PhD in Pharmacometrics / Pharmacoeconomics

Applications are invited for a Medical Research Council funded PhD studentship at the Centre for Health Economics and Medicines http://cheme.bangor.ac.uk/, Bangor University. This full-time, 3-year studentship provides full support for tuition fees, all associated research costs and a tax-free annual stipend of £17,726. In collaboration with the University of Liverpool and Pfizer, this PhD will be to develop and apply linked pharmacometric-pharmacoeconomic analyses in clinical drug development. How to Apply Interested candidates are advised to discuss the project with Professor Dyfrig Hughes [email protected]<mailto:[email protected]> before submitting an application, and the deadline for doing so is 24th January 2014. Applications, consisting of a CV and a cover letter, and indicating the project reference number (2013 P11), must be submitted by e-mail to [email protected]<mailto:[email protected]> no later than noon (GMT) 31st January 2014. Eligibility Requirements Applicants should have (or expect to be awarded) a Masters qualification, and a first-class or upper second-class degree in a relevant quantitative or pharmaceutical / health-related discipline. All candidates are required to have been resident in the UK for the past three years to qualify for home fees status. More details on eligibility can be found on the MRC website: http://www.mrc.ac.uk/Fundingopportunities/Applicanthandbook/Studentships/Eligibility/index.htm Title: Development and application of linked pharmacometric-pharmacoeconomic analyses in clinical drug development Reference: 2013 P11 Supervisors: Professor Dyfrig Hughes (lead), Dr Steven Lane (University of Liverpool); Advisory group: Professor Munir Pirmohamed, University of Liverpool; Dr Peter Milligan & Dr Richard Willke, Pfizer Project summary: Model-based drug development uses pharmacometric (quantitative pharmacology) approaches to inform trial design and optimise compound development strategies [1]. This approach aims to reduce late-stage failure and improve the efficiency of drug development. We conceived and subsequently proved the concept of linking such an approach with economic models to provide early estimates of cost-effectiveness, and inform pricing strategies [2-4]. In collaboration with Pfizer, and utilizing the expertise within the NWHTMR, this PhD project will aim to develop case studies for application in clinical drug development. The project will improve methods for strategic, clinical and pricing decisions during phase II/III drug development. Case studies of marketed drugs for which publicly available data are available will be identified to develop appropriate population pharmacokinetic-pharmacodynamics (PPKPD) models and /or pharmacological model-based meta-analyses that describe the time-course of drug action on relevant biomarkers or condition-specific outcome measures. In order to arrive at an economically meaningful health outcome (e.g. quality-adjusted life-year, QALY), the outputs of PPKPD analyses will be extrapolated using epidemiological data or mapped directly to the EQ-5D according to accepted methods [5]. Using standard pharmacoeconomic modeling approaches for defining relevant health states, applying NHS costs, and discounting to net present value, the analysis will reveal the price of the drug which would result in it being cost-effective at the threshold of £30,000 per QALY gained. This value-based price, consistent with the proposed UK approach for pricing new medicines will inform whether further development is commercially viable. Uncertainty in pharmacokinetic, dynamic and economic parameters will be propagated through the analyses and presented as cost-effectiveness acceptability curves. In order to inform trial design, value of information analyses, based on the Expected Net Benefit of Sampling (ENBS) will be performed [6,7]. A trial will be considered to be worth undertaking if the expected value of sample information is greater than the cost of the trial. As larger trials will be more costly, ENBS quantifies the expected net trade-off of the benefits of the trial its costs. The accumulation of evidence supporting pharmacometric/economic modeling will increase confidence in its application. Training: The student will be provided with a range of training opportunities, including access to Bangor University's early researcher development programme, specialist short courses on: health economics, pharmacometrics including use of NONMEM®, statistics and others available via the Network of Hubs for Trials Methodology Research. References: [1] Clin Pharmacol Ther 2013;93(6):502-14. [2] Pharmacoeconomics 2001;19(11):1069-77. [3] Pharmacoeconomics 2012;30(5):413-29. [4] Clin Pharmacol Ther 2013; doi: 10.1038/clpt.2013.190. [5] Health and Quality of Life Outcomes 2013;11:151. [6] J Health Econ 2001;20(5):797-822. [7] Stat Med 2005;24(12):1791-806.