Background. Meeting Objective. Participants

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1 Innovation in Antiretrovirals to Meet Developing Country Needs Co-organized by the Medicines Patent Pool, UNITAID, WHO and Chatham House 10 St James's Square, London July 2011 Background Over the past decade, access to lifesaving antiretroviral treatment (ART) for HIV infection increased over twenty-fold, to reach over six million people by But 10 million more people who are in need of treatment still do not have access to it, and this number will continue to grow. As the global community seeks to achieve universal ART access, a key challenge will be to ensure that drugs are adapted to resource-limited settings. But with more than 90 per cent of revenues from the sale of antiretrovirals in high-income countries, there is limited incentive to focus research on developing countries needs. As a result, urgently needed new formulations such as paediatric formulations, fixed dose combinations (FDCs), heat-stable products and other medicines adapted to specific requirements in resource-limited settings are often not developed, unless appropriate incentives are available. The recent establishment of the Medicines Patent Pool with the support of UNITAID provides a unique opportunity to explore ways to promote the development of HIV medicines suited to the needs of resource-limited areas. The Medicines Patent Pool aims to facilitate the development of affordable, adapted HIV medicines by providing access to the necessary intellectual property to do so. Meeting Objective The objective of the meeting is to identify challenges and opportunities for innovation in the field of antiretroviral treatment that targets specific developing country needs, and to discuss the role of different actors in ensuring that the necessary innovation is undertaken. The meeting will build on the priorities for treatment optimisation being established by the WHO in the context of Treatment 2.0, the Drugs for Neglected Diseases Initiative s product profiling for paediatric HIV, and the overview of priority missing essential ARVs prepared by the Medicines Patent Pool, UNITAID and WHO. It will also look at the opportunities for innovation that will arise as a result of the work of the Medicines Patent Pool. Participants A select group of experts and representatives from key institutions have been invited to participate, including governments, pharmaceutical companies, public research organizations, drug development initiatives, NGOs, community groups, funding and regulatory agencies. Each session will include brief presentations as well as general discussions. 1

2 Meeting Output A Report will be prepared following the meeting with conclusions and recommendations to promote and accelerate innovation in ART adapted to the needs of resource-limited settings. Based on the discussions at the Meeting, the report will seek to identify next steps in ensuring that innovation needs are being addressed. The outcomes of the meeting will be presented at the 6th IAS Conference in Rome, Italy. Venue Chatham House, UK. Dates The 11 July A dinner will be offered on July 10th 2

3 Innovation in Antiretrovirals to Meet Developing Country Needs Co-organized by the Medicines Patent Pool, UNITAID, WHO and Chatham House 10 St James's Square, London July 2011 Sunday, 10 July 19:00-21:00 Pre-meeting dinner (venue to be confirmed) Monday, 11 July Venue at Chatham House, 10 St James's Square, London Doors open at 8:30 8:30-9:00 Tea and Coffee OPENING Welcome and Meeting Objectives Dr. David Heymann, Head and Senior Fellow, Centre on Global Health Security, Chatham House Dr. Phillippe Douste-Blazy, Under-Secretary-General of the United Nations, Special Adviser on Innovative Financing for Development. 9:15 9:30: The Medicines Patent Pool s Role in HIV Treatment Innovation for Resource-limited Settings Ms. Ellen t Hoen, Executive Director, Medicines Patent Pool SESSION 1 Implementing a Short-term Innovation Agenda 9:30 11:00 Presentations and general discussion chaired by Dr Mariangela Simao, UNAIDS. Objectives: To discuss how priorities set by WHO for optimising treatment plans can be met, and identify the roles of various actors in ensuring the necessary steps are implemented. Key questions: - What are the main treatment needs and gaps in resource-limited settings? - What are the short-term priorities for drug optimisation and adapted formulations for adults? - What is the role of various actors (pharmaceutical companies, public research organizations, regulatory agencies, funding institutions, and others) to ensure that the identified priority formulations and fixed dose combinations are developed? Speakers: Prof. Francois Venter, Associate Professor in the Department of Medicine, University of Witwatersrand, South Africa 3

4 Mr. Craig McClure, Senior Adviser on Treatment 2.0 and Care Programme, WHO Respondents: Dr. Paul Stoffels, Company Group Chairman, Global Research & Development, Pharmaceuticals, Johnson and Johnson Dr. Yusuf K. Hamied, Managing Director, Cipla Dr. Zengani Chirwa, ART Technical Advisor, Ministry of Health, Malawi Dr David Ripin, Scientific Director, Drug Access Program, CHAI General Discussion (40 minutes) 11:00 11:30 Tea and Coffee Break SESSION 2: Responding to Specific Needs of Paediatric HIV Treatment 11:30 13:00 Presentations and general discussion chaired by Dr Sarah Zaidi, Executive Director, International Treatment Preparedness Coalition, Thailand Objective: To discuss research and development priorities in paediatric antiretroviral treatment and how different actors can contribute to implementing them. Key Questions - How is on-going research responding to paediatric ART needs? - What are the priority formulations? - What are the key market constraints for the development of paediatric ARVs? - What are the roles of various actors (pharmaceutical companies, public research organizations, regulatory agencies, drug procurement agencies, funding institutions and others) in responding to R&D needs for paediatric population? Speakers: Dr Ashraf Coovadia, Head of Empilweni Services and Research Unit, Department of Paediatrics. University of the Witwatersrand. South Africa Dr. Shing Chang, R&D Director, Drugs for Neglected Diseases Initiative (DNDi) Representative from UNITAID Respondents: Dr. Lillian Lou, Medical Director, International Access Operations, Gilead Sciences Dr. Khumo Seipone, Director of Health Services Ministry of Health, Botswana (to be confirmed) Representative from a Generic Drug Manufacturer General Discussion (30 minutes ) 13:00-14:00 Lunch Break 4

5 SESSION 3: Funding and Novel Incentives to Promote Innovation in HIV 14:00-16:00 Panel discussion and Presentations chaired by Mr Andrew Jack, the Financial Times Objective: To discuss incentives, policies and other mechanisms to promote the development of HIV medicines and formulations needed in developing countries, and to analyse the role of donor agencies, governments and other stakeholders in funding/facilitating their development. Key questions: - What kind of novel incentives can be put in place to promote innovation in ART? - How can more resources be mobilised to fund innovation in HIV to address the needs of developing countries. What could be the role of donors, governments and foundations in this area? - How can coordination and partnerships be developed, promoted and financed to meet R&D needs? Keynote speaker: Stephen O'Brien, Parliamentary Under-Secretary of State for International Development of the UK Panellists (60 minutes): Prof. Rifat Atun, Director Strategy, Performance & Evaluation Cluster, Global Fund to Fight AIDS, Tuberculosis and Malaria Dr. Philippe Duneton, Deputy Executive Secretary, UNITAID Dr. Charles Mgone, Executive Director, European & Developing Countries Clinical Trials Partnership Representative from a Generic Drug Manufacturer Representative from PEPFAR (to be confirmed) Representative from Bill and Melinda Gates Foundation (to be confirmed) General discussion (45 minutes) 16:00 16:30 Coffee break SESSION 4: Exploring Medium- and Long-Term Opportunities for Innovation in ART 16:30-18:00 Panel discussion and Presentations chaired by Dr Pedro Cahn. Director, Fundación Huesped,, former President of the International AIDS Society Objective: To examine the future of HIV treatment in the medium- to long-term and discuss mechanisms to ensure that developing country needs are adequately integrated in current and future R&D efforts. Key questions: - What are the potential future game-changers for antiretroviral treatment in developing countries? - How can various actors (pharmaceutical companies, public research organizations, drug development Initiatives, regulatory agencies, funding institutions, others) ensure that developing countries needs are integrated in the long-term research agenda? 5

6 - What mechanisms can be put in place to promote R&D and innovation that meet developing country needs and facilitate market uptake? Panellists (45 minutes) Respondents: Dr. Emily Erbelding, Deputy Director, NIH/NIAID Division of Acquired Immunodeficiency Syndrome (DAIDS) Prof. Beatriz Grinsztejn, Laboratory of clinical research on STD/AIDS, FIOCRUZ/IPEC Representative from ANRS (to be confirmed) Dr. John Pottage, Chief Medical & Science Officer, ViiV Healthcare Dr. John Ericksson, President and CSO, Sequoia Representative from Achillion General discussion (45 mins) Summary and concluding remarks 18:00 18:30 Summary of the meeting chaired by Dr. Elly Katabira, President, International AIDS Society (IAS) Uganda. Rapporteur: Dr. Charles Clift, Senior Research Consultant, Centre on Global Health Security Objective: Summary of conclusions, recommendations and proposals for further actions. 18:30-19:30 Cocktail 6

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