Freeman told delegates at the Financial Times Global Pharmaceutical and Biotechnology Conference on Tuesday that: “We see a continued shift from the one size-fits-all, blockbuster model.
“We all still yearn for those blockbuster drugs, we need them, but we also know that this sector [the drug industry] can’t rely on the old model of being expected to go away for 10 or 15 years, spend a billion and a half and come back to us, the NHS, the purchaser, the public with a drug that’s proven to work in everybody.”
“That model takes too long, is too expensive for you [the drug industry] and it doesn’t leave enough value in the patent life for you and it’s not working for patients” he said, adding that “we need to profoundly look at how we can accelerate this revolution of stratified, targeted and ultimately personalised medicines and how that will change the landscape for early adoption.”
“We need to build a runway to allow those new generation drugs to come in and be proven and developed in our clinical environment and get earlier proof-of-concept with patients.”
“Fundamentally, this will mean that our hospitals will become more important in the research ecosystem. From being the adopters, purchasers and users of proven late-stage drugs, our hospitals we see as being a fundamental part of the development process.”
Review process in 2015
Earlier today Freeman announced his intention to conduct a review of medical innovations and technology, with the aim being to speed up the drug development process and get mediciens to patients sooner.
While full details have not been provided, a report in the Times suggested this process will involve bypassing “traditional clinical trials by using patients as a test-bed for promising new drugs.”
The Government also announced that MSD, known as Merck in the United States and Canada, plans to invest a minimum of £42m to create a licensing hub in London, expand research at its Hertfordshire headquarters and fund clinical research in oncology and dementia.
Similarly, Becton, Dickinson and Company will spend £21m to build a next generation blood separation tube production line in Plymouth according to the Government.
"The project will create 40 jobs and safeguard 138, and is being supported by a Regional Growth Fund grant of £2.48m" according to a press release.
John Lewis, senior vice president of US-based industry group the Association of Clinical Research Organisations (ACRO) told Outsourcing-pharma.com that: "Freeman appears to be suggesting some type of accelerated “adaptive licensing” scheme.
"ACRO has not taken a formal position on this issue, though we are generally supportive of innovative development pathways as long as they are scientifically rigorous and patient safety is protected."
He added that: "The UK is a very important region for clinical research and for CROs. ACRO members managed more than 1,300 trials in the UK last year and have more than 9,000 employees there."
An MHRA spokesperson told us "As an important contributor to UK life sciences through our support for innovation, we look forward to playing our part in the Innovative Medicines and MedTech Review alongside other government agencies and the independent review organisation, which aims to get medical innovations to patients quicker. The Early Access to Medicines Scheme launched by the MHRA this year and the establishment of the Innovation Office are examples where MHRA supports innovation.
“MHRA’s primary role is to protect public health through regulating all medicines and medical devices in the UK. It is important to ensure that whilst getting effective products to the patient quicker, safety, and quality of products is fully tested and assured.”