As the ABPI launches an update to its white paper of April 2009 ‘The stratification of disease for personalised medicines’ Dr Louise Leong looks at what has been achieved and what still needs to be done to support a stratified medicine approach in the UK.
Since 2009 we have seen a slow but steady shift towards a more focused and stratified approach to medicine development which offers the potential to treat patients more effectively by delivering preventative or therapeutic interventions specific to those most likely to respond.
In some areas this potential has become a reality as stratified medicines are in the vanguard of treating some cancers and rare diseases and research is well underway to develop sophisticated ways of identifying patient populations who will most likely respond to specific interventions. Since 1999, at least 23 stratified medicines with safety or patient selection benefits based on genomic biomarkers have been authorised by the European Medicines Agency (EMA)1 and in December 2012, government announced a £100 million pilot to undertake whole genome sequencing of up to 100,000 patients with cancer or rare diseases, develop the associated data infrastructure and train the NHS workforce in genomic medicine.
This progress, along with related policies, has been achieved despite four years of economic recession. And, although overall progress in stratified medicine has perhaps been slower than hoped, it represents important steps towards realising the significant benefits to patients, prescribers and healthcare payers of a stratified medicine approach. As we start to see the shoots of economic recovery, now is the time to speed up in the race for developing and delivering stratified medicine. In the coming five years and beyond we must capitalise on work to date and accelerate progress by ensuring that the right policies, capabilities, partnerships, regulatory and reimbursement frameworks are in place to transform medical innovation.
A visionary stratified medicine roadmap, with realistic goals shared by patients, healthcare systems, government and industry will help us to achieve that. We believe that the UK is uniquely placed to accelerate stratified medicine because of our academic and industrial research base, the unique potential of the NHS as an engine for research and innovation, clinical research infrastructure and health informatics initiatives, and hope that our vision paper will stimulate discussion and development of a roadmap to position the UK as a world leader on this journey.
The 2014 vision paper ‘The stratification of disease for personalised medicines: research driven recommendations to strengthen a unified UK strategy through a stakeholder alliance’ is launched today (September 11) at a roundtable event to debate key developments and recommendations five years on from the 2009 ABPI white paper.
Our 2014 R&D Conference, on 20 November, also focuses on stratified medicines bringing together scientists, clinicians, patients, the NHS, and health technology assessment bodies so that we can continue to work together to further accelerate the development and use of stratified medicine.
Dr Louise Leong
1European Commission, Use of '-omics' technologies in the development of personalised medicine, SWD(2013)436, Oct. 2013