From:
`Sent:
`To:
`CC:
`Subject:
`
`rebecca conaghan/london/biogen
`Mon Aug 16 2004 11:42:40 EDT
`dmiller@saturn nmr.ion.ucl.ac.uk;r.gold@med.uni-goettingen.de;lkappos@uhbs.ch;ehavr@lf1.cuni.cz;ch.polman@vumc nl;
`gilmore o'neill/cambridge/biogen@biogen;
`Biogen Idec Study C-1900 - Phase IIb BG12 in MS
`
`Dear Members of the C-1900 Advisory Committee,
`
`There has been a lot of activity since our last correspondence which we would like to take the opportunity to update you on.
`
`Investigator Sites
`We are currently in the process of setting up 43 sites across the following 10 countries: UK, Germany, Sweden, Netherlands,
`Switzerland, Czech Republic, Poland, Hungary, Turkey and Russia.
`
`Ethics and regulatory submissions are well underway and I am pleased to report that we already have the following
`approvals:
`
`Central ethics committee(EC) approval in Russia
`LKP EC approval in Germany
`Conditional central EC approval in UK and Poland
`Local EC approval from all sites in Turkey
`Ministry of Health Approval in Russia
`Scientific committee approval in the Netherlands
`
`Drug Supplies
`The drug supplies are currently being packaged and are on track to be released to the sites from the end of September 2004.
`
`MRI Reading Centre
`The MRI Reading Centre has been set up with Professor Miller at the Hospital for Neurology and Neurosurgery, Queen
`Square in London. The MRI manual is currently being put together and will be forwarded to your site shortly.
`
`Investigator Meeting
`The investigator meeting has been scheduled for 14th and 15th September 2004 at the Trianon Palace Hotel in Versailles,
`France. This location was chosen in order to try to allow as many sites as possible to be able to take advantage of direct
`flights.
`
`Each site is sending 2 to 3 members of their team. This will allow examining neurologists to be trained and certified on
`EDSS by Professor Kappos and MRI technicians will be able to gain all of the information that they will need for the study
`from Professor Miller's team.
`
`We look forward to welcoming a number of you to this meeting, but we would also like to suggest that we have a short
`teleconference a few days prior to the meeting in order to address any of your questions or concerns about the study. If you
`are agreeable to this, a member of the study team will be in contact with you to arrange a convenient time.
`
`In the meantime please do not hesitate to contact either of us should you have any questions.
`
`With kindest regards
`
`Gilmore O'Neill and Rebecca Conaghan
`
`Gilmore N. O'Neill, M.B., M.R.C.P.I., M. Med. Sci.
`Associate Director
`Clinical Development-Neurology
`Biogen Idec
`14, Cambridge Center, Bio 4
`
`Biogen Exhibit 2089
`Mylan v. Biogen
`IPR 2018-01403
`
`Page 1 of 2
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`

`Cambridge, MA 02142
`Tel: 617-679-2000
`Fax: 617-679-3518
`
`Rebecca Conaghan
`Clinical Trial Manager
`Biogen Idec, UK
`Tel: +44 (0) 1628 501066
`Fax: +44 (0) 1628 501010
`
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