown of the treatments based on therapeutic areas is: 122 for lung cancer, 107 for breast cancer, 70 for colorectal cancer and 103 for prostate cancer. Additional treatments target brain, kidney, pancreatic and other forms of cancer.

While there are many other unmet medical needs that must be addressed by the life sciences industry, the burgeoning and ever-increasing numbers of cancer patients suggests that there is a dire need for development of improved anti-cancer treatments. To that end, if you are contemplating graduate school, already enrolled or trying to determine what therapeutic area makes sense for a postdoctoral fellowship, I highly recommend that you consider oncology. Job opportunities in this field (and neuroscience) will continue to outstrip all others in the near future.

Until next time...

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

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Emily Rachel Silverstein, a sophomore anthropology major and peace activist at Gettysburg College, was brutally murdered early last Thursday morning, allegedly by her ex-boyfriend, a fellow student and senior at the school. She went to visit him around 3:00 AM to console him because he called her and “he was not acting right” a family friend told me. While I didn’t know Emily well, I knew of her, and by all accounts, her response to her ex-boyfriend’s cry for help was consistent with who she was—a bright, compassionate, peace-loving, social activist who believed that the world could be a better place.   

I attended Emily’s memorial yesterday that was held in Roosevelt, NJ, a town founded by artists and social activists in the late 1940s. My wife, 15 year old son and I were there because Zach is good friends with Jaime, Emily’s younger brother and we know his parents Linda and Bob. Also, one of our best friends’ son dated Emily when she was a senior at Hightstown High School, our local high school. Everybody in the tightly-knit, surrounding communities of East Windsor and Hightstown, NJ has been grieving and affected in some way by Emily’s death.

There were hundreds of people at the memorial, many of whom who spoke and shared their stories about this beautiful and extraordinary young woman. At Gettysburg College she lived at the “Peace House,” founded a new chapter of the resurgent Students for a Democratic Society (SDS for those you who can remember) and was studying Arabic to spend a year abroad in Morocco helping battered women. As one of Emily’s best friends said “she was a vegan, but unlike some vegetarians, she didn’t chide her meat-eating friends because she believed that vegetarianism is a personal choice. That was Emily!” 

Many of the men and boys who spoke sported pony tails and beards and the women and girls who shared childhood and college stories about Emily had flowers in their hair. All of them, regardless of age, race, religion or ethnicity, spoke of Emily’s dreams and plans for peace and social change—the things that mattered most to this vibrant, smart, compassionate young woman who truly believed that she could help change the world by one act of kindness at a time.  

I hadn’t thought much about social activism since the early 1970s and found myself fondly thinking about those days and what they meant to me as young man trying to find his way in the world. And, as more people shared their stories about Emily, I remembered what it felt like to be 19 again and I began to recall my own dreams and plans to make the world a better place. Despite my profound grief and sadness, I began to experience feelings of joy and hope—because unlike some of us who have lost sight of the importance of social activism—many GenYers and Millenials have embraced it, believe in its power and plan to use it to change the world into a safer and more peaceful place.

Emily’s senseless murder was tragic, but the tragedy would be if we don’t try to keep her principles and ideals alive even though she is no longer with us. Please visit a Better World dot net a fund dedicated to the memory of Emily Rachel Silverstein. 

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Are you a life sciences or healthcare professional with a passion for computers, IT or software development? If so, you might want to consider a career in health informatics—one of the hottest, new fields in the life sciences and healthcare industries. Health informatics specialists typically have expertise in medical records and claims, clinical care and programming. In other words, they have a foot in two worlds— medicine and technology — and can easily bridge the often daunting gap between them. It is important to point out that there is a difference between healthcare IT and informatics personnel. The health IT people run the servers and install software, but the informatics people are the ones who analyze and interpret clinical/ medical information and work with clinical and other healthcare staff to advise and help them.

According to an article in this Sunday’s NY Times, health informatics specialists usually start as computer programmers or as doctors, nurses, pharmacists or health record administrators. After earning a graduate health informatics degree, they find jobs as mid level or senior employees at hospitals, doctor’s offices, insurance companies, pharmaceutical companies or other organizations concerned with health data. Mid level jobs, like those for clinical analysts or informatics analysts, are usually about $70,000 a year, but salaries can be much higher for more senior level positions.  Senior level jobs, which sometimes require a Ph.D., include chief clinical information officer or other management/leadership roles at medical devices, life sciences or insurance companies. Consulting firms are also hiring health informatics experts to serve many of their health care clients who frequently don’t have the resources to hire permanent informatics staff.

At present there are no educational, licensing or credential requirements to become a health informaticist. However, a growing need for health informaticists has resulted in the creation of a number of degree programs at two and four year colleges and universities. For example, within the past four years, Columbia University, St. Louis University, the University of Minnesota and Oregon Health and Science University have all added master’s programs or certificates in health informatics. Other schools offer short courses or part-time certificate programs to healthcare employees or programmers. Still others are adding undergraduate majors or associates degrees programs to their curricula.

While many schools are beginning to offer health informatics programs, not all informatics programs are “created equal.” Generally speaking, “medical” or “biomedical” informatics programs focus on data that doctors need for treating patients. Bioinformatics” programs concentrate on biological or genetic data, while “health informatics” programs often emphasize clinical data and health records. Even among programs with the same name, the emphasis and expertise may vary at different institutions that offer the training.

By all accounts, health informatics —despite some early confusion—is one of the fastest growing careers in the bioscience and healthcare fields. Unlike other fields in the shrinking life sciences industry, there are plenty of jobs out there for health informaticists. Ironically, the failing US economy is what is driving the growth of the health informatics industry. The US government’s economic stimulus package has allocated $19 billion to hastening the adoption of electronic health records, so demand for health informatics specialists is skyrocketing. “My rough estimate is that we need about 70,000 health informaticists,” said Don E. Detmer, president and chief executive of the American Medical Informatics Association, a nonprofit industry group.

However, as a word of caution, it usually takes more than technical skills and an understanding of health care to succeed as a health informaticist. Diplomacy and conflict resolution skills are crucial when dealing with two potentially contentious groups: healthcare workers and programmers. Nevertheless, healthcare informatics is an ideal field for bioscientists and healthcare workers who also like to work with technology, computers or develop software. Based on my recent experiences as a bioscience career counselor, I know that there are thousands of you out there that fit this description. Now be the time to take a closer look at the exciting, new field of health informatics to determine whether or not it may be a career option for you!

Until next time...

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

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Since 2007, approximately 80,000 pharmaceutical jobs have been eliminated. The recent consolidation in the industry, e.g., Merck-Schering, Pfizer-Wyeth and Roche-Genentech suggests that many more life sciences jobs will be lost over the next year or so. Typically, to avoid law suits and possible discrimination claims, most companies will layoff a mixture of experienced and entry level employees that cover the racial, religious and age spectra. For those of you who may not know, Americans who are 40 and older constitute a “protected class of employees.” In other words, companies that layoff employees cannot disproportionately give pink slips to employees 40 years of age or older. This law was enacted because older employees typically have higher salaries and have accrued more benefits and vacation time than their more junior counterparts and eliminating them can drastically cut costs. While most companies are careful to layoff a mixture of junior and senior employees during large layoffs, a quick perusal of the demographics of employees who lose their jobs reveals that many of them are older, more experienced workers. Sacrificing a few entry level employees (to prevent any red flags) is worth it to the accountants who charged with cutting costs and orchestrating large corporate layoffs.

Unlike consumer goods, pharmaceutical and biotechnology drug development is arcane, complex and may take up to 15 years to complete. There are many “go” or “no go” decisions that must be made during the drug development process. Typically, these decisions are rendered by experienced employees who have been “down the road” many times before and are able to recognize the oft-time nuanced attributes of successful drug candidates. Without the benefit of these employee and their experiences, drug companies may struggle to make the “right decisions” for new products being developed. Also, the loss of experienced employees can disrupt the flow of essential “corporate knowledge” to entry level and more junior employees. This is important because— while most entry level and junior employees are academically and technically qualified—it usually takes them years (under the tutelage of mentors and senior employees) to understand a company’s best practices. Put simply, the unrelenting loss of experienced pharmaceutical workers can alter the standing or dominance of pharmaceutical companies in certain therapeutic areas. While massive layoffs of experienced pharmaceutical employees bolster drug stock prices in the short term, the long term effects of these layoffs on the overall health of the pharmaceutical industry remains uncertain.

Jeff Kindler, Pfizer’s CEO, mentioned yesterday during a CNBC interview, that eight Wyeth senior executives will keep their jobs after the Pfizer-Wyeth deal closes later this year. Not surprisingly, he failed to mention how many “rank and file” employees of the combined company would keep their jobs after the merger. Don’t be shocked when Pfizer-Wyeth announces massive layoffs after the deal closes—Pfizer’s stock price has fallen 21% since it announced the Wyeth acquisition late last fall.

Until next time....

Good Luck and Good Job Hunting!!!

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Late last week, Roche raised the price of its hostile offer to buy out Genentech to $93 a share, from $86.50. While the Genentech board advised its shareholders that the company is worth $112 per share, many financial analysts believe that the $93 per share offer may entice institutional investors to “pull the trigger” on the deal. Roche also extended its offer to shareholders by a week, until March 20. Roche already owns over 65 percent of Genentech’s outstanding shares.

Roche has indicated that if fewer than half the minority shares were tendered, it would not buy any of the shares tendered by Genentech shareholders. The new offer is likely to bring in more than half the minority shares, which would raise Roche’s ownership to at least 78 percent. About 71 percent of 131 Genentech stockholders who responded to a survey by Deutsche Bank on Friday said they would tender at least some of their shares at $93, and of those, half said they would tender virtually all. It is not clear what will happen if Roche is unable to purchase 100% of Genentech's shares.

Roche is motivated to close the deal as quickly as possible before results are released next month from a clinical trial of Avastin, one of Genentech’s top-selling cancer drugs. That trial, testing Avastin as a treatment for colon cancer after surgical removal of the tumore, could open a huge new market for the drug, which is now approved to treat cancer only at a later stage. Positive results from the trial may push Genentech’s stock price to over $100 per share—something that Roche desperately doesn’t want to happen.

If Roche is successful in its takeover bid, it  will likely to result in massive layoffs at Roche’s Nutley, NJ headquarters. Previously, Roche announced that it would move its US headquarters from Nutley to the Bay area if it acquires Genentech. Not good news for the state of New Jersey which is still reeling from the Pfizer-Wyeth takeover announced six weeks ago and the Merck-Schering Plough merger mentioned earlier today.

Until next time...

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

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Merck announced today that it was buying Schering Plough, the Kenilworth-New Jersey based drug maker, for $41.1 billion. The deal comes only six weeks after Pfizer said that it would purchase NJ-based Wyeth Pharmaceuticals. Superficially, the deal may make sense for the two struggling drug makers—they co-market the cholesterol-lowering drug Vytorin and also have collaborations in the respiratory diseases area. Also, Schering Plough has the European rights to the anti-arthritis drug Remicade and its 2007 purchase of the Dutch biopharmaceutical company Organon Biosciences NV provides access to several potential biotechnology drugs. Nevertheless, the impending merger will ultimately result in job losses and higher unemployment in the state of New Jersey.

Merck currently employs 55,200 workers and Schering-Plough—which grew significantly with its purchase of Organon—also has about 55,000 employees. While no immediate job cuts are planned, a company spokesperson acknowledged that the size of the combined workforce will be reduced by approximately 15%-20% over the next year or so. This means that as many as 20,000 pharmaceutical employees may lose their jobs—a time when unemployment in NJ is approaching 10 percent! My sources tell me that Merck employees are already on edge because of surprise layoffs that occurred in early September, 2008. I suspect that employee anxiety will be extremely high at both companies for the foreseeable future—never a good thing from a productivity point of view.

According to press releases, Schering-Plough's shareholders will get $10.50 in cash and 0.5767 Merck shares for each Schering-Plough share they own. That's a 34 percent premium to Schering-Plough's closing stock price on Friday. Merck's top executive, Chairman and CEO Richard Clark, will lead the combined company, which will attempt to remain a dominant player in treatment areas including cholesterol, respiratory, infectious disease and women's drugs, as well as vaccines. Schering-Plough's CEO, Fred Hassan, will participate in planning integration of the two companies until the close of the deal, which is expected in the fourth quarter. The transaction is to be structured as a reverse merger. Schering-Plough will be the surviving corporation but will take the name Merck. The new company will remain at Merck's headquarters in Whitehouse Station, N.J. and a company spokesperson indicated that a "substantial majority" of employees of Schering-Plough will remain with the newly-formed company. The combined revenue of both companies in 2008 was $47 billion.

Mr. Hassan, a talented, “turn-around” pharmaceutical executive, took over Schering-Plough six years ago as chairman and CEO—a time when the company was struggling with a $500 million fine (the largest ever at the time) imposed by the US Food and Drug Administration because of chronic manufacturing problems. While Schering-Plough is now in much better financial shape than when Mr. Hassan first arrived at the company, its stock price is currently almost identical to the price when he took over (it lost 50% of its value in the past 18 months). Let’s see whether or not Richard Clark, Merck’s current Chairman and CEO, has the mettle to run the combined company. While Schering-Plough has long been rumored to be a takeover target, I don’t think that the Merck-Schering Plough deal is a particularly good or strategic one. Both companies have been struggling of late because of near empty drug pipelines and the ongoing brouhaha over Zetia, Vytorin and Merck’s Vioxx. Further, both companies face price reductions and slumping sales in the next year or so because several blockbuster drugs will lose patent protection and face stiff competition from generic drug manufacturers.

Like the Pfizer-Wyeth deal, the Merck-Schering Plough merger may little more than a red herring. I still fail to see how merging two oversized, struggling pharmaceutical companies can possibly result in the creation of a single successful one. The only upside of the deal is that it allows the newly-formed company to restructure operations, eliminate tens of thousands of jobs and cut costs to bolster its stock share price. That said, I don’t think that an artificially-inflated stock share price necessarily translates into the innovation that historically has been required to create new drugs to treat unmet medical needs!

Until next time...

Good Luck and Good Job Hunting (avoid NJ at all costs)!!!!!!!

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An intrepid reader of BioJobBlog alerted me to a new venture started by Donna Roberts and Dawn Abrams. They allegedly run an operation called Groomers United (based in Shamong, NJ) and advertise on AdoptAPet.com under the same name. The reader cautions “beware of their sob stories and how they are performing a service to the community—they are actually selling older puppy mill breeders at elevated prices claiming that they are “rescuing” these dogs.”  And, for all you cat lovers out there, you can also adopt rescue cats at AdoptAPet. 

I wonder if Groomers United is a registered not-for-profit animal rescue organization. Maybe the State of New Jersey ought to look into it?

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For the past year or so, I have been dealing with Donna Roberts, a so-called dog breeder who recently was convicted in New Jersey on three counts of animal cruelty. Ms Roberts recently contacted me because I chose not to post several of her most recent vitriolic and abusive rants against people who maintain that she is less than scrupulous.

In case you are interested, I didn’t post her most recent comments (like I have in the past) because I am frankly bored with them. That said, when Ms. Roberts has something honest to say, I will gladly publish her comments. I suspect that it will be a cold day in hell before I do that!

If you would like to contact Ms. Roberts directly --to hear what she has to say--please contact her a shadyoakhavs@yahoo.com  I am sure that she would love to  hear from you!

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 As many of you know, we launched BioCrowd about six weeks ago. Our membership is steadily growing and several early members suggested changes and improvements to the site. In typical Web 2.0 fashion, we listened to those suggested and decided to add several new features!

First, we added a new section to the home page called BioCrunch. BioCrunch will feature “fresh content” developed by BioCrowd members. Items that can be posted to BioCrunch include but are not limited to podcasts, PowerPoint presentations, manuscripts and possibly poster presentations. With this in mind, we urge interested BioCrowd members to send us stuff that you wanted featured in BioCrunch and shared with the rest of the community.

Second, you can now upload multiple files with discussion posts and add a single file to comments. Also, it is now possible to preview your comment or discussion posts (before you hit the send button) to insure that they are grammatically-correct and typo-free. 

Third and perhaps most importantly, we decided to publicly open the site so that RSS feeds from BioCrowd can be imported to other social media applications including blogs, Facebook and Twitter. It also means that member profiles and discussion posts are searchable by Google. However, all posted resumes and job listings will remain private and only available to BioCrowd members, i.e. you have to join to view them.

We are planning other improvements to BioCrowd—stay tuned for new updates!

Until next time….

Join Us and Be Part of the Crowd!

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The recent spate of corporate layoffs has forced many people to reconsider what their next career move ought to be. While looking for another corporate job (similar to your old one) is the most obvious thing to do, the likelihood of quickly finding a new job in these economic times is remote. That said, now may be a good time to consider leaving confines of the corporate world and striking out on your own! Based on my own personal experiences, this can be a very frightening and overwhelming undertaking fraught with anxiety and uncertainty. But, not to worry! Sharon Jaffe, a self described “passionate digital marketing and media strategist and former corporate executive” has written a great blog post that offer some helpful tips and suggestions  for people who may be thinking about leaving the comforts of the corporate world and striking out on their own.

Sharon’s Tips and Suggestions About Starting Out on Your Own

1. Feel the fear and do it anyway. This is a great book by Susan Jeffers, and it's my main point, since 96% of people don't start a new busineness because of the fear of failure.  Don't expect to be fearless, but don't be paralysed by your fears. Help and seek help, especially where you need it – be it logistics, network, introductions etc.

2. "Do unto others..."- The Ethic of Reciprocity. Don't underestimate your own value and your ability to help others. Realise that others want to see you succeed and need your help too, so jump in the "informal economy" of networking, connecting, giving and asking for help. I wouldn't be here today if it wasn't for key people who gave me their time and guidance. In turn, I always make time for others since you never know when the favour will be returned. ;-)

3. Network isn't everything, it's the only thing! It's what you know AND who you know. The people who've worked with you and know what and how you do it are the key people to hire you, help you and recommend you on. Almost all my business has come from my own network where I have spent many years building a reputation and building my personal brand.

4. Be resilient! Be prepared to bark up a lot of wrong trees. When there's nothing up the trees, pick yourself up and move on to the next one. Set-backs and disappointment are par for the course. Protect your self-esteem and be positive. Matt Crabtree, from Positive Momentum, was instrumental in helping me with most of these tips as well as recognising the power of the right attitude and positivity.

5. Be your own guiding light. Trust your internal instincts when making decisions and be true to yourself. If you're asked to do something which doesn't feel right or by someone who doesn't feel right, it generally isn't right. Don't accept work which you don't feel good about i.e. is not the type of work you want to be doing (you'll be hating every minute of it). At the same time, be open-minded. I was asked to do training and figured, "why not?". It has since turned out to be my main source of business second to consulting.

6. Quality is key! Maintain your own professional quality standards. Invest in your brand and pay attention to everything from the way you dress to showing up on time. Now more than ever it's important to realise that you are your own business card.

7. Have a clear vision. Always hold clear the vision of where you see yourself in 1 or x year's time. Let that motivate you! Make sure you create some goals and milestones, be it a revenue target, or your first press interview. Remember to also reward yourself and congratulate yourself on your achievements along the way with rewards.

8. Think big but start small. Don't be arrogant or overconfident in what you charge. Be willing to do stuff for free to build experience, reputation and a solid track record. Trust me, the rest will follow.

9. Watch your costs. Don't splurge unnecessarily but don't skimp on the important things like a good laptop and a business card. It's not necessary to have a glamorous website to get started – one year on I still don't advertise what I do on the web and yet I've been fully booked.

10. Manage your work-life balance. It's easy to start working evenings and weekends and it's hard to give yourself a break. I think this is a key driver of entrepreneurs and a danger in the general unwillingness or inability to take time off. I think I'm still learning this one, which is why I put it last.

I hope these tips are helpful! Good luck!

You can follow Sharon on Twitter @sharonjaffe

Until next time…

Good Luck and Good Job Hunting!!!!!

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For those of you who haven’t been able to keep up with the latest pharma layoffs, I came across an article in the Philadelphia Business Journal that does an excellent job of recapping all of the major life sciences layoffs that have taken place in the past year or so. The recent massive pharma layoffs prompted William Ashton, Acting Dean of the University of the Sciences in Philadelphia PA to say “I was in the pharmaceutical industry for 28 years. I’ve never seen such a sea change as is occurring right now. This is really dramatic.” Further, Dr. Ashton predicted that drug companies will increase their use of contract sales forces (CSFs) and contract research organizations (CROs) to contain expenses and that staffing firms will be the winners.

This led to me to wonder what Dean Ashton has been doing for the past 10 years or so because the life sciences industry has already increased its reliance on CROs and CSFs. A quick perusal of the pharma and biotech employees who lost their jobs over the past few years reveals that a majority of them were in sales and R&D. I don’t know whether or not I should break the news to Dean Ashton, but the future is already upon us—another example of how out of touch academia is with industry in the 21^st century.

I think that it is time for industry executives and academicians to begin a serious dialog to determine the type of training that would be appropriate for individuals seeking jobs in the life sciences industry. A failure to do so will likely have a negative adverse effect on the continued growth and future success of the US life science industry.

Until next time…

Good Luck and Good Job Hunting!!!!!

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Pfizer may announce new job cuts by the end of next month as the company tries to curb spending before cheaper generic versions of its top- selling drug Lipitor flood the market in 2010. The cuts will likely take place in sales and marketing—Pfizer has cut more than 14, 000 jobs since 2007. 

Aren’t you glad that you didn’t take me up on that land deal in Florida?

Until next time…

Good Luck and Hang On!!!!!!!!!!!

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Sometimes reality is stranger then fiction. The Pharmalot blog reported today that US Senator Sherrod Brown, an Ohio Democrat, is nominating several candidates for the post and one of them is Peter Rost, MD!

For those of you who may not know Dr. Rost, he is a former Pfizer marketing executive who blew the whistle on some alleged marketing and sales violations at the drug maker. His court case is working its way up the judicial ladder and Dr. Rost apparently has the upper hand so far.

Pfizer fired Dr. Rost “for cause” after a raucous, public skirmish that went on for almost 2 years. After he left Pfizer, he wrote a book, worked for the Huffington Post and started his own blog, which currently has a post about his candidacy for the FDA Commissioner job. 

I first met Peter when he was still at Pfizer and I was organizing a meeting on drug reimportation (he is an ardent supporter). He agreed to talk at the meeting but unfortunately the conference was canceled for one reason or another. I have no doubt that he has the medical credentials and business acumen to handle the job. The one thing that worries me is his penchant for self promotion—something that is not a desirable trait in  an FDA Commissioner.

Time will tell. Personally, I would like to see Dr David Kessler come back and run the agency—another whistleblower (at UCSF) who ran the agency from 1990-1997 and did an outstanding job. The way things are going at FDA these days maybe being a whistleblower ought to be one of the requirement for the job!

Until next time…

Good Luck and Good Job Hunting

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

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

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

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

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

Until next time…

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

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I am frequently asked by life sciences PhDs whether an MBA would improve their chances of finding a job in industry. And, my response is always “maybe— because it depends. I don’t think that getting a traditional MBA really gives you that much of an edge especially if you are an established PhD looking for career advancement or change.  However, if you are a graduate student or postdoc who has already decided that academia is not for you, then getting a certificate or M.S. through an established graduate program in biotechnology (Georgetown University’s M.S. in biotechnology or The New York Center for Biotechnology's  Fundamentals of Bioscience Program) may increase the likelihood of winning a job in industry. This is because hiring managers recognize that in addition to a job candidate’s technical competency, they possess an understanding of the business aspects of the industry—something that is vital for scientists to be successful in the biotech biz.

Recognizing this, Rutgers University recently created a program that they call ‘a mini-MBA for the biopharmaceutical industry’. In contrast with traditional MBA or M.S. programs, the mini-MBA is a 12 week long, degree-granting program that was designed to familiarize students with the nuances and intricacies of the business aspects of the biopharmaceutical program. The good news is that they are actively recruiting students to fill the slots available in their inaugural class. The bad news is that it costs $4,995 to enroll. That said, it may be worth the time to check it out because—in the end—the investment may be worth it!

Until next time…

Good Luck and Good Job Hunting!!!!!

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My recent post about Donna Roberts appears to be a very popular one. No fewer than 50 people have read the post and I am now starting to receive comments from people who have had similar experiences to mine after purchasing puppies from Ms. Roberts and her daughter Grace aka Dawn Abrams. Check out this story and another that I found on the Ripoffreport.com after being alerted about them by one of my readers.

It appears that I am not the only person who received threatening comments from Ms. Roberts. Check out this bogus diatribe against a former customer who dared to question Ms. Roberts’ integrity and veracity after she purchased a very sick puppy from her.

Donna, in case you are wondering (I know you will read this), veracity means “truthfulness”—something that you know nothing about.

Stay tuned for the next installment of the Donna Roberts and Grace Abrams story.

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Each year the World Bank compiles a report that assesses the world’s friendliest business climates for small companies. The top three companies on this year’s list, Singapore, New Zealand and the US have been there four years in a row. The real shocker this year was that several previously lagging nations moved up on the list, mostly because of business-friendly reforms. This year’s most improved nation is Azerbaijan, which moved up 64 spots to a overall ranking of 33^rd because it reduced the time required to start a new business from 122 to 16 days, reforming its civil code and creating an online tax filing system.

Singapore has habitually been number one on the list because of its low import and export costs, strong government-imposed legal protections for investors and lopsided, employer-friendly labor regulations. The US placed high on the list because its labor laws are among the least rigid in the world and because business can be started quickly with a minimum amount of “red tape”.

For those of you who may be interested the top ten list looks like this:

1. Singapore
2. New Zealand
3. United States
4. Hong Kong
5. Denmark
6. The United Kingdom
7. Ireland
8. Canada
9. Australia
10. Norway

To see the rest of the list and find out more about starting a small business in your own click here

Until next time…

Good Luck and Good Job Hunting (why not start one?)

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Let me begin with the good news. The Indianapolis Business journal reported today that Schwarz Pharma Manufacturing, Inc is planning a $12 million expansion of its Seymour, Indiana manufacturing plant and distribution center. When completed the expansion is expected to increase the company's employment in the southern Indiana city from 366 to 516 by 2011. The drug maker-a unit of Schwarz Pharma AG of Monheim, Germany-said it plans to begin hiring managers, business associates and production staff later this month.

And now, the bad news. The Pharmalot Blog reported today that the New Jersey-based generic manufacturer Par Pharmaceuticals is eliminating 26 percent of its workforce expected to save from $45 million to $55 million a year. Jobs will be lost in manufacturing, research and development, and other departments. How much more downsizing and job elimination can New Jersey take before it goes bankrupt? Maybe Icelanders can shed some light on that?

Until next time….

Good Luck and Good Job Hunting

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 I invite those of you who have been following this story to take a few minutes to read the comments that Donna Roberts continues to leave on my blog. Ms Roberts, who was convicted of several counts of animal cruelty in New Jersey last summer, is the mother of Grace aka “Dawn” Abrams who fraudulently sold me my dog Moose several months ago. Although, Ms. Roberts was not involved in the transaction between Grace and me, she continues to send me threatening and bullying e-mail messages proclaiming her daughter’s (and her own) innocence.

I continue to post Ms. Robert’s comments because I want people who read my blog to understand the type of person that I am dealing with! Unfortunately, she reminds me a lot of Sarah Palin—another woman of questionable ethics and integrity. And, I am sad to say that Ms Roberts is about as bright as Ms. Palin too!

Until next time….

Good Luck and Vote for Obama

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The Pharmalot Blog reported today that Schering Plough will eliminate 1,000sales jobs or 20% of its sales force by October. This latest round of layoffs is part of a reorganization plan that was announced last year to cut 10% of it workforce by 2012 (although must of the downsizing will occur by 2010). The reorganization was announced shortly after Schering purchased Organon Biosciences and the “wheels came off” of its Zetia/Vytorin anti-cholesterol medication franchise.

In other news, BioJobBlog heard through the grapevine that Merck has been quietly laying off workers (since Labor Day) in an attempt to reduce its workforce by 20% over the next few years. Many very talented people who have been with Merck for years are looking for new jobs.

Finally, Montvale, NJ-based Memory Pharmaceuticals announced that it was laying off 55 workers or roughly 50% of its workforce. The company, which went public in a much heralded IPO in 2004, focuses on developing treatments for cognitive disorders. Although the company has never been profitable, the person who ran the company for the past three years (first as president, then CEO and finally CFO) earned $876,807 last year. Not surprisingly, he will be leaving the company as part of the downsizing initiative.

The ongoing pharma slowdown coupled with this week’s Wall Street meltdown (many people who work on Wall Street live in New Jersey) should make New Jersey a very challenging and interesting place to live in the coming months.

Hat tip to Ed at Pharmalot.

Until next time….

Good Luck and Good Job Hunting (I would avoid NJ)!!!!!!

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As the saying goes—the plot thickens. A couple of days ago a person who has been following our unfolding doggy drama recommended that I look into a DNA testing kit for dogs called Wisdom Panel MX. The Wisdom Panel MX was developed by Mars Veterinary, a subsidiary of the candy bar maker that also manufactures and sells dog food.

Scientists at Mars spent about 6 years mining and analyzing canine genome databases and were able to develop breed specific probes that can distinguish between 130 different breeds of dogs with close to 85% reliability. That said, while the test may not be able to reliably tell you exactly what you have, the sensitivity of the test is sufficient to tell you what you don’t have i.e., it will tell you whether or not your dog is a purebred or a mix.

 As I mentioned in previous posts, we were purportedly sold two Havanese dogs. If the dogs are truly Havanese, then the Wisdom Panel should reliably verify that assertion. Similarly, if our dogs are not really Havanese or a mix of Havanese and some other breed (s) then the Wisdom Panel tests ought to be able to tell us that as well.

As luck would have it, on our recent excursion to Maine, we literally ran into two relatively uncommon purebred dogs ( at least uncommon to us) —one was a Maltese and the other a Bichon. Moose—the rescue puppy who was advertised and sold to us as a 9 month-old Havanese—looked almost identical to the Maltese. Further, a so-called groomer (who posted a comment on a previous post about Moose) referred to him a Maltese which tended to validate our idea that Moose was not a Havanese but really a Maltese or a Maltese-mix.  

Again, coincidentally, my wife took Sandy (our Havanese puppy that we previously bought from the same breeder who sold us Moose) to be groomed today. Since it was Sandy’s first visit, the groomer asked what breed she was. After pausing for a second, the groomer replied “I am not  completely sure but I don’t think Sandy is a purebred Havanese –she looks like she has a fair amount of yorkie (Yorkshire terrier) in her.”

The Wisdom Panel MX kits arrived by FedEx today and we are taking the dogs to the vet at 4:00 to have blood drawn. Stay tuned for future updates.

Until next time…

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

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On the heels of yesterday’s announcement that it wants to buy Genentech, Roche, in a surprise move, announced today that it will move its Nutley, NJ-based US corporate headquarters to California. According to a report, research and development activities in oncology and metabolism at the Nutley site will be expanded. However, the company will consolidate all Nutley-based finance and information-technology operations and close manufacturing facilities on the site by 2010. It is not clear how many of Roche’s 3,240 New Jersey employees will be affected by the proposed move to South San Francisco. Suffice it to say, more than a few Roche employees are likely to lose their jobs after the company’s headquarters heads west.

Once dubbed the”nation's medicine chest”, New Jersey has steadily been losing pharmaceutical jobs since 1990 when 20% of all US pharmaceutical jobs were in NJ—at present 13.7% of  American pharmaceutical jobs reside in NJ. It has been a long, slow burn for the pharmaceutical and biotechnology workforce in the Garden State.

The Roche announcement comes as several other New Jersey drug makers, including Schering-Plough and Johnson & Johnson's Ortho Biotech unit, have been laying off workers because of the economic downturn and tough times in the industry. It also comes several days after Barr Pharmaceuticals, headquartered in Montvale, announced that it is being acquired for $7.5 billion by Israeli generics giant Teva.  

The growing scarcity of pharmaceutical and biotechnology jobs coupled with the highest property taxes in the US may cause a mass migration from the state. Not that there is anything wrong with that!!!!!!

Until next time….

Good Luck and Good Job Hunting!!!!!

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Yesterday Pfizer announced that it would layoff 275 employees at its manufacturing facility in Kalamazoo County in Michigan. Not to be out done by big pharma, generics manufacturer Perrigo Co. said today that it is going to create 400 new jobs in the western Michigan town of Allegan. According to published reports, Perrigo plans to invest $10.5 million in its Allegan, MI headquarters and manufacturing facility in an expansion that is projected to generate 99 new jobs within a year and 400 others over five years. A Michigan Economic Development Corp’s analysis suggests that the Perrigo expansion could generate up to 1,039 jobs in Michigan by 2020

A Perrigo spokesperson said that as it has done with past jobs cuts in Kalamazoo, the company will recruit the Pfizer personnel losing their jobs. This is good news for the folks who were laid off by Pfizer yesterday. However, when you do the math (275-99), the will be a net loss of 176 pharmaceutical jobs in Western Michigan by year’s end. Although Perrigo said that another 300 jobs will be created over the next five years, I wouldn’t count on many jobs being added until the US economy finds its way out of its current recession.

Hat tip to Pharmalot for the heads up!

Until next ….

Good Luck and Good Job Hunting (Michigan may be better than I thought)!!!!!

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This may be one of the more notable years for Salmonella food poisoning. First, there was a modest outbreak in the eating clubs at Princeton University and now a larger outbreak in Texas and New Mexico. This is the first time that I can recall in my almost 30 years as a card-carrying food microbiologist that there has been this many highly-publicized cases of Salmonella food poisoning in one year. Although I don’t wish Salmonella gastroenteritis on anybody, it is kind of rewarding that an organism that led to my PhD is making headlines once again. Typically, Salmonella outbreaks are not noteworthy and rarely receive much notice— usually taking a backseat to potentially life-threatening outbreaks of enteropathogenic Escherichia coli.

Like the Princeton outbreak, the exact source of the Salmonella infection is unclear. That said, public health and CDC officials are leaning towards large, raw tomatoes. In 2006, the Food and Drug Administration discovered that consumption of tomatoes in restaurants had caused a salmonella outbreak that affected 21 states. , “until the source of the outbreak is identified federal and local health officials in both states have recommended that infants, the elderly and anyone with an impaired immune system avoid eating Roma and red round tomatoes that are not grown at home or sold attached to the vine.” So far, 40 confirmed cases, with patients ranging in age from 3 to 82, have been reported in New Mexico and Texas since April. To date, 17 people have been hospitalized, but no deaths have been reported.

Molecular analyses indicated that all of the cases in New Mexico and Texas were caused by the same strain, a relatively rare serovar called Saint Paul (6^th most common serovar infecting humans). Federal health officials at the Centers for Disease Control in Atlanta, GA fear that this may be the beginning of a large national outbreak of Salmonella gastroenteritis. This is because about 30 cases caused by the Saint Paul strain, have also been reported this year in Arizona, Colorado, Idaho, Illinois, Indiana, Kansas and Utah. Like the New Jersey, Texas and New Mexico outbreaks, the cause of those other outbreaks is under investigation.

Salmonella gastroenteritis generally last between four and seven days, and most people are able to recover without medical (antibiotic) treatment. But, it can sometimes lead to death in immunocompromised adults or young children. Symptoms include headache, nausea, abdominal pain, diarrhea and sometimes vomiting.  Although textbook descriptions of the pathogenesis of Salmonella gastroenteritis generally portray it as a mild illness, I can tell you that people I know (lab mates of mine) who came down with the disease (gee, how did that happen?) suggest otherwise!

I suspect that fecally-contaminated water may be source of the infection. But, then again, it has been almost 30 years since I thought about Salmonella gastroenteritis. That said, I don’t think that you ever forget the essence or minutiae of your thesis work!

For those of you who are interested, the electron micrograph of Salmonella typhimurium shown with this post is from my PhD dissertation. As I recall, the electron micrograph was taken in 1980 and the bacterium shown in the micrograph was grown for 48 hours on nutrient agar . Althought I would like to take credit for the shot (nice pose eh?),  it was taken by Phil Hegge in the Department of Bacteriology at the University of Wisconsin-Madison, my alma mater. if you look closely you may be able to see fimbriae along with the flagella.

Until next time

Good Luck and Good Job Hunting (and remember to wash your tomatoes)!!!!!

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It looks as though Enzon Pharmaceuticals, the first company to successfully commercialize protein PEGylation, finally buckled under the pressure exerted by Carl Icahn, one of its major shareholders.  As I mentioned in a previous post, Carl recently started buying large blocks of Enzon stock to gain a controlling interest in the company to maximize shareholder value. To accommodate Icahn’s "vision" and demands, Jeff Buchalter, Enzon’s Chairman and CEO has decided to spin out a new biotechnology company.  According to an Enzon press release, the new company (to be named later) will get Enzon’s core technology (PEGylation) and its entire preclinical pipeline (i.e.; their RNA antagonist oncology portfolio). Enzon will also invest $150m in the new venture.

So, what does Enzon get out of the deal? It retains ownership of a small, aging manufacturing facility and a portfolio of nominally-performing specialty pharma drugs. I think comments made by Eben Tessari, a financial analyst who follows Enzon, sums up of the essence of the proposed spin out.  He writes: “Maybe I’m way off here but it seems to me in analyzing this deal that the new company gets all the goodies while Enzon is left with a manufacturing plant and a stable of marginal drugs (zero out of four therapies have over $50m a year in revenue). Now, I don’t mean to imply that I think Enzon is a bad company - hell, they’ve managed to make more profit this quarter than any pharma company I’ve ever worked for - I’m just saying they are selling their future based on the advice of a man notorious for breaking up companies and wringing every last dime out of a shakeup.”

Not surprisingly, Jeff Buchalter, the brains behind the deal, thinks it will provide Enzon shareholders with the value that they demand. “By separating these unique businesses into two focused companies, the opportunities for both the specialty pharmaceutical business and the biotechnology business could be substantially enhanced and greater value could be created than under the current structure. Operating separately will allow each company to benefit from greater strategic and managerial focus and appeal to their own unique shareholders. The separation will enable the two businesses to compete more effectively in their respective markets and optimize their business goals, research initiatives and capital requirements. We look forward to creating this opportunity for the shareholders,” said Buchalter.

Jeff, who learned how to turn around failing companies from his former boss Fred Hassan (turn around specialist and current CEO of Schering Plough) ought to know a little something about value. According to SEC filings, last year Jeff made $773,558 (base salary) with $1,162,500 in bonuses for a total cash compensation of about $2 million. In addition, Jeff received just over $3.1 million in equity bringing his total 2007 compensation package to approximately $5.2 million —almost 3 times the amount received by any other Enzon executive.  Not that there is anything wrong with that!!!!!!!!!!!!

Until next time….

Good Luck and Good Job Hunting (try Enzon’s spin out, they are flush with cash)!!!!!!

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Stemcyte, a Taiwan-based company engaged in embryonic stem cell research announced yesterday that it would locate its East Coast operations in NJ. The company already has a research facility in California and is establishing operations in India. Earlier this year, Stemcyte inked a deal with Rutgers University to provide financial support and embryonic stems cells for research conducted by Dr. Wise Young, a long time spinal cord injury researcher and champion of embryonic stem cell research.  New Jersey induced Stemcyte to locate its facility in the Garden State by offering the company $589,000 in business development incentive grants. The new facility is expected to create new jobs and initially employ about 12 people.

This is a small but significant step in New Jersey’s quest to establish itself as leader in embryonic stem cell research. As many of you may know, last fall, New Jersey voters defeated a statewide referendum that would have allowed the State to spend almost $500 million on embryonic stem cell research initiatives. California passed similar legislation several years ago.

The defeat had little to do with the ethics or morality and everything to do with the oppressive property taxes in New Jersey. In case you’re wondering, New Jersey has the highest property taxes in the US!  Many voters simply didn’t want the State to increase its already staggering debt to borrow more money to fund stem cell research (and raise property taxes).

After the announcement, New Jersey Governor Jon Corzine, and former head of the investment firm Goldman Sachs, suggested that he is considering reinstating the referendum for a second vote. However, he noted “not until the economy shows some improvement”.

Until next time…

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

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