Product Development Partnership 2014

Product Development Partnership for Non-communicable Disease

Dr. Chris Hentschel (London)

Dr. Isil Guney (Istanbul)

Spring 2014

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

Product Development Partnership (PDP)

in Biomedical ResearchPart I

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

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)

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.

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

TurkeyR&D

Campus

Common Goods(Shared Values)

Private SectorBio Pharma and service

Private Goods

Growing investment in PDPs

Value doubled by in-kind donations from industry

387

309

223189

12784

4929124

0

100

200

300

400

500

USD

mill

ion

# 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

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

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

Current PDP Focus: Infectious/Neglected Tropical Diseases

HIV/AIDS TB Malaria NTD Diarrhea Respiratory

Diagnostics

Microbicides &prevention

Therapeuticproduct

VaccineVaccine

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, pneumococcal & meningitis vaccines

1977

Malaria vaccines1999

Malaria medicines2000

Dengue vaccines2003

VL, malaria, diarrhoea& STH medicines2000

HAT, VL, Chagas & malaria medicines2003

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

R&D Industry

Generic Industry

Manufacture

R&D Industry

Product DevelopmentPartnerships (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…

Proposed PDP’s R&D Focus: Non-communicable DiseasePart II

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 Diseases20.9%

Injuries 9.3%

Total Deaths58,000,000

2011 % Deaths: % Cost:

Source WHO and NCD Alliance

Non-communicable and Chronic Disease

NCDs are the leading causes of death worldwide

Incidence of NCDs is rapidly increasingIn 1990, 40% of deaths in developing countries were from NCDsIn 2001, 80% of deaths in developing countries were from NCDs

The most prevalent NCDs kill 3 out of 5 people worldwideCardiovascular disease; cancer; chronic lung disease; diabetes

PDPs can have a strong impact in combatting NCDsBorrowing experience from infectious disease PDPs and the knowhow of developed countries

Congo, Dem. Rep. 2008

China 2008Turkey 2008

Japan 2008Norway 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

Infa

nt

mo

rtal

ity

(rat

e p

er 1

,000

bir

ths)

60

4

A clear gap in NCD-related infant mortality

Research Focus

NCDs and Chronic DiseasesMaternal, Neonatal, Pediatric DiseaseCardiovascular Disease, Cancer, Diabetes, Respiratory Disease

Neuroscience; Cognitive and Behavioral Science

NCD Innovation focus of PDP will encompass a wide spectrum of technologies and products

NCD Innovation

Gap

Diagnostics and Devices

DrugsNCEs andPolypills

BiologicsBiosimilarsVaccines

An opportunity to respond & gain global visibilitySeptember 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

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 NationsWorld 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

NCDs on the Global Agenda

UN HIGH LEVEL MEETING ON NCDs, September 2011

NoteworthyThe second high level meeting of the UN on health, held September 2011The first in 2001 led to Global Fund for AIDS, TB and malaria

Participation130 countries; 200 civil society representatives; 40 side meetings.$60m committed by Russia, $3.9m by Australia

ResultsNew initiatives and raised awareness

Objective25 by 25 -> Reducing the global incidence of NCDs by 25% by 2025

Vision & Mission, TargetsPart III

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.

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

Benefits of a PDP to Turkey & StakeholdersPart IV

Reverse Brain Drain and Promote Brain Gain

Brain DrainLarge number of successful Turkish PhDs opting to work abroadThousands of Turkish students leave Turkey to receive education; many do not returnTUBITAK 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 HRSTIncrease the mobility of researchersDevelop the recruitment capacity of R&D personnel

PDP – Benefits to Turkey

Becoming a regional leader in responding to a global health crisisTurkish 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 educationUniversity co-op programs, fellowship programs

Aligned with 2023 targetsBecoming one of 10 largest world economies; Becoming a leading country in research and development

PDP – Benefits to Foreign Pharma and Biotech

Local R&D partner of international standardsCommitted to ICH guidelines

Bridge to emerging biomedical market in emerging economyCost 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 TurkeyEncourage drug price stability; Opportunity for R&D partnerships and government offset agreements

PDP – Benefits to Turkish Academic Institutions

Access to local life sciences R&D hubAccess to skilled workforce and research tools; Leverage for partnerships; Project development support

Joint research project & funding opportunitiesAccess to a global life sciences network

Commercial Spinoff Support SystemIncubation and entrepreneurship support system; Commercialization mentorship

Student Training ProgramsTraining at affiliate institutes; Co-op programs

PDP – Benefits to Foreign NGOs & Developmental Agencies

Addressing a global health crisisNon-communicable and chronic diseases, particularly pediatric and maternal disease

Transferring scientific technology and knowhow to an emerging economyMatching the shifting global economic balance; Advancing science and innovation in Turkey

Promoting development in the Middle EastSupporting a knowledge-based, sustainable economy, and societal prosperity

Building collaborative bridgesResearch partnerships between East and West; A united front against NCDs