What is ReMedDev®?
Reengineering Medicines Development improves patient benefit through greater affordability, and speed of access to medicines.
ReMedDev® is a partnership approach to agree a novel development plan. An open stakeholder partnership between patient representatives, innovators, regulators and payers delivers common objectives of faster availability of medicines, with reduced development time and costs. This improves value, reduces prices, and increases cost effectiveness.
ReMedDev can benefit everyone, especially patients, increasing the relevance and applicability of clinical studies.
Innovation and Impact
Using real world data from healthcare databases fundamentally changes the concept of development studies, vastly improving recruitment and analysis times. Building effectiveness measures in to these studies reduces the reliance on traditional non representative randomised trials as well as traditional investigator sites. Thus development plans better reflect real world medical practice while Value Indicator Scales provide a unique insight into price point and cost effectiveness decisions.
Smart technology allows faster data assessment and real time analyses in implementing adaptive designs and earlier go / no-go decisions. Our unique concept builds multiple standard of care treatment comparisons and avoids unnecessary use of placebos to substantially reduce recruitment time and complexity as well as costs. Efficacy, safety and quality of life measures can all be assessed against Value Indicator Scales to simulate and model cost effectiveness points for pricing. These savings in development time and costs provides more flexibility in pricing.
Reengineering Medicines Development maximises the opportunity of regulatory flexibility in EMA's MAPPs and PRIME designation, the USA's 21st Century Cures Act and the UK's Accelerated Access Collaborative. It is a fundamental change to the model of studying, assessing, approving and using new medicines. Reducing investment cost and time but maintaining profit increases the number of projects that can be managed in a portfolio. Even with identical success rates, an increase of late stage innovative medicines could result. By including stratification, patient sub groups may be identified to benefit from a medicine earlier, to further increase pipeline success rates and accelerated access in those strata.
While ReMedDev® principles are broadly applicable, each project requires individual tailoring based on its expected benefits and its development stage.
A summary document on Reengineering Medicines Development, authored with ABPI is available on the Publication page.
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ReMedDev® is a TM of
Vermilion Life Sciences Ltd