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
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
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…
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
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
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
