TUESDAY, MARCH 10, 2009
7:40 AM Morning Coffee (Breakfast Presentation Sponsorship Available**)
SPECIAL SESSION – REGULATIONS AND TIMELINES
FOR CLINICAL TRIALS IN LATIN AMERICA
The regulatory environment of Latin America has improved in recent years and increasingly operates in accordance with international standards and guidelines. This session will review the regulatory timelines and approval process in Argentina , Brazil and Chile as well as provide recommendations to companies conducting the trials on those countries. At the end of this session attendees will learn the regulatory requirements for conducting clinical trials in Argentina , Brazil and Chile and will have the opportunity to interact with the regulatory agency officials of each of those countries.
8:15 Introductory Remarks from Chairperson
Gustavo Kesselring, M.D., President, Brazilian Society for Pharmaceutical Medicine; Director, Clinical Operations, Clinical Research Center, Oswaldo Cruz Hospital, São Paulo Brazil
8:30 Regulatory Framework for Clinical Trials in Chile
Dr. Eduardo Johnson Rojas, Instituto de Salud Pública de Chile (ISPCH)
9:00 Regulatory Framework for Clinical Trials in Brazil
Jorge Taveira Samaha, Manager, Clinical Trials Office and New Drugs Approval, ANVISA – Brazil
9:30 Regulatory Framework for Clinical Trials in Argentina
Dr. Analia Perez, Director, Medical Evaluations, ANMAT – Argentina
10:00 PANEL DISCUSSION
Interactive Panel with Managers from Clinical Trials Offices of National Regulatory Agencies
Panel Moderator: Gustavo Kesselring, M.D., President, Brazilian Society for Pharmaceutical Medicine; Director, Clinical Operations, Clinical Research Center, Oswaldo Cruz Hospital, São Paulo Brazil
Jorge Taveira Samaha, Manager, Clinical Trials Office and New Drugs Approval, ANVISA – Brazil
Dr. Analia Perez, Director, Medical Evaluations, ANMAT – Argentina
Dr. Eduardo Johnson Rojas, Instituto de Salud Pública de Chile (ISPCH)
10:30 Networking Coffee Break
11:00 Registry Studies in Latin America: The Partnership between Academia and Pharmaceutical Industry
Laura Luchini, MD, Ph.D., Clinical Research Unit Director, Brazil, Sanofi-aventis Farmacêutica Ltda.
There is a significant lack of epidemiological data in Latin American Countries. Registries gathering data on physicians, products use, pathologies and patients (4P perspective) are important to better define unmet medical needs, diseases awareness and use of diseases treatment guidelines. The partnership between Academia and Pharmaceutical Industry is a key step to plan and execute these initiatives and cooperate for a better understanding of Latin America epidemiological data.
- To identify the opportunities registries or epidemiological studies may bring to strengthen the partnership between Pharma Industry and Academia
- To better define unmet medical needs in Latin America
- Identify tools to unveil market opportunities
11:30 Challenges in Conducting Clinical Trials in Mexico
Sergio Guerrero, M.D., Director, Medical Research, OCA Hospital/Monterrey International Research Center, Mexico; DIA Board of Directors for Latin America
This presentation will address:
- The challenges we face from feasbilities to implementation and development of clinical trials in the country
- Provide the challenges and updates of the regulatory and customs environment in registering and importing/exporting clinical trial materials
- Cultural barriers
Attendees will learn how to:
- Identify key elements when conducting business in Mexico
- Identify ways to avoid delays in initiating activities in the country
- Be better prepared with knowledge of the regulatory and cultural environment
12:00 PM Luncheon Presentations or Lunch on Your Own (Sponsorship Available**)
IDENTIFYING AND DEVELOPING APPROPRIATE INVESTIGATORS AND RESEARCH CENTERS IN LA
1:25 Chairperson’s Remarks
Gustavo Kesselring, M.D., President, Brazilian Society for Pharmaceutical Medicine; Director, Clinical Operations, Clinical Research Center, Oswaldo Cruz Hospital, São Paulo Brazil
1:30 Optimizing Oncology Clinical Research in Brazilian Public Hospitals via a Novel Public/Private Collaboration
Frederico Costa, M.D., Director of Clinical Research, Instituto Brasileiro de Pesquisa em Cancer (IBPC)
Instituto Brasileiro de Pesquisa em Cancer (IBPC) is the largest non-profit network of public oncology hospitals in Brazil. IBPC has established a unique model to provide structural and operational support to member public hospitals that enable them to more effectively interact with regulatory agencies, promote themselves internationally, negotiate agreements with pharma and biotech companies, screen patients for oncology programs, monitor key study metrics and receive regular GCP and study-specific training. IBPC is currently contributing significant numbers of patients to important global cancer protocols and offers a good example of creating centers of excellence at academic institutions and optimizing patient recruitment and retention strategies.
- The audience will gain an appreciation of the opportunity for sponsors to have well-controlled access to a significant patient population via the IBPC oncology network and, potentially through similar networks and collaborations in other Latin American countries.
- The audience will also hear about how creative partnerships and government grants can be used to create centers of excellence in the public hospital system.
- Given the challenges facing public hospital systems in Lain America and elsewhere, this presentation may provide a blueprint for others to create such mutually beneficial, self-sustaining public/private partnerships.
2:00 Feasibility and the Site Selection Challenge: Do We Need a Different Approach for Latin America?
Pedro Garbes-Netto, M.D. M.Sc., Professor, Internal Medicine, Universidade Federal Fluminense and Santa Casa de Misericórdia de São Paulo; Executive Director, GLICO (Grupo Latinoamericano de Investigaciones Clinicas en Oncologia)
One of the critical aspects in clinical trials management is regional resources allocation through feasibility and sites´ allocation process. This issue has greater implications in Latin America with a large geographic area and many different countries with different cultures, legislations and tricky language differences. We will present and discuss some alternatives on how to improve regional resources allocation through feasibility and site selection based on a collaborative group model.
- We will present data regarding exhisting collaborative groups acting in Latin America.
- Audience will have the opportunity to see and discuss how the different collaborative groups may influence the region.
- Finally we will present the experience of a transnational Latin America collaborative group.
2:30 Challenges and Opportunities of Expansion of Clinical Research into Private Hospitals and Hospitals Outside The Large Metropolitan Centers
Gustavo Kesselring, M.D., President, Brazilian Society for Pharmaceutical Medicine; Director, Clinical Operations, Clinical Research Center, Oswaldo Cruz Hospital, São Paulo Brazil
Clinical research is considered to be one of the main driving forces of health sector development in developed countries and clinical trials the most crucial and time-consuming phase of drug development. Clinical trials are performed within clinical research facilities (sites) that can be found in private hospitals and hospitals outside the large metropolitan centers. Many clinical research sites within large metropolitan cities in Latin America are saturated with ongoing trials and there are many small hospitals in the region that can be transformed into top recruiters for clinical research if CROs and pharma companies develop them with an ambitious GCP training program for investigators and clinical research staff.
- We will present how to develop a clinical research site into a Private Hospital and its challenges and opportunities
- Audience will also learn some practical examples of clinical research sites developed outside the large metropolitan centers with their experience to become top recruiters in the clinical trials setting
- The pros and cons of clinical research sites in large and small cities in Latin America
3:00 Afternoon Refreshment Break
CLOSING KEYNOTES – INDUSTRY PERSPECTIVE
3:30 The Clinical Research Dept in Latin America Subsidiaries of Big Pharma: Headquarters and Country Perspectives
Dalia B. Wajsbrot, Director, Scientific Support, Emergent Markets Business Unit, Pfizer
Co-developed with: Eduardo Motti, M.D., Head, Clinical Research Department, Pfizer-Brazil
The clinical research dept in the country offices of pharmaceutical industries is a servant of two masters. Its role and activities may differ significantly depending on the balance of power between headquarters and country management. Conflicting interests are not uncommon and are reflected in a number of areas such as:
- Accountability of decisions, reimbursement
- Size of the department, number and type of studies performed
- Investigator selection practices, resource development
- Insourcing vs outsourcing
4:00 Adaptative Designs (Phase I - III): Regulatory Challenges and Opportunities in Latin America
Jorge Rodriguez-Larrain, M.D., FACC, Director Regional Operations, Latin America, Merck & Co., Inc.
Drug development clinical research has been traditionally performed by standard, yet rigid, sequential phases, from phase I through phase III, with specific goals in each phase aiming towards gathering enough information about the product for registration, including PK/PD, dosing regimen, drug interaction, safety and efficacy. Today, there is a strong trend towards applying adaptative designs in drug development clinical research, particularly in some therapeutic areas such as oncology. In this new setting, there is a continuity of activities throughout the program, with pre-defined changes in sample size, dosing and study arms based on a continuous flow of information. These adaptative designs aim not only at decreasing the development program cycle time, but to provide scientists with a more flexible and efficient environment during the implementation of clinical trials. Institutions, investigators and regulators in Latin America are used to the traditional way of performing clinical trials. The implementation of protocols with adaptative designs becomes a challenge for all stakeholders including sponsors, investigators and agencies. Being an emergent market, with a not quite mature research environment, Latin America could quickly adapt to these new designs and models, and become one of the preferred regions for implementing drug development clinical research.
- Audience will have better understanding of traditional drug development phases, including phase I through III
- Audience will learn about new trends in the design of clinical trials
- Will understand the challenges and opportunities that we face in Latin America with the implementation of clinical trials with adaptative design
4:30 Topic to be Determined
Elaine Rahal, M.D., Brazil Medical Director, Global Development Medical Affairs, Bristol Myers Squibb Company
5:00 End of Conference