As a large proportion of my work involves translating documentation used for the regulatory approval and marketing of drugs, I’m always very keen on expanding my knowledge of the pharmaceutical industry. Last weekend I attended a very informative course which provided a comprehensive overview of the discovery and development of medicines. The course was held in the splendid surroundings of the 16th century Emmanuel College, the University of Cambridge.
Our course trainer Dr Ed Zanders of PharmaGuide, whose experience in biochemical research spans over 25 years, walked us through the key stages of the drug development process, from early discovery through to clinical trials and marketing. I especially enjoyed the opportunity of being able to discuss the issues with the trainer and fellow delegates there and then. I’ve read a lot about the subject, and even attended a few webinars relating to it, but there is nothing like a direct learning experience.
Among the many thoughts, ideas, and concepts I took home with me last weekend these were the main ones:
1. Some knowledge of chemistry is essential
The main objective of the preclinical development is to select the drug target, identify the molecules affecting it and finally turn these molecules in a medicine that will effectively increase or decrease the activity of the target. Producing the drug thus involves a great deal of chemical processes and to cope with the jargon that creeps up on you in texts written at the early stage of the drug discovery pipeline, you need to have at least basic knowledge of chemistry.
2. It’s not all about chemistry
The three main stages of the pharmaceutical industry include the discovery, clinical and marketing stages. While the discovery process very much revolves around the formulation development, the other two take the drug from the lab to the light of day. Documents written at the post-discovery stage require a good understanding of human physiology and pathology. In addition, some texts from the marketing stage, such as promotional materials, may even call upon your localisation and transcreation skills.
3. Agonist vs antagonist drug
Last year I attended a very informative workshop on drug addiction at the Karolinska Institutet in Stockholm, Sweden. The workshop speaker, Dr Nitya Jayaram-Lindström, often referred to agonist and antagonist drugs. She did explain the different in which they work in the body, but even after extensive research on my part I still couldn’t quite grasp the whole concept. That is, until last Saturday. Dr Zanders used a very simple analogy to depict the binding of drugs.
A natural ligand binds to the receptor (1). An agonist drug acts like a picklock that mimics the natural ligand to bind to the receptor (2). An antagonist drug acts like a twig that blocks or dampens the receptor. Simple!
4. Adverse events vs adverse drug reactions vs side effects
Any pharmaceutical document that relates to pharmacovigilance will include at least one of these terms. The tricky thing is to know the difference between them. Only yesterday, I was proofreading a translation in which adverse events were confused with adverse drug reactions. Thank you, Dr Zanders, you save me at least an hour of my time which otherwise I’d have spent looking for confirmation. An adverse event (AE) is an untoward symptom or laboratory finding that occurs after drug administration and which may not necessary be caused by the treatment. (An extreme and unlikely scenario would be if the roof caved in and the subject taking the medicinal product got injured That would be an AE). An adverse drug reaction (ADR) denotes all unintended and noxious responses to a drug administered at any dose. A side effect is a more colloquial term for any action or effect of a treatment other than the intended effect (I can’t help but wonder if the ‘Side Effects’ movie starring Channing Tatum and Jude Law would be equally popular if it were titled ‘Adverse Drug Reactions’.).
5. Carry on learning
Attending specialist courses, such as this one, makes me realise there’s always more to learn. I’m very thankful to Dr Zanders for providing us with a multitude of reference material to study at home. Learning isn’t only about understanding new things, but also about finding out where to look for answers if we do come across something unknown.
All in all, the course was a very enjoyable experience. Equally pleasant was my post-course visit to The Eagle pub where on 28th February 1953 Francis Crick and James Watson announced to the world that they had “discovered the secret of life” after they had come up with their proposal for the structure of DNA. The ‘Eagle’s DNA’ ale was delicious!
I highly recommend Dr Zanders’s courses and webinars to all translators working with medical and pharmaceutical texts. You can find out more about them on the PharmaGuide website.