Monolix Day 2011

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Monolix Day 2011

  1. 1. Monolix Day 2011 Current State & Future plansConfidential
  2. 2. 2011 – Birth of Lixoft  Incorporated in May 2011  Transfer from Inria to Lixoft   IP agreement – Monolix & technologies for population analysis   Research contract and transfer of know-how for current and future developments  4 full-time engineer employees of Lixoft  International Scientific Committee   Head: Marc Lavielle, Inria   Sylvain Durrleman, former Head of clinical development at Sanofi   2 or 3 additional members to be announced, including a former FDA DirectorConfidential 2
  3. 3. Where we are  Perennial organization for future Monolix developments and support  Monolix 4.0 and 4.1 – 1st year of commercialization   Several contracts in big pharma & biotechs •  Individual workstations and full cluster deployment   Strong demand from regulators and academics  Lixoft funded with   License revenues   Training & expertise fees   OSEO/Ministry of research prize for innovating companies   Inclusion in DDMoRE IMI projectConfidential
  4. 4. Monolix 4.1   Annual or perpetual licenses   Individual workstations or cluster grids   Platform support: Windows Windows Linux (all Linux (all XP/Vista/7 XP/Vista/7 distrib.) distribs) 32bits 64bits 32bits 64bits Standalone Workstation 32 bits mode Cluster 32 bits mode Matlab Workstation 32 bits mode (2009-2011) Cluster 32 bits modeConfidential 4
  5. 5. DDMoRe – The Vision Major deliverables Standards for describing models, data and designs Modelling Modelling Library Framework Model Shared knowledge System A modular platformDefinition for integrating and interchangeLanguage reusing models; standards Specific shortening timelines by removing disease barriers models Examples from high priority areas 5
  6. 6. Lixoft, Inria & DDMore Popix (Inria) Methods & Statistics o  Expression of needs & open issues o  Transfer o  Application expertise meets statistical o  Common development plaforms expertise DDMORE – EFPIA Lixoft Applications Software engineering, Proof of Concepts & Standards o  Standards compatibility, training & support interoperability o  IndustrializationConfidential 6
  7. 7. Future plans - overview 1.  Vision   Some lessons from EMA-EFPIA M&S Workshop   Enlarged audience to reinforce cross-department collaboration 2.  Product roadmap   Monolix   Trial Simulation   Complex models beyond PKPD 3.  Lixoft in three yearsConfidential
  8. 8. Lessons from EMA-EFPIA M&S Workshop   Breakthrough event, at EU level & beyond   Challenges raised   Better understanding between regulators and sponsors •  Importance of sound modelling & statistical methods •  Transparency of tools and output results   Building confidence in M&S beyond traditional community   Increasing complexity •  Quantitative & Systems Pharmacology •  Personalized therapy   Lack of people, need for trainingConfidential
  9. 9. Enabling greater deployment of M&S Adapted from Lalonde et al, 2007  Common platform through the value chain allowing shared ownerships of M&S studies by the project teams   Quality outputs, enhancing communication with decision makers and regulators   Allows interactivity with clinicians and other project team members   Communication enabler for effective translational medicine  State of the art in statistics, non linear modelling and efficient computations  Common platform ideal for hands-on and theoretical training, academic research and industryConfidential 9
  10. 10. Roadmap 2010-2011 2012-2013 2014- Monolix 4.0 Monolix 4.1+ Beyond traditional PKPD: • Cluster support • Windows native 64 bits • Pharmacogenetics • Batch mode • PBPK • New graphics Monolix 5.0 • Systems • Committee specifications • Imaging data Monolix 4.1 • Accelerated computations • Full MLXTRAN & (GPU) Structural models (PK, • New models & methods RTTE) • New outputs (graphics, reporting) Clinical Trial Simulator 1.0 CTS 2.0: • DDMoRE prototype converted in • Complex utility functions industrial tool • Non-conventional models • Decision tool for simulation • Trial planningConfidential 10
  11. 11. Lixoft in three years   Key player for M&S in pre-clinical and clinical studies   Technological leadership   Complex models   Advances in personalized medicine   Accelerated computations (GPU, etc.)   Industrial platform with excellent interoperability and standards compliance •  DDMoRE standards, ITIL compliance, regulatory guidelines   Large ecosystem - biotech & pharmas, academics & regulators… and many trained studentsConfidential 11
  12. 12. Thank youConfidential 12

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