You've recently joined the life sciences team within a pharmaceutical company or university legal department, and you'd like to speed up your integration by learning the lingo that drives the day-to-day business. As anyone with experience can attest, industry nomenclature can be incredibly confusing, which is why I decided to tackle this subject. Because just like you, I've walked a mile in those same shoes.
When I accepted my first global pharma legal role, I was assigned to "early-stage discovery," and thrust into a world of new terminology like "Hit," "Target," and "Leads." I felt awkward having to raise my hand every minute to ask what these terms meant (never mind the fact that they had a distinctly mafiosi ring to them). Today, with most meetings taking place virtually, this transitional period may be even more challenging.
In this blog post, I will cover the diverse world of the life sciences, including pharmaceuticals, cosmeceuticals, medical devices, and nutraceuticals, arming you with the key lingo used by veteran life sciences players in an effort to help you acclimate and integrate in your new organization. Let's get started!
First, it is helpful to distinguish each of the verticals:
- Pharmaceuticals are the drugs and medications being developed to diagnose, treat, or prevent diseases. This sector is driven by rigorous research and development (R&D) that aims to create safe and effective therapeutic products. Pharmaceuticals are often classified in categories such as prescription drugs, over-the-counter (OTC) medications, and biologics.
- Cosmeceuticals are products that combine cosmetics and pharmaceuticals to create topical formulations designed to improve skin appearance and health. Unlike traditional cosmetics, cosmeceuticals contain bioactive compounds that can penetrate deeper layers of the skin and deliver active ingredients with therapeutic benefits. Examples include anti-aging creams, acne treatments, and skin brighteners.
- Medical Devices encompass a wide range of instruments, machines, implants, and diagnostic tools used in healthcare. From simple tools like thermometers and stethoscopes to complex equipment such as MRI machines and pacemakers, medical devices play a critical role in diagnosing, monitoring, and treating medical conditions, contributing to better patient outcomes and improved healthcare delivery.
- Nutraceuticals are food-derived products that offer health benefits beyond basic nutrition. These can include dietary supplements, functional foods, and fortified products designed to support overall health, prevent chronic diseases, and enhance physical and mental performance. Nutraceuticals often contain vitamins, minerals, herbs, amino acids, and other natural substances.
Next, we dive deeper (and in alphabetical order) to review some of the most commonly used pharmaceutical terms:
- Active Pharmaceutical Ingredient (API): The biologically active component of a drug product responsible for its therapeutic effect.
- Adverse Event (AE): Any undesired and harmful effect experienced by a patient after taking a drug or undergoing a medical procedure.
- Bioavailability: The proportion of a drug that enters the bloodstream and is available for therapeutic action.
- Biologic: A type of drug derived from living organisms, including vaccines, blood products, and gene therapies.
- Clinical Trial: A research study conducted to evaluate the safety, efficacy, and side effects of a new drug or treatment in human subjects.
- Drug Delivery System: Methods or devices used to deliver medications to the body effectively, such as oral tablets, injectables, or transdermal patches.
- DTC(A): Direct to consumer advertising (US only)
- Early Stage Discovery: Early Drug Discovery and Development Early and preclinical drug development is a complex, regulatory and strategy-driven process. The most important element of the preclinical process is to select the best new molecular entities to enter into the clinical trials and to limit failure in full development
- Excipient: An inactive substance used in drug formulation to provide stability, bulk, or aid in drug delivery.
- Formulation: The process of combining different chemical substances to create a final drug product.
- Good Manufacturing Practice (GMP): Regulations that ensure products are consistently produced and controlled according to quality standards.
- Hit: In the drug discovery process, a hit is a compound that displays desired biological activity towards a drug target and reproduces this activity when retested.
- In Vitro: Laboratory studies conducted outside of a living organism, typically in test tubes or petri dishes.
- In Vivo: Studies conducted within a living organism, such as animal testing or human clinical trials.
- Indication: The specific medical condition or disease for which a drug is approved for treatment.
- Lead: A lead compound, or "leading" compound, is a chemical compound that may be useful in treating a disease and could lead to the development of a new drug. It's the first step in the drug discovery process,
- OTC: Over the counter
- Pharmacodynamics: The study of how a drug affects the body, including mechanisms of action and the relationship between drug concentration and effect.
- PDUFA Date: Once the FDA accepts a filing for the approval of a drug, the agency must complete its review process within 10 months in most cases. The date at the end of the review period is referred to as the PDUFA date
- Pharmacokinetics: The study of how the body absorbs, distributes, metabolizes, and excretes a drug.
- Placebo: An inactive substance or treatment given to a control group in clinical trials to compare its effects with those of the active drug.
- Regulatory Affairs: The field focused on ensuring that pharmaceutical products comply with all regulatory requirements and laws.
- Target: A drug target refers to a molecule, typically a protein, associated with a specific disease process that can be addressed by a drug to produce a desired therapeutic effect.
- Toxicology: The study of the adverse effects of chemical substances on living organisms.
Of course, this list is far from exhaustive, and new lingo is developed every day. Nonetheless, by understanding the different sectors within the industry and familiarizing yourself with the lingo, you will be better prepared to navigate your new role, and more importantly, able to contribute to the growth and success of your organization.
Whether you are working in pharmaceuticals, cosmeceuticals, medical devices, or nutraceuticals, each area offers unique opportunities to advance medical science through innovation, and make a meaningful impact on people's lives by enhancing quality of life. As you chart your own course as an industry legal professional, I'm sure that you will add many additional terms to your life sciences lingo dictionary in no time.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.