Klixar Presentation 2009

Contract Research Organization

Latin America

KLIXAR | Conesa 2046 – (C1428CUF) Buenos Aires, Argentina | +54 11 4706-3582 | www.klixar.com

Agenda

Who we are

Services

Our strengths

Our philosophy

Why KLIXAR

Why Latin America


Who we are

Clinical services Phase II to IV


Latin America


Who we are - Coverage

Brazil, Chile and Central America covered through local CRO partners


Managing Director

Clinical Operations Regulatory Affairs Quality AssuranceClinical Supplies

Administrative support

Who we are


Services


Services

The following services will be provided through three separate US-based companies whose sole focus is the activity for which they are contracted to provide quality, cost-efficient KLIXAR deliverables in a timely manner:

Medical Management, Drug Safety and Pharmacovigilance Data Management via Electronic Data Capture (EDC) Biostatistics and Data Analysis

Start-Up Activities (including regulatory and clinical operation services) Site Identification Feasibility Reports Clinical Operations (including but not limited to monitoring) Regulatory Affairs Project Management Clinical Trial Material Logistics In-sourcing

KLIXAR offers a broad spectrum of services in the clinical research field, including:


Services


Services – Clinical Study Supplies

Clinical supply logistic – Project Management

Start up study support and project/depot set up

Receipt, accountability, and storage

Warehousing management

Distribution, shipment handling

Labeling process

Final disposal, destruction

Comprehensive services and general project support

Customer support on regional services

Quality Assurance


StrengthsManagement team Flexibility

Local expertise

Investigator database

Communication

Efficiency

Quality

Regulatory

Our strengths


Our strengths - Quality


VP

Clinical OperationsExecutive Director

Clinical Operations Director

Associate Director

Associate Director

Project Manager

Clinical Team Leader

Monitor Monitor

Director, Regulatory Affairs

Associate Regulatory Manager

Regulatory Officer

Regulatory Officer

Clinical Start Up Manager

Regulatory Specialist


Clinical Start Up Coordinator

Clinical Start Up Associate

Clinical Assistant

Clinical Start Up Assistant

Regulatory Assistant

Clinical Operations

Clinical Start Up

Regulatory Affairs

Our strengths - Structure


Project Manager


Monitor Monitor

Clinical Assistant

Managing Director

Clinical Operations & Regulatory Affairs

Manager

KLIXAR

Clinical Start Up Manager

Clinical Start Up Coordinator

Associate Regulatory Manager

Regulatory Officer


Clinical Start Up Associate

Other CROs

Project Manager


Monitor Monitor

Clinical Assistant

Our strengths - Structure


TrainingOrganizational

structure EnvironmentCommunication Feedback

Our philosophy


Why KLIXAR


Why Latin America for Clinical Research?


Mean number of patients per site by region where patient enrolment was completed (2003-2005)

Why Latin America

Source: CMR International


81% of region population138% of EU population*113% of USA population

Why Latin America

Source: United Nations. Department of Economic and Social Affairs, Population Division (2007). World Population Prospects: The 2006 Revision

*Countries described

Country Population Country PopulationArgentina 38,970,911 USA 299,398,484 Brasil 186,770,582 France 63,714,000 Chile 16,432,674 Great Britain 60,777,600 Colombia 46,772,286 Spain 40,444,800 Perú 28,348,700 Italy 58,148,000 Central America 21,300,000 Romania 22,276,000

338,595,153


Central AmericaInhabitants: 21,3 mill

Inhabitants: 42,0 millBogotá: 8,5 millMedellín & Cali: 6,2 mill

Inhabitants: 28,7 millLima: 8,2 mill

Inhabitants: 40,3 millBuenos Aires: 14,9 millCórdoba y Rosario: 2,8 mill

Inhabitants: 190,0 millSao Paulo: 20,6 millRio de Janeiro: 12,3 mill

Why Latin America

Source: United Nations. Department of Economic and Social Affairs, Population Division (2007). World Population Prospects: The 2006 Revision

Inhabitants: 16,6 mill


Start up timelines (In weeks)

Costa Rica: Regulatory timelines for Phase I / II studies only. For Phase III / IV studies is 13 weeks

6.5

9.0

6.9

5.5

7.4

6.9

6.5

7.9

Months

0 5 10 15 20 25 30 35 40

Perú

Panamá

Guatemala

Costa Rica

Colombia

Chile

Brazil

Argentina

4

4

4

4

4

4

4

4

21

24

29

25

16

22

31

22

3

2

1

3

4

4

4

2

Translations/Doc collection Regulatory Importation process


Latin America

Why Latin America

Opportunities

Seasonal disorders

Indications (eg. Diabetes)


Large treatment-naïve populations concentrated in metropolitan areas

Large treatment-naïve populations concentrated in metropolitan areas

Centralized healthcare delivery

Centralized healthcare delivery

Strong patient-physician relationships

Strong patient-physician relationships

Rapid patient enrollment in clinical trials

English speaking investigatorsEnglish speaking investigatorsImproved medical infrastructure

Improved medical infrastructure

Increased awareness of ICH/GCP requirements

Increased awareness of ICH/GCP requirements

Patients have strong incentives to participate

-Access to U. Hospitals, medications-More intensive treatment, no waiting

Patients have strong incentives to participate

-Access to U. Hospitals, medications-More intensive treatment, no waiting

Why Latin America


Enrollment delay(% clinical trials)Enrollment delay(% clinical trials)

Latin AmericaLatin America

41%

EuropeEurope

55%

USAUSA

70%

Source: Thomson CenterWatch surveys

Why Latin America


In Summary

• Latin America can be taken into account not only as a rescue trials area

• KLIXAR offers services in the most important LA countries• Although regulatory frames are not on line with international

standards, the recruitment rates are usually higher than traditional countries

• Quality is not an issue


Indication Phase Country # Sites initiated

Enrollment target

Enrollment actual

Percent to target

enrollment

FPI target FPI Actual LPI target LPI actual Enrollment period

(months)

Enrollme nt rate

(pts/month)ARGENTINA 5 50 24 48% 1-Apr-06 2-May-06 30-Jul-06 29-Jun-06 1.9 12.8CHILE 2 10 11 110% 1-Apr-06 29-May-06 30-Jul-06 31-May-06 0.1 166.7COSTA RICA 2 10 24 240% 1-Apr-06 2-May-06 30-Jul-06 13-Jun-06 1.4 17.7GUATEMALA 2 10 21 210% 1-Apr-06 24-Apr-06 30-Jul-06 26-Jun-06 2.0 10.3PANAMA 2 10 27 270% 1-Apr-06 15-May-06 30-Jul-06 29-Jun-06 1.5 18.6

Internal Medicine*Pancreatic Insufficiency

III ARGENTINA 1 10 21 210% 20-Oct-07 19-Dec-07 30-Apr-08 26-May-08 5.2 4.1

ARGENTINA 6 36 64 178% 15-Sep-05 5-Oct-05 30-Sep-07 9-May-07 18.9 3.4

BRAZIL 6 36 85 236% 1-Sep-05 24-Sep-05 30-Sep-07 16-May-07 19.5 4.4

ARGENTINA 15 95 87 92% 22-abr-06 22-may-05 5-nov-07 13-nov-07 29.4 3.0BRAZIL 31 235 190 81% 31-mar-06 25-abr-06 5-nov-07 13-nov-07 18.4 10.3CHILE 4 25 14 56% 31-mar-06 3-may-06 5-nov-07 13-nov-07 18.1 0.8

ARGENTINA 26 57 50 88% 12-Aug-06 4-Sep-06 31-Jul-08 25-Jul-08 22.5 2.2BRAZIL 29 112 115 103% 15-Jul-06 13-Nov-06 31-Jul-08 25-Jul-08 20.2 5.7

ARGENTINA 2 12 12 100% 27-Feb-07 15-Aug-0 7 30-Jul-08 30-Jun-08 10.4 1.2BRAZIL 3 17 13 76% 30-Mar-07 15-Jan-08 30-Jul-08 30-Jun-08 5.4 2.4

ARGENTINA 5 15 32 267% 28-Jan-08 23-Apr-08 28-Nov-08 22-May-08 1.0 33.4BRAZIL 7 21 27 159% 28-Jan-08 23-Apr-08 28-Nov-08 3-Jun-08 1.3 20.5

Oncology*Prostrate Cancer III

IIINephrology*Renal Transplant

Oncology*Renal Transplant II

Oncology*Metastatic Colorectal Cancer

III

IIIInfectious Disease*H IV

IIINephrology*Type 2 Diabetes

Case studies


Indication Phase Country # Sites initiated

Enrollment target

Enrollment actual

Percent to target

enrollment

FPI target FPI Actual LPI target LPI actual Enrollment period

(months)

Enrollme nt rate

(pts/month)

ARGENTINA 2 10 11 11 0% 1-Nov-02 21-Jan-0 3 4-Mar-05 11-Mar-05 25.4 0.4

BRAZIL 6 64 90 14 1% 1-Dec-01 1-Jun-02 31-Jan-05 11-Mar-05 33.0 2.7

ARGENTINA 5 1 000 869 87% 17-Jun-04 14-Sep-04 31-Dec-05 12-May-05 7.9 110.7BRAZIL 8 360 1947 54 1% 17-Jun-04 31-Aug-0 4 31-Dec-05 2-Mar-05 6.0 324.3CHILE 2 396 54 14% 17-Jun-04 25-Oct-04 31-Dec-05 26-Jan-05 3.0 18.0COLOMBIA 6 265 820 30 9% 17-Jun-04 5-Oct-04 31-Dec-05 17-Mar-05 5.3 153.4

ARGENTINA 9 20 34 17 0% 22-May-08 26-May-08 6-Jun-08 6-Jun-08 0.3 103.1COLOMBIA 6 15 10 67% 19-May-08 28-May-08 6-Jun-08 6-Jun-08 0.3 37.9

ARGENTINA 7 24 20 83% 1-Aug-07 16-Aug-0 7 30-Nov-07 1-Nov-07 2.5 8.1CHILE 4 14 15 10 7% 1-Jul-07 28-Jun-07 30-Nov-07 22 -Oct-07 3.8 4.0COLOMBIA 5 17 16 94% 1-Aug-07 2-Aug-07 30-Nov-07 29 -Oct-07 2.9 5.6PERU 5 15 12 80% 1-Oct-07 23-Oct-07 30-Nov-07 5-Nov-07 0.4 30.3

ARGENTINA 10 110 136 12 4% 1-Jan-07 29-May-07 1-Oct-07 21-Aug-07 2.7 50.3COLOMBIA 5 50 49 98% 1-Jan-07 14-Apr-0 7 1-Oct-07 21-Aug-07 4.2 11.7PERU 3 75 15 20% 1-Jan-07 2 -Aug-07 1-Oct-07 22-Aug-07 0.7 22.7

ARGENTINA 11 112 122 10 9% 25-Dec-05 26-Dec-05 31-Aug-06 12-Sep-06 8.4 14.4CHILE 3 10 11 11 0% 25-Dec-05 4-Jan-06 31-Aug-06 6-Sep-06 8.0 1.4MEXICO 2 6 5 83% 25-Dec-05 4-Jan-06 31-Aug-06 31-Aug-06 7.8 0.6

IIIOncology*Primary Breast Cancer

IIINeurology*Parkinson's Disease

Rheumatology*Rheumatoid Arthritis

Rheumatology*Rheumatoid Arthritis

III

III

IIIOsteoporosis*Osteoporosis

Psychiatry*Schizophrenia IV

Case studies


Latin America

Klixar Presentation 2009

Documents

Transcript of Klixar Presentation 2009