Product Development Partnership 2014
- 1. Product Development Partnership for Non-communicable Disease Dr. Chris Hentschel (London) Dr. Isil Guney (Istanbul) Spring 2014
- 2. Contents I: Product Development Partnerships (PDP) in Biomedical Research II: Proposed PDP’s R&D Focus: Non-communicable Disease III: Vision & Mission, Targets IV: Benefits of a PDP to Turkey & Stakeholders
- 3. Product Development Partnership (PDP) in Biomedical Research Part I
- 4. Product Development Partnership (PDP) in Biomedical Research A PDP is a hosted international R&D initiative with a public good mission that also supports the commercial needs of its private sector partners It leverages public and philanthropic financial resources with those contributed by academia and industry partners It focuses on translational and clinical research and commercialization, with some basic research It allows for cost minimization by virtualization, by tapping partner R&D resources
- 5. Establishment and Growth of a PDP PDP is normally established via a legal body (such as a Foundation) with US 501c3 equivalency to enable US philanthropic and public funding Host government or industry establishes the legal entity and contributes seed funding Once established, PDP operates as an independent entity with independent expert scientific advisory board; builds research partnerships, develops R&D portfolio and product pipeline, raises money from various funding segments A PDP can be virtual (all research conducted at partner sites) or semi-virtual (has a dedicated facility for some research modules and conducts other research at partner sites)
- 6. Model Proposed for Turkey Semi-virtual: Operate out of its base in Turkey, with a network of partner institutions from within and outside of Turkey Ideal for Turkey and partners -> facilitates talent import, which Turkey needs -> facilitates access to technical knowhow, which Turkey needs -> partners benefit from Turkish government funds and incentives Win-win model for all partners: Rights to products developed are shared, with industry reserving commercial rights and governments distributing for public good. Excellent for marketing and government relations.
- 7. R&D Focus on „Common Goods‟ The Product Development Partnership will serve the interests of both the public and private sectors. WHO (UN) Governments Academia Public Goods Turkey R&D Campus Common Goods (Shared Values) Private Sector Bio Pharma and service Private Goods
- 8. Growing investment in PDPs Value doubled by in-kind donations from industry 387 309 223 189 127 84 49 29124 0 100 200 300 400 500 USDmillion # of PDPs . Avge Spent/PDP 2 4 6 7 7 11 12 13 14 14 $2M $3M $5M $7M $12M $12M $16M $17M $22M $28M 14 $33M $3M $8M $13M $19M $27M $31M $51M $48M $56MMedicines for Malaria Venture: 467 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008
- 9. PDP Example: Medicines for Malaria Venture (MMV) Established in 1999 by Swiss Government, with $3 million initial funding Within 10 years MMV raised over $500 million of funds, and had over 100 partner sites MMV has registered 3 products to date and currently has over a dozen products in its pipeline Virtual model of operation
- 10. PDP Singe Private Partner Example: Tres Cantos Open Lab Foundation (OLF) Established in 2010 by GlaxoSmithKline, with £5 million initial funding Has an independent Governing Board and currently over a dozen research partners 6 active projects, 10 completed projects Semi-virtual model of operation – facility integrated into GSK labs in Tres Cantos, Spain, with over 100 staff
- 11. Current PDP Focus: Infectious/Neglected Tropical Diseases HIV/AIDS TB Malaria NTD Diarrhea Respiratory Diagnostics Microbicides & prevention Therapeutic product Vaccine Vaccine Development ProgramHuman hookworm vaccine initiative
- 12. Central Role of PDPs in emerging R&D landscape Independent PDP-driven R&D Bringing partners together over the last decade… World Bank Rockefeller Bill & Melinda Gates Wellcome Trust USAID DFID PEPFAR PMI Grand Challenges CIDA Global Fund GAVI Doris Duke Clinton Foundation Carter Center Basic Research Organizations TB medicines2000 TB treatments1998 Hookworm vaccines2000 Rotavirus vaccines2003 Pneumonia vaccines2003 Malaria, rotavirus, JE, pn eumococcal & meningitis vaccines 1977 Malaria vaccines1999 Malaria medicines2000 Dengue vaccines2003 VL, malaria, diarrhoea & STH medicines 2000 HAT, VL, Chagas & malaria medicines 2003 TB vaccines2003 FocusSincePDP Funders Product Development Partnerships R&D Execution (Funders, PDPs, Basic Research Organizations & Industry Players - illustrative only - not comprehensive) Industry players
- 13. Industry is Committing Resources through Dedicated R&D Centres through multiple mechanisms… Industry Dedicated DDW R&D Centers Partnerships (Current industry involvement & partnerships - illustrative only - not comprehensive) Independent Efforts
- 14. 14 R&D Industry Generic Industry Manufacture R&D Industry Product Development Partnerships (PDPs) Research & Development Governments Industry Foundations Access (incl. Delivery) Academia Government Agencies R&D Industry Basic Research … to benefit patients and promote economic development Biomedical R&D in emerging economies: a Combined Effort…
- 15. Proposed PDP‟s R&D Focus: Non-communicable Disease Part II
- 16. 2006 Global Causes of Death Chronic Diseases/NCDs Heart disease 30.2% Cancer 15.7% Diabetes 1.9% Other chronic diseases 15.7% Infectious Diseases HIV/AIDS 4.9% Tuberculosis 2.4% Malaria 1.5% Other Infectious Diseases 20.9% Injuries 9.3% Total Deaths 58,000,000 2011 % Deaths: % Cost: Source WHO and NCD Alliance
- 17. Non-communicable and Chronic Disease NCDs are the leading causes of death worldwide Incidence of NCDs is rapidly increasing In 1990, 40% of deaths in developing countries were from NCDs In 2001, 80% of deaths in developing countries were from NCDs The most prevalent NCDs kill 3 out of 5 people worldwide Cardiovascular disease; cancer; chronic lung disease; diabetes PDPs can have a strong impact in combatting NCDs Borrowing experience from infectious disease PDPs and the knowhow of developed countries
- 18. Congo, Dem. Rep. 2008 China 2008 Turkey 2008 Japan 2008 Norway 2008 400 1,000 2,000 4,000 10,000 20,000 40,000 100,000 Income per person (GDP/capita, PPP$ inflation-adjusted) 2 200 100 40 20 10 6 Infantmortality(rateper1,000births) 60 4 A clear gap in NCD-related infant mortality
- 19. Research Focus NCDs and Chronic Diseases Maternal, Neonatal, Pediatric Disease Cardiovascular Disease, Cancer, Diabetes, Respiratory Disease Neuroscience; Cognitive and Behavioral Science
- 20. NCD Innovation focus of PDP will encompass a wide spectrum of technologies and products NCD Innovation Gap Diagnostics and Devices Drugs NCEs and Polypills Biologics Biosimilars Vaccines
- 21. An opportunity to respond & gain global visibility September 19, 2001: UN High Level Meeting on Non-Communicable Diseases Attended by Turkish Ministry of Health Delegation • 2012: work with WHO and all stakeholders to set targets • 2013: review of the MDGs; integrate NCDs • 2014: UN review of progress UN Resolution 64/265
- 22. Global Political and Philantropic Momentum “The UN Summit on NCDs in September in New York is our chance to broker an international commitment that puts non-communicable diseases high on the development agenda, where they belong” Ban Ki Moon, Secretary-General, United Nations World Economic Forum, Davos 2011 “We need a whole of government and a whole of society response” Margaret Chan, Director General, WHO If you are going to work, work on something important William Foege, Bill and Melinda Gates Foundation
- 23. NCDs on the Global Agenda UN HIGH LEVEL MEETING ON NCDs, September 2011 Noteworthy The second high level meeting of the UN on health, held September 2011 The first in 2001 led to Global Fund for AIDS, TB and malaria Participation 130 countries; 200 civil society representatives; 40 side meetings. $60m committed by Russia, $3.9m by Australia Results New initiatives and raised awareness Objective 25 by 25 -> Reducing the global incidence of NCDs by 25% by 2025
- 24. Vision & Mission, Targets Part III
- 25. Vision & Mission To reduce the growing burden of chronic and non-communicable paediatric and adult disease through significant innovation by science-based partnerships; To renew and sustain the supply of affordable public medicines and diagnostics; To advance science in Turkey and promote its transition into a knowledge-based economy.
- 26. R&D Targets To register one new product every five years once fully operational To pursue the development and registration of new products through partnerships and to ensure the commercialization of these products at affordable prices Where appropriate and possible, to offset future portfolio costs through royalty income To pursue in parallel, where possible, basic and fundamental research
- 27. Benefits of a PDP to Turkey & Stakeholders Part IV
- 28. Reverse Brain Drain and Promote Brain Gain Brain Drain Large number of successful Turkish PhDs opting to work abroad Thousands of Turkish students leave Turkey to receive education; many do not return TUBITAK providing grants to researchers who come back National Science & Technology Human Resources Strategy & Action Plan (2011-2016) Increase the number of personnel in Human Resources in Science and Technology (HRST) and improving the distribution of HRST across sectors Develop the research culture, the capabilities and experiences of researchers Improve the work environment of the HRST Increase the mobility of researchers Develop the recruitment capacity of R&D personnel
- 29. PDP – Benefits to Turkey Becoming a regional leader in responding to a global health crisis Turkish Ministry of Health has committed to combat NCDs in UN High Level Meeting in 2011 High technology and innovation-based commercial and economic growth Registering healthcare products; Brain gain; Job creation; IP generation; Commercial spinoffs Supporting cutting-edge science education University co-op programs, fellowship programs Aligned with 2023 targets Becoming one of 10 largest world economies; Becoming a leading country in research and development
- 30. PDP – Benefits to Foreign Pharma and Biotech Local R&D partner of international standards Committed to ICH guidelines Bridge to emerging biomedical market in emerging economy Cost effective research; Educated, young, dynamic workforce; Compelling R&D incentives; Istanbul projected to be 14th greatest contributor to global GDP by 2025 Strengthened corporate position in Turkey Encourage drug price stability; Opportunity for R&D partnerships and government offset agreements
- 31. PDP – Benefits to Turkish Academic Institutions Access to local life sciences R&D hub Access to skilled workforce and research tools; Leverage for partnerships; Project development support Joint research project & funding opportunities Access to a global life sciences network Commercial Spinoff Support System Incubation and entrepreneurship support system; Commercialization mentorship Student Training Programs Training at affiliate institutes; Co-op programs
- 32. PDP – Benefits to Foreign NGOs & Developmental Agencies Addressing a global health crisis Non-communicable and chronic diseases, particularly pediatric and maternal disease Transferring scientific technology and knowhow to an emerging economy Matching the shifting global economic balance; Advancing science and innovation in Turkey Promoting development in the Middle East Supporting a knowledge-based, sustainable economy, and societal prosperity Building collaborative bridges Research partnerships between East and West; A united front against NCDs