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!!!!!!!!!!!

FDA Announces Social Media Guidelines–Yawn!

Posted in Social Media

After a very long blogging absence, I decided that it was time for me to begin to write posts on things that continue to pique my interest.  The recent announcement that the US Food and Drug Administration (FDA) has finally released its long awaited guidance on the use of social media in the life sciences industry including pharma, biotech and med. devices.

While words like long awaited have been used to describe this monumental announcement, I think nobody really cares anymore about what the agency thinks about social media!  Put simply, despite some interested starts and stops, social media is not an integral part of the life sciences industry and likely will never be.  In the beginning (about a decade ago) social media transformed a number of industries by introducing transparency and engaging stakeholders to improve their bottom lines. Unfortunately, the modus operandi in the life sciences industry, by virtue of it business model, is opaqueness not transparency. Further, life scientists and life science employees are not the most social individuals and their use of social media for business purposes is almost non-existent. Consequently, social media and the life science industry are not a good fit!!!! Finally, early players in the life science social media space including Novo Nordisk and J&J have already leveraged what they could using social media and have moved on.

In summary, while it may be a banner day at FDA because the agency finally released its social media guidelines, I do not think anybody really cares anymore. The trajectory of social media is on its downward slope and it is no longer fresh or new (except maybe in the minds of pharma/biotech executives).  In fact, social media is no longer new media and is now considered a standard staple of all communication platforms. While many industries benefited from social media it was never a priority for the life sciences industry and industry executives (and US regulators) did everything in their collective power to ensure that social media did not interfere with the secrecy and intentional opaqueness that dominates the industry.

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!!!!!!!!!!!!!!

 

A New Way Forward for FDA?

Posted in BioBusiness

Last week, US Food and Drug Administration (FDA) Commissioner unveiled a “blueprint” that contained immediate and actionable steps that can be taken to spur innovation in the life sciences. The report’s proposals stem from a review of FDA’s current policies and practices, as well as months of meetings with major stakeholders nationwide, including key industry leaders, small biotech, pharmaceutical and medical device company owners, members of the academic community, and patient groups. Entitled “Driving Biomedical Innovation: Initiatives for Improving Products” the report focuses on seven major actions:

  1. rebuilding FDA’s small business outreach services
  2. building the infrastructure to drive and support personalized medicine
  3. creating a rapid drug development pathway for important targeted therapies
  4. harnessing the potential of data mining and information sharing while protecting patient privacy
  5. improving consistency and clarity in the medical device review process
  6. training the next generation of innovators
  7. streamlining and reforming FDA regulations

The blueprint was issued in response to growing concerns that—despite record investments in biomedical R&D—the drug pipelines at many US life sciences companies has grown exceedingly thin. Not surprisingly, most life sciences companies blame the agency for the thinning pipelines but in reality both side have contributed to the problem. Hamburg’s bold plan seems reasonable. But, it can only be implemented if Congress provides sufficient funding to underwrite the new initiatives proposed in the plan. And, while these funds ought to be allocated, it is not clear whether or not it is likely given the poor economy and the current, unprecedented political divisiveness that exists in Washington these days.

Moreover, Mark Senak, author of the Eye on FDA blog, suggests that FDA can improve its effectiveness by learning how to communicate better with its stakeholders. Mark, a social media advocate provides this compelling insight into FDA’s communication problems and the agency’s inability to grasp that the Internet and social media can help to improve its communication skills:

"The extremely long track record of FDA in attempting to figure out the Internet (first public meeting held in October 1996) and social media (first public meeting held in November, 2009) has yielded no guidance, with little transparency into the process.  It is time for FDA to seek outside communications expertise to help the agency better formulate policy on a timely basis."

While I believe that Commissioner Hamburg’s blueprint for improvement is a good one, it isn’t clear whether she will get the necessary support to implement it.

Until next time…

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

 

Alternate Career Options: So You Want to Be a Medical Science Liaison (MSL)?

Posted in BioJobBuzz

One of the new “hot career” opportunities in the life science industry is something called a medical science liaison or MSL. Increasingly, graduate students and postdocs are beginning to mention MSL as a possible career option. Of course, the first thing that I ask these persons is “Do you know what an MSL is or does on a daily basis?” In most cases, most of these would-be MSLs sheepishly admit that they don’t!

With this in mind, I invited Dr. Samuel Dyer an experienced MSL and CEO and Founder of the Medical Science Liaison Corporation and MSL WORLD to better inform those who may be interested in pursuing a career as an MSL.

What is a Medical Science Liaison?

By Samuel Dyer

The MSL is a therapeutic specialist (e.g. Oncology, Cardiology, Infectious Diseases, Central Nervous System) within pharmaceutical, biotechnology, medical devices, and clinical research organizations (CRO) who has advanced scientific training and generally a "terminal D" degrees in the life sciences (PhD, PharmD, MD).  It’s important to note that MSL’s are not sales reps and their function is very different.  The primary purpose of the MSL role is to be scientific or disease state experts for internal colleagues (sales and marketing), but more importantly for doctors in the Therapeutic Area of the Medical community in which they work (i.e. Oncology, Cardiology, CNS etc.).  The focus of the role has changed over the years, but the primary responsibility of the MSL role remains to establish and maintain peer-peer relationships with leading doctors, referred to as Key Opinion Leaders (KOL’s).

Medical Science Liaison’s (MSLs) were first established by Upjohn pharmaceuticals in 1967 as a response to the need for professionally-trained field staff that would be able to build rapport with Key Opinion Leaders (KOLs) in various therapeutic areas of research. Although originally called Medical Science Liaisons by Upjohn, over the years and today, pharmaceutical companies have used various names for the role including: Medical Liaisons, Medical Managers, Regional Scientific Mangers, Clinical Liaisons, and Scientific Affairs Managers among others.  

Originally, the first MSLs were selected from experienced sales representatives that had strong scientific backgrounds to bring a higher degree of clinical and educational expertise to the medical professionals they were working with to influence sales. Over the years, MSL teams have been made up of individuals with various scientific backgrounds including: “super” sales reps, those with nursing backgrounds, those with various doctoral level degrees or other clinical backgrounds.  However, the required educational and scientific background and purpose of MSL’s has progressively changed over the years since they were first established.  In the late 1980’s, a number of companies began to require those applying to MSL roles to hold a terminal “D” degree such as an MD, PharmD, or PhD degrees.  

Although, historically, the educational standard in the industry did not require MSL’s to have a terminal “D” degree, however, today the terminal “D” degree has become standard in the industry.  Today according to one benchmark study more than 90% of current MSLs hold terminal “D” degrees.  

While the MSL role has received some attention, including a CNN Money article entitled "#1 Job in Pharmaceuticals-10 Jobs for Big Demand-Good Pay”, it remains one of the best kept secrets and one of the most difficult roles to break into.  Few people know about it, and little is written about the role.  In fact, the MSL community is quite small when compared to other professions in the pharmaceutical industry however there has been an explosion in the growth of the position. According to a recent benchmark study, there has been an average growth of 76% of the MSL role since 2005 across the industry in the U.S.

To learn more about the MSL role and find free resources go to www.mslworld.com

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!!!!!!!

 

Using Social Media Tools to Improve Information Flow At Scientific and Medical Meetings

Posted in Social Media

Science and medical conference season is in full swing and tens of thousands of persons are attending scientific and medical meeting all over the US. While social media is no longer a new “thing” only a few scientific and medical societies understand its power and ways in which it may be harnessed to improve the experiences of their members who attend their national meetings. 

At most of the scientific conferences that I attend (usually four to fiver per year), people still lug around and are tethered to printed program guides. Further there is no easily accessible electronic repository (aside from the conference website) or guide that conference attendees can use to optimize time management and see “everything” that they want to at the meeting. Unfortunately, most scientific and medical conferences are still being run the same way that they have been for the past 30 years despite improvements to internet access and bandwidth, the advent of social media and the recent explosion of mobile devices and apps.

Finally, and perhaps most egregiously, rather than publicly disseminating what is being reported at these meetings, conference attendees and the lay public must rely on carefully orchestrated press releases (chosen in advance by the organizing committees of the meetings) for information and late-breaking news from the events. This is so web 1.0 that it is almost laughable.

Until last week, I thought that I was the only person who felt this way about social media and medical and scientific congresses. Imagine my surprise when no fewer than three others social media enthusiasts including Mark Senak, author of the EyeonFDA blog, Brian Reid, author of the WCG Common Sense Blog and Sally Church, author of the Pharma Strategy Blog, last week authored posts on the topic! It is always refreshing to find like-minded individuals to confirm that you are not alone!

Unfortunately, many scientific and medical societies like to tightly control information flow, limit access to it and, not surprisingly, are quite suspicious of social media. This is because the use of social media decreases the ability of these societies and their journals to control their messaging and content dissemination. With this in mind, is it any wonder why American scientific and medical literacy is pretty much in the “toilet?”  While the lay public may not be able to understand peer-reviewed scientific and medical publications, they have grown accustomed to gathering information on Facebook, Twitter and most importantly blogs. Why not use these vehicles to better inform the public about scientific or medical breakthroughs that have been validated and generally regarded as authentic?

Like it or not, social media is here to stay. And if leveraged correctly, it can be an extremely effective educational tool. I think that it is time for scientific and medical societies to consider using social media at their annual meetings. A failure to do so may have negative consequences for future membership in these societies and also reduce their effectiveness as purveyors of timely and accurate scientific and medical information!

Until next time…

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

 

Sales of Medical Marijuana Reported to Rival Those of Viagra: Who Knew?

Posted in BioBusiness

Can getting high be more important than sex? Probably not if you are in your teens or early 20s, but if you are of  an age where managing the nausea associated with cancer chemotherapy or the pain of glaucoma then medical marijuana is likely to be more important than the need for sex! But, to be fair, despite the title of this post, Viagra will lose patent protection shortly (in some places it already has) and the drugs sales have been shrinking. Nevertheless, a report authored by See Change LLC, a Colorado company that provides investment advice to businesses found that the sale of  that medical marijuana has already reached $1.7 billion (in states where it is legal) as compared with annual Viagra sales of $1.9 billion!  

Unfortunately, See Change LLC is charging $1,150 for the report. And since I don’t have the money to purchase  it, I cannot determine the veracity or accuracy of the report. But, according to comments made by the editor of the report roughly 1 in 4 Americans lives in a state in which medical marijuana is legal, and that nearly 25 million people in those states have medical problems for which the drug can be prescribed. The report suggests that medical marijuana sales will reach $8.9 billion in five years.

Despite repeated scientific findings that medical marijuana can be used to effectively treat a variety of clinical indications that include chronic pain, nausea and anxiety, the myth of marijuana as a gateway drug to more serious drug like cocaine, heroin and others has been indelibly burned into the American psyche—not withstanding the statistics that show that prescription drugs like OcyContin, fentanyl and methamphetamine are the most abused drugs in America.  

While marijuana hasn’t been a part of my life for over 35 years, there is no question that it has enormous therapeutic value and ought to be legally prescribed when appropriate. In my opinion, the only thing that is preventing marijuana from being legalized is a business model that allows corporate America and the US government to maximize profits  from sale of the "deadly weed." 

 

 

It is time for Americans to forever expunge the "unbridled horrors" of Refer Madness from their collective psyches!

Until next time…

Good Luck and Good Job Hunting (be careful out there)

 

Attention: All Science and Medical Writers–BioInsights Launches the BioWriters Forum

Posted in BioJobBuzz

Medical/science writing is increasingly becoming popular among PhD life scientists are having trouble finding traditional laboratory-based, research jobs. The transition from laboratory research to writing is not an onerous one; especially if you like to write.

As many of you may know, I am a freelance medical/science writer who entered the field about 10 years ago.  Because most freelancers work from home offices, the lack of communication with others can be overwhelming at times. Consequently, many of us subscribe to e-mail-based listservs which allow us to stay in touch with other writers and frreelancers. Most of these medical writing listservs are run and maintained by the American Medical Writers Association (AMWA). In order to access and participate at the listservs, you must be an AMWA member which costs $145 or more per year.

While the AMWA forums are very popular, AMWA officials assiduously monitors them and at times, restricts some of the content that can be posted. For example, members of the ‘freelance business only listserv’ are strictly prohibited from posting jobs or alerting others to potential freelance opportunities. AMWA officials contends that these posts are inappropriate and disruptive. However, the real reason for the prohibition may be that AWMA operates a separate, fee-based service that allows freelancers to hawk their services.  In other words, allowing  users to mention freelancing gigs or job opportunities on ‘freelance business only’ listserv, could potentially jeopardize an additional AMWA revenue stream.

Occasionally, freelancers like me break the rules (go figure) and mention "hot" jobs or employers who may be looking for writers. I do this because, as a freelancer, I am painfully aware that my success as a freelancer is contingent upon my ability to maintain a regular, ongoing stream of freelance gigs. Unfortunately, the AMWA officers who monitor the listservs (many of whom are not freelancers), don’t understand this. Consequently, repeat offenders– like me–have been threatened with financial sanctions and possible expulsion from the listserv.

Because I don’t like feeling oppressed and being told what to do, I decided to create my own forum where freelancers can freely exchange information, post jobs, alert others about potential gigs and jobs and generally have an open and ongoing discussion about medical and science writing.  To that end I launched the BioWriters Forum about two weeks ago. The forum is hosted by BioInsights, Inc and is sponsored by BioJobBlog and BioCrowd. The forum is free but membership is required in order to participate. Please check it out and join if you like.

For those of you who decide to join, please feel free to send me any ideas, thoughts, suggestions, kudos, kvetches etc, that you may have.  Enjoy!

Until next time….

Good Luck and Good Freelancing!!!!!!!!!

Employers

 

Pharmaceutical Markets: Sex, Drugs (Quality of Life) and Rock n' Roll

Posted in Career Advice

The Internet and print media were buzzing this past week about the decision by a US Food and Drug Administration (FDA) panel of expert medical reviewers to not recommend approval of Boehringer Ingelheim flibanserin; a new medication to treat female sexual dysfunction or perhaps more apt lack of sexual interest.

Flibanserin was originally developed as an antidepressant but while it failed to treat depression women who participated in clinical trials reported increased sexual interest. The lack of drugs to treat female sexual dysfunction propelled Boehringer to continue to develop flibanserin to treat low libido in women. Previously, drug makers attempted to develop Viagra-like drugs and testosterone patches (testosterone increases sexual desire) to increase female libido—neither worked (without substantial side effects) to warrant approval. The FDA panel decided to not recommend flibanserin for approval because its modest effects on heightening female sexual desire did not outweigh side effects like dizziness and nausea.

A 2005 article in Nature Reviews Drug Discovery suggested that the size of the female sexual dysfunction market in the US could exceed $4 billion annually with only about 15 per cent of patients receiving treatment. Not surprisingly, many pharmaceutical companies have invested billions to develop new drugs to treat this indication.

There is no question that quality of life drugs like Viagra, Latisse and Botox generate billions of dollars in sales each year. While these drugs may help small numbers of patients who truly suffer from serious medical conditions, they are mainly used for so-called recreational purposes (sexual performance and beauty enhancement) by a majority of “patients.” That said, pharmaceutical companies have the right to develop whatever drugs or treatments that they choose. However, I contend that there are more serious medical conditions out there than failure to achieve orgasm or the need to not apply mascara on a daily basis.

Hat tip to Ed at Pharmalot for some outstanding investigative reporting!

Until next time…

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