G-FINDER FACTSHEET AN EMERGING LEADER: GERMANY’S...

G-FINDER FACTSHEET

AN EMERGING LEADER: GERMANY’S ROLE IN NEGLECTEDAND POVERTY-RELATED DISEASE R&D

2013

1 G-FINDER FACTSHEET

INTRODUCTION

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Neglected and poverty-related diseasesi caused 6.4 million deaths and the loss of 371 million years of healthy and productive life worldwide in 2010.1 More than 1 billion people – one sixth of the world’s population – suffer from neglected or poverty-related diseases.2,3,ii Most of those affected live in low- and middle-income countries. In addition to the human toll, the economic cost of these neglected and poverty-related diseases is substantial. In Africa, for example, it is estimated that malaria will cause at least US$12 billion per year in direct SVZZLZ�HUK�ZPNUPÄJHU[S`�TVYL� PU� SVZ[�LJVUVTPJ�NYV^[O�4 Likewise, tuberculosis (TB) is estimated to cost the world’s poorest countries between $1 and $3 trillion US dollars over the next decade.5

Renewed efforts to respond to the economic and human devastation of neglected diseases have focused on improved access to existing products and research and development (R&D) of new technologies that can be game changers. Indeed, an effective vaccine to prevent TB, HIV/AIDS or malaria could halt the disease in its tracks.iii

Delivering on these goals requires global partnerships of ingenuity, investment and innovation. Germans are among the many scientists and funders who have already made significant contributions, and their investments have resulted in new technologies for neglected and poverty-related diseases already in action, with many more in the pipeline.

Germany is commit ted to R&D as a solut ion to overcoming global challenges, as manifest in the Strategy

for the Internationalisation of Science and Research in 2008.6 Germany is also committed to confronting the challenges facing global health in its recently released Global Health Strategy.7 In 2011, a new focus on research for neglected and poverty-related diseases was ushered in with the release of the funding concept paper: Research

Funding Concept: Neglected and Poverty-Related

Diseases.8 Taken together, these strategies form a strong policy platform from which Germany can take its place as a leader and collaborator in developing innovations to combat neglected and poverty-related diseases.

This report outlines the recent history of German public funding in neglected and poverty-related disease product development, and profiles the landscape of public funders and research institutes and their achievements to date.

INNOVATION IS NEEDED TO SOLVE GLOBAL HEALTH PROBLEMS

Neglected and poverty-related diseases are categorised as such because they dispropor t ionately af fect populations in low- and middle-income countries, there is a need for new pharmaceutical products to help fight the disease and there are insufficient commercial incentives to attract the pharmaceutical industry.iv

However, investment in R&D of new products in these diseases offers significant return for the global public good. Neglected and poverty-related disease products have a pivotal impact on the populations that need them the most. For example, in sub-Saharan Africa, 430 million people live in an area commonly known as the ‘meningitis belt’, and until recently, they lived in fear of a meningitis epidemic during the dry season.9 The onset of meningitis is swift and deadly, and one in ten people die within a few days of showing symptoms.10 Between 1999 and 2003, emergency vaccination was employed in the region as a response strategy, incurring costs of over €130m.11

Consequently, the World Health Organization (WHO) col laborated wi th the Program for Appropr iate Technology in Health to develop the Meningitis Vaccine Project, a Product Development Partnership (PDP) that was formed in 2001 to develop meningococcal conjugate vaccines that are appropriate for use in Africa.12 The collaboration was hugely successful and resulted in the registration of MenAfriVac in 2009, the first vaccine specifically developed for sub-Saharan Africa.13 From December 2010 to November 2012, over 58 million people were vaccinated against meningitis A.14 By the end of the 2010-2011 meningitis season, Burkina Faso, Mali and Niger reported no meningococcal A cases among the nearly 20 million people who received


one dose of MenAfriVac in 2010.15 The success of the vaccination program has continued in the last few years. In 2013, the World Health Organization noted that the number of cases of meningitis reported to date was the lowest recorded during the epidemic season of the last 10 years.9 Investment into products such as MenAfriVac WYV]PKLZ�H�ZPNUPÄJHU[�YL[\YU�HUK�OHZ�H�KYHTH[PJ� PTWHJ[�on the everyday lives of those most at risk in low- and middle-income countries.

ACTING GLOBALLY FOR HEALTH PROTECTION LOCALLY

Whi le neglected and pover t y- re lated d iseases disproportionately affect those in the low- and middle-income countries, they also affect those close to and at home. Neglected and poverty-related diseases such as TB, HIV/AIDS, Chagas’ disease, leishmaniasis and roundworm are prevalent in Europe, with TB and HIV/AIDS posing particular challenges in Germany and some of its neighbouring countries. There were over 4,000 new cases of TB in Germany, including 63 reported cases of multidrug resistant (MDR)-TB in 2012, with an estimated annual cost of €50m.16 In Eastern Europe the problem is much bigger, with TB causing 27,869 deaths and 1.3 million disability adjusted life years (DALYs) in 2010.1

In 2010, HIV/AIDS in Europe accounted for 82,010 deaths and 4 million DALYs.1 In Germany in 2011, 73,000 people were living with HIV/AIDS.17 In the same year, approximately 2,700 Germans contracted HIV, representing a decline from a peak in 2009. However, the number of people living with HIV/AIDS has risen.18

Every year the German healthcare system spends an average of €23,298 on each HIV/AIDS patient.19 As more people contract HIV, and there are less AIDS-related deaths due to available treatments, German healthcare expenses will increase too. R&D can play an important role in developing new technologies to prevent HIV [YHUZTPZZPVU�PU�[OL�ÄYZ[�PUZ[HUJL��

Frequent travel and high immigration rates20 increase the risk of introducing neglected and poverty-related diseases to Europe. This, coupled with the integrated nature of the European Union, means that no health issue is entirely reducible to one country or region. Chagas’ disease for example, was introduced into Spain through migration from Latin America, resulting in over 6,000 cases in Spain in 2003 and increasing prevalence throughout much of the European Union.21 Parasitic infections such as leishmaniasis are reported in Spain, Portugal, France, Italy and Greece, with 700 new cases occurring annually across Southern Europe.13 These infections could potentially spread to Germany, via travelling German citizens or tourists. The prevalence of roundworm, which affects up to 16% of children in Poland,22 and other soil and food based worm infections, represent new challenges and public health threats to the entire European community, Germany included.

Investment and collaborative global research on preventive vaccines, drugs and diagnostics for these diseases directly realises the f irst focal topic of Germany’s new Global Health Strategy. That is, to provide effective protection against cross-border threats to health.7

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G-FINDER investment / GDP (1/100,000)^

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GERMAN INVESTMENT IN AID AND NEGLECTED AND POVERTY-RELATED DISEASE R&D

Germany has the largest economy in Europe, and the fourth largest in the world. Germany also takes a leadership role in terms of Official Development Assistance (ODA), where over the last three years Germany has ranked second (in 2011) or third (in 2010 and 2012) in the world in terms of net contributions. However, in terms of ODA as a percentage of gross national income (GNI), Germany is in twelfth position, behind countries like Sweden, Norway, Denmark, The Netherlands and France.23 In 2012 German ODA was €10.2 billion,24 representing 0.38% of Germany’s GNI, well short of the 0.7% target set by the United Nations. The main portion of these funds goes to the Federal Ministry for Economic Cooperation and Development (BMZ) and is channelled through its implementing agencies, the KfW Development Bank and the Deutsche Gesellschaft für Internationale Zusammenarbeit (GIZ). Smaller portions of German ODA are spent via other ministries such as the German Federal -VYLPNU�6MÄJL��^OPSL�NSVIHS�OLHS[O�9 +�M\UKPUN�PZ�KPYLJ[LK�through the German Federal Ministry of Education and Research (BMBF).

Germany is now the fourth largest public investor in neglected and poverty-related disease R&D, contributing €47m in 2012, up from sixth position in 2011 in absolute numbers. However, when looking at Germany’s net

investment into neglected and poverty-related disease R&D in relation to the country’s gross domestic product (GDP) in 2012, Germany only ranks twelfth (see figure

1). Although Germany moved up six places compared to the previous year, it still falls behind its European counterparts Sweden, Ireland, Switzerland, Denmark, France and The Netherlands.

As a country that embraces shared responsibilities in, and support for, global health; and a country with a rich history of scientific innovation and current expertise, Germany has the potential to be a leader in the development of innovative tools to combat neglected and poverty-related diseases.

Figure 1. Public investment into neglected and poverty-related disease R&D by GDP (2012)

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In 2012, Germany was the fourth largest public investor in neglected and poverty-related disease R&D in absolute numbers – but Germany only ranked twelfth for net investment in relation to GDP.

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Over the last three years (2010-2012) a total of €123m was invested by German public organisations and industry into neglected and poverty-related disease R&D. In-text analysis here focuses on the three-year period

from 2010 to 2012 as survey participation in G-FINDER of German organisations significantly improved from 2010 onwards. The full dataset for the 2007-2012 period is included in the tables and graphs.

GERMANY’S NEGLECTED AND POVERTY-RELATED DISEASE R&D FUNDING

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Figure 2. Overall German public funding (2007-2012)^

Who are the key funders?

German public funders are the main players, contributing 89% (€109m) of German investment into neglected and poverty-related disease R&D over the three-year period, whilst industry provided 11% (€14m). There is virtually no philanthropic funding within Germany (€0.4m over the three-year period).

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Table 1. Top German public funders (2007-2012)^

The publicly funded neglected and poverty-related disease research landscape in Germany is shaped by three key organisations, and their respective funding structures and priorities. Between 2010 and 2012, the German Research Foundation (DFG), the German Federal Ministry of Education and Research (BMBF) and the German Federal Ministry of Health (BMG) together contributed 81% of total public German funding for neglected and poverty-related disease R&D in Germany. Examining trend data, we see an upward shift in funding with an increase from €31m in 2010 to €47m in 2012.v This is largely due to a €9m increase in funding from BMZ, a €6m increase in funding from BMBF and a €3m increase from BMG, which offset smaller decreases in funding from DFG (down €1.4m over the three-year period) and the Max Planck Society.

O D FG i s a n i n d e p e n d e n t r e s e a r c h f u n d in g organisation. Funding decisions are made by scient ists and fol low an invest igator-dr iven approach, funding German organisations only. In 2012 €2.7bn was invested overall, of which the largest portion (€493m) was allocated to research in medicine.25 However, only €12m (2%) went to neglected and poverty-related disease R&D. Prior

to 2012, DFG was the largest German funder of neglected and poverty-related disease R&D, and has historically dominated this funding landscape, contributing 33% (€37m) of funding between 2010 and 2012.

O BMBF allocates funding through a process of open JHSSZ�HUK�YL]PL �̂�^P[O�ÄUHS�KLJPZPVUZ�THKL�HJJVYKPUN�to the open call’s scientific or structural criteria. BMBF is committed to neglected and poverty-related disease R&D and in 2011 for the first time published a Research Funding Concept: Neglected

and Poverty-Related Diseases, which includes four pillars of funding for: 1) National research funding focused on basic research, 2) PDP funding, 3) the European & Developing Countries Clinical Trial Partnership (EDCTP) and 4) Health research systems through sub-Saharan African networks.8 Based on this concept, BMBF announced funding support for 7+7Z�MVY�[OL�ÄYZ[�[PTL�L]LY�[OYV\NO�HU�VWLU�YLX\LZ[�for proposals (RfP), with a duration of four years (over the 2012-2015 period) and a total commitment of €20m. Funding will focus on Millennium Development Goals (MDGs) 4 (reducing child mortality) and 5 (reducing maternal mortality). This includes a grant of €7.5m until 2015 to the Foundation for Innovative New

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German Research Foundation (DFG) 1,411,840 19,341,810 13,144,049 11,662,856 11,708,815 57,269,369

German Federal Ministry of Education and Research (BMBF) 4,324,957 800,604 5,774,264 7,879,805 7,193,744 13,726,494 39,699,868

German Federal Ministry of Health (BMG) 6,418,306 6,621,625 9,766,000 22,805,931

German Federal Ministry for Economic Cooperation and Development (BMZ) 1,985,335 1,922,059 1,890,545 793,714 769,820 10,000,000 17,361,473

Max Planck Institute for Infection Biology (MPIIB)A - 2,568,403 2,410,573 2,535,097 2,183,641 2,177,125 11,874,839

German GovernmentB 1,294,013 2,010,741 3,304,754

German Aerospace Centre (DLR) 1,024,551 324,774 307,569 1,656,895

Deutsche Gesellschaft für Internationale Zusammenarbeit (GIZ) GmbH (previously Deutsche Gesellschaft für Technische Zusammenarbeit GmbH; GTZ)

407,685 880,070 147,557 101,639 1,536,950

Subtotal of top 8 10,040,697 5,698,751 30,622,036 33,236,838 28,533,325 47,378,434 155,510,080

Total German public funding 10,132,589 5,721,199 30,622,036 33,236,838 28,533,325 47,378,434 155,624,421

20072008

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20112012 Cumulative

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Diagnostics (FIND) and an €8m grant over the four years to the Drugs for Neglected Diseases Initiative (DNDi).8,26,27 A third grant was made to the European Vaccine Initiative (EVI). BMBF has also supported the EDCTP since 2003, with its focus on clinical trials for the ‘big three’ (HIV/AIDS, TB and malaria), and is committed to intensifying its involvement in EDCTP’s second programme phase (2014-2024). Germany is the fourth largest funder of EDCTP, contributing 9% (€73m) of funding over the 2003-2012 period. BMBF’s funding now covers a large portfolio of vaccines, drugs and diagnostics for several diseases, and includes products in clinical trials.28

BMBF’s funding has doubled between 2011 and 2012 (€7m to €14m), making it the largest German funder of neglected and poverty-related disease R&D in 2012, and the 14th largest organisation global ly. Over the three-year per iod, i t has contributed €29m (26%) of German public funding.

O BMG administers research organisations such as the Leibniz Association, and it provides funds to the Bernhard Nocht Institute for Tropical Medicine (BNITM) and the Research Centre Borstel (S.A.). It is the smallest of the three players, investing €10 million in 2012.

O Germany’s aid organisations, BMZ and GIZ are smaller funders than their country’s scientific counte rpa r ts , p rov id ing €12m and €0.25m respectively between 2010 and 2012 for neglected and poverty-related R&D. In 2012, BMZ contributed €10m towards the formation of the Global Health Investment Fund. The Global Health Investment Fund i s an innovat i ve fund tha t w i l l make investments to provide capital for the development

of global health products while also attempting to generate a financial return for its investors. It will provide companies with investments structured to accelerate the development of products to address global health challenges and complete projects they might otherwise not pursue.29 The fund is a unique example of foundations, governments, pharmaceutical companies and an investment bank coming together to support global health. This contribution represents a significant increase in commitment to neglected and poverty-related diseases. Based on G-FINDER data, one hundred per cent of BMZ and GIZ’s neglected and poverty-related disease R&D funding has been directed towards PDPs or the Global Health Investment Fund.

O The Max Planck Institute for Infection Biology invested €7m from 2010 to 2012 towards in-house research focusing on basic research and TB vaccine R&D. These funds originate from the German federal and state governments, are given to the Max Planck Society, and the Society allocates the funds to separate institutes. These institutes are MYLL�[V�KLJPKL�^OH[�PZ�VM�ZJPLU[PÄJ�PU[LYLZ[�HUK�^VY[O�pursuing.

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BMBF has supported EDCTP since 2003 and is committed to intensifying its involvement in EDCTP’s second programme phase (2014-2024).

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What has Germany funded to date?

German investment since 2010 has focused largely on the big three neglected and poverty-related diseases, TB, HIV/AIDS and malaria, with 24% (€26m) of German public funding going to TB, 13% (€14m) to HIV/AIDS, and 11% (€12m) to malaria. Since 2010, German public funders distributed €31m (29% of total funding) as core-funding or for an unspecified disease area, to organisations working across multiple neglected and poverty-related disease areas. Over the 2010-2012 period, Year On Year (YOY) fundersvi have increased

their focus on TB and kinetoplastidsvii, with a decrease in funding for HIV/AIDS. Funding for TB increased from €7m to €10m during 2010-2012 due to a €3m investment in basic research for TB in 2012 by BMG. YOY funding for kinetoplastids increased from €3m in 2010 to €7m in 2012, thanks to a significant investment (€5m) by BMBF in 2012, largely in diagnostics and drugs. HIV/AIDS funding decreased from €6m to €4m, due to discontinued investment from DFG in HIV/AIDS drugs post-2010.

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funding has remained steady, while funding for vaccines decreased between 2011 and 2012 (down 15% [€0.5m]). Funding for drugs dipped down in 2011 by €3m (a 50% drop from the previous year), only to increase by €2m in 2012 (74% increase from 2011 to 2012). Funding for diagnostics increased in 2012 from a low base in 2010, attributable to BMBF’s PDP funding.

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Figure 4. German public funding by product area (2007-2012)^

German public sector funding recipients

Figure 5. German public funding by recipient type (cumulative total 2007-2012)

The largest proportion of known German public funding goes to academic and other research institutions. They receive funding support from three of the four largest German funders: BMG, BMBF and DFG.ix PDPs receive

the second largest proportion, with support from BMBF and BMZ. Over the 2010-2012 period, BMBF provided 77% of PDP funding, and BMZ 20%.

82 c

€1Every euro invested by German public institutions in neglected and poverty-related disease R&D leverages an additional 82 cents


To date, German public funders have contributed a very small amount to PDPs compared to their European counterparts. Based on public funds invested since the inception of the PDPs up to 2012, Germany has contributed only 1% of total PDP funding, while the UK, The Netherlands and Ireland have contributed 26%, 15% and 6% respectively. PDPs offer an innovative approach to neglected disease product development. PDPs act as facilitators, bringing resources from public and philanthropic organisations together with industry and scientific expertise to address the lack of commercial

incentive to undertake R&D for neglected diseases. Between 2000 and 2011, PDPs were involved in the development of almost half of the 43 products registered in that period. Likewise, in the 2012 pipeline, PDPs were developing 104 products, out of a total 359.22

Excluding core funding for PDPs, German PDP funding reported to G-FINDER over the last three years has been fairly narrow in disease coverage, with 72% directed to kinetoplastids, 15% to HIV/AIDS and 14% to malaria.

Based on G-FINDER data, over the last three years German public funding for neglected and poverty-related disease R&D has been largely invested at home (84%). These funds contribute to German research institutions and scientists who direct their skills and experience to produce innovations to combat global health challenges. The strength of Germany’s own research institutions and ZJPLU[PZ[Z�OHZ�IYV\NO[�HKKP[PVUHS�PU]LZ[TLU[�Å�V^Z�¶�V]LY�the last three years for every euro invested by German public funders into German research, an additional 82 cents has flowed into Germany’s research institutions from industry, philanthropic organisations and other governments across Europe and the US.x

GERMANY’S INSTITUTES ARE WORLD RENOWNED

Germany has a well-respected and highly-skilled research sector, and it can capitalise on these strengths through deeper involvement in, and commitment to, neglected and poverty-related disease R&D.

German industry partners – included as the aggregated PUK\Z[Y`�Ä�N\YL� PU�table 2 – have also made investments in neglected and pover ty-re lated disease R&D. Organisations such as BayerCropScience, Partec GmbH, VakzineProjekt Management GmbH, Lionex Diagnostics and Therapeutics GmbH are actively working in the f ield. For example, Par tec GmbH developed the CyScope®, an ultracompact, portable and battery-operated fluorescence microscope, which has been available since 2006 and is intended to assist with diagnosis of TB and malaria in resource-poor settings.30

Germany’s public research institutions are particularly active in this area. The Bernhard Nocht Institute for Tropical Medicine has been the largest individual recipient of funds in Germany for its neglected and pover ty-related disease research (€26m from all sources over the 2010-2012 period) – receiving funding from German funders and the European Commission. The Max Planck Society, in particular the Max Planck Institute for Infection Biology, receives international philanthropic support for its research from the Bill & Melinda Gates Foundation, along with support from BMBF (in total €12m over three years).

EVI, a PDP based in Heidelberg, attracts funding from European aid donors such as Irish Aid and the Dutch Directorate General of Development Cooperation, along with support from the European Commission and BMBF (in total €12m over the three-year period).

BENEFITS OF FUNDING NEGLECTED AND POVERTY-RELATED DISEASE R&D

x 9H[PV�VM�Á��JHSJ\SH[LK�IHZLK�VU�.�-05+,9�KH[H�HUK�KVLZ�UV[�PUJS\KL�M\UKZ�[OH[�TH`�Å�V^�PU[V�[OL�JV\U[Y`�MYVT�7+7Z��;OPZ�PZ�[OL�YH[PV�VM�PU]LZ[TLU[�MYVT�ZV\YJLZ�V[OLY�[OHU�.LYTHU�W\ISPJ�M\UKPUN�[V�.LYTHU�W\ISPJ�M\UKPUN��6[OLY�ZV\YJLZ�PUJS\KL�M\UKZ�MYVT�.LYTHU�WOPSHU[OYVW`�HUK�PUK\Z[Y �̀�HUK�V[OLY�NV]LYUTLU[Z�


^� �-PN\YLZ�HYL�HKQ\Z[LK�MVY�PUÅH[PVU�HUK�YLWVY[LK�PU��L\YVZ��HUK�PUJS\KL�M\UKPUN�[V�.LYTHU�YLJPWPLU[Z�HZ�YLWVY[LK�I`�HSS�NV]LYUTLU[�M\UKLYZ��T\S[PSH[LYHS�HUK�WOPSHU[OYVWPJ�VYNHUPZH[PVUZ�HUK�PUK\Z[Y`��

*�� :\I[V[HSZ�MVY�� YLÅLJ[�[OL�[VW�YLJPWPLU[Z�MVY�[OVZL�`LHYZ��UV[�[OL�J\T\SH[P]L�[VW�� A�� ;OVZL�PUZ[P[\[LZ�VM�[OL�4H_�7SHUJR�:VJPL[`�[OH[�HYL�HJ[P]L�PU�ULNSLJ[LK�HUK�WV]LY[`�YLSH[LK�KPZLHZL�HUK�VY�PUMLJ[PV\Z�KPZLHZL�YLZLHYJO� � � � �� 5V�YLWVY[LK�M\UKPUN� �

Table 2. Top 12 German R&D groups (2007-2012)^

Table 3 illustrates Germany’s research institutes’ depth – with a network of researchers in the areas of TB, malaria, HIV/AIDS, and to a lesser extent kinetoplastids and helminths; and breadth – with institutes like the Bernhard

Nocht Institute for Tropical Medicine, The Helmholtz Centre for Infection Research and Ludwig Maximilians University of Munich working successfully across more [OHU�Ä]L�ULNSLJ[LK�HUK�WV]LY[`�YLSH[LK�KPZLHZL�HYLHZ�

(MYPJHU�U\YZL�WYLWHYPUN�]HJJPUH[PVU��Credit: iStockphoto�

Aggregate industry 5,025,531 5,560,594 4,608,415 8,332,659 5,390,144 2,758,689 31,676,032

Bernhard Nocht Institute for Tropical Medicine (BNITM) 2,926,089 523,898 823,325 8,723,383 8,338,960 8,708,277 30,043,932

European Vaccine Initiative (EVI) 6,425,967 3,661,528 3,185,409 4,268,415 6,260,827 1,800,381 25,602,527

Max Planck SocietyA 2,830,444 4,982,872 3,791,464 3,386,023 2,990,550 5,479,017 23,460,370

The Helmholtz Centre for Infection Research 1,019,338 1,846,627 1,648,002 2,525,383 2,296,625 171,644 9,507,619

Research Centre Borstel - - - 2,816,788 648,087 3,731,271 7,196,146

German Society Fraunhofer, Fraunhofer Gesellschaft - 2,221,139 240,658 1,106,989 577,951 1,746,168 5,892,905

European Molecular Biology Laboratory (EMBL) - 335,440 1,313,907 1,271,449 1,302,930 1,239,991 5,463,717

Ludwig Maximilians University of Munich (LMU) - - - 552,356 935,833 2,635,271 4,123,460

Ruhr-University 1,504,118 933,571 918,265 - - 443,126 3,799,080

University of Tuebingen - - - 902,209 1,376,171 1,036,876 3,315,256

University of Heidelberg 709,048 686,449 620,243 22,793 84,671 214,623 2,337,828

Subtotal of top 12* 20,440,535 20,752,118 18,505,011 35,469,609 30,605,632 31,690,658 152,418,871

Total 22,021,509 21,301,277 18,588,134 36,677,838 31,242,852 33,266,915 163,098,526

20072008

20092010

20112012 Cumulative

totalRecipient

Organisation


Table 3. Top 12 German R&D groups disease areas^

^� +PZLHZL�HYLHZ�HYL�IHZLK�VU��KH[HA�� ;OVZL�PUZ[P[\[LZ�VM�[OL�4H_�7SHUJR�:VJPL[`�[OH[�HYL�HJ[P]L�PU�ULNSLJ[LK�HUK�WV]LY[`�YLSH[LK�KPZLHZL�HUK�VY�PUMLJ[PV\Z�KPZLHZL�YLZLHYJO

Selected German research institutes conducting neglected and poverty-related disease R&D

Bernhard Nocht Institute for Tropical Medicine

Founded in 1900, the Bernhard Nocht Inst i tute for Tropical Medicine (BNITM) is the only institute in Germany with the mission to focus on tropical diseases.31 Historically BNITM has been well-recognised for its achievements in neglected and poverty-related disease R&D, including for its key discoveries in the 1930s on schistosomiasis.31 At present, BNITM has a ZWLJPÄ�J�MVJ\Z�VU�THSHYPH��^P[O�HWWYV_PTH[LS`��VM�[OL�Institute’s work focused on this disease. Other disease focuses include helminth infections and leishmaniasis.32

Max Planck Society

The Max Planck Society for the Advancement of Science eV, established in 1948, is one of the most pre-eminent research organisations in Europe.33 The Max Planck institutes – Max Planck Institute for Infection Biology (MPIIB), Max Planck Institute of Colloids and Interfaces and Max Planck Institute for the Physics of Complex Systems – are most active in R&D of neglected and poverty-related diseases and primarily focus on TB and malaria.xi The Max Planck Institute for Infection Biology relies on public

funding to progress its promising neglected and poverty-related disease candidates from bench to clinic. MPIIB’s research activities are taking it beyond its roots in basic research, to clinical application and development. An example of this is MPIIB’s involvement in the development of the VPM1002 tuberculosis vaccine candidate (see next WHNL��9VILY[�.VSPUZRP��,_LJ\[P]L�4HUHNLY�:JPLU[PÄ�J�(MMHPYZ�of MPIIB, commented that,

“…we are constantly looking for additional funds.

We have to seek funds at the European level rather

than the German level – and over the last 10 years

MPIIB has benefited much more from European

funding than German funding. Major funding has

always come from the EU which helped to perform

immunological research with a focus on (pre-)clinical

application.” 34

The Helmholtz Centre for Infection Research

The Helmholtz Centre for Infection Research’s R&D activities focus on malaria, TB and HIV/AIDS.35 Projects currently in the Helmholtz pipeline include: FAST-XDR-DETECT, which involves the development of a diagnostic tool for fast and simultaneous detection of extensively drug-resistant (XDR) and MDR TB;36 and NOPERSIST, which looks at developing efficient, cost-effective diagnostic tests for diseases such as HIV and TB.37

xi )HZLK�VU�ZP_�`LHYZ�VM�.�-05+,9�KH[H��

Aggregate industry

Bernhard Nocht Institute for Tropical Medicine (BNITM)

The Helmholtz Centre for Infection Research

Ludwig Maximilians University of Munich (LMU)

University of Heidelberg

University of Tuebingen

European Molecular Biology Laboratory (EMBL)

Max Planck SocietyA

Research Centre Borstel

German Society Fraunhofer, Fraunhofer Gesellschaft

European Vaccine Initiative (EVI)

Ruhr University

TB MalariaHIV/AIDS

Kinetoplastids

Helminths

(Worms & Flukes)

DengueBuruli Ulcer

Platform

technologies

Diarrhoeal

diseases Bacterial Pneumonia

& Meningitis

Leprosy Salmonella

InfectionsTop 12 German

R&D groups


Research Centre Borstel

The Research Centre Borstel has a particular R&D focus on bacteria-induced infections of the lung, primarily TB.38 The Centre’s TB R&D activities include: epidemiological studies, investigation of resistance mechanisms, infection immunology and novel diagnostic approaches.39–41 The Research Centre Borstel also partners with the Tuberculosis Network European Trials group (TBNET) and is home to the international TBNET JVVYKPUH[PUN�VMÄJL�39

University of Heidelberg

The University of Heidelberg, founded in 1386, is one of Germany’s oldest research institutions. At present, the University of Heidelberg’s R&D in neglected diseases focuses on dengue, malaria, and leishmaniasis.42-44

Malaria is one of the main disease focuses and the

University is part of the European Virtual Institute of Malaria Research (EVIMalaR), a collaborative research Network of Excellence. The network conducts research on malaria parasites and their interactions with both mammalian hosts and mosquito vectors.45

Historically, German researchers and institutes have made signif icant contributions to neglected and poverty-related disease R&D, reflecting the impressive capabilities of the research sector. One of the earliest examples of Germany’s exper tise in this f ield is Robert Koch’s advances in sleeping sickness (African trypanosomiasis), cholera and TB.46 Koch is considered a founder of the science of bacteriology and also the father of the scientific study of TB, for which he was awarded the Nobel Prize in Physiology or Medicine in 1905.47 Likewise, in the 1930s, Hans Vogel of BNITM published research on the life cycles of parasitic worms – key to our modern understanding of the development and transmission of schistosomiasis.31 Building on this history, German scientists today are equipped to continue this ground-breaking research.

Researchers from the Institute of Microbiology at Universitaetsmediz in Charité, Berlin, have been working to identify suitable genes in the leishmania parasite to IL�\ZLK�[V�[YHJL�YLZPZ[HUJL�[V�[OL�ÄYZ[�SPUL�KY\N�\ZLK�[V�treat leishmaniasis, Miltefosine.48 In addition, the Free University of Berlin Medical School is a development par tner for the leishmaniasis vaccine candidate LeishDNAvax which is in pre-clinical development.49

Although the BCG (Bacillus Calmette-Guérin) vaccine exists for TB, the vaccine has been in use for over 80 years and its long-term efficacy is highly variable.50

The TB vaccine candidate VPM1002 is an outstanding example of the collaborative efforts of development partners within Germany and internationally. The VPM1002 candidate is a genetically modified strain of the BCG vaccine which originated from the laboratories of Professor Stefan Kaufmann at MPIIB in the mid-1990s. The MPIIB candidate has since progressed with the assistance of the Vakzine Projekt Management GmbH (VPM agency) and the Helmholtz Centre for Infection Research. VPM1002, under the stewardship of VPM and aided by funding from BMBF, has just completed Phase IIa trials in South Africa.51 In a promising development, in July 2013, VPM licenced the vaccine candidate to the Serum Institute of India, one of the few manufacturers able to ensure that the vaccine would be made available at a fair price.52 However, progression of the vaccine into Phase IIb clinical trials has stalled, in part due to funding uncertainty.34

Malaria is also a current disease focus with many German institutes involved in early stage product development of vaccines and drugs. The malaria

GERMANY CAN BUILD ON EXISTING SCIENTIFIC SUCCESSES

“…we are constantly looking for additional funds … over the last 10 years MPIIB OHZ�ILULÄ[LK�T\JO�TVYL�from European funding than German funding.”9VILY[�.VSPUZRP��,_LJ\[P]L�4HUHNLY�:JPLU[PÄJ�(MMHPYZ�VM�4700)


vaccine candidate GMZ2 is in Phase II clinical trials and is being developed through EDCTP; this candidate originally received support from VPM in the mid-2000s which helped to move the candidate into translational research.53,54 Germany’s contribution to EVI is also showing promise. EVI has six malaria vaccine candidates in discovery and preclinical stages or Phase I clinical trials.55 The University of Heidelberg is also involved in malaria product development and has a malaria vaccine candidate, MSP1 full length, in discovery stages of development.53

Capacity building and partnerships

Beyond traditional R&D within German institutions, capacity building activities, advanced training and par tnerships are core elements of the country’s involvement in neglected disease and poverty-related research and innovation. In 2012, the German Centre for Infection Research (DZIF) was launched as part of BMBF’s German Health Research Centres initiative. This represents a collaboration between 32 German research institutions across 7 different sites, aimed at coordinating and innovating new diagnostic, preventative and therapeutic methods for treating infectious diseases. DZIF research areas cover TB, malaria, HIV and diarrhoeal diseases, and include partnerships with African research institutions and medical centres in Tanzania, Burkina Faso, Ghana and Gabon.56 The Depar tment of Infectious Diseases and Tropical Medicine at the Ludwig Maximilians University of Munich is working in Tanzania with the Mbeya Medical Research Centre on HIV, TB and helminth infections, in the area of

diagnostics, vaccines and drug development.57 In Burkina Faso, the University of Heidelberg collaborates with the Centre de Recherche en Santé de Nouna on research studies and with the exchange of PhD students.58–60 In Ghana, BNITM runs the Kumasi Centre for Collaborative Research in Tropical Medicine together with the Ghanian Ministry of Health and Kwame Nkrumah University – the Centre conducts field and laboratory research on neglected and poverty-related diseases such as malaria, TB, river blindness, and Buruli ulcer.61,62 In Gabon, the collaboration is between the Medical Research Unit at the Albert Schweitzer Hospital in Gabon and the University of Tübingen, with BMBF and EDCTP as key partners.22 This unit has been involved in trials for the following registered malaria drugs: Malarone, LapDap, Coarsucam®, astesunate injection and Pyramax®.22

These successes in neglected and poverty-related disease R&D from the bench to the patient and in partnerships, illustrate the capacity and strength of the research sector in Germany. With so many institutions HUK�ZJPLU[PZ[Z�WYVHJ[P]LS`�LUNHNLK�PU�[OPZ�ÄLSK��.LYTHU�W\ISPJ�M\UKPUN�JV\SK�SL]LYHNL�[OPZ�Z[YLUN[O�[V�[OL�ILULÄ[�of populations around the world and its domestic ZJPLU[PÄJ�HUK�TLKPJHS�YLZLHYJO�ZLJ[VY��

The work of German researchers such as Professor Peter Seeberger, Director of the Max Planck Institute of Colloids and Interfaces, demonstrates the calibre of German research on the world stage in the area of neglected and poverty-related diseases. Following a graduate degree in chemistry at Universität Erlangen-Nürnberg in Germany, Professor Seeberger completed a PhD in the United States and accepted a Professorship at MIT. His research has focused on a new method to attack pathogens using synthetic carbohydrate cha ins, wi th promis ing resul ts demonstrated in animal experiments. He is currently working on ten carbohydrate conjugated vaccines, among them one for Leishmania. Professor Seeberger was recognised for this scientific achievement and

awarded the Körber European Science Award in 2007.63� 0U�HUV[OLY�ZJPLU[PÄJ�IYLHR[OYV\NO�HUUV\UJLK�in 2012, as Director of the Max Planck Institute of Colloids and Interfaces, Professor Seeberger led a project that developed a simple and cost-effective way to make artemisinin by using the waste of the current extraction process. The breakthrough increased the efficiency of artemisinin production making it significantly more affordable – essential when aiming to make the lowest cost products possible. German scientists, like Professor Seeberger, HYL�H[�[OL�SLHKPUN�LKNL�VM�YLZLHYJO�PU�[OPZ�ÄLSK��WVPZLK�and motivated to translate the science from the laboratory to clinical trials with low-cost drugs and vaccines targeted to those most in need.

PROFILE: PROFESSOR PETER SEEBERGER


Investments into neglected and poverty-related disease R&D can deliver life changing results, as seen by the success of the low-cost meningitis vaccine in Africa. While these investments can and do bring significant ILULÄ[Z�[V�[OVZL� PU� SV^��HUK�TPKKSL�PUJVTL�JV\U[YPLZ��they can also provide tools for prevention and treatment to those suffering from neglected and poverty-related diseases closer to home.

As a G8 economy, Germany has the economic potential, unlike some of its European counterparts struggling to respond to the global economic crisis, to boost its investments in neglected and poverty-related disease R&D.

.LYTHU`»Z�YPJO�HUK�Z[YVUN�ZJPLU[PÄJ�OPZ[VY`�PU�ULNSLJ[LK�and poverty-related disease research and its network of highly regarded research institutes places it in the enviable position to continue ground breaking research to combat the most pressing global health challenges.

With the potential to be a leading neglected and poverty-related disease innovator, particularly for kinetoplastids, helminths, malaria and TB; and the motivation to do so, Germany can make a significant impact on neglected and poverty-related diseases.

If implemented, the fol lowing recommendations would leverage previous German achievements and investments to create new drugs, vaccines, diagnostics and other products needed to combat neglected and poverty-related diseases.

1. Increase funding commensurate with Germany’s GDP for neglected and poverty-related disease R&D and maintain political commitment.

Germany should move to be one of the top five countries for neglected and poverty-related disease R&D investment relative to GDP.

Germany has increased its global health and poverty-related R&D funding and improved its tracking of funding, however, it is vital that the political commitment which was generated in the last legislative period continues and that neglected and poverty-related disease R&D funding remains high on the political agenda.

2. Unlock structural funding barriers to facilitate increased investments.

Structural funding inflexibilities between funders and researchers are potentially stalling progress of products in the pipeline. Germany’s DFG has focused on providing funding for basic research undertaken

by German researchers while BMBF is funding PDPs, EDCTP, basic research and research networks in Africa. Consequently, some German products in development stand at the cross-roads, with greater support needed to progress them to registration. A new approach ULLKZ�[V�I\PSK�VU�[OL�OVTL�NYV^U�ZJPLU[PÄJ�Z\JJLZZLZ�achieved in the laboratory and structure a new pathway so candidate products can progress to clinical trials and successful products can be made available to those who need them most. New pathways could be made through greater international collaborations at the highest levels, which will reduce duplication and LUJV\YHNL�JVZ[�LMÄJPLUJ �̀�5L^�WH[O^H`Z�JV\SK�HSZV�IL�made through changes to existing funding structures to HSSV^�TVYL�ÅL_PIPSP[ �̀��

3. Increase investments into PDPs without disease restrictions, and into EDCTP.

In terms of PDP funding, Germany has so far been a small contributor, providing 1% of the public funds invested in PDPs. However, this contribution is poised to change with BMBF’s Research Funding Concept:

Neglected and Poverty-Related Diseases and the first ever public PDP request for proposals (RfP) launched in 2011, providing that catalyst. Germany is now in the group of countries that fund PDPs – joining European counterparts the UK, The Netherlands and Ireland. There is an expectation that German funding for PDPs will continue beyond the pilot, with a second PDP RfP. Due to the size and strength of Germany’s economy it would be desirable if the second RfP could have an increased budget and be structured to allow for PDP proposals to be submitted that include all diseases and products.

Continue supporting EDCTP, intensifying support in the upcoming second programme phase.

By supporting partnerships that focus on translating research into products, like EDCTP and PDPs, Germany also provides pathways for industry to participate in neglected and poverty-related disease R&D.

By addressing conditions for change and increasing investments into neglected and poverty-related disease R&D, Germany can respond to global health challenges, build on its rich scientific strengths and leverage its economic potential to build innovative tools to tackle neglected and poverty-related diseases. Such actions directly contribute to the MDGs and the Post-2015 Development Agenda.

CONCLUSION AND RECOMMENDATIONS


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ANNEXE 1. G-FINDER DISEASES, PRODUCTS AND TECHNOLOGIES

9LZ[YPJ[LK�KLUV[LZ�H�JH[LNVY`�^OLYL�VUS`�ZVTL�PU]LZ[TLU[Z�HYL�LSPNPISL� � @��@LZ��KLUV[LZ�H�JH[LNVY`�^OLYL�H�KPZLHZL�VY�WYVK\J[�^HZ�PUJS\KLK�PU�[OL�Z\Y]L`� � �

HIV/AIDS Restricted Restricted Y Y Y

MalariaPlasmodium falciparum Y Y Y Y YPlasmodium vivax Y Y Y Y Y6[OLY�HUK�VY�\UZWLJPÄLK�THSHYPH�Z[YHPUZ Y Y Y Y Y

Tuberculosis Y Y Y Y Y

Diarrhoeal diseasesRotavirus RestrictedEnterotoxigenic E.coli (ETEC) Y YCholera Y Restricted Y YShigella Y Restricted Y YCryptosporidium Y Restricted Y YEnteroaggregative E.coli (EAggEC) Y YGiardia YMultiple diseases Y Restricted Y Y

Dengue Y Y Y Y Y

KinetoplastidsChagas’ disease Y Y Y Y Y YLeishmaniasis Y Y Y Y YSleeping sickness Y Y Y Y YMultiple diseases Y Y Y Y Y Y

Helminth infectionsRoundworm (ascariasis) Y YHookworm (ancylostomiasis & necatoriasis) Y Y YWhipworm (trichuriasis) Y YStrongyloidiasis & other intestinal roundworms Y Y Y Y3`TWOH[PJ�ÄSHYPHZPZ��LSLWOHU[PHZPZ� Y Y Y YOnchocerciasis (river blindness) Y Y Y Y YSchistosomiasis (bilharziasis) Y Y Y Y YTapeworm (cysticercosis/taeniasis) Y Y YMultiple diseases Y Y Y Y Y

Bacterial pneumonia & meningitisStreptococcus pneumoniae Restricted YNeisseria meningitidis Restricted YBoth bacteria Y

Salmonella infectionsNon-typhoidal Salmonella enterica (NTS) Y Y Y YTyphoid and paratyphoid fever (S. typhi, S. paratyphi A) Y Y Y YMultiple salmonella infections Y Y Y Y

Leprosy Y Y Y

Rheumatic fever Y

Trachoma Y Y

Buruli ulcer Y Y Y Y

Adjuvants and immunomodulators

Delivery technologies and devices Diagnostic platforms

7SH[MVYT�[LJOUVSVNPLZ��UVU�KPZLHZL�ZWLJPÄJ� Restricted Restricted Restricted

Basic research

Drugs Vaccines

(Preventive)

Diagnostics

MicrobicidesVaccines

(Therapeutic)

Vector control

productsDisease

G-FINDER FACTSHEET

NOTES

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