Going Global

GOING GLOBAL
 
  TUESDAY, FEBRUARY 26th: MAIN CONFERENCE DAY ONE KEYNOTES
  2. Going Global: A Focus on India & China
 
 2:00Opening Remarks from the Track Chair
Edward J. Brennan. President & CEO, IndiPharm LLC
  
 
 2:10
Opportunities of Clinical Research in India: Focus on Phase I and
Phase II trials
This session focuses on the opportunities for Phase I/II trials in India, including:
•A review the clinical research environment in India
•A focus on existing business models conduct clinical trials in India
•An evaluation the opportunities of potential collaborations
  
  Gangadhar Sunkara, PhD, MBA, Associate Director, NOVARTIS PHARMACEUTICALS
  
 
 2:50New Approaches to Global Clinical Trials Management
Organizations spend 41% of total R&D expenditure & 40% of R&D time on cts.
Today's Clinical Trial Management Solutions don't give organizations the complete
end-toend information needed to control multiple global studies. Effort for study setup/
maintenance by a CTMS often exceeds the value provided. Lack of confidence in data
reliability put subject welfare at risk. Learn how new workspace approaches are emerging
where activities are not just tracked- they are fully executed.
  
  John Orley, Product Manager, Clinical Management Applications, ARISGLOBAL LLC
  
 
 3:30
Featured Exhibit Hall Activity: CTC's February Frenzy- "Nothing but Net(working)" Event
This is the final chance of the day to walk around the exhibit hall and talk
to as many exhibitors as possible to earn "Nothing but Net(wo meeting is
just like shooting a basket- get 3 points (very relevant), 2 points, or 1 point.
The more ‘shots' you take, the more points you get
 
 4:10
Chinese FDA vs. US FDA: A Regulatory Perspective on the Role of China in
Global Drug Development
Based on both US FDA working experience and regulatory policy experience in China, we:
•Address how current Chinese regulatory environment affects the role of China in
global drug development by comparing Chinese regulatory review system
with that of US FDA
•Introduce 3 guiding principles for a better regulatory agency interaction and
understanding both challenges/opportunities of conducting trials in China
  
  Zili Li, MD, MPH, Director of Clinical Research Operations - Asia Pacific/Head of MSD China
Regulatory Policy Group, MERCK & CO, INC
  
 
 4:50
Global Registries Update: Clinical Trial Registries in India and China
•The aims and development of the Chinese Clinical Clinical Trials Registry (ChiCTR)
•The aims and development of the Clinical Trial Registry - India (CTRI)
•The impact of ChiCTR and CTRI
•Cooperation between ChiCTR & CTRI with the WHO ICTRP and other national &
international CT registries
  
 

Francis P. Crawley, Executive Director, Good Clinical Practice Alliance, Europe - International Clinical Trial Registry Platform, WORLD HEALTH ORGANIZATION

  WEDNESDAY, FEBRUARY 27th: MAIN CONFERENCE DAY TWO KEYNOTES
  2. Global : Emerging Regions
 
  
Clinical Development Strategies for India, China & Emerging Asian Countries
•Historical perspective on globalization of drug development
•GCP environment in emerging Asian countries
•Biotechnology products in emerging Asian countries
•Development strategies for biotechnology companies in emerging Asian countries
  
 1:10Helen Niu, MD, PhD, Director, Global Development Operations, AMGEN, INC.
  
 
 1:40
Clinical Trials in India 2008 Updates and Recent Trends
 
  Dr. Shashank Joshi, Scientific Advisor, IndiPharm Honorary Editor, Journal of the Association of Physicians of India
  
 
 2:10
Afternoon Networking & Refreshments Break
 
 2:30Clinical Research Outsourcing: Challenges and Solutions
Pharma/Biotech companies are not leveraging offshore capabilities to their full extent because they are concerned about: Loss of IP, Loss of project control, Loss of in-house
expertise, Lack of interest alignment, Perception of "low quality". We discuss strategies and
approaches to address these challenges.
  
  Sailaja Bhaskar, RPh, PhD, Senior Director, Clinical Operations, JDS PHARMACEUTICALS
  
  Vivek Soneja, Director, & Mark A. DeWyngaert, PhD, MBA, Managing
Director, HURON CONSULTING GROUP
  
 
 3:00
Asia-Pacific: An Emerging Power in Global Drug Development?
•Strengths and weakness of the region in global drug development
•Commercial and clinical research potential of the Asia- Pacific region
•Outlook of global drug development in Asia-Pacific
  Edmund Tsuei, Regional Head, Pharma Development Operations, Asia-Pacific-Africa, ROCHE PRODUCTS PTY LIMITED
 3:00Close of Clinical Trials Congress 2008