Sandoz Moves Its Biosimilar Development Strategy Forward

Sandoz, the generics division of Novartis, is currently the world leader in the biosimilar market. In fact, if it was not for Sandoz, the biosimilar industry may never have gotten started in the first place! As some of you may know, Sandoz sued FDA (and won) to gain approval of its biosimilar human growth hormone. While FDA contends that Omnitrope is not really a biosimilar (it was approved as a “drug” rather than a biologic) most analysts agree that it was the first biosimilar product ever approved and sold in the US. 

As part of its global biosimilar strategy, Sandoz today announced that it had initiated Phase III clinical trails for US approval of biosimilar version of recombinant human granulocyte-colony stimulating factor(G-CSF) or filgrastim (Amgen’s Neupogen®) and another for global launch of PEG-filgrastim (Amgen’s Neulasta®); a PEGylated form of G-CSF.

The filgrastim study is designed to evaluate the efficacy and safety of Sandoz's biosimilar filgrastim versus Neupogen® in breast cancer patients eligible for myelosuppressive chemotherapy treatment. These trials expected to support extension of commercialization to the US, the largest global market for biologics. The pegfilgrastim study, which is being conducted in breast cancer patients undergoing myelosuppressive chemotherapy treatment, represents the next major step in the Sandoz global biosimilar development program. Previously, Sandoz announced that it had initiated late stage clinical trials for a biosimilar version of Roche’s monoclonal antibody cancer treatment Rituxan®). Finally, Sandoz has eight to ten different biosimilar molecules at various stages of development in its pipeline.

Sandoz currently markets and sells three biosimilars: filgrastim (Zario®), somatropin (Omnitrope®) and epoetin alfa (Binocrit®) in countries across Europe and elsewhere. As mentioned above Omnitrope is also sold in the US. However, because FDA has yet to craft a regulatory approval pathway for biosimilars (despite legislation mandating their approval) it is illegal to sell biosimilars (with the exception of Omnitrope) in the US.

Once vilified and staunchly opposed by most major pharmaceutical and biotechnology companies, the biosimilar business has been picking up steam in the past few years. To that end, companies like Merck, Pfizer, Teva and more recently Amgen and Biogen (all of whom lobbied against an approval pathway for biosimilars in the US) announced plans to compete on the global biosimilar market.

The decision of these companies to enter the biosimilar market is largely a result of downward pricing pressures on pharmaceutical and biotechnology drugs and near-empty drug pipelines at most major life sciences companies. Nevertheless, it is still not clear whether or not a robust biosimilar market truly exists. To wit, biosimilars have been in the market in the EU for the past fiver years and have not gained much traction there. However, the real biosimilar markets probably exist in China, Brazil and other emerging countries where there are large populations and emerging middle classes but drug prices are under tight government regulation. Because of this, the uptake of biosimilars in these markets will likely be greater than in Europe and the US.

Until next time...

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

 

Asian Pharmaceutical Giant Takeda To Eliminate 2,800 Jobs in the US and Europe

Asia’s largest drug maker, Takeda, today announced that it will eliminate 2,800 jobs or about 9% of its workforce in the US and Europe. The job cuts, planned over the next four years, are intended to better integrate NycoMed, the Swiss company purchased by Takeda for $12 billion last September.

Most of the positions affected by the downsizing are in the US and Europe and will help the company save $1.7 billion over the next year or so.The plan includes the elimination of 2,100 jobs mainly in Europe and 700 in the U.S. across research, commercial, operations and administrative functions. Takeda currently has about 30,000 employees worldwide with operations in 42 countries.

The reason for the downsizing is slumping US sales of the company’s top selling drug Actos (diabetes) that will lose patent protection this August and face stiff generic competition. Like other pharmaceutical companies, Takeda is abandoning the US and European markets in favor emerging markets in China, India, Brazil and the Middle East.

Until next time...

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

 

China By The Numbers

Much has been written about the emerging markets in China. While there are likely thousands of business article and white papers on China’s economic expansion, I was unable to find a single source that provided me with some vital economic and social statistics to explain China’s rise as an economic power; that is until I received OnWisconsin, a quarterly publication from my alma mater the University of Wisconsin-Madison.

An article entitled “Delicate Balance” by Jenny Price ’96 provided me with a plethora of data that cogently and expertly explained the Chinese ascendancy as an economic power. Not surprisingly, the data offered by Price was compared with economic, social and business data from the US. Some of the information was startling to say the least (bold italics); so here goes:

Urban Population

United States 82%

China 47%

Median Age

United States 36.9 years

China 35.5

Total Fertility Rate

United States 2.06 children born per woman

China 1.54 children born per woman

Infant Mortality Rate (death per 1,000 live births)

United States 6.06

China 16.06

Net Migration Rate

United States 4.18 migrants/1,000 population

China -0.33 migrants/1000 population

Largest City

United States New York/Newark 19.3 million

Shanghai 16.6 million

Imports/Exports

United States $1.903 trillion/$1.27 trillion

China $1.307 trillion/$1.506 trillion

Gross Domestic Product (GDP) by Sector

Agriculture

United States 1.2%

China 9.6%

Industry

United States 22.2%

China 46.8%

Services

United States 76.7%

China 43.6%

External Debt

United States $13.98 trillion

China $406.6 billion

Public Debt

United States 58.9% of GDP

China 17.5 % of GDP

Budget Revenues/Expenditures

United States $2.092 trillion/$3.397 trillion

China $1.149 trillion/$1.27 trillion

Population (2011 estimate)

United States 313,232,044

China 1,336,718,015

Literacy (ages 15 or older or can read and write)

United States 99%

China, 91.6%

Life Expectancy at Birth

United States 78.37 years

China 74.68 years

After reviewing the data, it became much more apparent to me as to why so many companies, most notably pharmaceutical and biotechnology companies, are investing heavily in the Chinese market. Financial analysts predict that the Chinese pharmaceutical market will surpass the US (currently the world’s largest) by the end of the decade. That said, I think it may be time for the American public to learn more about China. Learning as much as possible about the competition is essential if you want to stay in the game.

Until next time...

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

 

Alcon Announces Plans to Expand Its Workforce In Texas

Despite a stalling economy, there are signs that some American companies are hiring and helping to improve local economies. A good of example of this is Alcon Laboratories located in Fort Worth, Texas. The company, which specializes in vision products, today announced that it leased 87,000 sq. feet of office space to house 400 new employees that it is moving into the Fort Worth area.

The company immediately needed the space to accommodate employees relocating from Atlanta and to house new hires as the company plans to expand existing facilities in south Fort Worth. Alcon was acquired this past April by Novartis, which operate the Atlanta-based CIBA Vision and Novartis Ophthalmic Units which are being consolidated into Alcon’s existing Forth Worth operations. While some of Novartis’ Atlanta employees lost their jobs as a result of the Alcon acquisition, many of them are relocating to new jobs at the Forth Worth facility.

Alcon notified Fort Worth city officials that it plans on expanding its current workforce of 3,200 to about 4,000 and spends millions of dollars to expand existing facilities over the next few years. Ironically, while most big US pharmaceutical companies are slashing domestic jobs and investing in emerging markets like China and India, Novartis, a Swiss company, is investing in America! Go figure!!!!!!!

Until next time...

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

 

Merck Continues Its Eastward Expansion

Merck today announced that it will establish an Asia Research and Development headquarters in Beijing, China as part of a $1.5 billion commitment the company made to invest in China over the next five years.

The new headquarters will be focused on new drug discovery and development. Merck’s Asian commercial operations (known as MSD outside of the US and Canada) are located in Shanghai, China and will remain a separate entity from the new R&D center in Beijing. In addition to these facilities, MSD possesses manufacturing capabilities at many other locations throughout China.

Merck joins a growing list of big pharma companies that are rapidly establishing R&D centers in China and other emerging markets. With this in mind, don’t expect US R&D jobs to return to the US anytime soon! Now, may be a good time for American students to reconsider an anticipated career in life sciences R&D. On the other hand, the future is bright for Chinese life sciences graduate students and postdocs who are training in the US.

While Horace Greeley may have gotten it right in his day, I think the saying “Go East young man/women” may be more apt for the 21st century life sciences industry.

Until next time...

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

 

Biotech Update: Samsung Biologics And Biogen/Idec To Compete In The Global Biosimilar Market

While Samsung is mostly know for flat screen televisions and other electronic appliances, one of South Korea’s largest companies has been quietly evaluating a play in the protein engineering and manufacturing space. For those of you who may not know, Korea possesses one of Asia’s most vibrant biotechnology industries. At present, there are over 600 Korean biotechnology companies in existence. In April 2011, Samsung created a business units called Samsung Biologics which specializes in biopharmaceutical manufacturing.

Today, Samsung formally announced that it would create a joint venture with America’s Biogen/Idec to develop market and manufacture biosimilar molecules. Under the terms of the agreement, Samsung will invest $255 million and garner a 85% stake in the venture which will be located in South Korea. Biogen/Idec will invest $45 million for a 15% stake in the joint venture. Samsung will take a leading role in developing and marketing the joint venture’s products whereas Biogen/Idec will contribute expertise in protein engineering and biomanufacturing. The joint venture will not develop biosimilar versions of Biogen/Idec’s proprietary, branded protein-based drugs which include Avonex (MS), Rituxan (oncology) and Tysabri (MS).

Biogen/IDEC is the first “big biotech” company to jump on the biosimilar train. The company joins Merck BioVentures and Sandoz (Novartis) as major players in the biosimilar marketplace. Teva, which began looking at biosimilars about eight years ago, is also widely believed to be a biosimilar player. While the financial fate of biosimilars is still uncertain in the US, these molecules are generally perceived as having a much higher financial upside in large emerging markets such as China, Korea, Brazil and Russia which are susceptible to government pricing controls.

Until next time...

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

 

Tis The Season: Novartis to Cut 2,000 Jobs

It seems that big pharma always waits for early Fall to announce pending job cuts. Novartis, Europe’s second largest pharmaceutical company, announced two days ago that it would eliminate 2,000 jobs mainly in the US and Switzerland but add new employees to operations in emerging markets like India and China. Novartis is just another addition to a growing list of big pharma companies that are slashing jobs in the US and Europe and hiring new employees in lower cost markets.

The announce cuts represent a 1 percent reduction in Novartis’ global workforce. The cuts will be implemented over the next three years and are predicted to save the company in excess of $200 million annually. 

According to a company spokesperson, Novartis will eliminate 1,100 jobs in Switzerland, with the balance in the U.S., Jimenez said. Some research will be moved to the U.S. from Switzerland, and reductions will be made in technical research and development, data management, clinical trial monitoring, drug safety and regulatory affairs. Novartis will add 700 positions in China and India in data management and trial monitoring.

As part of the reorganization and job cuts the company will close an over-the-counter drug manufacturing plant in Nyon, Switzerland and chemical production facilities in Basel and Torre, Italy.

The current cuts come after Novartis announced last November that it would eliminate 1400 U.S. sales jobs and more recently in March that it would reduce operations in the UK.

Although life science pundits recently suggested that job cuts in the pharmaceutical industry are slowing and may have hit rock bottom, it appears that the carnage is still taking place and will likely continue well into the future as more resources and monies are invested in emerging markets.

Until next time...

Good Luck and Good Job Hunting

 

Okay, Maybe Big Pharma Layoffs Are Not Over: AstraZeneca to Eliminate 400 US Jobs

Astra Zeneca today announced that it will eliminate 400 positions at the company’s Wilmington, DE headquarters. Most of the cuts will be in sales and marketing and the downsizing is intended “streamline portions of its commercial business to best serve patients in the US.”

According to a press release, about 70 of the estimated 400 job cuts will come from existing unfilled vacancies. Also, employees will have the option to choose to potentially leave the company with a possible package. All decisions will be finalized by early December.

Like many of its competitors, AstraZeneca is facing fierce competition from generic manufacturers and downward pricing pressures. The company currently employs 61,000 persons worldwide including 14,000 in North America.

Until next time...

Good Luck and Good Job Hunting!!!

 

US Graduate School Enrollment Dips for the First Time Since 2003

Conventional wisdom has it that when economic times are tough enrollment in graduate schools tends to increase. After all, there are no jobs to be had so jobseekers go back to skill to increase their knowledge or improve their skills to be more competitive on the job market. However, according to a new report issues by the Council of Graduate Schools, enrollment of American students in US graduate programs dropped 1.2% percent from 2009to 2010 despite a 8.4% increase in applications.  This is the first drop in graduate school enrollment since 2003 and the decrease came after a 5.5% increase the previous year. 

The decrease in new graduate students was most noticeable in business (MBA) and public administration programs. Interestingly, enrollment by Hispanic student grew by roughly 5.0% while black enrollment declined by more than 8.0%. A startlingly finding of the report is that the number of new international graduate students studying in the US increased 4.7% percent since 2009 to 2010; a trend that has been taking place mainly in the sciences and engineering for the past two decades which has now crossed over into non-science fields. Finally, another troubling statistic is that while enrollment in certificate and Masters Degree programs is beginning to wane, doctoral programs are growing at a faster rate than ever before.

The reasons for the decline in domestic enrollment are tied to the poor economy. Graduate school costs are rising and employers are no longer willing to pay for graduate education of their employees. Dr. Debra W. Stewart, president of the Council of Graduate Schools issued this warning:

“The decline in domestic students is very bad news for the nation’s economic future. “Higher education and, increasingly, graduate education are what drives prosperity, and if we get to the point where only people with significant bank accounts can afford graduate education, the country is doomed.”

Some other interesting tidbits found in the report included the statistic that more than 60 percent of the 445,000 first-time graduate students were enrolled at public institutions, and about 58 percent of them were women and women earned about two-thirds of the graduate certificates awarded in 2009-10; 60 percent of the master’s degrees; and 52 percent of the doctorates.

Until next time...

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

 

The Dumbing of America: Effects of the Economy on American Post Secondary Education Practices

By now, most of you have heard that tough economic times are forcing more students to enroll at community colleges because they can no longer afford the staggeringly-high tuition costs at most American four year  public and private colleges and universities. While this may be a financial boon for community colleges, technical schools and for-profit educational institutions, flagging enrollment numbers at second and third-tier public and private colleges has induced some admissions officers at these four year institutions to lower academic standards to admit students who can pay full tuition to attend them. In other words, rather than admit deserving academically-qualified and competitive students who may need financial aid to attend their institutions, admission officers will sometimes admit less academically qualified students to offset rising financial costs.

As the father of a college freshman, I had inkling that this practice was real but I had no formal proof or data to verify my suspicions. That all changed today after reading a troubling article in the NY Times entitled “Universities Seeking Out Students of Means.”

Based on a survey of 462 admissions officers conducted in August and early September, the article states

“More than half of the admissions officers at public research universities, and more than a third at four-year colleges said that they had been working harder in the past year to recruit students who need no financial aid and can pay full price.” 

Moreover,

“22 percent of the admissions officials at four-year institutions said the financial downturn had led them to pay more attention in their decision to applicants’ ability to pay.” Finally, “10 percent of the admissions directors at four-year colleges — and almost 20 percent at private liberal-arts schools — said that the full-pay students they were admitting, on average, had lower grades and test scores than other admitted applicants.”

So, why is this trend so troubling? And, what does it portend for future US competitiveness in the global economy? For one thing, admitting less qualified “wealthy” students will help to continue to “dumb down” the quality of the education currently offered at these institutions. To wit, over 50 percent of incoming freshman at most US colleges and universities already require remedial help in language arts and math. Second, this practice clearly hinders diversity because many minorities (and many middle class students) are either financially disadvantaged or struggling because of the economic downturn and cannot attend these institutions because they are simply out of their financial reach. Third, and perhaps most troubling, is that this practice clearly demonstrates that educational institutions are operating not on educational or academic principles but on business and financial ones. Put simply, generating revenue has replaced the educational and academic mission that all of these institution were founded upon.

Knowing this, is it any wonder why the US is losing it educational edge to lesser nations; many of whom are considered to be emerging countries? Unless the “pay-to-play” practices exhibited by many college admissions offices are eliminated, it is likely that US global dominance and world competitive will continue to wane. Money may “make the world go round” but it requires intelligent, motivated and competitive individuals to generate it! 

Until next time...

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

 

More Workforce Diversity is Needed in the Life Sciences

As scientists, we all  subscribe to the notion that diversity is a critical component to the evolution of any species. While we this is a well known fact, the life sciences industry, like others, struggles with workforce diversity mainly in the area of research and development. For example the number of minority students—blacks and hispanics—who receive PhD degrees is miniscule as compared with their white counterparts.  Graduate schools struggle to promote diversity in their programs but their efforts to date have been lackluster.

One of the factors that contribute to the lack of representation of minority students in the life sciences may be the lack of access to equal educational opportunities. With this in mind, the folks over at onlinecolleges.net sent me a post that has a plethora of information about the state of minority education in the US. I culled relevant information from the list and reproduced it for this post.

Stereotyping impairs performance

A startling Ohio State University study exploring the effects of racial stereotyping uncovered some very unfortunate truths. Nearly 160 African-American students were asked to write an essay about an average college student, either named "Tyrone" or "Erik," with the implication being that the former is black and the latter white. Those assigned Tyrone scored an average of 4.5 on a standardized test, while Team Erik ended up with 6.2. Although possessing equal academic aptitude, researchers believe prevailing stereotypes negatively impact performance — thus creating an unjust cycle reinforced by students and teachers alike. 

Hispanic high school students had the highest dropout rate in 2009

The National Center for Educational Statistics shows that 17.6% of Hispanic high school students drop out before completing their diplomas or GEDs. Reasons vary from kid to kid, of course, and do not necessarily denote poor grades or discipline. On a positive note, however, Hispanic dropout rates decline steadily every year, with 2008 seeing 18.3% of the high school population leaving before graduating. 

Minorities comprise 32% of undergraduate enrollees

Undergraduate enrollment has actually increased among all racial and ethnic demographics, although minorities remain heavily underrepresented on American college campuses. Only 32% of postsecondary students are minorities as of 2004 statistics, but their numbers increase yearly — certainly a positive trend. Between 1976 and 2004, Asians and Pacific Islanders experienced the highest rate of increase, boasting a whopping 461%. So while the number still seems low these days, minorities are definitely catching up on campus and enjoy more opportunities to have their voices heard and heeded.

Minorities comprise 25% of graduate enrollees

With increased minority undergraduate enrollment came more representation in graduate programs, though at a slower pace. 2004 statistics showed that 25% of master’s and doctoral students were minorities, up from 11% in 1976. The most rampant increase occurred among Hispanics, at 377%. Once again, there’s absolutely nothing "scary" about more opportunities and representation in higher education. But the numbers could definitely be higher, especially since more enrollees means more imperative to address diverse needs.

Minorities comprise 10.2% of private school principals

In total, of course, as statistics vary rapidly depending on what — if any — denomination owns and operates the schools in question. Seventh-Day Adventist institutions lead the way, with 26.4% minority principals. Administrators of black, non-Hispanic or Latino descent are most prevalent, particularly in Seventh-Day Adventist (17.7%) and Pentecostal (14.7%) schools. They also make up 5.2% of total minority principals. When it comes to private education, more needs doing to ensure minority students and staff alike see their requests properly met.

The majority of black and Hispanic students attend high-poverty schools

Statistics from 2005 school year revealed that black and Hispanic students populate high-poverty schools more than any other minority. The National Center for Education Statistics considers "high-poverty schools," which are those with 75% or more attendees receiving free or reduced-price lunches. Forty-eight percent of black and 49% of Hispanic 4th graders hail from such desperately wanting institutions, while Asians and Pacific Islanders are more evenly distributed across economic demographics. 

Hispanic and black students are less likely to have internet access at home

Because of this, they adapt to classroom technology at a slower pace than their white, Asian and Native American peers. Twenty-six percent of Hispanic and 27% of black students use the internet at home, compared to 58% of Asian and 47% of Native American kids, resulting in a very unfortunate achievement gap. Numbers are improving, of course, but there’s still a ways to go before the gulf starts shrinking.

Schools with black or Hispanic majorities are more likely to hire underqualified or novice teachers

In fact, 25% of math educators at schools with 50% or more black students do not hold a degree or any other qualifications in the subjects they teach — probably the most egregious example. And once said teachers rack up the experience, they usually flee to more affluent (and white) areas. Such an unfortunate and enduring phenomenon plays a major role in perpetuating, if not outright widening, the achievement gap. Without knowledgeable, experienced and engaged teachers, students in affected schools typically lag behind and never receive the academic opportunities that should be afforded all youngsters. 

More black students repeat grades than any other racial or ethnic demographic

Both genders, too. In 2007, 25.6% of black males and 15.3% of black females between kindergarten and 12th grade had repeated at least one grade. These numbers, though, only reflect the issue as it relates to public school students. 

More black students receive suspensions and expulsions than any other racial or ethnic demographic

Between 6th and 12th grades, the 2007 school year saw 49.5% of black males and 34.7% of black females reporting that they had received at least one suspension in their academic careers. When it comes to expulsions, 16.6% of males and 8.2% of females said they had been dismissed from school at least once.

Hispanic teenagers have the highest pregnancy rate

In 2007, 81.7 out of every 1,000 Hispanic teenage girls gave birth — more than any other race or ethnicity. Across all demographics, however, the numbers are steadily decreasing.

This probably has something to do with improved sex education and easier access to necessary birth control devices, though the problem still requires considerable intervention. Especially since popping out babies as a high schooler is all trendy these days.

Clearly, until some of these problems are addressed, then it is likely that workforce diversity in the life sciences will continue to lag.

Until next time...

Good Luck and Good Job Hunting!!!!!

 

US Global Competitiveness Continues Its Downward Slide

The US is slipping and emerging markets are growing in competitiveness according to an annual list compiled by the World Economic Forum. Perhaps even more troubling is that the same group found that the US is lagging in the adoption of internet, computing and mobile communication technologies. After all, adopting of new technologies has been widely viewed as a means to improve competitiveness.

According to the report, the US, which topped the list in 2008, slid from number 4 last year to number 5. Surprisingly, for the third year in a row, Switzerland ranked first. The list is compiled by assessing 12 categories that include innovation, infrastructure and the world economy. The fact that many EU countries continue to improve in their ability to compete on a global scale, suggests that socialist-leaning governments may not be as bad as many free market US zealots would have you believe!

Singapore replaced Sweden for the number 2 position in this year’s list. Behind Sweden (no. 3), Finland was ranked fourth, and Germany was ranked sixth. Germany was followed by the Netherlands and Denmark. The UK was 10, France was 18th and China moved up one place to 26 this year. Among other major Asian economies, Japan ranked ninth and Hong Kong 11th

Among other major emerging economies, South Africa was 50th, Brazil 53rd, India 56th and Russia 66th.

The weaker performance of the US was attributed to economic vulnerabilities and low public trust in politicians and concerns about government inefficiency. The loss of US competitive coupled with fewer students opting for careers in science, technology, engineering and math (STEM) and poorer adoption rates of new technologies suggests that the US decline will continue.

Until next time...

Good Luck and Good Job Hunting!!!!

 

MedImmune to Stimulate Maryland Economy By Building A New Biomanufacturing Facility

Unlike many of its big pharma competitors which are shuttering US manufacturing facilities, MedImmune, the biologics division of London-based pharmaceutical giant AstraZeneca, Friday, opened a second bioproduction site in Frederick, MD.

The site which will employ 250 or more workers was constructed to manufacture MedImmune’s products including Synagis, a monoclonal antibody-based treatment against respiratory syncytial virus infections in high risk children.

The acquisition of MedImmune by AstraZeneca three years ago signaled the company’s commitment to increasing it biologics offerings in its historically-traditional small molecule drug pipeline. While the reasons for the company’s decision to build a second plant in Frederick aren’t entirely clear, it is great news for Maryland’s expanding commitment to biotechnology. There are approximately 350 biotechnology companies doing business in the state.

The addition of over 250 biotechnology and manufacturing jobs is certain to stimulate the Maryland economy; something that other big pharma companies have been reluctant to do. Investing in biomanufacturing is something that can help the US reinvigorate its moribund manufacturing sector. And, whether you believe it or not, the US is still second-to-none when it comes to manufacturing biologics and other biotechnology products.

Hat tip to MedImmune for the bold move!

Until next time...

Good Luck and Good Job Hunting!!! (try Maryland)

 

Jobseekers: Find New Jobs Through Entrepreneurship

There is no question that the US is lagging behind other nations in science, technology, engineering and math. While this may be troubling to some, Americans possess one skill that provides them with an unheralded advantage; that is entrepreneurship. Entrepreneurial skills cannot be easily taught or learned. And while most Americans don’t know it, entrepreneurship is a passively acquired trait that most non-Americans would “kill for.” Unfortunately, the recent recession and increasing global competition had dampened Americans entrepreneurial enthusiasm to the point where risk-adverse business behavior is threatening to stifle US innovation.

Peter Sims addresses this issue in a NY Times piece entitled “Daring To Stumble on the Road to Discovery” where he laments “...our education system emphasizes teaching and testing us about facts that are already known. There is much less focus on our ability to discover, create and reinvent.”

He contends that Americans can no longer expect that jobs will be waiting for them and that everyone needs to think about “inventing” their own jobs. While this may seem unlikely for many jobseekers, he offers the following to those who may be willing to try.

“INVENTION and discovery emanate from the ability to try seemingly wild possibilities; to feel comfortable being wrong before being right; to live in the world as a careful observer, open to different experiences; to play with ideas without prematurely judging oneself or others; to persist through difficulties; and to have a willingness to be misunderstood, sometimes for long periods, despite the conventional wisdom.”

Further he offers:

“All these abilities can be learned and developed, but doing so requires us to unlearn many of our tendencies toward linear planning and perfectionism.”

In other words, take risks and dare to be different. The worst thing that may is happen is that you fail. And, if you ask many successful people what contributed most to their success, they will likely tell you about their failures and how they helped them to “get it right” the next time.

Until next time...

Good Luck and Good Job Hunting!!!

 

FDA Approves a First-Ever Scorpion Sting Treatment: Who Knew?

While there is enormous unmet medical need out there, I never knew that the morbidity and mortality resulting from scorpion stings was so great. But, as the old adage goes; you learn something new everyday. To wit, the US Food and Drug administration earlier this week approved the first-ever treatment for scorpion stings.

According to a press release about the new product called Anascorp

 “Venomous scorpions (Centuroides) in the U.S. are mostly found in Arizona. Severe stings occur most frequently in infants and children, and can cause shortness of breath, fluid in the lungs, breathing problems, excess saliva, blurred vision, slurred speech, trouble swallowing, abnormal eye movements, muscle twitching, trouble walking, and other uncoordinated muscle movements. Untreated cases can be fatal.”

Anascorp, Centruroides (Scorpion) Immune F(ab’)2 (Equine) Injection, is made from the plasma of  horses immunized with scorpion venom. Anascorp may cause early or delayed allergic reactions in people sensitive to horse proteins.

FDA approval of Anascorp was based on results from a randomized, double-blind, placebo-controlled trial of 15 children with neurological signs of scorpion stings. The data showed that neurological symptoms resulting from scorpion stings resolved within four hours of treatment in the eight subjects who received Anascorp, but in only one of the seven participants who received the placebo. Of course, as is the case with ALL medications, the most common side effects were vomiting, fever, rash, nausea, itchiness, headache, runny nose, and muscle pain. In total, safety and efficacy data was collected from 1,534 patients in both open-label and blinded studies.

Anascorp was designated as an Orphan drug by FDA and received priority review. It is licensed to Rare Disease Therapeutics Inc., Franklin, TN, distributed by Accredo Health Group Inc., Memphis, TN, and manufactured by Instituto Bioclon, S.A. de C.V., of Tlalpan, Mexico, D.F.

Obviously, Anascorp is not likely to be a blockbuster product. But, if you are in the US Southwest and inadvertently are stung by an American scorpion you can rest assured that you will no longer have to worry about dying or suffering neurological damage. This news allows me to sleep better at night!

Until next time...

Good Luck and Be Careful Out There!!!!!!!

 

The Top 10 Foodborne Illness Outbreaks in the US

The recent E. coli 0104:H4 outbreak of gastroenteritis in Europe that sickened thousands and killed over 20 people was one of the largest foodborne disease outbreaks in the world (for the latest updates check out this article). This prompted my colleagues over at Onlinecertificateprograms.org to post an article entitled “10 Worst Food Contamination Outbreaks” that outlines the most serious foodborne illness to afflict the US.

Some of you may remember some of the more highly publicized ones including the “Jack in the Box” and “Sizzler” E. coli outbreaks in 1993 and 2000 respectively. While E. coli is still on everyone’s mind, the other usual suspects including Salmonella, Listeria and botulism are also featured!

 Here is the list! 

  1. Washington Packing Corporation, Botulism (1963): After two women died from botulism due to eating a bad can of A&P tuna packed by the Washington Packing Corporation, health authorities began investigating the company's foods, eventually discovering that the bad tuna had been shipped and stocked in major population centers throughout the Midwest. Wary consumers immediately stopped purchasing tuna, causing the then $277 million industry to suffer a 35% decrease in sales. The families of the two women were paid $226,500 by Washington, which was shut down after the incident.
  2. Skewer Inn Restaurant, Botulism (1983): Botulism struck again 20 years after Washington, resulting in one death. The oversight occurred at Peoria, Illinois' Skewer Inn, a popular restaurant located in the constantly-busy Northwoods Mall. Each victim ate beef patty-melts containing contaminated onions, later experiencing symptoms such as blurred vision, slurred speech, trouble breathing and paralysis. Overall, 28 people were hospitalized, 12 of whom required ventilatory support for varying periods of time.
  3. Jalisco Cheese, Listeria (1985): The deadliest food contamination outbreak in US history was caused by listeria, a bacteria found in sewage, soil, stream water and plants that manifests through fever, aches and diarrhea. Many of the 142 Southern Californians who fell ill from Jalisco's Mexican-style soft cheese suffered dire consequences — 48 died including 19 stillbirths and 10 infants. When an investigation was completed, the bacteria were traced back to poorly pasteurized milk used to make the cheese at an Artesia plant.
  4. Hillfarm Dairy, Salmonella (1985): Consumers would've been best-advised to avoid dairy products altogether in 1985. The Hillfarm Dairy debacle wasn't as severe as the Jalisco debacle, but it was far more widespread, as 16,284 cases of food poisoning due to salmonella were confirmed and possibly 200,000 cases altogether existed in the Midwest. Two deaths resulted, and as many as 12 may have occurred due to two batches of tainted milk produced in Melrose Park, Ill.
  5. Jack in the Box, E. coli (1993): Highly publicized and nearly catastrophic for Jack in the Box, the 1993 E. coli outbreak in the Pacific Northwest could've been prevented if the fast food chain had selected better meat, or at least cooked the contaminated meat at the right temperature. According to reports at the time, the patties eaten by the victims contained fecal matter and weren't cooked at 155 degrees Fahrenheit as mandated by Washington state law. Four children died and more than 700 others became sick, prompting the USDA to enforce stricter regulations, and Jack in the Box to overhaul its food safety procedures.
  6. Sizzler, E. coli (2000): One of the nation's largest steakhouse franchises experienced a crisis in 2000 when an E. coli O157:H7 outbreak in Milwaukee, Wis., originating from two restaurants in the area, sickened 65 people and killed a three-year-old girl. Health officials discovered that raw meat shipped from the Excel meat packing facility in Colorado came into contact with food eaten by the victims. According to Sizzler, it required all of its restaurants to cook beef entrees at the 160-degree temperature recommended by the US Food and Drug Administration.
  7. Pilgrim's Pride, Listeria (2002): At the time, it spurred the largest meat recall in US history. The listeria outbreak of fall 2002 ended with 46 illnesses, three miscarriages and the deaths of seven people, causing Pilgrim's Pride, then the second-largest poultry company in the US, to suspend operations at its Franconia, Pa. plant. From there, products were shipped to grocery stores, food service institutions and restaurants around the country, specifically affecting Connecticut, Delaware, Maryland, Michigan, New Jersey, New York, Ohio and Pennsylvania.
  8. Chi-Chi's restaurant, Hepatitis A (2003): Typically a problem suffered by residents of developing countries where personal hygiene standards are poor, a hepatitis A outbreak is a problem most Americans don't worry about facing. Thanks to a batch of green onions used in food at Chi-Chi's Mexican restaurant in Beaver, Pa., more than 660 people fell ill and four people died in the nation's worst outbreak of the infectious disease. Almost all of the victims contracted it by eating mild salsa and cheese dip, which contained raw onions that were traced to Mexico.
  9. Natural Selection Foods, E. coli (2006): Veggie eaters across America halted their consumption of spinach in late 2006, as reports surfaced that certain helpings were contaminated with E. coli O157:H7. In early fall, 199 people were infected in 26 states — 31 of whom suffered kidney failure — and three people died. At fault was a farm in San Benito County, Calif., where CDC investigators suspected irrigation that was possibly contaminated from cattle feces, originating from nearby Paicines Ranch, came into contact with spinach fields.
  10. Peppers and Tomatoes, Salmonellosis (2008): Jalapeno peppers, serrano peppers and tomatoes contributed to the 2008 United States salmonellosis outbreak, which proved difficult for the CDC to trace. Ultimately, investigators discovered the strain in irrigation water and serrano peppers originating from a packing facility in Nuevo Leon, Mexico and grower in Tamaulipas, Mexico. It infected 1,442 people in 42 states, with the most incidences occurring in Texas (384). At least one death was attributed to the outbreak.

Until next time...

 Good Luck and Good Eating!!!!!!!!

 

Are US Immigration Laws Really Hurting Life Science Innovation?

A report in Bloomberg News today suggested that Eli Lilly & Co. Chief Executive Officer John Lechleiter, PhD told a technology conference today that unfavorable US permanent resident (green card) laws are to blame for declining US innovation in the life sciences. With this in mind, Lechleiter plans on calling for US immigration officials to issue more green cards and adopt a shorter and simpler process for highly skilled foreign nationals to gain permanent residence in the US. According to Dr. Lechleiter, one of only a handful of big pharma CEO who is also a PhD-trained scientist, current green card regulations are so-called job killers and force many talented foreign nationals to return to their native countries to work with firms that directly compete with American life sciences companies. Unlike most of his peers, Lechleiter has been very outspoken about the lack of US life sciences innovation.

While Lechleiter comments may have been appropriate five or more years ago, they are no longer germane to America’s waning innovation in the life sciences. There is little doubt that many bright and talented foreign nationals were denied permanent residency during the Bush era (2000 to 2008) because of stringent immigration policies and limits on the numbers of green cards allotted for persons from certain parts of the world; mainly China, India and the Middle East. This, in turn, forced many life scientists—many of whom desperately wanted permanent residency in the US—to return to their home countries to look for work and gainful employment.

As Lechleiter rightly asserts, these scientists found work with companies that began to directly compete with US life sciences. This phenomenon, coupled with the rapid assent of the middle class in many of these nations, made it possible to begin to conduct Western style research at a much lower costs in these countries. To that end, by 2007, most big pharma companies—many of whom had dwindling pipelines and monstrous overhead costs—realized that it would be more cost effective to outsource or move R&D to countries with emerging pharmaceutical and biotechnology markets and a well trained R&D workforce. And, for the past four years downsizing and outsourcing of R&D are exactly what have been taking place at many American big pharma and biotechnology companies.

In my opinion, the larger question that must be addressed, as far as US innovation in the life sciences is concerned is: why are so few Americans willing to pursue scientific careers? To wit, the main reason why so many foreign life scientists were educated and trained in the US over the past 20 years was because there weren’t enough American students to fill the incoming roster at most American graduate training programs. Put simply, America’s growing lack of innovation in the life sciences over the past decade can be directly attributed to far fewer Americans pursuing scientific careers and an increased reliance on foreign nationals—who were unable to stay in the US—to innovate! While changing US immigration laws may allow some foreign nationals to more easily remain in the US, there simply aren’t enough life sciences jobs left in the US to make it worth their while! In fact, the likelihood of them finding life sciences jobs in their home countries is now greater than it is in the US. In my opinion, the only way to restore American innovation in the life sciences is to convince American students that pursuing scientific careers is worthwhile and that the requisite training for industry jobs is available to them.

Interestingly, after leading with changes to US immigration laws, Lechleiter also suggested that America’s innovation problem could be solved by lowering US corporate tax rates and American companies should not be forced to pay taxes on oversea earnings. Also, he asserted that the US Food and Drug Administration (FDA) should stop putting off decisions or erring on the side of avoiding risk when considering new drug applications. 

This begs the questions, how do lower taxes, no overseas taxes and expedited drug approvals help to spur American innovation when most life sciences R&D is conducted outside of the US?

Until next time...

Good Luck and Good Innovating!!!!!!!!

 

Why Store the Smallpox Virus?

Vincent Racaniello, author of the award-winning Virology Blog and  a BioCrowd co-founder wrote in a recent post about the upcoming vote on whether or not to destroy the last remaining smallpox virus stockpiles in the world:

"After the eradication of smallpox in 1980, the World Health Organization called for destruction of known remaining stocks of the virus. The United States and Russia, which hold the known stocks of smallpox virus, have not destroyed their stocks. The WHO met in January 2011 to debate the future of smallpox, and a committee will issue a final recommendation sometime this year. For further information on this topic, there is an editorial in Vaccine entitled “Why not destroy remaining smallpox virus stocks“, and a WHO review on smallpox research."

For those of you less science-minded BioJobBlog readers (or those who prefer visual learning) I added a CNN video on the topic.

So what do you think?  Should the remaining American and Russian smallpox stockpiles be destroyed or saved?  You can weigh in on the topic by visiting Vincent's blog and voting!

Until next time...

Good Luck and Good Job Hunting!!!

Is There a Glut of Life Sciences PhDs? A Commentary

Last week’s special issue of Nature Magazine “The Future of PhDs” contains no fewer than six independently written articles assessing the value, importance worth etc of a PhD degree in the life sciences. All of the articles are extremely well written and insightful. The opinions of the authors range from maintaining the status quo to questioning whether a PhD degree is important for life scientists to completely revamping the requirements to obtain the degree. While I think that Nature’s decision to devote an entire special issue to problems facing PhD students and postdoctoral fellows is courageous and laudable, I can not help but ask “What took you so long?” That said, there is no questions that the proverbial “cat is out of the bag”—there was an article in last Friday’s USA Today which means that the American public (maybe) is now aware of the “problem.” Rather than immediately react to the plethora of posts, LinkedIn discussions and comments from bloggers and recruiters, I decided to take some time to organize my thoughts and offer some of my own insights and ideas about the issue.

For the past seven years, I, along with a few fellow career development experts, have been outspoken about the diminishing career and job prospects for PhD-trained life scientists. Like the authors of the recent Nature papers, we had determined in the early 2000s that career opportunities and job prospects for life sciences PhDs and postdoctoral fellows were rapidly declining in both academia and industry. And, more important, that there was an emerging “glut” of life sciences PhDs (mainly basic researchers) on the job market. Not surprisingly, many of the hundreds of graduate students and postdoctoral scientists—who we counseled during career development sessions at various national scientific meetings—were finding it increasingly difficult or nearly impossible to find jobs in their chosen fields of endeavors. While we were able to advise them on how to write a better resume/CV or provide them with alternate career options, we all knew that their prospects for gainful employment were severely limited. I cannot tell you how difficult and emotionally-wrenching it is to tell extremely talented graduate students and postdoctoral scientists that their prospects for gainful employment are bleak.

Yet, despite a rapidly deteriorating job market and our best efforts to alert those “in charge,” graduate training programs recklessly continue to annually “mint” as many new PhDs as possible. While the reasons for this are obvious—graduate students and postdoctoral scientists are sources of “cheap and reliable labor”— the conscious decision to continue to produce as many PhDs as possible flies in the face of basic supply and demand economics. While I can go on and on with finger pointing and assessing blame, it is not productive or helpful; nor will it help to solve the bleak employment prospects facing many PhD-trained life scientists. However, there are a few strategies that, if appropriately implemented, can help to improve the job prospects for graduate students and postdoctoral scientists.

First, graduate and postdoctoral programs could create career development programs and experiences for their students and postdocs. These programs could include seminars on alternate career options, job counseling, resume writing and interviewing clinics, internship opportunities and even annual career fairs at attended by local or national prospective employers. While many PIs will complain that this will take graduate students and postdocs out of the laboratory and impede their progress, I submit that career development activities will reduce stress and anxiety and allow persons to develop a career plan or roadmap. This, in turn, will allow them to establish goals better budget/manage their time and be more productive in the lab. Moreover, it will likely shorten the time to earn a PhD degree which will provide PIs with more employee turnover and allow them to take larger numbers of new students into their labs.

Second, training programs ought to develop and formalize alternate career tracks for their graduate students and postdocs. For example, if a student is interested in medical writing rather than a traditional academic research career he/she ought to be encouraged to take some medical writing courses or be allowed to do a medical writing internship as part of their training. If a student is interested in business, then it may make sense for the student to be able to take business courses or enroll in an online biotechnology training programs. In fact, several institutions now offer a joint PhD/MBA degree option. The bottom line here is that providing students and postdocs with alternate exit strategies will incentivize them to be more productive so that they can “get on with their careers.”

Finally, and perhaps most importantly, graduate training programs need to limit the number of PhDs that they train and produce. This means, admitting fewer graduate students each year until the demand for PhDs begins to rise again. While this is the easiest and most cost effective solution to the problem, I suspect that it is the one that will meet with most resistance and objections. After all, fewer graduate students means fewer postdoctoral scientists which translates into fewer bodies to do the research necessary to win grants and publish peer-reviewed papers. However, it is important to note that the increasingly competitive and challenging job market for life scientists has already taken a toll on US preparedness in science and engineering. To that end, fewer American undergraduate students are majoring in the life sciences than ever before. In fact, the most popular undergraduate major in the US today is business. Further, over the past 20 years or so, fewer American students have entered graduate school in the life sciences. A quick perusal of the rosters of graduate students and postdoctoral scientists at almost any major US research institution will reveal that a majority are foreign born nationals! New research reveals that many US-trained foreign nationals are going back to their home countries to work and in many instances, compete with American life sciences companies.

There is no longer any question that “something” must be done to improve the career and employment prospects for American life scientists. Regardless of the solution, it will likely be painful. However, this is no longer a problem that can easily be “swept under the rug” or consciously ignored by the “powers at be.” Failure to adequately and seriously address the issue may not only have serious consequences for the current American life sciences training paradigm (don’t be surprised when academic tenure is eliminated) but also may affect the future competitiveness and economic well-being of the US.

Until next time...

Good Luck and Good Job Hunting!!!!!

 

Careers: The Ten Fastest Growing Fields?

I am not a big fan of top ten lists but I decided to take a look at the list compiled by Cecilia Capuzzi Simon in a recent article that appeared in the April 13, 2011 New Times Education supplement. Entitled “Top Ten List: Where the Jobs Are.” The article was extremely well written and based on the Bureau of Labor Statistics’ list of the fastest-growing occupations. 

The Bureau gleefully announced that it expects there to more than a million new jobs by 2018, and a “worker pool that may not be trained to fill them.” While this may seemingly appear to be great news—given the almost 10 percent unemployment rate that has been plaguing the US for the past three years—I was puzzled by appearance of biomedical engineering (#1), medical scientists (#6) and biochemists and biophysicists (#9) on the lists mainly because I know that persons who are trained in these fields are having extremely difficult times finding jobs in the current economy. That said, with most life science R&D being shipped over seas or outsourced, it hard to see that any of these jobs will be in great demand in the US over the next seven years. Maybe the bureau knows something that I don’t? Or maybe, it is the US government’s way of gently nudging people into careers that they anticipate will be highly valued in the future? Whatever the reason, it is going to be tough to convince college freshman to major in these fields if the current job market for these professions is currently so bleak.

What is even more puzzling then the ranking of these three career choices list is the actually numbers of new jobs that are anticipated to be created. The total number of new jobs expected in these fields by 2018 is roughly 65,000 (biomedical engineers-12,000; medical scientists-44,000; and biochemists and biophysicists-9,000). Compare this with the number of jobs anticipated by 2018 for network systems and data communication analysts (156,000), home health aide (461,000), personal and home care aide (376,000) or physician assistants (29,000) and you will get a better idea about the urgency for biomedical engineers and other life scientists.

There is no question that life scientists will command higher salaries and wages than home health aids or possibly a physician’s assistant but life sciences jobs typically require a minimum of a MS or PhD degree. Moreover, the economic theory of supply and demand suggests that it will be much easier for healthcare informaticists or home healthcare aides to find a job as compared with a biomedical engineer or PhD biochemist—even by 2018. In other words, don’t expect the US job market for life scientists to get better any time soon. 

While it is unfortunate that the US is beginning to seriously lag behind much smaller countries in science, math and engineering preparedness, the current demand for these types of jobs is waning and undergraduate college students—who lived through the recent financial meltdown—will likely (and rightly) choose to pursue careers where the likelihood of future employment is greatest. Unfortunately, the life sciences isn’t one of them.

Until next time...

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

 

Pharmaceutical R&D Continues Its Eastward Migration

For the past three years or so, Eli Lilly CEO John Lechleiter has publicly criticized America’s lack of math, science and engineering preparedness. Further, he has lamented that this lack of preparedness has resulted in a lack of innovation and that it threatens the US standing as a leader in the pharmaceutical and biotechnology industries. Finally, Lechleiter squarely places the blame on American science educators. 

Therefore, it came as somewhat of surprise to me when I learned that Lilly (and many other pharmaceutical companies) are outsourcing an increasing amounts of drug discovery and development to Chinese contract research organizations (CROs pharma companies continue to outsource drug R&D to ostensibly lower development costs and get drugs to market faster. According to Chuan “Joe” Shih, a former Eli Lilly employee of 25 years and executive vice president of integrated drug discovery at Crown Bioscience a Shanghai-based CRO, the total annual cost for one researcher at Lilly might run $300,000 to $350,000 a year. The figure at Crown is one-third of that. Shih also disclosed that Pfizer was one of Crown’s clients.

In addition to Crown, Eli Lilly has outsourced R&D to other Chinese CROs that includeWuXi AppTec and ChemExplorer. It also operates its own research-and-development center in Shanghai and is building a diabetes research center here. Like Lilly, big pharma companies like Roche, Novartis and others have also established research centers in China.

Some analysts contend that the reasons given for the current R&D outsourcing trends—lower costs and faster market times—are red herrings. They suggest that establishing R&D in China helps position companies to sell into the huge, emerging Chinese market. Within the next decade or so, the Chinese market may eclipse the US as the major pharmaceutical market in the world.

Interestingly, in an interview in Shanghai Lilly’s Lechleiter said that he believed that CROs in China have more to offer than cost savings. “The skill level and the quality and the increasing availability of high-skilled and high-quality operations in the contract-research space render these firms globally competitive,” he said. Further, he added that in recent years, Lilly has had difficulty getting green cards or permanent resident visas for some of the Chinese people graduating from American universities it wants to hire. “So we need to follow the talent, and I expect there will be people recruited to the U.S. who will want to stay in the U.S. And there will be Chinese people and others who want to come back here. Our research center in Shanghai gives them a place to land.”

Does this mean that Lechleiter has given up on his quest to improve American science preparedness and American innovation? And, what will become of the 100,000 or so American pharmaceutical scientists who were laid off in recent years or those new minted American PhDs who cannot find work in the US? Is that the fault of the American education system or pharmaceutical companies that are trying to maintain profit margins at any cost or improving the likelihood of success in emerging markets in developing nations?

Until next time…

Good Look and Good Job Hunting (try the BRIC countries)

 

More M&A in the Life Sciences Sector: Valeant Pharmaceuticals Attempts Hostile Takeover of Cephalon

It seems like hostile takeover bids in the life sciences industry may be de rigueur (how can anyone forget the Sanofi-Aventis/Genzyme hostile takeover saga that dragged on for almost a year). Interestingly, there have been 219 acquisitions of U.S. pharmaceutical companies in the past 12 months, with an average disclosed price of $153.7 million and an average premium of 44 percent!

Late yesterday, Valeant Pharmaceuticals announced plans for a hostile takeover bid for Cephalon, a 24 year old Pennsylvania-based biopharmaceutical company with eight products on the US market and more than 100 products worldwide. The takeover bid became “hostile” after Cephalon’s management team rejected earlier proposals.

Cephalon’s main focus is on nervous system disorders, pain and cancers. It is one of the world’s top 10 and most profitable biopharmaceutical companies. The company had revenues of $2.81 billion last year from sales of its narcolepsy treatment Provigil ($1.2 billion) and its leukemia treatment Treanda ($393 million). Also, according to the Cephalon website, there are several oncology products (lung, melanoma and solid tumors) in its development pipeline. In 2010 Cephalon announced seven acquisitions many of which were intended to bolster its oncology expertise.

Valeant Pharmaceuticals International, long a struggling speciality pharma company, merged with Biovail Corporation late last year and re-emerged as a re-invented company with substantial financial resources at its disposal. Prior to the Biovail merger, Valeant had a long history of acquiring smaller companies to bolster its R&D capability and its flagging drug development pipeline. The new company specializes in neurology and dermatology and has a diverse product portfolio that consists of branded pharmaceuticals, branded generics and over-the-counter medicines. In 2009, its revenues were $1.65 billion and 2010 revenues (to be released) are likely to exceed $2.0 billion. 

According to Bloomberg News, Valeant has offered to buy Cephalon for $5.7 billion in cash. Under terms of the offer, Valeant would pay $73 a share in cash; a 24 percent premium on Cephalon’s Tuesday closing stock price or a 29 percent premium to company’s 30 day trading average. Not surprisingly Cephalon executives summarily rejected the offer as “too low.” Several financial analysts concur with Cephalon and contend that the $73 per share cash offer undervalues the company’s true worth. Valeant and Cephalon are main competitors in the oncology and neurology markets.

Unlike the Sanofi/Genzyme bid, where it was clear at the outset to most observers that Sanofi would ultimately prevail, it isn’t clear whether or not Valeant will be successful in its attempt for Cephalon. While Cephalon has had its share of trouble with FDA over the past few years (for a variety of infractions including off-label marketing of Provigil), the company is in much better shape than Genzyme and the current management team has more resources at its disposable to ward off Valeant’s hostile takeover bid.

The downside of a Valeant-Cephalon merger would be job loss for many current Cephalon employees. This is because Valeant’s bid for Cephalon appears to be a “pipeline grab” rather than an R&D play. Typically, these types of acquisitions result in reorganization and downsizing of personnel because of duplication of effort. Only time will tell if Valeant will prevail.

Stay tuned for more late breaking news!

Until next time...

Good Luck and Good Job Hunting!!!

 

Sales of Medical Marijuana Reported to Rival Those of Viagra: Who Knew?

Can getting high be more important than sex? Probably not if you are in your teens or early 20s, but if you are of  an age where managing the nausea associated with cancer chemotherapy or the pain of glaucoma then medical marijuana is likely to be more important than the need for sex! But, to be fair, despite the title of this post, Viagra will lose patent protection shortly (in some places it already has) and the drugs sales have been shrinking. Nevertheless, a report authored by See Change LLC, a Colorado company that provides investment advice to businesses found that the sale of  that medical marijuana has already reached $1.7 billion (in states where it is legal) as compared with annual Viagra sales of $1.9 billion!  

Unfortunately, See Change LLC is charging $1,150 for the report. And since I don't have the money to purchase  it, I cannot determine the veracity or accuracy of the report. But, according to comments made by the editor of the report roughly 1 in 4 Americans lives in a state in which medical marijuana is legal, and that nearly 25 million people in those states have medical problems for which the drug can be prescribed. The report suggests that medical marijuana sales will reach $8.9 billion in five years.

Despite repeated scientific findings that medical marijuana can be used to effectively treat a variety of clinical indications that include chronic pain, nausea and anxiety, the myth of marijuana as a gateway drug to more serious drug like cocaine, heroin and others has been indelibly burned into the American psyche—not withstanding the statistics that show that prescription drugs like OcyContin, fentanyl and methamphetamine are the most abused drugs in America.  

While marijuana hasn’t been a part of my life for over 35 years, there is no question that it has enormous therapeutic value and ought to be legally prescribed when appropriate. In my opinion, the only thing that is preventing marijuana from being legalized is a business model that allows corporate America and the US government to maximize profits  from sale of the "deadly weed." 

 

 

It is time for Americans to forever expunge the "unbridled horrors" of Refer Madness from their collective psyches!

Until next time...

Good Luck and Good Job Hunting (be careful out there)

 

The "Thing" About Scientists

Let’s face it; most scientists are lousy communicators. While this is not an inherited defect, the poor communication skills exhibited by most scientists are a direct result of a lack of emphasis placed on oral and written communication skills during their training. In fact, being a “good communicator” may actually hinder a scientist’s success as a world class researcher. After all, prematurely divulging information or breakthroughs may result in being “scooped by the competition” both in terms of winning grant monies and publishing first. Consequently, from a Darwinian standpoint, good communications skills are a trait that may actually be selected against because they more than likely will reduce the overall competitiveness and “fitness” of most research scientists.

Deborah Blum a Pulitzer-Prize winning science writer and journalist at the University of Wisconsin-Madison and author of the blog Speakeasy Science nicely summed up the consequences of poor communication skills among scientists in a blog post entitled “The Trouble with Scientists:”

“Real” scientists share their work only with each other and do not attempt to become “popularizers” because that would lead to “dumbing down” the research.

She further asserts that this attitude has seriously compromised the lay public’s understanding of science.

"Scientists won’t talk to journalists; they don’t want to waste their time “dumbing it down”; they don’t see it as “making us smarter.” So, many of the good stories in science don’t get covered at all. Or the stories get covered only for an already science-literate audience – explored in publications like Discover or Science News – rather than for that far larger group, the science disenfranchised."

And, while many politicians and scientists loudly complain about the lack of science awareness and literacy in America Blum astutely asserts:

“Science writers, journalists, broadcasters and bloggers became the voice of science during a time during which too many scientists simply refused to engage. Scientists have ceded that position of power amazingly readily; ask yourselves how many research associations offer awards to journalists for communicating about science but none to their own members for doing the same. Ask yourself how the culture of science responds even today to researchers who become popular authors or bloggers, public figures. Whether young scientists are rewarding for spending time on public communication? And ask yourself how hypocritical this is, to complain that the general public doesn’t understand science while refusing to participate in changing that problem?”

Not withstanding the negative impact that poor communication skills have on the public’s understanding of science, good oral and written communication skills are now critically important for those scientists seeking jobs outside of academia. Poor communication skills are no longer tolerated outside of the ivory tower! A quick perusal of ads for non-academic science jobs reveals that “outstanding oral and written communication skills” are second only to technical skills for prospective new hires. Finally, the meteoric rise of social media suggests that communication—whether virtual or real —is critically important to most human beings (Facebook and Twitter as selective pressures?—go figure!). For those scientists who disagree with me, think about what I just said the next time that you are perusing your Facebook page, LinkedIn profile or getting ready to send your next tweet!

Unfortunately, I was trained by a generation of scientists who—as Blum put it—“hate-to-share!” Somehow, I managed to overcome it. Nevertheless, despite changing attitudes about the importance of good communication skills, the hate-to-share attitude is still pervasive in most graduate and postdoctoral training programs today. Sadly, this attitude is no longer sustainable in a world of diminishing grant monies, lousy job markets and increasing global competition. Unless this attitude changes, fewer and fewer scientists will be successful in their chosen field of endeavor!

Hat tip to Deborah Blum @ for the insights and words!

Until next time....

Good Luck and Good Communicating

 

Decline in High School Student Participation at Science Fairs: The Obama Administration Responds!

The recent article published in the NY Times about the decline of high school student participation in science fairs resulted in many letters to the editor. Many of them were from concerned citizens and a few were from university researchers decrying the lack of government funding for research and the funding of sports over science programs. Another railed against the Bush’s Administration’s poorly crafted and ill-advised No Child Left Behind Act. However, there was one letter that surprised me. It was written by John P. Holdren, President Obama’s science and technology adviser (see below)

To the Editor:

Your article points to deep budget challenges that many school districts are facing and problems with the Bush administration’s No Child Left Behind law.

But it does not mention much of the Obama administration’s extraordinary agenda for improving science, technology, engineering and mathematics (STEM) education in this country: for example, the commitment to prepare 100,000 new math and science teachers over the next 10 years, the $4 billion Race to the Top program’s support for innovation in teaching these important subjects, and the administration’s blueprint for updating the Elementary and Secondary Education Act this year.

Recognizing that government alone cannot be the answer, moreover, the president has also called upon the business community, foundations, professional societies and others to do more. Already, the president’s “Educate to Innovate” campaign has attracted more than $700 million in nongovernmental financial and in-kind support for science and math programs.

And more than 100 chief executives have responded to the president’s “all hands on deck” call to action by launching “Change the Equation,” an unprecedented program to scale up effective models for improving STEM education.

John P. Holdren
Washington, Feb. 7, 2011

The writer is President Obama’s science and technology adviser.

What surprised me about the letter is that it took an article critical of the Obama Administration’s commitment to science education to provide the American public (at least part of it) with some insight into the government’s recognition of the problem and steps that it is taking to help to correct it. Perhaps the Obama administration needs to be a bit more proactive and publicly-vocal about its plans to improve American STEM education. This would go a long way to assuage some of the concerns about America's waning global competitiveness in science and technology.

Like Dr. Holdren, I believe that government alone cannot be the answer and American corporations must get actively involved by providing ideas on how to improve American science education and the financial support to implement them. While the CEO-endorsed program “Change the Equation” sounds great on paper, it is time for those CEOs to actually step up and do something about the problem. Many of these same CEOs have been complaining for decades about the lack of STEM preparedness of the American workforce. As somebody once said “Talk is cheap and actions speak louder than words!”

Until next time...

Good Luck and Good Teaching!!!!

 

Participation in High School Science Fairs Declines As The President Acknowledges American Science Competitiveness is At An All Time Low

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!!!!!!!

 

Science, Innovation and the Future of the America

I know that I have been blogging a lot lately about science and it importance in American innovation and global competitiveness. And, not surprisingly, some of you may be sick of hearing me drone on about it! But, if you want to get another perspective on the critical role that science plays in the lives of everyday Americans, you absolutely must read Tyler Cowen’s article in this Sunday’s NY Times Business Section entitled “Innovation Is Doing Little for Incomes.”

Cowen, a Professor of economics at George Mason University and a regular contributor to the NY Times, astutely points out the impact scientific innovations have had on economic growth and perhaps, more importantly on the median incomes of Americans over the past 65 years. He points out that from 1947 to 1973—a period of just 26 years—inflation-adjusted median income for Americans more than doubled. But, in the 31 years from 1973 to 2004, median income grew only 22 percent. And, over the last 7 years it actually declined! 

In the article, Cowen asserts that the lack of income growth in recent years can be attributed to the ongoing dearth of truly game-changing technological innovations. Sure, there are computer, the Internet and wireless technologies but as Cowen points out these innovations have not markedly changed the lives of Americans as much as “electricity, the automobile, flush toilets, antibiotics and small household appliances.” While the latter advances impacted ALL Americans, the former have mostly had an effect on the well-educated, curious and often more economically well off. And, while these technologies have yielded measurable monetary gains, they often have been concentrated among a small number of company founders. Put simply, recent innovations have not been “game changers” for the economic well being of most Americans!

So what are we to do about this troubling trend? Cowen rightly suggests that:

“Science should be encouraged with subsidies for basic research, as well as private charity, educational reform, a business culture geared toward commercializing inventions, and greater public appreciation for the scientific endeavor. A lighter legal and regulatory hand could ease the path of future innovations.”

Further, he contends that:

“Sooner or later, new technological revolutions will occur, perhaps in the biosciences, through genome sequencing, or in energy production, through viable solar power, for example. But these transformations won’t come overnight, and we’ll have to make do in the meantime. Instead of facing up to this scarcity, politicians promote tax cuts and income redistribution policies to benefit favored constituencies. Yet these are one-off adjustments and, over time, they cannot undo the slower rate of growth in average living standards.” In other words, it is time for the US to seriously address its waning proficiency in science technology, engineering and math. "

To that end, he states that:

“Until science has a greater impact again on average daily living standards, the political problem will be in learning to live within our means. Because neither major party seems to support a plausible path to fiscal balance, or to acknowledge how little control politicians actually have over future income growth, we unscientifically keep living in an age of denial.”

Call me crazy, but what Cowen says makes complete sense to me!

Until next time...

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

 

Employment Update: Who Is Hiring and Who Is Not!

While US unemployment continues to hover around 9.4 percent, there appears to be a steady increase in the number of companies that are posting ads on job boards like Simply Hired and Indeed.com. According to an article in the NY Times “A Sign of Hope for More Hiring” job postings at Simple Hired roe over 50 percent last year over 2009 and increased almost 70 percent in December 2010 as compared with December 2009.

The situation at Indeed.com, a major competitor of Simply Hired, appears to be similar. That is, there has been a substantial and continual increase in the number companies posting jobs on the Indeed.com website.

However, while this is great news, it isn’t exactly clear what the increased job postings mean. For example, some industries are hiring at a greater rate than others (see below).

Not surprisingly, the greatest increases are occurring in some of the industries that were hit hardest by the recession, e.g. transportation, automotive, legal, manufacturing and financial services. Hiring in healthcare, technology and education remains steady and respectable. On the other hand, two industries that have actually lost ground are media and the military. For a more comprehensive analysis check out the white paper on 2010 Employment Trends created by Simply Hired. Although things look like they may be picking up, the sad reality is that workers who have been unemployed for months have a much harder time landing new jobs as compared with those who have been unemployed for weeks. Unfortunately, many of the workers that make up the 9.4 percent unemployed, have been out of work for six months or more. Further, the availability of jobs will vary by industry and perhaps more importantly geography. Data from Simply Hired suggests that employment opportunities are greater in Washington, D.C, Baltimore, Boston, Milwaukee, Minneapolis/St Paul, San Francisco and Denver as compared with Miami, Detroit, Sacramento and LA. The availability of healthcare jobs appears to be greatest in San Francisco and San Antonio. Interestingly, many of the new job postings are coming from smaller companies rather than those that constitute the Fortune 500 list. This means that former corporate employees may want to focus their job searches on smaller companies rather than continue to seek employment at big name companies.

Despite these encouraging and optimistic signs, the road ahead for most R&D scientists and pharmaceutical sales reps looks pretty bleak. That said, now may be a good time to consider alternate career options or possibly going back to school for retraining. To that end, data from Indeed.com suggests that learning HTML 5, the new, highly anticipated Web development language which may make Flash obsolete, may be the ticket to guaranteed employment. Knowledge of HTML 5 in addition to experience with mobile apps, the Android operating system and Twitter skills that are highly coveted by employers in many industries. Finally, if more school or retraining is not in your future, you may want to consider switching industries, moving to a different type of job in your discipline or, if possible, relocating!

Until next time...

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

 

Promoting Science Literacy Among Undergraduate Humanities Students One Student At A Time

In 2005, The National Academy of Sciences issued a worrisome report entitled “Rising above the Gathering Storm: Energizing and Employing America for a Brighter Economic Future” that warned that America is slipping in competitiveness in all areas of science.

While this ought to have been a wake-up call for all Americans, in 2010, the Academy issued an update entitled “Rising above the Gathering Storm: Approaching Category 5." Not surprisingly, the findings in the update indicate that the US is still lagging in its capacity to innovate and compete and that the trend continues to move in a downward direction. For example, in 2006 (the most recent year for which data are available) 16 percent of American college students received undergraduate degrees in natural sciences or engineering as compared with 47 percent in China, 38 percent in Korea and 27 percent in France. Recommendations in the original report called for creation of 25, 000 undergraduate scholarships per year in math, science and engineering. Although the updated report indicated that Congress had taken some steps to implement the recommendation, progress has been severely lacking in this area.

Almost all US colleges and universities require that undergraduate students have some instruction in science. Unfortunately, most of these courses are lecture driven and lack a laboratory component (mainly because laboratory instruction is costly and time intensive). This is problematic because science is a laboratory driven discipline that requires data collection and analysis; neither of which is taught in most lecture settings. Recognizing the growing lack of science literacy among American undergraduate students, Leon Botstein—music director and conductor of the American Symphony Orchestra and President of Bard College an artsy liberal arts college in NY—decided to do something about it. To that end, he created a program at Bard called Citizen Science; a mandatory science course conducted during winter break that all Bard freshmen are required to take for graduation.

Citizen Science is a two and a half week long program in which students spend six hours per day immersed in laboratory science. The 2011 program taken by 480 students focused on the molecular biology of infectious diseases. Using laboratory equipment, computer modeling and classroom discussions, student explored various aspects of infectious disease research including bacterial and viral detection, creation of vaccines and techniques that can be used to manage global disease outbreaks. The students were taught by two dozen scientists who were recruited from all over the country. There are no grades or credits received by program participants. This was done to promote learning for learning sake according to Brooke Jude an assistant professor of biology and the director of Citizen Science.

Botstein, who incidentally is the brother of David Botstein a world renowned geneticist at Princeton University, has been an outspoken critic about deficiencies in American education. He previously has taken many of his colleagues to task for “shirking their responsibility to create a well-rounded citizenry.” Botstein, with help from his brother, decided to “put his money where is mouth is” by creating Citizen Science. 

According to Botstein, “The most terrifying problem in American university education is the profound lack of scientific literacy for the people we give diplomas to who are not scientists or engineers.” He added, “The hidden Achilles’ heel is that while we’ve found ways to educate scientists in the humanities, the reverse has never really happened. Everybody knows this, but nobody wants to do anything about it.”

Not surprisingly, the Citizen Science Program has received mixed reviews from the 480 Bard freshmen who participated in the inaugural program. After all, a majority of the students who chose to attend Bard have a decided bent toward music and the arts, not science. Nevertheless, many students suggested that their two and half week scientific sojourn has taught them to think more critically about science. Next year’s theme for the Citizen Science program may be energy or climate change.

While Bard’s Citizen Science program is a fantastic idea, not all colleges or universities have the financial largess or scientific connections necessary to create similar programs at their institutions. Perhaps Congress ought to establish funding mechanisms (in addition to the 25,000 math and science scholarships each year) for post secondary institutions interested in replicating the Bard program.

Government officials can no longer deny what the data are showing them; science literacy in the US is plummeting and we are REALLY at risk of losing our competitive and innovative edges in math, engineering and science. Put simply, it is no longer a question of “if” but “when.”

Until next time....

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

 

Merck Gets Serious About Biosimilars

Two years ago Merck formed a new division called BioVentures ostensibly to develop and manufacture biosimilar drugs. Interestingly, the announcement preceded creation of a regulatory approval pathway for biosimilars in the US.  While the approval pathway still isn’t in place, many regulatory experts expect the US government to issue the guidelines by mid-2011 after a meeting that was held on biosimilars by the US Food and Drug Administration last month.

Late last year, the company scuttled its plan to develop a PEGylated version of EPO which was to be its first so-called biosimilar. Unfortunately, PEG-EPO would not be allowed to be approved as a biosimilar via any existing or newly divined pathway because it is actually a new molecular entity and, therefore, would require numerous clinical trials to garner regulatory approval (maybe that is why Merck canceled development).

Nevertheless, Merck expects to have no fewer than 5 biosimilar molecules in clinical development by 2012. To that end, Merck  that it had created an alliance with Parexel International Corp—a global clinical research organization—to help to conduct the clinical trials necessary for regulatory approval of the biosimilars that Merck is developing. The financial terms of the deal were not disclosed.

Michael Kamarck, President of Merck BioVentures, declined to specify the products but did mention that the terms of the deal terms were intended to “motivate Parexel to enroll patients quickly and generally execute the clinical trials in a speedy fashion.” He also noted that the Parexcel deal is only “one of an number of strategic steps: that Merck is pursuing in the biosimilar field.

Let’s see whether or not Merck can meet the lofty goals that it has set for itself. Hopefully biosimilar legislation will be in place by 2012!

Until next time....

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

 

WikiLeaks, Pharma Manufacturing and US National Security

Ed Silverman, author of the fabulous Pharmalot Blog, showed his investigative reporting bona fides by revealing today that there may be a direct link between pharma manufacturing facilities, US national security and the brouhaha over WikiLeaks.

Ed uncovered a cable dated Feb. 18, 2009 from the US Secretary of State to all overseas diplomats that stated pharma facilities are vital to US national security and that “losing these facilities could critically impact the public health, economic security, and/or national and homeland security of the United States.”

The cable stressed that these facilities produce insulin, a variety of vaccines that protect against potentially devastating infectious agents and other medications and a vital part of the US National Infrastructure Protection Program. According to Ed’s post, the facilities mentioned in the cable are located all over the world and included companies such as Baxter, GlaxoSmithKline, Novo Nordisk, Sanofi-Aventis, Genzyme, Novartis, IDT Biologika, Vetter Pharma, Roche, CSL Behring and Grifols. Interestingly, only two of the companies mentioned, Baxter and Genzyme, are US-owned companies. Go figure!!!!!!!

Until next time...

Good Luck and Be Alert (you never know who may be watching)

 

Why American Math and Science Education is Failing

Sunday marks the beginning of “American Education Week”, the observance which was started back in 1921. It was created by the National Education Association (NEA) and other groups because 25% of World War I draftees were illiterate.

While a lot has change in the US since 1921 and the literacy rate has drastically improved, the quality of the American education system, especially in math and science, continues to be suspect and in many instances is failing its citizens. Much of this failure is rooted in skyrocketing college tuition costs which prevents many Americans access to an adequate post secondary education. 

Most politicians contend that education costs are too high and spending on education must be capped. However a quick look at some facts (provided by an article in USA Today written by its founder Al Neuharth) paints a much different picture

  • Families are spending an average of $64 billion annually to send 13.9 million students to public colleges and universities
  • For the past 10 years, the US has spent $1.1 trillion per year on wars in Iraq and Afghanistan; an annual average of more than $110 billion

As Mr. Neuharth aptly points out: $64 billion annually for higher education versus $110 billion per year for wars!

Is it any wonder that American students continue to lag in science and math preparedness as compared with much smaller countries where higher education is free or heavily subsidized by their respective governments? Think about this the next time you hear politicians and conservative talk show hosts about America’s dwindling competitiveness in math and science.

Until next time…

Good Luck and Good Job Hunting!!!!

 

Why For-Profit Post Secondary Education Companies May Bankrupt America

While I believe that tenure ought to be abolished and the cost of a college education is way too high these days, I cannot fault non-profit post secondary educational institutions for the job that they do educating students and preparing them for life. Most do a pretty good job despite the outrageous price tag.

Because of the recession and high unemployment, many displaced workers have chosen to “go back to school.” This has resulted in a booming business for many for-profit post secondary education companies. Because there are no perquisites at many of these schools, the main criterion for admission is the ability to pay tuition and fees. Not surprisingly, the quality of the education at many of these institutions is somewhat deficient and the attrition rates are exceedingly high. More egregiously, however, is the little known fact that much of the financial aid available to low income and minority college students is “eaten up” by for-profit education companies. And ironically, the tuition to earn certificate or associate degrees at these schools is 4-5 times higher than that required to earn comparable degrees at local community colleges.

Admittedly, I don’t think near enough about for-profit secondary education companies and their impact on students. However, my eyes were recently opened, after reading an article entitled “Degrees of Debt" by Jeremy Dehn; a journeyman adjunct instructor who works at both non-profit and for profit post secondary education institutions. Because he works at both non- and for-profit institutions he is in a unique position to compare the two educational experiences. This is a MUST READ article.

The notion that education can be accurately and adequately delivered based on the free enterprise system and unbridled capitalism is bogus. While non-profit education institutions leave a lot to be desired, relying for-profit companies (and prevailing market trends) to educate Americans is certain to continue to diminish American competitiveness on the world stage.

Until next time...

Good Luck and Good Job Hunting!!!!!

 

A Benefit of Climate Change? Fewer Cases of Plague Reported in the US

About 10 to 20 Americans are afflicted with bubonic plague each year, and 1 to 3 die from the infection according to statistics compiled by the Centers for Disease Control in Atlanta, GA. The natural reservoir of Yersinia pestis, the bacterium that causes plague, are  prairie dogs and ferrets, and fleas that infest those colonies can transfer it to squirrels, rats and mice, who like to live close to humans and their flea-carrying pets. Most of the reported cases of plaque occur in the so-called Four Corners, where Utah, Arizon, New Mexico and Colorado meet, and most victims live in rodent-infested rural dwellings. 

A study in this month’s issue of The American Journal of Tropical Medicine and Hygiene tracked climatic conditions in 195 counties in 13 Western states, from Washington to Texas, that reported even one plague case since 1950. Cases have dropped over time, and the study concluded that rising nighttime temperatures since 1990 had helped. Warmer nights melt winter snowpacks earlier, leading to drier soil in rodent burrows. When the soil gets too dry, fleas die and transmission of Y. pestis is much reduced. 

While a reduction in the incidence of bubonic plague may be a good thing, it certainly doesn’t offset the potential catastrophic effects that may result if global warming is not kept in check! 

Despite the fearsome reputation the disease earned in the Dark Ages, plague can be easily treated with antibiotics if it is caught early enough. Also, improvements in sanitation and urban livings conditions has relegated plague to be classified as an endemic and ancient disease.

Until next time...

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

 

 

Interview Questions That US Employers Are Not Allowed to Ask

I counsel a large number of foreign students as part of my career development activities. Over the years, I learned that questions regarding a job candidate’s personal information like nationality, religion, marital status etc are permissible and perfectly legal in countries other than the US. Consequently, I decided that it may be instructive for job candidates to learn what questions are acceptable and those that are not during a face-to-face interview for positions at US companies. 

Much of the information presented in the post was gleaned from an article written by Porcshe Moran of Yahoo Finance.

The following are examples of illegal questions that SHOULD NEVER be uttered by interviewers during a US job interview.

1. How old are you?

The Age Discrimination in Employment Act of 1967 (ADEA), protects individuals who are 40 or older from being discriminated against in the workplace in favor of younger employees. There is no federal protection in place to protect workers younger than 40 from age discrimination. To determine if you are legally eligible to perform a job, employers are allowed to ask if you are over the age of 18.

2. Are you married?

Questions about marital status are prohibited. Employers might be tempted to ask this question to find out if your relationship could have a negative impact on your work. For example, if you are married you might be more likely to leave the company if your spouse gets a job transferred to a different city. Even a question as seemingly innocent as "Do you wish to be addressed as Mrs., Miss, or Ms.?" is not allowed.

3. Are you a U.S. citizen?

Citizenship and immigration status cannot be used against a potential employee during the hiring process according to The Immigration Reform and Control Act of 1986 (IRCA). Employers must wait until after a job offer had been extended to require a worker to complete the Employment Eligibility Verification (I-9) Form and submit documentation that proves identity and employment authorization. It is lawful for an employer to ask an interviewee if they are authorized to work in the US.

4. Do you have any disabilities?

This question might seem necessary to determine if a job applicant can perform the required duties, but it is illegal to ask under the Americans with Disabilities Act of 1990. Employers cannot discount anyone from a job because of a physical or mental disability. In fact, the law requires that they accommodate disabilities unless they can prove it would cause significant difficulty or expense to do so. Employers also cannot ask you if you have had any past illnesses or operations.

5. Do you take drugs, smoke or drink?

Concerns about drug, alcohol or nicotine addictions are valid as they can impact an employee's quality of work and the rates of a company's health insurance coverage. However, an employer might find themselves in legal trouble if they don't frame questions about these potential problems in a careful manner. They are allowed to ask if you have ever been disciplined for violating company policies about the use of alcohol and tobacco products. They can also ask directly if you use illegal drugs, but an employer can't inquire about your use of prescription medications.

6. What religion do you practice?

Inquires about religious beliefs are a sensitive issue. An interviewer might be curious for scheduling reasons such as holidays that an employee might need off, or if the candidate will be unavailable to work on weekends because of religious obligations. It is illegal to intentionally discriminate against an employee or harass them based on their religious beliefs. Employers are required to accommodate an employee's religious beliefs or practices in regards to things such as dress and grooming policy and flexible scheduling.

7. What is your race?

There is no situation in which questions about an employee's race or skin color should be use to determine their eligibility for a job. This protection is granted under Title VII of the Civil Rights Act of 1964 that prohibits employment discrimination on the basis of race, color, religion, sex or national origin. Employers are permitted to ask an employee to reveal their race on a voluntary basis for affirmative action purposes.

8. Are you pregnant?

Questions about family status tend to affect women the most, but they can also pertain to men in certain situations. Employers might have concerns about an employee taking time off work for pregnancy leave or not having child care arrangements during work hours.

The Pregnancy Discrimination Act states that an employer cannot refuse to hire a pregnant woman because of her pregnancy, because of a pregnancy-related condition, or because of the prejudices of co-workers, clients or customers.

It is, however, lawful for employers to ease their nerves about an employee's availability or commitment to a position by asking about long-term career goals or the ability for an employee to work overtime and travel.

Click the link common interview questions for other examples of some questions that should not be asked.

The Bottom Line
It is important to know your rights as an employee. Unlawful questions are not acceptable on applications, during the interview process or in the workplace. Although improper questions by employers might be simple mistakes, they could also be intentional cases of discrimination. 

While it is good to know your “rights,” I wouldn’t be surprised if some of you may be asked these questions during a job interview. Whether or not you respond to the question(s) is up to you. However, if the personal questions that are asked make you uncomfortable, let the interviewer know as professionally as possible that he/she is treading in dangerous territory. After the interview is over, you may want to contact the company’s Human Resources department to report the incident so that future job candidates may avoid similar unpleasant and illegal experiences.

Until next time...

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

 

Are You Kidding Me?? New Jersey Childhood Vaccination Rates Are Among the Lowest in the US

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—45th 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!!!!!!!!!

 

In the News Again: Salmonella!

As many of you know, I am a big Salmonella fan (not really that strange for a microbiologist who did his PhD thesis on Salmonella gastroenteritis). However, this notorious food-borne pathogen has once again made its way into the US food supply chain. 

This time, an Iowa-based egg producer, Wright County Egg, is at fault. This outbreak which began in May and sickened hundreds of American has resulted in the recall of over 380 million eggs! Ironically, the outbreak started just weeks before new government safety rule went into effect to reduce the risk of Salmonella infection of eggs. Public health officials believe that this is the largest outbreak of salmonellosis of poultry-related products in recent years.

Like most other nationwide Salmonella outbreaks, this one is a result of poor sanitary conditions and inadequate quality control at the production facility. Wright County Egg had repeatedly been cited for violating US Food and Drug Administration regulations. Yet, the company was allowed to continue operations without fixing the problems identified by FDA inspectors and regulators.

For those of you who may not know, chickens are frequently infected by Salmonella spp and can be found in the feces from infected animals. Chickens are not the cleanest of animals and fecal contamination is expected and common at most egg laying and processing facilities. If adequate health, sanitary and quality control procedures are assiduously adhered to at these production facilities, the likelihood of Salmonella infection of poultry products is very low. Conversely, the incidence of infections is sure to increase if these rules and regulations are not adhered to.

Once again we are in the midst of another major “food poisoning” outbreak, because a company cut corners to reduce costs and failed to adhere to federally mandated Good Manufacturing Practices for foods and related products.

As Woody Allen quipped in the closing moments of his film “Annie Hall”....”Most of us need the eggs.” Truer words were never spoken!

Until next time....

Good Luck and Good Job Hunting (try microbiology)

 

Lilly CEO: "US is Losing it Edge in Life Sciences Innovation"

John Lechleiter, PhD, chairman and CEO of Eli Lilly & Co. today told members of the Detroit Economic Club that the US is losing its competitive edge and that “evidence is mounting for an innovation crisis in the life sciences

Lechleiter blamed the crisis on US tax and immigration policies over the last 10 years that have reduced research and investment funding and driven away foreign-born, U.S.-trained scientists.

He also attributed the problem to the US Food and Drug Administration’s new emphasis on drug safety.  “The FDA approved 92 drugs the last five years. That is the lowest of any five-year period,” he said. “We lose patent protections (on brand name drugs) and that is $100 billion less revenue for the industry and less for research and development” said Lechleiter. Further, he said that “American drug companies still spend 40 percent more on research in development in the U.S. than in other parts of the world.”

To avert the crisis, Lechleiter suggested the following: 

  1. Increase and improve education for students in math and science
  2. Change immigration laws to allow more H1-B visas for scientists and ease the process that allows immigrants to gain green cards to work in the U.S. The last time the H1-B visa cap was raised was in 1990
  3. Increase federal funding for pharmaceutical and basic science research, which has declined over the last five years
  4. Change tax policies to provide more incentives for research and development. The U.S. lags behind the rest of the world in offering R&D tax credits, he said. Moreover, the U.S. should not tax foreign subsidiaries of U.S. corporations

Lechleiter, who was trained as a chemist, is the only CEO of a major pharmaceutical company who holds a PhD degree. Therefore, his ideas resonate more for me than those of his business-only CEO counterparts. To that end, his suggestions regarding improving math and science education, immigration reform (which I have long contended is killing US competitiveness) and increasing federal funding for research make sense. However, the notion that US tax laws and lack of corporate tax incentives is stifling American innovation and competitiveness is pure hogwash.

While corporate tax rates may be higher in the US than elsewhere, there are so many loop holes that most corporations pay less than their share fair. Further, let’s not forget that the personal income tax rate is much higher in the rest of the developed world than it is in the US. It is just so “American” to not want to pay taxes and then demand and expect government services at no cost to the taxpayer (at least in Europe they pay high taxes and get good services).  And, let's not forget that despite their heavy tax burden it was American corporations not foreign ones that caused the recent global recession.

That said, I gotta give John some credit for his suggestions; three out of four (or a .750 average) isn’t bad in baseball or the pharmaceutical industry!

Hat tip to Ed at Pharmalot

Until next time...

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

 

More Changes at Novartis

Earlier this year, Dan Vasella, the longtime CEO of the Swiss drug maker Novartis, announced that he was resigning his CEO position to assume a full time role as the Chairman of the company’s board of directors. Joe Jimenez, an American, was appointed as the new CEO.

Today, Novartis announced the departure of Ludwig Hanston, the CEO of the US pharma business unit for the past two years. In addition to his departure, four new business units will be formed and 250 employees will lose their jobs effective May 1, 2010.

The four new business units are being formed to more accurately reflect the needs of patient populations. The new business units include 1) Primary Care, 2) Multiple Sclerosis, 3) Psychiatry/Neuroscience and 4) Respiratory/Transplant/Infectious Disease.

For a more detailed explanation of the changes taking place at Novartis please read the post on today’s Pharmalot blog.

Hat tip to Ed.

Until next time…

Good Luck and Good Job Hunting!!!!!

 

Ranbaxy to Hire 1,500 Marketing and Sales Employees to Boldly Go Where No Indian Pharmaceutical Company Has Gone Before

One economic downturn and it seems as though the pharmaceutical world has been turned upside down! Who would have thought a few years ago that emerging pharmaceutical markets in India and Asia will outpace the US and Western European markets in the very near future (I did but nobody listens to me). To that end, Ranbaxy Laboratories will hire nearly 1,500 marketing executives, expanding its sales team by at least 50%, to spur sales and regain its rank as India’s top drug maker. The recruitment push is among the biggest by an Indian drug maker in recent years.  Ironically, pharma sales reps are still being regularly layed off in the US.

The company plans to hire mostly medical representatives, regional managers and area managers by July to boost sales in the rural markets.  According to a Ranbaxy hiring manager “Ranbaxy is looking at new rural markets and deeper penetration in interior markets.”

Ranbaxy is owned by Japan’s Daiichi Sankyo which employs over 12,000 people in 46 countries.

Industry analysts suggest that Ranbaxy’s aggressive hiring push is a sign that the company is focusing on internal markets which are poised for exponential growth in the next few years. Also, Ranbaxy has had its share of legal and regulatory disputes over patents and generics drugs in the US and Western Europe signaling that the company may be pursuing those markets less aggressively than in the past.

Until next time…

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

 

US Sale of Prescription Drugs Tops $300 Billion in 2009

IMS Health, a market intelligence company that tracks US drug prescriptions, reported that the US sale of prescription drugs grew 5.1% in 2009 to $300.3 billion.

IMS identified the following key trends among the major therapeutic areas:

  • Antipsychotics remained the top-selling class of medications in the U.S., with 2009 prescription sales of $14.6 billion, equal to the 2008 level.
  • Lipid regulators continued as the largest therapy class in the U.S. by dispensed prescription volume, growing at a 5 percent pace to 212 million prescriptions dispensed in 2009. Sales of lipid regulators declined 10 percent last year to $13.1 billion, reflecting an ongoing shift toward lower-cost generic alternatives. Lipid regulators ranked #3 in overall sales in 2009.
  • Proton pump inhibitors replaced lipid regulators as the second-largest therapeutic class in sales last year. Proton pump inhibitors sales totaled $13.6 billion, a 2 percent decline year over year, while dispensed prescription volume for this therapeutic class rose 5 percent.
  • Antidepressants became the fourth-largest class in 2009, up from its #5 ranking the prior year, with U.S. prescription sales growth of 3 percent to $9.9 billion.
  • Sales of antineoplastic monoclonal antibodies, a leading oncology class that includes Avastin®, Rituxan® and Herceptin®, grew at a 9 percent pace in 2009 and ranked #6 in therapeutic class sales.

IMS also reported that use of generic products, including branded generics, continued to rise last year and now represent 75 percent of all dispensed prescriptions in the U.S., up from 57 percent in 2004. The total number of generic prescriptions dispensed increased 5.9 percent in 2009, while the number of branded prescriptions dispensed declined 7.6 percent.

While the US pharmaceutical and biotechnology industries continue to cry poverty, it appears that sale of prescriptions drugs continues to grow at a pretty good rate. Look for increased growth until 2014 when healthcare reform begins to kick in.

Until next time…

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

 

A Troubling Trend: Genital Herpes Infections are on the Rise

While studying the pathogenesis of Neisseria gonorrhoeae in Portland, OR in the early 1980s, genital herpes had replace gonorrhea as the scourge of the sexually transmitted disease community. To help to combat the spread of genital herpes, my labmates and I joined the Portland Venereal Disease Action Committee, a grass roots organization that provided public outreach and education about sexually transmitted diseases (STDs). A few years later, the Regan Administration finally admitted to the American public that HIV/AIDS was real and that HIV infections were likely to reach epidemic proportions. While genital herpes can be painful, uncomfortable and often emotionally debilitating, the unprecedented morbidity and mortality of HIV/AIDS almost pushed genital herpes into infectious diseases obscurity. Now that HIV/AIDS is more treatable than ever before, epidemiologists and sexually transmitted diseases experts have begun to reexamine the infection rates and incidence of other STDs (including herpes, gonorrhea, Chlamydia and syphilis) among Americans. To that end, I read today a very troubling article about the infection rates and incidence of genital herpes among sexually active Americans. Here are some of the facts gleaned from a recent CDC report on genital herpes:

  1. One in six Americans aged 14 to 49 are infected with genital herpes, making the virus — herpes simplex 2 — one of the most common sexually transmitted diseases in the United States
  2. Research shows that people with genital herpes are two to three times as likely to acquire H.I.V. as those without herpes
  3. H.I.V.-infected individuals also infected with genital herpes are more likely to transmit H.I.V. to others
  4. Infection rates for women are almost twice the rate of men
  5. Blacks are three times as likely to be infected as whites
  6. Black women have the highest rates of infection, with almost half infected

Looking back, it is understandable why HIV/AIDS took precedent over genital herpes infections. After all, most people usually don’t die from genital herpes. However, the rising infection rates of the disease suggest that the American public needs to be better educated the spread and prevention of genital herpes infections. There is no question that discussions about STDs are embarrassing and often difficult. However, these days, they can be the difference between live and death!

Until next time…

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

 

Why Five Years of Data Exclusivity Makes Sense for US Follow-on Biologics Legislation

In case you did not know, the 12 years of market exclusivity proposed for follow-on biologics by supporters and lobbyists for the pharmaceutical and biotechnology industries is part of the impending US healthcare reform legislation currently pending in Congress. While President Obama has publicly announced that he supports a five year period of data exclusivity for biologics (the same as the exclusivity period for generic small molecule drugs, it is unlikely that the President will be able to convince or coerce legislators to reconsider the 12 year data exclusivity provision. However, there was a brilliant Op-Ed piece in today’s New York Times written by Anthony So and Samuel Katz at Duke University which offers a plethora of financial and business reasons why the five year period makes a lot of sense!

  1. Generic small molecule drugs have been estimated to save the American healthcare system as much as $734 billion over the past 25 year or so since the inception of the Hatch Waxman Act.
  2. Biologics cost on average 22 times more than equivalent brand name prescription small molecule drugs
  3. In 2008, 28% of sales of the life science industry’s top 100 products came from biologics and biotechnology products: by 2014 that share is expect to rise to about 50%
  4. The Medicare Payment Advisory Commission found that the top six selling biologics which include Epogen (Amgen) Avastin (Genentech) and Remicade (Centocor) accounted for $7.0 billion (43%) of Part B drug spending in 2007 (Part B covers the cost of doctor spending and outpatient visits)
  5. Between 2006 and 2007, Medicare Part D (prescription drug coverage) spending on biologics increased by 36% as compared with a 22% increase in spending for small molecule drugs
  6. Prices for biologics and biotechnology products have increased more rapidly than those for small molecule drugs
  7. While industry leaders and their lobbyist contend that it costs more and takes longer to develop biologics and biotechnology products than small molecule drugs, based on reports by various industry trade groups it costs about $1.2 billion to develop biologics and roughly $1.318 billion for small molecule drugs
  8. The US Federal Trade Commission, the independent federal agency whose main goals are to protect consumers and to ensure a strong competitive market by enforcing a variety of consumer protection and antitrust laws, recommended that the data exclusivity period for follow-on biologics should not exceed six years.

Despite the likelihood that follow-on biologics will substantially reduce prescription drug costs and healthcare spending, Congress has chosen to support questionable legislation that will delay access of Americans to less costly, efficacious follow-on biologics until at least 2020.

Until next time...

Good Luck and Good Job Hunting

 

AstraZeneca Offers New Details About Its Global Layoff Plans

Ed Silverman, who runs the Pharmalot blog,reported today that AstraZeneca provided more details about its plan to layoff 8,000 employees or 12% of its workforce by 2014. 

According to the post, the company will R&D programs in thrombosis; acid reflux; ovarian and bladder cancers; systemic scleroderma; schizophrenia, bipolar disorder, depression and anxiety; hepatitis C and vaccines (other than respiratory syncytial virus and influenza).

The company will shutter research facilities throughout the UK and Sweden and shed about 3,500 R&D jobs. About 550 jobs will be eliminated at AstraZeneca’s US headquarters in Wilmington, Delaware; adding to the massive numbers of unemployed pharmaceutical workers in the Pennsylvania, New Jersey and Delaware region. The company is also looking for a buyer for its Arrow Therapeutics business.

AstraZeneca joins a growing number of big pharma companies that are jettisoning internal R& D programs in favor of licensing and merger and acquisition deals to sure up drug discovery pipelines. The lack of innovation in small molecule drug discovery and the loss in 2011 of patent protection for some of the industry’s largest blockbuster drug franchises is forcing big pharma companies to eliminate or outsource most of their R&D functions and capabilities to cut costs.  

I wish I could say that things will get better. But, the shift in the business model that has guided big pharma for close to 100 years is likely to be a permanent one. Now is the time to begin to consider alternative career paths!

Until next time...

Good Luck and Good Job Hunting (“Go West young man/man!”)

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Economic Recovery: US Contract Biomanufacturing Companies Are Experiencing an Upswing

For the past decade or more, small to mid-sized biotechnology companies had been outsourcing production of their preclinical and clinical protein-based products to Asian contract manufacturing organizations (CMOs). This was because manufacturing and labor costs were lower and product quality was consistent with Western standards and requirements. However, the recent economic down turn coupled with rising prices at Asian CMOs (mainly driven by increasing labor and project management costs) has forced many small to mid-sized companies to rely again on American CMOs to manufacture their products. Unlike cash-rich, larger companies, US small to midsize companies generally lack the financial resources and personnel to effectively manage operations in Asia. Many industry analysts contend that the lower initial costs of Asia-based companies are usually offset by the money and resources need to oversee a project.

While business returning from Asia improved the financial outlook for some American CMOs, 2009 was a bad year for most firms that service small to mid-sized pharma and biotech companies. However, industry analysts expect 2010 to be better than 2009. More importantly, the return of biomanufacturing to the US may signal the beginning of a new trend in the biomanufacturing outsourcing industry.

Until next time....

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

 

Job Cut Update: GlaxoSmithKline Mum on Number of US Jobs that will be Lost

Despite the announcement late last week in the London Sunday Times that GlaxoSmithKline (GSK) will eliminate 4000 jobs worldwide, company official are refusing to disclose the number of worker who will lose their jobs in the US. Cuts are expected throughout the US including GSK’s R&D facilities in the Philadelphia, PA area and at its US headquarters in Research Triangle Park, NC which employs roughly 5,000 people.

GSK officials typically refuse to share detailed information on how layoffs affect its Triangle work force. Nearly a year ago, the company cut an undisclosed number of workers at a customer response center in RTP. GSK announced a first cost-cutting initiative in October 2007, eliminating thousands of jobs worldwide, and then it expanded that effort in February 2009 with many hundreds losing jobs at it North Carolina facilities in RTP and nearby Zebulon.

This coming Thursday is expected to be pink slip day at GSK.

Until next time....

Good Luck and Good Job Hunting (forget RTP)!!!!!!!

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Improving the Public's Understanding of Science and Scientists

Alan Alda, a well known actor and science enthusiast, is doing his share to improve the science literacy of Americans. His was the host of the Science Frontiers (which ran for 15 seasons on PBS until it was cancelled in 2005) and more recently the host of Wired Science which failed to catch on and was also canceled. Alda’s approach to science education is asking questions that nonscientists could understand while throwing in a bit of humor as well. In a recent interview he stressed that he always tries to “keep it a conversation.” Sometimes, he added, scientists and researchers would “lapse into lecture mode, and I’d have to bring them back into a conversation. This isn’t surprising because many scientists are unfamiliar or lack the necessary training to engage in conversational science. For the most part, scientists are trained didactically and exchange information via formal traditional channels which include: seminars, oral and written presentations at scientific meetings and congresses and publication of research findings in peer reviewed journals. In other words, science education has historically resembled a one way conversation rather than a dialog. Unfortunately, web 2.0 and social media is all about conversations and one way conversations are becoming less acceptable, even in science circles! To that end, Alda just finished teaching a six-week course of workshops at Stony Brook University on Long Island instructing scientists how to use improvisational acting techniques to express themselves more clearly. “The idea is you can’t really communicate ideas unless you know what’s going on in the other person’s mind,” he said. 

Despite many incredible scientific advances in the past decade, the science gap in America continues to widen. Science is becoming increasingly complex and fewer Americans are capable of understanding it. Therefore, it is incumbent upon scientists to begin to understand that they have a critical role to play in improving the public understanding of science. This responsibility can no longer be relegated to primary and secondary school teachers nor should nonscientists like Alda,Ira Flato of NPR’s Science Friday, Robert Krulwich and Jad Abumrad of RadioLab (a great show), be expected to carry the banner and lead the charge! 

Interestingly, while listening to this week’s Science Friday, I learned of educational initiatives being sponsored by the National Institutes of Health and the National Science Foundations that are aimed at bringing more science into the entertainment fields. The computer systems institute also offers flexible programs as well.  While this is an important first step, it may be too little; too late. Throwing money at the problem won’t solve it: scientists need to step out of their comfort zones and learn how to better communicate and interact with the lay public. To that end, by way of a sport’s analogy “we scientists control our own destiny” We can choose to collectively learn how to better inform the American public about what we do and how we do it or allow the science literacy gap to ultimately become a chasm in the 21st century.

Until next time...

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

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Industry Exec Reveals Pharma's "True" Position on Healthcare Reform

Much has been written about how supportive the pharmaceutical industry has been about US healthcare reform. Prior to the debate, the Obama administration gleefully announced that pharma will give $80 billion in drug discounts in exchange for certain assurances that weren’t publicly disclosed. As most of us know, the US House of Representatives passed historic healthcare reform legislation last week and in addition to a public option it stipulates that pharma will be required to give $140 billion in drug discounts. According to Ed Silverman over at the newly reinstated Pharmalot blog, AstraZeneca CEO David Brennan, who is also this year’s chair of the industry trade group PhRMA, vowed that pharma would fight the house healthcare reform legislation. 

While Brennan’s statement isn’t surprising nor particularly noteworthy, his comments explaining pharma’s position on healthcare reform are revealing and important to understand. He told the Huffington Post “We said there were principles we didn’t want to see violated. And if those principles - price controls, Medicare rebates, moving dual eligibles back from Medicare and back into the Medicaid discount program - if those things happen, I can’t see how we could be supportive of the program.” In other words, we will support anything you propose— and may even be willing to kick in another $60 billion or so to support healthcare reform— but any discussion about government regulation of drug prices is a deal breaker! 

To my knowledge, this is the first public mention of price controls by any pharmaceutical executive during the almost year long debate on healthcare reform. The reason that I find Brennan’s statement interesting is that I have long contended that pharma will give the Obama administration and Congress anything it wants in exchange for assurances that the government will not attempt to control drug prices. For those of you who don’t know, the US is one of the only countries in the world where the government is prohibited from setting drug prices. This means that US drug makers in concert with insurance companies and third party payors can set drug prices based on what the American pharmaceutical market can bear. Not surprisingly, the profit margins on drugs sold in the US are the highest in the world. Obviously, pharma doesn’t want the US government hindering or limiting their profits by setting or capping drug prices. 

I am glad that pharma has finally decided to publicly “come clean” on the price control issue. The public option and issues surrounding data exclusivity for follow-on biologics pale in comparison to the financial havoc that price controls would wreak on the pharmaceutical industry. And, I suspect that pharma and its lobbyists will do whatever it takes to insure that price controls never become a reality in the US. However, at the end of the day, government regulation of drug and device prices will ultimately be required for any meaningful changes to take place to the US healthcare system.

Hat tip to Ed!

Until next time...

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

Addendum: After writing this post this weekend, an article appeared in Monday's New York Times that revealed that the drug industry has quietly been raising its wholesale prices on prescription drugs over the past year.  This, of course, was done in anticipation of possible federal legislation that might impose some government controls on drug pricing.  According to the Times article: "In the last year, the industry has raised the wholesale prices of brand-name prescription drugs by about 9 percent, according to industry analysts. That will add more than $10 billion to the nation’s drug bill, which is on track to exceed $300 billion this year. By at least one analysis, it is the highest annual rate of inflation for drug prices since 1992. The drug trend is distinctly at odds with the direction of the Consumer Price Index, which has fallen by 1.3 percent in the last year.  Not surprisingly, the US pharmaceutical industry justifies the practice because as an industry spokesperson put it  "they are having to raise prices to maintain the profits necessary to invest in research and development of new drugs as the patents on many of their most popular drugs are set to expire over the next few years."  Hmmmm, interesting comment considering the US pharmaceutical industry has layed off over 180,000 employees over the past three years, a majority of whom are R&D scientists...go figure!

Considering a Science Career in Government? You Must Read This!

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

 

More Consolidation in the Pharmaceutical Industry

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!!!!

 

Despite Surging Earnings Sanofi-Aventis is Restructuring and Planning Layoffs

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

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

 

Improving Public Awareness of Science: Now That's What I'm Talking About!

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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As Expected: the Debate Over Follow-on Biologics Legislation Hinges on Data Exclusivity

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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Lack of American Science Awareness: Who is Responsible?

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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Some Revealing Pharma Factoids

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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The Follow-On Biologics Debate: Innovator Companies Lose Round 2

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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Restoring Science to Its Rightful Place: The Obama Administration Addresses the Visa Issues Plaguing Foreign Life Sciences Researchers

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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Time for a Change: BIO Study--US Students Falling Behind in Bioscience Education

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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The Swine Flu Epidemic: It Isn't The First and Won't Be the Last!

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

 

US Congress Continues To Debate Follow-On Biologics Legislation

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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A New Year and Another Salmonella Food Poisoning Outbreak

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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Is the Recession Going to Kill Biotech?

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!!!!!

 

European Pharma Executives: Direct-to-Consumer Advertising Was a Big Mistake

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!!!!!!!

 

GlaxoSmithKline to Restructure US Pharma Operations

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.

 

The World's Best Places For Small Businesses

 

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 33rd 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?)

 

The US Federal Trade Commission Weighs in on Follow-on Biologics

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!!!!!!!!

News Flash: New Report Shows That US Healthcare is Inadequate and In Need of Change

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

It's Official--Siemens is Laying of 16,750 Employees

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!!!!!

It Had to Happen Sooner or Later: Health Canada Adopts Draft Guidance for Subsequent Entry aka Follow-On Biologics aka Biogenerics

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!

2009 FDA Budget Includes Provisions to Explore a Follow-on Biologics Pathway

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!!!!!!!!!!!