Ever read a story about some company’s new drug and not been able to make heads or tails of it? You’re not alone.
Try pronouncing some of the words on your pack of antibiotics and you might get tongue-tied — let alone making sense of a cancer-fighting company’s new drug.
If you’re keen to invest in the health space, the density of the terminology and information can present a barrier to entry.
There are barely-decipherable charts, mountains of scientific mumbo-jumbo and the boffins behind the treatments are more interested in helping patients than making sure you understand.
In a bid to demystify some of the common terms in biotech land, we've curated this A-Z guide of words to know.
We’ll add to this regularly, and if you’ve come across a term you don’t understand and want simplified, let us know here!
Biotech: Biotech, short for biotechnology, is the integration of natural sciences like biology and human engineering, to create things like organisms, cells and medicines for products and services.
CE mark: The CE mark is seen on any goods or products that comply with Europe’s health, safety, environmental and standards, and is a required regulation for medical devices to be used in Europe.
Clinical trial: Carefully monitored and highly-scrutinised medical research investigations designed to test new treatments, interventions or tests as a means to prevent, detect, treat or manage various diseases or medical conditions
Cohort: Refers to a group of patients in a clinical trial. There is often more than one cohort.
Commercialisation: The process of taking a drug, treatment or medical device to market, after it has successfully passed clinical trials.
Delivery: The method or technology via which a drug, treatment or medical device is administered to a patient.
FDA: The United States’ Food and Drug Administration, the highest relevant administrative body for biotech companies in the US, and whose approval companies need to bring drugs, treatments or devices to market.
Formulation: The chemical makeup of a drug or treatment.
GMP: Good Manufacturing Practice, a set of principles and procedures that when followed helps ensure that therapeutic goods are of high quality. Different guidelines apply in different countries.
In vitro: Latin for “in glass”, in vitro refers to medical procedures and experiments that researchers perform outside of a living organism, most often in glass test tubes or petri dishes.
In vivo: Latin for “in the living”, in vivo refers to medical procedures and experiments that researchers perform inside living organisms, whether they be animals or humans.
IP: Intellectual property.
Medtech: Medical technology, a term often used to refer to companies seeking to commercialise medical devices, rather than drugs.
Phase 1: The first in-human phase of a clinical trial, conducted in small groups of healthy patients and designed to establish safety.
Phase 2: The second in-human phase of a clinical trial, conducted in larger groups of patients with the condition the treatment is seeking to alleviate, and designed to establish efficacy and reinforce safety.
Phase 3: The third in-human phase of a clinical trial, conducted in even larger groups of patients and designed to compare the standard of the treatment against currently established treatments, and to study efficacy and safety further.
Pre-clinical: A clinical trial conducted in animals, such as rodents or sheep, before in-human trials, to establish efficacy.
Statistically significant: A determination that results from a clinical trial are not explainable by chance alone, and is related to the treatment’s efficacy.
TGA: Australia’s Therapeutic Goods Administration, the highest relevant administrative body for biotech companies in Australia, and whose approval companies need to bring drugs, treatments or devices to market.
- Daniel Paproth