05 Mar 2015 Posted in News Release By Press Office
Reengineering medicines development: a stakeholder discussion document for cost-effective development of affordable innovative medicines was launched at an ABPI roundtable event yesterday (March 4) and includes a suggested methodology to increase the relevance of clinical trials while substantially reducing timelines and costs. With the potential to bring innovative medicines to patients more quickly with improved value and cost effectiveness, this will only be possible through partnership working between patients, healthcare providers and practitioners, Health Technology Assessment bodies and payers, regulatory authorities and the pharmaceutical industry.
Chaired by Dr Stuart Dollow, Chief Executive of Vermilion Life Sciences, the roundtable event, which included a wide range of stakeholder representatives including regulatory bodies and government departments, patient groups, clinicians academic researchers and industry, used the report to stimulate discussion on how greater partnership can reduce medicine development time and cost in order to improve value, cost effectiveness and uptake of medicines for the benefit of patients.
Dr Dollow said:
“It is evident that we are all committed to ensuring the UK is an environment that facilitates and rewards research and development of innovative medicines. It is widely recognised however that the traditional development model is unsustainable and randomised controlled trials do not fully represent clinical practice.
“Significant change is needed to reverse the escalating costs and timelines of development, to maintain the affordability of innovative medicines. While several initiatives such EMA’s Adaptive Pathways and MHRA’s Early Access to Medicines Scheme are initiating changes to medicines development, further flexibility is needed for regulatory approval and value assessment to evaluate new medicines differently and assess their benefits earlier.”
“The commitment of the UK government to increasing use of health data for patient benefit, together with our unique healthcare system provides a significant opportunity to devise a new methodology that better reflects and serves patients’ needs. With a strong academic base and the international reputation of NICE and MHRA, the UK is ideally placed to lead towards a more sustainable future.”
Reengineering medicines development: a stakeholder discussion document for cost-effective development of affordable innovative medicines builds on research carried out by the ABPI on the development and delivery of stratified medicines in the UK and links to the theme of the affordability conundrum, being discussed at the ABPI Annual Conference on 23 April.
Vermilion Life Sciences works to Reengineer Medicines Development to reduce development times and costs, speed adoption of new technologies and improve the value of new medicines. Facilitating partnerships between patients, industry, regulators and payers can make medicines available more quickly, at lower cost with greater certainty in use.
We consult on strategic portfolio reviews, clinical strategies and organisational design to enable sponsors to improve their development efficiency and effectiveness.
The ABPI represents innovative research-based biopharmaceutical companies, large, medium and small, leading an exciting new era of biosciences in the UK.
Our industry, a major contributor to the economy of the UK, brings life-saving and life-enhancing medicines to patients. Our members supply 90 per cent of all medicines used by the NHS, and are researching and developing over two-thirds of the current medicines pipeline, ensuring that the UK remains at the forefront of helping patients prevent and overcome diseases.
The ABPI is recognised by government as the industry body negotiating on behalf of the branded pharmaceutical industry, for statutory consultation requirements including the pricing scheme for medicines in the UK.
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