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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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