Cannabis Testing Services: A New Alternative Career Opportunity For Life Scientists

Posted in BioJobBuzz, Career Advice

Increased use of medical cannabis, coupled with a growing trend to legalize cannabis for recreational use, has created a niche for companies that offer analytical cannabis testing services.  Not surprisingly, the cannabis testing market is dominated by North American companies with an annual market size of roughly $822 million in 2016 (1).  The size of this market is expected to reach approximately $1.4 billion by 2021 (1).

Typical services offered by cannabis testing companies include:

  • Potency testing
  • Terpene profiling
  • Pesticide screening
  • Residual solvent screening
  • Heavy metal testing
  • Genetic testing
  • Microbial analysis

Most of these analyses involve the use of standard laboratory instruments (and related software packages including 1) liquid chromatography (LC), 2) gas chromatography (GC), 3) mass spectrometry, 4) atomic spectroscopy and 5) automated DNA sequencing/genomic analyses.

While the analytical services offered by these companies may sound esoteric to  lay cannabis audiences, they are very familiar to life scientists with backgrounds in biochemistry, organic chemistry, molecular biology, pharmacology, botany, plant pathology and a host of other life science disciplines.  That said, the rapid growth of the cannabis testing industry has created job opportunities  for life scientists who are trained and skilled in the above mentioned analytical methods.

Industry leaders in cannabis analytical services  who may be looking to hire new employees can be divided into two distinct categories; companies that develop hardware and software to conduct the analyses and companies that actually provide analytical services to clients.  Companies involved in hardware and software development  include:

  1. Agilent Technologies Inc (hardware/software)
  2. Shimadzu Corporation (hardware/software)
  3. PerkinElmer, Inc (hardware/software)
  4. Millipore Sigma (hardware/software)
  5. AB Sciex LLC (hardware/software),
  6. Waters Corporation (hardware/software)
  7. Restek Corporation (hardware/software)

Leading companies that offer analytical services to clients include:

  1. Accelerated Technologies Laboratories Inc (hardware/software)
  2. LabLynx Inc. (hardware/software)
  3. Steep Hill Labs, Inc (analysis)
  4. CannaSafe Analytics (analysis)
  5. Pharm Labs LLC (analysis)
  6. Digipath Labs, Inc (analysis)

Because  the number of traditional life sciences job continue to decline and remain highly competitive, now may be a good time for entry level life life scientists to consider a career shift to the cannabis testing services market. However, do not wait or linger.  This market, like the traditional life sciences job market may be quickly  over subscribed!

References

  1. Cannabis testing market expect to reach $1.4 billion by 2021. http://www.marketsandmarkets.com/PressReleases/cannabis-testing.asp Accessed August 7, 2017

Merck Gets Serious About Biosimilars

Posted in BioBusiness

Two years ago Merck formed a new division called BioVentures ostensibly to develop and manufacture biosimilar drugs. Interestingly, the announcement preceded creation of a regulatory approval pathway for biosimilars in the US.  While the approval pathway still isn’t in place, many regulatory experts expect the US government to issue the guidelines by mid-2011 after a meeting that was held on biosimilars by the US Food and Drug Administration last month.

Late last year, the company scuttled its plan to develop a PEGylated version of EPO which was to be its first so-called biosimilar. Unfortunately, PEG-EPO would not be allowed to be approved as a biosimilar via any existing or newly divined pathway because it is actually a new molecular entity and, therefore, would require numerous clinical trials to garner regulatory approval (maybe that is why Merck canceled development).

Nevertheless, Merck expects to have no fewer than 5 biosimilar molecules in clinical development by 2012. To that end, Merck  that it had created an alliance with Parexel International Corp—a global clinical research organization—to help to conduct the clinical trials necessary for regulatory approval of the biosimilars that Merck is developing. The financial terms of the deal were not disclosed.

Michael Kamarck, President of Merck BioVentures, declined to specify the products but did mention that the terms of the deal terms were intended to “motivate Parexel to enroll patients quickly and generally execute the clinical trials in a speedy fashion.” He also noted that the Parexcel deal is only “one of an number of strategic steps: that Merck is pursuing in the biosimilar field.

Let’s see whether or not Merck can meet the lofty goals that it has set for itself. Hopefully biosimilar legislation will be in place by 2012!

Until next time….

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

 

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!!!!!!!!

 

How Social Media May Be Influencing Human Clinical Trials and Access to Potentially Life-Saving Investigational New Drugs

Posted in Social Media

It’s no secret that pharmaceutical and biotechnology companies are “not in love” with social media. However, whether life sciences company like it or not, social media is beginning to affect human clinical testing with an increasing number of patients demanding access to unapproved experimental drugs to treat life-threatening illnesses. 

In a recent article that appeared in the January 15, 2010 issue of Genetic Engineering and Biotechnology News entitled “Expanded Access to Investigational New Drugs”, Natalie Douglas, CEO of UK-based Idis Pharma wrote:

"…the trend toward greater transparency of drug development pipelines and the accessibility of powerful social media tools, have led us to a more informed empowered and vocal population of patients. This, in turn, has led to increased demands for access to unapproved drugs that are in various stages of human clinical testing. “Patients can easily access information about investigational drugs via the Internet and are leveraging social media tools such as YouTube, Twitter and blog to influence companies to garner access to them” Douglas added.

This can place enormous pressure on the companies that are testing investigational new drugs because the safety and efficacy of the drug candidates has yet to be determined. Understandably, companies are loath to provide patients who don’t meet clinical trial inclusion requirements access to experimental drugs with unknown safety and efficacy characteristics. Nonetheless, if requests for access to investigational drugs are denied, social media tools can easily be used to quickly and widely publicize the denial. According to Douglas, aggressive use of social media tools by patients seeking access to investigational drugs has helped their stories make national news. This can create gargantuan regulatory and public relations problems for companies with drugs in clinical development and put them at the center of an ethical and moral firestorm—despite their best intentions to develop new drugs that eventually may help millions of patients suffering from various diseases and conditions.

Many patient advocacy groups, consumers and shareholders understand the almost limitless reach of social media and its ability to influence public opinion, discussions and trends. Whether or not drug makers are willing to use social media, many have yet to understand that they are already part of the social media conversation that is taking place daily. And, as all social media enthusiasts have realized, if you are not part of the conversation then you don’t know what is being said about you on the Internet. More importantly perhaps, is that by choosing not to participate in the conversation, companies have lost all ability to influence and manage what is being said. In other words, life sciences companies that steadfastly choose not to use social media may, paradoxically, be setting themselves up for public relations and regulatory headaches that could have easily been avoided.

While the social media frenzy may be beginning to wane, there is no question that it has changed the way people interact and influenced the way business is transacted online and in real life. Companies that insist on clinging to past business practices that are exclusive, non-interactive and designed to promote opacity are likely to lose customers and market share as 21st century technology continues to unfold.

Hat tip to Natalie!

Until next time…

Good Luck and Good Tweeting!

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Another Day–Another Salmonella Outbreak

Posted in Career Advice

Tainted pistachio nuts are the culprit for this week’s Salmonella outbreak.  Fortunately, Kraft Foods’ quality unit was doing its job and was able to alert consumers about the problem before the outbreak reached epidemic proportions. At present, there are only two suspected cases of Salmonella gastroenteritis that may be linked to tainted pistachios. The contamination has been traced back to a California company which, according to reports, is the second leading producer of pistachios in the US.

As I have mentioned several times before, Salmonella outbreaks are nothing new and not out of the ordinary in the food industry. However, what is new is the growing lack of regulatory compliance that seems to be pervasive at American food manufactures. Many blame declining food safety on the US FDA’s lack of trained inspectors. While this may play a role, I believe that the real problem lies with the failure of many food industry executives to make a commitment to quality outlined in FDA’s Current Good Manufacturing Practices (cGMPs). 

I have been teaching cGMP to biotechnology students for the past six years or so.  I always tell them that the regulations are meaningless unless management makes a commitment to quality. And, the only way to accomplish this is by insisting that all manufacturing taking place at a company stringently adheres to all GMP regulations and guidelines. For those you who may not be familiar with cGMPs, they are the minimum regulatory standards that must be met to insure US product (food, drugs and cosmetics) quality and safety.

Over the past decade or so, Americans have grown accustomed to a wide variety of choices when it comes to raw and processed foods. To meet demand, US food manufacturers must source and import fruits, vegetables, spices and other foodstuffs from all over the world. Regardless of the origin of a food source, cGMPs clearly state the onus is on the manufacturer (not the supplier) to perform the necessary tests to insure food safety and quality. The recent spate of Salmonella outbreaks suggests that some food manufacturers are either cutting corners or don’t fully understand what testing is necessary to guarantee food safety. Unless something changes, Americans confidence in the safety of US food supply will continue to wane.

Until next time…

Good Luck and Good Easting (avoid pistachios)