The pharmaceutical industry often referred to as ‘Big Pharma’ is seen as a massively profitable sector however the profits and end product is what is often focused on rather than the process and efforts that go into making the said product. In this article I will be delving into the time, budgets, and the trail of the money from the budgets. Drugs are the active pharmaceutical ingredient which are the therapeutic agent, medicines are the drug delivery system comprising of said drug and excipients (any ingredient that is not the drug typically stabilisers or adding to the shelf life of the drug).
There countless medicines undergoing R&D to be used for a range of different purposes and a common occurrence is that they are derived from traditional plant treatments. Research is then conducted into the feasibility of extracting the active ingredient in the plant to then make a medicine based off it. This is not always the case however, the inspiration for the research and development of a new drug can be down to new scientific discoveries such as a specific enzyme which has behaviours that can be altered if targeted correctly, or even simply adapting a medicine which already exists to have less side effects or be more effective or in a new form (tablet/capsule to an oral solution).
From the initial research conducted for development of a medicine to the final stages of testing and releasing it for public use, this takes around 12 years and consists of 4 stages: discovery, preclinical trials, clinical development, and market approval.
Process
Discovery – previously touched upon it can either be a known plant is identified for having an effect or a biological target is identified and a match that would work for targeting said biological molecule (protein/enzyme/gene). Researchers find many potential candidates to interact with the target molecule and the most promising one’s progress to the next stage.
Preclinical trials – most promising candidates go through extensive testing to see if they are safe and are evaluated for their toxicity, solubility, pharmacokinetics (absorption, distribution, metabolization and excretion of the drug), and pharmacodynamics (drug’s biological influence)
Clinical development – split into 3 phases, 1st tests safety and dosage on small groups of people usually <100 people and determines dosage range and possible side effects. 2nd phase tests efficacy (effectiveness) and side effects in a larger group >300 this enhances the accuracy of the dosage range and side effects appear clearer in a larger group. 3rd phase tests efficacy and side effects on a larger scale in groups >3000 people and this provides a better understanding of the drug’s effectiveness and safety.
Market approval – all data from preclinical and clinical trials is sent to the authorities when submitting a New Drug Application (NDA) or eCTD (in the UK) and the application would include details of manufacturing and intended use case. This application is then moderated, and regulatory agencies ensure the drug is safe, effective and of high standard.
The price of all these steps and other actions behind the scenes is estimated to average around £1.15 billion. Whilst at first it may be hard to comprehend why or where this money is going it must be noted that actions behind the scenes must not go underappreciated and the amount of time it takes to develop these drugs also means numerous teams must be kept on payroll from start to finish. There are several teams involved in each stage, these include but are not limited to: biochemists, pharmacologists, toxicologists, clinical trial coordinators, regulatory affairs manager (focus on meeting regulations and compliance with laws) and manufacturing engineers just to name a few.
Once R&D has settled and production of a medicine will usually become more profitable for the pharmaceutical companies, this is achieved by either importing pharmaceutical ingredients from countries like India or getting them to manufacture the medicines entirely, despite the cost of taxation, packaging, and a share of profits this would remain profitable for the main pharmaceutical company.
To conclude, the time and money spent on research and developing medicine is not greatly appreciated, yet manufacturers benefit lucratively from the mark up on their final product