Research resources ways. For instance, by providing greater access <strong>to</strong> in-house compounds; provision of platform skills such as portfolio management or regula<strong>to</strong>ry support <strong>to</strong> PPPs; or encouraging <strong>and</strong> supporting senior staff <strong>to</strong> participate in PPP Scientific Committees or Advisory Boards. Finally, we would like <strong>to</strong> pose a challenge for our own community of experts, <strong>the</strong> international public <strong>health</strong> community. One of <strong>the</strong> concerns about PPP drug development organizations is that, since <strong>the</strong>re is generally only one PPP working on each disease, patients are at <strong>the</strong> mercy of that one group <strong>and</strong> its performance, or lack <strong>the</strong>reof. (O<strong>the</strong>rs, in particular governments, complain that <strong>the</strong>re are <strong>to</strong>o many PPPs <strong>and</strong> that <strong>the</strong>y should be rationalized!) In response, <strong>the</strong>re have been suggestions that we need <strong>to</strong> have a more competitive market for new neglected disease drugs, with multiple products being developed by different groups, thus allowing developing country patients <strong>the</strong> kind of choice that patients in developed countries have come <strong>to</strong> expect. This may well be true, but it also raises a number of questions. How many new products can developing country <strong>health</strong> systems absorb in each disease area? How many new Artemisinin Combination Therapies do we need in <strong>the</strong> near future (we currently have five additional adult formulations in development)? What about diseases that are largely managed through national control programmes (e.g. DOTS programmes for TB, or India’s planned leishmaniasis eradication programme?) Could national TB programmes cope with a new product every five years, in <strong>the</strong> happy event that this were possible? Will <strong>the</strong> previous private marketing of miltefosine, our first oral anti-leishmanial, help or hinder India’s plans for a controlled roll-out of <strong>the</strong> drug as part of its leishmaniasis programme? Would it be better <strong>to</strong> hold back new anti-malarial products until resistance has appeared or <strong>to</strong> market <strong>the</strong>m as <strong>the</strong>y became available? Who would be responsible for a decision <strong>to</strong> hold-back or <strong>the</strong> timing of a new release, or <strong>the</strong> task of dealing with producers keen <strong>to</strong> see rapid returns on <strong>the</strong>ir investment? Is it better <strong>to</strong> have one PPP managing a disease portfolio (allocating R&D investments, balancing <strong>the</strong> portfolio between discovery <strong>and</strong> development projects, <strong>and</strong> controlling product registration <strong>and</strong> release) or <strong>to</strong> have several groups independently pursuing products that could each be made available <strong>to</strong> patients as soon as it was ready? Given <strong>the</strong> paucity of funds, should R&D for each disease be planned <strong>and</strong> integrated (through a PPP or o<strong>the</strong>rwise) or should we rely on more traditional competitive approaches? We stress that we do not know <strong>the</strong> answers <strong>to</strong> <strong>the</strong>se complex questions. The lack of neglected disease R&D activity for many decades means we have never before had <strong>to</strong> face <strong>the</strong> question of product management for neglected diseases – for some diseases, we were lucky <strong>to</strong> have any products at all. As a result, <strong>the</strong>re has been little published <strong>and</strong> little open discussion of <strong>the</strong>se issues. We raise <strong>the</strong>m now only because <strong>the</strong>y sometimes seem <strong>to</strong> be <strong>the</strong> elephant in <strong>the</strong> room – <strong>and</strong> elephants are ultimately very hard <strong>to</strong> sweep under <strong>the</strong> carpet. ❏ Mary Moran trained as a medical doc<strong>to</strong>r, working for 13 years in Emergency Medicine in Australia. A postgraduate degree in international relations <strong>and</strong> politics at University of NSW <strong>and</strong> Monash University (1995) led her in<strong>to</strong> a diplomatic career with <strong>the</strong> Australian Department of Foreign Affairs & Trade, including a posting <strong>to</strong> London where she focused on climate change negotiations <strong>and</strong> international trade. Dr Moran subsequently worked for three years with Médecins Sans Frontières, initially as Direc<strong>to</strong>r of <strong>the</strong> Access <strong>to</strong> Essential Medicines Campaign in Australia <strong>and</strong> later as a Europe-based advocate on a range of issues relating <strong>to</strong> access <strong>to</strong> medicines for neglected patients. In 2004, she founded <strong>the</strong> Pharmaceutical R&D Policy Project (PRPP) at <strong>the</strong> London School of Economics & Political Science <strong>and</strong> subsequently moved <strong>the</strong> unit <strong>to</strong> Sydney, Australia, where it was consolidated as <strong>the</strong> Health Policy Division (HPD) of The George Institute for International Health in 2006. The HPD maintains a London office as part of <strong>the</strong> new International Development Centre in Bloomsbury <strong>and</strong> is associated with <strong>the</strong> London School of Hygiene <strong>and</strong> Tropical Medicine. Javier Guzman trained as a medical doc<strong>to</strong>r <strong>and</strong> worked in <strong>the</strong> planning <strong>and</strong> implementation of primary <strong>health</strong> care projects in <strong>the</strong> Colombian countryside for several years. He mainly worked in early detection <strong>and</strong> treatment programmes of endemic infectious diseases such as tuberculosis <strong>and</strong> Chagas’ disease. Dr Guzman moved <strong>to</strong> <strong>the</strong> UK in 2002, where he worked as a Postgraduate Clinical Fellow in Paediatrics at <strong>the</strong> Royal London Hospital. In 2004, he obtained his MSc in Health Policy, Planning <strong>and</strong> Financing from <strong>the</strong> London School of Economics <strong>and</strong> <strong>the</strong> London School of Hygiene <strong>and</strong> Tropical Medicine. In August 2004, Dr Guzman joined <strong>the</strong> PRPP where he has worked mainly on <strong>the</strong> performance of different R&D models <strong>and</strong> pipelines. He moved <strong>to</strong> Australia in April 2006 <strong>and</strong> now heads <strong>the</strong> HPD research team at The George Institute, Sydney. Anne-Laure Ropar originally trained <strong>and</strong> worked as a mechanical engineer. After completing a master’s degree in political economy <strong>and</strong> international relations at <strong>the</strong> University of Chicago, she worked for a number of years as a consultant specializing in European <strong>and</strong> developing country <strong>health</strong> systems <strong>and</strong> policies. Her clients have included <strong>the</strong> EU-based pharmaceutical industry, philanthropic organizations (Rockefeller Foundation, Bill & Melinda Gates Foundation), <strong>and</strong> government bodies (DFID, USAID). Anne-Laure Ropar’s project experience spans drug procurement policy in sub-Saharan Africa, market-based mechanisms <strong>to</strong> reduce <strong>the</strong> price of essential drugs in Ghana, <strong>to</strong> drug reimbursement policies in European countries. She joined <strong>the</strong> PRPP at its creation in 2004, where she has managed research on Product Development Partnerships <strong>and</strong> <strong>the</strong> pharmaceutical industry’s involvement in neglected diseases, <strong>and</strong> worked on incentive proposals for both large pharmaceutical <strong>and</strong> small biotechnology firms. Anne-Laure now heads <strong>the</strong> HPD research team in <strong>the</strong> London office of The George Institute. Global Forum Update on Research for Health Volume 4 ✜ 145
Research resources References 1. Source: Widdus et al. 2001. 2. Moran M et al. The new l<strong>and</strong>scape of neglected disease drug development. London School of Economics/ Wellcome Trust, September 2005. 3. Pyronaridine-artesunate, chlorproguanil-dapsone-artesunate <strong>and</strong> dihydroartemisinin-piperaquine (Artekin) by MMV; <strong>and</strong> AS-AQ <strong>and</strong> AS-MQ by DNDi (as h<strong>and</strong>overs from an earlier group). MMV are also developing <strong>the</strong> first paediatric ACT formulation (Coartem in non-tablet form, with Novartis). 146 ✜ Global Forum Update on Research for Health Volume 4
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