Hess Associates

A look at the Industry Canada web site will tell you that Canadian pharmaceutical sales represent 2.6% of the global market, the 8th largest market globally, and the fastest growing. Admittedly, these current statistics on the site are probably at least one year behind actual fact. Hiring within the manufacturing part of the industry itself rose from 23,714 in 2001 to 27,016 in 2012. Also, as expected, the greater majority of companies are located in ON or QC.

What are they manufacturing? 60% of prescriptions purchased in Canada are generic in nature, but generics in general represent one quarter of all sales.

Who are the leaders? Johnson and Johnson, Astra-Zeneca, Pfizer,Teva, Apotex, Merck, Novartis, GSK, Abbott, and Roche. One of the most inclusive lists of all companies is published by Contact Canada, which boasts many different publications in related industries, but one specifically focusing on drug development and outsourcing – listings are free, and carry information on Company profiles, key contacts, tel, fax, websites, emails, corporate data, and product andervice areas.

The Canadian Generic Pharmaceutical Association (CGPA) represents 9 manufacturers and distributors of finished generic pharmaceutical products and 1 distributor of active pharmaceutical chemicals. Canada has about 200 CMOs and CROs operating in the pharma space.

In 2012, Canada’s spending on drugs in terms of health expenditure exceeded 33 billion dollars. The foremost therapeutic categories are cardiovascular, neuro-therapies (anti-arthritics) and GI.

LABORATORY WORKPLACE PSYCHOLOGICAL HEALTH

Research indicates a strong correlation between psychological health, and obviously health
and safety in general, at work and the increased revenue derived from greater productivity,
and decrease in employee absenteeism and turnover.
(see The Dollar Cost of Employee Turnover (http://hessjobs.mobi/the-dollar-cost-of-employee-turnover)).

Recently the Mental Health Association of Canada commissioned
a new standard, “Psychological health and safety in the workplace, Prevention, promotion,
and guidance to staged implementation”, which was then published by the CSA.

For example, amongst lab workers, in addition to the biochemical and actual physical risks,
and over time hours’ stressors, psychological hazards ranked very high, as a stress provoking agent.
Not surprisingly, this impacts home life and personal interactions as well.
Particular areas of difficulty could include frequent introduction of new technologies
requiring frequent retraining, new learning while continuing to do ones’ regular work,
forced requests for workers to do shift work and overtime (often uncompensated) – leading to stress at home,
and in some cases –difficult, unavoidable interactions with demanding, irritated, bullying
clients (the public), demanding, non-understanding bosses, intimidation, forced change in status
such as demotion without cause, denigration by superiors or peers, removing all responsibility
so as to purposely make a person redundant, all lead to unbelievable stress, tension, eroding
of self esteem, and harmful effects on all aspects of life.

Thus, what were the suggestions and guidelines?
Essentially a focus on mandated adoption of a non-abuse policy, related education, available
coping resources for bullied victims, reasonable schedules re retraining for new technologies,
time management re approaches to overtime requirements, adequate break times, limit
to consecutive working days, and building respect within the workplace and encouraging
communication.

Some of these good practice guidelines can be found at
Accreditation Canada – http://accreditation.ca/en/content.aspx?pageid=66.

What are some of your stressors at work?

National Biotechnology Week 2013

 

Sept. 20 to 27 2013 saw the marking of Canada’s 10th annual National Biotechnology Week across the country. Cross country events were hosted by BIOTECanada and its partners – aimed at networking, education, raising awareness of the bio economy in general, and at creating a favourable government framework.

BIOTECanada is in fact a national industry association of nearly 250 representing the health, industrial and agricultural biotechnology sectors, with impact on the manufacturing, automotive, energy, aerospace and forestry industries.

Examples of some of the events illustrating the advances in and the role of Biotechnology
Across Canada included:

• U Waterloo: The Centre for Bioengineering and Biotechnology showcasing student RnD
• McMaster U, Hamilton: President and CEO, Centre for Commercialization of
Regenerative Medicine, re careers in biotech
• BioAlberta in Edmonton: A lunch network event
• Charlottetown: PEI Industry & Research Connector Event
• Regina: Saskatchewan Science Centre Molecular Biology demo weekend
• Toronto: Life Science Ontario LSO September Breakfast Meeting
• Saskatoon: Why Health Innovation Matters Chamber of Commerce Panel Discussion and Canadian Light Source tours
• Winnipeg: Let’s Talk Science Graduate Student demos and Intelligent Hospital Systems demo
• BIOQuebec: Annual General Meeting and Networking Cocktail Reception
• Vancouver: Student network presenting Building BIOTECH 2013

Biotechnology should be supported – it is a major contributor to disease prevention and healthcare, safe and abundant food, bio energy, bio-based materials for modern manufacturing, clean technology to sustain the planet.

Use of Contract Workers in the Biopharmceutical Industry

What are contract and temporary workers? Temp workers are short term employees often used to fill short term staffing needs – e.g. holidays, sickness, whereas contract workers are often strategically required specialists, often running special projects or assignments. Recently due to skill shortages and the desire to attract key staff, the use of especially contract staff has increased and is increasing.

In Q1 2013 US companies hired close to 3 million such workers per day. 1

The use of temp or contract workers is increasing within the biopharmaceutical industry – certainly in Canada. 2
This has partly been ascribed to more women entering this industry over the past few years – thus companies are dealing with maternity leaves where contract replacements are common. Additionally biopharmaceutical companies have feast or famine years, wherein it is better to reduce fixed costs – hiring contract specialists obviates the necessity of high employee overhead commitments.

From the worker’s perspective,this form of insecure employment can offer an opportunity to enter the biopharmaceutical industry, to learn or hone specific skills, to grow a network, to evaluate a type of position or career, without a major commitment.

Companies are hiring contract sales, upstream or downstream contract manufacturing, legal, paralegal, accounting, quality, regulatory, scientific, clinical research, and other specialists as required in an effort to hire quickly and cut operating costs.

[Please contact Hess Associates to discuss/ evaluate your contracting requirements.]

1 http://www.americanstaffing.net/statistics/employment.cfm
2 http://www.pharmaceutique.ca/conseils-emploi/travailler-dans-le-secteur-de-la-pharmacie/travail-temporaire-dans-les-metiers-pharmaceutique-1/

What is Epigenetics?

Epigenetics is the study of changes in gene expression or cellular phenotype (observable characteristics) caused by mechanisms other than changes in the underlying DNA sequence – hence the name epi (over, above, outer) genetics, some of which are able to be inherited. Essentially it refers to functionally relevant modifications to the genome that do not involve a change in the nucleotide sequence.

It is also a reflection of the genome’s response to the environment, resulting in chemical modifications of the actual DNA (addition of methyl groups) and of enzymes or proteins that control the structure and/or activity of the genome.

Whereas the DNA (genome) sequence (code) does not change, the epigenome will, affecting which genes are expressed, and possibly leading to abnormal cellular behaviour and cancer.

For example, a certain protein may be involved in not allowing a certain gene to be expressed (direct the production of a product) but changes to this protein may allow expression, upsetting a biochemical balance. Dangerously, this change may survive cell division and continue to be enforced.

Conversely, some genes express proteins involved in tumour suppression, and any epigenetic changes can prevent this expression, and allow tumour growth.

Any technology which can artificially interfere with epigenetic behaviour can have an effect on cell growth and function, and potentially reverse a cancerous trend or direction.
One such place that studies epigenetics/epigenomics in Canada is the Michael Smith Genome Sciences Centre in Vancouver, BC, one of 2 Canadian centres studying epigenetics under the umbrella of the Canadian Epigenetics, Environment, and Health Research Consortium,. Here with massive DNA sequencing power, scientists are seeking to determine how short lived or stable alterations in protein or DNA (DNA can be modified by methylation without a change in sequence) can allow our genomes to develop disease or stay healthy.
Already, clinical trials are being carried out using epigenetic therapeutic approaches, to treat leukemia, and this is just the beginning.

Studies continue as well in Europe, Germany, USA, Italy, Japan, South Korea, and as part of the International Human Epigenome Consortium Assay Standards working group.

Excerpted in part from http://biotechnologyfocus.ca/?p=2203

2012 Pharma/CRO Employment/Salary Picture

Employment in the US pharmaceutical or clinical research segment has been devastated, over the past few years, with several elements at force, including M&As, outsourcing, global competition, increasing regulations, restructuring, actual closings, decrease in new drug development, and cost-cutting. In 2010 and 2011, the overall pharmaceutical industry lost 50,000 and 20,000 jobs respectively in the US, and close to 9,000 in the first half of 2012. Despite a levelling off trend in job cuts, the hiring prospects within pharma remain challenging. The 3 main areas where outsourcing from pharmaceutical companies seems to be heading include full service CROs, monitoring, and patient recruitment, suggesting a positive outlook in the CRO employment sector. This is 10% more than most other industries.

For the last 6 years, Applied Clinical Trials has carried out a biannual “Salary and Career Development” survey of the US CRO industry. The over 1000 respondents (at least half with advanced degrees vs bachelor’s degrees, 75% US) were also chosen from related fields such as biotechnology, government labs, private consultants, medical devices, sponsors, and trial site management organizations. Results were in their report based on September/October 2012 data (done together with Center Watch)1.

Due to the number of job downsizings in the pharmaceutical industry, global CRO market growth, and increased pharma outsourcing to CROs, pointed questions were asked:

1. Change you foresee in CRO industry economy – CRO respondents 51% positive, investigative sites or sponsors 25%,

2. Industry sector where you still see most opportunity – Biopharmaceutical (65%), then CROs (26%) – where 46% of the respondents were in the CRO sector, and 27% in medical devices.

3. Job security –30% of respondents felt secure in their positions, and 52% somewhat secure (higher values than the previous year), and by industry, more CRO respondents felt very secure in their positions than site respondents or sponsors.

4. Salaries – median salaries within Biotech rose from $96K to $110K between 2010 and 2011, in CROs from $98K to $100K, in medical devices $104K to 108K, the lowest being clinical study-investigative sites, up to $60K in 2011.

Looking at individual positions, all earnings average, scientists, researchers, data managers – $70K, managers – $95K, associate directors – $130K, directors – 150K, VPs – $190K (for exact details please refer to paper).

Overall, there was a positive outlook amongst CRO respondents, not surprising, as Business Insights sees the CRO market to be $35 billion in 2013.

Nor does this mean that all CRO positions will go off-shore, as there are still hurdles, such as supply chain, unmet regulatory requirements, lower enrolment rates, and difficulties with infrastructure, and difficulties overseeing the CROs. Let’s hope a positive outlook prevails.

1 Applied Clinical Trials 21, 18-22, 2012.

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