Regulatory and commercial barriers to stratified medicine development and adoption

Posted by Kinapse on 17 November 2014

Despite encouraging technological developments, the number of stratified medicines has not reached expectations since Herceptin’s approval from the Food and Drug Administration in 1998. The article explores key hurdles to the development and adoption of stratified medicines. Using a series of influential case examples of stratified medicines and diagnostics we have identified critical success factors along with barriers that exist at the levels of clinical development, business development, regulatory, reimbursement and the clinical setting. The findings indicate an urgent need for the many stakeholders to develop a coordinated response if the benefits of advances in pharmacogenomics are to be realised by patients.

The publication follows another successful collaboration with the Centre for the Advancement of Sustainable Medical Innovation (CASMI) and involved inputs from a suite of pharmaceutical professionals, regulators, policy makers, healthcare professionals.

To read the article please follow this link

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