Lixoft was incorporated in 2011 to commercialize the Monolix population modeling software and further its development. It has 4 employees and collaborates with Inria on research. Monolix 4.0 and 4.1 saw initial commercial success with several contracts in big pharma. Lixoft plans to expand Monolix's capabilities to new areas like pharmacogenetics and PBPK modeling, develop a clinical trial simulator, and establish itself as a leader in modeling and simulation for drug development within 3 years.

1. Monolix Day 2011
Current State & Future plans
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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
Director
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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 project
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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 mode
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5. DDMoRe – The Vision
Major deliverables
Standards for describing models, data and designs
Modelling Modelling
Library Framework
Model Shared knowledge System
A modular platform
Definition for integrating and interchange
Language reusing models; standards
Specific shortening timelines
by removing
disease barriers
models
Examples from
high priority areas
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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 Industrialization
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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 years
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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 training
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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 industry
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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 planning
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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 students
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12. Thank you
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