21 countries, Area: 21 069 501 km2

Population: 590 million people

Heterogeneous population

Two major official Languages: Spanish and 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 Aires

Source: www.paho.org and www.unep.net

GDP (Billionsof USD)*

Incomeequality (2000-2010)Gini Index*

Real GDP Growth (2010)*

Literacy Rate**

Brazil 2, 181.677 55.0 7.5 90%

Mexico 1,549.671 51 5.0 93%

Source: es.wikipedia.org (*)data.worldbank.org (**)

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%

Comparing Argentina/ Chile/Venezuela/Colombia and Peru:

�Peru suffers the most from communicable diseases, while Chile is atthe other end of the scale

�With the exception of Venezuela, the economies of all of the countrieshave bounced back strongly from the global recession

Source: Mark Doxey IMS Health, IHS Global Insight. BI00042-025 Report December 2011.

�Chile and Argentina boast the strongest economies, with respectiveper capita GDPs of $15,893 and $15,044

� Public healthcare systems in Chile and Colombia cover over 90% oftheir populations, the highest levels of the 5 countries examined

� Venezuela, which has free pricing, has among the highest drug pricesin the region at $12.33 per unit, compared with a regional average of$7.74

Life Expectancy* years (2010)

Infant MortalityRate(2010)

Brazil 69 (men)76 (women)

21.9

México 73.1 (men)77.8 (women)

17.8

Source : * www.web.worldbank.org. **U.S. Bureau of Census, International Database.

77.8 (women)

Argentina 72 (men)79 (women)

11.1

Colombia 69 (men)77 (women)

16.9

Perú 71 (men)76 (women)

22.9

Chile 79 (men), 82 (women)

7.5

7 Major Players: Argentina, Brazil, Chile, Colombia, Mexico, Peru and Venezuela

3 Top Markets: Argentina, Brazil and Mexico.

50 billion (2008) projected to 80 billion (2013)

Venezuela Argentina

Brazil Mexico

Peru Chile

Colombia 50 billion (2008) projected to 80 billion (2013)

Different growth between countries: •Government cost containment policies•Economic Stability a concern

Generics Drug Industry encouraged

Health Care reforms for more people to access Medication

Source : Julianne Lewis. International Regulatory Affairs. John Hopkins University

9% 11%

34%35%

3%3% 5%

Colombia

Source: Mark Doxey IMS Health, IHS Global Insight. BI00042-025 Report December 2011.

Country # open studies 3

Trend

Brazil 962

Mexico 439

Argentina 350

Country # open studies 3

Trend

Venezuela 21

Panama 32

Chile 190

Perú 153

Colombia 172

Costa Rica 12

Ecuador 17

Uruguay 13

Bolivia 8

Paraguay 3

Info captured as open studies in clinicaltrials.gov on (3) 24 Sep 2011 compared to 26 December 2011

1000

1200

Título del gráfico

Brazil

0

200

400

600

800

01-ago-10 01-ago-11 01-ago-12

Tít

ulo

de

l e

je

Brazil

Mexico

Argentina

Chile

Peru

Colombia

Info last captured as open studies in clinicaltrials.gov 24 September 2012 (Open Studies)

Comparing Argentina/ Chile/Venezuela/ Colombia and Perú:

� Argentina leads the 5 countries in Phase IIand III clinical trial numbers

� The majority of trials were sponsored byinternational pharma companies

� Pfizer, Sanofi, GSK, Novartis are the mostactive companies by trial numbers acrossthe 5 countries

� International pharma have also establishedmanufacturing bases in several countries inthe region, especially in Chile

Source: Mark Doxey IMS Health, IHS Global Insight. BI00042-025 Report December 2011.

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)

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 (minimal4. 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

Region Recruitedsubjects/site/month2006

Recruited Subjects/site/month 2008

Latin America 2.2 2.3

Spain 1.6 2.2

France 1.4 2.2

USA 0.8 2.1

UK 1.0 2.1

Canada 1.2 1.2

Source: Leem- Leem Recherche. Place de la France dans la Recherche Clinique Internationale Enquete 2008. Paris 10 October 2008

Region Number of Studies Analyzed

#of recruited subjects

% of recruited patients

Patients per million 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% 442

Source: Leem- Leem Recherche. Place de la France dans la Recherche Clinique Internationale Enquete 2008. Paris 10 October 2008

� Quality proven regional vendors for support services: couriers, warehouses, regional and

national central labs, investigator meeting locations.

� Clinical Research Professionals Certification and Post Graduate, University Level, Clinical

Research Masters available locally for Physicians, Study Coordinators and CRAs since 2007.Research Masters available locally for Physicians, Study Coordinators and CRAs since 2007.

� Highly controlled regulatory environment, aligned and experienced with ICH-GCP guidelines

compliance (e.g. in Argentina and Brazil since 1996).

�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 in

research highly competitive compared to those of USA/Canada/Europe.

�Reference Sites concentrating less prevalent diseases help optimize costs and simplify site

selection.

� Similar time Zone as the USA/ Europe (5 hour difference or less)

� Adequate communication & IT technology at most sites

� Presence 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 foster

training and shape regulations for an continuously improving environment for clinical

trials.

� 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 densely

populated 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 the

latest standards and technology.

� Disparities in economic resources and access to health.

� Most health research funded by industry.

� Significant treatment-naïve patient population.� Significant treatment-naïve patient population.

� Poor access to newly available (expensive) treatments and frequent requirement that

best proven treatment after the study to be provided at no cost.

� Placebo use rationale needed, Medical and Scientific opinion within the research

location a plus.

� 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 administration Research dedicated infrastructure such as Phase I units and Biologics administration

facilities. More are needed as research grows.

� Legal instruments at local or district level must synergize to stimulate research and

continue 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.

Country Agency Website

Argentina www.anmat.gov.ar

Chile www.ispch.cl

Colombia www.invima.gov.co

Costa Rica www.ministeriodesalud.go.cr

Bolivia www.sns.gob.bo

Brazil www.anvisa.gov.br

Ecuador www.msp.gov.ec

Guatemala www.mspas.gob.gt

Mexico www.salud.gob.mx

Paraguay www.mspbs.gov.py

Uruguay www.msp.gub.uy

Opportunities Challenges

CTA REVIEW PROCESS

•CONEP and ANVISA reviews are now parallel process in Brazil.•New electronic submission possible in Chile (ISP) and Argentina (ANMAT).

•Importation process in all countries may delay FPFV planned date.•Local valid Insurance policy is needed in Brazil and Argentina.

INSPECTIONS •ANMAT consolidates Inspections Information on Inspection performanceINSPECTIONS BY MOH

•ANMAT consolidates Inspections program and increases scope to sponsor/CRO overview, ISP (2008) and ANVISA (2009) program currently ongoing

Information on Inspection performanceresults not publicly available.

ETHICS/ ICF •ANMAT incorporates GCP compliance requirement for all Institutional IRBs reviewing research (6677/2010). •Ministry Of Health in Argentina issues 1480/2011 regulation, a practical guidance for Boards Reviewing Research.

•Questions about rational for placebo use and trial design by ANMAT/CONEP. •CONEP (Brazil) and ANMAT (Argentina) may require treatment availability after study at no cost.

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.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.

Three major countries in Latin America, with a total population of 250 million people are:

� Brazil (190.732 million),� Mexico (113.910 million)� Mexico (113.910 million)� Argentina (40.091 million), � Peru (29.077 million)� Chile (16.503 million).

The region's ethnicity make up makes patient enrollment for any clinical study simpler.

Blanchard & AssociatesBlanchard & Associates1172 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.com

www.blanchardyasociados.com.ar