Afranio Kritski. Medical School Federal University of Rio de Janeiro - Rede TB

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1 Afranio Kritski. Medical School Federal University of Rio de Janeiro - Rede TB

2 Outline 2015 Global End TB Strategy Rede TB - Platforms Brazilian Response Role of RePORT Brazil Final Comments

7 10 year vision: Specific Objectives Globally: - New diagnostic tests Point of care; - New drugs for treatment of DR-TB (and DS-TB) - New vaccine(s) infancy or childhood - Plus global TB networks topic specific - Monitoring of progress

8 5 year plan: By 2020 what is needed? In middle income countries with TB burden 1. National strategic plan for TB research 2. Plan to build and maintain capacity for TB Research 3. National funding mechanism for TB Research 4. Integrated research communities within these countries. With regional and international collaborations

Universal access to health care provided by Unified Health System (SUS) Brazil Area: 8.514.877 km² Population (2014): 202.033.670 hab.

12 Universal access to health care provided by Unified Health System (SUS) Brazil Area: km² Population (2014): hab. Urban Population: 85% Income (2013): - Per capita: US$ ,50 USD Social Indicators - IDH(2013): 0,744 (79º) - Living Expectancy: 74 years - Infant Mortality: 12/ Literacy: 90.4%

13 Brazil 2015 (Innovation) 7th largest economy in the world 4th largest pharmaceutical market (US$ 26.2 billion) 143 Biotech companies (31% focus on health sector) Government offers strong R&D incentives and public grants and financing but Low overall private investment on biotech Lack of professional management Difficult regulatory framework Import reliance: raw materials and equipment used as basic tools in the industry still need to be imported, GDP list, available at:

14 Brazil 2015 (Innovation) Biotech companies (subsectors) Health Care (therapeutic products, vaccines, molecular diagnostic methods, etc) - 55% Technology and Services (production and bioinformatics, CROs, CDMOs, CSOs) - 20% Agriculture and food - 16% Industry and environment (processing of chemicals, materials and fuels) - 9% EuropaBio, available at:

15 Brazil 2015 Partnerships and incubation Principal reasons for partnerships with Universities and Research Institutes Co-development of products 28% Contracting of special services 22% Infrastructure sharing 20% Licensing of Technology 10% Research and Development 5%

Eight of the 22 HBCs met 2015 targets for

2004-2014: -> Incidence decrease: 41.1 to 33.

16 Eight of the 22 HBCs met 2015 targets for reductions in TB cases and deaths: Brazil, Cambodia, China, Ethiopia, Philippines, Uganda, United Republic of Tanzania, Viet Nam Brazil, : -> Incidence decrease: 41.1 to 33.5/ (22.8%) -> Mortality reduction: 2.9 to 2.3/ (21%)

17 Country Tuberculosis in Brazil, 2014 Brazil New TB cases: 68,000 TB/ HIV: 7,700 (14%) TB/ MDR: 1,630 MDR (2.3%) TB deaths: 4,600 (6.8%) Leading cause of death among HIV individuals Treatment cure: 74.3% Treatment default: 10.9% Contacts screened among those identified: 52.7% (MoH, 2015; SINAN/MoH, 2015)

18 MCT: Ministry of Science and Technolgoy; MoH: Ministry of Heatlh MEd: Ministry of Education; MDIC: Ministry of Industry and Trade ; MSD: Ministry of Social Development; Civil Society: NGOs, Health Council, Professional Associations Private and public industry Research Institutes MDIC TB RESEARCH IN BRAZIL ( ) Researchers from Universities and Research Institutes MST Civil Society NIH FDA USAID CDC PAHO Int. Org No Interaction NGOs-Advocacy Biomedical Associations NTP - SVS MoH MSD MEd Universities Technology Schools

19 TB RESEARCH IN BRAZIL ( ) TB Arena was coordinated by NTP-MoH TB Research was not a priority Focus was on Science and Technology Publish papers, and PhD Thesis / Master Dissertation No comments on Innovation No Interaction with Public or Private Industry Prejudice from Health Policy Makers against Industry

20 MCT: Ministry of Science and Technolgoy; MoH: Ministry of Heatlh MEd: Ministry of Education; MDIC: Ministry of Industry and Trade ; MSD: Ministry of Social Development; Civil Society: NGOs, Health Council, Professional Associations Private and public industry Research Institutes Global Fund USAID CDC BMGF FDA NIH E.U. UNION PAHO MSH NTP SVS Decit-SCTIE Fiocruz MDIC Int. Org MoH TB RESEARCH IN BRAZIL ( ) Researchers from Universities and Research Institutes MST Rede TB MSD Civil Society Stop TB Partnership NGOs-Advocacy Biomedical Associations MEd Universities Technology Schools

21 MCT: Ministry of Science and Technolgoy; MoH: Ministry of Heatlh MEd: Ministry of Education; MDIC: Ministry of Industry and Trade ; MSD: Ministry of Social Development; Civil Society: NGOs, Health Council, Professional Associations Private and public industry Research Institutes MDIC TB RESEARCH IN BRAZIL ( ) Researchers from Universities and Research Institutes MST Civil Society NIH E.U. PAHO Int. Org Rede TB Stop TB Partnership NGOs-Advocacy Biomedical Associations NTP SVS Decit-SCTIE Fiocruz MoH MSD MEd Universities Technology Schools

25 TB RESEARCH IN BRAZIL according to Institutions ( )

26 TB RESEARCH IN BRAZIL according to Institutions ( ) Rede TB (>80% of publications)

27 P E S Q U I S A E C O M B A T E A T U B E R C U L O S E Platforms Research Sites

28 Brazilian Response to "Global End TB Strategy Brazilian TB Research Roadmap (2013) carried out by REDE TB, NTP and WHO in Sao Paulo City Situational Assessment (2015) carried out by Rede TB during March and April 2015 questionnaire answered by 114 participants /institutions

29 Brazilian TB Research Roadmap Challenges Regulatory Agency /Anvisa National Ethic Committee /CONEP since 2014, laws changed Fast track for International projects co-funded by government (like RePORT)

30 Brazilian TB Research Roadmap Challenges Lack of a common research agenda for all partners Ideological barriers for international research collaboration Lack of funding for cohorts and clinical trials originated in the country Scarce funding for NGOs National Industry just started to interact

31 Brazilian Response to "Global End TB Strategy Initiated the interaction with Parlamentarians /Congress Men Go beyond NTP-MoH Include Ministry of Education, Science Technology, Social Development and Industry Creation of National TB Research Committee that will promote the inclusion of Pillar 3 on National TB Strategic Plan to build its framework and monitor its implementation Allocate more funds for TB Research pursuing the sustainable develop goals Start Interaction with other high TB burden countries using National TB Research Agenda as a starting point

32 Brazilian Response to "Global End TB (2015) Developed National TB Research Agenda June 2015 Using Research Platforms approach It was included officially in the National TB Plan Elimination, Oct 2015 It was published in Journal of Brazilian Society of Tropical Medicine, Feb 2016

34 Global End TB Strategy ( ) Pillar 3 Research Pillar 2 Bold Policy Pillar 1 TB Programmes

35 Pillar 1 TB Programmes Interaction with Civil Society Health System /Epidemiology Research Operational Implementation Research Research Capacity Building and Training Biosocial and Biomedical Approach Pillar 3 Research Innovation Interaction with Industry

36 Interaction with Civil Society Biosocial and Biomedical Approach Pillar 2 Bold Policies Health System/ Epidemiology Research Research Capacity Building and Training Operational Implementation Research Pillar 3 Research Innovation Interaction with Industry

37 RePORT Brazil (NIH-MoH) Research Capacity Building and Training Biomedical Approach Pillar 3 Research Clinical Research Diagnostic /Drug /Vaccine Development Fundamental/ Translational Research Innovation Interaction with Industry

38 Pillar 1 TB Programmes Interaction with Civil Society Biosocial and Biomedical Approach Pillar 2 Bold Policies Pillar 3 Research Health System Research Operational Implementation Research Clinical Research Research Capacity Building and Training Diagnostic /Drug /Vaccine Development Biomedical Approach Fundamental Translational Research Innovation Interaction with Industry

39 Fundamental Research New PPD Bacfil (manual) MLPA Proteomic and lipidomic plataform Fusion Proteins BioMarkers New drugs Mucosal rbcg Moreau RDJ Vaccine Auxotrophic MTB vaccine INCT-TB (CNPq -2001) Research Training Long Term Projects Portfolio REDE TB (2016) Translational Research New PPD Kit SIRE Nitratase Q3 /Real time PCR Bacfil automated TB sprint plus MLPA Detect MDRTB 45 lidipic fractions 5 Fusion proteins New drugs (IQG 607) INCT-TB (CNPq- 2001) Report Project (NIH) Research Training Medium term projects Clinical Research Linezolid/Levo/Gati/M oxi PK and EBA studies Moxifloxacin trials for active TB TMC 207 trial -MDR-TB Rifabutine and RIF trials fo LTBI STAND (PAMZ) Trial Detect-TB kit study (with brazilian industry) INCT-TB (CNPq-2001) Report Project (NIH) Research Training Short term projects Operational /Implementaion Health System Research New Diagnostic Tests RIF vs INH for LTBI Xpert vs AFB for TB MGIT vs LPA vs Xpert - MDRTB MGIT vs LJ for DSTB Detect-TB kit /Clinical Score Effectiveness of TB control in Primary Health Care Level Vulnerable Populations Pediatric TB /DR/MDR-TB TB and co-morbidities Research Training Medium term projects

RePORT Brazil Study sites / 3 regions North Region Manaus/Amazonas Marcelo Cordeiro Santos Northeast Region Salvador/Bahia Bruno Bezerril Andrade Southeast Regiong Rio (UFRJ/Caxias) Afranio Kritski

40 RePORT Brazil Study sites / 3 regions North Region Manaus/Amazonas Marcelo Cordeiro Santos Northeast Region Salvador/Bahia Bruno Bezerril Andrade Southeast Regiong Rio (UFRJ/Caxias) Afranio Kritski Rio (Rocinha) Betina Durovni Rio (IPEC-Fiocruz) Valeria Rolla USA P.I. Timothy Sterling Vanderbilt Univ Brazil Government Decit-MoH Antonio Carlos Campos Carvalhoh USA Government - NIAID /NIH Peter Kim Diverse Human and bacterial genetics Use Common Protocol Central Data Managament Central Biorespository

41 Principal areas for cooperation Translational studies M. tuberculosis transmission Role of mixed infection Biomarkers to identify patients at risk for active TB and infection TB Risk factors for tuberculosis recurrence, Host directed therapies Epidemiologic studies TB comorbidities, (HIV, Diabetes, Mental Diseases, Hepatitis, other Tropical diseases) TB in Women/Children Nutritional status Clinical trials (diagnosis and therapeutics)

42 International Collaboration Interactions with China

43 CNPq (MRC)/ NSFC Co-Operation Workshop Biomedical Platforms Research Priorities June 09, 2015 Brasilia - DF

44 Priorities for Chinese and Brazilian Government Infectious diseases, especially tuberculosis and tropical diseases 1. Host-pathogen interaction 2. Medical biotechnology: new drugs and vaccines, new diagnostic methods

45 Research Topics to be tackled Tuberculosis To develop and evaluate new drugs against specific molecular targets for drug sensitive and drug resistant TB To develop and evaluate new biomarkers for latent and active TB diagnosis To develop new vaccines based on new biotechnologic methods such as, knockouts, knockdown and Crisp-Cas-9 approach

46 Rede TB/MoH/Fiocruz Brazil Center for Disease Control and Prevention China Workshop Biomedical Biosocial Research Priorities Rio de Janeiro, December 9, 2015.

47 Translational Science: diagnostics, biomarkers, latent Tb detection, treatment and preventive therapy Priorities TB Research

48 PRIORITIES 1. POC diagnostics 2. Production and registration of first line drugs, with WHO licensing of production facilities 3. Validate each others prototypes and kits for TB diagnostics 4. Capacity building for pre-clinical and clinical trials for each others products

49 Implementation Science, Epidemiology, Operational and Health System Research Priorities TB Research

50 TB Priorities China's main objective: To reduce TB incidence; Brazil's main objective: increase cure rate.

51 Conclusions 1. This a good moment to develop a new research agenda Country leadership for End TB Stragtegy can be fostered by RePORT World needs more research investment new tools and approaches Big Pharma getting out = vacuum Still strong donor support Still strong international collaborators

52 Conclusions 2. RePORT is in an excellent position to assume more leadership on Translation, Clinical Research Arena and Interact with Industry Establishing an excellent network of TB researchers. But, may have strong links to NTP Promote strong capacity and rapid capacity building Foster Industrial capacity/technological know-how 3. There is an opportunity. And a challenge!!!

53 Acknowledgments Rede TB Members NTP-MoH Fiocruz TB patients and contacts that participated in several research projects Funding NIAID- NIH Decit-MoH CNPq MCTI State Foundations (FAPs)

The New Diagnostics WG and The Global Plan to Stop TB

The New Diagnostics WG and The Global Plan to Stop TB 2011-2015 Working Group on New Diagnostics Annual Meeting 11 th November 2010, Berlin Christian Lienhardt Stop TB Partnership Geneva Aims of this presentation