IAS-ILF Industry Roundtable on Paediatric ARVs

Transcription

1 Meeting Report IAS-ILF Industry Roundtable on Paediatric ARVs Paediatric antiretrovirals: The barriers to and solutions for improved access to optimal drugs in resource-limited settings 27 November 2013 Geneva, Switzerland

2 Acknowledgements This report is the result of an industry roundtable organized by the International AIDS Society-Industry Liaison Forum (IAS-ILF) on 27 November 2013 in Geneva, Switzerland. The IAS-ILF would particularly like to thank the experts and key informants that graciously provided their time and insight. IAS-ILF Secretariat Bertrand Audoin Bernard Kadasia Shirin Heidari Sébastien Morin Janette Bennett IAS-ILF Advisory Group Boris Renjifo Bryan Cobb Catherine Hankins Celia DC Christie-Samuels Cheryl Smith Elly Katabira Heidi Nass Jim Rooney Joel Gallant Linda-Gail Bekker Michael Rabbow Nicholas Hellmann Perry Mohammed Rahab Mwaniki Sandra Nusinoff Lehrman Scott Purdon International AIDS Society, Switzerland International AIDS Society, Switzerland International AIDS Society, Switzerland International AIDS Society, Switzerland Copy Editor, South Africa AbbVie, USA Roche Molecular Systems, USA Amsterdam Institute for Global Health and Development, The Netherlands University of the West Indies, Jamaica Burkina Foundation, USA Makerere Medical School, Uganda AIDS Treatment Activists Coalition, USA Gilead Sciences, USA Johns Hopkins University, USA Desmond Tutu HIV Foundation, South Africa Boehringer Ingelheim, Germany Elizabeth Glaser Pediatric AIDS Foundation, USA Janssen, UK National Empowerment Network of People Living with HIV/AIDS, Kenya Merck, USA ViiV Healthcare, UK Support The IAS-ILF is grateful for the support received from AbbVie, Boehringer Ingelheim, Gilead Sciences, Janssen, Merck, Roche and ViiV Healthcare. Copyright International AIDS Society, Switzerland Produced by Avenue de France 23 CH-1202 Geneva Switzerland Tel: Fax: IAS-ILF Industry Roundtable on Paediatric ARVs

3 IAS-ILF Industry Roundtable on Paediatric ARVs Co-Chairs: Roundtable discussion facilitator: Shirin Heidari, International AIDS Society (IAS), Switzerland Martina Penazzato, World Health Organization (WHO), Switzerland Shaffiq Essajee, Clinton Health Access Initiative (CHAI), USA Background The International AIDS Society-Industry Liaison Forum (IAS-ILF) recently convened industry and non-industry stakeholders to a roundtable on paediatric antiretrovirals (ARVs), entitled Paediatric antiretrovirals: The barriers to and solutions for improved access to optimal drugs in resource-limited settings (27 November 2013, Geneva, Switzerland). The meeting, attended by paediatric ARV manufacturers (both originator and generic) and other stakeholders with vested interests in paediatric treatment and care, directly followed the Joint WHO/UNAIDS Annual Consultation with Pharmaceutical Companies and Stakeholders on Forecasting global demand of antiretroviral drugs for (25-26 November 2013, Geneva, Switzerland). The main objective was to allow a dialogue with global partners and stakeholders on better coordination and collaboration while also informing the various stakeholders, in particular industry, about the on-going global efforts to address some of the specific challenges facing the paediatric ARV market. The meeting sought to build on recent efforts to address the treatment gap in children and adolescents affected by HIV. Introduction Shirin Heidari (IAS, Switzerland) opened the meeting, introducing her Co-chair, Martina Penazzato (WHO, Switzerland), and welcoming the participants. She explained that the IAS-ILF was created in 2001 as a multi-stakeholder platform consisting of industry, community, academia, normative agencies and international organizations with a mission to accelerate scientifically promising, ethical HIV research in resource-limited countries, with a particular focus on the roles and responsibilities of industry as a sponsor and supporter of research. It emerged from a shared need to tackle a number of ethical issues related to conducting research in resource-limited settings (RLS). It was based on the recognition of the roles and responsibilities of pharmaceutical and diagnostics companies as partners in the fight against HIV. Initially, the IAS-ILF promoted dialogue around key issues in HIV research in RLS, including considerations around post-trial care provision, as well as the quality of generic drugs. Pre-exposure prophylaxis (PrEP) later became a priority of the IAS-ILF. In 2010, a multi-stakeholder consultation resulted in a Consensus Statement 1, endorsed by 16 organizations, emphasizing the importance of appropriate interventions for women and children. Heidari and Penazzato reminded meeting participants that the number of children younger than 15 years living with HIV is estimated at around 3.3 million and that despite major efforts to scale up elimination of mother-to-child transmission (emtct), many children still get infected. Hence, although the market for paediatric ARVs is often considered to be shrinking, at present, global paediatric treatment coverage is just over one in three of those in need, and estimates show that the number of children needing treatment will remain substantial until at least continued on next page» 1. Asking the Right Questions: Advancing an HIV Research Agenda for Women and Children. IAS, Geneva (Switzerland), 2010 [link]. IAS-ILF Industry Roundtable on Paediatric ARVs 3

4 » continued from previous page Diverse challenges exist for paediatric ARV development and distribution: technical (need for safe, potent, palatable, childfriendly, heat-stable and fixed-dose combinations [FDCs]); programmatic (product selection, forecast, procurement, inventory and other elements related to supply chain management); and financial (small and fragmented market, lack of financial incentives and low return on investment). The diversity of suboptimal formulations currently contributes to the large gaps in treatment coverage. The co-chairs mentioned that this multi-stakeholder meeting, convened by the IAS-ILF as an independent third party, was intended to provide an overview of the efforts underway (see Figure 1) while encouraging a more lively dialogue between diverse organizations and, importantly, industry stakeholders. Figure 1 Mechanisms in place to optimize paediatric ARVs and better shape the market PADO New drugs, mid- and long-term priorities New formulations EOI New drugs, mid- and long-term priorities New formulations Guidelines Existing drugs Existing formulations IATT formulary Optimized formulations for procurement Minimum number of products to build regimens recommended by guidelines PAPWG Coordinated procurement of paediatric ARVs Figure 1. Mechanisms in place to optimize paediatric ARVs and better shape the market. PADO: Paediatric ARV Drug Optimization Conference, EOI: expression of interest, Guidelines: including WHO guidelines, IATT: Interagency Task Team on the Prevention and Treatment of HIV Infection in Pregnant Women, Mothers and Children, PAPWG: Paediatric ARV Procurement Working Group. Source: Shirin Heidari and Martina Penazzato, IAS-ILF Industry Roundtable on Paediatric ARVs, Geneva (Switzerland), IAS-ILF Industry Roundtable on Paediatric ARVs

5 New paediatric treatment recommendations Following the introduction, Penazzato reminded participants of the consolidated WHO guidelines 2, focusing on the updated paediatric treatment recommendations. In line with the guidelines for adults, the guidelines for children are simplified from their previous format, with recommendations to treat all children less than five years of age, irrespective of their immunological or clinical status. For children older than five years, the recommendations are as for adults, with treatment to be initiated when CD4 counts are less than 500 cells/mm 3. Harmonization between adults and paediatric regimens remains a challenge. A unique set of first-line regimens for children younger than three years, with a preference for ritonavir-boosted lopinavir (LPV/r) and two nucleoside reverse transcriptase inhibitors (NRTIs) zidovudine (AZT) or abacavir (ABC) + lamivudine (3TC) is recommended. Provided viral load can be monitored and upon reaching sustained virological suppression, substitution of the boosted protease inhibitor, LPV/r, by a non-nucleoside reverse transcriptase inhibitor (NNRTI), such as efavirenz (EFV) or nevirapine (NVP), can be considered. For children between three and 19 years of age, the recommended regimens are based on one NNRTI (EFV) and two NRTIs (e.g., ABC + 3TC, tenofovir [TDF] + emtricitabine [FTC]). For second line, the recommendations depend on age and first-line regimen, with no second-line regimen recommended for LPV/r-based first-line regimen in children younger than three years where, instead, adherence should be improved. IATT Optimized List of Paediatric ARV Formulations Marianne Gauval (CHAI, USA) presented the Optimized List of Paediatric ARV Formulations, developed by the Child Survival Work Group of the Interagency Task Team (IATT) on the Prevention and Treatment of HIV Infection in Pregnant Women, Mothers and Children. She started her presentation by highlighting the diversity and wide range of formulations for children. She mentioned that children, as a group, need different regimens for different ages and different doses for different weight bands; in comparison, adults are given the same regimens and doses. This situation gives rise to the multitude of paediatric ARV formulations, contributing to market fragmentation. For this reason, the IATT Child Survival Work Group has developed a subset of optimal formulations in order to consolidate demand and thus promote a sustainable supply and ensure uninterrupted treatment for children. The outcomes of this work are lists of: (1) optimal formulations; (2) limited-use formulations; and (3) non-essential ARV formulations. These lists are based on diverse criteria and follow WHO s regimen recommendations while trying to ensure coverage of all weight bands and requiring that products meet specific selection criteria. These criteria include: inclusion in WHO guidelines; available in RLS; stringent regulatory agency (SRA) or WHO prequalification (PQ) approval; user friendly (e.g., FDC, palatable, heat-stable, flexible dosing); and cost. Limited-use formulations are listed for special circumstances or transition (phase-in or phase out) of drugs, while non-essential ARV formulations are non-optimal and thus should not be procured. The IATT Optimized List of Paediatric ARV Formulations list developed in 2011 was updated in September 2013 and is available online. One question raised by industry was why the list includes scored dispersible tablets as formulations. It was explained that scored tablets allow for dosing flexibility whereas dispersible formulations allow for flexibility in administration (delivery). Moreover, the current guidance is for half-tablet steps for the lowest weight bands with up to three tablets before switching to adult formulations. Concerns were raised regarding dosing because of uniformity issues when breaking dispersible tablets and dissolution of the tablets on fingers. One approach suggested was to include smaller tablets instead of asking the patients or their carers to break larger tablets. 2. Consolidated Guidelines on the Use of Antiretroviral Drugs for Treating and Preventing HIV Infection. WHO, Geneva (Switzerland), IAS-ILF Industry Roundtable on Paediatric ARVs 5

6 Paediatric ARV Procurement Working Group Martin Auton (Global Fund, Switzerland), who is coordinating the Paediatric ARV Procurement Working Group (PAPWG) spoke next, briefly discussing challenges and solutions to paediatric ARV procurement and supply. He mentioned that the paediatric ARV market is particularly challenging as it is relatively small and highly fragmented with low-volume orders leading to long and variable lead times, contributing to a higher risk of stock outs. In addition to advocating for the use of the IATT Optimized List of Paediatric ARV Formulations, the PAPWG and its subset of members forming the Procurement Consortium coordinate procurement, through collaboration between funders (Global Fund, PEPFAR, UNITAID, USAID) and procurers (CHAI, MSF, PFSCM, SCMS, UNICEF), to place orders in a synchronized manner, and act on sub-batch-order issues, optimizing the supply chain. As of 2013, 64 countries used the Procurement Consortium (see Figure 2). Advocacy of the PAPWG also includes working with countries to join or align with the mechanism s coordination practices and ordering timelines for improved access to affordable high-quality ARVs in line with guidelines and guidance. One of the next steps is to start dialogue with large-volume countries (e.g., Kenya, Ethiopia, South Africa) to explore mutually beneficial synergies, including, for example, the ordering timelines of the Procurement Consortium. Overview of the Paediatric ARV Drug Optimization meeting Martina Penazzato gave an overview of the outcomes of the recent Paediatric ARV Drug Optimization (PADO) conference held in Dakar, Senegal (meeting conclusions reported online). She presented projections that were discussed at PADO, which show that at least until 2020, close to 2 million children will still be living with HIV, with slightly less than 1.5 million in need of antiretroviral therapy (ART) based on 2013 WHO guideline criteria. There is a real need for prioritizing formulations in the medium and long terms as a measure to facilitate procurement, prevent stock-outs and stabilize the market. Such an approach will help industry forecasting the demand and planning its future investments. The IATT Optimized List of Paediatric ARV Formulations serves this role. Another challenge concerns drug approval and in-country licensing. Several approaches exist to streamline these processes, including fast-tracking mechanisms, initiatives to harmonize regulatory approval between countries, and use of the same weight bands by all regulators. Patent sharing is also an approach to increase availability of paediatric drugs. In terms of funding, it is important to ensure mechanisms for funding in the context of a slowly diminishing market, while guiding industry with accurate forecasts for demand of paediatric ARVs. Lists of formulations to be developed as a priority, as well as several key research questions, were presented. A technical update based on the PADO conference will be published along with a supplement to the WHO 2013 guidelines. 6 IAS-ILF Industry Roundtable on Paediatric ARVs

7 Figure 2 African countries using the PAPWG Procurement Consortium MAURITANIA MALI NIGER EGYPT CHAI SCMS (Supply Chain Management System) UNICEF VPP (Voluntary Pooled Procurement Mechanism) Multiple mechanisms GUINEA-BISSAU GUINEA LIBERIA CÔTE D'IVOIRE BURKINA FASO TOGO GHANA NIGERIA CAMEROON CONGO ANGOLA C.A.R. DEMOCRATIC REPUBLIC OF THE CONGO ZAMBIA KENYA TANZANIA SOMALIA UGANDA BURUNDI MALAWI ZIMBABWE MOZAMBIQUE Figure 2. African countries using the PAPWG Procurement Consortium with list of funders (Global Fund, PEPFAR, UNITAID, USAID), procurers (CHAI, MSF, PFSCM, SCMS, UNICEF) and observers (DNDi, IAS, WHO). Source: Martin Auton, IAS-ILF Industry Roundtable on Paediatric ARVs, Geneva (Switzerland), 2013 SWAZILAND Funders Procurers Observers IAS-ILF Industry Roundtable on Paediatric ARVs 7

8 Roundtable discussion on creative solutions to overcome barriers to development and delivery of optimal paediatric ARV formulations SCIEN 8 Shaffiq Essajee opened the roundtable discussion by highlighting some of the issues faced by industry in the development of paediatric ARVs. The discussion then focused on the key challenges and potential solutions at each of five steps along the paediatric ARV development continuum: A. Research and development B. Development of normative guidelines and guidance on appropriate formulations and, if needed, FDC ratios C. Regulatory approval and commercial production D. Reliable forecasting and funding to stabilize SCIENCE the market E. Post-marketing surveillance IAS-ILF Industry Roundtable on Paediatric ARVs A. Research and development Investment in research is necessary for development of new ARVs and to determine product safety and efficacy of current and new ARVs into established paediatric indications. The roundtable identified two key issues that manufacturers face in paediatric ARV drug research and development: the technical challenges of developing child-friendly formulations; and the difficulty of recruiting children under 12 years of age into clinical trials. A Paediatric Investigation Plan (PIP) is mandated by regulators at the time of a new drug submission, but setting up clinical trials using existing networks is challenging. While there is a large unmet need for ART among children, identifying treatment-naive children to enrol into a safety trial or convincing existing patients (and their parents) to switch to a trial drug is a problem. The resulting slow pace of enrolment contributes to the lengthy time for paediatric approvals. What is needed is better coordination among research stakeholders or establishment of a dedicated research agency that specifically exists to assess new ARVs in children (as opposed to seeking to address other competing clinical and scientific research priorities). CO CON SHIP SCIENCE ICY CONFERENCES DVOCAC POL

9 B. ART guidelines and formulation guidance One major issue is how to include industry before guidelines are developed so guidelines do not come as a surprise to industry. The recommendation of drugs originating from different companies to be combined in a FDC, among others, is a challenge that would be better addressed at the development stage and not after regulatory approval. PIPs for the FDA consider children under two years in a separate category, whereas in the latest ART guidelines, WHO draws the line at three years of age. If all of these differences were harmonized across all disease areas (e.g., including TB) and by all agencies (e.g., including WHO PQ, FDA and EMA) there could be one universal approach to direct the development and utilization of paediatric dugs. This could greatly streamline the process and potentially achieve faster development and approval of products and faster uptake once those products are approved and available. CIE Another area where things could be improved concerns consultation between industry and WHO. Often, WHO guidelines include recommendations on formulations without specifically consulting industry about its own experience, and this can result in formulation guidance that is impractical or unfeasible. Although WHO has clear rules that some processes cannot involve industry stakeholders, there are some areas where industry can be consulted. For example, industry cannot be involved in development of normative guidelines, i.e., what ART regimens should be used, but it would be appropriate to consult with industry on the specifics of formulation and/or FDC guidance. C. Regulatory approval and commercial production One important issue that was discussed relates to the apparent disconnect between what some SRAs (e.g., the US Food and Drug Administration [FDA]) request for product specifications compared with the specifications that are deemed most useful for RLS according to WHO and the IATT. Using the same weight bands across all formulations is another area that would benefit from harmonization of WHO PQ, FDA and the European Medicines Agency (EMA) (as well as any other SRA) requirements. As one participant expressed, the particular definitions and weight bands are not that important; what is important is that all regulatory authorities follow the same weight bands, and that these are used from product development to delivery. Often age groups and weight bands submitted to regulators don t align with WHO weight bands or age groups. For example, in PIPs submitted to the FDA, adolescents are defined as being years old, whereas WHO defines adolescents as 10 and older (i.e., up to 19 years). BERSH CON ENCE AD Using orphan disease clauses to short cut (or fast track) regulatory approval for paediatric ARVs could be a potential approach, but such issues as the small but persistent paediatric HIV population even in high-income countries (where 1-2% vertical transmission rates are observed despite effective use of ARVs for prevention of transmission) would prevent this solution from being useful and might also have a detrimental impact on the quality of delivered drugs. Several participants noted some differences between what generic and originator manufacturers are required to provide to regulators in terms of data (e.g., clinical trials versus bioequivalence data) for product submission. For example, the FDA approves both a product and its dosage and requires submission of pharmacokinetics (PK) data in support of the dosing table. WHO PQ of generic products is based on bioequivalence, and the dosage table may be extrapolated from literature searches and simple mathematical models and does not necessarily require clinical trials of the new combination product. Even though PK modelling is useful to predict exposure (DNDi published a report on this topic: link), more transparency seems necessary. A concern raised by stakeholders centred on the long delays between ARV approval for adults and for children, especially the youngest. Although the logic of gradually going down in weight bands holds in terms of safety considerations, it is also known that younger children clear ARVs more rapidly and in fact tolerate them better than adults. Discussion focused on ways to make the approval process easier, for example, by changing the approach to study recruitment so that enrolment of age groups can happen in parallel once a basic safety threshold has been met. An alternative approach might be to include adolescents in the adult protocol and then have just children younger than 12 years in the PIP to help speed up enrolment by reducing the number of weight bands in the PIP. CO PO HIP CONFERENCES MBERSHVOCA OCACY PO IAS-ILF Industry Roundtable on Paediatric ARVs 9 NFERENC

10 D. Forecasting and funding The issue of costs was brought to the discussion several times. While everyone agreed that research and development of a drug is a lengthy and costly process, originators mentioned that costs are currently not an issue for them since the issue of cost is far outweighed by other more limiting issues related to regulatory approval and cohort recruitment. Nevertheless, the importance of not pushing industry away from capital interest was highlighted as this is how most generic (and other) companies can eventually get involved in an area. In other words, it should still be possible for companies involved in the development and commercialization of these products to make profits. For academia and small companies, a lack of incentives is also perceived. Although full funding for development of formulations is probably not viable, it could be possible to identify the minimum requirements needed for reproducing the necessary parts of the successful DNDi/Cipla/UNITAID model. Indeed, this model for the development of two 4-in-1 combinations (containing, respectively, LPV/r, AZT and 3TC, and LPV/r, ABC and 3TC) was described as a good example of surpassing formulation development finance issues in order to address a very specific task. Approaches to minimize market fragmentation through competition should be envisioned. There would probably be room for two or three suppliers per formulation and this is an issue that could be discussed within the PAPWG. Although procurement agencies can certainly catalyse this kind of approach, manufacturers should also proactively discuss these issues, maybe even signing non-competition clauses. In fact, these issues should be discussed at an earlier stage. Regulatory approval requirements could also have a high impact on formulation development costs, with development of formulations and combinations and subsequent approval based solely on PK data being possible at a reasonable cost, potentially below US$1 million. One way to incentivize development may be for procurers to commit to buy certain volumes in advance. The current situation is the contrary, where manufacturers commit to develop and produce formulations without any guarantee that procurement of their product will be done. The imperative of profitability and the volume required to recover investment impacts on finances and is a real challenge for industry when making decisions to invest in development of specific formulations; this is also often tied to dosing guidelines, which change in time. Indeed, another aspect raised is the sustainability of guidelines in relation to long times for development, sometimes leading to mismatches and even to some products becoming useless before getting to the market. WHO guidelines are updated every two or three years and the IATT Optimized List of Paediatric ARV Formulations is reviewed more frequently (i.e., approximately every six months), but really only changes if a new or improved product comes to market based on predefined criteria that are now publicly available. E. Post-marketing surveillance One aspect raised during the discussion was the need for informed decisions about quality and price, with a shift from countries simply going for lower prices and, instead, to also assess quality of products and formulations (user friendliness, heat stability, palatability, etc.). Post-marketing surveillance is important in these aspects to inform countries and policy makers about real-life advantages and issues related to individual regimens and formulations. MEMB SCIE POLI 10 ADVOC MEMB SCIENCE ICY CON IAS-ILF Industry Roundtable on Paediatric ARVs SC ACY POLICY EMBERSHIP NCES CO MEM POLICY CONFERENCES CON CIENCE

11 Closing remarks This first IAS-ILF Industry Roundtable on Paediatric ARVs ( Paediatric antiretrovirals: The barriers to and solutions for improved access to optimal drugs in resource-limited settings ) touched on different aspects and clearly identified regulatory approval as an area where improvements are both necessary and possible. In particular, there is an urgent need to reach harmonization between different regulatory processes in terms of data required for approval, as well as definitions of weight bands and age groups, making sure information is available for industry during development phases and before guidelines and guidance are made. There is a need for better dialogue, coordination and harmonization to address the challenges related to treatment of paediatric populations. More opportunities for discussion are needed and should aim at promoting exchanges between industry and regulatory agencies, such as WHO PQ, FDA and the EMA, and at working together to accelerate strategic and effective investments in paediatric ARVs. Paediatric ARVs are of crucial importance in our progression towards an AIDS-free generation. Eventually, these efforts will allow for an increase in the number of children in resourcelimited settings on ART. NCE C MEMBERSADVOCA POLICY M CONFEREN VOCACY CONFE S SCIE Y CONFE MEMBER DVOCA PO IAS-ILF Industry Roundtable on Paediatric ARVs 11 SCIENC

12 Appendix 1: Agenda Paediatric antiretrovirals: The barriers to and solutions for improved access to optimal drugs in resource-limited settings Roundtable organized by the International AIDS Society-Industry Liaison Forum (IAS-ILF) Room Paris-Madrid, InterContinental Hotel 7-9 Chemin du Petit Saconnex / 1209 Geneva / Switzerland Wednesday, 27 November, 09:00 13:00 CET 09:00 09:30 Welcome and roundtable introduction Co-chairs: Shirin Heidari (IAS) and Martina Penazzato (WHO) 09:30 09:40 New paediatric treatment recommendations Martina Penazzato (WHO) 09:40 09:45 Q & A 09:45 09:55 IATT optimal paediatric formulary Marianne Gauval (CHAI) 09:55 10:00 Q & A 10:00 10:10 Paediatric ARV Procurement Working Group (PAPWG) Martin Auton (Global Fund) 10:10 10:15 Q & A 10:15 10:25 Overview of the Paediatric ARV Optimization Meeting Martina Penazzato (WHO) 10:25 10:30 Q & A 10:30 11:00 Break 11:00 12:50 Discussion on creative solutions to overcome barriers to development and delivery of optimal paediatric ARV formulations What are the bottlenecks with paediatric ARVs? What are some solutions to these bottlenecks? Facilitator: Shaffiq Essajee (CHAI) 12:50 13:00 Summary and closing Co-chairs: Shirin Heidari (IAS) and Martina Penazzato (WHO) 12 IAS-ILF Industry Roundtable on Paediatric ARVs

13 Appendix 2: List of participants List of industry participants Affiliation AbbVie Aurobindo Pharma Cipla Name Josh Mugo Umesh Shirsavkar Rahul Lande Gilead Sciences Amadou Diagne Gilead Sciences Jim Rooney Gilead Sciences Sean Bennett Hetero Drugs Hetero Drugs Hetero Drugs Janssen Merck Mylan Laboratories Quality Chemical Industries Namrata Vyas Prashant Sisodia Tarang Verma Luc Denys Isabelle Girault Arvind Kanda Michael Maynard Ranbaxy Laboratories Ravi Mehta Ranbaxy Laboratories Sumit Misra Ranbaxy Laboratories Taher Karampurwala Strides Arcolab Strides Arcolab Teva Pharmaceutical Industries ViiV Healthcare ViiV Healthcare ViiV Healthcare Rajesh Maheswaran Vinod Nair Inon Schenker Helen McDowell Katy Hayward Scott Purdon MEMB Joined the meeting through WebEx SCIE POL ADVOC MEMBE SCIENCE LICY CON SC ACY POLICY continued on next page» EMBERSHIP ENCES CO MEM POLICY CONFERENCES CON IAS-ILF Industry Roundtable on Paediatric ARVs 13 CIENCE

14 C» continued from previous page List of non-industry participants Affiliation Clinton Health Access Initiative Clinton Health Access Initiative Clinton Health Access Initiative Drugs for Neglected Diseases initiative Drugs for Neglected Diseases initiative Elizabeth Glaser Pediatric AIDS Foundation Global Fund Global Fund International AIDS Society International AIDS Society International AIDS Society International AIDS Society International AIDS Society Medicines Patent Pool Medicines Patent Pool Name Marianne Gauval Shaffiq Essajee Vadim Shepel Janice Lee Marc Lallemant Philip O Brien Dania Ghostine Martin Auton Bernard Kadasia Manoj Kurian Marissa Vicari Sébastien Morin Shirin Heidari Fernando Pascual Sandeep Juneja O R Médecins Sans Frontières Arax Bozadjian Médecins Sans Frontières Clara Van Gulik Partnership for Supply Chain Management Partnership for Supply Chain Management UNAIDS David Jamieson Wesley Kreft Carlos Passarelli UNICEF Atieno Ojoo UNICEF Gitanjali Sakhuja UNITAID World Health Organization World Health Organization World Health Organization World Health Organization World Health Organization Carmen Perez-Casas Boniface Dongmo Nguimfack Martina Penazzato Meg Doherty Raúl Gonzalez Montero Vincent Habiyambere Joined the meeting through WebEx 14 IAS-ILF Industry Roundtable on Paediatric ARVs

15 SCIENCE CONFERENCES POL IENCE SCIENCE CONFERENCES SCIENCE CONFE POLICY SCIENCE LICYCONFERENCES CONF SCIENCE POLICY CON ENCES POLICY CONFERENCES CONFERENCES MEMBER RSHIP

16 IAS-ILF Mission The mission of the Industry Liaison Forum is to accelerate scientifically promising, ethical HIV research in resource-limited countries, with a particular focus on the role and responsibilities of industry, namely pharmaceutical and diagnostic companies, as sponsors and supporters of research. The IAS-ILF fulfills its mission by: identifying research gaps; promoting targeted research; identifying challenges and best practices; analyzing available data and evidence; disseminating information; consulting and convening stakeholders; providing industry expertise; and supporting capacity building for research and health delivery. International AIDS Society Avenue de France 23 CH-1202 Geneva Switzerland Tel: Fax: ilf@iasociety.org