Panel: Differentiating the BRIC Countries

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Differentiating the BRIC Countries to Overcome Unique Difficulties within those Regions

Clinical Research in Emerging Countries

Panelists Include:
Ms Lais Koelle, Director, Clinical Operations, Latin America, Medpace
Mr Joe Zimmerman, Senior Director, Clinical Operations, Amylin
Ms Annie Lyubchenko, Manager, Global Regulatory Affairs Strategic Policy & Support, Johnson and Johnson

Moderator:
Mr William Chang, JD, Associate Director, Clinical Operations, Gilead Sciences


Opening Comments from panelists. BRIC Countries include: Brazil, Russia, India, and China.



L. Koelle –
Brazilian economy is growing ~5%/year, which makes it an important market for pharmaceutical products. 8th Pharma market globally. Clinical Research is an important piece to capitalize upon that growth. Primary challenges are the complex regulatory system and bureaucratic "ANVISA" to avoid further delays in trial approvals.

Advantages:
Quality of Data is top notch
Investigators are extremely motivated
Accelerated Patient Recruitment AND High Retention
Worth the challenges of the regulatory.



J. Zimmerman
Why are we interested in BRIC Countries?
Macroeconomic growth is exponentially greater in BRIC countries than the developed world. Data quality is good, recruitment time is less, and we are currently seeing success in a trial that is running in all four BRIC countries. However, cost is not the most compelling reason to go to a BRIC country…it’s access to patients
Lessons Learned:
1) Think Locally (Additional training for sites/CRAs; Translation Offerings)
2) Things Change (Governments, Internal Conflict, Foreign FDAs may later reconsider allowing to run your trial)
3) Don’t do it alone (Development and Services Organizations to partner with for importation and management)
A. Lyubchenko
Why do Pharma go to BRIC Countries? At J&J, our credo states to bring products to everyone in need. Regulatory Challenges: Brazil is tough and complex; Russia takes awhile to get approval but nothing too challenging; India is changing; China is long and extensive, similar to submitting the NDA in the USA.
Takeaways: Include China early in the process to stay on timelines.