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Drug Development Latin America


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CHI’s and the BioPharma Strategy Series’ Second Annual Drug Development Latin America: Effectively Planning and Implementing Clinical Research and Trials will be held March 10-11, 2010 at the Crowne Plaza Philadelphia Downtown in Philadelphia, PA. This year this gathering will be co-located with the Summit for Clinical Ops Executives (SCOPE), a four-day cluster of events taking place March 8-11, 2010. CHI’s Drug Development Latin America will open with an inclusive short course on ‘Country and Site Feasibility and Selection for Global Clinical Trials’ and will be preceded immediately by its sister conference, the Third Annual Patient Recruitment in Clinical Trials conference.

The globalization of R&D into emerging regions continues. Growing R&D spending in Asia, Latin America and CIS countries has been driven by many factors including the attractiveness of commercial markets there, more favorable economics including lower relative costs for greater speed, access to highly skilled professional labor and a large pool of patients, particularly treatment-naïve ones. Pharmaceutical and biotechnology companies are seeing rapid growth in the volume of their clinical research, development, and clinical trials activity in Latin America. At the same time, this region presents unique challenges that must be anticipated and managed. This conference is intended to cover the key issues, opportunities, and challenges of clinical research, development, and clinical trials in Latin America.

Wednesday, March 10, 2010

7:30 AM Morning Coffee or Sponsored Breakfast Presentation (Sponsorship Opportunity Available) and Short Course Registration


Country and Site Feasibility and Selection for Global Clinical Trials

8:30 Organizer’s Welcome & Chairperson’s Opening Remarks

Micah Lieberman, Executive Director, Conferences, Cambridge Healthtech Institute (CHI)

Luis RussoLuis Augusto Russo, M.D., Medical Director and Chief Executive Officer, CCBR Brasil; Director, Brasilian Society of Investigators and Research Centers (APCB)

8:45 Part 1: Understanding Regional and Country-Specific Challenges and Opportunites for Country and Site Selection

Julio CampsJulio Camps, M.D., Director, Regional Head Latin America, Amgen Development Operations



• How to position Latin America when competing with other Regions in the allocation of global sites
• Understanding the best approach when selecting the Region to participate in a Global Clinical Trial
• Once the Region is selected, which countries should be explored?
• The Regulatory Factor: Is there a preferred Therapeutic Area expertise in certain countries?
• Site selection: Experienced big sites vs. and small new sites. Academic sites vs. private clinics. Sites located in big cities vs. sites located in peripheral cities.

9:15 Part 2: Using Qualitative and Quantitative Data to Drive Global Country and Site Selection from the Sponsor Perspective

Charles SchweizerCharles Schweizer, Ph.D., Senior Director, Clinical Operations, Morphotek, Inc.

Selection of optimal countries and sites is pivotal to the success of clinical programs. Factors to be considered include a balance of long-term strategic objectives versus short-term study goals and requirments. This session will review these strategic and tactical considerations, and then review the methods used to collect and analyze primary and secondary data that can be used to facilitate decision-making. This methodology should be comprehensive and identify both risks and opportunities to the sponsor. Reviews both traditional and newer methods to comprehensive country/ site selection, including a shift toward a more comprehensive analysis rather than the more traditional focus primarily on patient accrual. Understanding of the importance of a comprehensive analysis for country and site selection, and what methods should be considered for the overall analysis. Focus is on the application of health service/epidemiological methods to country/site selection, with the session aimed toward additional risks sponsors should be cognizant of during the analysis process.

Sponsored by
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9:45 Part 3: Overcoming Common Challenges in Global Site Selection

Gaynor Anders Gaynor Anders, Vice President, Global Operations, MMG
Considerations and strategies for accelerating patient recruitment in Latin American countries will be presented by a pair of global patient recruitment experts.  Case studies illustrating specific enrollment barriers and the tactics used to overcome them will be shared.  Attendees will apply session learnings to sample scenarios in work groups. 

• Learn how variable regional and country conditions impact patient recruitment
• Deepen understanding of how to maximize the effectiveness of patient recruitment programs in Latin America
• Discuss specific challenges with patient recruitment in Latin America

10:15 End of Short Course; Networking Coffee Break and Exhibit Viewing 


Drug Development Latin America: Session A

10:15 Main Conference Registration

10:55 Chairperson’s Opening Remarks

Luis Augusto Russo, M.D., Medical Director and Chief Executive Officer, CCBR Brasil; Director, Brasilian Society of Investigators and Research Centers (APCB)

11:00 Latin America vs. Other Emerging and Non-Emerging Markets in Clinical Research: Regulations, Investigators, and Ethics Committees

Ana Maria ValderramaAna Maria Valderrama, M.D., Area Head, Clinical Operations, Canada/Latin America/Africa/Middle East Region, Pfizer, Inc.

Latin American countries operate increasingly in accordance with international standards and guidelines. Even though they are considered to have many similarities, it is important to keep in mind that in reality these are different countries, with different cultures, regulatory requirements, pathologies, incidence rates, standards of care, etc. For this reason it is very important to have local knowledge to accommodate diversity while leveraging shared characteristics. Also, of great importance is the increasing competition from other countries to attract clinical research. This session will provide a quick overview of LA’s current clinical research environment, summarize its challenges and opportunities, will share the successful stories of other countries out of LA, and will close with a discussion on lessons learned.

11:30 Use of Customer Capital Management to Identify and Develop Study Sites in Brazil

Carlos SanmarcoCarlos Sanmarco, Clinical Operations Manager, Clinical Development Organization, Eli Lilly do Brasil Ltda.

This presentation will demonstrate a new and excellent way to understand how to manage the customer capital in a pharmaceutical company or CRO and how to transform this knowledge not used or mapped in the main competitive weapon of the area. The audience will be able to identify and map the main processes and factors that must be considered in Customer Capital Management, and also will have an example tool that may be used to manage this information.


12:00 PM Luncheon Presentation (Sponsorship Available. Contact Arnie Wolfson: 781.972.5431, or Lunch on Your Own

1:40 Chairperson’s Remarks

Julio Camps, M.D., Director, Regional Head Latin America, Amgen Development Operations

1:45 Implementing Trials in Brazil, Mexico, Argentina and Other Countries in Latin America

Oscar Enrique García GálvezOscar Enrique García Gálvez, M.D., Clinical Research Director, sanofi aventis Mexico

Latin America is more and more attractive for Clinical Trials, however the implementation is not as easy as could be expected. There are several differences among the Latin American countries that do not allow managing the region easily, so when trying to involve Latin America we should take differences into account to succeed. Main issues in Latin America are the timelines for getting the protocols approved and in some countries the increasing concern about the use of a placebo. Knowledge of the region and some flexibility to adapt to local needs are key to succeed.

2:15 Contracts and Budget Negotiation in Latin America

Luis RussoLuis Augusto Russo, M.D., Medical Director and Chief Executive Officer, CCBR Brasil; Director, Brasilian Society of Investigators and Research Centers (APCB)

This presentation will discuss the key issues and trends for contract and budget negotiation in Latin America. Attendees will better understand timelines, turnaround in private and public centers, average reimbursement, comparison with U.S. and Europe, complex issues to be solved and currency to be used in the future. Lastly, advantages of good negotiation for all sides (sites, sponsors, and for health public and private systems) will be summarized.

2:45 Optimizing Patient Recruitment in Argentina by Streamlining Approval Process

Ing. Andrea Pascual, Head, Clinical Operations Latin America, GRS Worldwide

Enrolling subjects in Argentina can greatly benefit a global clinical trial program. However, lack of knowledge of the approval process in Argentina can halt a study in its tracks and prevent timely subject enrollment. This session will instruct attendees on how to work effectively with investigational sites, IRB’s/EC’s and the government regulatory agency in Argentina to streamline approval timelines and avoid costly delays in study start up and time to first patient in.

3:00 Networking Refreshment Break and Exhibit Viewing




3:45 Interactive Break-Out Discussion Groups

Concurrent break-out discussion groups are interactive, guided discussions hosted by a facilitator or set of co-facilitators to discuss some of the more poignant questions facing the industry. Delegates will join a table of interest to them and become an active part of the discussion at hand. It is an informal yet informative format that allows attendees to learn from each other and make some new contacts. To get the most out of this interactive format, please come prepared to: share examples from your work, vet some ideas with your peers, be a part of group interrogation and problem solving, and, most importantly, participate in active idea sharing.

TABLE 13: Designing and Planning Clinical Trials in Brazil: What has Changed and What Needs to Be Considered from Now On

Carlos Sanmarco, Clinical Operations Manager, Clinical Development Organization, Eli Lilly do Brasil Ltda.

• ICD language: What must be considered?
• Clinical trials for chronic diseases (considering post-trial access to study drug).
• Clinical trial comparing two unapproved drugs. Is that possible and ethical?

TABLE 14: How to set up a Private Research Center in Brazil and Latin America

Gustavo Kesselring, M.D., President, Brazilian Society for Pharmaceutical Medicine; Director, Clinical Operations, Clinical Research Center, Oswaldo Cruz Hospital, São Paulo Brazil

• Understanding pros and cons to start up a private clinical research center
• Burdens of private research centers outside public hospitals
• How to measure if a clinical trial  is profitable for the clinical research site

TABLE 15: Access to the Drug Test After the Trial

Luis Augusto Russo, M.D., Medical Director and Chief Executive Officer, CCBR Brasil; Director, Brasilian Society of Investigators and Research Centers (APCB)

• In case of "benefit" should subjects continue on investigational medication? The extent of benefit: How long? Who are responsible for that? Investigators, Sponsors or Country health care system?
• Is access to the drug post-trial the 'real' motivation for subject’s participation in Latin America? Experience and results of survey in -Rio de Janeiro-Brazil
• What is authorities’ reservation about access to the drug in the region? Brazilian position in comparison of Helsinki declaration

TABLE 16: The Importance of Site Support in Enhancing Enrollment and Compliance for Oncology Clinical Programs

Michael Choukas, CEO and President, Oncopartners
Helio Pinczowski, Ph.D., Executive Director of the Centro de Pesquisa en Hematologia e Oncologia da Faculdade de Medicina do ABC

• Highlights of the patient population and support staff limitations at the public hospitals
• How the supported site staff augment traditional sponsor and CRO team members’ roles
• Examples of enhanced enrollment and compliance using metrics from a completed Phase III program
• Investigator feedback on the difference between supported vs. non-supported programs

TABLE 17: Latin America, a Growing Target for Clinical Research: Are we exhausting the region’s capacity?

Oscar Enrique García Gálvez, M.D., Clinical Research Director, sanofi aventis Mexico
Dennis Hurley, Vice President, Latin America, Kendle Intl.

• What are the main obstacles to make R&D grow up in Latin America?
• What countries have more opportunities to participate in R&D?
• How to involve smaller Latin American countries in R&D? :  Two Steps Strategy
• Trials' Density and other indicators for Latin America
• What Latin America needs to improve to be more competitive in front of other Emerging countries?
• Which countries do we consider as having the existing sites saturated?
       • Is this because the sites are saturated with trials?  Or because some Health Systems are very difficult to authorize trials in their potential sites (eg. IMSS in Mexico,) Or because of  the recent registration requirements of MOH in Colombia for new sites, etc.?
• Is there any other bottleneck that is restricting existing from being used to their fullest potential?   In which countries?
       • Are there any initiatives going on that will solve these bottlenecks?  
• Is this saturation in most Therapeutic areas or is it concentrated in just some Tx areas?
• What is our experience as regards the enrollment at our Latin American sites as compared to sites in CEE?  Advantages?  Disadvantages?
      • What is our experience as regards the enrollment at our Latin American sites as compared to sites in A-P (eg. India)?  Advantages?  Disadvantages?
• Are there efforts occurring in some countries to have more sites prepared to enroll patients?    In which countries?
      • Are these efforts considered worthwhile by your company  as compared to  just going to another region to get more sites (eg. India)?

4:55 Closing Comments and Welcome to Reception

5:00-6:00 Networking Cocktail Reception and Exhibit Viewing


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