Getting new drugs to market: how individuals could do this without leaving their desksBMJ 2006; 333 doi: https://doi.org/10.1136/bmj.39055.610764.47 (Published 21 December 2006) Cite this as: BMJ 2006;333:1315
- Joe Collier, professor of medicines policy and consultant in clinical pharmacology
- 1Department of Basic Medical Sciences, St George's Hospital and Medical School, London SW17 0RE
At one time, all of the products that came out of a pharmaceutical company were researched, devised, developed, and manufactured within its four walls; the company offered the complete package. Now, although vast amounts of money, intellectual property, and management capacity remain within the imposing headquarters of the multinationals, much of the real work is done elsewhere—by start-up companies, contract houses, university departments, and public bodies.⇓
One way or another, the work of big drug companies has changed, and inevitably this change, which will continue and probably accelerate, will lead to the collapse of the monolithic system and its replacement by smaller, leaner, and more nimble companies. As this process continues, virtual companies, run by individuals working from their desks in cyberspace, could well develop.
The development of medicines for human use is a tricky business and one that is continually evolving as new technologies, such as genetic engineering, emerge. At its simplest, the process involves finding “new” molecules, purifying them, checking that they do what they are designed to do, showing that they work in clinical practice without causing unacceptable harm, and then scaling up their manufacture to make the product of acceptable quality in commercial amounts. Along the line the product needs to pass legal hurdles to allow it to be sold and marketed to ensure returns. All of these steps, some running simultaneously, take time (currently 10-12 years), need money (estimated as being between $500m and $800m1), and require careful coordination.
These steps consist of discrete packages of work relating to, for example, molecule synthesis, target validation, animal efficacy, animal toxicology, animal and human pharmocokinetics and pharmacodynamics, teratogenicity, carcinogenicity, effects in patients (clinical trials through phases I-IV), drug side effects, and drug interactions. Added to these …