`Agenda Item Meeting Minutes
`
`Date:
`Agenda Item:
`
`Support:
`
`*
`Not Support: *
`
`Attendees:
`
`19 FebtUary 2004
`
`Double-blind, placebo-controlled, dose detenn inatioo,
`efficacy, safety, and tolerability study ofBG00012 in
`patjents wid1 relapsing remitting MS
`Support with Minor Revisions: *
`
`Rework Required:
`
`X
`
`The following people were present during the
`discussion of the above-referenced agenda item_
`
`Yes
`
`Yes
`
`Yes
`
`Yes
`
`Yes
`No
`No
`
`No
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`Page 1 of2
`
`Biogen Exhibit 2310
`Coalition v. Biogen
`IPR2015-01993
`
`
`
`Clinical Trial Review Board Meeting
`Agenda Item Meeting Minutes
`
`Summarized Discussion
`
`• Gilmore O'Neill presented the concept to the CTRB. Four options were included in
`the presentation as shown in the table below:
`
`Optio
`n
`#1
`
`#2
`
`#3
`
`#4
`
`120 mg/day
`Single dose
`120 mg/day
`Single dose
`
`240 mg/day
`2 div dose
`
`Dosing Regimes
`
`480 mg/day
`2 div dose
`480 mg/day
`2 div dose
`
`360 mg/day
`3 div dose
`360 mg/day
`3 div dose
`360 mg/day
`3 div dose
`
`720 mg/day
`3 div dose
`720 mg/day
`3 div dose
`720 mg/day
`3 div dose
`720 mg/day
`3 div dose
`
`1080
`mg/day
`3 div dose
`
`The discussion focused on Options 1, 2, and 3. Option 4 was discarded.
`
`• Dosing emerged as the most critical issue. Option 2 appeared confusing to some
`CTRB members. Commercial representatives were not in favor of a 240 mg dose
`because this dose might affect the marketing strategy of the 720 mg dose under
`development for psoriasis. Regulatory representatives were concerned that bypassing
`a 240 mg dose might raise questions with regulatory agency reviewers. Research
`representatives felt that a true dose ranging study was only reflected in Option 3, or
`possibly adding a 120 mg arm to Option 1.
`• Reformulation of study drug was discussed (i.e., developing a 60 mg capsule in
`addition to the 120 mg capsule now available). However, this was thought to be not
`possible due to time constraints.
`• BID dosing was discussed and it was thought that this dosing regimen was beneficial
`on many different levels.
`
`Summarized Action Plan
`
`• The concept was not approved. The team was instructed to seek alignment amongst
`the different interests (i.e., research and commercial) and reconvene an ad hoc CTRB
`a soon as possible, preferably the week of February 23rd, with an updated and agreed
`upon study design.
`
`2
`
`Page 2 of 2
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