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Sunday, August 18, 2013

Blue Collar Scientists

In biopharma, the PhD is the white collar worker. The laboratory worker is the blue collar worker. There are also administrative, regulatory, statistics and various other people, but what I want to focus on here is the science. Who does it? What is their role in developing a new drug? What do they know about the disease for which they are developing drugs?

In science we have the hypothesis to begin our work. A hypothesis is a testable statement based on accepted grounds. Contrast hypothesis with conjecture. Conjecture is an unproven proposition, often times mistaken as fact (or hypothesis) by an unscientific (Cargo Cult) mind. The first thing to note here today, on this concept of white and blue collar scientists, is the role hypothesis and conjecture play in the two disparate occupations.

The white collar worker swims in a sea of conjecture. The New Coca Cola recipe, for example, was developed because white collar workers decided that people wanted a better Coke. The sales proved them wrong. In science, we start on solid ground with the hypothesis and push the idea forward as directed by what we find. Penicillin, for example, was found in the laboratory by accident. From Wikipedia:
Fleming recounted that the date of his discovery of penicillin was on the morning of Friday, September 28, 1928.[19] It was a fortuitous accident: in his laboratory in the basement of St. Mary's Hospital in London (now part of Imperial College), Fleming noticed a Petri dish containing Staphylococcus plate culture he mistakenly left open, was contaminated by blue-green mould, which formed a visible growth. There was a halo of inhibited bacterial growth around the mould. Fleming concluded the mould released a substance that repressed the growth and lysing the bacteria. He grew a pure culture and discovered it was a Penicillium mould, now known to be Penicillium notatum
Here we have a biotechnology project that is the antithesis of New Coke. There was a good reason to start the project. The anti-bacterial effect of the Penicillium mould was already known, dating back to the 1870s. Back before big business science projects were funded to the tune of billions of dollars per year, scientists had to make observations on their own. This observation is in the realm of blue collar work. It took years and years of blue and white collar work to make penicillin what it is today, but it all began with an observation.

Not many white collar workers of the caliber of Alexander Flemming. How many biotech/pharma executives would walk into the laboratory and make observations? The Nobel Prize winning scientist I worked for had his picture taken in a white lab coat sitting by a hood with a bunson burner lit up in the back ground. We hung the picture in the lab with the caption, "This isn't like my piano at home." We put it in the lab so he wouldn't see it and get angry.

The identification of Alexander Flemming caliber talent would be difficult to do considering laboratory observations are not part of the white collar scientists job description. The discovery scientists we wish for are neither blue nor white collar. They are pure scientists who require a large support network of both blue and white collared workers. Flemming didn't single handedly send penicillin out to the world from that lab where he first saw the mould fighting off the germs.

We can see that there was a long path taken to place penicillin in the world of modern medicine. With this in mind, let's examine the modern world of blue collar science. Undoubtedly there were many hospital laboratory technicians as well as biotechnology laboratory workers who contributed to the penicillin effort.

If you are looking for a transition from the biotech lab, you might want to look at the field of Medical Laboratory Science (MLS). In order to take on this work you must have a Bachelors degree with specific math and science coursework. If you graduated more than 7 years prior you must go back and take a senior level chemistry and microbiology class plus lab. You'll need three formal references, the forms to be filled out are provided by the school. You fork over $50 and apply. The school selects candidates in for interviews. Once selected you will embark on a one year $20K education involving senior level courses in clinical lab skills, intro to clinical lab practice, chemistry, clinical chemistry, micro I and II, clinical microbiology, parasitology, mycology, hematology, serology, immunology and molecular diagnostics. After the year of education you must take and pass the MLS exam to become certified. Now you can begin applying for a lab job down at the hospital.

Let's compare the requirements for a typical laboratory job in biotechnology:

Research Associate/Senior Research Associate - Target Validation - Seattle Genetics 

The successful candidate will:
• Design, conduct, and interpret experiments utilizing a diverse array of techniques aimed at validating early targets in Seattle Genetic’s drug discovery pipeline. 
• Standard target validation methodologies will include flow cytometry, cytotoxicity assays, and immunohistochemistry. 
• Additional techniques will include cell-based assay development, cDNA/RNAi transfection, qPCR, RNA/DNA purification, Western blotting, protein-protein binding assays, and epitope mapping. 
• There will also be direct involvement in the discovery/development of predictive biomarkers.
• The successful candidate will prepare for and present their result at departmental and integrated project team meetings.

• BA/BS with 8+ years or MS and 5+ years of experience in the biotech/pharmaceutical industry
• Significant training/experience in Oncology, Biochemistry/Pharmacology
• Experience with physical and functional genomic screening is a plus
• Experience with high throughput robotics is a plus
• Experience with biologic therapeutics is a plus
• Experience in predictive biomarker discovery is a plus
• Excellent interpersonal skills
• Excellent presentation skills

You will not need any certifications, just the ability to convince the hiring manager that you have the skills to do the job. You should also believe that the hiring manager can do all of this him/herself, but due to white collar duties, they don't have the time. The two of you will be on the same page at all times and always move on to the next logical step. 

Notice the first objective; to validate their targets. One would think they have already done that, thus the targets have become theirs. Why would someone outside of the organization have to come in at the blue collar level and validate their targets? Also note the very first word, "Design"... experiments. Have they blurred the line between PhD and laboratory work? 

Alas, the biotechnology blue collar worker has a lot to do. The medical laboratory worker must compete for the higher education that lead to hospital blue collar work. Maybe not as blue as the janitors but still... they aren't the doctors.  The MLS performs standardized tests. They report everything they do. The biotech research associate on the other hand, has only a college degree. A degree in biology is the same as biochemistry. Both are vocational diplomas for entry level biotech or prerequisites for the MLS program. There is no formal training in research. They report most things they do to the white collar worker, but not to a regulatory agency. Somewhere along the line the research associate (RA) must pick up "significant training/experience in Oncology", AND ROBOTOTICS! And in contrast to the Steve Jobs concept that difficult personalities can sometimes be the most creative, you must finish off your skill set with an agreeable personality (excellent interpersonal skills). 

It is too much to ask but the Seattle Genetics job description is par for the course in the pharmaceutical industry. The white collar workers design these job descriptions based on conjecture. The perfect worker to develop drugs operates somewhere between white collar scientist, Alexander Flemming scientist, and laboratory technician. Modern day biopharma white collar workers want to wrap up all of the talents and skills that went into developing penicillin as a medicine, and create one blue collar lab worker. Note also the timeline from Flemmings 1928 observation to the widespread use in penicillin in WWII (1940s). The Seattle Genetics RA won't have 15 to 20 years to accomplish the oversimplified goals, i.e. validate the companies drug targets. They may get up to 10 years maximum, if they have excellent interpersonal skills. 

Like the lemming who runs to the sea and jumps off the cliff to certain death, the RA will take on the job, prepared to do whatever they can to validate the companies drug targets. They may feel that they are lemmings facing the mass suicide but times are tough and they didn't get the white collar credentials before entering the world force. They must do their part and live year to year not knowing when the end is near.

I can envision a future where the laboratory workers in biotechnology must also go through a similar additional education as the Medical Laboratory Scientist. To gain respectability, this class of worker must somehow unite and form their own certifications and specialties. How do you convince Seattle Genetics that you have Oncology training/experience? Actually go out and get it. Make yourself useful and make the people you pay for the education market their product. Best of all, make the white collar scientist less authoritative over the laboratory and thus over reality. This newly empowered laboratory class will cease to operate like the current lot of blue collar lemmings. They may even operate separately from biopharma. Science does not really need the blue collar mentality. Not all work is equal but ultimately, we can all think and observe. We can all be practice science somehow. 


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