Advances in genomics will change the way pharma discovers, regulates and reimburses new medicines, Amgen’s R&D head in Europe has said.
Speaking at a +91 Europe and KPMG genomics event yesterday, Jeremy Haigh, European chief operating officer, R&D, said the current drug discovery model was unsustainable and that scientific discovery would drive change.
Haigh expected, as a result of genetic and genomic advances, a greater shift away from symptoms to classify disease to more emphasis on biomarkers and subtypes, which would impact on medicine development.
He singled out Herceptin as to what the future would look like – targeted therapies, stratified patients and companion diagnostics.
“This naturally creates orphan diseases. These will be niche-busters not blockbusters,” he said.
Alongside this shift he also expected increasing access to real world data – a “positive for patients and society” – but added that this was currently incompatible with the current drug development process, which involved waiting for data from previous stages before a new stage was started.
“If we’re going to keep pace with advances in innovation and ensure patients needs are put first then this way of doing things is no longer rational or sustainable. We can’t take 14 years to bring drugs to market that people may not view as valuable. This model has to change remarkably.”
He called for adaptive clinical trials to become the mainstay and he said he hoped for a real shift in this direction within the next few years. Likewise he said regulation will need to change with more emphasis on early access to medicines, while health technology assessments will have to broaden their definition of value “if we advance with what genomics promises us”.
“Only through a new landscape can we take advantage of the new practices and genomics for the benefit of patients.”