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Sunday, February 6, 2011
PM Pre-Conference Workshop* with CenterWatch:
1:00 - 2:00 PM Workshop Registration
2:00 – 5:30 PM Optimize the Process of Site Selection, Study Activation and Patient Recruitment
This workshop focuses on the strategies, tools and technologies for site identification and selection, study and budget planning, and explores a variety of new initiatives that sponsors, CROs and investigative sites are implementing to improve patient recruitment and retention effectiveness. Specifically, the workshop focuses on the following critical areas:
Site Identification, Assessment and Selection: Strategies and metrics employed by Sponsors and CROs in this process
Study and Budget Planning: Positioning your site for success in the study and budget planning process
Patient Recruitment: Exploring a variety of new approaches to improve patient recruitment and retention
Workshop Leader: Joan Chambers, COO, CenterWatch
Nye Pelton, CPC (Clinical Portfolio Consultant-Enrollment), US Medical Division - Oncology, Eli Lilly
Bonnie Brescia, Founding Principal, BBK Worldwide
Michael Jay, Vice President, RxTrials
*Separate registration required
Monday, February 7, 2011
7:30 am Conference Registration and Morning Coffee
(Shared Session with Global Site Selection)
8:15 Chairperson’s Opening Remarks
Matt Kibby, Market Intelligence, BBK Worldwide
8:30 Regulatory Challenges and Expectations in Emerging Markets to Effective Clinical Trial Development
Michael Young, MPH, Senior Manager, Worldwide Regulatory Affairs - Emerging Markets, Pfizer, Inc.
Today, more than ever, clinical research is experiencing a geographical shift in country selection, and clinical trials are truly becoming more and more “global.” One of the industry’s goals is to execute simultaneous global development. That is, to use global data to develop a single dossier (e.g., Clinical Trial Application) that supports the next critical phase of development, enabling simultaneous submissions to and approvals from health authorities and ethics committees globally. There are a number of barriers that significantly restrict simultaneous development, ultimately delaying the availability of innovative drug therapy to emerging markets and limiting patient access to new and preventative treatment. Presentation topics: Regulatory barriers in the AP and LA regions to simultaneous clinical development; Industry’s expectations of a health authority’s regulatory framework; Clinical elements to the ideal clinical trial infrastructure.
9:00 FDA Inspections of Clinical Research Sites
Jeanne Morris, President, J2 Quality Consulting Inc.; former Investigator, FDA
This presentation discusses what to expect during FDA inspection of a Clinical Investigator site. Applicable federal regulations will be reviewed as well as common citations and problems. Presentation will identify ways that sites and sponsors can best prepare for the inspection to influence a positive outcome.
9:30 Ethical Challenges in Site and IRB Selection in Multi-Regional Clinical Trials
Marjorie Speers, Ph.D., President and CEO, Association for the Accreditation of Human Research Protection Programs (AAHRPP)
Managing multi-regional clinical trials poses legal, drug regulatory and ethical challenges. In this presentation, Dr. Speers will describe four common misunderstandings about IRBs/ECs that can lead to regulatory challenges, delays in starting trials, and unnecessary risk exposure. While virtually all sponsors follow ICH-GCP, they are also bound to in-country laws that govern the conduct of research and the ethical review of trials by IRBs/ECs. Informed consent processes, protection for vulnerable populations, initial and continuing review processes, and training will be discussed. She will illustrate the challenges and solutions using Brazil, China, India, and Mexico.
10:00 Networking Coffee Break in Exhibit Hall
10:40 Chairperson’s Remarks
Cecilia D’Antuono, Ph.D., Manager, Site Management, Regional Clinical Operations, Bristol-Myers Squibb Argentina
10:45 Generic Drug Development in Latin America: Focus on Methodological and Regulatory Issues
Francisco Estevez-Carrizo, Ph.D., Professor, Clinical Pharmacology, University of Montevideo
Generic regulatory legislation in Latin America began to be implemented around the year 2000. Brasil, Argentina and Mexico have led this effort in the field of generic substitution. However, there is a wide disparity between the regulations of these countries. This presentation will focus on these issues and will envisage future developments.
11:10 Regulatory Affairs in Argentina: Challenges and Perspectives
Florencia Masciottra, Clinical Trials Reviewer, ANMAT (Argentina)
ANMAT is the national organism involved in regulation of clinical trials, including approval of protocols and inspections to investigators. Clinical trials have been conducted in Argentina during more than 15 years. Increasing number, new designs of clinical trials and new regulations in other countries in the last few years are challenging opportunities to improve the quality and efficacy of our work.
11:35 Logistical and Regulatory Challenges of Importation: Getting Investigational Drug into Latin American Countries
Cecilia D’Antuono, Ph.D., Manager, Site Management, Regional Clinical Operations, Bristol-Myers Squibb Argentina
To develop clinical trials in Latin American a sequential regulatory process of IRB and later MOH approval is needed to start the protocol. Import permit is requested as a part of MOH approval and has different requisites in each country. Regulations are not harmonized in the region, some regulations are being modified. The challenges and opportunities towards getting harmonization will be discussed though a comparison of requisites in different countries.
12:00 pm Luncheon Presentation (Sponsorship Opportunity Available) or Lunch on your Own
1:25 Chairperson’s Remarks
Pedro Garbes, M.D., Regional Director, Clinical Development Latin America, Sanofi-Pasteur Latin America; Professor, Internal Medicine & Clinical Research, University Federal Fluminense & Santa Casa de Sao Paulo
1:30 Planning and Conducting Trials in Costa Rica
Dr. Isabel Trejos, Project Manager/Latin American Business Development Specialist, Clinical Trials Area, WestatCosta Rica offers excellent opportunities for conducting high quality clinical trials in a cost-effective manner. It has a politically stable environment which offers high standards of medical care at a relatively low cost. The country makes an attractive headquarters from which to expand operations throughout Central America. This talk will present a general overview of the Costa Rican research environment, outline specific examples of local challenges to clinical research, and discuss strategies for overcoming these challenges to conduct successful projects in the region. It will include an overview of the in-country regulations for clinical trials, a description of the Costa Rican health system, and the general characteristics of the local facilities and the research personnel.
2:00 A Case Study in “Insourcing” Regulatory & Safety In Support of Clinical Trial Execution in Latin America
Chet Elias, Director, Global Regulatory Affairs and Safety, Emerging Markets, Amgen
Emerging markets such as Latin America represent a significant area of growth to the pharmaceutical industry both from a clinical development and product registration perspective. Outsourcing can provide a robust and cost effective strategy to effectively access these markets, which has historically be executed through full-service Contract Research Organizations or CROs. Recently, Amgen broke from the full-service mold and successfully implemented a novel “insourced” strategy for the execution of regulatory and safety activities leveraging Functional Service Providers (FSPs). This presentation will summarize Amgen’s experience to date in implementing and executing this novel strategy, highlighting key successes and challenges across Latin America.
2:45 Afternoon Refreshment Break in Exhibit Hall
3:15 How Do the Characteristics of Global Biopharmaceutical Trials Affect Participation of Centers in Latin America?
Fabio Thiers, M.D., M.Sc., Ph.D., CEO, VIS Research Institute; Co-Director, Global Clinical Trials Research Program, MIT/NBER
Trial planners need to make sure that their trials can be effectively conducted in Latin America. Such task can be informed by an objective analysis of the research that has been conducted in this region recently. We will describe findings of a systematic study designed to determine which types of trials (by condition; design; comparator drug; size/duration or phase) are more likely to be successfully implemented, while discussing how certain patient-selection criteria can restrict participation in Latin American countries.
Sponsored by4:00 Dominican Republic: Drug Development ParadisePatricia Alvarez, M.D., Medical Director & Principal Investigator, Latin American ResearchExcellent location, rapid patient recruitment and easy regulatory process all make Dominican Republic an ideal location for drug development. The Dominican Republic has a well established medical community, quick, nonstop jet service into the country, same time zone as the East coast and a large population of naïve patients. Dr. Alvarez will present an overview on conducting trials in the Dominican Republic.
4:30 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.
TOPIC 16: Latin America: A Clinical Trial Rescue Region?
Moderator: Marlene Llopiz-Aviles, Regional Director for Latin America, Venn Life Sciences, Mexico; Board Member, AMEIFAC
• Why is LA usually seen as a rescue region?
• For what indications and trials should LA countries be considered from the start as part of all clinical trials?
• What is the availability of patients with specific diseases and what are the steps involved in having Latin America participate in clinical trials early on in the selection of sites and principal investigators?
TOPIC 17: Start up Challenges in Latin American Countries
Moderator: Cecilia D'Antuono, Ph.D., Manager, Site Management, Regional Clinical Operations, Bristol-Myers Squibb Argentina
• Which are the steps to follow to achieve a FPFV? Which activities can be done in parallel and which are sequentially done? What are the expectations regarding metrics in each Country?
• Opportunities to create alignment of MOH requirements in the region.
• Upcoming regulations: Perspectives for future start ups.
TOPIC 18: Thinking Outside the Box: Alternatives to Expedite Clinical Development in Latin America
Moderator: Pedro Garbes-Netto, Regional Director, Clinical Development Latin America, sanofi pasteur
• Regulatory framework: A constraint or a strength?
• Liaising locally: Finding the right partners
• Planning to deliver
TOPIC 19: Understanding and Overcoming Regulatory Challenges in Latin America
Moderator: To Be Announced
5:30 - 6:30 Networking Cocktail Reception