The Value of Product Development Partnerships in Vaccine Innovation. Hansi J. Dean International AIDS Vaccine Initiative

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1 The Value of Product Development Partnerships in Vaccine Innovation Hansi J. Dean International AIDS Vaccine Initiative

2 The Product Development Partnership Model A non-profit partnership of public and private organizations that Addresses a clear public health need for which the perceived commercial market is small Facilitates partnerships that bring together expertise, resources and investments of public, philanthropic and private sectors towards highly focused public health goals Assume the risk and cost of product development, in exchange negotiating licensing and IP rights to ensure that eventual products will be available at an affordable price to the populations who need them most Strengthens research and manufacturing capacity in most affected countries

3 PDPs: harnessing the product development cycle for global health needs Product Development Partnerships (PDPs) National & academic institutions Biotech / SMEs Multinational pharma & biotech Basic Research Applied Research Product Design Early Development Late Development Efficacy Trials Delivery & Access EDCTP

4 PDP Impact on Global Health STRONG PIPELINE of candidates in development: vaccines, drugs and diagnostics for HIV, malaria, TB, parasites, diarrheal diseases... >10 PRODUCT LAUNCHES ENHANCED ABILITY TO DEVELOP NEW PRODUCTS BEYOND THE INITIAL TARGET.by strengthening infrastructure for research and clinical trials in developing countries ENCOURAGES INDEPENDENT INDUSTRY INVESTMENT.by improving market information for developing countries such as disease burden, health system and user requirements and product demand

5 Top 12 PDP Donors Total $350M These 12 donors provided 93% of PDP funding in 2012 Policycures.org G-Finder Report 2013

6 No single PDP Model Less virtual Manage products and conduct key activities Operating Models More virtual Partner-managed or outsourced VAC Human hookworm vaccine initiative BCG analysis, 2009 Product intermediaries Limited/no product IP ownership Business Models Product "owners" In-license or own product IP

7 IAVI is a product development partnership, which fill gaps and accelerates HIV vaccine R&D by bridging government and foundation funding with academic and industry capabilities IAVI's mission is to ensure the development of safe, effective, accessible, preventive HIV vaccines for use throughout the world. Our vision is a world without AIDS Imagine a World Without AIDS

8 Government and private sector funding BMGF Private Sector & Other Denmark USAID Norway Ireland Japan US NIH Netherlands UK DFID

9 IAVI s niche: To bridge basic research to advanced product development, translating vaccine concepts into the clinic R&D partnerships Regional partnerships Advocacy and outreach Research labs to identify new vaccine leads Research consortia Product development to advance IAVI and others candidates Clinical trials Clinical research centers in Africa International academic and biotech partners Joint IAVI-India lab Advocacy and outreach from community to international level Policy on HIV vaccine potential impact, access

10 IAVI is building on successes to address key HIV vaccine challenges Successes Focus on African & Asian HIV clades Challenges Vaccines that address HIV variability Discovery of HIV broadly neutralizing antibodies which define conserved targets Design vaccines which elicit broadly neutralizing antibodies to prevent infection Advance new T cell immunogen designs to control infection 27 phase I/II trials Advance next generation candidates to efficacy trials

11 The job isn t finished until a safe, effective HIV vaccine is available for everyone 2.3 million Number of new infections in 2012

12 Optimism for an AIDS-free generation Research continues to yield clues to how we might rationally design an effective HIV vaccine, yet many scientific challenges remain. When we do succeed, an HIV vaccine will be the main driver to not only accelerate the decline of new HIV infections and to do so more efficiently and cost-effectively but also to maintain an AIDS-free generation once we get there. While an HIV vaccine will be integral to achieving an AIDS-free generation, it also will be essential to realizing our ultimate goal: a world permanently without HIV/AIDS. Imagine a World Without AIDS Anthony S. Fauci, July 11, 2013

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