The Other Shoe Has Finally Dropped: Merck to Eliminate 8,500 Jobs

Posted in BioBusiness, BioJobBuzz

After Merck rehired Roger Perlmutter to replace Peter Kim as head of R&D (he left Merck about 10 years ago to lead Amgen R&D), it was pretty obvious that reorganization and job cuts were likely. However, it was not clear, until today, how extensive the cuts would be and what exactly what would be changing at Merck.

Today, Merck revealed plans to eliminate about 8,500 jobs–mainly in R&D, marketing and sales–in an attempt to save $2.5 billion by the end of 2015. In addition to the job cuts, R&D focus will be shifting and Merck’s headquarters will be relocated again (it was moved from Whitehouse Station to Summit several years ago) to Kenilworth, NJ (the former headquarters of Schering Plough which Merck purchased for roughly $41 billion in 2009)

According to a post at the Pharmalot Blog, while it is not exactly clear where the job cuts will take place, most industry insiders expect that the majority of them will likely take place in NJ.  The shift in R&D focus is intended to emphasize oncology, diabetes, acute hospital care, vaccines, oncology and a greater effort in biologics. Further the company intends to either license or discontinue research on “selected late-stage compounds” and reduce its investment in “platform technologies.”

Once one of America’s preeminent pharmaceutical companies, Merck has stumbled over the past decade (with the Vioxx scandal and the Vytorin and Zetia controversies) and it continues to struggle with regulatory approval of some of its new medicines. Perlmutter was hired to transform R&D and bring his expertise in oncology to bear at Merck.

Time will tell.

Until next time…

Good Luck and Good Job Hunting!!!!!

A Possible Dark Side of a Career in Big Data Management

Posted in Career Advice

For the past year or so, I have been touting the job opportunities in the field of “big data” in which massive amounts of personal data including medical information, social media usage, mobile device usage, buying behaviors, etc are accumulated, analyzed and used for marketing purposes. While there may be growing career opportunities for life scientists in the field, especially bioinformaticists, computational biologists and database managers, before you take the plunge you may want to read an article in today’s NY Times entitled “You For Sale: Mapping, and Sharing the Consumer Genome” (great title for us biologists).

The articles walks readers through how Acxiom —a 40 year old data mining company and the second largest provider of consumer information in the US—mines and “refines” (Acxiom executives call what they do, refining rather than mining”) personal information and sells it to paying customers. Admittedly, I previously knew little about how data mining algorithms work but I must say reading the article provided me with me insights and clarity about the pervasiveness and potential for misuse and abuse of the services and features offered by Acxiom and other companies of its ilk. BTW, the largest provider of data mining services in the US is Epsilon.

According to the article, “Acxiom maintains its own database on about 190 million individuals and 126 million households in theUnited States. Separately, it manages customer databases for or works with 47 of the Fortune 100 companies.” And, not surprisingly the company hires top talent from the software industry including its CEOScottE. Howe, previously a corporate vice President of advertising at Microsoft and Phil Mui, formerly group product manager for Google Analytics as it chief product and engineering officer.

There is little doubt that electronic healthcare records will help to improve patient access and health outcomes once it is fully implemented. And, the success of this new industry will be contingent upon hiring talented biologists, healthcare professionals and software engineers. But, for every benefit that a new technology can bestow upon humanity, there is always a down side.

To that point, it is important to get a complete picture of an industry before you make a decision about a career in it! If big data management is the direction that you want your career to take, then go for it but remember to keep your “eyes and ears open.”

Until next time…

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

 

 

So You Want To Be A Regulatory Affairs Professional?

Posted in BioEducation

As anyone who works in the drug development industry and they will invariably tell you how complex the environment has become in the past 10 years to get a new drug or medical device approved. While this increased regulatory scrutiny has been brought on by drug and device makers themselves (has there been a time over the past decade when there has not been some reports in the news media about drug recalls, tainted drugs or marketing scandals?), it does not obviate the growing need for more regulatory affairs professionals at drug and medical devices companies. To that end, people looking to break into the life sciences industry ought to consider whether becoming a regulatory affairs professional may be right for them.

Zachary Brousseau, who is Senior Manager of Communications for the trade group the Regulatory Affairs Professional Society (RAPS), alerted me to a recent annual survey conducted by the group entitled “Global Scope of Practice and Compensation Survey”. This survey which has been conducted by RAPS for the past 20 years provides insights into the regulatory affairs profession and the compensation persons interested in this career might expect.

I highly recommend those of you who are considering regulatory affairs careers to read the post below and to also look at the entire survey. Also, RAPS offers traditional classroom and online courses for those who are looking for training to break into the profession.

RAPS Scope of Practice Study: Tracking the Regulatory Profession

RAPS recently fielded the 2012 iteration of its ongoing research initiative on the regulatory profession, the RAPS Global Scope of Practice & Compensation Survey.

This research has been conducted by RAPS for more than 20 years, and it continues to be the largest, most comprehensive study of the healthcare product regulatory profession. RAPS Executive Director Sherry Keramidas, PhD, FASAE, CAE, recently spoke with Regulatory Focus about the study and its implications.

Regulatory Focus (RF): What is the goal of the Scope of Practice Survey?

RAPS Executive Director Sherry Keramidas (SK): The Scope of Practice Survey gives us a look at the development of the regulatory profession, monitoring trends and changes in what we call the scope of practice: the duties and responsibilities of regulatory professionals. It also gives us a look at their career progression and compensation.

RF: Why is it important?

SK: Like any profession, the regulatory profession must adapt and evolve. This research provides a way of seeing how it has adapted and changed over time, and gives us insight that helps regulatory professionals respond to the changing needs and anticipate what may be coming next. What we learn helps RAPS create and improve professional development initiatives to ensure regulatory professionals have the knowledge and skills to excel in their roles today and tomorrow. It also provides critical information for RAPS to help the world beyond the profession understand what regulatory professionals do and its importance.

RF: What have you learned about the regulatory profession from previous surveys and what do you expect to learn from the current survey?

SK: We have seen a number of important developments over the 20-plus years we have been conducting this research. We have seen increased movement of professionals across product lines—from more pharma-oriented jobs to medical device jobs and vice versa, and we have witnessed increased involvement in combination products. We have seen a trend away from country-specific specialization to more professionals who have multinational or worldwide responsibilities. And we see strong similarities in the scope of practice of professionals around the world, regardless of where they live and work. Today’s regulatory professionals have to be more familiar with regulations and requirements for many different global markets and different products. There is still specialization, certainly, but there is an increasing need for regulatory professionals to understand the broader regulatory landscape. Another interesting development has been that regulatory professionals have become more involved in business and strategic decision making. I would expect each of these trends to continue.

RF: What do you think is driving the increasing involvement in business?

SK: The shift toward more business involvement is something we started to see more than 10 years ago. I think the increasing number of regulatory professionals ascending to higher executive levels played a role in companies’ and organizations’ burgeoning recognition that regulatory expertise can provide valuable insight to drive more-effective organizational strategies. The fact that regulatory professionals were increasingly being called upon to influence business and strategy decisions led RAPS to launch its Executive Development Program in partnership with the Kellogg School of Business at Northwestern University. That is a pretty good example of how this research helped RAPS identify and respond to a growing need within the profession.

RF: What other changes in the profession have you seen, and what do you think is driving them?

SK: Another trend and an important factor, I think, in the business involvement has been regulatory’s increasing engagement throughout the product lifecycle. This made regulatory professionals more important players in all aspects of healthcare products—from research and development through postmarketing. Regulatory has a role at every stage, whereas years ago, the emphasis for regulatory professionals was on submissions and compliance. This change aligns with what is going on in the overall the healthcare product sector. In recent years, we have seen industry’s focus shift a bit toward more postmarketing activities and keeping existing products on the market.

RF: Have there been any surprising results from past years’ surveys?

SK: I don’t think we expected to see the business involvement when it first emerged. Other interesting trends we have seen develop include increased engagement in reimbursement and health technology assessment. Issues of regulation and reimbursement are more often being considered in coordination with one another at earlier stages. A viable product needs to be both approvable and reimbursable, and regulatory professionals are increasingly being asked to help bridge the gap between the two areas.

RF: What new questions have been added to the survey this year? What do you hope to glean from these questions?

SK: We have refined the breakdown of where regulatory professionals spend their time based on feedback from those in the field, and we have added some new questions about what brought them into the profession in the first place and what factors help shape their career decisions. For organizations that employ regulatory people, there is a need to find the best way to recruit, develop and retain regulatory professionals. More information will help both professionals and employers better address career development and talent management.

RF: What can the Scope of Practice survey tell us about the importance of the regulatory profession?

SK: The profession continues to evolve closely in step with the overall healthcare product sector, including the pharmaceutical, medical device and biotechnology industries. Translating scientific and technological breakthroughs in these areas into real, accessible patient treatments demands that regulation keeps pace. In many ways, the regulatory profession is on the cutting edge, at the intersection of innovation, regulation and business. There is a growing recognition of the critical role of regulatory professionals, even as work remains to help those outside the profession more fully understand what they do. Regulatory professionals do important work that, as RAPS’ tagline says, ‘helps make better healthcare products possible.’ The Scope of Practice Study helps us tell this important story.

The 2012 RAPS Global Scope of Practice & Compensation Survey is open now, and regulatory professionals can complete it online at www.raps.org/2012globalstudy.

Until next time

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

 

An Analysis: Big Pharma and Social Media Usage

Posted in Social Media

A study conducted in November 2011 by Cegedim Strategic Data, a market research and promotional audit firm analyzed the world’s top 100 pharmaceutical companies expenditure on traditional promotional (marketing spends) and then compared that spending with their presence on Facebook and Twitter.

Not surprisingly, Pfizer, Novartis and Merck (the world’s largest big pharma companies) finished in the top three for traditional promotional spending. However, their use of social media i.e. Twitter and Facebook varied widely. For example, Pfizer—the top promotional spender—was first in its number of Twitter followers and third in the number of likes on Facebook. On the other hand, second ranked Novartis was fifth in the number of Twitter followers and in seventeenth position for likes on Facebook. Finally, third ranked Merck was fifteenth in the number of Twitter followers (third for the number of tweets) and in the tenth position for the number of likes on Facebook (but has more pages than any of its Facebook competitors).

Other notable companies included:

  • Johnson &Johnson, eleventh in promotional spending and number two on the number of Facebook likes
  • Roche, number fifteen on the promotional spending list was ranked number two for the number of Twitter followers
  • Proctor and Gamble which ranked a distant 54th in promotional spending was number four on the Twitter follower list

What does this all mean? A whole lot of nothing because nobody can determine what effects the use of social media has on the bottom line for most pharmaceutical companies. Unlike other industries, where social media can be used to sell products, it cannot be used for direct promotional purposes in the life sciences industry. While most people will tell you this is because of the lack of guidance by FDA on the use of social media, the bottom line is that social media will never be allowed for direct-to-consumer advertising in the pharmaceutical industry. That said, pharma and biotech will have to find other uses for social media including clinical trial recruitment and retention, adverse event reporting, employee recruitment and retention and education and outreach.

Until next time…

Good Luck and Good Tweeting (and Liking)

 

EyeonFDA Blog: Why FDA Needs to Be Clear About Social Media

Posted in Social Media

Mark Senak, author of the EyeonFDA blog and a life sciences/healthcare social media enthusiast, wrote a fantastic piece yesterday that provides cogent ideas and insights into the need for FDA to expeditiously craft guidance on the use of social media in the pharmaceutical and healthcare industries.

Here are the facts. First, according to the Pew Internet and American Life Project, social media has fundamentally changed the way in which we interact with one another and ushered in a new era of communication. Unlike the old, so-called “broadcast communication method”—information is continuously streamed from a static source, websites, television, radio etc, to perspective customers and stakeholders—the new paradigm requires that communications must be personal, portable and participatory for effective messaging. Second, the primary source of information sought by most persons who use the Internet is healthcare and medical information. While much of the content is accurate, some is not; which may put persons seeking medical information at great risk. In other words, social media is not just about marketing and medical education; it is also about preserving public health.

The agency has historically been unable to issue guidance on new forms of communication. For example, FDA held its first public meeting in 1996 on Internet use by life sciences and healthcare companies. Sadly, the agency has yet to issue any official guidance on this topic. In late 2009, FDA held another public meeting and promised that draft guidance on the internet and social media would be forthcoming by the end of 2010. Unfortunately the guidance did not materialize in 2010 and it has been delayed twice in 2011. Recently, the agency publicly reaffirmed its commitment to issuing the guidance but without a specific timetable for its release. Consequently, it is anyone’s guess when or if the guidance will be released.

Unlike many, I do not believe that FDA guidance on the Internet and social media is absolutely necessary. However, I will admit that issuance of said guidance will provide drug and healthcare companies with some of the assurances that they need in order to actively use social media to engage patients, physicians and other stakeholders. For this reason alone, FDA ought to issue the guidance (which is never perfect and always a work in progress) and end the social media stalemate that currently exists. Failure to do so may have serious consequences on the public health of many Americans.

Hat tip to Mark!

Until next time…

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

 

Okay, Maybe Big Pharma Layoffs Are Not Over: AstraZeneca to Eliminate 400 US Jobs

Posted in BioJobBuzz

Astra Zeneca today announced that it will eliminate 400 positions at the company’s Wilmington, DE headquarters. Most of the cuts will be in sales and marketing and the downsizing is intended “streamline portions of its commercial business to best serve patients in the US.”

According to a press release, about 70 of the estimated 400 job cuts will come from existing unfilled vacancies. Also, employees will have the option to choose to potentially leave the company with a possible package. All decisions will be finalized by early December.

Like many of its competitors, AstraZeneca is facing fierce competition from generic manufacturers and downward pricing pressures. The company currently employs 61,000 persons worldwide including 14,000 in North America.

Until next time…

Good Luck and Good Job Hunting!!!

 

Boston-Based Life Sciences Job Opportunities

Posted in BioJobBuzz

Interest in the diagnostic sector of the life sciences industry began to wane shortly after development of a test for HIV in the 1980s. However, the emergence of molecular diagnostics and personalized medicine coupled with the 2001 anthrax attacks and the SARS outbreak have helped to reinvigorate this sector. In fact, the diagnostic industry is one of the fastest growing segments of today’s life sciences industry. 

For those of you who may not know, diagnostics tests are regulated in the US as medical devices not therapeutic entities. And, for the most part, the regulatory approval process for diagnostic tests is less stringent and quicker than that required for FDA approval of new therapeutic agents.

Unlike most pharmaceutical and biotechnology companies, companies focused on developing new diagnostic products are hiring. Boston-based Immunetics, a diagnostic company that focuses on developing tests to detect viral and bacterial pathogens including HIV, anthrax and others, is currently looking to hire a regulatory affairs and sales and marketing professional (Product Manager). 

The requirements for the regulatory affairs position can be found here whereas the qualifications for the sales and marketing opportunity can be found here. Neither of the two positions requires a PhD degree. However, persons with PhD degree who possess a strong background in regulatory affairs or pharmaceutical sales and marketing experience will be considered.

For those of you PhD degree holders out there, getting additional training in regulatory affairs or sales and marketing (for those with a business bent) would be extremely useful for those of you seeking employment in the life sciences or medical devices industries.

Until next time…

Good Luck and Good Job Hunting!!!

 

The Hidden Costs Of Prescription Drug Development That Nobody Likes To Talk About!

Posted in BioBusiness

Depending upon the source, the cost of bringing a new prescription drug to market these days ranges from roughly $1.2 to 1.5 billion. While there is no question that clinical studies represent the most costly aspect of getting new drugs approved, the hidden costs—mainly promotion and marketing—are what actually inflate the costs of new drug development. Not surprisingly, drugmakers fail to disclose that these costs are included in the estimates for new drug development. If these costs were eliminated from the total, then the cost of developing new drugs will be significantly less than the current $1.2 to $1.5 billion price tag.

I suspect that many BioJobBlog readers—mainly those who work in the drug industry—will likely write me off as someone who doesn’t know what he is talking about. But, an interesting tidbit that I found in an article in today’s New York Times entitled “A Fight Over How Drugs are Pitched” suggests that my claims ought not be summarily dismissed simply because I am a “left-leaning histrionic democrat.” To wit, according to IMS Health (a competitive intelligence firm that tracks physician prescription rates) in 2009 alone, the branded prescription drug industry spent about $6.3 billion on marketing visits to doctors! This amount does not include costs associated with marketing and advertising that support direct-to-consumer (DTC) advertising campaigns that are run by companies that sell approved prescription drugs. DTC costs are generally much higher than those spent on direct marketing to physicians.

It is important to remember that a drug maker’s main goal is to convince physicians to prescribe “their” drugs. After all, physicians not patients write prescriptions! That said, physician prescribing behaviors are vitally important to the success or failure of a marketed prescription drug. Consequently, it should come as no surprise that marketing costs are factored into the cost associated with new drug development. Obviously, if less money was spent on marketing than the cost of bringing new drugs to market would likely be substantially less.

Interestingly, the States of Vermont, New Hampshire and Maine recently enacted laws to limit the uses of a doctor’s prescription records for marketing. On Tuesday, the US Supreme Court will hear arguments in a case, Sorrell v. IMS Health that tests whether Vermont’s prescription confidentiality law violates the free speech protections of the First Amendment. The federal government, the attorneys general of several dozen states, AARP, professional medical associations, privacy groups and the New England Journal of Medicine have filed briefs in support of Vermont’s law. The National Association of Chain Drugstores, the Association of National Advertisers and news organizations like Bloomberg and The Associated Press have filed briefs aligning themselves with the data firm.

Although a Vermont federal district court upheld the law after a lawsuit challenging the statute brought by IMS Health and the Pharmaceutical Research and Manufacturers of America, an appellate court overturned the decision suggesting that it violates free speech provisions afforded by the First Amendment of the US constitution.

It will be interesting to see how the “Supremes” adjudicate the appeal given the growing recognition that laws and regulations designed to control medical costs and minimize safety risks associated with newly approved drugs are becoming increasingly necessary.

Until next time…

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

 

FDA Delays Social Media Guidance Yet Again!

Posted in Social Media

The Pharmalot Blog today reported that FDA, for the second time in four months, has postponed plans to issue its widely anticipated guidance on social media. Guidance was initially expected last December. When FDA announced it wasn’t going to be able to make its original deadline, the guidance was rescheduled for release in the first quarter of 2011, which was presumably was to occur this month. At this point it is anyone’s guess as to when the long awaited guidance document(s) will be issued by the agency.

According to the Pharmalot post the guidance will address:

“responding to unsolicited requests; fulfilling regulatory requirements when using tools associated with space limitations; fulfilling post-marketing submission requirements; online communications for which manufacturers, packers, or distributors are accountable; use of links on the Internet and correcting misinformation…”

The agency further added:

“We are developing multiple draft guidances to address these topics to benefit industry and the public by ensuring that these draft guidances are meaningful and well thought out when they are issued.”

While many companies still contend that FDA’s guidance will be necessary for them to engage in social media, most have realized that if they wait for the agency’s guidance the social media craze may pass them by; possibly jeopardizing substantial financial opportunities afforded by social media in other industries. The notion that FDA’s guidance on social media will help pharma unravel the so-called social media conundrum is misguided and, in my humble opinion, wishful thinking. 

Companies who are familiar with working with FDA understand that guidance documents may offer some help to better understand certain regulations. But, it is generally up to a company with questions to directly solicit input from the agency rather than rely on an interpretation of a specific guidance recommendation (s). The goal of social media is to promote conversations and provide greater transparency surrounding both business and social interactions. Ironically, it appears the many of the companies that are most anxiously awaiting FDA’s social media guidance are the very ones that want to continue to develop products without involving the agency unless absolutely necessary. Go figure…..

Until next time…

Good Luck and Good Tweeting*

*Although FDA has yet to issue social media for the life sciences industry it has a YouTube Channel, Facebook Page  and at least two twitter accounts (@FDA_Drug_Info and @FDArecalls)!

 

Social Media And Advertising

Posted in BioBusiness

Facebook has over 500 million users and Twitter has close to 175 million who write 95 million tweets daily. Conventionally wisdom suggests that using either of the platforms to advertise or brand a product or service would be a no brainer. However, my experience with paid ads on Facebook (I haven’t tried Twitter yet) suggests that the ROI on using social media to advertise may not be that substantial. There is no question that using social media tools like Facebook, Twitter, GroupOn  to build brand awareness or create a buzz about a product or service or to share coupons is extremely useful. But for straight up advertising and click through rates—not so much!!!

I will be the first to admit that I know little about marketing and advertising (although I did take an advertising class as a microbiology major @Cornell). However, the sheer number of users on Facebook and LinkedIn, suggested that I may be able to grow membership @ BioCrowd and promote readership @ BioJobBlog by advertising on these platforms. To that end,  I invested several hundred dollars into advertising campaigns on both platforms. Unfortunately neither campaign had any noticeable effects on enrollment at BioCrowd or readership at BioJobBlog. I attributed the lack of success of these campaigns to my woeful understanding of the arcane disciplines of marketing and advertising —I am a scientist, after all! 

Imagine my surprise (and delight) when I read an article in a local newspaper entitled “More and More Executives Using Social Media to Promote Business” which described several business owner’s experiences with advertising on social media that were identical to mine! Like me, they thought that advertising on Facebook and other social media platforms was so obvious that they couldn’t pass on the opportunity. Also, like me, they were extremely disappointed with the results. For example, a Princeton, NJ-based clothes retailer (which caters to college students) invested $500 on a Facebook ad. While the ad, that offered 20 percent discounts on clothing, received 1 million page views, not a single one translated into a sale! Others described similar experiences. I guess the old saying “misery loves company” may be apt here.

Although some still consider social media to be a passing fan, I strongly disagree. I think that social media is clearly here to stay and has become an essential way in which we communicate with one another. That said, because social media is only about six years old, it may be too soon to determine whether or not advertising on Facebook, Twitter, LinkedIn or other social media platforms can translate into a reasonable ROI. I guess only time (and money) will tell!

Until next time…

Good Luck and Good Job Hunting!!!!