Drug Development: No Small Undertaking

From taking a novel treatment and moving through rigorous evaluation and testing stages, developing drugs to become accessible to health professionals and patients is often a complex process.

Typically, the process involves 5 key stages, including:

1. Disease analysis for counteractive drug discovery
2. Preclinical research; narrowing down a lead compound from thousands of potentials
3. Investigations into new drug application using cells and animals to establish safety for use in humans
4. Rigorous clinical trials
5. Regulation, approval and ongoing safety evaluation

The Licensing approval phase alone can take an average of 12 years and it costs approximately one billion dollars to develop one new successful medicine. Even once a new drug has been licensed it will be closely surveyed for any signs of hazards to health presenting after long-term use.

Researchers must complete every phase in the process to succeed in getting a new drug to market. This is not only vital to ensure the drug’s effectiveness, but also to protect populations from potentially harmful side-effects, complications and risks that could otherwise be avoided.

At any point in the development process a new drug could be rejected, due to safety issues, quality or overall efficacy – usually at the expense of millions of dollars. Although for good reason, as a drug is never pulled from testing for the sake of it, this can be devastating not only to researchers, but also to suffering patients in need of innovative new treatments.

It takes time, money and commitment to develop a new drug. Despite the lengthy process, pharma companies will always continue to develop their research so that patients can benefit from new and pioneering clinical trials for many years to come.