Healthcare is an enormously complex part of the global economy. It consists of multiple stakeholders, many distinct industries, highly sophisticated technologies, and critical products and services that affect the lives of virtually everyone in the world at some point. To fully appreciate the complexity of this field, consider the drug you just took this morning for allergies or the medical device you used after exercising to measure your heart rate and blood pressure. How did those products come about?
Most likely, the process began decades ago, with life scientists in academia making discoveries about the specific biological mechanisms of a given disease or condition. These discoveries were then used by a different set of scientists and clinicians—most likely in a biotechnology company—to hypothesize potential methods for disrupting those mechanisms, typically using chemical or biological agents. These agents were then tested, first in animals such as mice, dogs, and primates, and if the results showed promise, then in human clinical trials.
Because of potentially toxic side effects of any experimental therapeutic on a human subject, when trials go wrong, people can die. Therefore, the highly methodical process by which clinical trials are designed and conducted requires extraordinary skill, patience, and regulatory oversight by government agencies such as the U.S. Food and Drug Administration (FDA) or the European Medicines Agency (EMA). From start to finish, this process can take a decade or longer, and biotechnology companies will often partner with or be acquired by larger pharmaceutical companies to complete the trials. And at the end of this lengthy process, there’s no guarantee that the drug or device candidate will turn out to be safe and effective. In fact, historically, the probability of success is about 12%, which translates to a failure rate of about 88%.
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