MONDAY, MARCH 9, 2009
7:30 AM Pre-Conference Workshop Registration and Morning Coffee
In-depth Patient Recruitment and
Retention Workshop*
|
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:
- Learn about region and country considerations that impact patient recruitment
- Gain understanding of how to maximize the effectiveness of patient recruitment programs in Latin America
- Have opportunities to discuss specific challenges they are facing with patient recruitment in Latin America
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:
- Present an update of the biotechnology industry in Brazil and other Latin American countries
- Discuss local perspectives
- Show opportunities of outsourcing and partnering for international companies in the region
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:
- Quality assessment
- Environmental health and safety
- Financial assessment of the business
Key Considerations in contract negotiations:
- Intellectual property and confidentiality
- The impact of regulatory policies
- Cultural integration
- Capital investment
- Insurance
- Product cost / currency volatility
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:
- Ability of the companies in identifying potential sites in academic institutions not usually participating in clinical trials through the development of their capabilities;
- How sponsored trials can motivate R&D initiatives in academic institutions;
- Governmental initiatives to support R&D.
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:
- Strengths of Brazil pharma R&D system
- Role of biodiversity in Brazilian pharma R&D
- Capacity weaknesses
- Policy and regulatory challenges
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:
- Conducting clinical trials in Brazil: Strengths and weaknesses
- National pharmaceutical industry expansion: R&D challenges and opportunities
- The market for early drug discovery: chemistry, biology, toxicology and screening services
3:00 Afternoon Refreshment Break
CLINICAL GRANT BUDGETING & NEGOTIATING IN LATIN AMERICA
Sponsored by
3:45 Clinical Grant Budgeting & Negotiating in Latin AmericaMs. Ying Jiang, Senior Client Manager, TTC,llc
This presentation will discuss the findings from a series of interviews conducted with clinical grant specialist and country managers in Latin America. The interviews identify country specific clinical grant budgeting and negotiating trends. Additionally, the presentation will make use of actual clinical grant data to compare the relative grants costs of Latin America to more established markets for clinical research.
- As more trials are allocated to Latin America, these findings will assist clinical research professionals when budgeting and negotiating clinical grants in this region.
- The audience will gain an understanding of the country specific trends and nuances involved in budgeting and negotiating investigator grants in Latin America.
- Audience will also gain an understanding of clinical grants costs in Latin America verse clinical grant costs in more established markets.
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
VIP DINNER AND DISCUSSIONS*
Hosted at Porcão Churrascaria (Authentic Brazilian Steakhouse)
* Separate registration is required.
At the close of the day an optional VIP Networking Dinner will be hosted at Porcão Churrascaria. Conference faculty will be participating as will a guest speaker. Attendees must register in advance, as seating is limited. Sponsorship Available**
7:00 Introductions & Guest Speaker
Bringing more Clinical Trials into Latin America: " Competing with other regions in the world"
Julio Camps, M.D., Director, Regional Head, Latin America Development Operations, Amgen
7:15 Dinner and Discussions
8:45 Coffee and Dessert
9:15 Close of Evening Activities
|