1. Monolix Day 2011
Current State & Future plans
Confidential

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

12. Thank you
Confidential 12