`109-MS-301 and 109-MS-302
`
`Thursday, 2"‘ November 2006
`
`DISTRIBUTION I ATTENDEES
`
`BIIB Attendees
`
`awson
`HIIIIIUE Ian ate
`
`Names In BOLD attended this meetin
`
`Page 1 Of 6
`
`Biogen Exhibit 2214
`Coalition v. Biogen
`IPR2015-01993
`
`
`
`
`
`MINUTES
`
`109MS301: Study Start-up Update -E
`
`re urned
`243 CDAs have been sent out, 1
`-
`181 SRQs have been sent out, 75 returned
`-
`about 30 sites have been approved to participate
`-
`Australia:
`-
`EC submission for‘ and‘ pending
`New Zealand:
`o
`EC central submission scheduled for 14 Nov
`
`fiiu_m:
`- Approval received for coordinating site‘
`-
`EC submission on 20 Nov
`
`Action:- to contact Imperial Graphics to get VAS for Belgium by Friday 3 Nov
`
`195 CDAs have been sent out, 1?! relurned
`
`loo
`
`158 SRQs have been sent out, 7 returned
`2 has begun contacting sites for 302 this week
`
`# of sites that will receive approval for 109MS301 protocol version 1
`Worst case scenario: 3 Aus sites, 3 NZ. 6 Belgium
`Recommendation provided to]: use protocol V1 in Belgium for the first regulatory submission
`
`
`
`Brazil Update
`- Move Brazil from 302 to 301
`
`o
`o
`
`BIIB Commercial has identified a potential lead physician
`BIIB requested for
`to begin contacting sites for 301
`
`Actiofl will forwar
`
`list to
`
`email/information for Brazil potential lead site and. will forward Brazil
`
`South Africa 8 am Ireland
`
`South Africa:
`
`-
`
`Potentially out of both 301 and 302, however
`approve the 1996 version of the Declaration o
`
`is looking into regions within S. Africa that will
`elsinki, more info to follow from- next week
`
`Page 2 of 6
`
`
`
`
`
`
`
`Page 3 of 6Page 3 of 6
`
`Page 3 of 6
`
`
`
`ACTION ITEMS
`
`Ongoing
`
`ICF to be modified due to results from EOP2
`mwtin
`
`dT
`
`d—
`
`05 October 2006
`
`_ SITE $_ELEC n_oN
`email‘/inforrnationvfiom
`F will toiward
`razil gotentjal ead site
`to Biazil liivesligatoi list to
`to send! the site number ist
`to provi 9 update on potential sites in
`u h Afflcla
`to discuss sites with!
`_.$.ll9995?‘?£5.?!dd.l1l9f!'¢l‘, $_l?_°f5_ 9
`ICF
`
`to send
`
`301 Sign Offof NA model ICF
`
`301 Sign Off NA model ICF
`
`301 Sign Off of suppleiiieiilal lCFs (Duiiiiiv
`M&_MR9
`301 Sign oft ol supplemental I(Zl~ (Pipedia
`lCF, Canadian Version of Plll)
`301 Sign Off of supplemental ICFS
`aimacoenomic
`
`Rog to confirm date for Health Canada
`B612 SMI Meeting Minutes
`
`Page 4 of 6
`
`
`
`—
`°°'“"'°“*—
`U
`°°"“"°‘“—
`d
`Complete
`d
`
`Pending
`
`Pending
`
`d d
`
`28"” 5°“
`23’ 5°“
`28* Sept
`
`28* Sew
`
`28”‘ Sept
`
`Pending
`
`25" Oct
`
`d
`o
`Pendi
`--
`2""~°vE—
`WV -E—
`O
`
`submission date for 301
`302 Sign Off of International model ICF
`
`302 Sign Offof NA model /C/'
`
`302 Sign Off of supplemental ICF (disease
`progression / rolapso)
`
`302 Sign Olfol supplerrrerital ICF (Dummy -
`Ml~‘cI/MRI)
`30') Sign on of supplemental l()l- (P/pedra
`ICF, Ca/iadia/i Version of PH!)
`302 Sign Off of supplemental ICF (PHI)
`
`302 Sign Off of supplemental ICF
`(plmrrnacogennmic)
`
`to follow ug with MRI center on MRI ICF I
`F
`
`F in contact Impenal Graphics to get VAS
`or t3,9|£1i9m_I2y Friday 9. Nov 7
`to distr bute 3o1v'i Gdidéitnes and 302
`F5 and schedule review meetings
`to follow up
`on CRF Completion
`uideline date
`
`Questionnaires
`
`KKl')"td dévein réieptirme reiahse
`questionnaire for 301 and 302.. KD and
`the team to consider whether to capture in
`
`up Sept
`
`9“ Nov
`
`Page 5 of 6
`
`
`
`
`
`
`
`Page 6 of 6Page 6 of 6
`
`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
