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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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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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As many BioJobBlogger readers know, the life sciences industry is highly regulated. And, companies that market and sell drugs must be compliant with the Current Good Manufacturing Practices (CGMPs) mandated by the US Food and Drug Administration (FDA) and other regulatory agencies.

While frequently overlooked, packaging and labeling of approved drugs plays a major role in the quality assurance standards that the FDA demands from licensed drug and devices manufacturers. The CGMPs mandate adherence to a variety of internal and external standards for packaging and labeling drugs. These include managing component materials suppliers and product sampling as well as in-process management of production personnel and the manufacturing process. FDA and other regulatory agencies frequently make changes to update and refine the guidelines for packaging and labeling requirements. Therefore, it is important for quality and manufacturing personnel to remain abreast of the most recent guidance documents issued by the agency.

To that end, the Global Strategic Management Institute (GSMI) is offering a course entitled “Packaging and Labeling for Quality Management Systems” which will be held April 27-28, 2011 in San Diego, CA.

Those who attend this two-day course will:

• Learn best practices for implementing changes in packaging and labeling operations
• Interact with instructor and attendees to assure system and regulation under standing
• De­fine the components of a packaging and labeling system-based inspection
• Establish maintenance standards for documentation and reporting
• Determine validation standards
• Mitigate risk by addressing compliance before inspections
• Communicate, train and set quali­fications for personnel
• Assess development and manufacturing practices that will be targeted
• Provide controls to assure no negative impact on your products quality
• Understand current legislation and trends set by FDA regulations

For more details, please download the brochure for the event by clicking here.

Those who register today will receive a 50% discount on the registration fee for the remaining 15 seats in the course. Also GSMI offer group rates for attend. Please use the promo code “cliffm” when you register.

Until next time...

Good Luck and Good Job Hunting (try regulatory compliance; it is a great career option)

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Mark Senak who writes the EyeonFDA blog has compiled a list of the life sciences companies that presently have a Twitter account and use it. While there are only 12 companies on the list, he provides a nice commentary on their use and makes some recommendations for improvement.

Although I am a staunch supporter of the use of social media in the life sciences, it appears to me that the discussion about its use has been somewhat muted since the FDA convened a public hearing on the topic last month. I suspect that many of the companies and stakeholders who participated in the discussion prior to the FDA meeting are presently in “wait and see” mode. However, don’t be surprised if the social media guidance issued by FDA is lacking and excruciatingly wanting!!!! For those of you who may not be familiar with the ways in which the agency operates, its regulators tend to craft guidance and regulation that are broad, loosely defined and open to interpretation. The agency intentionally crafts its guidance and regulations this way because it doesn’t want its rules and regulations to be “literally interpreted” by companies and other stakeholders. Generally speaking, its regulations represent the “minimum” requirements that must be met in order to insure regulatory compliance. In other words, there is no upper limit on what companies can do to insure compliance but there certainly is a minimum requirement that must be met to avoid regulatory sanctions and penalties. As one lawyer who used to work for the agency shared with me recently, “FDA crafts the regulations but it is left to the companies and courts to interpret them.”

Most of the current discussions about social media and the life sciences industry primarily focus on its use as marketing and promotional vehicle. And, as many of you may already know, FDA isn’t exactly keen or pleased with the current marketing and advertising strategies and practices utilized by a sizeable number of life sciences companies. Perhaps a shift away from marketing and advertising discussions to more regulatory-friendly and practical applications like clinical trials recruitment and public outreach may lead to a more rapid uptake of social media by FDA and life sciences companies? Just sayin’

Until next time...

Good Luck and Good Tweeting!!!!

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For the past year or more, the US media has been vociferously bashing tainted imported Chinese goods any time it can. The tainted products have ranged from toys to dog food and most recently to Baxter’s heparin which has been associated with illnesses and deaths in this country.  

I suspect that this recent spate of China bashing has more to do with political and future economic issues than the safety and well being of the American public. Nevertheless, according to US Food and Drug Administration Current Good Manufacturing Practices (CGMP) regulations, companies that hold the licenses to manufacture pharmaceutical and biotechnology products assume full responsibility for the quality and safety of their products. To accomplish this, companies are required to test all raw materials, excipients and APIs (regardless of their source) before they are assembled to make a finish pharmaceutical or biotechnology product. The results of these tests must be carefully analyzed and compared with the product quality specifications established by the company and approved by FDA. If the test results for product ingredients are outside of the normal range of established specifications, then the company is obliged to reject the materials and not used them to manufacture product. To that end, there was clearly, something was wrong with quality testing at the Baxter heparin manufacturing facility because the adulterated heparin API should have been detected long, before it was used to manufacture the final product. Although the Chinese heparin may have adulterated, the onus was on Baxter (the company that holds the product license) and not the Chinese government to insure its final product met quality standards and was safe for public use.

Outsourcing is a fact of life in almost every sector of the American economy. Pharmaceutical and biotechnology companies import the materials they use in their products from all over the world. It is FDA’s job to insure that American companies remain CGMP compliant so that they produce safe and effective medications. To blame America’s regulatory shortcomings on foreign manufacturers and their governments is dangerous and naïve-not to mention chauvinistic.

Until next time…

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

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