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Modelling and simulation SIG (brainstorming) meeting

Modelling and simulation SIG (brainstorming) meeting. Introduction Michael O’Kelly. What I’m going to say. SIG plans Plan for today What has the SIG found out about modelling and simulation?. Aims of the special interest group (SIG). (First meeting January 2010)

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Modelling and simulation SIG (brainstorming) meeting

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  1. Modelling and simulation SIG (brainstorming) meeting Introduction Michael O’Kelly

  2. What I’m going to say • SIG plans • Plan for today • What has the SIG found out about modelling and simulation?

  3. Aims of the special interest group (SIG) • (First meeting January 2010) • To develop knowledge and opinions about statistical modelling and simulation related to pharmaceutical development and to consider ways of sharing this with the PSI membership. To provide a forum for discussion and the sharing of experiences regarding the use of statistical modelling and simulation in pharmaceutical development. • The SIG will also seek to form an opinion on any new developments in the use of statistical modelling and simulation and to pass on any learning to the wider PSI membership.

  4. Communication plan of the SIG • The SIG will communicate with the PSI members via the following methods: • Emails to mailing list of contacts • Articles in SPIN including write-ups of meetings • Presence at PSI Conference (inc in 2010 a poster introducing the SIG) • Discussion meetings on specific topics • Use of the SIG area on the PSI website • Summary of activities to the AGM • Possible future scientific meetings or papers

  5. Events planned by the SIG so far • Poster at PSI 2010 • 3 part one-day seminar on statistical modelling and simulation software covering software for modelling recruitment, PK/PD modelling and trial design • Session at PSI conference 2011 • Joint session with Biomarker SIG

  6. Today... • Two people present their experiences (somewhat) formally • 3-4 looser “brainstorming” sessions • will hopefully include • learning from each other and sharing of experience in modelling and simulation • ask ourselves what the SIG should do • ask ourselves what modelling and simulation would we like to see developed further • explore questions sent to Vincent Haddad by participants • perhaps some software issues? • other things we haven’t thought of! • Biomarkers SIG experience: some discussion in smaller groups is worthwhile • some participating via telephone

  7. What has the SIG found out about M&S? How we use modelling and simulation Studies in a development program Logistics (enrolment, workflow, event times) Drug in the body

  8. What has the SIG found out about M&S? Studies in a development program Logistics (enrolment, workflow, event times) Drug in the body

  9. What has the SIG found out about M&S? Studies in a development program Logistics (enrolment, workflow, event times) Drug in the body

  10. Model • Data • Design A picture • Execute Pharmaco-economics NPV Analysis Target Selection & Program NPV

  11. Model Model Data Design A picture Execute Model Model Simulate subjects’ outcomes with a variety of safety+efficacy profiles for dose-response Pharmaco-economics NPV Analysis Target Selection & Program NPV

  12. Model Model Data Design A picture Execute Model Model ...informed by PK/PD models of exposure and response Simulate subjects’ outcomes with a variety of safety+efficacy profiles for dose-response Pharmaco-economics NPV Analysis Target Selection & Program NPV

  13. Model Model Data Design A picture Execute Assess simulation, improve design, simulate again Model Model ...informed by PK/PD models of exposure and response Simulate subjects’ outcomes with a variety of safety+efficacy profiles for dose-response Pharmaco-economics NPV Analysis Target Selection & Program NPV

  14. Over to you...

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