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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!!!!!!!!!

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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!!!!!!!!

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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!!!!!!!!

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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!!!!!!!!

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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)

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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!!!!!!

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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!!!!

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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!!!!!!!

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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!!!!!!

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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!!!!!!!!!! 

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I want to let my readers know that a beta-version of BioCrowd is ready for review. For those of you who may not know about BioCrowd, it is a social network for life sciences students and professionals that was created by Vincent Racaniello a Professor at Columbia University College of Physicians and Surgeons and me. 

The reason we started BioCrowd was that Vincent and I both perceived a need for undergraduate and graduate students and postdoctoral fellows to more effectively network with established scientists and life sciences professionals to further advance their careers or find jobs. The social interactivity of Facebook and the business connectivity of LinkedIn are what led to the creation of BioCrowd.

We are looking for a few brave women and men who want to help to beta-test BioCrowd before we launch.  If you are interested, please visit us at www.biocrowd.com and drop us a line.   For those of you who don't want to participate at the moment, but want to learn about our progress, you can follow us on Twitter and FriendFeed ,

Until next time...

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

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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!!!!!!!!

.

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Ed Silverman at the Pharmalot blog reported that Abbott disclosed in a Securities and Exchange filing that it will cut about 1,000 jobs in medical diagnostics over the next four years to cut costs and save about $150 million per year.

According to an Abbot spokesperson “The streamlining includes the closing of a clinical chemistry plant in South Pasadena, California and transferring production of some diagnostic products to plants in Europe that are closer to a big part of the company’s customer base.”

I guess this is good news for Abbott employees—the company could have eliminated all 1,000 positions in one fell swoop. The four year timeline gives current Abbott employees some time to beef up their resumes.

Until next time…

Good Luck and Good Job Hunting!!!!!

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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!!!!!!!!!

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Roche Diagnostics plans to transfer about 300 jobs from its Indianapolis facility to Germany over the next three years as part of a consolidation plan.

A Roche spokesperson announced yesterday that transfers will start in October and most will be completed by 2011. A limited number of employees will be offered transfers to Germany, but most will be laid off.

Most of the positions are in research and development of reagents, which are chemicals used in test kits for HIV, West Nile virus and other diseases. The company says about 85 percent of production for the unit affected by the transfers is already in Germany. Roche has about 2,800 employees in Indianapolis.

Like other sectors of the US economy, the pharmaceutical sector is getting whacked.

Until next time…

Good Luck and Good Job Hunting??????

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Sometimes things just seem to occur randomly or by cosmic convergence. Yesterday, my good friend Pete learned that he had prostate cancer. His prostate specific antigen (PSA) levels were slightly elevated over the past few years (they were in a gray zone that made a definitive diagnosis difficult without doing a biopsy). After being urged by his wife and urologist, he had the biopsy performed and, unfortunately, a diagnosis of prostate cancer was made. Hopefully, his cancer is localized to the prostate and will be easily treated via conventional therapies. As many of you may know, prostate cancer is easily treat and the cure rates high if it is detected early.

The use of PSA levels to diagnosis prostate cancer is notoriously unreliable and inaccurate.Today, a group of Swedish scientists announced that they developed a DNA-based test that showed that men carrying a combination of known risk genes run a four to five time higher risk of developing prostate cancer. They envision that this test could be used in tandem with PSA monitoring to more accurately diagnose prostate cancer. I hope that they are right!

Unfortunately, the new test wasn't developed in time to help Pete; but perhaps it can be used in the future to more accurately assess the risk and diagnose prostate cancer quickly so that treatment begins as soon as possible!

Until next time…

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

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