Fellow sci-fi fans might share memories of Star Trek’s Dr ‘Bones’ McCoy scanning J.T. Kirk with a futuristic hand-held gadget to discover a mysterious illness… which of course provided the medical team with a quick fix, every time.
“Just imagine,” those screenplay writers must have thought. “By 2250, doctors will be able to use some kind of technology to detect exactly what’s wrong with a patient, and then fix that exact problem.”
Well, a mere 230 years ahead of schedule, current technologies are heading towards this goal already. With ever greater insights into the human condition, new discoveries are enabling a new model for healthcare – one of ‘personalized medicine’ – in which all patients receive exactly the right diagnoses and treatments, personalized to them as individuals.
Genome sequencing and data analysis are essential components of this movement. Digitization technology has invited genome sequencing into everyday clinical practice – what took the Human Genome Project team 10 years to complete can now be done in a couple of days. Among other advances, we have wearable sensors and digital health, which provide information about people’s lifestyle choices, eating habits, sleep and exercise patterns, exposure to pollutants, and more. These data are already being used to predict responders to particular cancer treatments, for example, and to identify patients at risk of various cardiac conditions. Analysis of data from millions of people helps researchers to study patterns, make new discoveries and better understand how to prevent, treat and manage different diseases.
Like many significant scientific breakthroughs, the first personalized therapy was discovered almost by accident. Roche’s Herceptin (trastuzumab), widely considered to be the first personalized therapy, was ineffective against metastatic breast cancer in original clinical trials, but further analyses revealed that a subgroup of women benefited from treatment – specifically, those with HER2 receptor positive breast cancer. This made Herceptin the first drug for which biomarker data at diagnosis was a prerequisite for use.
Due to the natural heterogeneity of different types of cancer, which can be biomarked, the field of oncology has seen the most rapid advancement in the movement towards personalized medicine. As well as Herceptin, other examples in use today include nivolumab (Opdivo) for cancers lacking the BRAF mutation, and anti-EGFR antibody therapies (e.g. geftinib, Iressa; erlotinib, Tarceva) for colon cancers with a normally-functioning KRAS protein. Oncology agents are among the fastest growing segments in the pharmaceutical industry – a status that has probably been helped by the US FDA introducing less rigorous regulatory procedures for cancer drugs, encouraging an increased rate of innovation in this field and, consequently, adding further to the growth of the personalized medicine movement.
As a result of these successes, we now see biomarker-based approaches being integrated in more than 40% of new prospective drug development programmes. As well as enabling healthcare providers to get the right drug to the right patient at the right time, the new concept of ‘biomarker-enabled drug discovery’ is helping drug developers to maximize the efficiency – and minimize the risk – of their drug discovery and development programs by linking diagnostics with therapeutics. Markedly increased success rates for new drug approvals are achievable, as higher response rates in specific populations are predicted and achieved.
As science fiction merges into reality, personalized medicine is enabling some of the most exciting revolutions in 21st century health. New models of care, and better ways of developing, manufacturing, distributing and prescribing drugs are all emerging as more organizations and enterprises embrace the digital age and its impact on the pharmaceutical industry.
Here’s to hoping that personalized medicine will help many more of us to live long and prosper.
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