Regulatory Affairs Update; FDA 483 and Warning Letters Trends for 2012

Those of you who manufacture products approved by the US Food and Drug Administration (FDA) are well aware of the importance of complying with Current Good Manufacturing Practices (cGMP) during FDA mandated inspections of your manufacturing facilities. Failure to comply with cGMP requirements during an inspections results in the issuance of 483s. And if you fail to adequately address the concerns of the agency outlined in 483s, it may ultimately result in issuance of warning letter to your company.

FDA is more vigilant and aggressive than ever before with its 483 and warning letter enforcement procedures. In the words of Commissioner Margaret Hamburg, FDA is quick, visible and vigilant.  With this in mind, it may be worthwhile to participate in a webinar offered by Expert Briefings.com entitled “Top Compliance Trends for 483 and Warning Letters for 2012—Based on Rare FDA Data.”

The webinar will be held on March 8, 2012 from 2:00-3:30 PM EST and Dennis Moore, Managing Partner, AUK Technical Services and a 28 year veteran FDA investigator will lead it. 

Topics to be covered include:

  • Top warning letter trends for 2012, such as more 806 enforcement
  • The Top 10 QS 483 Observations for 2010 and 2011
  • Most common quality system failures for drugs for 2010
  • Top drug and device citations in 483s for 2010
  • Top drug and device warning letter citations for 2010
  • Total 2010 BIMO inspections for CDER, CBER, CDRH, and CVM
  • Details on clinical investigator, sponsor/monitor and IRB audits for 2010
  • Most common sponsor deficiencies for 2010
  • The rising trend of ‘cease to market’ letters, one of which hit a NY pharma company in 2011
  • The total number of 483s issued in 2010 and 2011 – an all time high
  • Total CAPA 483 observations in 2010
  • How long to receive a warning letter, based upon which offices issues it
  • 483 inspection targets for drugs and devices for 2010, 2011, and 2012
  • Total warning letters issued by drug and device category in 2010
  • Which district offices write the most warning letters
  • How long to receive a warning letter, based upon issuing office
  • Warning letters issued by QS system for 2010
  • 483s broken down by QS subsystem for 2010
  • Warning letters by CFR section
  • Top device 483 observations for 2010
  • Details on process validation observations for 2010
  • Design control 483 observations by category for 2010
  • Click here to visit Expertbriefings.com.

Click here to visit Expertbriefings.com.

I hope to see (hear ?) you at the webinar!

 

Abbott Slashes 700 Jobs From Its Medical Devices and Diagnostics Unit

Chicago-based Abbott Laboratories today announced that it would lay off 700 employees from its medical devices and diagnostics division as part of an ongoing restructuring effort. 

Most of the layoffs will take place in the Chicago area and affect employees that manufacture the company’s cardiovascular stents and diagnostic tests. According to a company spokesperson approximately 500 persons who work in stent manufacturing and 200 who work in diagnostics will lose their jobs.

The restructuring of Abbott’s manufacturing operations began several years ago and about this time last year the company layed off about 1,900 employees in Lake County, Illinois.

In October, Abbott surprised investors and analysts with the announcement that it would spin off its branded drug business, including Humira (psoriasis and rheumatoid arthritis) it’s largest selling branded pharmaceutical product. Company executives argued that the split would allow stakeholders and investors to separately and more accurately value Abbott’s other less risky businesses which include nutritional (baby) formula, generic drugs and medical devices and diagnostics.

Despite signs of economic recovery, it appears that layoffs are still occurring at a pretty good clip at many pharma and biotech companies. It now appears that medical devices and diagnostic company employees, who were once immune to downsizing and reorganization, are now fair game.

Until next time...

Good Luck and Good Job Hunting!!!!

 

Breaking Up Is Hard to Do: Abbott Labs Announces Plans to Split into Two Separate Companies

Abbott Laboratories today announced that it will split itself into two companies by spinning off its branded prescription drug business and creating a second company responsible for its medical implants, diagnostic tests and baby formula businesses.

The pharmaceutical company will exclusively sell its branded prescription drugs (including its blockbuster biologic Humira) and will be lead by Abbott’s Richard Gonzalez who currently head the company’s pharmaceutical business. Current Abbott CEO Miles White will lead the diversified medical products company. 

The reason for the split is to allow investors to value each of the companies on their distinct characteristic. Abbott’s decision to split the company is consistent with the prevailing notion that companies that sell both prescription drugs and consumer products don’t perform well. This led Bristol Myers Squibb to sell off its medical devices and consumer products divisions several years ago. Interestingly, prescription pharmaceuticals/consumer products/medical devices were de rigueur in the 1990s and early 2000s. Abbott’s decision leaves companies like Pfizer, Novartis and Johnson & Johnson as examples of the few remaining companies that still house pharmaceuticals, devices and consumer goods under one roof. Don’t be surprised if in the future these companies also decide to spin off or divest themselves of their consumer goods/medical devices divisions.

Finally, while the split may be good for investors, it may not be that great for Abbott employees. Usually, spin offs or divestitures

Until next time..

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

 

Boston-Based Life Sciences Job Opportunities

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

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

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

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

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

Until next time...

Good Luck and Good Job Hunting!!!

 

Abbott Laboratories and Progenics to Cut Jobs

Abbott Laboratories today announced it is eliminating 160 jobs in an attempt to shore up its diagnostics business. Most of the job cuts (150) will take place at the company’s Santa Clara, CA production facility. The remaining jobs will be eliminated at Abbott’s North Chicago corporate headquarters. 

Similarly, Tarrytown, NY-based Progenics announced that it was undergoing a strategic reorganization and it will reduce headcount by 38 or 26% of its staff. The company recently closed it manufacturing facility and discontinued work in virology and infectious diseases, the therapeutic areas that the company was founded on almost 25 years ago. The company is now working in the oncology area and has a prostate cancer diagnostic monoclonal antibody in early clinical development. 

Progenics has one approved product, RELISTOR (methylnaltrexone bromide) a subcutaneous injection treatment for opioid-induced constipation. Regulatory approval is pending for the use of RELISTOR to treat chronic, non-cancer pain. A Phase III clinical trial of an oral formulation of methylnaltrexone is in progress.

Until next time...

Good Luck and Good Job Hunting!!!!!

 

Social Media Update: US Food and Drug Administration To Regulate Mobile Apps?

Mark Senak, author of the highly informative and well written Eye on FDA blog, reported today that a recent article that appeared on the American Medical News website suggests that the US Food and Drug Administration (FDA) may be considering regulating mobile apps that contain medical or clinical components. While the agency has yet to officially publish guidance on the use of social media in the life sciences industry, it now appears that FDA may be turning its attention on the development of mobile apps; one of the fastest growing segments of the social media movement.

The reason why FDA is taking notice of mobile apps is because a handful of app developers have sought and received FDA clearance for their mobile apps that—because of clinical components —are considered to be “medical devices.” As many of you may know, medical devices which include band-aids, surgical instruments, heart monitors, cardiovascular stents and diagnostic kits, all must receive marketing approval by the agency before they can be sold in the US. Although the agency yet to craft any guidance for clinical/medical app development, it makes sense that FDA ought to evaluate and regulate these products to insure that they are medically-effective and safe. 

According to the American Medical News article, the first app developer to receive FDA market clearance was AirStrip Technologies in San Antonio, for its AirStrip OB application. The app, which was approved in 2009, allows physicians to monitor mother and newborn remotely during delivery. In February, the FDA granted clearance to MobiUS, an app developed by Mobisante, a medical device company in Redmond, Wash. The app permits viewing of medical images for diagnostic purposes. Mobile MIM, a remote diagnostic imaging tool developed by Cleveland-based MIM Software, was also granted market clearance that month. A number of pharmaceutical companies, most notably Pfizer, have been extremely active in the mobile clinical app development space.

The reason why it makes sense for FDA to regulate certain clinical/medical apps is because physicians will rely on them to make medical decisions. For example, the AirStrip OB mentioned above will ostensibly allow physicians to remotely monitor a mother and neonate during delivery. Consequently, the app, aka device, must be evaluated by the agency to determine whether or not it can be used safely and effectively by physicians during childbirth. In this case, the app is similar to a heart monitor that is used during childbirth. And, like all other medical devices, the heart monitor required FDA clearance to determine its safety and effectiveness, before it could be used in real-life childbirth situations. To that end, the agency has hinted that it will be much more proactive in monitoring this new class of devices.

I have no doubt that many pharmaceutical companies and medical devices manufacturers will not be pleased when they learn that the agency is going to “stick its nose” into mobile app development. Nevertheless, in my opinion, if a mobile app is going to be used in possible “life or death” situation, then it ought to be regulated by FDA—the agency that is legally responsible for regulating these types of products. That said, Eye on FDA’s Mark Senak raises a number of valid and insightful points about FDA and its possible role in mobile app development.

“Related to a possible guidance for apps, there are a lot of questions that need to be answered when considering its development – when is an app a medical app?  When does it require regulation?  Who will pay for the oversight – will there be App Developers User Fee Act (ADUFA?) and if so, what will that do to the price and to access.  Will insurance companies have to cover apps?  And what will the process for approval be – something like a 510(k)?”

Finally, I think that the app developers who proactively approached FDA for guidance abut the clinical apps that they were developing “got it right.” This will get the agency “thinking” about clinical/mobile apps and how they ought to be approved and regulated in the future. In turn, this will provide future app developers with a clear regulatory framework that will guide the development of cost effective, safe and efficacious mobile clinical apps.

Until next time...

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

 

Bucking the Trend: Roche to Add 500 Jobs in Tucson, Arizona

In contrast with many of its competitors, which have layed off thousands of pharmaceutical employees over the past two weeks, Roche today announced that it was creating 500 new life sciences jobs at Oro Valley, Innovation Park in Tucson Arizona.

Roche already has a strong presence in Southern Arizona, having acquired Oro Valley-based Ventana Medical Systems in January 2008. The new positions will garner median salaries of $70,000 per year or more and new employees are expected to be added over the next year or so.

Oro Valley and, in particular, Innovation Park, is quickly becoming a regional hub for cutting-edge bioscience research. In addition to Roche, Sanofi-Aventis also has a research center at the 535-acre campus. Further, the University of Arizona recently acquired Sanofi-Aventis’ older, smaller lab space a few miles from the park. Plans for that lab call for drug research, but the lab will also be used as a business incubator.

Mix in the UA’s Bio5 Institute, which helps move research in science and engineering into the marketplace; and Tucson-based Critical Path Institute, which focuses on shortening the process it takes to bring medical innovations to the public, and there is a growing cluster of bioscience research taking place in the Tucson area.

While this may be good news for scientists and other white collar workers, it isn’t clear who will be responsible for maintenance and operation of these facilities given Arizona’s egregious and indefensible anti-immigration laws!

Until net time...

Good Luck and Good Job Hunting!!!!!

Meeting Update: BioConference Live:Clinical Diagnostics

The fourth BioConference Live: Clinical Diagnostics meeting will be taking place on October 20-21, 2010.   This online-only, live, interactive virtual event will cover new technologies, best practices and other pertinent topics for Clinical Diagnostics professionals. Registration is free and all interested persons can attend!  The conference is accredited by the ASCLS American Society for Clinical Laboratory Science and Professional Acknowledgment for Continuing Education (P.A.C.E.).

Therapeutic areas to be covered include: Infectious Diseases, Cancer, Diabetes, Allergy & Immunology, Cardiology, Point of Care, Automation, Molecular Diagnostics, Hematology, Laboratory Testing, Stem Cells, Protein Arrays, and Clinical Chemistry.

Some of the featured speakers include:

  1. Alan Wu Ph.D., Chief of Clinical Chemistry & Toxicology & Prof. Laboratory Medicine, San Francisco General Hospital and University of California, San Francisco
  2. Steven Burrill, CEO Burrill & Company
  3. David Persing M.D. Ph.D., Chief Medical and Technology Officer, Cepheid
  4. Peter Gilligan Ph.D., Professor of Microbiology-Immunology UNC Hospitals
  5. Thomas Goodwin Ph.D., Project Scientist (NxPCM) and Director Disease Modeling & Tissue Analogues Laboratory NASA
  6. Steven Binder, Director Technology Development Bio-Rad Laboratories
  7. Brad Karon M.D., Ph.D., FCAP, FACB, Vice Chair of Education in the Department of Laboratory Medicine Mayo Clinic
  8. Alex Rai Ph.D., Director, Specialty Laboratory, Chief Scientific Officer, Center for Advanced Laboratory Medicine, Columbia University
  9. Robert Fitzgerald Ph.D., Associate Professor, University of California San Diego

Login will take place on October 20th and 21st between 9 AM and 6 PM EST.

Sign Up Now and have a chance to win an iPad if you refer a friend!

Until next time...

Good Luck and Good Learning!!!!!!!!

 

FDA Begins Reining In Genetic Testing Companies: It's About Time!

The US Food and Drug Administration (FDA) announced on Friday that it will begin monitoring and investigating the services offered by consumer-focused, personal genomic testing companies. In warning letters to five companies, the agency notified company executives that their tests are considered medical devices and therefore must be federally approved as safe and effective. None of the companies have submitted their products for approval, according to the FDA. Further, the agency contends that personal genomic tests as medical devices must be “analytically and clinically accurate so that individuals are not misled by incorrect test results or unsupported clinical interpretations." Previously, the agency hadn’t definitively classified the tests as medical devices. However, the agency has become increasingly concerned that results from the tests may ultimately be used for diagnostics and prognostic purposes by various entities including insurance companies and employers.

The companies that received letters on Friday included California-based 23 and Me (backed by Google Health), Navigenics and Illumina and Knome of Cambridge, Mass.; and deCode Genetics of Lake Barrington, Ill. The FDA sent a similar letter in May to Pathway Genomics of San Diego, after Pathway announced it intended to sell its tests through Walgreens drugstores. Many industry insiders believe that the proposed Pathway Genomic-Walgreens was the proverbial “straw that broke the camel’s back” which prematurely forced the agency to take regulatory action.

The letters deal with specific tests marketed by: 23andMe Inc., deCODE Genetics, Illumina, Navigenics and Knome Inc. FDA asks each of the companies to contact the agency to make arrangements for submitting their tests for review. 23andMe and Navigenics and DeCode Genetics, sell tests that scan a person’s DNA, looking at genetic variations that can suggest whether a person is at a higher or lower risk of getting certain diseases like cancer or diabetes. Illumina sells DNA chips that are used by some companies to do the DNA scans whereas Knome offers consumers a complete sequence of their DNA, which can be used to glean disease risk information. While 23 and Me is pushing back, deCode Genetics CEO stated that the company will work with the agency to legitimize its tests as part of “standard medical care.” Knome, whose whole genomic sequencing platform will ultimately supplant the services offered by 23 and Me, Navigenics and Pathway Genomics, has also expressed a willingness to work with the agency.

Despite the existence of theGenetic Information Nondiscrimination Act (GINA) enacted in May 2008—which ostensibly would shield patients from potential “genetic discrimination”—many privacy and medical information advocates fear that loopholes will allow insurance companies and prospective employers to abuse the results from personal genomic analyses. To that end, GINA does not cover life, individual disability insurance, or long-term care insurance, and the potential for genetic discrimination still exists in these areas. For example, a person at genetic risk for developing Alzheimer’s could be denied long-term healthcare insurance because Alzheimer’s patients have been known to live for long periods of time, and their care is costly.

Another legitimate concern raised by some people is ownership of the results of personal genomic analyses. Surprisingly, at present, it isn’t clear who owns or ultimately controls a person’s genetic information data after it is generated. For example, it is likely (but not certain) that a consumer who purchases whole genome sequencing services from a personal genomics company owns and controls his/her sequence data. Ownership and control of the information isn’t likely to be straightforward or easily defined until rules and regulations are crafted to clarify how genomic information is owned, stored, and accessed by individuals and third parties.

While companies like 23 and Me and their ilk aren’t pleased that FDA has finally classified their tests as medical devices, they had to know that regulatory oversight of the personal genomic testing business was inevitable. This is because the results from personal genomic tests have been and will continue to be used by various and sundry entities a diagnostic and prognostic tools.

It is obvious to almost everyone in the life sciences industry that there are huge sums of money to be made in the personal genomic testing space. Consequently, the last thing that personal genomics company executives wanted was regulatory oversight by FDA (it tends to interfere with business and profit margins). However, we all have experienced first hand what happens when companies are allowed to operate in the absence regulatory oversight.

Hat tip to FDA for finally taking a stand on this important issue!

Until next time...

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

 

Patents, Genes and the Future of Biotech

The decision yesterday rendered by Federal District Court Judge Robert W. Sweet that invalidated the patents issued to Myriad Genetics for the breast cancer marker genes BRCA1 and BRCA2 is analogous to the “shot heard round the world” that kicked off the American Revolution in 1775. While it isn’t clear whether or not the decision will stand (Myriad has appealed the ruling), it does have the potential to change the way in which life sciences companies may operate in the future.

Patents are the lifeblood of the biotechnology industry. Because of this, scientists, university technology transfer offices and many would be entrepreneurs have sought to patent any and all ideas, inventions and potential products that may serve as the basis for a life sciences community. This has resulted in the issuance of a surfeit of composition of matter patents for many human and non-human DNA sequences that encode potential industrial and therapeutic proteins.

Prior to the sequencing of the human genome, many scientists and entrepreneurs had compelling and legitimate arguments to patent newly discovered DNA sequences. While these sequences existed in nature prior to their discovery, their commercial potential could not be fully realized until the genes and their products were isolated and fully characterized which generally required many years of scientific study. In contrast, however, the advent of whole genome sequencing allows scientists, to easily identify genes and their products that are likely to have future commercial potential and value. Because this renders inventions that make use of the genes or proteins themselves obvious, composition of matter patents are no longer feasible or warranted. Also, while composition of matter patents may have been lucrative in the past, it is usually secondary process patents that extend the commercial lifecycle of protein-based drugs. For example, the composition of matter patent for recombinant erythropoietin (held by Amgen) expired in 2004. However, Amgen has recombinant erythropoietin process and production patents that preclude competition in the US until 2017.

While composition of matter patents may be important for therapeutic proteins, the same isn’t true for diagnostic products. In fact, composition of matter patents in this case (like Myriad Genetics patents for BRAC1 and BRACA2) tend to stifle innovation and create monopolies for the companies that own them. The elimination of composition of matter patents for DNA sequences will give scientists the requisite freedom to operate and necessary creativity to develop new tests and uses for novel genes and their products.

To that end, the diagnostic industry would be well served if it adopted the open source business model pioneered by the software industry. This has resulted in the creation and development of new products, commercial applications and business opportunities that have exceeded the expectations of the companies that developed the original code. I see no reason why the same approach couldn’t be used in the diagnostic and personalized medicine industries as they continue to mature.  After all, the human genome is the ultimate source code and allowing free and unfettered access to its contents will undoubtedly result in many innovative, useful and previously unimagined commercial scientific and healthcare advances in the future.

Until next time…

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

 

Study Finds that Funding for Life Sciences Research Continues to Wane

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!!!!!!!!!

 

Novartis Offers $38.5 Billion to Purchase Alcon and Position Itself as a World Leader in the Eye Care Market

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!!!!!!!!

 

FDA-Social Media Update: Will FDA Guidance Really Solve the Problem?

Unlike many of my social media colleagues, I’m not attending the FDA public hearing taking place in Washington, D.C today (Friday the 13th 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!!!!!!!!

Career Development for Life Scientists: An Ongoing and Disturbing Trend

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 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 think that 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 that they are best suited for. I don’t think that it is too much to ask or very labor-intensive for PIs to learn about 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 have  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 must be overhauled to remain relevant. Unfortunately, systemic changes are unlikely because tenured faculty members can’t be forced or induced to change their 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!

To learn how to more effectively manage employees, please check out the 360 feedback solution.

Until next time...

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

 

Social Media: Pharma's Continuing Web 2.0 Inertia

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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VCs Bullish on Biotech

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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NYC BioBuzz: Social Media and Healthcare Meeting on July 23, 2009

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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Life Sciences Layoffs Beginning to Spill Over To Medical Devices Companies

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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Job Market For Bioscientists May Be Better Than Expected

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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Eye on FDA Talks with FDA's Division for Drug Marketing, Advertising and Communications (DDMAC) about Pharma, Social Media and Web 2.0

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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BioCrowd-Beta Is Ready For Launch

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!!!!!!!

FDA is Taking Some Heat....Again

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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Abbott to Shed 1,000 Jobs

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!!!!!

A Sign of the Times--Siemens to Layoff 17,000 Workers

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!!!!!!!!!

 

Roche Announces It Will Move 300 Jobs from Indiana to Germany

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??????

A New DNA-Based Diagnostic Test to Predict Prostate Cancer

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!!!!!!