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Combining health and social protection measures to reach the ultra ...

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Research resourcesthat many public donors may be used <strong>to</strong>. This is a veryimportant point <strong>to</strong> underst<strong>and</strong>. As discussed below, inpractice effective PPPs operate more like a cross between<strong>social</strong>-VC funders <strong>and</strong> multinational drug company (MNC)divisions.Just as VC firms do when looking for optimal new products<strong>to</strong> take forward from a commercial perspective, <strong>the</strong> PPP alsoassesses <strong>the</strong> field <strong>to</strong> hone it down <strong>to</strong> a shortlist of <strong>the</strong> mostpromising R&D projects from a public <strong>health</strong> perspective.The PPP raises <strong>the</strong> funds, bears <strong>the</strong> risks, finances <strong>the</strong>chosen groups, provides support <strong>to</strong> get <strong>the</strong>ir products across<strong>the</strong> line, <strong>and</strong> finally reaps <strong>the</strong> (<strong>social</strong>) dividend. Likewise, <strong>the</strong>PPP plays a VC-like role in setting miles<strong>to</strong>nes, moni<strong>to</strong>ringprogress against <strong>the</strong>se <strong>and</strong> making go/no-go decisions basedon how well each project performs. PPPs are assisted in thistask by <strong>the</strong>ir Scientific Advisory committees, composed ofexperts (often world-leaders) in industry pharmaceuticaldevelopment <strong>and</strong> developing world <strong>health</strong> needs. Watchingone of <strong>the</strong>se committees grill R&D groups on <strong>the</strong>ir projects isa fascinating exercise in how public <strong>health</strong> <strong>and</strong> industryexpertise can work <strong>to</strong>ge<strong>the</strong>r <strong>to</strong> ensure that <strong>the</strong> target productsare not only possible from an industrial perspective, but alsooptimal in terms of affordability, suitability, efficacy <strong>and</strong> safetyfor <strong>the</strong> target developing country populations.This VC-like role is often unacknowledged, which is a greatpity since it is an area where government funders of R&Dprojects (for example, via grant programmes) are often mostexposed <strong>to</strong> <strong>the</strong> risk of poor investments <strong>and</strong> failed decisions.Shifting <strong>the</strong>se decisions <strong>to</strong> PPPs with industry <strong>and</strong> public<strong>health</strong> expertise represents a clear bonus for governmentfunders. If allied <strong>to</strong> additional government funding of PPPs, itcould also help provide <strong>the</strong> magical formula of increasedpublic involvement <strong>and</strong> accountability, but decreased publicrisk. An important proviso is that <strong>the</strong> PPP must, of course,have sufficient industry <strong>and</strong> public <strong>health</strong> expertise – somegroups are stronger on this than o<strong>the</strong>rs, an issue that isaddressed through proposals set out elsewhere .PPPs also play a role that we have loosely categorized as“MNC-like”. In o<strong>the</strong>r words, <strong>the</strong>y provide smaller or lessexperienced drug development partners with technical <strong>and</strong>scientific skills that <strong>the</strong>y may lack <strong>and</strong>, importantly, provideoverall management of <strong>the</strong> lengthy <strong>and</strong> complex drugdevelopment process. MNCs often play a similar role whenworking with small biotech companies. For instance, PPPscan supplement <strong>the</strong>ir partner’s skill gaps by arranging (<strong>and</strong>often funding) outsourcing <strong>to</strong> Contract ResearchOrganisations (CROs), by finding industry partners for fur<strong>the</strong>rdevelopment, or by putting <strong>to</strong>ge<strong>the</strong>r manufacturing deals witho<strong>the</strong>r firms. These activities closely mimic <strong>the</strong> modularapproach that MNCs increasingly take <strong>to</strong> drug development,keeping core activities in-house but outsourcing o<strong>the</strong>r jobs <strong>to</strong>contracted groups who can do <strong>the</strong>m more cheaply.PPP assistance of this nature can be invaluable foracademic groups, developing country firms with limitedexperience of registering novel drug products (as opposed <strong>to</strong>generics) or biotech firms who are strong in drug discoverybut have limited, if any, experience of regula<strong>to</strong>ry approval orlarge-scale manufacturing <strong>and</strong> distribution. In each of <strong>the</strong>seinstances, <strong>the</strong> PPP can contract in <strong>the</strong> necessary skills <strong>to</strong> fill<strong>the</strong> gap (e.g. a CRO skilled in <strong>to</strong>xicology or regula<strong>to</strong>ryapprovals; a developing country company with experience inlarge-scale manufacture) <strong>and</strong> provide overall management ofPPPsCumulative directR&D spendUS $76m*34.8Academics30.2SMEs/CROs/DC firms35%Big pharmaOne thirdtranslationof researchin<strong>to</strong> drugleadsTwo thirds<strong>to</strong> industry* – Covers period 2000-2004– PPP R&D spend only (<strong>to</strong>tal PPP spend was Us$112 million)– TDR figures are excludedSMEs: Small- <strong>and</strong> Medium-sized Enterprises, CROs: Contact Research Organisations DC: Developing CountriesFigure 3: Resource allocation by PPPs 2000-2004142 ✜ Global Forum Update on Research for Health Volume 4

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