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Recruiting, retaining and managing patients that participate in clinical trials for approval of new medicines and devices have becoming very challenging in the past decade or more. Ironically, the ready availability of experimental new medicines in the US for certain therapeutic areas including oncology, neuroscience and vaccines have forced life sciences companies and CROs to conduct many Phase I and Phase II trials outside of the US. In turn, the globalization of clinical trials has forced many sponsors to increasingly rely on e-based and mobile solutions for patient recruitment, retention and compliance.

The Advance Learning Institute’s conference entitled “Patient Recruitment, Compliance And Retention For Clinical Trials: Integrating The Latest Technologies With Traditional Tools To Maximize Patient Engagement” that will be held in Manhattan on October 24-26, 2011 will provide attendees with insights into the best practices to maximize patient engaged in clinical trials. Presentations will be given by a variety of pharmaceutical companies, CROs and academic institutions including Pfizer, Merck Research Laboratories, Shire Pharmaceuticals, Celgene Corporation, Quintiles, Omniscience Mobile, Albert Einstein College of Medicine and the Michael J. Fox Foundation for Parkinson’s Research. A complete agenda for the conference can be found here.

Those of you who mention BioJobBlog or BioCrowd when registering for the conference will receive a $200 registration discount.

See you at the meeting!!!!!!!

Until next time...

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

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Late last Friday, Sanofi-Aventis announced that it was restructuring it US pharmaceutical business to meet the demands of a more challenging American healthcare market. The company said that it will streamline U.S. Pharmaceutical Operations and reduce its workforce by an estimated 25 percent. This translates into eliminating approximately 1,700 positions. Decisions about the breadth and scope of the cuts will be finalized by mid-December.

Of the 13,000 US employees, 6,900 work in the Pharmaceutical Operations division. Other Sanofi-Aventis affiliates in the United States include its R&D group, Sanofi Pasteur Vaccines, BiPar and Chattem: its consumer healthcare business.

According to Gregory Irace, President of Sanofi-Aventis and CEO of Sanofi-Aventis US/.Canada Pharmaceutical Operations,

“Given the serious challenges facing our organization and the healthcare industry, it is important to act decisively now so that our organization has greater stability moving forward and that our resources are allocated to our strategic growth priorities. These changes will foster a renewed focus on the strong growth and pipeline opportunities that will drive our vision of being a diversified healthcare leader.” Sanofi faces a serious “patent cliff” in the very near future; mainly because its top selling anti-clotting drug Plavix is slated to lose patent protection in 2011. Also, the company lacks expertise in biotechnology: the discipline that most big pharma companies is going to drive future growth in the industry."

The lack of biotechnology prowess is largely responsible for Sanofi’s attempt to purchase Genzyme, one of the largest and profitable biotechnology companies in the world.

Last week, Sanofi confirmed that its bid for Genzyme had become hostile because its management team and board of directors failed to seriously consider a bid tendered at $69 per share or $18.5 billion. Genzyme’s management team and board of directors immediately rejected the hostile bid (as it did in the past when the offer was “friendly”). The hostile bid allows Sanofi-Aventis to bypass Genzyme’s Board and appeal directly to its shareholders to consider the offer.

Restructuring of its US pharmaceutical operations, may be a sign that Sanofi-Aventis is attempting to cut costs to finance the all cash deal.

I suspect that Sanofi-Aventis will prevail in its bid for Genzyme; but it will have to sweeten the offer to appease activist investor Carl Icahn who is likely seeking an offer in excess of $75 per share.

If I were a betting man, I would put my money on Icahn—a brilliant financial strategist who frequently gets what he wants

Stay tuned for more late-breaking Sanofi-Aventis/Genzyme news!

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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