BRAZILBRAZIL

Brazil Clinical Development

Profile

Info@ISRreports.com

©2014 Industry Standard Research www.ISRreports.com

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Report OverviewIn this report, ISR provides insight into the clinical trial regulation and development environment, sponsor and

service provider activities, and population “health status” for Brazil.

Methodologies:ISR gathered content for this report via an exhaustive secondary research effort and from company profile

questionnaires that were distributed to CROs profiled in this report.

Q1, 2014Publication Date

79Pages

56Charts and Graphs

Report Structure: 1. Introduction

2. Brazilian Health Statistics

3. Clinical Trial Overview and Trial Metrics

4. Profile of Domestic Clinical Service Providers

5. Brazil Pharma/CRO Associations

6. International CROs Operating in Brazil

Valuable for: Clinical Operations, Medical Directors, Patient Recruitment,

Site Selection, Portfolio Management

What you will learn in this report:

How you can use this report:

• How population health status, regulations and clinical trial activity, and international and domestic company partnerships make Brazil one of the top emerging global pharmaceutical markets

• Insights from domestic service provider

organizations on conducting clinical trials in Brazil

• Clinical trial operational metrics for Brazil-only clinical studies

• Compiled lists and contact details for domestic and international service providers in Brazil

• Understand how Brazil compares to other countries on a variety of health condition scales so the reader can best consider the areas in which Brazil may be beneficial as a trail site

• Understand the legal, logistical, and regulatory details for conducting Brazilian trials, and illustrate the benefits and drawbacks of conducting trials in Brazil

NEXT: Table of Contents and Sample Pages

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Table of Contents

Copyright and Usage GuidelinesMethodology and SourcesIntroductionBrazil Health Statistics

Health status summary

Life expectancy

Cancer incidence rate

Female breast cancer incidence

Male prostate cancer incidence

AIDS incidence

HIV prevalence

Tobacco consumption

Alcohol consumption

Prevalence of diabetes – adults

Prevalence of dementia

Prevalence of obesity – adults

Practicing doctors

Health expenditure per capita

Total health expenditure as a share of GDP

Clinical Trial OverviewRegulatory overview

Clinical trial legislation

Clinical Trial Activity

Number of Clinical Trials

Clinical trials, by phase

Study type distribution (e.g. interventional)

Interventional trials, by phase

Observational trials, by phase

Industry-funded study type distribution

Industry-funded interventional trials, by phase

Industry-funded observational trials, by phase

Average Length of Clinical Trials

Average trial length, by phase

Average interventional trial length, by phase

Average observational trial length, by phase

Average industry-sponsored interventional trial length, by phase

Average industry-sponsored observational trial length, by phase

Projected vs. actual ongoing trial length, by phase

Projected vs. actual ongoing interventional trial length, by phase

Projected vs. actual ongoing observational trial length, by phase

Projected vs. actual ongoing industry-sponsored interventional trial length, by phase

Projected vs. actual ongoing industry-sponsored observational trial length, by phase

Average Clinical Trial Enrollment

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Average enrollment by phase

Interventional enrollment, by phase

Observational enrollment, by phase

Industry-sponsored, interventional trial enrollment, by phase

Industry-sponsored, observational trial enrollment, by phase

Selected Sponsor Distribution of Clinical Trials

Funding Source Distribution of Trials

Total funding source distribution of trials

Funding source distribution of phase I trials

Funding source distribution of phase II trials

Funding source distribution of phase III trials

Funding source distribution of phase IV trials

Domestic service provider capabilities

Domestic Clinical Service ProvidersCIDP Biotech - Brazil

Background / History

Regulation and ethic committee

GC - 2

Background / History

Company Profile Responses

Map of clinical activity

Press Release

HRPC

Background / History

Intrials

Background / History

Delays in site enrollment

Phases of operation breakdown

Press Release

Medicamenta MRS

Background / History

Newco Trials

Background / History

PGS Medical Statistics

Background / History

PHC – Consulting and Scientifc

Background / History

Company Profile Responses

Company organization

Article from Exame Magazine

Techtrials

Background / History

Company Profile Responses

Oracle partnership description

Domestic Service Provider Contact ListBrazil Pharma/CRO AssociationsInternational CROs operating in BrazilAbout Industry Standard Research

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Introduction

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Introduction

Welcome to ISR’s second Investigator Payments report highlighting Europe’s clinical trial compensation. In this report, ISR wanted to gain a better understanding of what drives investigator payments so that sponsors and CROs can benchmark their payment levels and better plan for study costs.

Determinants of investigator payments come in many forms such as therapeutic area, compound orientation, trial complexity, and patient needs. Is there a one-size-fits-all formula that can be applied uniformly across studies to produce the most effective compensation plan? Perhaps not, but by using this array of compensation averages provided by site personnel and by understanding their non-monetary motivations for trial participation, ISR believes a sponsor or CRO can recruit and retain high quality sites without breaking the budget.

This is a site-wide license and this file is not to be distributed beyond the terms of this agreement. For information on the license holder, please contact ISR (info@ISRreports.com).

Sample Page

Brazil’s population is approximately 200 million and represents enormous potential for the pharmaceutical industry. The country is beginning to build a reputation for high-quality clinical trials and biodiversity, and is attracting multinational pharmaceutical companies as it continues to develop its domestic providers as well.

According to IMS Health’s Medicines Outlook Through 2016 Report, the pharmaceutical mar-ket in Brazil has experienced, on average, a 15.6% compound annual growth rate (CAGR) from 2007-2011. IMS forecasts that Brazil will experience a CAGR of 12-15% from 2012-2016. It is also estimated that Brazil’s pharmaceutical spend per capita will be $180.

The Brazilian pharmaceutical market does pose a number of challenges due to its diverse nature. A challenge for foreign players planning to enter the market is the legal framework of the country. This forces the companies into partnering with local companies, resulting in profit and control sharing. The legal and regulatory framework for patents is limited, leading to a lack of protection for intellectual property rights.

In the process of writing this report, ISR reached out the CROs profiled in this report. Question-naires were sent to contacts within these companies that asked questions regarding the com-pany’s profile, the benefits and shortcomings of conducting trials in Brazil, and trends they’ve noticed in those planning to outsource clinical studies in Brazil. Not all of the CROs profiled in this report provided answers to the questionnaire that was sent.

The complete responses from the CROs that responded are included in their entirety in this re-port. However, there were a few trends ISR noticed in the responses that we believe are worth highlighting in this portion of the report. Primarily, ISR noticed that regulatory related concerns are the primary concerns respondents voiced with regard to conducting clinical trials in Brazil.

The question posed by ISR was: “What are the challenges in conducting a trial in Brazil?” Some of the responses received are shown below:

“The main challenge is to improve regulatory submission timelines.”

“Regulatory approvals timing”

“The current regulatory scenario shows that depending on the project type it could take around 7-9 months for having the study approved by all required regulatory agencies (CEP, CONEP and ANVISA).”

Timeline issues are typically a main concern in clinical research and, within the Brazilian contract research market, regulatory issues are a major factor contributing to timeline delays. Respondents from the domestic Brazilian CROs realize regulatory delays associated with con-ducting clinical trials in Brazil are substantial and often reach out to clients to make them aware of the delays that could be experienced.

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Brazil Health Statistics

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Female breast cancer incidenceThe following chart, from the Health at a Glance OECD 2011 report, shows age-standardized female breast cancer incidence rates, 2009 (or nearest year)� Brazil reports a rate of 42�3 per 100,000 females� This number is lower than the OECD average of 71�6�

21.6 22.9

27.2 28.3

36.2 38.9 40.1 41.0 42.3 42.7 43.2 44.9

48.9 50.2

53.4 57.9

60.0 61.0

65.5 67.7

69.9 71.6

76.0 76.2

81.8 82.3 82.7 83.2 84.8 86.2 86.3 86.6 87.9 89.1 89.4 89.4

93.9 96.8 96.8

99.7 109.4

0 20 40 60 80 100 120

China India

Mexico Turkey

Indonesia Korea Chile

South Africa Brazil

Japan Russian Federation

Greece Poland Estonia

Slovak Republic Hungary Portugal

Spain Slovenia

Czech Republic Austria OECD

United States Norway

Germany Luxembourg

Sweden Canada

Australia Iceland

Italy Finland

United Kingdom Denmark

Switzerland New Zealand

Ireland Netherlands

Israel France

Belgium

Age-standardized rates per 100,000 population

Female breast cancer incidence The following chart, from the Health at a Glance OECD 2011 report, shows age-standardized female breast cancer incidence rates, 2009 (or nearest year). Brazil reports a rate of 42.3 per 100,000 females. This number is lower than the OECD average of 71.6.

©2014 Industry Standard Research

This is an enterprise-wide license and this file is not to be distributed beyond the terms of this agreement. For information on the license holder, please contact ISR (info@ISRreports.com).

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Clinical Trial Overview

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Regulatory overviewAccording to SOMO’s Putting Contract Research Organisations on the Radar, the Brazilian regulatory agency ANVISA or Agência Nacional de Vigilância Sanitária (the Brazilian equivalent of the United States FDA) changed the regulatory process to expedite the regulatory approval of multicenter clinical trials in 2009� Today, only local ethics committees of the coordinator sites have to approve the study instead of all local ethics committees that have jurisdiction over each investigative site involved� After this approval is granted, the National Ethics Committee (CONEP) and ANVISA are approached simultaneously for approval� ANVISA is also the agency that gives approval for importation�

SOMO also goes on to reveal there are no regulatory requirements to disclose the conditions of the contracts between the sponsors of the study and the CROs, or between the sponsors and the principal investigators, to the ethics committees� ANVISA has access to the conditions but it is not used to evaluate whether the contractual arrangements protect the rights of the research participants�

SOMO’s Brazil regulatory flowchart

Putting Contract Research Organisations on the Radar

CROs in case study countries 45

The choice of the coordinator site is now crucial as the approval for all investigators sites is now in the hands of one local ethics committee. If used appropriately, the new legislation should not weaken the protection of clinical trial participants. However, in an interview, a member of the National Ethics Commission expressed concern and emphasised the need to monitor the implementation of the new process.125 The interviews with CROs indicate that the speed of proposal approval by the ethics committees is an important decisive factor in selecting the coordinating centre.126

Figure 5: Regulatory flowchart – Brazil127

Source: Business Insights.

The first Brazilian regulation that mentions the word CRO (known as ORCP in Brazil) is the RDC number 39, which was approved on 5 July 2008. This regulation defines the concept of CRO and its obligations. Like in Argentina, the only requirement is that the CROs obtain a license to operate, as any other health provider. ANVISA does not register a CRO until they present a project to the regulatory agency.

Contrary to the situation in Argentina, there is no obligation to disclose the conditions of the contracts between the sponsors of the study and the CROs, or between the sponsors and the principal investigators, to the ethics committees. This means that ECs cannot include the lines of responsibility in their judgement when deciding whether to allow a clinical trial to proceed. ANVISA has access to this information, but it is not used to evaluate whether the contractual arrangements protect the rights of the research participants.

For an overview of the main legislation regarding clinical trials in Brazil, see Table 10.

125 Brasília, 9 September 2010. 126 Interview clinical investigator, Sao Paulo, 17 August 2010. 127 Emerging Clinical Trial Locations. Market dynamics and the changing healthcare and regulatory environment, Business

Insights, July 2009.

Source: SOMO

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Clinical Trial Overview

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Average interventional trial length, by phase

The table represents the average number of months trials conducted only in Brazil took (recently completed trials) or are scheduled to take (ongoing trials) by their phase of development� How to read the table: Ongoing Phase I interventional studies are projected to take, on average, 19 months to complete�

Ongoing(projected trial length)

(months)

Recently Completed Trials

(actual trial length)

(months)

Average(months)

Average(months) 32 (N=415) 22 (N=556) 26 (N=971)

Phase 1 19 (N=3) 30 (N=5) 26 (N=8)

Phase 2 15 (N=15) 23 (N=27) 20 (N=42)

Phase 3 43 (N=54) 25 (N=65) 32 (N=119)

Phase 4 31 (N=91) 22 (N=144) 25 (N=235)

No Phase 36 (N=78) 24 (N=87) 29 (N=165)

Average observational trial length, by phase

The table represents the average number of months trials conducted only in Brazil took (recently completed trials) or are scheduled to take (ongoing trials) by their phase of development� How to read the table: Ongoing observational studies are projected to take, on average, 36 months to complete�

Ongoing(projected trial length)

(months)

Recently Completed Trials

(actual trial length)

(months)

Average(months)

Average(months) 36 (N=60) 30 (N=71) 32 (N=131)

Phase 0 23 (N=1) 39 (N=1) 31 (N=2)

Phase 1

Phase 2 45 (N=1) 45 (N=1)

Phase 3

Phase 4

No Phase 37 (N=57) 29 (N=70) 32 (N=127)

©2014 Industry Standard Research

©2014 Industry Standard Research

This is an enterprise-wide license and this file is not to be distributed beyond the terms of this agreement. For information on the license holder, please contact ISR (info@ISRreports.com).

Average interventional trial length, by phase

The table represents the average number of months trials conducted only in Brazil took (recently completed trials) or are scheduled to take (ongoing trials) by their phase of development. How to read the table: Recently completed Phase I interventional studies took, on average, 30 months to complete.

Ongoing(projected trial

length)

(months)

Recently Completed Trials

(actual trial length)

(months)

Average(months)

Average(months) 22 (N=556)

Phase 1 30 (N=5)

Phase 2 23 (N=27)

Phase 3 25 (N=65)

Phase 4 22 (N=144)

No Phase 24 (N=87)©2014 Industry Standard Research

Data available in full report

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Sample Page

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Clinical Trial Overview

www.ISRreports.com ©2014 | Brazil: Clinical Development Profile 35

Average interventional trial length, by phase

The table represents the average number of months trials conducted only in Brazil took (recently completed trials) or are scheduled to take (ongoing trials) by their phase of development� How to read the table: Ongoing Phase I interventional studies are projected to take, on average, 19 months to complete�

Ongoing(projected trial length)

(months)

Recently Completed Trials

(actual trial length)

(months)

Average(months)

Average(months) 32 (N=415) 22 (N=556) 26 (N=971)

Phase 1 19 (N=3) 30 (N=5) 26 (N=8)

Phase 2 15 (N=15) 23 (N=27) 20 (N=42)

Phase 3 43 (N=54) 25 (N=65) 32 (N=119)

Phase 4 31 (N=91) 22 (N=144) 25 (N=235)

No Phase 36 (N=78) 24 (N=87) 29 (N=165)

Average observational trial length, by phase

The table represents the average number of months trials conducted only in Brazil took (recently completed trials) or are scheduled to take (ongoing trials) by their phase of development� How to read the table: Ongoing observational studies are projected to take, on average, 36 months to complete�

Ongoing(projected trial length)

(months)

Recently Completed Trials

(actual trial length)

(months)

Average(months)

Average(months) 36 (N=60) 30 (N=71) 32 (N=131)

Phase 0 23 (N=1) 39 (N=1) 31 (N=2)

Phase 1

Phase 2 45 (N=1) 45 (N=1)

Phase 3

Phase 4

No Phase 37 (N=57) 29 (N=70) 32 (N=127)

©2014 Industry Standard Research

©2014 Industry Standard Research

This is an enterprise-wide license and this file is not to be distributed beyond the terms of this agreement. For information on the license holder, please contact ISR (info@ISRreports.com).

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Market access

Med community access

Multilingual

Medical writing

Patient recruitment

Pharmacovigilance

Reporting & analytics

Site management

General

Allergy

Anesthesiology

Antibiotics

Antivirals

Cardiology

Dermatology

Devices & Imaging

Diabetes

©2014 Industry Standard Research

Data available in full report

Domestic service provider capabilities

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