Multi-criteria value-maximization methods for the prioritization of R&D investments in global health product development International Collaboration

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1 Multi-criteria value-maximization methods for the prioritization of R&D investments in global health product development International Collaboration for Capitalizing on Life-Saving and Cost- Effective Commodities (i4c)

2 Limited resources invested in R&D for global health product development Neglected disease R&D funding (G-FINDER 2014)

3 Women and children particularly at risk

4 R&D investments key for sustaining product development pipelines *BVGH (2007) Closing the Global Health Innovation Gap: A Role for the Biotechnology Industry in Drug Discovery for Neglected Diseases

5 A systematic prioritization of R&D investments is required Which diseases? What products? What R&D areas? Which actors? NTDs? The big three (HIV/AIDS, TB, malaria)? Emerging infectious diseases? Maternal and child health conditions? other? Vaccines? Drugs? Diagnostics? Vector control products? MCH essential commodities? Other medical devices? Basic research? Discovery? Preclinical? Clinical? Postlicensure? Industry? Academic and government research organizations? Product Development Partnerships?

6 Risk of misallocation of scarce resources in absence of systematic prioritization Can Stock Photo csp

7 Dearth of industry R&D investments due to time, risk, cost and lack of incentives Milions Basic research / translational Basic & translational research research Discovery & preclinical Clinical I/II Clinical III Licensure Average Time: years Average Risk: 95% chance of failure at discovery Average Cost: $500mm - > $1.3bn $500 $450 $400 $350 Industry investments in neglected disease R&D (G-FINDER 2014) $447 $418 $391 $401 $401 $359 $300 $250 $236 $200 $150 $100 $50 $0 FY 2007 FY 2008 FY 2009 FY 2010 FY 2011 FY 2012 FY 2013

8 A Complex funding flow structure Product Developers Funders Fund Managers

9 Variable concerns and motivations to R&D priority setting Social returns? Health returns? CSR / reputational concerns? R&D awareness Technical constraints Financial constraints x R&D priority setting and investment decision making

10 Project purpose Overall - Assess whether a multi-criteria value-maximization tool can be applied for the prioritization of R&D investments in global health product development First step - Review approaches to pharmaceutical R&D priority setting and identify appropriate methodologies for R&D investment prioritization in global health product development Next steps - Develop and test methodologies for the systematic prioritization of R&D investments in various settings, applying suitable multi-criteria decision analysis (MCDA) techniques

11 The partnership Organization Harvard Global Health Institute Harvard School of Public Health Instituto de Evaluación Tecnológica en Salud K Marsh Consulting Ltd. Technical University of Crete Universitair Medisch Centrum St Radboud University of Bergen University of Bergen University of California, San Francisco University of California, San Francisco WHO Global Health R&D Observatory World Health Organization - PHI World Health Organization - TDR Name Suerie Moon Joshua Salomon Javier Guzman Kevin Marsh Constantin Zopounidis; Michael Doumpos Rob Baltussen Ole Frithjof Norheim Trygve Ottersen Dean Jamison Gavin Yamey Riek Viergever Zafar Mirza Rob Terry

12 Paper 1: purpose and methods Purpose: conceptual framework for systematic prioritization of R&D investments in global health product development Targeted review according to: nature of the prioritization decision type of options considered Who is making the choices What level of aggregation choices are made at What concerns, objectives and criteria influencing choices What the model is for processing objectives and criteria What additional processes are being deployed Critical appraisal of pros / cons for identifying options; identifying criteria; valuing and comparing options

13 Paper 1: Issues from the broader R&D priority setting literature guiding the proposed methods Perspective Health research Healthcare (more broadly) Literature history since 1990s since 1970s / 1980s Examples 3D CAM; ENHR; CHNRI; COHRED; WHO Ad Hoc Committee method; numerous informal methodologies PBMA; health economic evaluation; QALY league tables and BoD approaches; value of information approaches; historical allocation processes; partnership approaches; clinical variations and payback approaches; conjoint analysis and DCE methods; MCDA methods; ethical frameworks Emerging issues - a consensus building process around research issues requiring urgent attention, making use of stakeholder judgments based on multiple explicit or implicit values and objective criteria. - suitability of approaches varies according to level of application, comprehensiveness of topics addressed, mix of technical and interpretive techniques, nature and degree of stakeholder involvement - a process of rationing limited resources to meet target group needs - stakeholder preferences matter and how target groups are approached is critical, including ethical considerations - central are also issues of what evidence is provided to inform the prioritization process, and what analytic methods are applied to assess performance of options against a range of values and quantitative criteria - a systemic process of benefit-cost trade-offs between preferred areas of science towards certain national goals, where interplays occur between user-based, institutional, and political forces - dynamic process whereby priorities change with goals Public policy (linked to health) since 1970s / 1980s category-based (cost-benefit) models; user-based models; institutional models; political models - recognition of complex political and interactive interactions involving multiple stakeholders is key - central are issues such as who makes the choices, at what level choices are made and in what relation to national goals and needs - the consideration of funding outcomes transform priorities from ways of stressing issues for attention to methods for managing resource allocation - an organization-specific decision problem of R&D project selection or portfolio management under specified constraints and criteria, accompanied by good managerial judgment R&D management since 1960s capital budgeting and pharmacoeconomic models; efficiency and productivity analysis models; optimization and simulation models; MCDA models - earlier models of limited practical application possibly because they over-emphasized mathematical sophistication while being contextually naïve - recent models from the portfolio management and MCDA literature recognize importance of stakeholder interactions in resource allocation decisions, with managerial perception and satisfaction acquiring a central role

14 Paper 1: Progress to-date x Database searches 5,492 records identified 391 duplicates removed 5,101 records screened by title/abstract 5,010 records excluded 91 records preselected for full text review Google scholar views Excluded if: 1,000 records viewed 13 additional records selected for full text review Not a method for pharma R&D priority setting; Theoretical approach without application on pharma R&D priority setting; Method from chemical or biology perspective without focus on strategy or resource allocation problems

15 Thank you Dimitrios Gouglas Adviser / Stipendiat Norwegian Institute of Public Health Postbox 4404 Nydalen, 0403 Oslo Norway Dimitrios.Gouglas@fhi.no Phone:

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