simcyp presentation - rebecca martell

© 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]


• 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 (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:


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


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


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


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


Simcyp Grant History (2004 onwards)

FP6 , FP7, IMI

6 International Collaborative Projects

€1, 155, 099 since 2004


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!


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!


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)


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


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/)


THANK YOU

Please contact me if you have any questions

[email protected]

simcyp presentation - rebecca martell

Technology

simcyp limited email

oral presentations

director ec sme definition

infants animal compare

grants coordinator

rebecca martell