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AstraZeneca and Charles River presentation on simplifying outsourced preclinical safety studies

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We are pleased to make available the presentation ‘Use of a Collaborative Tool to Simplify the Outsourcing of Preclinical Safety Studies: an insight into the AstraZeneca-Charles River Labs strategic relationship’ by AstraZeneca and Charles River, as delivered at Bio2Business and the World Preclinical Congress. The presentation describes how they used iTraX™  to simplify the outsourcing of preclinical safety studies, as published in Drug Discovery Today.

Frederic Martin, Senior Externalisation Specialist, Alliance & Project Management at AstraZeneca, said: “By using iTraX as our main collaborative tool to manage strategic outsourcing with CRL, we were able to visualise and share our portfolio and all studies at different stages of the outsourcing process. We could also benefit from all the new possibilities iTraX offers in refining, simplifying and improving our processes.”

David Hollinshead, Technical Director at Elixir Software comments, "It's gratifying to see iTraX become an indispensable tool for study portfolio management, covering study design, planning/costing, scheduling, and also tracking delivery". He adds, "The benefits ascribed by AstraZeneca and CRL immediately resonate with other company internal and external study management needs. We are now helping many new customers maximise value through effective study management".

Contact us to find out how Elixir and iTraX™ can enhance your project.

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AstraZeneca and Charles River presentation on simplifying outsourced preclinical safety studies

  1. 1. Use of a Collaborative Tool to Simplify the Outsourcing of Preclinical Safety Studies: an insight into the AstraZeneca-Charles River Labs strategic relationship Frederic Martin, Senior Externalisation Specialist Alliance & Project Management, AstraZeneca, UK. 19th June 2018
  2. 2. BOSTON CAMBRIDGE GOTHENBURG GAITHERSBURG SHANGHAI Gaithersburg (US) Gothenburg (Mölndal) (SE) Cambridge (UK) Three strategic R&D sites close to global bioscience clusters CALIFORNIA OSAKA
  3. 3. 61,100 employees $22.5bn Total Revenue $5.8bn invested in R&D with research across 5 countries AstraZeneca (AZ): Global dimensions 3 As of 31/12/2017 144 projects More than 600 collaborations and partnerships globally
  4. 4. AstraZeneca / Charles River strategic relationship • In 2012, AstraZeneca took the decision to outsource all pre-clinical safety studies • A strategic relationship with Charles River Laboratories began shortly afterwards 4 •Global company •Revenue ~$1.1 billion in 2012, ~$1.8 billion in 2017 •>7,000 employees in 2012, currently >11,000 employees •Pharma recognized CRO for the delivery of pre-clinical data
  5. 5. AstraZeneca / Charles River strategic relationship 5 • Fixed standard study design price with add-on/removal price list • Transition from AZ to CRL was complete in January 2013 • Initial 2-year deal with option to extend to 5 years • Contract has been further extended Master Services Agreement (MSA) • Pre-clinical toxicology studies • Safety pharmacology • Formulation analysis • Bioanalysis and pharmacokinetics • In vivo ADME Studies outsourced
  6. 6. Benefits of the strategic relationship 6 Benefits to AZ Reduced costs Increased flexibility of AZ resources Shortening of timelines Benefits to CRL Guaranteed work Advance forecast of work Pre-study lead in times
  7. 7. The original process 7 Forecasting and scheduling Study trigger Study soft- scheduled Study schedule finalised Study Study designed Study plan completed Study phase Study reporting Finance Study quoted Purchase order raised Invoices submitted Invoices paid
  8. 8. Process simplification 8 ExTraX
  9. 9. Process simplification 9 Scheduling •Study requested by AZ FPM •Scheduling of study •Progressed by CRL Study design •AZ scientists enter study specifications •SM to progress flow Quote •CRL to provide quote based on specifications •SM to approve quote •IS to raise PO Study plan •Study plan written by CRL and approved by SM •Study progressed when study plan signed Study phase •Study conducted by CRL •Reporting dates and milestones kept updated by CRL RC AZ= AstraZeneca; CRL= Charles River Labs; FPM= Functional Project Manager; SM = Study Monitor; IS = invoicing specialist; CRL RC = CRL report coordinator
  10. 10. ExTraX – project board 10
  11. 11. ExTraX – study board 11
  12. 12. Collaboration in numbers 12 289 active studies outsourced in CRL as of May 2018
  13. 13. Benefits and challenges of using ExTraX 13 Benefits • Visibility of portfolio for CRL • Visibility of individual studies and where they are in process • Ability to see when next stage of process is due • Ability to create individual views • Ability to share individual tickets with different companies Challenges • Understanding of new processes • Understanding of responsibility / accountability for different phases • Be mindful of who you are sharing information with • Use of new tool
  14. 14. Continuous optimisation through evolving partnership 14 2012 2014 2016 2018 2020 Processimprovement Relationship
  15. 15. Summary 15 Shared overview of the portfolio and planned studies Better communication channels Simpler integrated workflow Faster turn-around time Deliver medicines to patients more rapidly
  16. 16. Confidentiality Notice This file is private and may contain confidential and proprietary information. If you have received this file in error, please notify us and remove it from your system and note that you must not copy, distribute or take any action in reliance on it. Any unauthorized use or disclosure of the contents of this file is not permitted and may be unlawful. AstraZeneca PLC, 1 Francis Crick Avenue, Cambridge Biomedical Campus, Cambridge, CB2 0AA, UK, T: +44(0)203 749 5000, www.astrazeneca.com 16

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