Output Explorer

Al: Joint decisions have to be made to come up with a starting dose based on information.
WRAP- UP
Epidemiologic studies to be conducted starting at the preclinical development stage. This can be
done depending on how successful you expect the drug to be. For example, to assess class effect,
Epidemiologic studies from the outset are needed to characterize what is known about the drug
in the class.
Glyn: Good studies with placebo controlled data are more beneficial; open label long term
studies do not define this drug safety profile. Looking at the placebos subjects course long term
gives valuable data.
Plans / Next Steps/ Closing Comments
Question: Agency will come out with guidelines in September, 2004. How do we formalize the
company's standpoint?
Answer: We do risk management all the time. We simply need to put it down on paper,
o White paper- concept paper needs to be created
Put data together in better ways: yearly getogether to formalize these perhaps at
the time of IND Annual Report
CA issue
Example: 559 uterine CA issue: nothing has been done for this unlike the bladder
o On preclinical review, need to work these details out
o Global Reorganization: Global Safety Meeting in Japan is a good place to start
discussion. There is little manpower in safety in TCI. Clinical and Safety
divisions should have a joint say in things. Create a global story in Actos. Need
product stewardship. Glyn & Cal to further discuss rasing issue at the Global
Safety Mig
o Need a multidisciplinary team approach (Astro Zeneca) to create awareness of
safety issues as they develop. Consider yearly (or other periodic) joint meetings
between Clinical and Safety to look at and analyze safety data,
Takeda Forum Risk Management
March 22, 2004
Confidential - Subject to Protective
TAK-BAROND-00208934
Produced in MDL on 09/02/12
Source: https://www.induspop5-00604s.ucsf.edu/docs/gmjf0226

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