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Monolix Day 2011 Current State & Future plans

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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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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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Monolix 4.1

  Annual or perpetual licenses   Individual workstations or cluster grids   Platform support:

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Windows XP/Vista/7 32bits

Windows XP/Vista/7 64bits

Linux (all distrib.) 32bits

Linux (all distribs) 64bits

Standalone Workstation 32 bits mode

Cluster 32 bits mode

Matlab (2009-2011)

Workstation 32 bits mode

Cluster 32 bits mode

DDMoRe – The Vision Major deliverables

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Modelling Library

Shared knowledge

Modelling Framework

A modular platform for integrating and

reusing models; shortening timelines

by removing barriers

Model Definition Language

System interchange standards

Specific disease models Examples from

high priority areas

Standards for describing models, data and designs

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Lixoft, Inria & DDMore

Popix (Inria) Methods & Statistics

Lixoft Software engineering,

training & support

DDMORE – EFPIA Applications

Proof of Concepts & Standards

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o  Transfer o  Common development plaforms

o  Expression of needs & open issues o  Application expertise meets statistical

expertise

o  Standards compatibility, interoperability

o  Industrialization

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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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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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Enabling greater deployment of M&S

  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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Adapted from Lalonde et al, 2007

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Roadmap

2010-2011 2012-2013 2014- Monolix 4.0 • Cluster support • Batch mode • New graphics Monolix 4.1 • Full MLXTRAN & Structural models (PK, RTTE)

Monolix 4.1+ • Windows native 64 bits Monolix 5.0 • Committee specifications • Accelerated computations (GPU) • New models & methods • New outputs (graphics, reporting)

Beyond traditional PKPD: • Pharmacogenetics • PBPK • Systems • Imaging data

Clinical Trial Simulator 1.0 • DDMoRE prototype converted in industrial tool • Decision tool • Trial planning

CTS 2.0: • Complex utility functions • Non-conventional models for simulation

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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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Confidential

Thank you

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