Life Scientists:Looking for a Job? Consider the Cannabis Industry

Posted in BioBusiness, Career Advice

According to a recent article, the 2013 to 2014 US market for legal Cannabis (medical and recreational) grew 74% from $1.3 billion to $2.7 billion. Industry analysts predict that the legal marijuana industry is (and will continue to be) the fastest-growing industry in the US over the next 5 years with annual revenues topping $11 billion by 2020.  And, as the industry grows so will employment opportunities. At present, salaries associated with various job functions in the Cannabis industry range from $50,000 to $90,000. As many businesses that support the Cannabis industry continue to grow, the competition for qualified employed will intensify and salaries will concomitantly rise. Currently,, there aren’t enough trained job candidates to fill the many job openings at Cannabis companies. I am sure that many of you who hold graduate degrees in the life sciences are wondering why I am pitching jobs in the Cannabis industry.

First, traditional jobs for PhD-trained life scientist are getting scarcer and the election of Donald Trump suggests that this trend will not be reversed anytime soon.

Second, consider that growing and cultivating marijuana and extracting cannabinoids (the pharmaceutically active molecules in Cannabis buds) require a background in laboratory methods, chemistry, biology and in some cases plant science. For those of you who may not know, the medical Cannabis market is focusing almost exclusively on cannabis extracts and vaporization of these extracts (rather than smoking) is the preferred delivery methods. This suggests that those of you with backgrounds in biomedical engineering and medical devices  can leverage your expertise and skills to obtain jobs in the delivery side of the cannabis industry.  

Third, the expansive growth and sheer economic size of the Cannabis industry suggests that other jobs that require a life science background are likely to emerge. These include quality control/assurance jobs for strain identification, diagnostic jobs to determine THC levels/intoxication, molecular biology and bioinformatic jobs to continue to explore and unlike therapeutically relevant molecules from the Cannabis genome and synthetic biology jobs to increase cannabinoid yields and reduce production costs. Finally, there is currently a dearth of qualified job candidates with scientific backgrounds to fill entry level grow and extraction jobs in the Cannabis industry.

At present, the industry is mainly dominated by long time Cannabis growers, people who use marijuana on a regular basis and some moxy business people/investors who see an an enormous upside for the Cannabis industry. Put simply, now is the time to get in on the ground floor of an industry that is exploding and will ultimately become a legal multibillion dollar a year industry. While I’m sure that neither you nor your parents/family envisioned a career in Cannabis, the jobs are there and ripe for the picking (pun intended).

Until next time…

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

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

Posted in BioEducation

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

Posted in BioEducation

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

Posted in BioBusiness

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

Posted in BioJobBuzz

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

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

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

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

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

Until next time…

Good Luck and Good Job Hunting!!!

 

Abbott Laboratories and Progenics to Cut Jobs

Posted in BioJobBuzz

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?

Posted in Social Media

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

Posted in BioJobBuzz

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

Posted in BioEducation

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!

Posted in BioBusiness

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!!!!!!!!