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
Confidential 2
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
Confidential
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
Confidential 4
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
5
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
Confidential 6
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
Confidential
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
Confidential
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
Confidential 9
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
Confidential 10
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
Confidential 11
