MONDAY, MARCH 9, 2009 

7:30 AM Pre-Conference Workshop Registration and Morning Coffee

8:15-10:45   Hosted by:   * Separate registration is required.

Gaynor Anders, Vice President, European Operations, MMG

Jeff Goldfarb, Vice President, Oncology, MMG

OPTIMIZING PATIENT RECRUITMENT IN LATIN AMERICA
Considerations and strategies for accelerating patient recruitment in Latin American countries will be presented by a team of two global patient recruitment experts.  Case studies illustrating specific enrollment barriers and the tactics used to overcome them will be discussed.   Attendees will apply session learnings to sample scenarios in work groups.  Particular attention will be given to recruitment for oncology trials.
Workshop attendees will:

10:15 Registration for Main Conference

MAIN CONFERENCE

STRATEGIES AND OPPORTUNITIES OF
OUTSOURCING IN LATIN AMERICA

10:55  Organizer’s Welcome and Chairperson’s Remarks 
Micah Lieberman, Conference Director, Pharmaceutical Strategy Series, Cambridge Healthtech Institute

Jorge Rodriguez-Larrain, M.D., FACC, Director Regional Operations, Latin America, Merck & Co., Inc.

11:00 Update and Perspective from the Investment Community on the Status of R&D and Biotech Collaboration in Latin America
Eduardo Emrich Soares, CEO & President, Fundação Biominas
Latin America has a growing bioindustry with most of the companies still in its early stages. The region is internationally recognized by academic competence in several areas, as agriculture, bioenergy, genomics, infectious diseases and clinical trials. As these scientific projects start to be transformed in start-up companies due to strong governmental support and private investment, it opens new perspectives and opportunities for international companies in outsourcing product development and establishing partnerships. that is becoming more and more open to international collaborations. This talk will:

11:30 Strategies and Opportunities of Outsourcing of Product Development and Manufacturing Services from Latin America – Business and Technical Perspectives on OTC, Pharmaceutical and Animal Health Products
Daisy Rivera, Senior Director, Established Products Product Licensing, Portfolio Devlopment, Established Products Business Unit, Pfizer, Inc.
This presentation will describe key considerations needed to capture the advantages and to manage the challenges of outsourcing product development and manufacturing services from Latin America.  The region offers a growing market of contract manufacturing services for both animal and human health pharmaceutical and biological products. To maximize its potential, both suppliers and customers need to foster a collaborative environment and assess the implications for each party before entering a partnership.  Successful outsourcing strategies rely heavily on a systematic risk assessment process based on a thorough business and technical due diligence.  The audience will learn about critical elements required to promote the growth of contract manufacturing operations in LA and the prospective role of this region in capturing health business opportunities in emerging markets.
Critical elements to consider for conducting an effective due diligence:

Key Considerations in contract negotiations:

Sponsored by
 12:00 PM Luncheon Presentation  
Academic Sites in Clinical Trials: Optimizing Participation and Motivating Institutional R&D Initiatives
Ana Paula Ruenis, Ph.D., Director of Clinical Operations, Latin America, inVentiv Clinical Solutions, LLC
Latin America has established itself as a major market for clinical research, with a large treatment-naïve population. Highly proficient investigators are mostly concentrated in large urban centers and in public hospitals, and a significant percentage is related to academic institutions.  During this presentation, the following topics will be discussed:

OPPORTUNITIES FOR PARTNERING AND INNOVATION IN
LATIN AMERICA

1:25 Chairperson’s Remarks
Jorge Rodriguez-Larrain, M.D., FACC, Director Regional Operations, Latin America, Merck & Co., Inc.

1:30 The New World of Pharmaceutical Innovation in Brazil
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: 

2:00 Opportunities for Partnering and Innovation in Latin America
Sonia M. de Morais, Ph.D., Director, GPRD, Abbott Laboratories
This presentation will describe the landscape of innovative biotechs and top academic institutions in Latin America and how these can be leveraged to boost the pipelines of pharma and biotech companies. There is a scarcity of information on innovation in Latin America. Drug development companies need to look into these opportunities. The audience will learn who is who in LA and how to go about starting partnerships.

2:30 Brazil: An Emerging Player in Drug Research and Development 
Debora Garcia Rodrigues, Pharm. D., MSc, Ph.D., Clinical Research Department, Libbs Pharmaceuticals Ltd., Brazil
Offshoring clinical trials and others components of drug R&D process to developing countries have become a trend. Brazil is the largest pharmaceutical market in Latin America. Positive economic growth, stabilizing political structures, growing patient populations and increasing governmental, private and foreign investments are creating a new scenario in the country. As Brazilian pharmaceutical companies are becoming stronger, new opportunities for partnership and collaborative alliances in drug discovery process, co-manufacturing and co-marketing are available. This presentation will focus on the following issues:

3:00  Afternoon Refreshment Break

CLINICAL GRANT BUDGETING & NEGOTIATING IN LATIN AMERICA

Sponsored by

4:15 INFORMAL BREAK-OUT ROUNDTABLES Attendees will join a table with their peers and a moderator to discuss some of the more poignant questions facing the industry. It’s 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 session and 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.

Country and Site Selection for Global Clinical Trials Fidela Ll. Moreno, M.D., Vice President, Global Development Operations, Allergan       Allocation of Trials of Different Therapeutic Areas Fabio Thiers, M.D., MSc, Ph.D., Co-Director - Strategic Global Trials Research Program, MIT Center for Biomedical Innovation (CBI) & National Bureau of Economic Research (NBER)       Public Awareness and Education Regarding Drug Development Research 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)     Opportunities and Challenges for Breast Cancer Trails in Latin America Jeff Goldfarb, Vice President, Oncology, MMG       Pros and  Cons of Different Models and Partnerships  Julio Camps, M.D., Director, Regional Head, Latin America Development Operations, Amgen       Sponsors Meet the PI before the PI Meeting: Documents adaptation to local regulation in Brazil  Dr. Luis Augusto Russo, Executive Director, CCBR Brasil; President, Associação de Pesquisa Clínica (APCB)     Conducting Feasibility Studies in Latin America  Sergio Guerrero, M.D., Director, Medical Research, OCA Hospital/Monterrey International Research Center, Mexico; DIA Board of Directors for Latin America

5:30 - 6:30 Networking Cocktail Reception

6:30  Close of Conference Day

7:00 - 9:15 Optional VIP Networking Dinner