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Ct In Latin America SEP 2012

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Updated status of FDA Site inspections and open studies by September 2012

Updated status of FDA Site inspections and open studies by September 2012


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  • 1. 21 countries, Area: 21 069 501 km2 Population: 590 million people Heterogeneous population Two major official Languages: Spanish and Portuguese (Brazil) Average Life expectancy 75 years Population Concentrated in Major Urban Areas such as Mexico City, Sao Paulo or Buenos AiresSource: www.paho.org and www.unep.net
  • 2. GDP (Billions Income Real GDP Literacy Rate of USD)* equality (2000- Growth (2010)* ** 2010) Gini Index*Brazil 2, 181.677 55.0 7.5 90%Mexico 1,549.671 51 5.0 93%Argentina 632.223 48 7.5 98%Colombia 429.866 58.5 4.7 93%Perú 273.276 50.5 8.3 90%Chile 257.546 52.0 5.0 99% Source: es.wikipedia.org (*)data.worldbank.org (**)
  • 3. Comparing Argentina/ Chile/Venezuela/Colombia and Peru: Peru suffers the most from communicable diseases, while Chile is at the other end of the scale With the exception of Venezuela, the economies of all of the countries have bounced back strongly from the global recession Chile and Argentina boast the strongest economies, with respective per capita GDPs of $15,893 and $15,044 Public healthcare systems in Chile and Colombia cover over 90% of their populations, the highest levels of the 5 countries examined Venezuela, which has free pricing, has among the highest drug prices in the region at $12.33 per unit, compared with a regional average of $7.74 Source: Mark Doxey IMS Health, IHS Global Insight. BI00042-025 Report December 2011.
  • 4. Life Expectancy* Infant Mortality years (2010) Rate (2010) Brazil 69 (men) 21.9 76 (women) México 73.1 (men) 17.8 77.8 (women) Argentina 72 (men) 11.1 79 (women) Colombia 69 (men) 16.9 77 (women) Perú 71 (men) 22.9 76 (women) Chile 79 (men), 7.5 82 (women)Source: * www.web.worldbank.org. **U.S. Bureau of Census, International Database.
  • 5. Venezuela Argentina 7 Major Players: Argentina, Brazil, Chile, Colombia, Brazil Mexico Mexico, Peru and Venezuela Peru Chile 3 Top Markets: Argentina, Brazil and Mexico. Colombia 50 billion (2008) projected to 80 billion (2013)3% 3% 5% Different growth between countries: 9% 11% •Government cost containment policies •Economic Stability a concern Generics Drug Industry encouraged 35% 34% Health Care reforms for more people to access MedicationSource: Julianne Lewis. International Regulatory Affairs. John Hopkins University
  • 6. Source: Mark Doxey IMS Health, IHS Global Insight. BI00042-025 Report December 2011.
  • 7. Country # open Trend Country # open Trend studies 3 studies 3Brazil 962Mexico 439 Venezuela 21Argentina 350 Panama 32Chile 190 Costa Rica 12Perú 153 Ecuador 17Colombia 172 Uruguay 13 Bolivia 8 Paraguay 3 Info captured as open studies in clinicaltrials.gov on (3) 24 Sep 2011 compared to 26 December 2011
  • 8. Título del gráfico 1200 1000 BrazilTítulo del eje 800 Mexico 600 Argentina Chile 400 Peru 200 Colombia 0 01-ago-10 01-ago-11 01-ago-12 Info last captured as open studies in clinicaltrials.gov 24 September 2012 (Open Studies)
  • 9. Comparing Argentina/ Chile/ Venezuela/ Colombia and Perú: Argentina leads the 5 countries in Phase II and III clinical trial numbers The majority of trials were sponsored by international pharma companies Pfizer, Sanofi, GSK, Novartis are the most active companies by trial numbers across the 5 countries International pharma have also established manufacturing bases in several countries in the region, especially in Chile . Source: Mark Doxey IMS Health, IHS Global Insight. BI00042-025 Report December 2011
  • 10. Country # Inspections (% OAI) Brazil 31 (0%) Mexico 26 (19%) Argentina 48 (2.00%) Chile 9 (0%) Peru 8 (25%) Colombia 3 (0%) Venezuela 2 (0%) Panamá 2 (0%) Costa Rica 9 (0%) Ecuador 1 (0%)http://www.accessdata.fda.gov/scripts/cder/CLIIL/, (updated 24 Sep 2012)
  • 11. 1. Large, ethnically diverse population.2. Availability of treatment-naive patients in all therapeutic areas.3. Complementary to northern hemisphere sites for indications with seasonal variations (such asrespiratory diseases).4. Strong patient-doctor relationship, leading to good compliance & retention rates (minimaldropout rates).5. Niche for emerging and neglected diseases.6. Many significant metropolitan areas with population concentration in big cities: Sao Paulo 11.24m in Brazil Buenos Aires 13.82m in Argentina Santiago 6.1m in Chile (www.worldpharmaceuticals.net/editorials/013_march08/013_latin.pdf; http://www.ghf06.org/reports/35
  • 12. Region Recruited Recruited subjects/site/month Subjects/site/month 2008 2006Latin America 2.2 2.3Spain 1.6 2.2France 1.4 2.2USA 0.8 2.1UK 1.0 2.1Canada 1.2 1.2Source: Leem- Leem Recherche. Place de la France dans la Recherche Clinique Internationale Enquete 2008. Paris 10 October 2008
  • 13. Region Number of #of % of Patients per Studies recruited recruited million Analyzed subjects patients citizens Latin America 161 23 341 7.5% 46 USA 181 40 433 12.9% 133.1 Australasia 185 9 653 3.1% 140.8 UK 173 16 873 5.4% 276.9 Canada 191 14 695 4.7% 442Source: Leem- Leem Recherche. Place de la France dans la Recherche Clinique Internationale Enquete 2008. Paris 10 October 2008
  • 14. Quality proven regional vendors for support services: couriers, warehouses, regional andnational central labs, investigator meeting locations. Clinical Research Professionals Certification and Post Graduate, University Level, ClinicalResearch Masters available locally for Physicians, Study Coordinators and CRAs since 2007. Highly controlled regulatory environment, aligned and experienced with ICH-GCP guidelinescompliance (e.g. in Argentina and Brazil since 1996).
  • 15. Decreased travel to and from sites (densely populated cities).Multiple academic, public and private hospitals in small areas.Salaries and Professional fees for Researchers and medical procedures involved inresearch highly competitive compared to those of USA/Canada/Europe.Reference Sites concentrating less prevalent diseases help optimize costs and simplify siteselection.
  • 16. Similar time Zone as the USA/ Europe (5 hour difference or less)Adequate communication & IT technology at most sitesPresence of major pharmaceutical companies and CROs.Just two Languages spoken across the region: Spanish and Portuguese.Potential for growth of the Clinical Research activity.Clinical Research Professionals (Investigators and Sponsors) are organized to fostertraining and shape regulations for an continuously improving environment for clinicaltrials.
  • 17. Relatively fast accrual of patients.Smaller competition for patients compared to EU countries and USA.High prevalence of certain diseases and big reference institutions in denselypopulated cities with a long research tradition.Climate, racial and social diversity.Research Ethics Committees meet ICH GCP standards.Specific legislation for Clinical Research continuously reviewed, keeping up to thelatest standards and technology.
  • 18. Disparities in economic resources and access to health.Most health research funded by industry.Significant treatment-naïve patient population.Poor access to newly available (expensive) treatments and frequent requirement thatbest proven treatment after the study to be provided at no cost.Placebo use rationale needed, Medical and Scientific opinion within the researchlocation a plus.
  • 19. Research Review Committees are improving: following up, independence, transparency,competency, clinical research ethics and GCP training for members.Research dedicated infrastructure such as Phase I units and Biologics administrationfacilities. More are needed as research grows.Legal instruments at local or district level must synergize to stimulate research andcontinue actual oversight and improve timelines.Focus on the question that the protocol needs to answer, not on the Investigator fees.Follow up on protocol final results.
  • 20. Country Agency WebsiteArgentina www.anmat.gov.arChile www.ispch.clColombia www.invima.gov.coCosta Rica www.ministeriodesalud.go.crBolivia www.sns.gob.boBrazil www.anvisa.gov.brEcuador www.msp.gov.ecGuatemala www.mspas.gob.gtMexico www.salud.gob.mxParaguay www.mspbs.gov.pyUruguay www.msp.gub.uy
  • 21. Opportunities ChallengesCTA REVIEW •CONEP and ANVISA reviews are now •Importation process in all countries mayPROCESS parallel process in Brazil. delay FPFV planned date. •New electronic submission possible in •Local valid Insurance policy is needed Chile (ISP) and Argentina (ANMAT). in Brazil and Argentina.INSPECTIONS •ANMAT consolidates Inspections Information on Inspection performanceBY MOH program and increases scope to results not publicly available. sponsor/CRO overview, ISP (2008) and ANVISA (2009) program currently ongoingETHICS/ ICF •ANMAT incorporates GCP compliance •Questions about rational for placebo requirement for all Institutional IRBs use and trial design by ANMAT/CONEP. reviewing research (6677/2010). •CONEP (Brazil) and ANMAT (Argentina) •Ministry Of Health in Argentina issues may require treatment availability after 1480/2011 regulation, a practical guidance study at no cost. for Boards Reviewing Research.
  • 22. Early planning a must: always review processes and steps involved.Selecting a CRO based in the region a plus: Regulatory affairs professionals native to the country, and familiar with culture, laws and regulations and standards. Be aware of local requirements on regulatory setup critical documentation.Plan ahead, pick sites smartly and fit them into your strategy.
  • 23. Three major countries in Latin America,with a total population of 250 million people are:Brazil (190.732 million),Mexico (113.910 million)Argentina (40.091 million),Peru (29.077 million)Chile (16.503 million).The regions ethnicity make up makespatient enrollment for any clinical study simpler.
  • 24. Blanchard & Associates 1172 South Dixie Hwy Suite# 442 Coral Gables FL33146 USA TEL: +54 11 4553 2682/ 4554-9346 FAX: +54 11 4554 8933 Anne Blanchard, CCRA, CEO ab@blanchardyasociados.comwww.blanchardyasociados.com.ar