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The bad news is that the US unemployment rate is close to 10 percent. The good news is that the government is looking for scientists at FDA, NIH, USDA, CDC, EPA and other agencies. For those of you who haven’t applied for a government job, the process can be daunting and overwhelming. To alleviate some of the pain, Cyndi Fischer, MSA at the BioCareer Center has written a post on the salient features of filling out a job application for a government job!

Capturing Your Worth in a Government Job Application 

You’d like to consider government employment but are not sure where to start. You know the government has a generous compensation and benefit plan, can offer long term employment stability, and in most cases its employees do not need to seek research grants or funding to continue their rewarding scientific work. Sounds like a dream, so why haven’t you applied? Perhaps you’ve heard that it’s hard to get a government job, that the hiring process is mysterious, slow and a confusing maze of information. While some of those concerns are valid some of the time, government employment has such positive benefits it is indeed a career path you don’t want to overlook. The most important thing to remember about applying for a government position is that all the items that appear to be drawbacks to you in the application phase, are really set in place to ensure that the most qualified candidate, hopefully you, will get the job!

So what do you need to know to ensure that you have the best shot at being considered for a coveted research position within the government? First you must apply to a vacancy announcement published by the government in order to be considered, and subsequently offered employment. Almost all government entities now use an automated system to post vacancy announcements and receive applications. The most widely used website to post vacancy announcements is USAJOBS.opm.gov. Once you have established an account on the site and placed your resume in the space available, you are ready to apply for any vacancy announcement you would like. Be keenly aware though, this is where attention to detail separates the candidates to be interviewed from the resumes in the scrap pile. The government hiring system revolves around merit. Specifically, the candidate who has the most knowledge, skills and abilities (KSA) to be successful in the vacant position should be offered the job, as the desired KSA’s for an opening are derived from the position description itself. Your role is to ensure that you capture your KSA’s as accurately as possible so that you are considered for the positions you are most qualified to hold.

If KSA’s are the key to government employment, how do you ensure you include everything that needs to be considered? In many cases this will be easy to discern as the vacancy announcement will list specific KSA questions prompting your response. If there are questions that seek specific answers, it is a requirement that you answer them or your application will not even be considered. In the event there are not specific questions presented, you must ensure you cover the likely KSA’s for that position within the body of your resume. Knowing what the KSA’s are for the position being advertised is one

aspect of being qualified for the position you are seeking. Let’s take a quick look at each element of the KSA’s so you know how to present your talents.

Knowledge covers the body of intellectual information you possess that will assist you in the position. This knowledge is not limited to your academic knowledge, though critical, but encompasses all aspects of what you know that pertain to the position. Included in your mental reference library are federal, state and local regulations that govern the work you will be doing, policies and procedures that apply to the work environment, industry standards and cutting edge technology that you are current in that would make you a good fit for the position. Essentially any knowledge that you possess and can articulate in your resume that is pertinent to the job you are seeking is something you should capture in your resume or the KSA questions presented as part of the announcement.

Skills represent the manipulation of systems, processes, people and things that will allow you to be competent in the position in question. They can include specific skills that require you to operate technical equipment or work with particular software or hardware systems or they may be more generic such as the skills required to communicate effectively. These skills are often the core competencies of the position and are incredibility important. Conversely, some of them are areas that professionals often under-report in their resumes as they take many of these skills for granted such as problem solving, creative thinking, decision making and stress tolerance. In most cases, government application software systems allow you a very generous amount of character space to document your KSA’s or resume, so leave no skill uncaptured!

Abilities refer to your capabilities as they apply to the work environment. Your ability to manage people and programs; to organize, plan, implement, and evaluate; to analyze, supervise or otherwise effectively impact the mission of the organization. One of the unique aspects of this element is that you do not have to have a vast work history to quantify what you can offer an employer in this category. You may have organized a large volunteer effort or been part of a regional political campaign. Any quantifiable information that depicts your role in a challenging environment which allows you to capture the results of your efforts is value added in this element.

Government employment has many rewarding aspects – not the least of which is that the infrastructure of the whole civil service is based on merit. Now that you know a little more about how to present yourself and what you have to offer in the three key government consideration areas (KSA’s) you are one step closer to accepting your first federal research position. Remember it’s not what you know and what you can do that counts in a job application; it’s what the selecting official knows you can do that matters. Good luck!

Cyndi Fischer, MSA is the Director of Strategic Recruitment for STG International. As a Human Capital Management specialist her work concentrates on agency level recruitment strategies and workforce planning. During her tenure at STG, Mrs. Fischer has designed and implemented recruitment strategies, branding techniques, and succession plans for many federal agencies seeking Phd/MD level candidates for research, managerial, and professional opportunities. Mrs. Fischer has a Bachelor of Science degree in Criminal Justice and Psychology and a Master of Science in Administration degree in Human Resources. www.stginternational.com

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Sepracor shareholders may be able to sleep better at night without the aid of the company’s top selling insomnia drug Lunesta after agreeing to be purchased on Thursday by Dainippon Sunmitomo Pharma of Japan. Dainippon will pay $2.6 billion for the rights to Lunesta and other drugs in Sepracor’s pipeline. 

This is the third deal in the last two year involving the purchase of American pharmaceutical companies by Japanese drug makers seeking to aggressively expand their reach into the US drug markets. Last year, Takeda Pharmaceutical purchased Cambridge, MA-based Millenium Pharmaceuticals for $8.8 billion and Eisai brought MGI Pharma of Minnesota for $3.9 billion. 

Sepracor, a specialty pharmaceutical company founded in 1984 focused on strategy of developing single isomers or chiral drugs and active metabolites of top selling drugs with the goal of developing a pipeline of proprietary pharmaceutical products. The company’s most successful product is Lunesta, a prescription sleep aid that had sales of almost $500 million in 2008.

Last January, the company layed off 20% of its workforce (350 sales reps, plus 410 contract sales reps) as Lunesta sales slumped because of competition from generic versions of Ambien and branded Ambien CR and revenue losses from its Xopenex COPD franchise. It isn’t clear whether or not more Sepracor will shed more jobs after the Dainippon deal closes sometime next year. 

Stay tuned for updates!

Until next time...

Good Luck and Good Job Hunting!!!!

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Reuters reports that French drug maker Sanofi-Aventis (S-A) beat analysts second-quarter earning forecasts and that next year’s earnings will likely benefit from increased demand for its new H1NI swine flu vaccine. The company is the largest flu vaccine manufacturer in the world. Yet, despite surging profits, S-A continues to restructure and cut jobs in an effort maintain its stock share price. —and an “impeccable source”— that US managers are in France discussing cuts to American operations. The cuts are expected to be announced during the first week of August. More bad news for the US economy and  tens of thousands of American pharmaceutical employees who have already lost their jobs.

Until next time

Good Luck and Good Job Hunting????????

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Several weeks ago, I blogged about a growing need to improve the American public’s perception and understanding of the life sciences if the US wants to remain competitive in science and technology. Much to my delight, there was an article this Sunday’s NY Times entitled “Microbes R Us” which explores the evolutionary relationship with bacteria and humans. It was written by Dr. Olivia Judson an evolutionary biologist and author of “Dr. Tatiana’s Sex Advice to All Creation: The Definitive Guide to the Evolutionary Biology of Sex,” which was made into a three part television program.

While the evolutionary relationship between bacteria and humans isn’t as titillating as the biology of sex, the article sheds light on the importance of bacteria and how genetic changes in bacteria that normally inhabit the human intestinal track can have a positive impact on human nutrition and health. Many lay people believe that bacteria are “bad” because certain species can cause serious and potentially life threatening diseases. However, the benefits, advantages and uses of bacteria e.g., to make food, antibiotics and other medicines, far outweigh their negative impact on society. 

Articles like the one written by Ms. Judson, offer the public unqique insights into  the amazing and often fascinating world of microbiology. I hope that a few aspiring young scientists read the article and tell all their friends about it!

Until next time....

Good Luck and Good Reading!!!!!!

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

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

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

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

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

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

Until next time...

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

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A survey involving 2000 members of the public and 2500 scientists conducted by the Pew Research Center for the People & the Press and the American Association for the Advancement of Science (AAAS) revealed that almost two-thirds of Americans hold scientists and engineers (and their contributions to society) in high regard. However, in marked contrast, 85% of the scientists surveyed said that public ignorance of science was a major problem. And, not surprisingly a majority of the scientists surveyed feel that American media coverage of science is “fair or poor.”

While the reasons for this disconnect in opinions aren’t readily apparent, perhaps some insights into the public’s understanding of scientific concepts like evolution and climate might be informative. For example, almost 35% of Americans believe that “humans existed in their current form since the beginning of time” whereas only 2% of scientists hold this belief. Further, only about 50 percent of Americans agree that humans are behind climate change and a whopping11 percent believe that there isn’t global warming at all. These beliefs trouble many scientists because there is no credible scientific evidence to refute the theory of evolution and there is incontrovertible data which shows that humans are a major contributor to global warming. So, what’s the deal with Americans?

There is little doubt that American science education is lacking. For the most part, this deficiency has been blamed on poorly trained and uninformed primary and secondary school science teachers. While this may be partly true, scientists and engineers also bear much of the responsibility.  According to the report, only 3 percent of the scientists surveyed said that they “often” spoke to reporters and the media. In other words, a majority of scientists don’t feel that it’s important to engage the public in fundamental discussion about evolution and climate change.  A facile and convenient way for scientists to eschew any responsibility for the problem is to label the American public as “ignorant about science” and not do anything about it. If scientists truly want to improve the public understanding of science, it will be necessary to roll up our sleeves and do some work to better inform and educate them!  New social media tools like blogs, videos, podcasts and social networking sites like BioCrowd represent ideal vehicles to begin to make headway against this vexing problem! 

Until next time...

Good Luck and Good Teaching!!!!!!!

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

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

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

Until next time...

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

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A much-anticipated Federal Trade Commission (FTC) report was released on Wednesday that will likely help House Energy and Commerce Chairman Henry Waxman bolster support for his fledgling follow-on biologics (FOB) bill. For those of you who haven’t been closely following the debate over proposed legislation to create a regulatory framework for approval of FOBs in the US, I provide a brief synopsis.

The Promoting Innovation and Access to Life-Saving Medicines Act (H.R.1427) introduced by US Representatives Henry Waxman (D-CA), Frank Pallone (D-NJ) and Nathan Deal (R-GA) calls for an abbreviated development pathway (at the discretion of the agency), the possibility of substitution or interchangeability (if the follow-on biologics manufacturer can prove a high degree of structurally similarity and an identical mode of action) and five years of data exclusivity. In contrast, The Pathways for Biosimilar Act (H.R. 1548) introduced by US Representatives Anna Eshoo (D-CA), Jay Inslee (D-WA) and Joe Barton(R-TX) requires clinical data, rigorous immunogenicity testing and limits on interchangeability and substitution provisions for follow-on biologics. Further, it calls for a minimum of 12 or up to 14 years of data exclusivity for innovator companies—a period during which FDA can’t rely on innovator data to approve follow-on biologics. For example, if a biotechnology drug was approved in 2009, the earliest that FDA could consider and approve an application for a competing follow-on product is 2021.

The FTC report concluded that a 12- to 14-year wait is unnecessary because follow-on biologics will not be offered at the same steep discounts as traditional generic drugs. It also pointed out that no evidence exists that biologic patents will not hold up. The agency estimates follow-on biologics would be sold at discounts ranging from 10 percent to 30 percent. Not surprisingly, the FTC did not recommend a specific number of exclusivity years. This allows legislators to continue to squabble and debate the point ad nauseum, until concessions are made by both innovator and follow-on biologics proponents.

The measure by Eshoo and Barton has garnered 88 co-sponsors, while Waxman and Deal's bill has 11. In the Senate, the Health, Education, Labor and Pensions Committee reached a bipartisan compromise on follow-on biologics in 2007 that allowed for 12 years of exclusivity, but that deal seems unlikely. Democrats are trying to address generic firms' concerns that brand companies could make slight changes to their products and start the exclusivity period over again. Some senators introduced a more generic-friendly bill like Waxman's earlier this year.

Conventional wisdom suggests that the data exclusivity provisions in the final legislation will be five years—a period identical to that provided stipulated in the 1984 Hatch Waxman Act, which created the US generic pharmaceutical industry. 

Stay tuned for new updates on this unfolding drama!

Until next time...

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

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After months of complaints by university officials and scientific organizations, the US State Department announced on Tuesday that it is taking action to speed up the delay-plagued visa process for foreign graduate students and post-doctoral researchers.

For the past few years, foreign science and engineering graduate students and postdoctoral seeking to obtain or renew visas have routinely experienced long delays sometimes taking as long as several months. The problem became so acute that students and researchers who left the US often found themselves stranded abroad, not knowing when their visas might be approved.  Not surprisingly, the delays have caused enormous problems for American universities, which heavily rely on foreign nationals to fill slots in graduate and post-doctoral science and engineering programs. Over the last year or so, visa difficulties having discouraged many scientific organizations from holding meetings in the United States. Some life sciences researchers said the apparent reluctance of the United States to accept them encouraged them to seek work in other countries.

The State Department has hired additional personal to deal with the visa backlog but will not say how long it will take to correct the problem. A state department official indicated that they hope to handle routine visa requests within a two week time frame.

While never officially acknowledged, the Bush Administration intentionally slowed the visa process for foreign researchers to “guard against proliferation of science and technical information.” In other words, the visa backlog was likely intentionally created to prevent foreign drug companies and national scientific agencies from infringing on American intellectual property and patent rights—an ongoing practice that clearly frightened many of the jingoistic officials running the Bush State Department.

However, what the Bush administration failed to understand was that a majority of foreign students who train in the US want to remain here after completion of their studies. The visa backlog and its protectionist intent forced many foreign nationals to forgo their US training and return to their home countries to seek employment. This was beginning to threaten scientific and technical innovation in US laboratories because for the past decade or longer American students have shied away from science and engineering to pursue careers in business and computer science. Ironically, the Bush Administration’s protectionist leanings may have contributed—more than they care to admit—

 to the massive job cuts that have taken place at American life sciences companies in the past few years because of availability of a US-trained work forces in countries like India and China. This provides American life sciences companies with reasonable assurances that preclinical and clinical research outsourced to these countries will be conducted according to US standards. Further, it also provides foreign companies with unbridled access to a growing cadre of US-trained scientists that will enable them to compete on a head-to-head basis with American life sciences companies.

Fortunately, the Obama Administration, unlike the previous one, delivers on its promises and appears to be willing to work hard to restore science and technology to its rightful place in American society.

Until next time...

Good Luck and Good Job Hunting (it may now be possible for many foreign students!)

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The Biotechnology Industry Organization (BIO) kicked off its annual meeting in Atlanta, Georgia today and shortly thereafter, issued a press release detailing an education study (that it commissioned) which suggests that American high school students are continuing to fall behind in life sciences education and competitiveness. The timing of the BIO education report is curious, given that over 100,000 life sciences employees have lost their jobs over the past several years and more job cuts at pharmaceutical and biotechnology companies are expected in the next six months or so.

The report concluded that “middle and high school students across the country are generally falling behind in life sciences, and the nation is at risk of producing a dearth of qualified workers for the life sciences industry. Students are showing less interest in taking life sciences and science courses, and high schools are doing a poor job of preparing students for college-level science, The deficiencies will hurt the country's competitiveness with the rest of the world in the knowledge-based economy.”

Some of the report's finding include:

• 52 percent of 12th graders are at or above a basic level of achievement in the sciences as measured by the NAEP science test
• Average scores on the NAEP for 12th graders in the sciences and life sciences declined from 1996 to 2005
• Only 28 percent of high school students taking the ACT reached a score indicating college readiness for biology.

The report also found a deficiency in the number of well-qualified biology teachers available in high school, with one-in-eight biology teachers not certified to teach biology. To improve U.S. competitiveness in the biosciences industry, the report recommends that states incorporate biotechnology into their science standards, make sure students are ready to take college biosciences courses and focus more on professional development for teachers.

While BIO ought to be commended for the study, the results and the conclusions of the report are nothing new and have been known for over a decade by industry thought leaders and life sciences industry executives. The crux of the problem is that neither academia nor industry is willing to provide funds or invests in ways to find a solution to this vexing, ongoing issue. Also,while high school science curriculum experts and teachers are typically cited as the cause of the problem, most of the blame more aptly lies with life science educators at the undergraduate and graduate school levels.

Today, many US high schools and community colleges already offer life sciences and biotechnology training to their students. In fact, biotechnology curriculum development and outreach has been ongoing in US for well over a decade. For example, Bio-Link, an NSF-funded consortium of community colleges that began in the late 1990s, has diligently worked to create a network of community colleges and high schools that offer biotechnology education and training ranging from biomanufacturing to bioinformatics to forensic DNA sciences. Further, a quick perusal of many high schools and science academies in biotechnology-rich locales like the Northeast, California, New Jersey, Maryland, North Carolina and others reveals that life sciences education and training are readily available to many students interested in biology and bioscience.

In my opinion, the system doesn't break down at the high school level but at the undergraduate and graduate school levels. This is because for the past 15 years, many undergraduate life sciences courses have jettisoned their hands on laboratory components in favor of more lecture driven and e-based learning experiences. This is because these laboratories are costly to run and extremely labor intensive. Further, many undergraduate students may choose not pursue science careers because of the mistaken perception that life sciences jobs require a PhD. Ironically, there are many more jobs in the life sciences industry for students with undergraduate or masters' degrees than for those with PhD. This is because there is a glut of PhDs in today's market and the number of jobs in academia and the life sciences industry are growing smaller. I believe that academia and industry are responsible for the rapidly declining job market for PhD-life sciences.

First, let's look at academia. Most academicians who are charged with training PhDs and postdoctoral fellows have little appreciation or understanding of the technical and regulatory skill sets required in the life sciences industry. Second, many academics don't feel that it is their responsibility to prepare students and postdoctoral fellows for jobs in industry because that is tantamount to job training—a big no-no in academic circles. Finally,and perhaps most important, graduate programs are reluctant to provide career counseling or job-specific training for their students because it might interfere with their productivity, which in turn may reduce the amount of data principal investigators have to write papers and win grants to fund their laboratories. In other words, there is little or no incentive for education and training to change at the graduate level because there is no benefit or upside to principal investigators and tenured faculty members.

While the American life sciences industry has loudly and repeatedly complained about a lack of qualified job candidates to work at its companies, they have done little to support and fund efforts to reform US life science education and training. This is likely because many life sciences executives contend that they are in business not education and the responsibility to prepare students for careers in science should not fall on them. Rather, it rightfully belongs in the purview of secondary and post secondary educational institutions. And, rather than train new employees without previous industrial experience (to inject new talent and ideas into their organizations), companies typically only hire job candidates with previous industrial experience. As many newly minted PhD and postdoctoral students frequently ask: “How are we suppose to get industrial experience if nobody will hire us without previous industrial experience?” Good question! 

The BIO report warns that the US is falling behind in bioscience education and American life science companies may experience workforce shortages in the future. The fact that about 100,000    (many of whom were scientists) pharmaceutical employees have lost their jobs over the past several years, suggests otherwise. Nevertheless, American science education and training needs to be improved and reformed if the US wants to maintain its dominance in the life sciences. The piecemeal approach that has been pursued for past decade or so hasn't worked. And why should it? Neither academia nor industry, the two main players in the story, don't really have any “skin in the game.” In other words, they have nothing to lose right now!

I believe that its time for academia, industry and government to come together to craft a cohesive, national life science curriculum that meets the needs of all stakeholders. We have a President in the White House who believes in science, the ingenuity of the American people and change. The time is now!

Until next time...

Good Luck and Good Job Hunting!!!!! 

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Do you lie awake a night overwhelmed by the possibility of another infectious disease outbreak? Well, if you want to get a good night’s sleep, I highly recommend that you take a look at a brief history of American epidemics that was published in this past Sunday’s New York Times. According to the article, history shows that the number of American epidemics has been relatively small. In fact, the author suggests that there were only nine major epidemics in the US since 1892. 

While there were several major outbreaks in the early to mid 1900s (Spanish flu, 1918; smallpox, 1947 and polio, 1952), the US has been relatively unscathed in recent years—with the possible exception of the HIV/AIDS epidemic and possibly the herpes and HPV epidemics. This is because of America’s outstanding infectious diseases surveillance networks, its comprehensive vaccination programs and modern medical and hospital infrastructures.

However, no matter how vigilant we are, there is no way to prevent infectious disease outbreaks unless the pathogens that cause the diseases are eradicated from the planet as was the case for the smallpox virus. That said, the best way to manage infectious disease epidemics is to be prepared for all contingencies.  In my opinion, the recent swine flu outbreak—this was its second appearance, the first taking place in 1976—was a practice run. And I think the world did “pretty, pretty good” as Larry David, my former NYC softball teammate and co-creator of Seinfeld would say!

Until next time...

Good Luck and Good Job Hunting

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Previously, the US Congress proposed legislation to create a regulatory approval process to allow the Food and Drug Administration (FDA) to approve generic versions of blockbuster biotechnology drugs known as follow-on biologics (FOBs). While a regulatory pathway exists for approval of generic versions of small molecule drugs (as outlined in the Hatch-Waxman Act) there is no legally-approved regulatory pathway to bring FOBs to market in the US. In contrast with the US, the European Union crafted legislation five years ago that allows biosimilars —the name given to FOBs in Europe—to be approved and sold in EU member states. Since 2004, the European Medicines Agency (EMEA), the EU regulatory body, has approved the sale of six biosimilar drugs with many more in the queue awaiting regulatory review.

The debate over FOB legislation started in the US about 10 years ago when patent expiry of many  multi-billion blockbuster biotechnology drugs was fast approaching. From the beginning, many so-called innovator companies (the companies that produced the original branded biotechnology drugs) and the trade associations that represent them on Capital Hill, the Biotechnology Industry Organization (BIO) and the Pharmaceutical Manufacturing Association (PhRMA), aggressively lobbied against any form of FOB legislation. However, late last year, several senators introduced legislation that would permit FDA to approve generic versions of many blockbuster biopharmaceutical products following patent expiry. The proposed legislation stipulated that FOB manufacturers would have to wait 12 years —after patent expiry of previously approved biotechnology drugs—before generic versions of those drugs could be sold in the US. That legislation, which unabashedly favored innovator drug manufacturers, passed the Senate health committee but died without being voted on. The new measure, introduced Thursday, cuts by more than half — to 5 years, from 12 — the time allowed before cheaper versions of biotechnology drugs could compete with the originals. A similar bill was introduced two weeks ago in the House by Representative Henry A. Waxman, Democrat of California and chairman of the Energy and Commerce Committee.

While the proposed reduction in the so-called “FOB waiting period” is commendable, I don’t think that any waiting period is necessary before FOBs can be sold in the US. It is difficult to understand why innovator companies require an additional patent protection—beyond the 20 years already afforded to them under US patent law—to continue to sell their blockbuster products! To that end, Jeff Joseph, a spokesman for the BIO said that the FOB waiting period reduction, “.... Would jeopardize patient safety and undermine our ability to develop future cures and therapies.” I believe that the FOB waiting period being championed by innovators companies is nothing more a thinly veiled attempt by them to continue to maintain monopolistic control over lucrative multibillion dollar biopharmaceutical drug franchises. Biotech executives have vowed to vigorously fight the new legislation, saying it could result in unsafe medicines, fewer cures and fewer jobs in biotechnology centers like Boston, California and elsewhere. Interestingly, similar arguments were put forward by the pharmaceutical industry before the Hatch-Waxman act was passed by Congress in 1984..

Despite the claims that FOBs will stifle innovation and may jeopardize the safety of Americans, the current high costs and lack of access to affordable healthcare will almost certainly leave Congress no choice but to pass legislation that permits the marketing and sale of FOBs in the US. While FOB legislation is a likely fait accompli, US drug manufacturers remain steadfastly opposed to any FOB legislation. I believe that innovator company opposition to FOB legislation is really a “red herring” that serves to detract attention away from the real issue that the drug industry is deathly afraid of federal regulation of drug prices. Interestingly, the US is one of the only countries in the world where drug prices are not regulated or controlled by the government. This permits drug manufacturers to set prices based exclusively on “what price the US market will bear.” In other words, they can charge as much as they want for their drugs, as long as third party payors, insurance companies and Medicare and Medicaid agree to continue to cover the costs of the drugs that they manufacture (it should come as no surprise to anyone that the American pharmaceutical and biotechnology markets are the largest and most financially lucrative in the world).

I have no doubt that innovator companies will continue to fight hard and as long as possible prevent adoption of legislation regulating the approval of FOBs. After all, there are huge sums of money and corporate profits at stake. Like it or not, FOBs will ultimately be sold in the US—the current costs of drug and healthcare are simply too high to sustain. Despite a fierce decade-long struggle, most American drug makers will privately concede that sale of FOBs in the US is inevitable. Nevertheless, innovator companies will likely not publicly endorse FOB legislation until the US government provides them with assurances that it will not seek to regulate American drug prices for the foreseeable future.

Until next time...

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

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Salmonella enteriditis, an organism dear to my heart (luckily not my posterior small intestine) is a common cause of food poisoning. As some of you may know, I did my PhD thesis work on Salmonella gastroenteritis (aka food poisoning) and I like to think that I am something of an expert on the topic. 

Typically, Salmonella food poisoning outbreaks are localized and rarely reach epidemic proportions. However, there have recently been two major nationwide Salmonella outbreaks in the US —one in 2007 and now in early 2009.

The current outbreak has afflicted 388 people in 42 states and may be caused by the same strain (Saint Paul) that was responsible for the 2007 outbreak. Ultimately, the 2007 outbreak was linked to contaminated tomatoes. The jury is still out on the cause of the most recent outbreak. Needless to say, CDC scientists are scurrying to quickly identify the source of the current outbreak because it took the agency over 5 months to conclusively identify the culprit in the 2007 epidemic. Not surprisingly, many grocery stores and restaurants suffered financially because of the outbreak.

Many of you may be wondering why Salmonella food poisoning is becoming such a problem in the US. I don’t believe that the strains responsible for the most recent outbreaks are more virulent than the ones that have traditionally caused more localized outbreaks. Instead, the reliance of food manufacturers and grocery store chains on one or two major food distributors (rather than multiple suppliers) is likely responsible for the severity and breadth of these nationwide outbreaks. This suggests that regulatory agencies ought to more closely scrutinize the microbiological quality of the operations of the major distributors. I believe that those efforts would greatly reduce the likelihood of future major outbreaks of food poisoning.

Until next time.

Good Luck and Good Job Hunting (avoid raw vegetables, undercooked poultry and raw eggs)
 

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Recently, I have come across posts on blogs and websites reporting on lay offs and cost-cutting measures that are taking place at some biotechnology companies. A good example of this is a post that appeared yesterday on the Fierce Biotech Web Site. The headline read: “New round of layoffs, cost-cutting at biotechs.”  I thought “OMG this can’t be happening—not the biotechnology industry too!”

However, I am happy to report that many  of my concerns were assuaged after I read the post and realized that the reported downsizing was taking place at small companies, most of which were on shaky ground before the recession even began. Some of the companies that were mentioned included: Titan Pharmaceuticals, Pressure BioSciences, Insite Vision, WuXi PharmaTech Cayman and Targeted Genetics—not exactly titans (pardon the wordplay) of the biotechnology industry. 

There is no question that the current economic downturn will hurt some biotechnology companies (mostly because debt financing is so difficult to secure these days). That said, I think that the biotech industry may struggle a bit over the next couple of years but it will survive because it is in much better financial shape than most other American industries. 

It is important to note that the downsizing and cost-cutting taking place at many pharmaceutical companies is based almost exclusively on projected lost revenues that may occur 2-5 years two years from now—when many blockbusters drugs begin to lose patent protection— not on immediate cash concerns (most pharma companies have plenty of cash on hand). Pharma companies began downsizing in earnest about two years ago because they realized that they had gotten too big and their empty pipelines could no longer justify employing large numbers of unproductive employees. In my opinion, the current economic downturn provided pharmaceutical companies with a good excuse to continue to lay off employees, slash costs and maintain their stock prices. 

Many of the companies mentioned in the Fierce Biotech post have been around for 5-10 years and haven’t been profitable since their inception. As a former business partner once said to me “You don’t really have a business unless you have a product to sell and are profitable.” I suspect that many of these so-called biotechnology “companies” will go out of business—not because of the recession—but because they were unable to develop financially-viable products or services.

 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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The Pharmalot blog reported yesterday that GlaxoSmithKline (GSK) will tell its US pharma employees today about a new reorganization plan that will include more job cuts. The restructuring will primarily affect sales reps and some R&D personnel. GSK, like most other pharma companies, has been steadily downsizing operations and headcount for the past year or so at its US locations in Research Triangle Park, NC and Philadelphia PA

Look for the layoffs to occur before Thanksgiving—just about the time when employee’s annual bonuses are calculated.

Until next time…

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

P.S.  It was learned today by the Phamalot Blog that 1,880 sales reps and sales support staff job will be eliminated over the next few months. Also, the company may consolidate its Philadelphia and Research Triangle Park headquarters.

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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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Just when I thought the absurdities surrounding the American follow-on biologics debate couldn’t get any sillier, the US Federal Trade Commission (FTC) announced today that it would sponsor public workshops and round table discussion to learn more about the impact of follow-on biologics on American competitiveness, regulatory policies and healthcare costs.

I am not certain what role the FTC has in the follow-on biologics debate (as far as I am concerned, it shouldn’t have much of one) but what new information does the FTC think that it is going to get that other more relevant government agencies like FDA or the US Congress don’t already have about follow-on biologics? After all, the debate to formulate an approval pathway for follow-on biologics in the US has gone on for almost 10 years now. How ineffectual and ineffective can the US government and its agencies be (rhetorical question)?

As far as I can ascertain, the main reason why follow-on biologics are not already being sold in the US are the never-ending efforts of power, well-funded lobby organizations like BIO and PhRMA. The data are incontrovertible: 1) the cost of branded drugs is out of reach for many Americans, 2) access to potentially life-saving drugs and treatments is hindered by restrictive drug formularies and onerous insurance co-pays and 3) many local and state governments and large, multi-national corporations can no longer provide adequate healthcare coverage for their employees because of out-of-control medical costs and expenditures.

In my opinion, the irony of the US follow-on biologics brouhaha is that it is putting American companies at a competitive disadvantage in the biosimilar/follow-on biologics space. Selling profitable, cheaper generic versions of blockbuster drugs is no longer a dream but a reality in countries like China and India whose middle class has finally come of age. True, the American pharmaceutical/biotech market is still the largest in the world—but will it still be the largest 10 years from now? Only time (and Asia) will tell.

Until next time….

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

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Like my kids frequently say when I mutter something obvious…”Like..DUH.! According to an article in today’s New York Times, “American medical care may be the most expensive in the world, but that does not mean it is worth every penny. A study to be released Thursday highlights the stark contrast between what the United States spends on its health system and the quality of care it delivers, especially when compared with many other industrialized nations.” No surprises here—the US spends more per capital on healthcare than all other industrialized nations but a greater percentage of the US population is without adequate healthcare.

One of the things that irritate me the most is that many Americans still believe that US healthcare is second to none. True, Americans have greater access to experimental and new cutting-edge treatments than others in the world, but when it comes to preventing or prophylatically delaying the onset of chronic diseases like diabetes, high blood pressure, obesity etc, the American healthcare system is grossly deficient.  

Healthcare insiders and third party payors have known that the system has been failing for past 20 years. Unfortunately, the healthcare and drug maker company lobbies have effectively blocked and prevented any changes to correct the glaring deficiencies of the American healthcare system. Anytime, anybody utters the phrase “nationalized healthcare” a collective shudder is exhibited by most Americans. The truth is that Medicare, a government-run healthcare insurer, is responsible for covering almost 60% of all medicals claims that are filed annually in the US. This means that healthcare benefits supplied to a majority of Americans are under the auspices of a nationalized healthcare program. Why not go all the way and cover the medical costs of all Americans?????

Politicians can no longer deny that it’s time for a change—the health of America depends on it!

Until next time…

Good Luck and Good Job Hunting

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Siemens, the German conglomerate that manufactures everything from locomotives to medical imaging devices, officially announced on Tuesday that it will be sacking 4% of it workforce or 16,750 employees. Although the company didn’t specify where all of the cut would be taking place—it is a global workforce reduction—a company spokesperson did indicate that 1,500 administrative jobs in its healthcare division would be eliminated and most of those jobs are in the US. Many of these cuts will likely take place in the tri-state area (New York, New Jersey and Pennsylvania)—not welcome news for the already battered pharmaceutical and biotechnology industries in the region.

While the cuts seem pretty substantial to most people (especially those Siemens employees who are losing their jobs) one company executive quipped “If you have 400,000 people on your payroll, cutting 17,000 is not that big a deal” — only if you aren’t one of the people who is losing a job.

Until next time….

Good Luck and Good Job Hunting!!!!!

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Ed Silverman over at Pharmalot reported today that Health Canada, the Canadian equivalent of the FDA has beaten the FDA to the punch and issued draft guidance for follow-on biologics known in Canada as subsequent entry biologics. The Canadian regulatory agency recently posted on its website requirements for manufacturers and says it could approve products under existing regulations until laws are amended to include the new approval pathway.

If approved, a subsequent-entry biologic would have to be similar to a previously approved biologic, relying in part on publicly- available safety and efficacy data. Product interchangeability and substitutability would not be automatic, but would be decided on a case-by-case basis, according to the draft guidance. Health Canada says it plans to publish additional guidance documents on specific product classes.

A subsequent-entry biologic would not automatically be approved for all the same indications as the reference product, and data would be required to support each indication in most cases. A meeting to review the draft document is scheduled for May. The proposed Canadian legislation is very similar to that adopted by the European Union for biosimilar products (what they are called in Europe). Not surprisingly the recently proposed US legislation is markedly different than the Canadian and European legislation. Go figure!

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The Bush administration's proposed 2009 fiscal year budget for the FDA includes not only a 5.7 percent increase but a plan to seek authority to allow the agency to approve abbreviated applications for follow-on biologics.

As part of the budget package, the administration said it is seeking regulatory authority for the FDA to approve follow-on biologics, also called biosimilars or biogenerics, which would be financed through user fees.

The House and the Senate both introduced follow-on biologics legislation in 2007, with the Senate's bill moving the furthest by achieving passage by the Health, Education, Labor and Pensions Committee. Lawmakers have pledged to move the legislation forward in 2008.

Jim Greenwood, CEO of the Biotechnology Industry Organization (BIO), said "BIO strongly believes that the FDA should have a pathway for the approval of follow-on biologics, which protects patient safety and promotes continued innovation," Greenwood added that "The creation of a pathway for follow-on biologics is a top legislative priority for BIO, and we are meeting with members of the House and Senate to encourage them to consider and pass follow-on biologics legislation this session." This is quite a policy turnaround for BIO which over the past 8 years has spent tens of millions or more lobbying against allowing follow-on biologics in the US.

Even more shocking than the BIO turn around, was the first ever plea last week by the Whitehouse to pass legislation to craft legislation to create a regulatory approval pathway for follow-on biologics-what’s up with that? I guess Bush and his big biotech buddies finally realized that large sums of money can be made in the follow-on biologics/biogenerics business. This possibility was not lost on the Europeans, who created a regulatory pathway for approval of biosimilars (what follow-on biologics are called in Europe) several years ago! Biosimilars are already on the European market–who said that Europeans were less entrepreneurial than Americans?

Contrary to statements made by FDA officials last week, which suggested that FDA would craft the follow-on biologics legislation, it now appears that FDA will  work closely with Congress to draft a legislative proposal for approval of  follow-on biologics. I don’t think that Congress’s involvement is a good idea given the political wrangling, deal-making and concessions that must be made in order to get legislation passed. As the old adage goes, something is better than nothing.

It looks as though follow-on biologics may become a reality in the US. As I mentioned in previous posts, I don’t think Americans will see follow-on biologics on the market before 2010 or 2011. That said, it gives us Americans something to look forward to!

Until next time…

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

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