Day 1 | Day 2 | Download Brochure
Thursday, March 11, 2010
7:45 AM Morning Coffee or Sponsored Breakfast Presentation (Sponsorship Opportunity Available)
8:40 Chairperson’s Remarks
Carlos Sanmarco, Clinical Operations Manager, Clinical Development Organization, Eli Lilly do Brasil Ltda.
8:45 Early Phase Development in Latin America: Challenges and Opportunities
Jorge Rodriguez-Larrain, M.D., FACC, Director, Regional Operations, Latin America, Merck & Co., Inc.
Sponsored by
9:15 Emerging Jurisdictions in Latin America
Maureen Bennett, Partner, Global Life Sciences Practice Group Leader, Squire Saunders
• Ethical issues in informed consent
• Continuing access to investigational medicines
• Investigator and institution payment issues
• Recent Costa Rican suspension of clinical trials
9:45 Networking Coffee Break and Exhibit Viewing
10:45 Enhancing Accessibility to Innovative Medicines in Latin America
Anthony Ventura, Senior Director, Latin America Region, Worldwide Regulatory Strategy, Pfizer, Inc.
Emerging Markets are expected to grow five times faster than Developed Markets in 2008-12. Pharmaceutical spending will grow almost four times faster in Emerging Markets than in Developed Markets. Regulatory Affairs plays a critical role in developing and implementing a regulatory strategy which brings medicines to the market. This presentation will highlight the importance of both internal partnerships within the company and the importance of meeting with the agencies before the filing. Ultimately, the presentation will discuss working partnerships and strategy to achieve rapid market introduction of medicines.
11:15 Interactive Panel and Presentations: Improving and Unifying Training Curriculum and Standards for Clinical Research Investigators in the Region
Moderator: Gustavo Kesselring, M.D., President, Brazilian Society for Pharmaceutical Medicine; Director, Clinical Operations, Clinical Research Center, Oswaldo Cruz Hospital, São Paulo Brazil
Honório Silva, M.D., President of IAFCR (Inter American Foundation for Clinical Research)
Integration of the Latin American countries in the modern clinical drug development bring these countries in direct contact with the highest scientific standards in methodology and procedures used in clinical trials and requires significant resources and trained personnel. Integration also fosters the development of expertise and experience among all involved parties (regulators, academic institutions, investigators and industry) and helps to create a new source of high-technology employment. However, one of the main bottlenecks in the region is to have a workforce of trained personnel and implementation of regional and/or national training programs in clinical research become more important as the entire Latin American region evolves as part of a globalized world with scientific and technical ambitions of becoming an effective partner in the drug development arena.
Attendees will learn about the development of IAFCR (Inter American Foundation of Clinical Research) and its program to foster education, training and development of clinical research to improve health care throughout the Americas.
Attendees will learn about an innovative initiative from the Brazilian Government to foster the clinical research capabilities in Brazil through a Brazilian Research Network of Academic Hospitals and supporting a National Clinical Research Course for this network.
Attendees will learn about an innovative funding program for clinical research activities developed by the Brazilian Health Ministry.
Promoting Education and Training on Clinical Research in Latin America
Honório Silva, M.D., President of IAFCR (Inter American Foundation for Clinical Research)
Brazilian Government Program for Clinical Research (academic hospitals network and national clinical
research course)
Gustavo Kesselring, M.D., President, Brazilian Society for Pharmaceutical Medicine; Director, Clinical Operations, Clinical Research Center, Oswaldo Cruz Hospital, São Paulo Brazil
12:00 PM Luncheon Presentation (Sponsorship Available. Contact Arnie Wolfson: 781.972.5431, awolfson@healthtech.com) or Lunch on Your Own
1:25 Chairperson’s Remarks
Oscar Enrique García Gálvez, M.D., Clinical Research Director, sanofi aventis Mexico
Sponsored by
1:30 Leveraging Site Networks to Enhance Performance in Global Oncology Programs: Update on the IBPC Network of Public Oncology Hospitals in Brazil
Helio Pinczowski, M.D., Executive Director of the Centro de Pesquisa en Hematologia e Oncologia da Faculdade de Medicina do ABC
Denise de la Reza, M.D., Director of Clinical Operations, Oncopartners
Instituto Brasileiro de Pesquisa em Cancer (IBPC) is the largest non-profit network of public oncology hospitals in Brazil. In collaboration with Oncopartners, a U.S. and Brazil-based SMO/CRO, 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. This presentation highlights the challenges and the lessons learned from the network’s participation in a recently completed international oncology protocol. Contributing over 50% of the patients, the IBPC team developed novel approaches to regulatory, patient identification and site support challenges which we now apply to new programs. Of particular interest to the audience, IBPC has developed a strategy to expand opportunities to include referral sites that do not routinely participate in clinical research.
2:00 Identifying and Developing Appropriate Investigators and Research Centers in Latin America
Celso Arabetti, M.D., Director, Clinical Research Unit, Austral University Hospital
This presentation will discuss the efforts to develop high performance Research Centers focused in quality and efficiency and how this strategy impacts in the Clinical Research Process. The CRU at the Austral University Hospital actually is in charge of 100 different protocols and developed management tools to deliver quality and efficiency.
2:30 Networking Refreshment Break and Exhibit Viewing
3:00 Case Study: Advancing International Collaboration and Partnerships in Scientific and Clinical Cancer Research, Training, and Infrastructure Development in Latin America
Jorge Gomez, M.D., Ph.D., Director, OLACPD (Office of Latin American Program Development),
NCI, NIH
This presentation will discuss recent efforts and outcomes to date of the OLACPD (Office of Latin American Program Development). OLACPD represents an exciting new partnership between NCI (National Cancer Institute) and FIC (Fogarty International Center) of NIH (National Institutes of Health). OLACPD was founded in 2008 by Dr. Gomez with the goal of supporting and advancing international collaboration and partnerships in scientific and clinical cancer research, training, and infrastructure development in Latin America.
3:30 Biotechnologly Product Development in Cuba, From Me-too`s to Original Drugs: The Heberprot P Case
Pedro A. López-Saura, Ph.D., Head of Department, Clinical Trials, Center for Biological Research, Cuba
Cuba’s Biotechnology program, launched in the early 80`s, first developed me-too products such as interferon, streptokinase and hepatitis B vaccine to satisfy national needs and self-sustainable development. In recent years original, patent-protected drugs have emerged. These required full clinical program design and performance. Heberprot P, a parenteral formulation containing epidermal growth factor, is a good example. Starting from preclinical data the project passed through proof of concept and phase I to III trials, following GXP and has already impact on advanced diabetic foot ulcer management and outcome.
4:00 Brazil is Becoming a Pharma Innovator, But......
Michael P. Ryan, Ph.D., Director, Creative and Innovative Economy Center,George Washington University Law School
In this presentation research findings regarding pharmaceutical R&D in Brazil will be discussed as will Brazilian public research and university roles, private sector business strategies, and policy and regulatory environment issues. Key points to be covered:
• Strengths of Brazil pharma R&D system
• Role of biodiversity in Brazilian pharma R&D
• Capacity weaknesses
• Policy and regulatory challenges
4:30 Close of Drug Development Latin America Conference
Day 1 | Day 2 | Download Brochure