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Remember when Amgen was the world’s largest and most profitable biotechnology company? That was way back in 2006 before its marketing and sales team got in trouble for “pushing” the sale of its erythropoietin (EPO) product Epogen and Aranesp beyond acceptable patient safety limits. This, along with a relatively thin new drug pipeline, has for the past five years or so relegated the company to second tier biotech company status.

To make matter worse, a company spokesperson mentioned its third-quarter earnings conference call today that the company is

 “...currently evaluating some changes within our Research & Development organization to improve focus and to reallocate resources to key pipeline assets and activities." This typically means that the possibility of layoffs is real. The last major restructuring of the company took place in 2007 and it resulted in the elimination of more than 2,000 jobs worldwide, including about 700 in Thousand Oaks.

This past June, Amgen announced plans to eliminate 134 jobs at two of its manufacturing sites in Colorado.

The company employs about 17,000 people, including about 6,200 in Thousand Oaks. Amgen also has research and development facilities in Thousand Oaks, South San Francisco,; Cambridge and Woburn, Mass.; Seattle; Burnaby, British Columbia, Canada; Abingdon, Cambridge and Uxbridge, Great Britain; and Regensburg, Germany.

In 2010, Amgen's revenue totaled $15.1 billion, while research and development cost $2.9 billion, according to the company. Its net profit last year totaled $4.63 billion, up slightly less than 1 percent from 2009.

Could this signal the beginning of the end of this once formidable biotechnology giant? If I was an Amgen employee I would be feverishly updating my CV right about now!

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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"I want to know if you're somebody who feels comfortable enough to talk about dumb things that you have done or dumb advice that you have taken.  It tells you something about the character of the person."

---Founder and CEO of TheLadders.com, a job search Web site, when asked "What's the most effective question that you use in most interview?"

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About a year ago I posted an article to BioJobBlog that suggested that social media can be leveraged to improve clinical trial recruitment to test investigational new drug candidates. Yesterday, Mark Senak, author of the EyeonFDA posted an article which suggested that the use of video on YouTube and other video-viewing sites makes complete sense to recruit prospective participants for human clinical trials. Here are some of Mark’s thoughts on the topic:

“The reasons I think video is a good way to expose people to learning about clinical trials are multiple. First, it allows me as a prospective clinical trial participant to learn about a clinical trial when I want to learn about it and where I want to learn about it - a hallmark of social media.  Second, it is private - I can learn from a video that can be developed to address a wide range of issues - issues that I might not be so comfortable addressing with a live person.  Thirdly, and perhaps most importantly, I learn about the clinical trials perhaps from someone on a video who is very much like me.  He can be someone with my condition - someone who has gone through a trial, and talk about how his concerns were addressed, what his fears were and what the benefits of participation were.  That, I think, is a much more convincing way to learn about a trial than an ad in a newspaper or even a discussion with a clinical person.  Video can't replace the medical professional, but it sure can get my interest and perhaps trust to make recruitment much easier.”

While the industry’s use of social media for this purpose is not quite there yet, there are some signs that pharmaceutical and biotechnology companies may be trending in that direction. First, a growing number of clinical research organizations (CROs) which help companies plan and manage clinical studies are already using social media tools to recruit prospective clinical trials participants. Second, as Mark reported yesterday, Pfizer launched a YouTube channel called PfizerClinicalTeam last July which presumably would bolster clinical trial recruitment. Unfortunately, as Mark pointed, its most recent video was posted in April, 2010, regarding a new study on schizophrenia. Don’t be surprised if other companies launch social media-focused clinical trials recruitment campaigns in the not too distant future. Like Mark, I believe that social media tools are ideal for this purpose!

In other news, Pfizer, a late entrant to the fledgling pharmaceutical social media space, is showing signs that it is beginning to embrace the social media web. Yesterday, Pfizer and Epocrates announced a collaboration to create an application for the iPhone that gives healthcare providers mobile access to the Pfizer Medical Information Group to obtain medical and science information about Pfizer products or to report adverse events. According to Pfizer, it is creating the app to: “enable easy, direct access to its Medical Information services, via the Epocrates channel, in an effort to enhance the safe and effective use of its medicines, and help improve the quality of patient care.”

Direct access to medical information via mobile devices is growing in popularity among physicians and other healthcare providers because it enables them to get answers on the go without wasting time to fire up a laptop or find a tethered computer to use outside of the clinic.

Despite assertions to the contrary by most pharmaceutical and biotechnology companies, social media tools are ideal vehicles for adverse event reporting and post market drug surveillance activities. Pfizer’s creation of a mobile medical information app coupled with the launch last week of a joint US Food and Drug Administration (FDA) and National Institutes of Health drug safety portal called Safety Reporting Portal (original eh?) suggest that the use of social media tools for online adverse event reporting and drug safety purposes is not too far off. Let’s see what develops over the next year or so after FDA issues regulatory guidance on the use of social media in the life sciences industry.

Until next time...

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

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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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The debate, if you can call it that, over whether or not interactive social media platforms like Facebook and Twitter can be used in the life science industry is moving forward at glacial speed. I decided that it was time to propose some ideas rather than continue to admonish the US Food and Drug Administration (FDA) for a lack of guidance.

There are several reasons which may explain the inertia surrounding the adoption of social media by pharmaceutical, biotechnology and medical devices and diagnostics companies. First, and perhaps foremost, FDA has been consistently reluctant to craft any useful guidance on the use of Web 2.0 technologies for research, clinical or promotional purposes. The FDA’s Division of Drug Marketing, Advertising and Communications (DDMAC) is still trying to figure out how to regulate website content. Is it any wonder that FDA is reluctant to tackle the regulatory implications and issues associated with social media platforms like Facebook and Twitter? Second, a majority of social media advocates— who are leading the charge at many life sciences companies—are marketing and advertising executives who tend to look at social media strictly as a promotional tool. Finally, much of what takes place at life sciences companies is proprietary and confidential—information flow between the company and its employees and the public is fastidiously monitored and tightly regulated. Because of this, the life sciences industry’s “process” is intentionally opaque—which is contrary to the goals of social media which is to promote transparency (or the illusion of it).

There is no doubt that the life sciences industry is the most highly regulated industry on the planet. While this represents a formidable challenge for adoption of social media, it is by no means insurmountable—especially if social media is used for purposes other than branding, marketing and advertising. For example, the most straight forward application of social media at life sciences companies would be in the areas of corporate recruitment and employee retention. Many Fortune 500 companies outside of the life sciences industry have been using Facebook, MySpace and LinkedIn for years for recruiting purposes. While not commonly acknowledged, life sciences companies have quietly begun to use Facebook, LinkedIn and MySpace to recruit prospective employees. Interestingly, the new kid on the block—Twitter—looks to potentially be a more powerful recruiting tool than any of its predecessors. Unfortunately, employee retention is no longer a priority at many companies. However, before the economic meltdown a number of companies, most notably Best Buy, were experimenting with social media to retain talented employees.

Another potential use of social media is for pharmacovigilance and adverse events reporting. Companies with approved products on the market are required by FDA (and other regulatory agencies that approved their products) to set up post marketing surveillance programs for adverse events reporting. By law, companies that receive adverse events reports from consumers, physicians or other entities must report them to the regulatory agencies that approved the product. Regulatory agencies maintain adverse events databases for all approved drugs and devices to monitor drug safety.  If designed and implemented correctly, interactive social media platforms like Facebook and Twitter (which operates in real-time) would make excellent pharmacovigilance and adverse reporting tools. Quite coincidentally, John Mack, who runs the Pharma Marketing Blog, reported a partnership between UCB and PatientsLikeMe.com to create a pharmacovigilance reporting platform for UCB products.

Recruiting patients for participation in clinical trials (to assess efficacy and safety of prospective new drugs) has become extremely challenging over the past few years.Traditional patient recruitment strategies include print, television and radio ads and in some instances, websites. All of these recruitment methods are costly, labor intensive and limited in their effectiveness because they only reach small number of prospective clinical trial participants. I contend that Facebook with over 200 million users, LinkedIn with members in over 140 different countries and Twitter which is growing rapidly would be ideal for clinical trial recruitment and retention purposes. Others have also proposed this idea.

Finally, while the use of social media to promote approved drugs and devices may be difficult because of regulatory constraints, it can be utilized to keep the public informed about prospective new medicines and promote a company’s image or brand. There is no question that the public perception of the pharmaceutical industry has been severely tarnished over the last few years.  The industry’s continued lack of transparency and failure to adequately disclose potential safety risks about some approved products continues perpetuate a negative image. One way to restore public trust and confidence is to use social media to actively engage the public in conversation on wellness, addressing unmet medical needs and prospective new medicines and treatments that are being developed. Also, social media platforms could be employed to showcase community outreach programs and discuss educational initiatives to improve science education and training.

Social media is no longer a new phenomenon or technology. It is a legitimate form of communication which has become an integral part of the Web 2.0 experience. I suspect that the life sciences industry will have to make a decision about social media in the not so distant future—or possibly miss a potentially game-changing business opportunity. And, as Ken Kesey aptly said in Tom Wolfe’s ‘The Electric Kool-Aid Acid Test’—“You’re either on the bus…or off the bus.”

 Until next time...

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

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There is a growing worldwide shortage of nurses and other typically female-dominated medical professionals. The acute shortage of nurses in Europe has induced at least one Czechoslovakian clinic to develop a novel—albeit somewhat controversial— approach to retain and recruit hospital personnel. According to an article in today’s New York Times (which was also reported on NPR several weeks ago) “When Petra Kalivodova, a 31-year-old Czechoslovakian nurse, was considering whether to renew her contract at a private health clinic special perks helped clinch the deal: free German lessons, five weeks of vacation, and a range of plastic-surgery options, including complimentary silicone-enhanced breasts.” She opted for cosmetic breast surgery (which normally cost about $3,500) and also had liposuction on her thighs and stomach citing that she her appearance is important to her and her patients.  Perhaps, more importantly, she could never have afforded to have the procedures done on her current salary which is lower than most bus drivers. Of the 50 nurses working at the clinic, 10 opted for plastic surgery, while several more were considering it. And, at least one male employee is seriously considering liposuction.

While offering plastic surgery as an inducement to recruit and retain hospital employees is somewhat controversial, it highlights the need to improve the salaries and benefits of nursing and other medical care professionals. In many places in Europe, nurses and other hospital employees make considerably less than bus, truck drivers and other non-technical workers. The same is true in the US which has also been experiencing ongoing nursing shortages. But, hospitals and clinics here have yet to offer plastic surgery options to recruit or retain medical and support staff personnel. Unlike Europe, where cosmetic surgery is booming, plastic surgery procedures have dropped about 9 per cent this year as compared with years past.

Like it or not, cosmetic surgery is an option in today’s world and, accordingly, people ought to have the right to choose whether or not it is right for them. However, it is important to remember that cosmetic surgery is invasive and potentially serious medical complications including infection, disfiguration and death can occur. The fact that 20 per cent of the Czech nurses chose cosmetic surgery over more vacation time or free German lessons may be indicative of the growing pressure placed on both women and men to look young, vibrant and remain sexy. Further, there are marketing and employment studies which suggest that younger more attractive people get hired more easily and advance their careers more rapidly than average, older-looking ones.

When Petra Kalivodova, the 31-year-old Czechoslovakian nurse who opted for breast augmentation and liposuction was asked about her choice she said “People of my mother’s generation look down on me for getting the surgery—“I see it in their eyes. But I don’t care. I did this because I wanted to and I didn’t ask anyone’s permission, including my boyfriend.” I think her comments reflect a changing and growing attitude among women 35 and under who believe that personal choice, feminine beauty and pursuing professional careers are no longer mutually exclusive.

Until next time.

Good Luck and Good Job Hunting!!!!

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Using Facebook and Twitter to find jobs is becoming routine in many industries including healthcare. However, the life sciences industry is lagging behind most others when it comes to social media and recruitment. Nevertheless, many companies and academic institutions are beginning to realize that Facebook (FB), Twitter and other science social networks are good source of qualified candidates for  those difficult-to fill job openings. 

Lindsey Pollak, a GenY career guru who, writes on the use of social media for job searching, alerted me to a post (via Twitter @biojobblog) that describes how to effectively use FB to find a job.  While FB may be useful to scientist looking for work, there are many other bioscience social networks like BioCrowd (@biocrowd) that regularly post jobs and career opportunities for life scientists.

Until next time...

Good Luck and Good Job Hunting 

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