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Let’s start with the good news first. A report issued by the National Capital Association and PricewaterhouseCoopers found that venture capital investment in biotechnology grew 22 percent in 2011. And, now the bad news; initial funding for biotechnology startups seeking investment hit a 16 year low last year. The consensus among financial analysts is that life science investors are increasingly focusing on later stage companies because they carry less clinical and regulatory risks as compared with early stage ones. Put simply, VCs, like everyone else, have become much more risk adverse and do not want to invest in companies that don’t have a minimum history of success.

According to the report, venture firms spent $4.73 billion on 446 biotechnology companies in 2011, the highest dollar amount since 2007. Approximately, 153 biotechnology and medical devices companies received their first round of funding last year.

Finally, the US Food and Drug Administration approved 30 drugs in 2011; 13 of which were developed in part by venture funding.

Until next time...

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

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BioJobBlog readers who understand Current Good Manufacturing Practices (CGMP) for pharmaceuticals and biologics know that the US Food and Drug administration is mandated to review approved drug manufacturing facilities once every two years. While this is the mandated inspection schedule, most industry insiders know that manufacturing plant inspections now take place once every three or more years. This has resulted because of an increased reliance by US drug makers on foreign manufacturing facilities to produce licensed pharmaceuticals and biologics, a lack of regulatory oversight by the agency during the Bush administrations and funding shortfalls that have resulted in a shortage of FDA inspectors.

Congress recently took the agency to task about a lack of oversight for food and drugs manufactured in foreign countries. In September, the Government Accountability offices reported that FDA inspects foreign drug facilities on average once every nine years as compared with every 30 months or more with US plants. To correct this, FDA announced that it aims to increase reliance on third party inspectors in other countries to maintain better oversight of ex-US manufacturing plants. In other words, it is less costly to train and work with inspectors already in foreign countries rather than send US inspectors overseas.

In a post last week on the Pharmalot Blog, Ed Silverman reported that Bloomberg News reviews almost 10,000 inspections at US manufacturing plants from 2000 until September 30, 2010. While the Bloomberg report did not provide details on the frequency and nature of violations uncovered at the inspections, the results of the reports were eye-opening. According to Ed:

“The FDA makes 0.9 visits, on average, to each facility each year, compared with 0.6 visits annually when George W. Bush was in the White House. Looked at another way, the agency NOW visits each of the 2,567 plants registered in the US almost once a year.”

Further he noted:

“Some of the biggest drugmakers do not have a good track record when it comes time for FDA inspectors to visit their plants. Overall, the FDA found violations at 54 percent of plants inspected last year, up 20 percent from a decade low in 2007, according to data obtained from the agency by Bloomberg News. And 80 drugmakers failed more than half of their inspections.”

So, which companies had the poorest inspection track records? Ed noted

“Abbott Labs failed 59 percent of 111 inspections; Pfizer flunked 57 percent of 202 inspections; Merck bombed out on 52 percent of 134 visits and Johnson & Johnson failed 48 percent of 161 inspections. By contrast, [generic drug manufacturer] Mylan passed 79 percent of 56 inspections!”

Republicans are threatening to slash FDA funding for US inspections mainly because the agency is focusing more on overseas manufacturers and suppliers. In response to the funding cut threats, the Obama Administration proposed that drug manufacturers whose production plants fail inspections would be required to pay fines of roughly $49,000. At present, there are no mandatory fines levied against drug makers that fail FDA inspection (the agency can and does impose fines if companies that fail inspections refuse or are reluctant to fix the problems that were uncovered).

I find it interesting that despite the numerous drug recalls and problems with drug safety of approved drugs over the past few years that the Republicans, could in good conscience, threaten to cut FDA funding to increase the frequency of inspections to bring them in line with the mandated once every two years rather than once every 2.5 to 3.0 years that has been the norm for the last decade.

Until next time....

Good Luck and Good Job Hunting!!!!!

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In his State of the Union Address last week, President Obama acknowledged that US global competitiveness in science, technology engineering and math is at an all time low and that now may be America’s “sputnik moment” to turn this trend around. While I was pleased to hear the President say that we have a problem, neither political rhetoric nor turning the lack of science literacy into a challenge that resembles an arms race is going to solve the problem. What is needed are better trained science teachers who can engage science-minded students and a repeal of the No Child Left Behind Act that forces schools to focus limited financial resources on bolstering math and reading scores to maintain public funding. Sadly, neither of these things is going to happen any time soon. But I digress...

Historically, an option for science-minded students who wanted to be “engaged” was local, regional and national science fairs where students competed with one another for recognition of innovative scientific achievement. According to an article in the NY Times, science fairs grew in popularity after World War II and were intended for those who may not have considered themselves science fanatics but were interested in general science. Michele Glidden, director at the Society for Science & public, a nonprofit organization that administers 350 regional fairs contends that “Science fairs develop skills that reach down to everybody’s lives, whether you want to be a scientist or not. The point is to breed science-minded citizens.” Unfortunately, the number of high school students and high school participating in science fairs is waning. For example, in Indiana participation in the state’s science fairs plummeted 15 per cent in the last three years.

Experts contend that declining participation may be linked to competing demands placed on high school students for other extracurricular options like sports, music, and volunteering. Yet many science educators contend that meeting mandated state standards that usually require teaching fact-based knowledge rather than the scientific method leaves little time for them to stimulate students who may be interested in participating in science fairs. Further, many high school teachers lack the training or subject matter expertise to help students who want to enter science fear. Some have reached out to scientists in industry or local colleges and universities to help interested students but these types of connections are frequently difficult to make. 

Yet, despite these challenges, several hundred thousand American high school students will participate in over 350 science fairs during the next three months or so. If now is truly a “sputnik moment” for America, than President Obama and perhaps more importantly Congress ought to “put its money where its mouth is” and provide support to improve US science literacy.

Until next time...

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

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While I don’t advocate postdoctoral positions for individuals unless they plan on doing bench science for the rest of their lives, postdoctoral training is a fact of life for those interested in pursuing academic careers. To that end, The Scientist.com conducts an annual survey that ranks the best 40 places for postdoctoral associates to work. The survey ranks the strengths and weaknesses of individual training institutions based on funding, facilities and infrastructure, benefits, training and mentoring and family and personal life. Surprisingly, institutions are also ranked on networking, career development and mentoring and training and mentor and training that they offer to their postdoctoral trainees.

The institution that snagged the top spot on the 2010 list was the Trudeau Institute in Saranac Lake, NY. Nestled in the Adirondack Mountains in Upstate NY, the not-for-profit Trudeau Institute has a deserved international reputation in immunology, infectious diseases and vaccinology. When I was a graduate students (back in the dark ages), some of the greatest minds in infectious diseases held positions at Trudeau. These days; not so much—but I bet the skiing is great! Interestingly, one of Trudeau’s strengths is networking opportunities (how much networking can take place at a secluded institute on a lake in the Adirondacks). Curiously, however, one of its major weaknesses is the lack of career development opportunities. Based on my life experiences, I always thought that networking was a crucial part of career development. But then again, what do I know?

The top 10 of the list featured a couple of Massachusetts-based institutions including the Whitehead Institute for Biomedical Research (3) and the Novartis Institute for Biomedical Research Institute in Cambridge (4) and Woods Hole Oceanographic Institute in Woods Hole, MA (9). Two national laboratories, Sandia National Laboratories, Livermore, CA (8) and Rocky Mountain Laboratory, NIH Hamilton, MT (6) cracked the top ten. By all accounts, the fly fishing is outstanding in Hamilton.

As usual, there were some surprises. These included Samuel Robert Noble Foundation (2) in Ardmore, OK, the University of Colorado, Denver (7) and the Mayo Clinic (10) in Rochester, MN (not exactly cities on my top ten list). Not surprisingly, there were only two life sciences companies that made the Top 40 list; Genentech (5) in South San Francisco and as mentioned above at number 3, the Novartis Institute for Biomedical Research. Once a mainstay, industrial postdocs are becoming increasingly scare and difficult to land. In many cases, these positions are not advertised and generally filled by word-of-mouth recommendations to principal investigators who are looking for postdoctoral fellows.

A quick perusal of the list revealed, as expected, that most of the 40 institutions excelled in categories that included funding, facilities and infrastructure, benefits and family and personal life. In marked contrast, many of the institutions on the list were disappointingly weak in the areas of networking, career development and training and mentoring. Of the top 40, six got kudos for networking (15%), 11 for career development (28%) and only 6 for training and mentoring (15%). These abysmal statistics are somewhat shocking given that postdoctoral fellowships are mainly intended to train and prepare aspiring individuals for lifelong careers as scientists. The fact that only 25% of the nation’s best places to perform postdoctoral research offer career development training and support for postdoctoral trainees suggests that the future of the American life sciences industry may be in serious jeopardy!

Hat tip Ed at Pharmalot.

Until next time....

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

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Ed Silverman, over at the newly reinvigorated Pharmalot Blog, today reported that a recent study publicized in the Journal of the American Medical Association showed that, after a decade of doubling, the rate of increase in biomedical research funding slowed from 2003 to 2007, and after adjusted for inflation, the absolute level of funding from the National Institutes of Health and industry appears to have decreased by 2 percent. The NIH remains the largest federal contributor to biomedicalresearch, accounting for 84% of total federal funding in 2007 

Further, the report indicated that research funding provided by pharmaceutical and biotechnology companies and medical devices and diagnostics manufacturers rose from $40 billion in 2003 to $58.6 billion in 2007; an increase (adjusted for inflation) of roughly 25 percent. Most of the funding came from large pharmaceutical companies. Interestingly, however, the sector of the life sciences industry that exhibited the greatest increase in growth over the same period was diagnostic and device makers (59 percent), followed by biotechnology (41 per cent) and lastly, pharmaceutical companies (25 per cent).

While the results of the study are not surprising, it is clear that the life science sector is beginning to focus more on device and diagnostics than on small molecules and even biotechnology products. Further, reductions in federal funding are forcing researchers to increasingly rely on grants and contracts from private sector companies. This suggests that an ever expanding percentage of the research conducted at many academic institutions will be financed and underwritten by for profit companies. Although more product-focused academic research is not necessarily a bad idea, it does call into question the direction and possible breadth of academic research and the availability and sharing of important scientific information, data sets and discoveries. 

Until next time...

Good Luck and Good Grant Writing!!!!!!!!!

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The competition for National Institutes of Health (NIH) grant funding has been intensifying over the past five years or more. In the past, NIH had gone to extraordinary lengths to insure that senior investigators didn’t lose their funding so as to not hinder the progress of long standing research programs. However, in recent years, NIH funding managers have eschewed the unwritten policy of preferentially funding established investigators in favor of younger ones!  According to an article in today’s New York Times, NIH grant managers are increasingly ignoring the advice of study sections and funding scientists whose projects receive less favorable reviews than those denied money. Many of the favored funding recipients are “new investigators,” or scientists who had never before received a grant from NIH. Further, in 2007, the last year for which figures are available, “19 percent of the grants awarded to individual scientists were made as exceptions, or given outside of rankings by scientific reviewers, according to a report by the Government Accountability Office. Nearly all of the increase in exceptions in 2007 went to new investigators, with the young scientists’ share rising from 20 percent of all exceptions in 2003 to half in 2007.”

Not surprisingly, many senior investigators are calling “foul” despite the fact that the median age at which scientists win their first NIH grant has risen steadily, to 41 years, from 35 in 1980. While all meritorious grant proposals ought to be funded, the reality is that there simply isn’t enough money to around. As a former tenure track faculty member, I believe that new investigators deserve something of a handicap or edge when it comes to competing for their first grants. After all, how can an overwhelmed, newly minted faculty member be expected to successfully compete with established investigators who have mastered their jobs and more importantly, the art of grant writing? Sadly, the old practice of preferentially funding established investigators over new ones tended to stifle innovation and reward scientists who liked to play it safe!

We live in an increasingly competitive world where innovation is at a premium. American scientists and granting agencies must abandon their old practices if they want to remain competitive on the world stage. To that end, funding some young, innovative investigators over a few established faculty members who have enjoyed long successful scientific careers doesn’t seem like a bad investment to me! After all isn’t all about retun on investment these days?

Until next time...

Good Luck and Good Job Hunting!!!!

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The appearance of the Swine Flu aka H1N1 last spring not only created a worldwide panic, it demonstrated to Albert Osterhaus, head of virology at the Erasmus Medical Center in the Netherlands how uninformed the lay public was about viral outbreaks, epidemiology and public health. This prompted Dr. Osterhaus and his colleagues to create a free, online video game called the “The Great Flu” which challenges players to control a new viral pandemic.

As the virus has spread worldwide, countries have tried different methods to slow it down and pharmaceutical companies are now racing to produce a swine flu vaccine (sound familiar?). To fight the emerging outbreak, players use public health measures including setting up surveillance systems, stockpiling antivirals and vaccines, and closing schools and airports. Players also have a limited budget and are warned that "your actions to control the virus cost money, so keep an eye on it." In other words, while the goal is to control the pandemic, there may not be sufficient funds and resources to accomplish those goals!

A running tally of the numbers of people infected and those who have died are displayed above the budget. Newspaper stories about the deadly virus and the global response to it — like riots breaking out worldwide — pop up to help players monitor the outbreak and plan their next moves. Messages from governments mirror the difficulties faced by international agencies like WHO that are responsible for containing worldwide epidemics. For example, when players set up costly surveillance systems, sometimes participating governments will send a message "we will comply with your directions...but we must inform you that the political support for this action is low in this region. Therefore, the effectiveness of the system to control the outbreak may differ from your expectations."

The goal of the game is make the lay public aware of the difficulties that public health officials encounter during pandemics and the tight rope they sometimes must walk to insure that the virus is contained and doesn’t continue to spread. To test your skill level at controlling pandemics, you can choose different viruses (which range from easy to difficult to manage) at the beginning of the game.

I think “The Great Flu” is a great way to educate the public about infectious diseases and epidemiology and have fun at the same time. If you are interested in more sinister online swine flu games check this out.  Who said learning science has to be tedious and dull?

Until next time...

Good Luck and Good Virus Hunting!!!!!

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Despite dire predictions, the biotechnology industry appears to be weathering the recession better than most. According to a CNN Money.com post “Biotechnology leapt ahead as the biggest recipient of U.S. venture capital money in the second quarter, but first-time venture investments in companies overall dropped to a 15-year low.”

Biotechnology funding grew 54% to $888 million in 85 deals, software came in flat at $644 million in 135 deals and Internet companies fell 15% to $524 million in 124 deals. While biotechnology company investments are leading the pack, the current funding levels pale in comparison to those of the late 1990s and early 2000s. Also, it is important to note that many of the biotechnology company investments were in mid to late stage ventures. Fewer investments were made in seed or early stage companies which historically have outpaced funding in late stage ones.

Venture capitalists may be favoring biotechnology investments because there is a clear exit strategy—there are more acquisitions and initial public offerings in life sciences as compared with other industries.

Look for continuing investments in the biotechnology sector—especially in molecular diagnostics and medical devices.

Until next time...

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

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For those of you interested in the Canadian biotechnology scene I want to mention a good resource that I came across recently. The Canadian BioTechnologist 2.0 Blog (http://cbt20.org) has its sights set on helping to advance the development of the Canadian Biotechnology sector and the people who study biotechnology and life sciences at the college and university level and bench scientists and technicians who work in the field across the country.   

Readers are invited to contribute content: posters, tools, research and presentations, articles white papers, multimedia, music downloads and entertainment, conference announcements, videos.

The site is sponsored by the Canadian operation of Bio-Rad so it has a good selection of non-commercial content from the company including papers, tools, workshops and for fun some of their recent music videos. The blog manager, Howard Oliver of What If What Next  a Toronto based  Web 2.0-PR firm has done a great job of collecting content that covers Canadian biotechnology news and useful tools and career information for bench scientists and technicians and students.

Do drop by The Canadian BioTechnologist2.0 Blog (http://cbt20.org) to learn about the Canadian scene and get your voice heard.

 Until next time,

Good Luck and Good Jo

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

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

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

Kudos to Dr. Glick!

Until next time,

Good Luck and Good Investing!!!!!!

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For the past 60 years, American science was second to none. However, the US is perilously close to losing that distinction. Put simply, American science, like its economy, is in free fall.

Federal funding, primarily through the National Institutes of Health (NIH), is the lifeblood of American life sciences research. Between 1998 and 2003, the federal government doubled NIH’s budget every year—almost 25% of all grant applications were funded and life was good! However, since 2003, budget increases have vanished and the NIH remains trapped in a five year run of flat funding. Research funding rates have fallen to 10% or less and many academic scientists are voluntarily leaving or being forced out of their jobs.

This is not the first time that funding levels have plummeted. From 1989 to about 1994 (when I was a tenure track Assistant Professor), funding rates fell from about 20% to less than 10%. However, back then, there was little global research competition and American was able to recover to retain its scientific dominance. However, the world is a very different place now and the supremacy of American science, particularly in the life sciences, is clearly at risk.

According to an article in the Trenton Times, (my local paper), science and engineering have accounted for close to half of the growth in the American economy since World War II. Analysts suggest that without adequate research funding and ready access to research grants fewer scientists will enter the profession. “Already Asian countries are graduating 10 times the number of scientists and engineers as the United States. If the current trends continue in about a decade 90% of the world’s scientists and engineers will be in Asia” According to Elias Zerhouni, current director of NIH “In 10 to 15 years we’ll have scientists older than 65 than those younger than 35. This is not a sustainable trend in biomedical research.” Unless federal funding for research is increased this ominous trend will continue. That said, it may be too little too late. As you all know, finding science jobs in the US these days is becoming increasingly difficult even for qualified applicants. With this in mind, one of the most well attended talks that I give at career development symposia is entitled “The Road Less Traveled: Alternate Career Paths for Life Scientists”. As much as I hate to admit it, traditional career pathways for most life scientists may be things of the past.

Clearly, something must be done to fix the problem in order to maintain the quality of American science. The easy fix, which has been used ad nauseam for the pasts two decades, is to increase short term federal research spending. However, history indicates that this approach fosters the boom and bust cycles that have continually plagued American academic science. Although the boom and bust approach is quintessentially American, I don’t think that it will enable American science to sustain its scientific dominance in today’s increasingly competitive world.

The number of young people interested in or entering science continues to plummet in the US. Ironically, the quality and access to American science education has never been better! So, why the disconnect? It’s simple—science jobs are scare, the pay is not great and life as an academician has become almost unsustainable. In my opinion, something has to change very soon or America will almost certainly lose its status as the preeminent purveyor of science in the world.

Until next time,

Good Luck and Good Job Hunting!!!!

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