1. Le sfide della nuova cooperazione: il diritto alla salute
Audino Podda

2. Emerging and re-emerging infectious diseases
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3. Children from developing countries pay the biggest toll
99% of DALYs and 96.5% of deaths due to infectious diseases are in low & middle income countries
53% of DALYs from infectious diseases are in children <5 years of age
43% of deaths from infectious diseases are in children <5 years of age
70% of DALYs from infectious diseases in children <5 years of age are from diseases for which no vaccines are available
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4. Access to Medicines in developing countries
Medicines of the rich world are only partly accessible for poorer populations
Cost
Distribution
Education, compliance, cultural differences
Lack of research into diseases endemic in poorer countries
Others like: clean water, hygiene
Pharma companies traditionally invested only where large markets existed
Developed societies have evolved to accept some responsibility for the developing world
Pharma shareholders accept that part of the profits are allocated to alleviate the access to medicine problem
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5. Access to Medicines Options for Pharma Companies
Money Mostly wasted
Existing drugs at cost / free Useful
Discovery of new medicines1 Great need
Training of discovery scientists Useful
Education of patients and health workers Necessary
Distribution Necessary
Medical treatment on site Necessary
1 Leveraging modern drug discovery science and technologies for neglected diseases
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6. Novartis access to medicines programs 79
Novartis access to medicines programs million patients supported in 2009
Coartem® subsidized 84 million treatments shipped – cumulatively delivered 300 million treatments, helping to save about 750,000 lives
2009
Programs and research valued at USD 1.5 bn3
Contributed 3% of net sales
Leprosy medication free of charge >4.5 million patients cured since 2000
Tuberculosis medicine donations 500,000 treatments committed, 50% delivered
Glivec® patient assistance Free to >37,000 patients in about 80 countries
NITD1 in Singapore Focus on tuberculosis, dengue fever and malaria
Recognizing the urgent medical need Novartis wanted to contribute new medicines to poor patients, in addition to donating therapies in its pipeline.
Novartis works to ensure that life-saving medicines are accessible to patients in a variety of ways. We are fighting leprosy, malaria and tuberculosis in developing countries through an innovative partnership with the WHO. We offer our innovative cancer medicine, Glivec, free to patients who would otherwise not be able to afford it. We also work to break down barriers to access, including access to treatment centers and acceptability of treatment, through the Novartis Foundation for Sustainable Development.
Two nonprofit research institutes, NITD and NVGH, research neglected diseases of the developing world, and commit to make treatments available to patients in poor countries without profit.
Even in the economic downturn during 2009, Novartis continued its commitment to support patients by contributing 3% of net sales to access-to-medicine programs.
Novartis therefore decided in 2001 to allocate some of its research and technology resources to address neglected diseases normally not taken up by commercial Pharma companies as a further significant contribution to the solution of the problem of access to medicine in the developing world
NVGH2 in Siena, Italy Vaccines research institute for neglected diseases
1Novartis Institute for Tropical Diseases; 2Novartis Vaccines Institute for Global Health; 3Based on approximate market value
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7. Novartis Vaccines Institute for Global Health Siena, Italy
Subsidiary of Novartis AG
Part of Novartis Institute for Biomedical Research (NIBR)
Co-located in Siena with Novartis Vaccines & Diagnostics
Started operations in February 2008
Currently ~40 staff and students
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8. NVGH Mission & Role
To develop effective and affordable vaccines for neglected infectious diseases of developing countries ....
.....Starting from an idea produced in a laboratory through assessment of the clinical profile in humans and final transfer of the vaccine to a manufacturer
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9. Which diseases cause the greatest burden
Which diseases cause the greatest burden? DALYs from diseases for which vaccines are not available in children <5 years
Other
Lower respiratory
Malaria
Diarrhea
HIV
35% of DALYs are caused by diarrheal diseases
STD (not HIV)
WHO 2008 Global Burden of Disease
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10. Initial NVGH Vaccine Development Programs Focus on diarrheal diseases
To develop effective and affordable glyco-conjugate vaccines for Salmonella related diseases. Currently in development are:
Vaccine against Salmonella enterica serovar Typhi (Typhoid vaccine)
Vaccine against S. Typhi & S. Paratyphi A (Bivalent vaccine)
Vaccine against S. Typhimurium and S. Enteritidis [Non-Typhoidal Salmonella (“NTS”) vaccine]
To develop an effective and affordable pan-specific protein- based vaccine against Shigella related diseases 
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11. The NVGH Typhoid Vaccine Global Relevance of Typhoid Fever
Typhoid Fever is a recognized global health issue
There are about 20 million cases of typhoid fever causing 200,000 to 600,000 deaths worldwide each year
To these numbers should be added at least another 5 million cases of paratyphoid fever
High disease incidence in under 5 year old children
Development of antibiotic resistance (which makes treatment of the disease more difficult) is an additional cause for concern
90% of cases and deaths in Asia (mostly South & South East Asia)
Crump et al, Bull WHO 2004
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12. The NVGH Vi-CRM197 vaccine Clinical development
A Phase 1 trial is currently ongoing in Europe to compare the safety and the immunogenicity of the conjugate vaccine with the licensed polysaccharide vaccine
Preliminary Results
Conjugate vaccine is very immunogenic (Antibody levels are six times higher than with polysaccharide vaccine)
Conjugate vaccine is safe (No serious adverse events reported)
Age de-escalation trials are planned to start in Asia by the end of the year
Phase 1 Antibody response
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13. NVGH Education Programs
PhD programs for post graduate students from developed & developing countries
Stages and MSc opportunities
Exchange programs
Vaccinology Masters for MD’s from developing countries
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14. Masters in Vaccinology & Pharmaceutical Clinical Development
Two year program jointly sponsored by the University of Siena Medical School, NV&D and NVGH.
The program teaches specific topics in the field of vaccinology and clinical development and provides an extensive practical training
The Masters is an important opportunity for young physicians from developing countries to become well trained clinical investigators and be involved in the testing of new vaccines going back to their countries
Additionally, the students are prepared for a possible career in public health and vaccine development within academic institutions or the pharmaceutical industry
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15. Vaccinology Masters: students’ countries
Ghana
Cameroun
Pakistan
Nepal
Philippines
Ethiopia
Nigeria
Uganda
Kenya
Tanzania
Zambia
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16. Conclusion
Novartis is a leading contributor to the medical needs of poor patients all over the world
Projects include making accessible medicines in its pipeline for leprosy, tuberculosis and malaria
It has dedicated two discovery institutes to neglected diseases of the poor (one of which is NVGH)
It contributes to the education of healthcare personnel and patients in the developing world
It fosters an open debate on corporate social responsibility and sensitizes affluent societies to the needs of poorer ones.
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17. Grazie