`1 09-MS-301 and 1 09-MS-302
`Thursday, oth December 2006
`
`DISTRIBUTION I ATTENDEES
`
`8118 Attendees
`
`BG12 SMT Meeting Minutes
`
`07 December 06
`
`Page 1 of 4
`
`Biogen Exhibit 2217
`Coalition v. Biogen
`IPR2015-01993
`
`
`
`109MS301 Study Status Update- P. Gallacher
`Australia:
`• Site Initiation Visit (SIV) a t - site scheduled for 14 Dec to be confirmed
`•
`(BIIB Lead CRA) will be the only individual in direct contact with the site
`•
`as back-up site for FPI
`•
`IB Australia) said she would approve us to ship drug after TGA completed
`is ready to enroll
`Action: P
`will follow-up wi th . to make sure that is in accordance with . . SOP (we
`will submit a deviation if it is not)
`Canada:
`• Response from Health Canada: had some CMC questions only, responses to questions are going
`in today (07 Dec), and regulatory is waiting to see if they have any clinical questions
`Austria:
`• Potentially able to bring submission date forward
`Belgium:
`• EC submission due to go in today, submission deadline is 11 December
`Germany:
`• Have had good response, there are a lot of PSSV to be done there
`Action: By next Friday (15 Dec) the team to make the decision to go forward with current sites
`selected to make the submission deadline, then add other sites as they are identified
`Site Selection:
`• The team is working with . and Commercial to add sites in Bulgaria, Romania and Serbia if
`Avonex and Copaxone are confirmed as approved therapies. Post Meeting Note: Serbia does
`not have Avonex or Copaxone approved
`
`109MS302 MRI Vendor
`intent and is working on the contract
`• MRI center Administrator has
`• A few administrative documents are being finalized and will be ready before Christmas
`• The Scope of Work (SOW) is in progress and should be finished by end of next week
`
`Page 2 of 4
`
`
`
`ng
`• 301 advisory committee list announced, 302
`• MP agreed in principle and wants to add extra members so there is an odd number
`•
`Internally,-
`P Gallacher and K Dawson will be on the committees
`
`•
`•
`•
`•
`•
`•
`
`is external independent non-voting statistician and is un-blinded
`the voting statistician, but he has not formally committed to be on the DSMC
`data out
`ng
`Committee duration: have commitment end after last patient visit
`Looking into adding cardiologist
`Following the teams' discussion,- - will incorporate the comments into the DSMC
`Charter, such charter will be pres~s to the DSMC Members, following their
`review/comment the charter will be finalized
`
`Page 3 of 4
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`
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`Page 4 of 4
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