`Agenda Item Meeting Minutes
`
`Date:
`
`19 February 2004
`
`Agenda Item:
`
`Support:
`
`*
`
`Double-blind, placebo-controlled, dose determination,
`efficacy, safety, and tolerability study of BGOOOlZ in
`patients with relapsing remitting MS
`Support with Minor Revisions: *
`
`Not Support:
`
`*
`
`Rework Required:
`
`X
`
`Attendees:
`
`The following people were present during the
`discussion of the above-referenced agenda item.
`
`
`TITLE
`
`NAME or NAME OF DESIGNEE
`
`PRESENT
`
`Clinical Project Manager
`
`Rcbccca Conaghan
`
`Medical Director
`
`Gilmore O'Neill
`
`Ed Berkhoff/Anne Read
`Medical Writer
`
`
`Vice President, Drug Safety and Medical
`Information
`
`John Ferguson
`
`Senior Vice President. Medical Research
`
`Whaijen 800
`
`
`
`Senior Vice President. Regulatory Affairs Nadine Cohen
`
`
`
`Vice President, Biometrics and Data
`Mana ement
`
`Vice President, Preclinical and Clinical
`Develo ment Sciences
`
`Laura Meyerson
`
`0ther(5)
`
`Hans Peter Haslcr, Bill Sibold, Bob
`
`Hamm, John Oram, Carey Smith, Dale
`Spriggs, Ying Zhu, Boyd Hanson,
`Minhua Yang, Sven Lee, Deborah
`Kinch, Susan Home, Mary Spellman,
`C hn's Tenhoor, Sharon MacBain, Paul
`Flyer, Al Sandrock, James Stella,
`Susan Goelz, Cara Lansden, Theresa
`
`Pondrebrac, Bany Ticho
`
`Page 1 of 2
`
`Biogen Exhibit 2088
`
`Mylan v. Biogen
`IPR 2018-01403
`
`
`
`Clinical Trial Review Board Meeting
`Agenda Item Meeting Minutes
`
`Summarized Discussion
`
`0 Gilmore O'Neill presented the concept to the CTRB. Four options were included in
`the presentation as shown in the table below:
`
`Dosing Regimes
`
`
`720 mg/day
`480 mg/‘day
`360 mgjday
`240 mg/day
`
`2 div dose
`3 div dose
`2 div dose
`3 div dose
`
`
`
`120 mg/day
`Sin le dose
`
`120 mg/day
`Single dose
`
`360 mgjday
`3 div dose
`
`480 mg/day
`2 div dose
`
`720 mg/day
`3 div dose
`
`360 mgv’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.
`
`o 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.
`
`o 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
`
`0 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 C TRB
`a soon as possible, preferably the week of February 23rd, with an updated and agreed
`upon study design.
`
`Page 2 of 2
`
`
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