Working with Countries that are Difficult to Budget and Negotiate - Ying Jiang January 10, 2012

1. Working with Countries that
are Difficult to Budget and
Negotiate (Investigator Grants)
Ying Jiang, TTC
Dr. Alan Braverman, Independent Consultant
Dr. Mitchell Katz, Purdue
Dr. Peter Carberry, Astellas
January 10, 2012 | Philadelphia, PA

2. Countries of Interest
• Poland
• Brazil
• Russia
• Argentina
• China
• India
• Japan

3. Question #1
• Do you budget centrally for your global
investigator budgets?

4. Question #2
• Do you negotiate all of the investigator
agreements or do you outsource it to CROs?

5. Question #3
• How do you budget for emerging countries or
countries that you have less experience with?

6. Question #4
• How do you gather market intelligence?
Country specific requirements and etc.
• Are you prepared for to pay for ancillary
items such as concomitant meds or even
things like IV tubing or IV bags which may
be considered a ‘given’ here?

7. Question #5
• How do you ensure FMV and ensure your
budgets stay competitive?
• Do you have benchmarks?

8. Question #6
• Multiple parties agreements: how do you deal
with the timing of CTA vs MOH/Ethics
• For example: Poland needs a fully executed
CTA to accompany the submission.

9. Question #7
• Timelines: do the lower per patient costs
make up for the extended start-up times in
some of these countries?

10. Thank You For Your
Participation!
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