Over the past 20 years since the Human Genome Project was initiated, precision medicine has come to prominence in the clinical trial space. In the early 90s, genomics came to the fore as a discipline, and served as a precursor to the shift towards pharmcogenomics in the late 90s/early 00s.

In recent times, there has been a clamor towards personalized medicine, a form of treatment that's tailored toward a person based on a number of factors: their genes, proteins and their environment. In cancer, "personalized medicine uses specific information about a person's tumor to help diagnose, plan treatment, find our how well a treatment is working, or make a prognosis," according to the National Cancer Institute (NCI).[1] Even the term ‘personalized medicine’ has taken many guises in the form of targeted medicine, stratified medicine, before evolving into what is now commonly termed precision medicine.

As the stock in precision medicine continues to grow, questions have been raised over its potential to transform drug development, especially in the fight against cancer.

“The key question to be asked over the last 20 years is: Are the innovators – the pharma companies – prepared to embrace this trend?” said Sean Hu, senior VP & head of consulting, GlobalData.

Looking at the initial years when pharmacogenomics became a trend, there was a period of uncertainty and fear from a pharma business perspective. Speaking in an interview with The Pharma Letter at the recent ASCO conference, Hu said that was largely down to the fact that by only applying the medicine to a sub population of patients, one can cut their potential market size, thereby reducing their commercial return for their investment.

Since the turn of the century, however, there has been a period of catch up and transition within the industry, from initially being reticent to personalised medicine to eventually embracing it. From 2010 onwards that mindset has changed with an ever increasing number of pharma companies launching precision medicine.

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“We’ve reached a definitive point where there’s a consensus that precision medicine is an unstoppable trend that will benefit, not only patients but industry as a whole,” said Hu. “That is because of the benefit it will bring – better medicine and reduced costs for healthcare.

Over a period of 11 years (1998-2009), GlobalData sought to quantify the impact of personalized medicine. According to Hu, experts subsequently found the use of personalized medicine had increased from one to 22.

“If you look at the last few years, since 2013 the use of personalized medicine had grown to 113,” he said. “By the end of 2015, you’ll be looking at an extra 22, bringing the total number to 135, which is a huge change in terms of total number.”

Among newly approved oncology drugs in 2015, one of the leading therapeutic areas for precision medicine, 36 percent were personalized medicine. If you look at the clinical trials taking place today, according to GlobalData, 18 percent have a biomarker component, which Hu says is significant.

“The approval rate for personalized medicine is higher compared to those that aren't. This proves to a large degree that personalized medicine will benefit patients and pharma companies alike.”

For the latter, specifically, Hu said it helps them boost their productivity and improves the probability of having their drug approved. With all the advancements being made in oncology, there is a growing need for the development and commercialization of personalised medicine. However, scientific challenges remain as biomarkers are not easy to find, Hu says.

“The future is bright. The momentum is unstoppable, but there are many challenges that we need to tackle.”




[1] National Cancer Institute – http://www.cancer.gov/publications/dictionaries/cancer-terms?cdrid=561717