A map of the alternative biomedical R&D landscape ACKNOWLEDGEMENTS We would like to acknowledge all the engaged and active student leaders in UAEM who have supported, participated and activated around the critical global health issue of alternative biomedical R&D, the role of universities and ensuring access to medicines for all. Thanks as well as to the staff and board of UAEM. Special thanks to Els Torreele PhD, Director of the Open Society Public Health Program’s Access to Essential Medicines Initiative, for her advice, support and encouragement. And thanks to the team at signals.ca for providing us with their design talent and enthusiastically agreeing to complete this project in record time! AUTHOR BIOGRAPHIES Rachel Kiddell-Monroe LL.M is a humanitarian, a lawyer and an activist. She is Special Adviser to Universities Allied for Essential Medicines (UAEM) and served 6 years as President of the UAEM board of directors. She is also a member of the International Board of directors for Médecins Sans Frontières/Doctors Without Borders (MSF). She lives in Montreal and has worked in south east Asia with human rights and environmental grassroots activists as well as with MSF in Djibouti, Rwanda, the Democratic Republic of Congo and throughout Latin America. Rachel has also served as the Canadian director of MSF’s Access to Medicines Campaign. Rachel sits on the board of UAEM Europe, on the Advisory Council of UAEM Brazil and the board of the Young Professionals for Chronic Disease Network. Rachel is a Professor of Practice at McGill University, lectures on international development and is part of the Adult Clinical Ethics Committee at McGill University Health Centres. She holds a Masters in Law and Bioethics from McGill. Alexandra Greenberg is a second year candidate for a Masters in International Health at the Johns Hopkins Bloomberg School of Public Health and is living in Lima, Peru conducting qualitative research on asthma care and treatment adherence as well as dengue vaccine introduction. She has been on the North American student coordinating committee of UAEM since September 2013 and worked as UAEM’s summer intern that same year. She led the North American Report Card project and was the researcher for UAEM’s map of alternative R&D initiatives. She has been the chapter president of UAEM at Johns Hopkins since September 2014. Merith Basey MSC has over a decade of experience in global public health, advocacy and project management. Following her postgraduate studies on Latin America, the UK native spent many years leading AYUDA, where she was responsible for fostering new partnerships, growing youth-led programs and strengthening local capacity in type 1 diabetes communities across Latin America and the Caribbean. After a Master’s degree at the London School of Hygiene and Tropical Medicine, she worked with the World AIDS Campaign in Amsterdam and went on to co-found the 100 Campaign. She is based in Washington, DC. TABLE OF CONTENTS Important User Notes ...................................................................... 1 Rationale......................................................................................... 3 Methodology ................................................................................... 5 Limitations of the Mapping ............................................................. 10 Executive Summary ....................................................................... 11 Mapping A Existing Initiatives .................................................................. 18 1. Drug discovery and data-sharing platforms......................... 19 2. Drug discovery incentives a. Prizes ........................................................................... 35 b. Tax subsidy/priority review incentives ............................. 39 c. Innovation fund/platform ............................................... 49 d. Venture philanthropy for drug discovery and development .......................................................... 60 3. Drug Licensing: Drug patent pools and related initiatives .... 65 4. Drug Advancement: Larger PPPs or organizations that house multiple innovative R&D initiatives ........................... 70 5. Drug development a. Disease-specific Product Development Partnerships challenging current R&D system ................................... 91 b. Product Development Partnerships working across diseases ..................................................................... 102 B Proposed Initiatives ............................................................. 118 1. Drug discovery and data-sharing platforms....................... 122 2. Drug discovery incentives ................................................ 125 a. Prizes ......................................................................... 125 b. Tax subsidy/priority review vouchers ............................ 130 c. Innovation fund/platform ............................................. 134 3. Drug Licensing: Drug patent pools and related initiatives .. 148 4. Drug Development a. Disease-specific Product Development Partnerships challenging current R&D system ................................ 149 b. Product Development Partnerships working across diseases ..................................................................... 152 5. Initiatives addressing 4 or more innovative R&D mechanisms ........................................... 154 Acronyms .................................................................................... 165 Glossary ...................................................................................... 168 Bibliography ................................................................................ 172 Appendix 1 ................................................................................. 194 RE:ROUTE • 1 TABLE OF CONTENTS 01 IMPORTANT USER NOTES We have an historic opportunity to take the long-running debate on transforming biomedical R&D to a new level. Today, millions of people globally fall between the ever-widening cracks in access to medicines. At the same time, outrage in rich countries over drug prices charged by pharmaceutical companies grows and our publicly funded healthcare budgets balloon to bursting point. Therefore, despite the limits to this mapping, which we readily acknowledge, we have decided to launch it now because we believe this is needed to support and inform the public and civil society debates taking place worldwide. Readers and users of this mapping should see this In the spirit of openness, transparency and mapping as the start of a process and not the end. collaboration, users of the mapping are invited to This mapping is not intended to be a comprehensive take an active part in developing this document review nor does it seek to make judgments on the with us so that it can evolve over time and remain merits of initiatives included. Rather it is intended current. We see this project as a continuously to give an overview of what is happening today in evolving contribution to the important dynamic response to the gaps left by the current biomedical gaining traction in the alternative biomedical R&D model. In this sense the initiatives included research and development (R&D) space. are referred to as alternative since they respond to a need in a different way from the current We invite and welcome your comments and biomedical R&D system and are based on different criticisms. As we launch this document, we accept goals. This mapping provides a short description that it is imperfect. Therefore, while maintaining of each initiative’s goals and principles. Beyond our methodology and criteria, we are expecting being a simple catalogue of initiatives, however, we to be challenged on the way we have categorized have sought to provide a new way to think and talk initiatives and for having missed information. about the different approaches aiming to promote We only ask that these challenges be based on and incentivize needs-driven R&D. We hope this information available in the public domain. mapping can provide a platform for discussion, collaboration and exchange to learn more about Any errors and/or misrepresentations are the sole what each of these initiatives have achieved, the responsibility of the authors. successes, the challenges and any lessons learnt. “We have known for years that we need to change how biomedical R&D is done. This report maps out 81 ways change is being made. While they may not set out a whole new system, they do represent important building blocks of a new approach to biomedical R&D where the needs of the people are put first.” Rachel Kiddell-Monroe, LL.M, Special Adviser, UAEM. RE:ROUTE • 3 TABLE OF CONTENTS 02 RATIONALE The inertia of the current R&D system in the face of recent, ongoing, and emerging global health crises is all too evident. The growing worldwide threat of antimicrobial innovation principles. On top of that, the landscape is resistance; the ongoing challenge of neglected changing so rapidly that the reports or articles that do diseases; and the tragic impacts of the 2014- exist are already out of date. 2015 Ebola epidemic all highlight the urgent need to ensure that affordable and appropriate In order to address this gap in the literature, medicines are available for all. These public health UAEM has created this mapping of alternative emergencies demonstrate yet again that we need R&D initiatives with support from the Open Society new and ethical ways to carry out biomedical Foundations. Based on a first review of over