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/

 

The cure for cancer for pennies?

 Di-Chloro-Acetic Acid- is this the answer to cancer?

 

 

 

I doubt it. First there is no answer for "cancer". there are many types of cancer and the drugs are not the same to treat a breast cancer, for example, and liver cancer. Second, this is just a piece of news, I would like to see the studies they did, the trials, etc, etc. Third, if indeed this drug proves to have some efficacy in cancer treatment it will need a Big Pharma industry behind it, there is R&D to do and so much more; if the drug is not patented, I cannot see any interest arising in pharma companies, after all, they only invested in orphan drugs because legislation was passed by the FDA and EMEA to grant them so many benefits it made it worth investing in this field. Remember there is patent protection of 10 years in Europe and 7 in US, apart from many other incentives. Maybe some university will want to explore it, but.... it will always come to Big Pharma and big pharma is not interested, not this way...

Are you an entrepreneur?

 

Ask yourself some questions to see if you have the mentality for being an entrepreneur, such as:

 

Do you have an open, curious and restless mind? Can you accept the possibility of failure, and are you able to survive a business failure?

 

 Finding startup capital can be your biggest challenge. The more time and effort you put into planning a new venture and creating a business plan can pay dividends in the end. To be successful you need a great upfront work on planning and executing your business plan and business model; remember it takes time and good preparation to achieve success.

 

You own your time but small tasks take over your life; they are an emotional roller-coaster (the ups and downs are more extreme than one is prepared for); they need persistence; you must think long-term; there are lots of little things you have to do.

 

When I first did it the biggest challenge was to find clients, a Portuguese lawyer cannot advertise and lives of “word of mouth”; the second one is that it takes some 5 or more years before you can say for sure what your yearly income is, but the expenses are always there to be paid

Untitled

 

 

The bio-pharma industries have one of the more complex supply chains because it needs to include cold chain. In Europe, we are used to it, even though since March 2011 the European Commission issued new rules about many issues including cold chain - the cold chain distribution is imperative because based on projected market growth rates, 7 of the top 10 global pharma products in 2014 will require cold-chain handling. 

 

I have had many talks with big US and Canadian supply chains to explain how the concept of pharmacy is so different between English speaking countries and non-English speaking ones. For instance, take Portugal: I cannot have a vaccine to sell that is not conveniently stored in a cold facility with a temperature range of 3º to 8ºC.

 

This makes us have very advanced technologies in the pharmacies that are checked by health authorities and double-checked by us every month. Now, I have no use to such a big investment to secure that the vaccine is in perfect good conditions to sell, if I am not sure that it was always kept this way since it left the pharmaceutical industry that produced it. 

 

We have cold chain distribution and I can watch with a special software program all the “route” that vaccine did, and in what cold chain conditions, since that vaccine started its way to my pharmacy. There is a cold chain along the way that assures me that when that vaccine gets into my cold storage, it was never exposed to different temperatures, not even for a second. If I am not happy with what I watched ( I have batch numbers and special coding) I will not accept it in my pharmacy and will not be responsible to sell something that can kill someone because it lacked the cold surveillance/maintenance. 

 

This goes to several other medicines that need cold chain/storage, as well as those that need intermediary cold storage, not the special facility, but a special warehouse within certain temperature and humidity parameters. 

 

 

This is a vast operation; we all need to have training in cold chain. Furthermore, the supply chain is such that when I order products from my wholesaler and will have them in two hours time max, no matter what and where those products are. 

Everything in the pharmacy is behind the counter, you cannot buy any non-prescribed medicine as you wish and in the quantities you may fancy, we are there to assure you take the one you need and in the quantity you need. 

 

 

It is a total different model and during these conversations I mentioned, I have been astonished many a time and the US and Canadian people too due to the enormity of differences between these two models. 

It is going to be a lot more difficult to implement cold chain in these countries, and more expensive too, I mean now because we already have it and still needs to be “trimmed”.

 

 

 

The supply chain has other issues, addressed by the European Commission known as “The 'Pharmaceutical Package', and contains three important initiatives: 
- a proposal for a directive on how to modernize pharmaco-vigilance in order to improve medicine-safety; 
- a proposal to improve patient safety by reducing the infiltration of counterfeit medicines into the supply chain; and 
- a directive on the future direction of the supply of health information to patients”
Counterfeiting proved the weakness of the supply chain; the Directive also sets out provisions covering internet sales - however, the reality is that not only can those selling channels not be closed, but counterfeited lifesaving drugs can actually be found in the legitimate supply chain as well.

 

 This means additional costs as it will imply a new process of coding, a “pan-European system to provide unique serial numbers on each genuine medicine pack/ repack” . 

This represents great expense to all pharmaceutical industries and pharmaceutical allies, to be met by partnership between manufacturers, logistics providers and wholesalers, to ensure simplicity throughout the cold chain process. Furthermore, each new change will have to bear the “green” stamp, towards a more sustainable environment, with the related additional charges.

 

Virtual Organizations

 

Many researchers conceptualize the virtual organization as a new organizational form. It represents a radical shift from the traditional organization and makes new ways of organizing possible. Such expectations are explored, and the meanings and interpretations of the virtual organization for its designers

 

 

 

 

and virtual workers are investigated in a project that seeks to develop a virtual (reality) organization. The research involved longitudinal participant-observation with the virtual organization design team and interviews with organizational members.

 

 

 

Contrary to indications in the literature, this research found that designers and users predominantly conceive the virtual organization in this instance as an extension of the existing organization, rather than representing radical organizational change.

 

An Imperfect Union: Europe's debt crisis

http://www.cbsnews.com/video/watch/?id=7404666n&tag=component.0;topnews

An Imperfect Union: Europe's debt crisis

http://www.cbsnews.com/video/watch/?id=7404666n&tag=component.0;topnews

An Imperfect Union: Europe's debt crisis

http://www.cbsnews.com/video/watch/?id=7404666n&tag=component.0;topnews

An Imperfect Union: Europe's debt crisis

http://www.cbsnews.com/video/watch/?id=7404666n&tag=component.0;topnews

Business Constellations, Paradigm Shifts and Change Management

 

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A Business Constellation is a solution-focused process, which helps leaders of organizations to identify the complex, often informal, relationships and inter-dependencies within their organization and to develop a deeper understanding about the underlying dynamics in a very time- and cost-efficient manner. The effectiveness of this method has of late been scientifically proven by various research studies. 

It has become a widely accepted discipline in business consultancy, organizational development and change management. The process serves as a platform to solve business issues and to create future change – e.g. developing a sustainable corporate culture, optimizing the organization’s performance and enabling the strengths of individual team members as well as the team as a whole to fulfill their tasks in the most productive way.

Business Constellations can be used in a stand-alone workshop setting or be embedded within the wider scope of a change management process and be combined with other methods of intervention.

This was an approach to what can be an individual process regarding change.

Change it is all about people, starting by the executives, who, many a time are the first ones to resist and not understand what change is about.

Now, about shifting values, we are faced with the concept of “paradigm shift” – what is it really about? 

 

Leaders of cultures recognize that their traditional paradigm is out of date, and perhaps this leads them to assume that a ‘paradigm-shift’ program will provide the remedy. Culture change is not simply about how you see yourself and others. 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 organization as a system. However, initiatives which threaten the current operating culture are typically resisted to extinction, and many initiatives simply bear no relation to the economic performance of the organization

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 you successful in the old paradigm may not even be necessary in the new paradigm

What does that mean? It means that whatever made you successful in the old paradigm may not even be necessary in the new paradigm. But then one is faced with a paradox:  changing a culture starts with different thinking about the work

If it would improve performance to do the work differently, how does it mean we should behave? Focusing on behavior without embedding it in a work context creates an entirely new pathology – people try to play a new game. By contrast, focusing on how we work, anchors improvement in things that are real, and opens the door to working on culture, in a way which has relevance and, more importantly, is palpably relevant. This new global world surrounds us with paradox.

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Filed under Business Constellations, Change Management, organizational development,paradigm shift

Tagged as 'paradigm-shift' program, business constelations, Change,change management, changing a culture, corporate culture, economic performance, Going back to zero, how we do the work together, how we work together, organizational development, paradigm shifts, People,solution-focused process, success in the old paradigm, think different

Cross-functional and cross-cultural teams

 

 

You have different disciplinary perspectives, different regional or national cultures: the notion of traditional trust must be adapted to the development of trust between cross-functional, geographically distributed partners.

 

 

 

 

For a cross-functional team what matters more is the outcome (product, system, service); this will be a better one due to the combined expertise of people from a variety of functions. The major input of these teams is viewing a problem or an issue from many vantage points, but this cannot be attained if there is not a free flow of information.

 

 

What are the issues deterring the free flow of information? Different terminology and lack of agreement on common definitions; different work orientations; different degrees of interest in the team’s outcome, and mistaken goals. 

The goal is not establishing harmony among the team members; if they mistake the real goal for this, they might be are afraid to express their real opinion, less it should destroy the positive feelings among team members; this will lead to a false sense of unanimous consensus and the outcome will not be the expected one.

 

 

 

It is very much the team leader’s job to see that there is open communication (to create and maintain honest communication, allowing open talk among the team members with exchange of feedback, and working through misunderstandings); there is a common purpose and performance goals; there is understanding of shared responsibility.

The team leader will also ensure that all resources and talents are being used.

Global population control - educating women and birth control?

 

 

It is also about educating men

 

 

 

 

and make them see that having many kids they cannot provide for is not a sign of virility. This is a very big issue with some communities worldwide.