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From:
`Sent:
`
`T0:
`Subject:
`
`gilmore o'neill/cambridge/biogen;nsf;gilmore.oneill@biogenidec.com;smtp
`Wed Feb 01 2006 12:27:58 EST
`
`dmiller@saturn.nmr.ion.ucl.ac.uk;
`Fw: ENS abstract
`
`Sorry, forgot to attach the minutes
`
`
`
`fidvisury Committeeh‘linutes U4E|EIEIELVZEIDC
`
`Gilmore N. O'Neill, M.B., M.R.C.P.I., M. Med. Sci.
`Director
`
`Clinical Development-Neurology
`biogenidec
`14, Cambridge Center, Bio 4
`Cambridge, MA 02142
`Tel: 617-6792000
`Fax: 617-679-3518
`
`----- Forwarded by Gilmore O'Neill/Cambridge/Biogen on 02/01/2006 11:23 AM -----
`
`Gilmore O'Neill/Cambridge/Biogen
`02/01/2006 11:22 AM
`
`Message Size: 2.8 KB
`
`To
`David Miller
`cc
`
`Subj ect
`ENS abstract
`
`Dear David,
`
`as you are aware, we are putting together two abstracts for the ENS.
`
`I pulled out the advisory commitee minutes from September 2004 to check on the authorship charter. I have attached
`the minutes below.
`
`Would you be able to identify the following three people from the MRI reading centre who are supposed to be authors:
`
`0 Trial Manager
`0 Clinical Fellow (analyses scans)
`0 Consultant Neuroradiologist (supervises scan analysis)
`
`Page 1 of 5
`
`Biogen Exhibit 2092
`
`Mylan v. Biogen
`IPR 2018-01403
`
`Biogen Exhibit 2092
`Mylan v. Biogen
`IPR 2018-01403
`
`Page 1 of 5
`
`

`

`Will they be able to sign authorship forms in time for the ENS deadline? We Will probably send those out as soon as
`the SAC members have provided final comments on the abstracts.
`
`Thanks and best regards
`
`Gilmore
`
`Gilmore N. O'Neill, M.B., M.R.C.P.I., M. Med. Sci.
`Director
`
`Clinical Development-Neurology
`biogenidec
`14, Cambridge Center, Bio 4
`Cambridge, MA 02142
`Tel: 6l7-679.2000
`Fax: 617-679-3518
`
`Page 2 of 5
`
`Page 2 of 5
`
`

`

`C-1900 Scientific Advisory Committee Meeting
`Wednesday 8th September 2004
`
`Attendees: Professor Kappos (LK), Professor Miller (DM), Professor Gold (RG), Dr
`Havrdova (EH), Professor Polman (CP), Dr Limmroth (VL), Dr Gilmore O’Neill
`(GO), Rebecca Conaghan (RC)
`
`Agenda
`
`0 Discussion of authorship
`- Data Safety Monitoring Committee
`0 New pre-clinical data
`0 Discussion to address any outstanding concerns about the C-1900 protocol,
`for example:
`0 Patient Population
`0 Endpoints (clinical and radiologic)
`0 Treatment Groups
`- AOB
`
`General Issues
`
`0 Professor Kappos (LK) requested that the list of attendees for future meetings
`was added to the agenda when it is circulated
`o LK suggested that it would be beneficial for the trial and the motivation of the
`investigators if the members of the Advisory Committee take more of an
`active role in the investigator meeting and be involved in some of the
`presentations, particularly on aspects of the protocol and study design.
`Everyone agreed that this would be a great motivating tool for all of the
`investigators
`- Rebecca Conaghan (RC) will forward the protocol overview slides to LK to
`review and to determine if he would be interested in presenting some or all of
`them at the meeting.
`
`Discussion Of Authorship
`
`- The committee discussed who should be named as author on the study paper.
`0 There was general agreement that the entire Advisory Committee will be part
`of the writing group.
`0 Professor Miller (DM) requested that members of the team from the MRI
`Reading Centre are included on the paper due to the large role that they will
`play in processing the data from the study. There was general agreement on
`this.
`
`0 Dr O’Neill (GO) suggested that the top 3 highest enrollers are also included on
`the paper. If a member of the advisory committee is one of the highest
`enrollers then an additional investigator will not be added. Everyone was in
`agreement on this.
`0 The current
`list
`is to be forwarded to the Advisory Committee for their
`approval:
`
`AC vl 8‘h Sept 04
`
`Page 3 of 5
`
`Page 3 of 5
`
`

`

`I Coordinating Investigator
`I Advisory Committee Members
`I
`3 members of the MRI Reading Centre team
`0 Trial Manager
`0 Clinical Fellow (analyses scans)
`0 Consultant Neuroradiologist
`(supervises
`analysis)
`Study Medical Director
`Lead Statistician
`
`I
`I
`
`scan
`
`
`
`l Comment [G01]: Should we do this?
`
`I
`
`Top 3 recruiting Investigators (not to be replaced if one of the
`top recruiting investigators is an advisory committee member)
`
`Data Safety Monitoring Committee
`
`The entire Advisory Committee felt very strongly that an external Safety
`Monitoring Committee would be necessary. This will allow the members to be
`unblinded and therefore able to review all of the data and highlight any safety
`concerns.
`
`In addition it was pointed out that if there were to be any concerns in the
`future, Biogen Idec would not want to have only had an internal committee.
`It was agreed that the external committee should consist of at least 3 people.
`One of the members can be someone from the Advisory Committee as long as
`they are not an investigator in the study or involved in MRI review.
`(Post meeting note — further discussion has clarified that no members of the
`Advisory Committee should serve on the Independent Safety Committee even if
`they are not involved in recruiting patients).
`(Post meeting note — LK requested that if the DSMB wants to make specific
`proposals regarding the study this should be done through the Coordinating
`Investigator and the Medical director on behalfofthe sponsor.)
`
`New Preclinical Data
`
`GO reviewed the preclinical data from an ongoing toxicity study that was
`recently sent to all of the members.
`GO confirmed that the risk / benefit ratio to the patients remains unchanged.
`Following GO’s explanation of the data, there were no further concerns.
`GO confirmed that
`the Investigators only need to inform their ethics
`committee.
`
`Discussion to address any outstanding concerns about the C-1900 protocol, for
`example:
`
`0 Patient Population
`0 Endpoints (clinical and radiologic)
`0 Treatment Groups
`
`AC v1 8‘h Sept 04
`
`Page 4 of 5
`
`Page 4 of 5
`
`

`

`o All of the members of the Advisory Committee were happy with the current
`version of the protocol with reference to patient population, endpoints (clinical
`and radiologic) and treatment groups. No additional concerns were raised.
`
`AGE
`
`0 LK asked what will be in place for patients that have a positive response after
`48 weeks on the study. It was pointed out that the first look at the data will be
`in November 2005 by which point, the first patients to be recruited into the
`study will have completed the trial. Ideally an extension protocol should be
`put into place.
`0 GO agreed to look into this and to report back to the committee.
`I
`It was requested that a statement on this was available at the investigator
`meeting.
`
`0 Professor Gold (RG) updated the group regarding ongoing preclinical work
`with BG00012. .
`
`I GO confirmed that if a patient is to be recruited on the inclusion criteria,
`shows evidence of Gal-enhancing lesions of the brain on an MRI performed
`within 6 weeks prior to randomization, this decision is to be made by the local
`investigator at that site.
`
`0 The next meeting will be scheduled for the start of November as recruitment
`will have been underway for a few weeks and so it will be a good opportunity
`to discuss recruitment and general progress to date.
`
`C-l900 Advisory Committee Meeting Minutes — 8th September 2004
`
`
`
`Signed:
`
`Date:
`
`Rebecca Conaghan
`(Reviewed by Gilmore O’Neill)
`
`AC vl 8‘h Sept 04
`
`Page 5 of 5
`
`Page 5 of 5
`
`

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