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The German pharmaceutical company Boehringer Ingelheim (BI) today announced that it plans on investing 70 million Euros to expand its manufacturing facility in the Zhangijiang High-Tech Park in Shanghai China. The expansion will continue through 2013 and the number of employees will increase from 240 to 400 at the new facility

BI was one of the first pharmaceutical companies to enter China in 1994 and the planned expansion was proposed to solidify the company’s position in the emerging Chinese market. The expansion will be modular and based on lean manufacturing practices to provide world class manufacturing capability at the site.   The company already sells certain therapeutic products in China including respiratory, cardiovascular, and CNS. Expansion of the existing manufacturing facility is intended to allow BI to expand into other therapeutic areas that include diabetes, oncology and stroke prevention.

Late last week Merck announced plans to build a new R&D facility in Beijing. Other companies have also announced plans to increase their presence in the Chinese market. I think it may be the time for American student to begin to consider Mandarin as their foreign language in primary and second school education programs.

Until next time...

Good Luck and Good Job Hunting!!!!!

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Despite the fact the US unemployment rate has hovered around 9.0 percent for the past several years and over 200,000 pharmaceutical employees have lost their jobs since 2001, many life sciences executives contend that they cannot find qualified employees to fill job openings at their companies. Most executives blame the US education system for not providing prospective employees with necessary training and immigration laws that prevent companies from hiring highly-skilled foreign workers. According to a recent survey conducted by the staffing company ManpowerGroup, over 52% of US employers that they have difficulty filling open positions because of talent shortages.  Some other revealing statistics about employer’s attitudes include:

• 47% of employers blame job candidates’ lack of hard job or technical skills for their inability to hire
• 35% of companies cite job candidates’ lack of experience as a reason not to hire
• 25% blame lack of business knowledge or formal educational qualification as a deterrent to hiring

While a majority of US corporate executives may believe this, the reality is that employers simply cannot find employees to accept jobs at the wages that they are willing to offer! In other words, there is a plethora of skilled American workers out there; but many US employers are willing to outsource or hire skilled foreign nationals who frequently work for lower wages than most Americans. Further, American employers are unwilling to spend money to train college graduates or re-train existing employees who may be able to step into these so-called difficult-to-fill positions. This may help to explain why an increasing number of students are willing to accept unpaid internships or, in some cases pay to work at companies for free to garner valuable industrial experience which may ultimately lead to a job.

In a recent article in the Wall Street Journal, Peter Cappelli, the George W. Taylor Professor of Management at the University of Pennsylvania’s Wharton School, offered three possible solutions to the current American unemployment conundrum

Work with education providers

If job candidates lack the skills or qualifications to do certain jobs, companies ought to make them go to school to acquire them. To that end, a growing number of community colleges in North Carolina and New Jersey have partnered with prospective employers to develop courses or degree programs tailored to meet their employment needs. For example, about 10 years ago my local community college (Mercer County College) developed a program (in a partnership with the clinical research company Covance) to train students interested in becoming clinical research assistants and managers. Not surprisingly, many of the students enrolled in the program ultimately where hired by Covance. 

In another variation of this model, extant employees, who may be interested in advancing their cares, would be able take classes at local community colleges (in off hours) and have their tuition subsidized via company tuition reimbursement programs. This would help to obviate the high costs and inordinate amount of time typically required to hire external candidates for newly created positions.

Reintroduce on-the-job training programs

Back in the day, companies tended to hire persons who were the brightest, most talented and most likely to benefit an organization.  New hires were required to participate in internal training programs so that they would better understand their positions and allow management to best evaluate new talent. Generally speaking, this allowed most companies to operate more efficiently; mainly because this allowed managers to determine the best fit of new hires into the existing corporate structure. Sadly this is no longer the case at most companies. These days, companies tend to hire worker who possess the technical skills and qualifications to do a certain job and are expected to “hit the ground running” Put simply, short term needs are placed before the long term needs and future success of an organization.

Promote from within

According to data from the talent management company Taleo Corp., in recent years a surprising two-thirds of job vacancies, even in larger companies, have been filled by outside hires. While it may be cheaper to hiring from the outside, the loss of experienced workers and historical corporate knowledge may affect a company’s performance and ultimately its bottom line.

While the US economy is beginning to show signs that it is beginning to recover, I believe that surest way to prosperity is to put Americans back to work. Although this may require a substantial financial investment by US corporations, we simply can no longer rely on outsourcing or a cheaper immigrant workforce to allow American to continue to compete on the world stage.

Until next time...

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

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Over the past 10 years or so there has been an enormous amount of consolidation in the life science industry. While this activity has been very good for shareholders, it has had a devastating effort on pharmaceutical R&D says John  LaMattina PhD, a chemist, blogger, author and former President of Pfizer Global R&D.

In his article “The Impact of Merger on Pharmaceutical R&D," LaMattina asserts:

“Mergers and acquisitions of pharmaceutical companies over the past 15 years have had a major consequence on the internal research and development productivity of these organizations. Industry consolidation has eliminated a high degree of competition and resulted in the downsizing of internal research efforts. The execution of these mergers has caused a loss of momentum in the development pipelines of these companies along with loss of scientific talent.”

In addition, he believes that M&A and outsourcing of R&D operations has resulted in the loss of scientific talent required for innovation and development of novel new medicines. “Sadly, this loss of innovation comes at a time when we are trying to find treatments for challenging and difficult-to-treat diseases like Alzheimers and many cancers” says LaMattina.

While most life sciences executives believe that consolidation is good for business, LaMattina, along with John Lechleiter, the outspoken CEO of Eli Lilly& Co (who is also a PhD-trained chemist) believe that continued consolidation in the industry will have devastating consequences. “We are still very much opposed to a large-scale combination. We don’t think size is necessarily supportive of innovation.” says Lechleiter. 

LaMattina added “Downsizing R&D hinders the ability of companies to develop new drugs because they lack the scientific expertise required to make critical decision as a drug candidate makes it way through the pipeline.”

Unfortunately, most current pharmaceutical and life sciences executives don’t think like LaMattina. Since 2001, over 300,000 pharmaceutical employees, mostly R&D scientists and sales representatives have lost their jobs.

Until next time...

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

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The Pharmalot Blog today reported that a group of protesters aligned with the Occupy Wall Street movement will conduct a vigil at Pfizer's Groton,CT R&D facility to protests recent job cuts made by the company. 

Pfizer was targeted because it took tens of millions of dollars in local and state government subsidies to build an R&D facility in New London, Connecticut. But earlier this year, the company abandoned the facility and decided to transfer about 1,100 R&D job from Groton to Cambridge, Massachusetts.Also, the company jettisoned its antibacterial drug discovery efforts at the Groton facility and shipped those jobs overseas to China.  Roughly, 2,500 Pfizer jobs are leaving Connecticut which will likely have a negative impact on the state.

One protest leader quipped “When huge companies like Pfizer take tens or hundreds of millions of dollars in public money, and then pull up stakes as soon as the money disappears, that’s what wrong with our economy”

Also, Pfizer is one of the top US ten companies to shed employees despite an estimated $48.2 billion in offshore funds that the company does not pay any taxes on. Between 2004 and 2011, the company  laid off  58,071.

Don't be surprised if the Occupy Wall Street Movement spreads from the banking to the pharmaceutical industry.  At this point there appears to be little distinction between the two!

Until next time...

Good Luck and Good Job Hunting

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From 2001 to present, roughly 300,000 pharmaceutical employees have lost their jobs. That is a massive number; second only to the job losses in the automotive and financial services industries. The main reasons for the layoffs have been a lack of return on investment on R&D activities and impending patent cliffs in 2013 for as many as 15 blockbuster drugs. 

Ed Silverman who runs the Pharmalot blog speculated in a post yesterday that the number of pharma layoffs may be dwindling. His assertions are based on an analysis of the annual number of pharma layoffs provided by the outplacement firm of Challenger, Gray and Christmas. Ed’s wrote:

 “So far this year, pharma layoffs have totaled 19,076, and this includes the 13,000 job cuts planned by Merck, which is actually eyeing many foreign positions, therefore, swelling the latest tally. Last year, pharma eliminated 53,636 jobs, down from 61,109 in 2009, when annual layoffs peaked. In fact, the 2009 bloodletting was outsized compared with every other year - the next highest annual layoff tally occurred in 2008, when 43,014 industry cuts were announced. Between 2003 and 2007, the number of jobs that were eliminated ranged from about 15,000 to 31,000 annually, according to the firm.”

This led Ed to posit that the worst may be over and those pharma employees who still have jobs may be able to relax a bit. However, it is important to note (as Ed also points out) that many big companies are still purchasing or opening new  R&D and manufacturing facilities in emerging markets like India and China and more and more R&D jobs are being outsourced. Further, while many US pharma reps have lost their jobs hiring reps in emerging markets continues to explode. Interestingly jobs that are in demand and still available to Americans include those in regulatory affairs, compliance, IT, clinical operations and marketing. Unfortunately, these are very specialized jobs and many of those pharma employees who have been layed off lack the requisite skills to compete for those jobs!

While I think we may have seen the last of massive layoff in big pharma, smaller and less publicized layoffs will likely continue at many US life sciences companies. The downsizing trend taking place in America will likely continue until drug pipelines are populated with new candidates and life science executive realize that outsourcing R&D job is not a viable solution for their productivity problems.

Until next time...

Good Luck and Good Job Hunting!!!!!

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There is no longer any doubt that big pharma companies are beginning to reduce their emphasis on internal R&D activities. Instead the companies will increasingly rely on outsourcing, partnerships, closer collaborations with academia, public private partnerships and M&A to keep their drug development pipelines full

Therefore it was not surprising when Merck’s new CEO, Kenneth Frazier recently mentioned in a conference call to financial analysts and investors that its multi-billion spending on new drug R & D will likely decline as a percentage of overall sales in the coming years. Merck is one of the largest pharmaceutical companies in the world

According to an article on Nasdaq.com, in 2010, Merck spent $11 billion on R&D, or 24% of total sales. Adjusted to exclude certain acquisition-related and other costs, R&D spending was $8.1 billion. Merck has predicted 2011 adjusted R&D spending would be $8.1 billion to $8.5 billion for 2011.

Frazier, the first African American CEO of a major pharmaceutical company, came under pressure earlier this year after he decided to not substantially cut R&D as many of Merck’s rivals, most notably Pfizer, did. He noted that cuts in R&D spending would have jeopardized Merck’s long term product development pipeline.

While rumors persist that Merck may be seeking to jettison its non-pharmaceutical consumer health and animal health businesses, Frazier insisted that the two units are complementary to its core pharmaceutical and vaccine focus and are not for sale. That said, if I was a Merck employee in either of those divisions, I would be updating my resume just about now.

Until next time...

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

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The clinical trial phase of the drug development process is labor intensive, costly and usually takes the largest amount of time to complete. In the past, most human clinical trials for new molecular entities discovered by American scientists were conducted in the US. However, growing healthcare costs and shortages of “treatment-naive” trial participants have forced drug makers to take the effort global. To that end, many companies now routinely conduct Phase I (safety) and Phase II (proof of principle) trials in Eastern Europe, Latin America and Asia. Moreover, a growing number of pharmaceutical companies are beginning to conduct pivotal Phase III trials in which a majority of participants come from outside of the US.

Last year, a report from the inspector general of the Department of Health and Human Services revealed that in 2008 a whopping 78 percent of all subjects participating in trials to support drug applications submitted to the US Food and Drug Administration were enrolled in foreign sites. Likewise, in Europe, approximately 61 percent of patients in human trials submitted to the European Medicines Agency (EMA) from 2005-2009 were from developing countries. Additionally, 11 percent of the participants were enrolled in studies conducted in Eastern Europe. Poland and Hungary appear to have benefited the most from this trend; the number of Poles involved in trials rose fivefold over the period while Hungary was up almost fourfold.

According to a recent article from Reuters, ClinicalTrials.gov—a public website managed by the National Institutes of Health that tracks current US clinical trials—lists roughly 106,000 human clinical trials that are underway around the world. Approximately 50 percent of these trials are being conducted in the US. Interestingly, at present, only 43 percent of all pivotal Phase III trials are being conducted in the US.  Not surprisingly, China is the beneficiary of the trend and is experiencing exponential growth in the number of clinical trials conducted within its borders. To date, over 2,700 clinical trials have been performed in China and that number is likely to drastically increase over the next five years as Chinese medical and healthcare infrastructure continue to improve.

While outsourcing human clinical trials may be favorable to drug makers, the trend is beginning to anger many American physicians who previously benefited from managing US-based clinical trials. These physicians blame their misfortune on the life sciences industry’s endless pursuit to lower costs and the increasing regulatory bureaucracy and red tape surrounding clinical trial procedures in the US.

In addition to physician anger, outsourcing human clinical trials poses several other problems. First, there is a question of ethics. For example, is it right to test an expensive new drug in a country where locals may never be able to afford it if approved? And, are foreign patients always adequately informed or educated about the potential risks and side effects associated with experimental medicines? Second, can ethnic differences between patients contribute to differences in drug effectiveness and safety? In other words, will Caucasian patients respond to a new drug in the same ways as Asian patients? Finally, in the absence of rigorous regulatory inspections can Good Clinical Practices be routinely maintained across all global clinical trial sites? To that end, as pointed out in the Reuters article from 2005 to 2009 EMA inspectors only conducted 44 good clinical practice inspections (outside of the US and Europe) from a total of 44,034 clinical sites. Meanwhile, during the same period, the US FDA inspected only 0.7 percent of foreign clinical trial sites as compared with 1.9 percent of domestic sites.

Like it or not, outsourcing of human clinical trials in emerging markets is a trend that is likely here to stay. Hopefully, in the future, regulatory agencies will be able to better oversee foreign human clinical trials to insure that the drugs that they approve continue to be safe and efficacious.

Until next time...

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

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"Instead of crying and blaming China for producing goods at a lower cost for the whole world, countries like the US, for example, should realize that outsourcing most of the production is a big mistake"

--NIck Hayek, Chief of the Swatch Group; NY Times April 23, 2011

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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)

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The Japanese drug maker Eisai, Co announced that it will cut at least 900 jobs over the next five years to improve operating margins to offset the impending lost of patent protection for Aricept its blockbuster Alzheimer’s  disease treatment. The company did not specify where the cuts would take place.

In other news, based Eli Lilly & Co announced plans to outsource its R&D bioanalytical functions to Advion Biosciences a contract research organization that is building new laboratories Lilly’s home town of Indianapolis, Indiana. Ithaca NY-based Advion is building a 22,000 sq ft facility that will focus on ADME and toxicology experiments that are required for new molecules to enter human clinical testing.

Advion offers a range of Good Laboratory Practice-compliant and discovery bioanalytical services, including liquid chromatography-tandem mass spectrometry (LC/MS/MS) for determining small-molecule drugs, macromolecule therapies and biomarkers; immunoassay services; ADME (absorption, distribution, metabolism, and excretion) screening; cytochrome P450 inhibition and induction study support; metabolism profiling; metabolite identification; sample management; and sample storage.

According to a press release:

 “Lilly will transition its own drug discovery bioanalytical capabilities to Advion and will offer employees affected by the move the opportunity to join Advion. The new laboratory is expected to be fully operational by the end of May 2011.”

This is another example of big pharmaceutical companies exiting the R&D space. Because of the rampant downsizing and outsourcing of R&D functions to CROs, now could be one of the better times in years to start a biotech company. Big pharma is relying on starts up companies and academic laboratories to be the major source of new molecules that they develop. That said, the age of big “in-house” drug discovery operations at big pharmaceutical companies is drawing to an end. 

Until next time...

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

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Little is published in the blogosphere about the life sciences industry in Canada. Because of this, many people think that Canadian scientists and other bioprofessionals may have fared better than their US counterparts. However, like the US, thousands of scientists and others have lost jobs throughout Canada during the almost three year global recession.

While the number of layed off employees is no where near the almost 200,000 American pharma employees who have lost their jobs over the past four years, over 3,600 Canadian pharmaceuticals employees lost jobs in the second half of 2010. Most of the jobs were lost in pharmaceutical manufacturing. Like the US, these jobs were mainly lost as a result of outsourcing and corporate downsizing because of escalating financial pressures. Despite this, government officials expect the Canadian life sciences industry to recover by 2015.

Until next time...

Good Luck and Good Job Hunting (Eh)

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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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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!!!!!!!!!!

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American competitiveness in engineering, technology and science. Unfortunately, while American competitiveness and innovation in these areas continues to wane, little has been done (except talking) about it! Yesterday, Intel and 24 venture capital funds announced that they plan to invest $3.5 billion in American startups and early stage ventures over the next two years. Further, in addition, several of America’s leading technology companies including Google, Cisco Systems, Intel Microsoft and 13 others pledged to add as many as 10,500 jobs into 2010—mainly by hiring Americans graduating from colleges with degrees in computer science and engineering.

The initiative, named the Invest in America Alliance was formed in response to “steadily declining long-term investments in education, technology and human capital” that has been taking place in the US for past 20 years or more. Put simply, the American education system is not training enough qualified individuals to allow the US to compete with other emerging technology and engineering powerhouses that include China, India Finland, Korea and the Netherlands. 

According to Robert Compton, a venture capitalist, entrepreneur and education enthusiast “Fewer than 10 percent of college graduates in the US have engineering degrees, compared with more than one-third in India and China and more foreign-born graduates of US universities are returning to their home countries.” For those of you with degrees in math and science (and you base your calculations on population size), the magnitude of the problem (for Americans anyway) is glaringly obvious. Compton went on to say what many others have been thinking for a while, “Early indicators are that we are not the center of innovation anymore. It is shifting to the East.” And he may be right! Based on surveys conducted by the World Intellectual Property Organization in the last year, patent filings increased 30 percent in China while declining 11 percent in the US.

While the Invest in America Alliance appears to be a great public relations opportunity for the companies and venture firms that are participating in it, its critics doubt whether investing more money in technology startups is going to fix the ongoing problem. Education analysts contend that a better and cheaper solution may be changing US immigration laws so that foreign students who train in the US are allowed to remain in the country after they complete their training. Other naysayers contend that most of the venture money committed by the alliance would have likely gone to American startups anyway (US based venture firms already invest 70 percent of their money in American start ups) and that 10,500 new jobs isn’t enough to make a dent in the US unemployment rolls.

Like the technology industry, a decade of wrong-head immigration policies coupled with a waning American interest in science has begun to jeopardize the US dominance in the life sciences. Further these trends are largely responsible for the massive layoffs and unrelenting outsourcing of pharmaceutical R&D jobs to foreign countries.

Toothless or not, the Invest in America Alliance shows that engineering and technology industry leaders are willing to cooperate with one another and get behind an initiative that raises public awareness about America’s waning competitiveness in these fields. Perhaps,   pharmaceutical, biotechnology and medical devices and diagnostic companies ought to take a page out of the Alliance’s play book to similarly insure the future innovation and competitiveness of the American life sciences industry.

Until next time...

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

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The increasing costs of conducting human clinical trials and the requirement for more stringent safety data for new molecular entities is forcing a growing number of pharmaceutical and biotechnology companies to outsource clinical development of new drugs to Central and Eastern Europe and Asia, most notably India. If your company is considering this option, you may be interested in attending an upcoming conference and workshop sponsored by Next Level Pharma. 

 “Clinical Outsourcing Alliances in Central & Eastern Europe” is a one day conference that will be held on October 8, 2009 in Boston, MA. Company representatives from American and European life science companies and clinical research organization will present talks on the “nuts and bolts” of setting up and conducting human clinical trials in Europe.

A half-day workshop entitled “Clinical Outsource Alliances in India” is being offered on day 2 of the conference. The workshop is intended to introduce American clinical trial sponsors interested in conducting human clinical trials in India to prospective Indian CROs. Presentations from American pharmaceutical executives and Indian CRO representatives will describe the realities of running clinical trials in India and allow attendees to identify potential clinical development partners.

Don’t miss this opportunity to learn the “ins” and “outs of outsourcing foreign clinical drug development.

Until next time...

Good Luck and Good Job Hunting!!!!!

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It’s no secret that major pharmaceutical companies are no longer investing in internal drug discovery initiatives as much as they have in the past. However, I was unaware how drastic the decline in R&D spending was until I read an article entitled “Significant Change Predicted for Bioindustry” by Benjamin J. Conway in the July issue of Genetic Engineering & Biotechnology News. 

Mr. Conway notes that in 1989 more than 50% of the pharmaceutical industry’s budget was spent on preclinical drug discovery and development. During the 1990s, the percentage slowly declined and was approximately 44% by 1999. He asserts that beginning in 2000, “the drop became precipitous” as pharmaceutical companies spent increasing amounts of their R&D budgets on downstream activities including expanded clinical trials. By 2006, big pharma was spending about 25% of its budget on R&D. Strikingly, Mr. Conway contends that “when measured in terms of constant absolute dollars, spending on pre-clinical R&D activities actually declined 0.4% annually over the period, despite annual increases of nearly 7% in total R&D spending.” 

Not surprisingly, the almost decade-long decrease in pharmaceutical R&D spending is best reflected in the lack of new drug approvals over the past five years or so. According to Mr. Conway, throughout the 1990s more than 50% of all new drug approvals originated at big pharma companies. By 2001, these companies were responsible for approximately 60% of new drug approvals. However, since then, pharma’s new drug approvals have plunged to 25% to 30% of annual totals. Some analysts suggest that the figure has been as low as 15%. The decline in new drug approvals almost parallels the decrease in R&D spending at most major pharmaceutical companies. Many industry analysts and thought leaders contend that big pharma companies have gotten too big and unwieldy and can no longer innovate. The unprecedented drops in pharma’s new drug approval rates tend to support that assertion. Mr. Conway points out that the so-called “innovation gap” has been filled by biopharmaceutical companies that “today account for 75% or more of new therapeutics developed each year.”

These changing market dynamics suggests that big pharma must reconfigure the business model that it has clung to for the past 50 years to remain competitive. Not surprisingly, almost all of the major pharmaceutical companies have begun to do just that! For example, over the past three years more than 60,000 R&D scientists have lost their jobs with little likelihood that the vacated jobs will ever be resurrected. Further, big pharmaceutical companies have increasingly begun to outsource many R&D activities to Asia, Eastern Europe and elsewhere. Finally, most big pharma companies have publicly demonstrated—through mergers and acquisitions—that biotechnology products as well as small molecules are in their future.

While big pharma may be retrenching and evolving, don’t expect the pharmaceutical industry on internal drug discovery initiatives —or small molecules for that matter— to disappear any time soon. The industry is going through a transitional period and the companies of the future will look only slightly different than they do today. These companies will still be large and well capitalized, but likely more diversified in their product portfolios (which will surely contain biotechnology drugs). Also, they will continue to excel in new product development, marketing and distribution. However, unlike the past, much less emphasis will be placed on internal R&D programs to discover new molecular entities. This means that pharmaceutical R&D operations will remain lean and companies will increasingly rely on M &A and licensing deals (with smaller specialty pharma and biotechnology companies) to keep their pipelines full.

Until next time...

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

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The drug maker Eli Lilly and Co quietly launched a new website today for a program dubbed Lilly Phenotypic Drug Discovery Initiative or PD². According to the company, “The PD² initiative is a unique opportunity for investigators from external institutions to submit proprietary compounds for potential screening in Lilly's phenotypic assay panel. This highly collaborative process is enabled by a web-based application that facilitates efficient transfer of information between Lilly and the investigator. The PD² screening panel is currently comprised of five modules which are relevant to therapeutic areas of long-term strategic interest, including oncology, neurological disorders, and metabolic diseases. This panel may change over time to reflect additional research interests.”

Company officials believe that program will allow it to evaluate and possibly license treatments from biotech companies and academic institutions "that are never fully evaluated as potential drug candidates." The launch of the PD² website—perhaps the first of its kind—clearly sends a signal that pharmaceutical companies are reducing their reliance on internal discovery programs to identify prospective new molecular entities and are eager to enter into licensing deals to find and acquire them. 

Membership in the PD² requires that a legal representative from the investigator's academic institution or biotech company executes a Material Transfer Agreement (MTA). Once the MTA is reviewed and approved by Lilly officials, the institution can create an account. Until that time, use of the site is limited to browsing only. I have no doubt that technology transfer offices at most major universities will be signing up for membership in short order.

I think the PD² initiative is an innovative and timely one given the massive reductions in R&D jobs that have taken place at many pharma companies over the past two years. Expect other pharma companies to follow Lilly’s lead.

Until next time....

Good Luck and Good Job Hunting!!!!!

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As many of you may know, I attend national science meetings where I offer resume critiquing services and give career development seminars on topics ranging from resume writing to alternate career opportunities for life scientists. Frequently, I critique the resumes of foreign PhD students and postdocs who want remain in the US but cannot for a variety of reasons related to visa status. I usually tell them that there are more job opportunities for them in their home countries; usually India and China, than there are in the US which no longer has a great demand for R&D scientists. 

Until recently, I hadn’t heard of any Asian recruiting firms or organizations that would help to find jobs for US-trained life scientists. Much to my surprise, I heard from Shyam Suryanarayanan, an entrepreneur who started a recruiting organization called ABLE C-Drive that helps place US-trained Indian nationals into life science jobs at Indian pharmaceutical and biotechnology companies.   I asked Shyam to send me a description of the services offered by ABLE C-Drive. Here is what he wrote:

"ABLE C-DRIVE (www.cdrivejobs.com) is a specialist Life Science Career Platform for the Indian Life Science Industry.  It is an initiative launched by C-DRIVE ( a specialist Life Science Career Solutions Company), in collaboration with ABLE - (Association of Biotechnology Led Enterprises), the Industry Association and the face of the Indian Biotech sector. The company is a pioneering initiative in the Indian Life Science Careers space to help Life Science Professionals be accessible/visible to a whole host of hiring organizations in a discreet manner, with a view to getting hired.  The 'Returning Indian' Community is a preferred group, given their strong training and experience in World Class research labs.

The list of companies hiring from this platform includes a mix of large global home grown leaders, as well as exciting small and medium-sized outfits across pharma, biotech, agricultural sciences (nutraceuticals), bioinformatics, clinical research, contract research and manufacturing." 

Our platform is a boon to hiring companies, because it is a single destination for pre-screened, quality life science professionals which significantly lower the cost, time and effort required for hiring. For additional information, please visit www.cdrivejobs.com or send your resume to lifejobs@cdrivecareers.com”

Those of you who are seeking life sciences jobs in India ought to check ABLE-C Drive out!

Until next time...

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

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

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

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

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

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

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

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

Until next time...

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

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Over the past three years, more than 90,000 pharmaceutical employees have been layed off. While many of these former employees were drug reps, a majority who lost their jobs were R&D scientists. If drug makers have already jettisioned tens of thousands of R&D jobs, how is the next generation of medicines going to be discovered and developed? Like it or not, pharmaceutical and biotechnology R&D is beginning to be outsourced—much like information technology (IT) was in the late 1990s. And, like the IT industry much of R&D is being outsourced to countries like India and China. This should not be surprising because for the past 20 years or so, most of the people receiving PhDs in the life sciences were foreign nationals—many of whom were unable to stay in the US because of post-9/11 immigration policies and visa quotas. Without many options, many had no choice but to return to their home countries to seek employment and in some at contract research organizations (CROs) that specialize in pharmaceutical and biotechnology R&D.

According to a recent article written by J B Gupta Senior Vice President Collaborative Research GVK Biosciences Pvt. Ltd. India, for the last five years or so, Indian CROs like GVK Biosciences, Aurigene, Syngene, Advinus, Jubilant, Suven Life Sciences, Sai Lab, Accunova, iGate etc. have been positioning themselves as purveyors of R&D services to pharmaceutical and biotechnology companies. These efforts have apparently paid off! Companies like Merck, GlaxoSmithKline, Forrest Laboratories, Eli Lilly & Co, Johnson & Johnson, Merck Serono, Wyeth, Bristol Myers Squibb and others have entered into strategic R&D partnerships with many of India’s leading CROs. 

A recent study by the Kauffman Foundation suggests that India better positioned and ahead of China in R&D outsourcing. Further, the pace at which discovery collaborations are being established in India suggests that the western pharmaceutical industry is looking to Indian CROs not only to cut costs but to innovate as well.

Unfortunately, while this doesn’t bode well for American scientists, the US has nobody to blame but itself. Wrong-headed immigration policies coupled with inadequate training for life scientists who want to pursue industrial careers are largely responsible for the current R&D outsourcing activities. Like IT, I suspect that outsourcing will work for some companies but not others. Nevertheless, I think that outsourcing is here to stay and like it or not American life scientists will have no choice but to adapt to the “new normal.”

Until next time...

Good Luck and Good Job Hunting (try India or China)

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The relationship between science, education and industry has always been a tenuous one. To learn more about the complexity of this relationship check out this article that was recently published in a local New Jersey business publication.

Until next time…

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

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As you all know by now, American pharmaceutical companies have been intermittently laying off thousands of employees for the past two years or so. Many of the employees who have lost their jobs are R& D scientists, marketing personnel and sales representatives. This seemingly makes sense—because fewer drugs are being discovered and brought to market, fewer people are required to market and sell them. That said, isn’t discovering new drugs the currency and lifeblood of the pharmaceutical industry? How do these companies plan to stay in business if they continue to layoff employees who are seemingly responsible for developing new sources of revenue for them? Taking their cues from the IT and software industries, many US drug makers are beginning to either transfer R&D operations to foreign, company-owned research facilities or outsourcing some or all R&D activities to foreign contract research organizations (CROs).

For those of you who may not know, US pharmaceutical companies have been routinely outsourcing various aspects of R&D and drug manufacturing for many years. For example, a majority of the active pharmaceutical ingredients (APIs) and excipients found in many drug sold in the US are routinely manufactured in places like China, India and elsewhere. Until recently, many pharmaceutical companies were reluctant to outsource many critical R&D activities, e.g., screening, medicinal chemistry, pre-clinical testing, etc. for fear of inferior quality. However, the increasing costs of conducting US-based R&D coupled with a worldwide glut of American-trained, foreign scientists (who were unable or not permitted to find jobs in the US) has made the practice of outsourcing R&D operations less risky and more economically feasible. After all, many of the scientists who work in company-owned foreign research facilities or foreign-owned CROs were trained by American scientists who work at some of America’s pre-eminent academic and government research institutions.

From a business perspective, it makes complete sense that pharmaceutical companies might opt to transfer or outsource R&D operations to foreign countries—the quality is good and it is much cheaper! That said, don’t expect the price of pharmaceutical drugs to plummet anytime soon as more drug makers outsource or expand their R&D operations in foreign countries. Put simply, pharmaceutical companies are outsourcing R&D to cut costs, drive up stock share prices and insure financial growth by preserving the staggering product profit margins that they currently enjoy. Take Bristol-Myers Squibb (BMS) for example. Late last Wednesday, its CFO told a group of financial analysts and investors that the company plans on trimming $2.5 billion by 2012 from its operating budget through US job cuts and revamping operations. Shortly after the announcement, I read with amazement that BMS is expanding its R&D operations in Bangalore, India and that they are looking to hire no fewer than five new Department heads—America’s loss is India’s gain!

While outsourcing or expanding R&D operations in foreign countries at the expense of American workers may help the bottom line of many US drug makers, it will do precious little to reverse the decade-long, decline of America’s global competitiveness in science and technology.

Until next time…

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

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