Currently, many available drugs are used to treat patients under the assumption that ‘one-size-fits-all’, but drugs don’t work the same way for every patient. The precision – or personalised – medicine approach, based on comprehensive diagnostic and clinical characterisation, ensures that the right patient gets the right treatment at the right time.
Precision medicine involves using various technologies including genomics, diagnostics and data analytics. Diagnoses are subsequently adapted to the detailed information that is emerging about our specific genetic make-up. Pharmaceutical solutions tailored to our DNA – rather than one-size-fits-all medicines aimed at the mass-market – are the future of medical treatment, which treats the person, not the disease.
Dr Sandra Horning, Roche’s Chief Medical Officer and Head of Global Product Development, says: “The confluence of new medicines, sophisticated diagnostics and advanced technologies has created an unprecedented opportunity to improve outcomes for patients today and in the future.”
Accelerating the process
As people live longer and diagnosis and treatments improve, the prevalence of non-communicable diseases, such as cancer and diabetes, present a significant challenge as lifestyle choices act together with the genetic make-up of a patient. The need to treat the individual, rather than the group of individuals with the condition, is the catalyst for the personalised medicine approach.
Is the pace of development able to keep up with the evolving needs of the patient population?
Steven Shak, MD and chief scientific officer, Genomic Health, told Pf Magazine: “There is no question that innovations and new discoveries are being made at an accelerated pace today, compared with the past. As researchers and caregivers in the world of cancer, we know that patients have an incredible urgency for us to move even faster to make sure that we identify both drugs and tests that really work, and make sure they are used appropriately in clinical practice.”
NHS England’s National Director Sir Bruce Keogh announced the transition, to a personalised approach, in September last year, while outlining his emerging strategy for personalised medicine in the health service. He called it “the future of the NHS”.
He said that the work already being done, through the NHS’s contribution to the 100,000 Genomes Project, must be capitalised on, and fast.
“The shift to personalised medicine is already underway – our role as a system leader and commissioning organisation is to consider how this transformation can be accelerated,” he said. Embracing technology and innovation is clearly key to the success of this shift.
An example of this comes from Genomic Health, which has developed the Oncotype DX® Breast Recurrence Score™. The therapy has now been used in over 600,000 patients around the world, to help them decide whether they need chemotherapy or not, when they’re first diagnosed with breast cancer.
“With new technologies we can now look at tens of thousands of genes and at their expression. We used a very innovative and creative approach to find and identify the genes that mattered,” said Shak. “In precision medicine it’s incredibly important that innovations are developed, used appropriately and reimbursed and paid for, so patients can benefit.”
Scientists cracked the human genome code thirteen years ago, resulting in the evolution of genomics. This discipline studies each individual’s complete set of DNA which, in turn, helps in the understanding of the person’s predisposition towards genetic diseases, and helps to inform the personalised treatment that is best for that patient.
Chief Scientific Officer for England, Professor Sue Hill, recently delivered an overview on how genomics and personalised medicine is set to transform the NHS. With the knowledge gained from the project, researchers are learning how inherited differences in genes affect the body’s response to medicines. These differences will then be used to predict whether a medication will be effective for an individual and help to prevent adverse drug reactions.
Shak points out, however, that innovations take time to reach those who need them: “Healthcare innovations can take 10 to 20 years to disseminate into actual practice. One of the things that’s going to be very important for bringing innovation into clinical practice in the future is to better take advantage of technology.”
The Precision Medicine Catapult’s (PMC) aim is to make precision medicine a reality in the UK. It has six regional centres of excellence, all working on locally driven programmes, using the PMC network to harness the breadth of UK expertise, while developing innovative technologies and solutions for broader use across the UK’s healthcare sector.
It is headquartered in Cambridge, where AstraZeneca is creating a new research centre, led by Dr Menelas Pangalos, Executive Vice President of AstraZeneca’s Innovative Medicines and Early Development Biotech Unit.
Earlier this year the PMC announced a strategic partnership with the UK Pharmacogenetics and Stratified Medicine Network to drive the growth of the UK industry and accelerate the delivery of precision medicine to patients. It has over 400 individual members drawn from academia, medicine, industry, regulatory authorities and patient groups across the UK and elsewhere.
Meanwhile, pharma pipelines that include precision medicine-based targeted therapies are continuing to grow, with the added benefit of the maximisation of patient populations, for clinical trials, by the use of genomic information as an integral part of trial enrolment.
Precision medicine is gaining momentum, which has the potential to reshape how therapies are developed in the future, and industry is perfectly placed to capitalise on incorporating huge amounts of genomic and clinical data in their R&D processes, creating greater success in drug development and the understanding of disease.