`Sent:
`To:
`Subject:
`
`
`
`cara lansden/cambridge/biogen;nsf;cara.lansden@biogenidec.com;smtp
`Tue Apr 25 2006 10:33:05 EDT
`
`BG-12 MS docs
`
`Per our meeting today, attached are the documents we discussed.
`
`Regards,
`Cara
`
`
`
`
`____________________________
`Cara Lansden
`Sr. Manager, Clinical Development
`Biogen Idec
`Tel +617-679-2658
`Fax +617-679-3518
`Email: cara.lansden@biogenidec.com
`
`Page 1 of 26
`
`Biogen Exhibit 2096
`Coalition v. Biogen
`IPR2015-01993
`
`
`
`CDT I SMT Charters
`
`Boston, Massachusetts
`
`May 11, 2004
`
`Page 2 of26
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`Page 3 of 26
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`Page 4 of 26
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`Clinical Development Team (CDT)
`
`Charter
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`Page 5 of26
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`biogen idec I
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`
`
`CDT Membership
`
`Core
`a Manager, Clinical
`Development
`g
`Lead program MD
`
`Program Statistician
`
`Ad h0C
`t_ V
`’
` gata Ma”a-9(‘:'5e”t
`_an._n'ng”a"r
`p.etag.'1°"tS
`L Clinical Ctommumcatioens
`.' DSRM
`
`L Commercial
`e Regulatory Affairs
`
`t PCDS
`
`l
`
`a Research and Program
`Exeoutlivelcore Team
`Leader Funeotitonal Areas
`a Drug Log istics
`
`t Corporiate Drug
`Compliance
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`Page 6 of26
`Page 6 of 26
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`Page 7 of 26
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`Page 8 of 26
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`Page 9 of 26
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`Page 10 of 26
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`Page 11 of 26
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`Clinical Development Team
`
`Main Deliverables/Goals
`
`Argreed to by team and confirmed by the MRMT
`
`'_
`
`s Develop, maintain, and oversee CDP:s
`
`p
`
`i
`
`~ Define and cichieve the business critical goals for the
`program
`
`~ Resolve any unresolved conflictsat the study level
`
`Ensure standardization across protocols and
`consistency with the CDP
`
`Coordinate investigator brochure, annual reports and
`other program ‘related documentation
`
`Participate in long rang, annual and resource planning
`in order to execute the CDP
`
`Work toward CDT standardizatiorn across all
`t;hera_peutic areas
`
`
`b biogenidec
`
`'
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`Page 12 of 26
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`Page 13 of 26
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`Page 14 of 26
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`Page 15 of 26
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`Study Management Team (SMT)
`
`Charter
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`Page 16 of26
`Page 16 of 26
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`biogen idec I
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`
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`Study Management Team Charter
`
`; Scope
`
`. Applies to Biogen ldec Development Organization
`
`Policy
` The Sl\zlT manages the day to day activities of «a clinical
`study and ensures the achievement of appropriate
`quality, financial and timeline goals critical to the clinical
`development strategy for the product
`
` SMT is empowered and accountable to meet key goals
`and deliverables as agreed by team members,
`approved by the CDT and confirmed by the MRMT
`
`s SMT will be formed for each clinical protocol
`d An SMT may exist for multiple protocols if the protocols are
`similar (population, drug) and the team srep;r{e)sentaf;tionwould be
`essentially the same as that on a new team.
`a
`
`sbiogensidec I
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`Page 17 of 26
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`Page 18 of 26
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`
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`SMT Membership
`
`Core
`
`Ad HOC
`
`i Clinical Trial lvlanager
`a
`in Zioiectit Medical: Director
`C C3 '5'“
`i Data |\/lanagemient
`+ Planning and poperations
`a Drug Safety and; Risk
`Managemente
`
`i Clinical Communications
`
`a
`
`i Training and
`Development
`
`Page 19 of26
`Page 19 of 26
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`
`
`Manager, Clinical
`p
`p
`Development
` Regulatory Amrs
` Clinical Logiestiics/Proeductci
`|_0igi;3t;C3;
`%
`Bio/Asslay./Cplincicail
`Immunology (CST)
`« . Statistical and Clinical
`Procgramming
`Pre.—clinical/PK and
`Metabolism
`
`C
`
`e
`
`a Corporate Drug
`Compliance
`C
`
`e Other areas as
`ap prop;ri‘ate
`
`
`
`
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`Page 20 of 26
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`Page 21 of 26
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`Page 22 of 26
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`Page 23 of 26
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`
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`Study Management Team
`Main Deliverables and Goals
`
`Accountable for achieving key deliverables
`
`i As agreed byteam members, approved by the
`CDT and scosntiermed by the ll/IRMT
`Define and achieve the goals the project
`
`Develop the study protocol, case report form
`and study tools
`
`or Design and implement ongoing Data Review
`Plans
`
`a Work toward SMT standardization across all
`Biogen Idec SMT groups
`
`Page 24 of26
`Page 24 of 26
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`Page 25 of 26
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`Page 26 of 26
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