Bio Job Blog : Bio Jobs : Biotechnology Jobs : Biopharmaceutical Jobs : Bioscience, Biotech Jobs : Bio Job Blog : Biocareer : Bio-Business Training, Biotechnology Training : Jobs in Biology : Internships in Biology : Internships in Biotechnology

For the past decade or more multiple drug resistant strains of bacteria such as methicillin resistant Staphylococcus aureus (MRSA), enterococci and other Gram positive cocci have been highlighted and showcased in the medical and lay press. While the incidence of infections caused by MRSA and other Gram positive cocci has steadily risen, antibacterial drug discovery experts have long known that the greatest disease threat in the future will be from emerging multiple antibiotic resistant strains of Gram negative bacteria including Acinetobacter baumannii, Klebsiella pneumoniae, Serratia marcescens and Pseudomonas aeruginosa.

Last Spring, in an interview that I conducted with Barry Eisenstein, MD, Senior Vice President of Scientific Affairs at Cubist Pharmaceuticals and an antibacterial drug discovery expert, he indicated that there are currently no drugs in development to treat infections caused by antibiotic resistant Gram negative bacteria. He warned that this, coupled with the loss of interest in antibiotic development by large pharmaceutical companies, will cause infections caused by multiple drug resistant Gram negative bacteria to become a serious unmet medical need in the not so distant future. The appearance of an article in the New York Times this past Saturday chronicling the rise of infections caused by antibiotic resistant Gram negative bacterial suggests that the not so distant future may have already arrived! For the record: would newspaper and television reporters please refrain from identifying bacteria as “germs.” It is an anachronistic term which was coined in the 19^th century before bacteria and viruses were conclusively identified as the cause of most infectious diseases.

Despite the media hype about antibiotic resistant Gram positive bacteria, a variety of new drugs have been developed to treat infections caused by these bacteria. Interestingly, because of greater public awareness about MRSA infections and improved hospital infection control and surveillance programs, the incidence of disease caused by MRSA and other Gram positive bacteria is finally beginning to wane. Unfortunately, the same is not true for infections caused by antibiotic resistance Gram negative bacteria.

For those of you who may not know, the cell wall architecture of Gram negative bacteria (and a multitude of antibiotic resistance mechanisms) makes it much more difficult and costly to develop new antibiotics to treat Gram negative infections. Consequently, research in this area has been largely ignored for the past 15 years or so. This means that in the future the morbidity and mortality associated with infections caused by antibiotic resistant Gram negative bacteria is certain to rise. With this in mind, persons at the greatest risk of developing these infections include patients in hospitals and long term care facilities and individuals receiving implantable medical devices.

Because most large pharmaceutical companies abandoned antibiotic drug discovery in the mid to late 1990s, it is unlikely that new Gram negative antibiotics will come from the pharmaceutical sector. While there are several small biopharmaceutical start ups working on antibiotics for Gram negative bacteria (KaloBios Pharmaceuticals, Calixa Therapeutics and Novexel) the increasing regulatory scrutiny and rising development costs suggests that these companies may have trouble bringing new antibiotics to market. Sadly, this places the onus of new Gram negative antibiotic discovery squarely on the shoulders of the US government. To that end, as much as it pains me to say this, it will likely take the death of government official or family member before sufficient resources are allocated to address this rapidly growing unmet medical need. Maybe the Obama Administration ought to think about allocating stimulus monies to begin to address the problem!

Until next time...

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

• Email This
• Print
• Comments (1)
• Trackbacks
• Share Link

Mark Senak, social media enthusiast and author of the EyeonFDA blog, raised the question on his blog today as to whether or not the US Food and Drug Administration (FDA) ought to have a fan page on Facebook: the ever expanding, ubiquitous social media platform. He aptly points out that FDA has already created a channel on YouTube and has a twitter account. So, why not a fan page on Facebook, he asked.

While Mark and I agree on most things, I am not convinced that having an FDA fan page on Facebook would make a difference in the way in which FDA communicates with the American public. FDA is already behind on the social media curve and, as the FDA public hearings held late last year suggest, the agency is struggling with formulating regulatory guidelines for its use by drug and devices manufacturers. Might not creating a FDA fan page on Facebook be the proverbial straw that broke the camel’s (agency) back? 

Perhaps I am overreacting to the whole Facebook phenomenon and grossly under estimating the agency’s capabilities. But I simply don’t get Facebook!  At best, it is overwhelming, difficult to navigate and seemingly cluttered mindless chatter and people engaging in Mafia wars. There is no question that a fan page would increase FDA’s exposure and its “hipness quotient” but to what end? The agency already has trouble maintaining and managing its existing web assets (have you ever tried finding information at FDA.gov?). Adding a new website would simply mean more work for overworked and underpaid government employee who seemingly play by different rules than the outside world.

Don’t get me wrong. I am an avid social media enthusiast who believes that persons who engage in social media must be “all in” to be effective. Having said that, I believe that the agency would be better served if it works to improve the navigability and accessibility to information on its existing web assets. There is no question that building an agency fan page on Facebook may convince Americans that FDA gets “the whole social media thing.” But if the fan page doesn’t provide Americans with relevant and useful scientific, medical and regulatory information, then adding a FDA fan page to Facebook will do little more than increasing the heft of an already bloated social media platform whose utility and effectiveness is already beginning to wane.

In my experience, building a website or fan page is the easy part; continuing to populate the pages and sites with useful, meaningful and temporally-relevant content is the difficult part!

Hat tip to Mark for starting the conversation!

Until next time...

Good Luck and Good Job Hunting!!!!!

• Email This
• Print
• Comments (1)
• Trackbacks
• Share Link

Ed Silverman, over at the newly reinvigorated Pharmalot Blog, today reported that a recent study publicized in the Journal of the American Medical Association showed that, after a decade of doubling, the rate of increase in biomedical research funding slowed from 2003 to 2007, and after adjusted for inflation, the absolute level of funding from the National Institutes of Health and industry appears to have decreased by 2 percent. The NIH remains the largest federal contributor to biomedicalresearch, accounting for 84% of total federal funding in 2007 

Further, the report indicated that research funding provided by pharmaceutical and biotechnology companies and medical devices and diagnostics manufacturers rose from $40 billion in 2003 to $58.6 billion in 2007; an increase (adjusted for inflation) of roughly 25 percent. Most of the funding came from large pharmaceutical companies. Interestingly, however, the sector of the life sciences industry that exhibited the greatest increase in growth over the same period was diagnostic and device makers (59 percent), followed by biotechnology (41 per cent) and lastly, pharmaceutical companies (25 per cent).

While the results of the study are not surprising, it is clear that the life science sector is beginning to focus more on device and diagnostics than on small molecules and even biotechnology products. Further, reductions in federal funding are forcing researchers to increasingly rely on grants and contracts from private sector companies. This suggests that an ever expanding percentage of the research conducted at many academic institutions will be financed and underwritten by for profit companies. Although more product-focused academic research is not necessarily a bad idea, it does call into question the direction and possible breadth of academic research and the availability and sharing of important scientific information, data sets and discoveries. 

Until next time...

Good Luck and Good Grant Writing!!!!!!!!!

• Email This
• Print
• Comments (1)
• Trackbacks
• Share Link

As part of their licensure requirements, all physicians and other healthcare providers (HCPs) in the US must participate in continuing medical education (CME). CME requirements are established on a state-by-state basis HCPs who fail to meet annual quotas face reprimand, censure and possibly loss of their medical licenses. As you may imagine, CME is a big business and, not surprisingly, there is no dearth of CME content developers and providers. Unfortunately, CME course development costs are high and, despite state mandated licensure requirements, no one seems to want to sponsor or underwrite the CME development programs except drug and devices companies. Obviously, this creates the potential for monumental conflicts of interest mainly because physicians and other HCPs are drug and device company primary customers.

While I don’t profess to be an expert on CME rules and regulation, I know that the rules and regulations that guide CME content development have become increasingly restrictive over the past few years. In the past, drug and devices manufacturers were able to identify relevant product-related topics within certain therapeutic areas, engage a CME provider to create a curriculum and then offer a product-focused program to physicians. Today, drug companies aren’t allowed to create CME program built around specific products. Instead, CME developers compete for grant monies from drug and device manufacturers and are asked to create CME around relevant issues in certain therapeutic areas. Of course, most of the companies that award the grants have products in those therapeutic areas; but i digress. Companies that award the grants cannot participate or influence the content that appears in the CME programs. Of course this is impossible!

For example, several years ago I was working at an agency that received a “grant” from a client that was developing a new treatment for a virus-associated metabolic syndrome. While we weren’t allowed to highlight or suggest specific treatment options we did receive in direct and subliminal guidance (through various company channels) regarding messaging around content development. To that end, while the company wasn’t directly involved in content development, its medical affairs and marketing departments were “aware” of the content that we were developing. While this was appropriate and well within regulatory guidelines, it is not difficult to see that potential conflicts of interest and bias may have existed in this instance.

Over the last year or so, questionable medical writing practices and conflict of interest concerns about CME course development have come under intense scrutiny in the US Congress. Consequently, there have been ongoing and repeated calls to prohibit industry participation in CME content development. While this may be a great idea, if drug companies no longer are allowed underwrite or sponsor CME course development, there isn’t likely to be any CME in the future. And, if there is no CME, physicians and other HCPs won’t be able meet state-mandated CME requirements to maintain their licenses to practice? What a conundrum!

One solution to the problem is to require state governments, the American Medical Association, university medical schools, hospitals and other organizations (insurance companies?) to underwrite CME development costs! After all, these are the entities that require CME for HCPs to retain their licenses. While this is a perfectly logical solution to a vexing problem, don’t expect any of them to step up to the plate anytime soon. The bottom line: drug companies support and underwrite CME because they recognize that it is a viable marketing vehicle—albeit a subtle one—that is certain to improve product awareness and ultimately sales. For example, if Pfizer sponsors a CME program on erectile dysfunction at a high end resort in some exotic locale and, its logo or mention of a grant to develop the curriculum is acknowledged, it is not unreasonable to assume that physicians attending the course may possibly choose to prescribe Viagra over a competitor’s product. To make matters worse, CME sponsors often time help to defer costs of hotel accommodations, provide support for meals, and even sponsor receptions for physicians who attend CME training programs.

I suspect that some of you may be wondering why I am ranting and raving about CME today. Well, there was an article in today’s New York Times about Stanford Medical School receiving an unrestricted, three-year $3.0 million grant from Pfizer to develop unspecified new CME curricula for physicians. Philip Pizzo, MD, dean of Stanford’s medical school lauds this as the beginning of a new age in CME and suggests that Pfizer will have no say on how the grant monies will be spent. 

Dr. Pizzo contends that the “no-strings-attached” provisions of the grant will insure that the new curricula will be devoid of drug industry influence that has permeated CME courses in the past. Stanford plans to set up “unbiased programs” of postgraduate education on the Stanford campus rather than the industry-selected topics of the past that have been presented to rooms full of doctors at hotels and resorts.” While the new grant sounds promising, I wonder whether or not Stanford is going to disclose the amount of research funding it annually receives from Pfizer. Further, will faculty members who receive or previously have received research monies from Pfizer be prohibited from contributing to content development?  The point I want to make is that, despite Stanford’s good intentions and assertions to the contrary, there is no way to insure that there will be no bias or conflicts of interest in the new curriculum that is developed. 

Finally, I don’t think that there is any question that CME is essential to insure that Americans receive the latest and best possible medical treatments that are available. However, to insure farness and no bias, drug makers and device manufacturers should not be allowed to underwrite or participate in CME content development. This activity should be in the purview of not-for-profit entities (that don’t receive drug industry money) and state government agencies. Like it or not, we live in a quid pro quo society and drug and devices companies (like all “for profit” companies) don’t make investments unless there is an anticipated or guaranteed return on the investment!

Until next time...

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

• Email This
• Print
• Comments (2)
• Trackbacks
• Share Link

Novartis AG today announced it plans to take over Alcon Inc. by paying $38.5 billion for the 77 percent stake it does not already own in a deal that would make it one of the biggest players in the global market for eye-care products.

The Swiss pharmaceutical and generics giant had already purchased 25 percent of Alcon from Nestle in April 2008 for $11 billion, with the option of buying the food and drinks company's remaining stake at a later date. With the acquisition of Alcon, Novartis will control about 70% of the world’s vision market (it already owns the Ciba Vision brand). Alcon is based in Huenenberg, Switzerland, and has its U.S. headquarters in Fort Worth, Texas. The company employs some 15,000 people worldwide and specializes in surgical equipment and devices, contacts lens solutions and other consumer eye-care products.

Daniel Vasella, MD, Novartis’ Chairman and CEO, said "This is the right time to simplify Alcon's ownership to eliminate uncertainties for employees and shareholders." He added "It will also allow us to strengthen innovation power by combining R&D efforts and grow our global market presence thanks to our complementary product portfolios."

If I were a betting man, I would say that Novartis is the pharmaceutical company to watch over the next decade. Like Johnson and Johnson, the company has diversified its business to include consumer goods, vaccines and perhaps most importantly generic pharmaceuticals via its Sandoz division. One area that Novartis hasn’t fully embraced to date is devices. However, as we enter the age of personalized medicine, don’t be surprised if the company acquires or invests in a variety of medical devices and diagnostic companies!

Until next time...

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

• Email This
• Print
• Comments
• Trackbacks
• Share Link

I realize that I have been blogging about adverse events for the past couple of day but, let’s face it; the pharmaceutical industry lives or dies by the number of adverse events (AEs) that are reported for approved and marketed drugs. In any event, I came upon an interesting post in a Pharmaceutical Processing e-blast about the results of a survey  (conducted by Pfizer) which revealed that physicians are more likely to report side effects and adverse events through an electronic health records (EHR) system as compared with traditional paper methods. Nearly 60 percent of the 300 physicians who responded to the survey also agreed that AE reporting through an EHR would improve patient care.

While the results of the survey are not surprising (to me anyway), they suggest that the use of electronic methods for adverse events reporting may be a boon to drug manufacturers that are required (by FDA and other regulatory agencies) to collect information regarding the safety and tolerability of approved and marketed drugs.

In a previous post, I opined that social media would be an ideal platform for AE reporting. The results of the Pfizer survey tend to support this supposition. While EHR aren’t exactly social media, they are electronic and, it appears to me (based on Pfizer survey results), that healthcare providers and consumers may be more likely to report potential AEs using electronic as compared with conventional methods. Put simply, electronic reporting is much simpler, quicker and more facile than the current pen and paper model for AE reporting. And, in today’s rapidly paced and hectic world, time savings can translate into cost savings and improved efficiencies.

Paradoxically, the Pfizer survey results tend to contradict the notion that social media would be a bane to AE reporting for most drug makers. As I mentioned yesterday, many drug makers who have almost universally shunned social media, contend that the use of social media would overburden their AE reporting systems and possibly put them at enormous legal and regulatory risk. However, as I pointed out many times in the past, AEs are an expected reality in the pharmaceutical, biotechnology and medical devices industries. And, while drug makers are deathly afraid of AEs and reluctant to learn of them, the more information this is available about potential safety and tolerability issues, the better off most drug manufacturers may be. For example, if Merck was alerted earlier about the cardiovascular problems that Vioxx patients were experiencing, then possibly fewer patients may have been affected and harmed and perhaps, an improved version of Vioxx, an effective pain medication, might still be availability to patients who benefit from it.

To that end, providing physicians, healthcare workers and consumers with an accessible e-based AE reporting system built around social media would allow drug makers to quickly determine whether or not one of their drugs exhibits tolerability or safety issues that might warrant further investigation.  And, I believe that putting the appropriate social media AE reporting systems in place would allow drug and device manufacturers to monitor the performance of their products in real time and more accurately monitor, collect and analyze safety and tolerability data for certain drugs. This, in turn, would likely lead to the development of improved safer and more effective medications and devices, lower drug development and manufacturing costs and ultimately reduce drug makers’ exposure to legal and regulatory actions.

Until next time...

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

• Email This
• Print
• Comments
• Trackbacks
• Share Link

Unlike many of my social media colleagues, I’m not attending the FDA public hearing taking place in Washington, D.C today (Friday the 13^th oh my). I wanted to attend and actually testify but I didn’t understand how the process works and blew my opportunity. However, I will be prepared for rounds 2 and 3 and beyond. I can assure you that this will not be the last public meeting organized by the agency to develop guidance for the use of social media in pharmaceutical marketing and advertising. 

The brouhaha over social media and its use in the life sciences industry is purportedly taking place because of the lack of regulatory guidance on the topic. While I agree that FDA needs to craft a reasonable regulatory policy for the use of social media for promotional purposes, the discussion taking place has little to do with the medium and everything to do with the fair balance of ads that are used to promote drug sales. For those of you who may not know, fair balance (in regulatory parlance) means that drug manufacturers are required to fully disclose in print, television, radio and internet ads the benefits as well as the side effects and risks associated with a specific product. Unfortunately, too often, drug makers tend to promote the therapeutic benefits of a drug but downplay its side effects and risks. This isn’t surprising because drug makers, like other for-profit companies, must sell as much product as possible to generate sufficient revenues to remain profitable.  And, as we all know, consumers and physicians are more likely to use or prescribe drugs that have therapeutic benefits without many side effects or risks.

Since the inception of direct-to-consumer advertising, FDA and drug makers have been playing a cat-and mouse-game with the fair balance issue. Most drug makers understand the “balance” that FDA requires for traditional promotional ads, but rather than abide by the rules, many choose to determine how far they can bend the rules before they appear on FDA’s radar. Therefore, it should come as no surprise that drug companies have adopted the same strategy when it comes to Internet advertising and search result ads. To be fair, FDA hasn’t crafted any definitive guidance on Internet advertising or search ad fair balance requirements. However, rather than apply what they have learned over the years about fair balance in print and television advertising, many drug makers chose to ignore fair balance requirements for Internet advertising simply because there are no written regulations or rules. To that end, 14 pharmaceutical and biotechnology companies recently received warning letters about their misuse of promotional drug ads that appeared with Google search results. FDA cited the lack of fair balance in the search ads as reasons for the warning letters. By issuing identical warning letters to 14 different drug companies, the agency was essentially saying “c’mon guys, who are you trying to kid—you ought to know better by now!”

Unfortunately, even when there are regulations, many companies spend hundreds of millions of dollars to look for deficiencies and loopholes that can be exploited to increase and improve drug sales. Therefore, I contend, that regardless of the social media guidance that FDA ultimately issues, drug and device manufacturers will continue to look for work arounds to regulations that they perceive hinder product sales.  

Social media is all about transparency, accessibility and communications between participants. The guidance that FDA issues about the use of social media in the life sciences industry will likely be circumspect and open to interpretation as it usually is. As one FDA legal expert explained to me, “FDA crafts the laws but it is up to the judiciary  to interpret how they ought to be applied.”

I suspect little will change until drug manufacturers realize that full disclosure and transparency, not half-truths and opaqueness, will ultimately lead to improved drug sales in the future.

Until next time...

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

• Email This
• Print
• Comments
• Trackbacks
• Share Link

For the past 10 years or so, I have been providing career counseling and development seminars and workshops for life scientists. In the early years, students, postdocs and a smattering of faculty members would attend to learn about the industry trends, the job market and more recently alternate careers for PhDs and postdoctoral fellows. However, over the last few years, a disturbing trend has emerged—the lack of faculty participation at these events. 

Yesterday, I was invited to participate as a panel member to moderate a career development event sponsored by the graduate student and postdoctoral associations at the University Of Rochester School Of Medicine. The event was well attended (over 85 participants) and the discussion lasted for more than 2 hours. Joining me on the panel was a PhD-trained scientist/manager from Bristol Myers Squibb and a healthcare company executive who received his PhD degree from the university about 16 years ago. Many of the questions asked by the participants were spot on and revealed that graduate students and postdoctoral fellows are extremely anxious about their futures. The panel did its best to describe what it takes to get a job in the life sciences, the process and steps required to successfully win jobs and some ideas for alternate career options for PhD-trained scientists. Unfortunately, not a single University of Rochester medical school faculty member attended the event. In fact, I met the PI of one of the postdocs who sponsored my visit and he said with all sincerity (I think) “Thanks for coming...the students are really looking forward to your talk.” Obviously, I don’t it ever crossed his mind that he, like his students and postdocs might learn and benefit from a discussion about career options and hear (probably for the first time) how anxious and fearful his and other students are about future job prospects.

The fact that faculty members are routinely eschewing career development seminars and forums is troubling and extremely disturbing for a variety of reasons. First, as I have said many times before, I believe that PIs have moral and ethical obligations to help their students determine what careers they are best suited for. I don’t think it is too much to ask or labor-intensive for PIs to learn about what is going on with the job market outside of academia. Despite an ongoing lack of tenured track faculty positions and the extremely fierce competition to win them, academicians continue to exclusively train and prepare students for academic careers. This makes absolutely no sense from a “supply and demand” perspective. Second, the lack of faculty support and participation sends a clear message to graduate students and postdocs that their anxieties, fears and concerns about job prospects simply isn’t that important to their PIs.  The mantra of most academicians —“just continue to do good science and everything will be okay”— is outdated, anachronistic and self serving (for PIs) at best.  Finally, and perhaps most importantly, the failure of  tenured faculty members to actively engage and participate in discussions about career options reveals the unbridled contempt that most academicians have for scientists who work outside of academia. Most academics choose to not concern themselves with non-academic and mundane issues like jobs and careers. And why should they? Once they win tenure, their lives are set because they are guaranteed jobs and benefits for life!

We are living in very challenging and troubling times. In the past three years, over 180,000 pharmaceutical workers lost their jobs and national unemployment will likely hit 15%.  Academic and government jobs are hard to come by and the competition for these jobs is ferocious and extremely competitive. And, sadly, current academic training programs are woefully inadequate to prepare graduate students and postdocs for alternate career opportunities in the life sciences. 

As I have stated numerous times before, life science graduate training programs are in dire need of systemic change and be overhauled to remain relevant. Unfortunately, systemic changes are unlikely because tenured faculty members can’t be forced or induced to change their practices, attitudes or beliefs. While a minority of life sciences faculty members realizes that the system is broken, the majority doesn’t.  To that end, if graduate students and postdoctoral fellows want change to occur than they must band together and collectively send a message to their PIs and mentors that “We are mad as hell and we aren’t going to take it anymore!” Anything short of a widespread massive protest will be ineffectual!

Until next time...

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

• Email This
• Print
• Comments (1)
• Trackbacks
• Share Link

In today’s edition of the incisive EyeonFDA blog, Mark Senak, provides a historical perspective on events leading to the US Food and Drug Administration public hearing on the use of social media and medical promotion that will be held on Thursday and Friday, November 12 and 13, 2009. As Mark points out, registration for the meeting was closed because of an overwhelming response and the number of people who wanted to offer testimony on the topic. Many social media enthusiasts view the public hearing as something of a “game changer” that may influence the future direction of social media in the life sciences industry. But, as Mark, astutely points out, only four pharmaceutical companies and one or two trade organizations will be participating at the hearing. 

The lack of industry participation at the meeting is curious given that 14 companies received warning letters several months ago about their misuse of ad associated with the results obtain by Google search. Further, pharmaceutical companies have consistently and publicly stated that their aversion to social media is contingent upon the lack of FDA’s regulatory guidance for its use. By not actively participating in the public hearings later this week, many pharma companies have chosen to remain silent and will likely allow FDA to craft social media policies that guide the promotional activities of drug makers on its own. This begs the question: why would drug makers allow a federal regulatory agency to unilaterally dictate policy, when the policy will likely affect their bottom lines, i.e. sales and profits? The industry’s refusal to actively participate in these hearings is another example of the cat and mouse game that drug makers like to play with FDA. Put simply, drug makers expect and want FDA to commit (in writing) to certain policies and guidelines and once established, company regulators and lawyers are instructed to find loopholes and work-arounds. I liken the drug industry’s refusal to actively participate in the upcoming public hearings to the now infamous rope-ad-dope strategy Mohammed Ali used to knock out George Foreman in the now infamous Rumble in the Jungle in 1974. This is how wikipedia defines the rope-a-dope: “The rope-a-dope is performed by a boxer assuming a protected stance, in Ali's classic pose, lying against the ropes, and allowing his opponent to hit him, in the hope that the opponent will become tired and make mistakes which the boxer can exploit in a counterattack.” I hope that I am wrong about the drug industry’s strategy and motives.

Without active industry participation it isn’t clear how effective the FDA public hearing on social media will be. As Mark adroitly points out in today’s post, “The bulk of the other presentations are tertiary stakeholders perhaps sensing a vehicle for free self-promotion such as advertising and public relations firms and bloggers, but they aren't the real stakeholders in this issue.  The real stakeholders are those who are referred to in the meeting notice - the medical products industry.” I would also add the American public to the stakeholder list who also has considerable “skin in the game.”

Pharma’s active participation at many of the social media conferences that I recently attended indicates that something must be in it for pharma; otherwise they wouldn’t attend. There is no question that social media isn’t a passing fad and is now an integral part of the Web 2.0 experience. That said, for the first time in many years, drug makers have a unique opportunity to actively voice their ideas and concerns and collaboratively work with FDA to craft meaningful social media regulatory guidance. As many of us “outside observers” know, the agency doesn’t have all the answers and we would like to think that drug makers would extend a helping hand to avoid confusion and misunderstandings about the use of social media to promote their products and services. While only 4 companies are scheduled to speak at the hearings, I suspect that there will be many life science company representatives in attendance. Nevertheless, despite what may happen at this week’s hearings, I hope that, going forward, drug makers and device manufacturers will begin to view FDA as a partner rather than an adversary!

Until next time...

Good Luck and Good Job Hunting!!!!

• Email This
• Print
• Comments
• Trackbacks
• Share Link

The answer to this question is not yet! However, the The Wall Street Journal recently reported that 64% of U.S. physicians are using smart phones (up 50% from two years ago) and increasingly are relying on them to find medical information, manage patients and transmitting clinical data. To that end, a post at the Medical Translation Insights blog discusses the changing role of smart phones in healthcare and the regulatory challenges they may face if classified as medical devices.

 When Cell Phones Become Medical Devices

The definition of "medical device" is shifting, quickly and dramatically.  The revised MDD now includes stand-alone software in the definition. In other words,if software has a medical purpose, it probably can/must be CE marked. And smart phones are quickly becoming the conduit of choice for collecting and researching, disseminating, and evaluating clinical data.

As Bob on Medical Device Software points out, its unique user interface, display, and broadband capabilities make the Apple iPhone a particularly attractive platform for medical applications. For example, the AirStrip OBSERVER suite of applications is custom-designed for the iPhone, makes some components available for download at the Apple App Store, and received FDA clearance for some modalities.

While most medical apps fall into the reference category, applications are getting more sophisticated and are taking advantage of the devices networking abilities. A trio of applications developed by researchers at the University of Utah aptly demonstrate these advances. Another factor is the appeal and widespread use of these devices. The Wall Street Journal reports [login required] today that 64% of U.S. physicians are using smart phones.

There are several big questions and unknowns hanging over these developments: First and foremost, there is the question of data security. As quoted in the same WSJ article, Deborah Peel of Patient Privacy Rights worries that "the vast majority of health information technology has not been designed to ensure that patients control access to that data and use of that data". So, paradoxically, the more ways that doctors can access patients' records, the more their confidentiality is threatened.

Second, what is the quality threshold for smart phone applications? Just because something is on the iPhone doesn't mean it's necessarily a quality application

Regulators around the world are bound to tackle these questions. FDA, for instance, is already looking at this issue and sooner or later will regulate certain phones. It's certainly not the end of the world to be classified as a medical device, but verification and validation of these applications won't be easy.

 As these applications get developed and become part of a networked medical device, language will also become an issue again. Translation service providers will need to become familiar with smart phone development and localization issues and support consistently translated content across multiple platforms and media.

Until next time...

Good Luck and Good Job Hunting

ForeignExchange Translations provides specialized language services to pharmaceutical and medical device companies

• Email This
• Print
• Comments
• Trackbacks
• Share Link

I came across a recent post on Adage.com entitled “Pharma Drops Search Advertising After FDA Warning” that revealed that paid search ads by pharmaceutical companies dropped a 84% between March 26 of this year and the end of June. As you may recall, March 26 was when 14 companies received warning letters from the US Food and Drug Administration (FDA) indicating that they had violated marketing guidelines for search ad advertising. The letters stated that sponsored-link advertisements for specific drugs were misleading due to the exclusion of risk information associated with the use of the drug -- even though the regulatory agency's guidelines are for print and broadcast, not online or social media. Pharma companies that believed they were in compliance with the unwritten "one-click rule"— taking the consumer from the ad to a site that offered fair balance and the risk information by clicking on the ad. What? Did I read that correctly; the words “unwritten and FDA” in the same sentence? This is very surprising since anybody who has worked with the agency is well aware of the “if it isn’t written it didn’t happen” principle. But I digress....

The post went on to say that pharmaceutical companies are “fearful of running afoul” of the agency again. Say what? The words “pharma and fearful” used in the same sentence? The point that I am trying to make is that pharma chose to keep things vague about web-based advertising to see how far they can push the envelope with FDA instead of taking the proverbial “bull by the horns” and directly asking FDA for guidance on web 2.0 technologies and their uses. Wouldn’t it be in everyone’s best interest if companies took a more active role to help craft new rules on the use of new media technologies rather then rely on and wait for FDA to do it for them? While the old “cat and mouse” game worked for old media, it is no longer tenable when it comes to Web 2.0 and related technologies.

The FDA is holding public hearings next month to begin the process of establishing internet advertising guidelines and the use of social media in the life science industry. This offers drug and devices companies an opportunity to show FDA that they no longer want to be part of the problem but part of the solution.  I have always subscribed to the notion that “you don’t get if you don’t ask!”

Until next time...

Good Luck and Good Surfing (on the Internet that is)

blog comments powered by Disqus

• Email This
• Print
• Comments
• Trackbacks
• Share Link

Mark Senak at the EyeonFDA blog reported yesterday that the US Food and Drug Administration (FDA) is seeking public input on the use of social media in the pharmaceutical, biotechnology and medical devices/diagnostic industry. Meetings to solicit input will be held in Washington DC on November 12 and 13^th.  This will be the first opportunity for industry representatives and the public to begin a discussion with FDA on the policies that will guide the use of social media in the life sciences industry.

According to EyeonFDA, on Monday, the agency will publish a notice in the Federal Register announcing this historic event (see excerpt below)

Questions have arisen regarding the application of the prescription drug and device advertising and labeling provisions, regulations, and policies of promotion on the Internet, especially with regard to the use of emerging technologies such as blogs, microblogs, podcasts, social networks and online communities, video sharing, widgets, and wikis. This section briefly discusses the issues the agency has identified as most frequently raised by regulated companies and other interested parties. It should be noted that although a question may raise a particular issue, that does not necessarily mean that the agency will issue guidance or a regulation on that issue. The agency invites comment at the public hearing on the general concept of Internet promotion, positive or negative; on any aspect of Internet promotion that is of interest to the presenter; and on the topics outlined in the following paragraphs. We are specifically interested in data and research on the use of social media tools in promotion, including data from companies on their own experiences, the extent to which health care professionals and consumers are using and are influenced by various social media tools, and the impact of Internet and social media promotion on the public health.

For the past year or more, many bloggers and other social media enthusiasts have taken FDA to task for not taking action on the topic. Finally, the agency realized that something had to be done given the growing use and popularity of social media tools and strategies in other less regulated industries. Earlier this week, in an unexpected move, FDA launched its first Twitter feed. Perhaps this was a hint that FDA is beginning to emerge from the dark ages into the digital world of Web 2.0 and social media.

Hat tip to Mark!

Until next time...

Good Luck and Good Twittering !!!!!!!

• Email This
• Print
• Comments
• Trackbacks
• Share Link

Mark Senak who runs the EyeonFDA blog reported yesterday that the US Food and Drug Administration (FDA) had launched a Twitter account. As Mark aptly points out, FDA’s unexpected leap into social media is ironic given that the agency has been steadfastly reluctant to craft any guidance whatsoever on the use of Web 2.0  technology or social media by drug and device manufacturers. Maybe, the agency was tired of being overshadowed by the Centers for Disease Control in Atlanta, GA whose rapid adoption and use of social media for public health and related issues has been outstanding. 

For those of you FDA aficionados, FDA can be found on Twitter at @FDA_Drug_Info. Despite its very recent launch, the agency already has over 1,700 followers. Not surprisingly, FDA_Drug_Info is following only six individuals and is largely a one-way informational channel. Maybe somebody ought to tell the agency that social media, most notably Twitter, is suppose to be interactive and conversational? Also, couldn’t FDA staffers come up with a better Twitter handle? I mean the use of underlines to separate words in FDA_Drug_Info is so ......Web 1.0!!!! Finally, most of the information tweeted by the agency has to do with drug approvals, workshop announcements, safety warnings, etc. Maybe somebody also should tell them that most life sciences companies block Twitter and other forms of social media. Nevertheless, based on some recent tweets, it appears that the agency is targeting healthcare providers and consumers as their main audiences.

Despite FDA’s Twitter presence, I wouldn’t expect any Web 2.0 guidance or a drug and device social media policy any time soon. I say this because the agency yet to craft guidance on website design and Google Ads—two very ancient internet tools!!!! Maybe they ought to appoint a social media czar at the agency?

Until next time....

Good Luck and Good Tweeting!!!!

• Email This
• Print
• Comments
• Trackbacks
• Share Link

Eli Lilly & Co announced today that it is eliminating another 5,500 jobs or roughly 14% of its global workforce over the next two years. This would reduce to size of Lilly’s worldwide workforce from 40,500 to 35,000 by 2011. In addition to the job cuts, the company is reorganizing itself into 5 business units and hopes to save about $1.0 billion in annual costs.

These newly announced job cuts come after the company eliminated 4,000 sales representative jobs this past August and restructured its sale force. Also, prior to the recent cuts, Lilly launched the Lilly Phenotypic Drug Discovery Initiative or PD² a new program to ostensibly strengthen relationships with academic institutions to speed drug discovery and thereby reduce its reliance on internal drug discovery efforts to keep its pipeline full.

Unlike other major pharmaceutical companies that conducted massive layoffs over the past two years, Lilly was content, until the past few months, to lay off small numbers of employees and offer others retirement packages. Unfortunately, the loss of patent protection on several of its blockbuster drugs coupled with generic encroachment on several brands and impending health care reform, forced Lilly to take more draconian action.

Layoffs have been something of rarity in the life sciences sector over the past eight months or so, but this is usually the time that marks the beginning of the corporate “layoff season.” Don’t be surprised if other large life sciences companies announce similar layoffs in the coming months. Luckily, the economy seems to be improving and there are signs that hiring is beginning to ramp up in the pharmaceutical, biotechnology and devices industries.

Speaking of pink slips, those of you who have been downsized or find yourself out of a life sciences job may be interested in a new organization called Pink Slip mixers. According to a description on the group’s website:

“Our Pink Slip Mixers are about hundreds of professional, mid- to upper-level executives who are (might be) victims of the "economic downturn" of 2008. Our parties are about banding together, networking and bonding with the recently "Pinked". We will share our experiences of why we were let off, what companies are hiring, and the "buzz words" that specific hiring managers want to hear. Aside from the usual imbibing, commiseration and fun that every pink slip party brings, headhunters, direct-hire companies, and recruiting firms will also on-hand to learn a little bit more about what you do. Maybe you'll meet a new contact, or find a new job!” 

Sounds like these mixers might be good networking opportunities and a place to kick back and commiserate with others who are no longer gainfully employed. I am planning to attend a Pink Slip Mixer when one is organized in the NYC metropolitan area. Like many of you, I lost my full time contract copywriting job over a year ago!

Until next time...

Good Luck and Good Job Hunting!!!!

• Email This
• Print
• Comments
• Trackbacks
• Share Link

Despite dire predictions, the biotechnology industry appears to be weathering the recession better than most. According to a CNN Money.com post “Biotechnology leapt ahead as the biggest recipient of U.S. venture capital money in the second quarter, but first-time venture investments in companies overall dropped to a 15-year low.”

Biotechnology funding grew 54% to $888 million in 85 deals, software came in flat at $644 million in 135 deals and Internet companies fell 15% to $524 million in 124 deals. While biotechnology company investments are leading the pack, the current funding levels pale in comparison to those of the late 1990s and early 2000s. Also, it is important to note that many of the biotechnology company investments were in mid to late stage ventures. Fewer investments were made in seed or early stage companies which historically have outpaced funding in late stage ones.

Venture capitalists may be favoring biotechnology investments because there is a clear exit strategy—there are more acquisitions and initial public offerings in life sciences as compared with other industries.

Look for continuing investments in the biotechnology sector—especially in molecular diagnostics and medical devices.

Until next time...

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

• Email This
• Print
• Comments (1)
• Trackbacks
• Share Link

BioJobBlog and BioCrowd along with the Business Development Institute, the Journal of Communication in Healthcare and others are co-sponsoring a meeting entitled “Social Media and Healthcare” that will be held on July 23, 2009 in NYC at the Graduate Center of The City University of NY (365 Fifth Avenue at 34th Street). Topics that will be covered include:  

1. Managing regulatory and legal issues when planning and implementing social media strategies
2. Is there a role for social media in President Obama’s healthcare reform plans?
3. Why real-time social media tools like Twitter are gaining momentum and when it makes sense to use them
4. How social media has affected crisis communications in the healthcare industry
   
5. Selling social communications projects and proving ROI to senior management
   
6. Creating and participating in communities to achieve communication, educational and branding objectives
7. Planning and executing a social communications plan with little or no budget
8. Building relationships and partnerships with new healthcare media leaders beyond advertising
9. Best practices for using social communications to connect internally with employees and stakeholders
   
10. Tools, technologies, and best practices for monitoring and measuring social communications

The meeting’s agenda features case study presentations and a series of roundtable discussions on social media topics. I will be leading a roundtable discussion called “How to Build a Social Networking Site for Bioscientists.” Approximately 300 senior marketing, communications and media professionals from Fortune 1000, middle market and emerging growth companies are expected to attend from leading pharmaceuticals, medical technology/device companies, managed care providers, hospitals, healthcare media companies, government and nonprofit organizations.  

BioCrowd members can register for the meeting at a discounted rate of $155. Check it out—it will be money well spent!

Hat tip to Steve Etzler at the BDI and Mario R. Nacinovich Jr., Editor-in-Chief, Journal of Communication in Healthcare for organizing this topical and important meeting.

I hope to see you at the meeting next Thursday!!!!

• Email This
• Print
• Comments (1)
• Trackbacks
• Share Link

Medtronics, the world's largest medical-device company, announced today that it will lay off 1,500-1,800 employees after posting a fiscal fourth-quarter profit that plunged 69 percent on slipping sales,restructuring and other charges. About 400 employees already have accepted buyout offers and will leave the company by the end of the month.

Until now, the medical devices and diagnostic industries, unlike pharma and biotech had had remained unscathed by the current economic downturn. Medtronic’s financial woes are mainly a result of questions about its implantable devices which have come under fire recently because of safety concerns. Nevertheless, don’t be surprised if you see other medical devices and diagnostic companies begin to layoff workers as the financial crisis deepens and medical and healthcare costs continue to rise.

Hat tip to Iguana Bio.

Until next time...

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

• Email This
• Print
• Comments (1)
• Trackbacks
• Share Link

Are you a life sciences or healthcare professional with a passion for computers, IT or software development? If so, you might want to consider a career in health informatics—one of the hottest, new fields in the life sciences and healthcare industries. Health informatics specialists typically have expertise in medical records and claims, clinical care and programming. In other words, they have a foot in two worlds— medicine and technology — and can easily bridge the often daunting gap between them. It is important to point out that there is a difference between healthcare IT and informatics personnel. The health IT people run the servers and install software, but the informatics people are the ones who analyze and interpret clinical/ medical information and work with clinical and other healthcare staff to advise and help them.

According to an article in this Sunday’s NY Times, health informatics specialists usually start as computer programmers or as doctors, nurses, pharmacists or health record administrators. After earning a graduate health informatics degree, they find jobs as mid level or senior employees at hospitals, doctor’s offices, insurance companies, pharmaceutical companies or other organizations concerned with health data. Mid level jobs, like those for clinical analysts or informatics analysts, are usually about $70,000 a year, but salaries can be much higher for more senior level positions.  Senior level jobs, which sometimes require a Ph.D., include chief clinical information officer or other management/leadership roles at medical devices, life sciences or insurance companies. Consulting firms are also hiring health informatics experts to serve many of their health care clients who frequently don’t have the resources to hire permanent informatics staff.

At present there are no educational, licensing or credential requirements to become a health informaticist. However, a growing need for health informaticists has resulted in the creation of a number of degree programs at two and four year colleges and universities. For example, within the past four years, Columbia University, St. Louis University, the University of Minnesota and Oregon Health and Science University have all added master’s programs or certificates in health informatics. Other schools offer short courses or part-time certificate programs to healthcare employees or programmers. Still others are adding undergraduate majors or associates degrees programs to their curricula.

While many schools are beginning to offer health informatics programs, not all informatics programs are “created equal.” Generally speaking, “medical” or “biomedical” informatics programs focus on data that doctors need for treating patients. Bioinformatics” programs concentrate on biological or genetic data, while “health informatics” programs often emphasize clinical data and health records. Even among programs with the same name, the emphasis and expertise may vary at different institutions that offer the training.

By all accounts, health informatics —despite some early confusion—is one of the fastest growing careers in the bioscience and healthcare fields. Unlike other fields in the shrinking life sciences industry, there are plenty of jobs out there for health informaticists. Ironically, the failing US economy is what is driving the growth of the health informatics industry. The US government’s economic stimulus package has allocated $19 billion to hastening the adoption of electronic health records, so demand for health informatics specialists is skyrocketing. “My rough estimate is that we need about 70,000 health informaticists,” said Don E. Detmer, president and chief executive of the American Medical Informatics Association, a nonprofit industry group.

However, as a word of caution, it usually takes more than technical skills and an understanding of health care to succeed as a health informaticist. Diplomacy and conflict resolution skills are crucial when dealing with two potentially contentious groups: healthcare workers and programmers. Nevertheless, healthcare informatics is an ideal field for bioscientists and healthcare workers who also like to work with technology, computers or develop software. Based on my recent experiences as a bioscience career counselor, I know that there are thousands of you out there that fit this description. Now be the time to take a closer look at the exciting, new field of health informatics to determine whether or not it may be a career option for you!

Until next time...

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

• Email This
• Print
• Comments
• Trackbacks
• Share Link

The US economy has lost about 7.1 million jobs since December 2007 and nationwide unemployment is hovering around 8.5 percent. Despite the lost of  about 80,000 pharmaceutical jobs over the past three years and unprecedented consolidation taking place in the life sciences sector—Merck-Schering Plough, Pfizer-Wyeth and Roche-Genentech—the job prospects for scientists at biotech companies, medical devices and diagnostics, and government appear to be stronger than anticipated. While drug discovery and sales jobs may be scare, there are rapidly emerging opportunities in the fields of medical communications, regulatory affairs, biomanufacturing, clinical trials management , bioengineering, medical devices/diagnostics and website development and management.

President Obama’s promise to restore science to its rightful place, his reversal of the ban on federal funding for embryonic stem cell research and an unwavering commitment to alternate energy technologies suggest that the future may be very bright for bioscientists. For example, there are massive hiring initiatives at federal agencies like the US Food and Drug Administration (FDA) and the Unites States Department of Agriculture (UDSA) — as the Obama administration attempts to overall these agencies— and funding levels at the National Institutes of Health are on the rise (aided in part by a $200 million Challenge Grant stimulus program).

While the road to economic recovery may be a long one, graduate students and postdoctoral fellows who are currently engaged in life sciences research should “stay the course and not jump ship just yet.” The life sciences industry is more recession proof than others and it will be one of the first to experience an economic turn around. And, when it does it is best to prepared to find a job!

Until next time…

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

• Email This
• Print
• Comments
• Trackbacks
• Share Link

As many of you know, the life sciences industry, one of the most highly regulated industries of the economy has been hesitant and reluctant to embrace social media to reach out to patients, physicians and the lay public. This is because the US Food and Drug Administration, specifically Division for Drug Marketing, Advertising and Communications (DDMAC), has been mute on the subject and hasn’t issue one iota of guidance on the use of social media in the pharmaceutical, biotechnology or medical devices/diagnostic industries.

Mark Senak, a regulatory affairs lawyer and owner of the blog eyeonfda.com, invited Dr. Jean Ah Kang, Special Assistant at DDMAC in charge of Web 2.0 policy development to talk about FDA’s views and ideas about social media and its use in the life sciences industry. Listening to the 15 min podcast would be, according to Mark, “time well spent” for social media advocates in the pharmaceutical, biotechnology and medical devices/diagnostics sectors.

Hat tip and much “love” to Mark who wrote “BTW, I absolutely expect waves of love for this (the podcast)."

Until next time....

Good Luck and Good Listening!!!!!!!!!! 

• Email This
• Print
• Comments
• Trackbacks
• Share Link

An article in today’s New York Times reports that several FDA scientists have accused the agency of granting market approval to several unsafe medical devices. According to published reports, “the House Committee on Energy and Commerce will investigate the accusations, first aired when eight agency scientists wrote a private letter in May to FDA commissioner Andrew von Eschenbach.”

Unfortunately, the allegations made by the eight scientists against the agency are nothing new. Frequently, agency managers (and sometimes political appointees) lean toward approving drugs or devices when the data pertaining to efficacy and safety are equivocal.

My sources at FDA suggest that this is what happened with approval of Merck’s ill-fated pain medication Vioxx.

Recently, there has been a spate of safety claims made against medical devices manufacturers. This is not surprising because the regulatory hurdles for marketing approval of devices are much lower for devices as compared with drugs and the medical devices and diagnostics business is the fastest growing sector in the life sciences. For an overview of the medical devices and diagnostics industry please read my recent article published in Science Careers.

Hopefully, new leadership at the agency will turn things around!!!!!!!

Until next time…

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

.

• Email This
• Print
• Comments
• Trackbacks
• Share Link

Just when the medical device industry is gaining steam and poised to challenge pharma and biotech companies for market share and profits, some lawmakers have begun to question the medical devices industry’s direct-to-consumer (DTC) advertising practices. Last year, the medical device industry spent about $193 million for DTC advertising on television and the Internet—a mere fraction of what was spent on DTC consumer advertising for prescription drugs sold by pharmaceutical and biotechnology companies.

One reason given by lawmakers to justify its current scrutiny of medical devices DTC advertising practices is that “medical devices can have more of an impact on a patient’s well-being than a drug because devices often require surgery to implant and may remain inside the body for years.” However, in response, a representative from the Advanced Medical Technology Association, a medical devices trade group said, “While an advertisement may stimulate a patient to ask a doctor about device, the process of receiving one involves a discussion of its benefits and risks.” He went on to say “You may take a pill because it doesn’t involve very much. But you don’t undergo surgery unless you think you have a serious need for it.” 

Another reason cited by Herb Kohl, a Democrat from Wisconsin is “The medical device industry is just beginning to get into the game.” Yes, Mr Kohl’s assertion is absolutely correct. Unlike most pharma and biotechnology companies, which have engaged in unregulated DTC advertising for the past 10 years or so—and literally made billions— the medical devices industry was slow to recognize that DTC advertising could be used to effectively hawk its products. I guess the thought here is: “to head ‘em off at the pass!”

The current call for an investigation into the DTC practices of some medical devices companies raises several interesting questions. First, is the investigation simply a red herring to distract FDA from crafting new regulations to rein in and more tightly control DTC advertising by pharmaceutical and biotechnology companies? (While FDA has recently revised some of its DTC advertising guidelines, the changes are still not rigorous enough). Second, could the call for increased scrutiny of the medical devices industry simply be an attempt (by pharma and biotech lobbyists) to stifle the recent, explosive growth of the medical devices industry?  Finally, why are lawmakers rather than the agency (which oversees the device industry) investigating the DTC advertising practices of medical devices companies?

On a personal note, I support tighter regulations and increased scrutiny of the DTC advertising practices for all  life sciences companies. Although DTC ads are directly aimed at consumers, their real purpose is to influence prescribing practices of physicians by inducing patients to ask questions about whether or not the drugs or devices that they “saw on TV” are appropriate for them. That said, I believe that it is up to FDA to insure that all DTC ads are fairly balanced (risks vs. benefits) and medically accurate before they are viewed by the American public.

Until next time…

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

• Email This
• Print
• Comments
• Trackbacks
• Share Link

The social development of the web 2.0 has largely bypassed science. Hugely popular websites such as Facebook, MySpace, Twitter, Digg, Delicious and the like have millions of members and generate huge amounts of traffic. But those who use these sites come from all walks of life. None are devoted solely to science.

With this in mind, it would seem that social networking sites that cater to scientists would have special value and appeal. A few have been launched —but there is certainly room for improvement.

This fall, Vincent Racaniello at the College of Physicians and Surgeons at Columbia University and I will launch BioCrowd.com, a new social network designed by scientists (Vincent and me) for bioscientists (and others in the life sciences) who wish to connect with others to advance, promote or shape their careers.

Please visit the home page to sign up to be notified when we launch. BioCrowd will combine the interactivity of sites like Facebook and the networking capabilities of LinkedIn to help to advance your career in the biosciences.

Be part of  "The BioCrowd" !!!!!!!!

• Email This
• Print
• Comments (1)
• Trackbacks
• Share Link

In an attempt to assuage the jitters and financial concerns of investors who own stock in pharmaceutical, biotechnology and medical device companies, the US Food and Drug Administration announced yesterday that it will be change the format of the letter received by companies whose products are not ready for approval.

In the old days (at least until yesterday), when the agency determined that drugs were not suitable for sale, it would send companies a so-called non-approval letter. This letter was designed to inform drug and device makers that their products had issues that needed to be resolved before the agency will approve them. Apparently, (at least according to drug and device manufacturers), receipt of non-approval letters by companies signaled to investors that the product in question would never, under any circumstances, be approved by FDA. This urban legend was born because most companies that receive non-approvable letters decide against investing more time and money into products that FDA has deemed “unapprovable” i.e. there isn’t enough of a financial inducement or upside to continue further development.

Now, when new products are not up to snuff, companies will receive something called a “complete response letter.” According to the agency, the new letters will describe what is missing from a new drug or device application and, when, appropriate, offer advice on how to fix or address the problem(s). However, because contents of FDA letters are not released to the public, investors may now be less informed about the prospects of a new drug than in the past when the agency was able to send “approvable” or “non-approval” letters to companies.  “While this new plan may provide more detailed information to a company regarding issues that need to be addressed, investors will likely be kept in the dark on the true status of a drug’s approvability” said a pharmaceutical analyst after learning about the format changes. He went on to say “Investors will no longer know whether a drug is truly dead in the eyes of FDA.”

In my opinion, this is another example of FDA cow towing to the whims and wishes of industry. Whether you call it, a “non-approvable” or “complete response letter”, it still means the same thing—the drug or device is not ready for prime time! I don’t think that the change in semantics will do anything to assuage concerns of jittery investors. What it WILL do is force investors to rely solely on the honesty of the management teams that receives these letters—Oy!

I think that FDA ought to stick to the business of evaluating the safety and efficacy of drugs and be less concerned with the political and economic needs of the drug and device industries. Finally, it would be prudent for FDA to allow appropriately trained professionals to provide psychotherapy to all of the frightened and jittery investors out there!!

Until next time…

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

• Email This
• Print
• Comments
• Trackbacks
• Share Link

Siemens, the Germany engineering, electronic and healthcare company is planning to layoff more than 17,000 workers worldwide.  Although primarily known for its engineering and electronic products like cellphones, Siemans has a large healthcare practice primarily in medical devices and diagnostics. A good portion of the layoffs are likely to take place in Germany and elsewhere in Europe.

The loss of this many jobs at one of the world's largest and most reputable companies may unfortuantely be a harbinger of things to come.

Until next time....

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

• Email This
• Print
• Comments
• Trackbacks
• Share Link

Much like Paul Revere back in the day, there have been repeated, urgent warnings about the impending recession that will strike the US economy. Not surprisingly, the Bush administration has done its best to deny the notion that the moribund US economy is actually in recession. 

Today, it was reported that the US unemployment rate hit 5.5% and nearly 49,000 people lost their jobs last month. This is the biggest monthly rise in the unemployment rate since 1986. So far this year, the Unemployed people grew by 861,000 in May rising to 8.5 million. To keep things in perspective, a year ago, the number of unemployed stood at 6.9 million and the jobless rate was 4.5 percent

Last month employers sharply cut jobs in manufacturing, construction, retailing and professional and businesses services. The recent and highly publicized meltdown of the airline industry insures that as many as 10,000 others or more will lose their jobs in the coming weeks. These layoffs, coupled with $4.00 per gallon gasoline, will undoubtedly have a substantial and lasting ripple effect on the American travel and leisure industries. Can anyone still believe that the US economy isn’t in recession (I can think of at least one!).

Until very recently, many of my disgruntled corporate colleagues (who I eat lunch with from time to time) indicated that they were actively seeking new employment. At lunch the other day, a soft spoken but vocal woman who previously said that “she couldn’t take it anymore and was outta here the first chance that she got” quipped; “What’s with all the complaining. We should all consider ourselves lucky that we even have jobs!” I think that says it all….

Until next time….

Good Luck and Good Job Holding!!!!!!

• Email This
• Print
• Comments
• Trackbacks
• Share Link

Minnesota-based Medtronic, Inc., one of the world’s largest medical devices companies, announced  that it was cutting about 1,100 jobs; 350 of which will be in Minnesota. This is the first layoff at the medical devices manufacturer in over 5 years. According to a press release, slightly over a third of the layoffs will come from the company’s local operations, which has about 8,000 employees. The overall effect of the reorganization will be relatively small—affecting roughly 3% of the company’s worldwide workforce of 39, 500.

Medtronic attributes the realignment (not restructuring according to company executives) to slumping sales of its spinal and cardiac devices. Accordingly, the company’s cardiac rhythm and neuroscience businesses along with local operations will bear the brunt of the job cuts.

It looks as though the entire life sciences sector is under assault. Belt yourself in—it’s going to be a rough ride for the foreseeable future!

Thanks to Ed at Pharmalot for the heads-up!

Until next time….

Good Luck and Good Job Hunting (are there any left?)!!!!!

• Email This
• Print
• Comments
• Trackbacks
• Share Link

Bristol-Myers Squibb announced today that it has sold its medical device and wound care business, ConvaTec, for approximately $4.1 billion to Nordic Capital and Avista Capital Partners. The divesture is part of BMS’s corporate restructuring that was announced late last year to become a “next generation biopharma” company—whatever that means.  

ConvaTec which became part of BMS after Bristol Myers bought Squibb back in the 1980s, will continue to operate as an independent entity according to analysts close to the deal.

I suspect that there may be some downsizing in ConvaTec’s future since it is no longer a part of the BMS.  This is not good news for New Jersey, which is already struggling with major pharma layoffs and ongoing corporate right sizing moves.

Until next time…

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

• Email This
• Print
• Comments
• Trackbacks
• Share Link

As I mentioned in a post about a month or so ago, the US Food and Drug Administration (FDA) floated a proposal to ease the rules regarding promotion of off-label use of previously approved drugs. According to the newly proposed rules, FDA would allow drug makers to provide physicians with reprints of journal articles that conspicuously promote off-label uses for previously approved products. At present, drug companies are strictly forbidden to promote off-label use of their products.  A major proviso of the proposed rule changes is that the articles/reprints must be published in peer reviewed medical journals before they can be disseminated to physicians and other healthcare professionals. Apparently, FDA officials believe that peer review can take the place of the rigorous regulations and requirements that are currently in place for US approval of drugs, biologics and medical devices!

For those of you who don’t know, an editorial appeared in last week’sJournal of the American Medical Association (JAMA) that took drug maker Merck to task for using alleged ghostwriters and ghost authors on clinical studies that were published about it painkiller Vioxx. As you all know, Merck voluntarily took Vioxx off the market in 2004 after it was revealed that the drug could lead to increased risk of heart attack and stroke.

The incendiary firestorm that has ensued since the appearance of the  Although I believe that the practices of ghostwriting and ghost authoring are not as widespread as the JAMA authors would like you to believe, I think that it is a good thing that FDA may scuttle its proposed new off-label drug promotion rules.

In my opinion (humble or otherwise), drug makers MUST be required to prove that off-label uses of previously approved products  don’t pose any serious safety or health risks before companies are allowed to promote them for new indications. As we have seen time and again in recent years, safety issues and serious health risks can arise for drugs even though they received FDA approval. With this in mind I ask: “Why would FDA allow drug makers to provide less rigorous proof for an off-label indication than that required for approval of the intended use of the original product?”  It makes little sense to me. However, looking more closely at the proposed rule changes,  it would obviate the need for companies to spend additional monies (possibly hundreds of millions) to garner FDA approval for a new product indication.  Hmmm….maybe I am beginning to see a pattern here!!!!!!!

Until next time….

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

• Email This
• Print
• Comments
• Trackbacks
• Share Link

There’s a ton of stuff online about what kinds of interview questions to expect, and how to answer them to impress the interviewer.  But, you have to remember (and it does wonders for your confidence if you do) that you’re interviewing them, also.  You need to find out if this is a medical sales company that you’re going to be happy working for.  So, what kinds of questions should you ask?  Here’s an article on 10 Questions to Dazzle Would-Be Employers to help you.  Some of my favorites:

“How do you see me benefitting the company?”  Find out what caught their eye about you in the first place, and then you can bring up those qualities for a better sell.

“Why did you choose this company?”  If they haven’t tried to sell you on the company already, this answer gives you some insight.

“When will a decision be made?”  Suprisingly, many people don’t ask that, and end up frustrated if it takes longer than they were expecting. 

Your questions about the company and the job will set you apart from other candidates and show how interested you are in the position.  Not to mention it will give you extra insight into your decision whether or not to work for them.

If you have any  questions for Peggy aka the Medical Sales Recruiter contac her  at: the medical sales recruiter blog!

Until next time.....

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

• Email This
• Print
• Comments
• Trackbacks
• Share Link

 A report on the state of the Massachusetts biotechnology industry suggests that global competition and shortages of trained workers might cause the state to loss its reputation as one of the world’s top life sciences cluster. The report points out that there simply aren’t enough trained workers to meet the growing demand from Massachusetts-based biotechnology companies-both because of a lack of adequate training programs and lack of interest from students.  

To help to remedy the situation, the study recommended that more job training programs ought to be created at two- and four-year state colleges and that Massachusetts should do more to encourage students to pursue careers in the life sciences. As usual, the report recommended that math and science education should be improved at the K-12 levels. Other suggestions included setting up a “summer bio camp” and launching an unpaid bioscience internship program.

Unfortunately, this report, which was prepared by Boston-based Mass Insight Corp and McKinsey & Co and was likely very expensive, is almost identical to other studies published over the past decade about ongoing workforce shortages in the life sciences industry. Like its predecessors, it contains the same tired and unimaginative recommendations that others have proposed to solve bioscience labor shortages. To learn more about some creative solutions to avert life sciences workforce shortages click here.

Despite what the experts and pundits would have you believe, the etiology of the workforce shortages in the life sciences industry is easy to decipher. Put simply, most universities and colleges don’t believe that job training or career development should be part of their academic initiatives or educational missions. Likewise, companies don’t feel that education or training should fall within their purview–according to industry executives, college and professional school graduates ought to be sufficiently prepared to enter the workforce after they complete their education.

Because neither academia nor industry wants to assume responsibility (financial or otherwise) to prepare or train students for careers in the life sciences, it should come as no surprise that there are workforce shortages in this industry. Although a number of federally-funded biotraining programs were initiated in the late 1990s, these programs were poorly promoted and are incapable of sustaining themselves without government support. Paradoxically, there are many more innovative, industry-focused biotechnology and bioscience training programs at the high school level as compared with the undergraduate and graduate levels. I suspect that many professors in undergraduate and graduate life sciences departments are more concerned about their own research programs than about the careers of their students. Go figure………!!!!!

There will continue to be workforce shortages in the biotechnology, pharmaceutical and medical devices industry until either academia, industry or both claims ownership of bioscience training and career development.  I think that it time for academicians and industry professionals alike to put their heads together to solve this serious and ongoing problem. Failure to do so will result in the loss of America’s global dominance in the life sciences industry.

Until next time…

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

• Email This
• Print
• Comments (1)
• Trackbacks
• Share Link

A Johnson & Johnson Co. plant in Bedford MA that manufactures medical devices was sold for $45 million in cash to an Indiana-based provider of orthopedic products used in arthroscopy, dental and other medical professions.

The plant’s 200 workers will keep their jobs, and additional jobs could be added in the future depending on customer demand, said Fred L. Hite, senior vice-president and chief financial officer of Symmetry Medical Inc.

Symmetry, a public company listed on the New York Stock exchange, purchased the 82,000 square-foot facility from DePuy Orthopaedics, Inc., which is owned by Johnson & Johnson. Both Symmetry and DePuy are headquartered in Warsaw, Ind., known to some as the orthopedic capital of the country.

According to a release from Symmetry, DePuy is required to make minimum purchases from the New Bedford plant for four years following the acquisition, which is expected to be completed within 60 days.

Until Next Time.....

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

• Email This
• Print
• Comments
• Trackbacks
• Share Link