Moderator: Jeffrey Kasher, PhD, Vice President and COO, Global Clinical Development, ELI LILLY & COMPANY
Panelists: Graeme Currie, PhD, Vice President, Clinical Operations, SEPRACOR
Mitchell Katz, PhD, Vice President, Global Clinical Development, EISAI
Elspeth Carnan, PhD, Executive Director, Head Global Clinical Site Management, Global Development Operations, AMGEN
Ginny Payeur, Vice President, Global Sales, PSI
This was a Q&A session where several questions were posed to a panel of four members.
The first question asked was related to the percentage of patients that each member had outsourced to an emerging market. The responses varied from less that 10% up to more than 50%. One member stated that they will continue to outsource as much as possible.
The second question asked was whether cost was the motivating factor for outsourcing to emerging markets. The responses were one yes and 4 no.
The third question asked to the group was what were the top three reasons for doing business in an emerging market. Most all panel members stated speed of development, a decrease in available subjects , reduced costs, regulatory hurdles within varying countries, the in-country practice of medicine, the feasibility of each region given medical practice and qualifications, delivering of study objectives within agreed upon timelines, quality of the data and key opinion leaders (KOL).
The fourth question involved whether a company would conduct studies in a given country even though they had no commercial interest in marketing their products there. The answers were that yes, there are instances where it makes sense o conduct studies in countries where there is no marketing interest.
The fifth question asked was related to which country was the most difficult to conduct studies in. The major markets identified included Russia, Asia Pacific, Eastern Europe and India.
The final question asked was how to deal with differences in medical care in the various emerging markets. The majority of answers included the data collected as a part of the feasibility study and extensive training for all involved parties.



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