ATA - Thoughts on Pharmaceutical Translation

ATA Science & Technology Division

ATA Science & Technology Division is for translators of texts relating to science and technology. This blog is for specialized technical translators who can benefit from the networking, terminology research, and professional development opportunities offered by other translators specializing in technical or scientific fields.

FRIDAY, APRIL 27, 2012

Thoughts on Pharmaceutical Translation

By Karen Tkaczyk

Every so often you read an article and wish you’d written something like it. This happened to me recently, with the piece called “Big Pharma Cannot Afford to be Lost in Translation” by Portuguese translator and consultant Cristina Falcão. It can be found here, on the PharmaIQ website http://www.pharma-iq.com/medical-devices-and-diagnostics/columns/big-pharma-cannot-afford-to-be-lost-in-translation/  . If you translate for the pharmaceutical industry you will find other insightful articles and useful resources there, including others by Cristina.

I contacted Cristina to ask her if she minded me reporting on her article to the ATA Science and Technology Division’s blog and adding a few thoughts of my own. She didn’t mind, so here we are.

The target audience for Cristina’s article is pharmaceutical companies, not translators and interpreters, but I feel that in order to do a good job as we work for those industries we also need to keep in mind the principles she raises.

Cristina starts with the commonly stated concept that we must understand to do a decent job, let alone an excellent one. But she stated it in a way that caught my attention, quoting the late Henry Fischbach, co-founder, charter member, and honorary member of the American Translators Association. I couldn’t find a better quote if I tried for hours, so I’ll restate it. 

“The hallmark of a good scientific translator is intellectual honesty and a sixth sense to realize that something is amiss.” 

We cannot translate effectively if we do not understand properly. Personally, I love the quote because it sets me straight. When that sixth sense kicks in, and I realize that something is amiss with a text, paragraph, or term in spite of my best efforts, I know I need to ask a colleague for help. Sometimes it is not that something is wrong but that I need confirmation from an expert in the field that they really would say it that way. When used wisely, LinkedIn (www.linkedin.com) is a good resource for making contacts like that, if you do not have them. Sometimes I am that other colleague to whom technical translators come for help, when they are translating chemistry and know their instincts are not as well-honed as mine. At times early in my career I truly did need help because I had taken on a text that was outside my areas of expertise, and it ended up being more than I could handle in the allotted time. Nowadays, I have a great, mutually beneficial working relationship with a biologist-turned-translator who can provide a quick confirmation and the reassurance I need before delivering a text.

Cristina then refers to several articles of European Union Directive 2001/83/3 and gives insights on each of them: costs, metric conversions, diacritical marks, patent effect, cross-cultural communication, and readability.

Her examples are powerful. The only area where I see things differently is metric units. Much of the English-speaking world widely uses metric units these days. Even in the US, where Imperial measurements are used for many general applications such as groceries and weather forecasts, I find they are rarely used in scientific and technological situations. I rarely see Imperial units in pharmaceutical documents with the exception of pressures, which are often expressed in pounds per square inch (psi). Regardless, we need to understand units of measure and how usage differs from region to region, and industry to industry, because we need to make the right choices as we harmonize our texts.

The Patent Effect is something well known to those of us who work in that area. Often terms appear to be unrelated, because in one language a terminological oddity is used, and in another an obvious name is used. To complicate matters, the internet is usually full of examples of fairly literal translation mingling among the correct terms. For terminology related to cosmetics, I have to research deeply, frequently due to the Patent Effect. An innovative French cosmetic company that files many patents in that field generally transliterates its own French neologisms when writing patent abstracts in English. This leads to some very odd and calque-like terms, some of which have good English equivalent terms; however, some of them are commonly used by English speaking cosmetic companies. It takes time and insight to sort out the subtleties in each case.

The pharmaceutical industry has a heavily ethical component. So do we translators, as we seek to produce a faithful translation to the best of our ability. I look forward to reading more insightful articles from Cristina and other pharmaceutical translators as I explore my area of expertise, and I hope referring to it here has been of use to readers.

Karen works from French and Spanish into English – both UK and US. She translates documents on chemistry and its industrial applications, including patents. 

ATA Science & Technology Division: Thoughts on Pharmaceutical Translation

ATA Science & Technology Division: Thoughts on Pharmaceutical Translation: By Karen Tkaczyk Every so often you read an article and wish you’d written something like it. This happened to me recently, with the...

How to lose weight in a healthy way

 

 

In order not to get depressed, try to cut back slowly on food you really like but is not healthy. 
Have one day/week when you can indulge yourself with a bit more of that food. 
If you go to a party don't cut back, but be sure to diet the very next day. 
Drink a lot of water (1, 5 L)/day. 

 

 

Don't eat more than 3 pieces of fruit/day and try to eat those with fewer calories like apples, strawberries, oranges… And don't eat fruit salad (what a bomb!). 

 

 

At a morning or an afternoon break, should you eat a piece of fruit, than eat a cookie too because both are "sugars" but one is fast digested and the other is of slow absorption so you won't feel hungry. 
Remember that what you eat until noon you will use; after noon eat less and never eat before you go to bed at night. And eat a good, plentiful and healthy breakfast. 
Wine and other liquor provide useless calories. 

 

 

I could say a lot more, but I will just say that remember that losing weight is a slow process, it may take a year, but diets are depressing and you will gain back all the lost weight plus extra weight. Go to a gym in order to keep your muscular tonus in a good look.

Why do people resist change?

 

Because they are people and it is a known fact that people do not welcome any change in their comfort zones.

 

 

 Changing is adding new “problems”, more work, new rules and people wonder why, is it necessary, why change, most times they cannot see or refuse to see that they are changing for the better.

 

 

In my years of professional experience I have always heard that change equals a leap to the unknown and is it worth it? The general answer is no. I don’t see things that way, but I welcomed change all my life and I go look for change very frequently because I see change as a necessity, not as a burden.

 

Does the pharmaceutical industry fabricate mental illness?

 

No, it does not. The fact that people are not conveniently medicated is not something you can pharma industry accountable for. There are too many people actually asking for anti depressants to their doctors, I have seen this in my professional experience as a healthcare provider.

 

Don’t take me wrong I write about the pharma industry and I know what is not so right there, but fabricating mental illnesses is not one of their “sins”.

 

 

Of course you cannot be talking about Europe where off labeling marketing and prescription is strictly forbidden.

Is the Customer always right?

 

 

If you want to keep your business that should be the rule; if you want to conduct your business in a smart way you talk to customers and make them see they are not always right.

 

 

If someone comes back to my pharmacy wanting to have their money back for a medicine they bought, I explain in very nice terms that if I accept it back I cannot put in the shelf to sell to another customer

 

because I am responsible for medicines as long as they are in a controlled environment such as the pharmacy; after they leave the pharmacy I cannot guarantee they are in good conditions; I always ask what would that customer think if he/she knew I was selling a medicine that had been in someone else’s home.

 

 Up to date I only had two customers refusing to understand this, so I gave the money back and put the medicine next to the expired ones, to be collected and then treated as pharmacy waste.

A Revolutionary Paradigm Shift in Big Pharma's Organisational Development

A paradigm is the conceptual framework upon which we build our world; it is built upon past experiences; if we are not willing to make shifts in our paradigms, we will remain stagnate in our growth; a paradigm shift is a change from one way of thinking to another; it is something that does not happen like self generation it is driven by change.

Culture change is not simply about how we see others and ourselves. It is about how the system works, i.e. how we do the work together, rather than how we work together. The paradigm shift is to understand how to act on the organisation as a system.

The most critical thing to understand about a paradigm is that, in a paradigm shift, everything goes back to zero. What does that mean? It means that whatever made us successful in the old paradigm may not even be necessary in the new paradigm.

We have seen pharma industries changing their business models to collaborative networks (http://www.pharma-iq.com/logistics/articles/where-have-all-the-experts-gone-long-time-passing/); we have seen the catch 22 of  M&A and downsizing (http://www.pharma-iq.com/logistics/columns/when-change-management-is-about-big-pharma-disrupt/), and we have seen outsourcing as general panacea for pharma cost cutting (http://www.pharma-iq.com/regulatory-legal/articles/pharmaceutical-outsourcing-where-do-you-draw-the-l/).

What Has Changed? Everything – 2012 Portrays Big Pharma’s Future Scenario

Governments around the world are grappling to arrive at solutions for health account deficits. Political pressures have increased during the economic crisis.

Personalised medicine means changing drug portfolios from primary care driven blockbusters towards specialties, where the medical need is so high that regulators are more ready to accept the prices. Evidence of the value that medicines bring to healthcare systems will be required to achieve access and funding in both developed and emerging markets. 

However, changing portfolios to address the changing pharma landscape is not enough; the pipelines are dry and R&D costs continue to skyrocket - the new paradigm is not about portfolios. Broadly, to raise innovation returns back to the level that prevailed in the era of blockbusters, pharma companies need transformational change.

Index:The Hidden Cost of M&A; R&D Models; Commercial Approach; “The Core of the Paradigm Shift -The Virtual Model and Continuous Manufacturing”; Regulations

The Hidden Cost of M&A

Overcoming post-merger integration issues is a non-trivial task. There is a hidden potential cost of billions of dollars that is not seen on any P&L statement – M&A slow down the ability of organisations to execute because it takes years for companies to fully develop a combined culture, and sometimes it  does not even happen at all.

Furthermore, the growth of organisations will end up in more complex structures and processes that, over time, become a drag on the quality and speed of decision-making.

R&D Models

Some companies are moving to downsize their R&D operations and diversify into market sectors that are less R&D intensive. 

Not only has the pharmaceutical industry gone through an acute phase of cost cuttingand downsizing but many pharmaceutical companies are now aggressively working to change their company's behavioral culture and R&D operations. Companies need to make strategically important commitments to new R&D models, which may be experimental models right now but have the potential to be new growth engines.

Commercial Approach

Go-to-market capabilities are very necessary for a new commercial approach.

Pharmaceutical companies relied (over the past two decades) on a sales/marketing approach that was aimed at prescribers in the world’ largest markets— Europe, U.S. and Japan.

However, going forward implies  not just more significant cuts in traditional resources, but a focus on building distinctive new capabilities because  the Emerging markets are forecast to make up 30% of the global pharmaceutical market by 2015, and they have very different healthcare models for marketing authorisation, pricing, reimbursement and distribution.

The core of the paradigm shift in Pharma’s organisational development: the virtual Model and Continuous Manufacturing

The virtual model- The popular phrase for outsourcing drug discovery nowadays is “virtual.”

Virtual pharmaceutical/biotech companies are knowledge-based organisations with a core management team, contracting out nearly all of the services they need for drug discovery, development, manufacturing, and marketing. In this way, a virtual company can reduce its fixed costs to around 25% compared to the 75% of a standard company.

The virtual R&D drug development model allows for a high degree of flexibility in being able to respond rapidly to threats and opportunities. In addition, it allows for a small group of individuals to work on a larger number of projects simultaneously.

Dismantling the functional staffing model and replace it with a more flexible human resource model is a viable answer allowing managing costs by limiting full-time employees, reducing fixed assets and clamping down on overheads.

Continuous Manufacturing

Continuous manufacturing has been the norm in almost all manufacturing industriesbut in pharma, the profits coming from the established blockbuster discovery model have covered manufacturing inefficiency. However, the pressure on all parts of the pharmaceutical value chain has increased and, like any other department, manufacturing has to improve its outcome, reducing time, waste, and cost.

As manufacturing models embrace process analytical technology, big pharma has to reassess the way it produces drugs.

Only then big pharma can shake off the outdated model of batch processing and enter a new era of drug production. The switchover to continuous is without question more cost-effective than batch manufacturing.

The big challenge is the organisation of a new type of facility, which goes hand in hand with the investment in the complete new form of production equipment.

Novartis is currently finalising a lab-scale pilot facility, called 'Technikum', where only a few months ago MIT scientists produced one of the company's drugs in a continuous way for the first time ever.

Regulations on Continuous Manufacturing:

EMEA has issued a new guideline on process validation “Continuous Process Verification (CPV) is an alternative approach to traditional process validation in which manufacturing process performance is continuously monitored and evaluated (ICH Q8).(http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2012/04/WC500125399.pdf)

FDA

“The regulatory definitions of “batch” and “lot” do not present hurdles for implementing continuous manufacturing, FDA is stressing in highlighting the potential the new processing approaches offer to advance the objectives of its 21st Century quality initiative. The adaptability of the batch/lot concerns in the GMPs to continuous manufacturing (CM) has been addressed in key presentations given at recent public forums by Center for Drug Evaluation and Research (CDER) officials Christine Moore and Francis Godwin.” (http://www.ipqpubs.com/news/continuous-manufacturing-does-not-present-regulatory-hurdles-fda-experts-say/)

http://www.pharma-iq.com/logistics/articles/a-revolutionary-paradigm-shift-in-big-pharma-s-or/