Academic Research in LA

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1 Academic Research in LA Dr. Carlos H. Barrios Faculdade de Medicina, PUCRS Instituto do Câncer, HMD LACOG, Latin American Cooperative Oncology Group Porto Alegre, Brasil

2

3 36% improvement

4 Age-Adjusted Male Mortality Siegel R, et al. CA Cancer J Clin 2011;61: VC 2011 American Cancer Society.

5 Age-Adjusted Female Mortality Siegel R, et al. CA Cancer J Clin 2011;61: VC 2011 American Cancer Society.

6 Age adujsted mortality rates, women. Brazil ( ) Source, INCA, MS, Brazil

7 Number of Studies (N= ) ClinicalTrials.gov currently lists studies in 181 countries Researched on Feb 2 nd

8 Number of Studies (N= ) ClinicalTrials.gov currently lists studies in 181 countries Non-US Only (45%) US Only (40%) Not Specified* (9%) Both US/Non-US (6%) Total 160,326 Researched on Feb 2 nd

9 Clinical Research in South America World South America 5474 (3.4%) Argentina 1689 Bolivia 24 Brazil 3708 (2.3%) Chile 904 Colombia 724 Ecuador 84 Guyana 1 Paraguay 15 Peru 688 Suriname 1 Uruguay 48 Venezuela 137 (Feb, 2014)

10 Number of Studies in Cancer (N=41.757) Researched on Feb 2 nd

11 Clinical Cancer Research in South America World South America (2.4%) Argentina 452 Brazil 711 (1.7%) Chile 213 Colombia 146 Ecuador 19 Peru 231 Uruguay 20 Venezuela 38 (Feb, 2014)

12 Clinical Cancer Research Europe World (Feb, 2014)

13 Early vs. Late Phase Trials in Emerging Regions Asia 102 6% Latin America 22 4% 35 6% % % % 52 3% % 26 6% 61 14% % 16 3% % 1% 41 22% % 18 4% % Middle East % 6 3% Africa clinicaltrials.gov

14 CLINICAL RESEARCH REGULATORY TIMELINES ACROSS THE WORLD 5-12 months CANADA 3-4 months 5 months REINO UNIDO SUÉCIA 3 months 4-5 month s UNITES STATES 3 months FRANÇA 12 months MÉXICO 3 4 months COLOMBIA PERU 4 5 months BRAZIL months 3 months 4 months AUSTRÁLIA CHILE ARGENTINA 4 4,5 months 9 months 4 months Adapted from: Hurley D. GCP Journal March st Annual Drug Information Association Meeting, 2005.

15 REGULATORY AGENCIES APPROVAL TIMES in the ALTTO trial (BIG02-06) Average* 58d 26d 60d 171d TIME TO APPROVAL IN DAYS P=.046 P=.21 P=.05 In this study the regulatory agencies in South America required many more days to approve the protocol in comparison to remaining regions EUROPE NORTH AMERICA ASIA-PACIFIC SOUTH AMERICA AFRICA PARTICIPATING COUNTRIES ANOVA F = 3.39, P = 0.031

16 Nature, Vol 450, November 29 th, 2007

17 Nature, Vol 450, November 29 th, 2007 US$28 billion investment in S&T 1.5% of GDP (increase of 50%)

18 US$28 billion investment in S&T 1.5% of GDP (increase of 50%) Lack of technological innovation in the private industry. Most researchers in the public sector. Nature, Vol 450, November 29 th, 2007

19 US$28 billion investment in S&T 1.5% of GDP (increase of 50%) Lack of technological innovation in the private industry. Most researchers in the public sector. 2% of scientific publications Ranking 15 th in the world Nature, Vol 450, November 29 th, 2007

20 US$28 billion investment in S&T 1.5% of GDP (increase of 50%) Lack of technological innovation in the private industry. Most researchers in the public sector. 2% of scientific publications Ranking 15 th in the world 0.1% of global registered patents Nature, Vol 450, November 29 th, 2007

21 Nature, Vol 450, November 29 th, 2007

22 Brazil Research and Development Expenditure (% of GDP) Brazil 2010: 1.1% Nature, Vol 450, November 29 th, 2007

23 In 2011, R&D expenditure was 0 65% of GDP, which is many times less than in developed countries

24

25

26 Saturation of Clinical Trial Sites Region Number of Trial Sites (per 1M Population) US 82 Western Europe 11 Central / Eastern Europe 8 Latin America 2 Asia Pacific < 1 Source: Raps Focus, 2009, Latin American CTAs

27 Private Participation in R&D is Relatively Low in LA (% of R&D financed by the private sector) Sources: RICYT (Red de Indicadores de Ciencias y Tecnologia, 2007 OEDC Data, 2008

28 Where are the Researchers? Private Sector Government University Brazil, Ministry of Science and Technology Main Science and Technology Indicators OECD, 2007

29 Industry-University Collaboration in LA (relatively low as compared with other countries) Weighted Average: Rating is from 1-7 (7 means highest collaboration) World Economic Forum: Global Competitiveness Report

30 Comparative Patenting by LA Countries (Cumulative ) US Patent Office Data,

31 Scientific Publications by Researchers from Brazilian Institutions ( ) Thomson Reuters (Scientific) Inc. Web of Science (Science Citation Index Expanded), May 2010.

32 Brazilian Science in Latin America Source: Thomson Reuters. National Science IndicatorsBrazilian Ministry of Science and Technology, 18 Sep Source: Thomson Reuters. National Science Indicators Brazilian Ministry of Science and Technology, 18 Sep

33 The Geography of Clinical Cancer Research. Analysis of ASCO Abstracts Saad ED, et al. Annals of Oncology 21:627, 2010

34 The Geography of Clinical Cancer Research. Analysis of ASCO Abstracts There was a statistically significant temporal trend in the proportion of multinational studies. Multinational studies and abstracts with United States nationality were more frequently presented in oral and poster fashion and had more frequent involvement of the pharmaceutical industry. Saad ED, et al. Annals of Oncology 21:627, 2010

35 Clinical Research in LA: Challenges Regulatory Processes; Bureaucracy. Lack of Investment (Public and Private). Sponsor is responsible for 100% of costs (need to cover standard procedures). Post-study medication provision. Restrictions in sending biological material across borders for genetic testing. Human Resources: Training and support of young talents. Public Education (general population) with regard to Clinical Research. Need to develop and support a Culture of Cooperation.

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37 Potential of Accrual members 57 sites 12 countries LACOG Institutions Number of new cases per month = Breast Prostate Colorrectal: Lung Skin Stomach Cervix Head and Neck Uterus 204 LNH Sarcoma Melanoma Larynx Brain Thyroid 213 Kidney Esophagus Pancreas Leukemia Hepatic LH Mieloma

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