Core Team Meeting Minutes
`July I?, 1997
`
`Attendees:
`
`J. Walling, M. Amett, G. Thompson. M. Miller, IC. Hartsock, D. Gardner, D. Balogh
`1). Thornton, S. Hamburger, C. Niyikiza, B. Tauke, I. Woodworth.
`Via teleconference: F. Ruighaver, F. Martetet.
`
`Please submit corrections to Jim Wilkins by July 28,1997
`
`D. Thornton and C. Niyikiza presented some very encouraging news: There is a possible
`correlation between increased Homocystine levels and Toxicity, and the hypothesis that
`Vitamin Supplementation prior to and during treatment could eliviate some toxicity.
`This potential theory, if clinically proven could possibly be patented and utilized with
`other drugs such as GARFT.
`More Information to follow as available.
`
`0. Gardner gave a update on Study enrollment:
`JMBB -29 patients enrolled with S Stable Disease reports to date.
`JMBM -20 Patients enrolled, we are expecting several Scans coming in the
`next few weeks.
`JMBN- Enrollment up to 10 patients to include some Chemo-Nieve Patients.
`There is to date only 4 non-evaluable patients across the board on above listed studies.
`
`ECCO:
`D. Gardner stressed that they have identified a lodging problem and at this point the
`closest available hotel to the meeting site is 40 miles away.
`Recommendation: Decisions on attendance need to be made ASAP, and arrangements to
`be coordinated through Diana Kelley.
`
`Discussion : Regarding the process for presentation of MTA at ECCO, the decision is to
`still be made on weather a representative from ILEX or from Lilly will conduct the PK
`analysis. Also the determination is to stilt be made on weather we will focus on MTA as
`a hole, or on just the Renal Impaired data.
`3. Woodward stated that the Internal Lilly PlC department has increased staff; and he
`believes that the can handle the presentation, he is to confirm and get back to the team.
`
`J. Walling to drop a letter to Joe Beitino this afternoon to confirm his involvement in the
`li-fr presentation. They are to look at the Pre-Clinical data, to determine what additional
`data is needed to position LY23 1514 as a multi-targeted antifolate.
`
`Agenda topics: Head & Neck Prognostic Markers, and Reference Database were tabled
`until the next meeting due to time constraints.
`
`Meeting was adjourned.
`
`CONFIDENTIAL
`
`FUEPOSJ11ON
`
`I
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`AV00365851.
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`TX 64
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`Lilly Ex. 2111
`Sandoz v. Lilly IPR2016-00318