Dear Colleague:
I am pleased to announce production of CHI’s and the BioPharma Strategy Series’ 3rd Annual Drug Development Latin America: Effectively Planning and Implementing Clinical Research and Trials, being held February 7-8, 2011 at the Westin Colonnade Coral Gables in Miami, FL.
The gathering will once again be co-located with the Summit for Clinical Trials Operations Executives (SCOPE), a three-day cluster of events that attracted over 300 leaders in clinical operations and research in March 2010. Please see the program map below for 2011.
The globalization of R&D into emerging regions continues. Growing R&D spending in these regions has been driven by many factors, including the attractiveness of commercial markets there, more favorable economics including lower relative costs for greater speed, and access to highly skilled professional labor and a large pool of patients, particularly treatment-naïve ones. Pharmaceutical and biotechnology companies are seeing rapid growth in the volume of their clinical research, development, and clinical trials activity in Latin America. At the same time, this region presents unique challenges that must be anticipated and managed. Join us for two days of interactive presentations and discussion on the following topics:
CORE SESSION TOPICS:
Latin America vs. other emerging markets in clinical research
Drug regulatory harmonization efforts led by PAHO
Understanding regulatory timelines vs. those in the US, Australia, Canada, etc.
Designing and planning trials in Brazil, Mexico, Argentina and other countries
Identifying and developing appropriate investigators and research centers in Latin America
Challenges and opportunities of expansion of clinical research into private hospitals and hospitals outside the large metropolitan centers
Participation of academic institutions as Centers of Excellence in drug development research
Feasibility and the site selection challenge: Do we need a different approach for Latin America?
Managing the ethical review committee process
Utilizing and integrating local clinical data to mutually support global and regional applications
Managing logistics and shipping of investigational medical product (IMP) and lab supplies to support trials
Review of key logistic suppliers in Latin American region (drug storage depots, centralized and per country clinical lab solutions)
Optimizing patient recruitment and retention strategies in the region
Adaptive protocol designs (Phase I-III) and regulatory challenges
Experimental medicine, exploratory pharmacogenomics research, and Phase I studies in Latin America
Status of IP protection in the Latin America region
If you are interested in presenting, please click here to submit a speaking proposal for review. Please note that due to limited speaking slots, preference is given to pharmaceutical and biotech companies with operations and trials in Latin America, regulators and those from academic/hospital centers. Additionally, as per CHI and PSS policy, a select number of vendors/consultants who provide products and services to these biopharmaceutical companies are offered opportunities for podium presentation slots based on a variety of Corporate Sponsorships.
The deadline for submission is July 2, 2010.
For Further Information
For questions or suggestions about the meeting, please contact:
Micah Lieberman
Executive Director, Conferences
Pharmaceutical Strategy Series
Cambridge Healthtech Institute (CHI)
Phone: (+1) 541.482.4709
Email: mlieberman@healthtech.com
For partnering and sponsorship information, please contact:
Arnie Wolfson
Manager, Business Development
Cambridge Healthtech Institute (CHI)
Phone: (+1) 781.972.5431
Email: awolfson@healthtech.com
For media and association partnerships, please contact:
Rich Handy
Senior Director, Marketing
Cambridge Healthtech Institute (CHI)
Phone: (+1) 781.972.5456
Email: rhandy@healthtech.com
About Cambridge Healthtech Institute (CHI)
Founded in 1992, Cambridge Healthtech Institute (CHI) (www.chicorporate.com) is the industry leader offering the preeminent source of information to the leading researchers and business experts from top pharmaceutical, biotech, and academic organizations. Delivering an assortment of resources such as events, reports, publications and eNewsletters, CHI's portfolio of products include Cambridge Healthtech Institute Events, Pharmaceutical Strategy Series, Barnett International, Insight Pharma Reports, Marketing Services, and Cambridge Healthtech Media Group.