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Monolix Day 2011 Current State & Future plansConfidential
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
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
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
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
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
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
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
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
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
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