simcyp presentation - rebecca martell
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© 2001-2011 Simcyp Limited
Simcyp Limitedwww.simcyp.com
Experience as an SME involved in funded research
Biocity Framework Focus Event, Nottingham, May, 2011
Rebecca Martell, Grants Coordinator, Simcyp [email protected]
© 2001-2011 Simcyp Limited
• Main activities
• Population-based Simulator (M&S of PKPD virtual populations)
• Paediatric (PK behaviour in infants)
• Animal (Compare data without allometric scaling)
• Education programmes (workshops)
• Practical training
• Consultancy
• Active R&D team
• Publications, oral presentations, poster presentations
Simcyp Limited:
© 2001-2011 Simcyp Limited
• 2001 (The University of Sheffield)
• Professor Geoff Tucker (Chairman)
• Professor Amin Rostami-Hodjegan (Director of R&D)
• Mr John Evans (Managing Director)
• EC SME definition
• <250 employees (53 and growing), annual turnover <€50 million
• Prestigious awards
• 2010: ‘Queen’s Award For Enterprise’
• 2009: ‘Outstanding Scientific Contribution to Animal Replacements’
Simcyp Limited:
© 2001-2011 Simcyp Limited
Simcyp – how is it used?
• Provide Modelling and Simulation tools
• Examine pharmacokinetic behaviour in virtual populations
• Extreme clinical scenarios, safety of a computer
• Pharmaceutical companies, Simcyp consortium
• Consortium guide development, determine R&D priorities
• Annual meeting
• 70% of top-40 pharmaceutical companies use Simcyp
• Also used by regulatory bodies / universities
• Scientific Advisory Board
• Board of independent experts in field provide guidance
© 2001-2011 Simcyp Limited
Simcyp – how is it used?
• Simcyp helps...
• Reduce and refine animal testing
• Enable more informed decisions
• Assists development of safer medicines
• Improve drug development process (time and costs)
• External citations
• External publications / presentations demonstrating application of Simcyp
• Strong Academic Links
• Used in teaching and research in academic centres of excellence
© 2001-2011 Simcyp Limited
Simcyp’s Grant History (2004 – 2007)
• 2004 - 2010 ‘BIOSIM’ FP6 ‘Biosimulation – a new tool in drug development’
In silico M&S tools to reduce time / costs of developing new drugs and animal experiments
Results: successful, wide dissemination, PhD students trained, collaborations with healthcare / regulatory agencies
• 2007 - 2010 ‘LIINTOP’ FP7 ‘Optimisation of liver and intestine in vitro model for pharmacokinetic
and pharmacodynamic studies’
In vitro tests to replace animal experiments
Results: successful, wide dissemination, objectives achieved
© 2001-2011 Simcyp Limited
Simcyp’s Grant History (2008 – present)
• 2008 - 2013 ‘PREDICT-IV’ FP7‘Profiling the toxicity of new drugs: a non animal-based approach integrating toxico-dynamics and biokinetics’Safety assessment for early drug development / late discovery
• 2010 - 2013 ‘NEUROBID’ FP7‘Neuroscience on barriers in development’Understanding BBB in the developing brain and neurological disorders
in infancy
• 2011 - 2016 ‘TINN2’ FP7‘Treat infections in neonates 2’Evaluate azithromycin to treat infections in preterm's / neonates
• 2011 - 2016 ‘DDMoRe’ IMI‘Drug Disease Model Resources’Common language for data / models / workflows
© 2001-2011 Simcyp Limited
Simcyp Grant History (2004 onwards)
FP6 , FP7, IMI
6 International Collaborative Projects
€1, 155, 099 since 2004
© 2001-2011 Simcyp Limited
Key breaks:
• Early publications raised awareness
• Proctor et al, Xenobiotica 2004, 34: 151 -178.
• Rostami et al, Drug Discovery Today: Technologies 2004, 1: 441 – 448
• Active R&D team (the key!)
• Present at international conferences on range of topics, all scientists involved
• Simcyp approached to participate in BioSim after a EUFEPS presentation
• Recommendations
• Recommended by others (SAB)
• All demonstrates application of Simcyp to opinion leaders!
© 2001-2011 Simcyp Limited
Benefits / things to consider:
• Significant Benefits to Simcyp
• Scientific development to meet industry needs
• Basis for future collaboration
• Demonstrate application / utilisation of Simcyp & expands team!
• Things we have learnt to consider
• Administrative effort (proposal, timesheets, reports, emails, meetings...)
• 75% of costs covered, need ‘strategic fit’ to company
• Agreement clauses, particularly IPR for SME’s
• Partner / Coordinator - what suits your company
• Achievable deliverables, reporting thoroughly checked!
© 2001-2011 Simcyp Limited
What have we learnt?
• Experience
• Understanding agreements / guidelines / eligibility / requirements
• Awareness of resources involved, can plan
• But things change, it’s a learning process
• Early communication on possible projects crucial
• Dedicated person
• Joined company in 2008, appointed to role 2010
• Prior to appointment, submitted full ERA-NET proposal
• Don’t conduct research but work closely with R&D team
• Involved in full process (from research new grants to managing existing ones)
© 2001-2011 Simcyp Limited
Points to emphasise in a proposal:
• Well established Consortium
• International collaboration / strength / previous collaboration / coordination / management
• Expertise of Consortium members
• Scientific points
• Relation to EC topic call
• Achievement of deliverables / objectives
• Knowledge gaps addressed
• Dissemination
• Management of IP
• SME’s significantly contribute to dissemination / impact
© 2001-2011 Simcyp Limited
Advice for SME’s looking to participate:
• CORDIS website valuable tool (www.cordis.europa.eu/)
• Grant and Consortium agreements
• Intellectual property rights and negotiation guidelines
• Help desk for enquiries
• Partner search
• Utilise existing networks
• National Contact Points
• Provide individual advice and assistance (list on CORDIS)
• Courses
• ‘FP7 Consortium Agreements’, ‘Coordinating FP7 Research Projects’ (http://www.singleimage.co.uk/)