CASMI Fellow - Adaptive Licensing @ Centre for the Advancement of Sustainable Medical Innovation
Bachelor of Pharmacy with Honours, Pharmacy @
University of Nottingham
Associate Director Science Policy and Research @ The Associate Director for Scientific Policy and Research is responsible for the planning and delivery of NICE’s R&D agenda relating to methodology and clinical research. Responsibilities include scientific policy development; liaison with national funding bodies and the research community; identification and promotion of clinical research recommendations; NICE’s Citizens Council; NICE’s
Associate Director Science Policy and Research @ The Associate Director for Scientific Policy and Research is responsible for the planning and delivery of NICE’s R&D agenda relating to methodology and clinical research. Responsibilities include scientific policy development; liaison with national funding bodies and the research community; identification and promotion of clinical research recommendations; NICE’s Citizens Council; NICE’s Technical Forum and the Institute Research Advisory Group. From August 2008 to Present (7 years 5 months) Honorary Professor @ Institute of Epidemiology and Public Health Care From December 2013 to Present (2 years 1 month) CASMI Fellow - Adaptive Licensing @ CASMI is the Centre for the Advancement of Sustainable Medical Innovation, a partnership between Oxford University and UCL, created to develop new models for medical innovation. The centre aims to address the issues that have lead to current failures in the translation of basic bioscience into affordable and widely adopted new treatments.
Adaptive approaches to licensing aim to streamline the research, licensing and market access processes by involvement of all stakeholders including the sponsor, regulator, payers/providers and the research community. A drug-specific development plan is agreed that provides sufficient information on risk versus benefit to enable prompt authorization in a defined group of patients and/or treatment settings. This followed by monitoring of ‘real-life’ effectiveness and safety and leads to further license adaptation. AL may use existing regulatory pathways or explore novel methodologies. From May 2012 to Present (3 years 8 months) WP1 Co-lead @ GetReal is a project of the Innovative Medicines Initiative (IMI), a public-private consortium consisting of pharmaceutical companies, academia, HTA agencies and regulators (e.g., NICE, HAS, EMA and CVZ), patient organisations and SMEs.
The GetReal consortium aims to improve the efficiency of the medicine development process by better incorporating estimates of relative effectiveness into drug development and to enrich decision-making by regulatory authorities and HTA bodies.
The overall aim of WP1 is to create a shared platform to address the inclusion of alternative study designs in drug development strategies. Such a platform is required to ensure that the identified options meet the needs of all relevant parties as a medicine transitions from its development stages through to use in the clinical setting, while also increasing the efficiency and/or reducing the cost of the research and development process. This should be achieved without compromising the robustness of the data for decision-making both from a regulatory and health technology assessment (HTA) perspective.
WP1 will bring together multiple stakeholders, to ensure that it takes into account a wide range of perspectives. From October 2013 to Present (2 years 3 months) Person Appointed @ The Regulation of Medicines Review Panel is a permanent panel of individuals who are independent of the pharmaceutical industry, the licensing authority or its advisors. The panel carries out independent reviews of licensing authority decisions, performing the function of the ‘person appointed’ in the Medicines Act 1968 and subordinate legislation. From January 2009 to Present (7 years) London, United KingdomHonorary Professor @ From January 2015 to Present (1 year) Editor, Skin Group @ From 2005 to October 2012 (7 years) Harkness Fellow in Healthcare Policy and Practice @ A one year research fellowship in the United States focusing on the inter-relationship between comparative effectiveness research (health technology assessment) and innovation. An evaluation of policy solutions including adaptive licensing of pharmaceuticals and value-based insurance design.
Mentors: Peter Neumann (Tufts University), Sean Tunis (CMTP), Ruth Faden (Johns Hopkins University), Alan Garber (Stanford University). From 2010 to 2011 (1 year) Pharmacist Lead @ From January 2006 to December 2007 (2 years)
PhD, Health Technology Assessment @ University of Nottingham From 1996 to 2000 Bachelor of Pharmacy with Honours, Pharmacy @ University of Nottingham From 1989 to 1992 Sarah Garner is skilled in: Policy, HTA, Healthcare, Clinical Research, Public Health, Health Economics, Healthcare Management, Research, Clinical Trials, Pharmaceutical Industry, Strategic Planning, Medical Devices, Adaptive Licensing, Management, Health Policy, Medicine, Market Access, Evidence-based Medicine, Clinical Development