`l09—MS-301 and l09—MS-302
`
`Thursday, 8"‘ February 2007
`
`DISTRIBITION I ATTENDEES
`
`BIIB Attendees
`
`atna , noamaneni
`
`Pliill Gallacher
`
`Kate Dawson
`
`
`
`
`Names in BOLD attended this ulccmiz
`
`Clinical Ifggdatez
`109318301 Shidv Status Ugdate
`o
`120 sites Sponsor approved
`0
`150 PSSV coiuplclcd — cum-iitly following up Wllll US. Roiuzmia & Bulgana to gm: 160 sites
`Australia:
`-
`SIV dalc 20"‘ ;\rlarcl1
`o
`update: 6 patient: identified:
`I
`1 Rcjected
`dosing schedule
`'
`3 currently IL'\"lC\Vll1g l(‘l-‘
`SH: to follow up
`I
`2 clltrcmly reviewing medical history
`
`BG12 SMT Meeting Minutes
`
`Page 1 0‘ 6
`
`Biogen Exhibit 2198
`Coalition v. Biogen
`IPR2015-01993
`
`
`
`Belgium:
` SIV dates for Belgium have been targeted for between 15th – 28th Feb
`Post meeting note - Confirmed SIV dates
` 19th Feb,
` 23rd March
` Awaiting Regulatory approval – 15th March final date (60 days) for approval, however should receive
`approval before this date
`Post meeting note - Belgium approval received 13th Feb 07 – awaiting confirmation letter
`
` 20th Feb,
`
` 13th March &
`
`
`Canada:
` SIV date 28th Feb
`
` Local EC submissions have been completed, however those sites will not be initiated until March 07
`
` update: 1 outstanding document (contract). Once received site can be activated and drug
`released.
` and local affiliate have all been in contact with site. If nothing has been received from
`site by Friday 9th Feb – K. Dawson to call and follow up with site
`
`New Zealand:
`
`
`
` SIV dates 1st – 15th March
`
`109MS302 Study Status Update
` 100 PSSV completed
` 8 PSSV scheduled
`
`
`
`Canada:
`
`:
`o Local EC submitted on 7th Feb
`o Potential FPI site
`o SIV scheduled for last week March 07
`:
`o Prefers 301 study
`o Has confirmed to submit to MRI committee on 20th Feb – need clarification what this means.
` to follow up
`:
`o Need site to confirm if they can meet the submission date of 20th Feb
`:
`o Site will not commit to making a submission.
`
`
`
`
`
`BG12 SMT Meeting Minutes
`
`Page 2 of 6
`
`
`
`Russia:
` Potentially 3 sites could be initiated in April
`
`Other:
` Target countries: Canada, Russia, NZ, Germany and Czech
` Timelines:
`o FPI – May 07
`o LPI – Q2/2008: Jun 08
`
`INEC Members Update
` 3 members
` have been a few issues with contracts
`currently approaching other potential members
`
`
`Data Management Update
` 301 & 302 CRFs including the questionnaires will be in the warehouse by 14th Feb
` CRFs can be ordered by
`
`
` for the addresses
` to contact
` Regulatory to share info with DM regarding which CRF version is being submitted for each country
`
`:
`o Version 2 of CRF has not been submitted. Awaiting comments as these have to be included into
`the submission
`o
`Important to submit Version 2 before Version 3 is released
`Clinical Operations Update
` Copaxone label requirements: label is required stating “for clinical trial use”
` Clinical operations to set up a meeting with regulatory to discuss and clarify regulatory requirements for
`the new backup countries
` Clinical operations need details of backup countries in order to ensure sufficient supplies are available
` Clinical operations to clarify if current label is acceptable in India – may need to be revised
`
`Protocol Amendment update
`
` Sign off of amendments – 22nd Feb
` Version 1 of draft has been reviewed. Version 2 to be reviewed 9th Feb
`
`
`
`
`
` Regulatory update:
`o
`IMPD has now been finalized
`IB addendum should be released today - 8th Feb
`
`
`BG12 SMT Meeting Minutes
`
`Page 3 of 6
`
`
`
`BG12 SMT Meeting Minutes
`
`Page 4 of 6
`
`
`
`Page 5 of 6
`
`
`
`BG12 SMT Meeting Minutes
`
`
`
`8th February 2007
`
`Page 6 of 6
Accessing this document will incur an additional charge of $.
After purchase, you can access this document again without charge.
Accept $ Charge
Still Working On It
This document is taking longer than usual to download. This can happen if we need to contact the court directly to obtain the document and their servers are running slowly.
Give it another minute or two to complete, and then try the refresh button.
A few More Minutes ... Still Working
It can take up to 5 minutes for us to download a document if the court servers are running slowly.
Thank you for your continued patience.
This document could not be displayed.
We could not find this document within its docket. Please go back to the docket page and check the link. If that does not work, go back to the docket and refresh it to pull the newest information.
Your account does not support viewing this document.
You need a Paid Account to view this document. Click here to change your account type.
Your account does not support viewing this document.
Set your membership
status to view this document.
With a Docket Alarm membership, you'll
get a whole lot more, including:
- Up-to-date information for this case.
- Email alerts whenever there is an update.
- Full text search for other cases.
- Get email alerts whenever a new case matches your search.
One Moment Please
The filing “” is large (MB) and is being downloaded.
Please refresh this page in a few minutes to see if the filing has been downloaded. The filing will also be emailed to you when the download completes.
Your document is on its way!
If you do not receive the document in five minutes, contact support at support@docketalarm.com.
Sealed Document
We are unable to display this document, it may be under a court ordered seal.
If you have proper credentials to access the file, you may proceed directly to the court's system using your government issued username and password.
Access Government Site
