Pistoia Alliance USA Conference 2016
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Pistoia Alliance USA Conference 2016
- 1. October 18, 2016 Investment opportunities An overview of the developing and emerging portfolios Carmen Nitsche and John Wise
- 2. ©PistoiaAlliance Agenda • Introducing new Portfolio Investment committee • Developing portfolio – Unified chemistry data model – User experience/User centered design – Sequence analysis in the regulated domain • Emerging portfolio – Wearables – Real-world data platform – IoT • Other discussion topics – Identification of medicinal products (IDMP) – Non-Clinical Development Community of Interest – Blockchain Standards • UDM • Wearables Data sharing • RWD platforms • IoT • Non-clinical development Best practices • UXUCD • Seq an. In reg dom • IDMP • Blockchain 2
- 3. ©PistoiaAlliance Introducing Portfolio Investment committee 3 Operations Board Investment committee Innovation committee Advisory Panel David Murray AZ Angeli Möller Bayer David Nirschl BMS Devendra Deshmukh Merck & Co Simon Thornber GSK Veit Ulshoefer Merck Group Mohit Agnihotri Novartis Tom Pianko Elsevier
- 4. ©PistoiaAlliance Developing Portfolio Standards • UDM Data sharing Best practices • UXUCD • Seq analysis (reg domain) 4
- 5. ©PistoiaAlliance Unified [chemistry] data model (UDM) +Problem Statement: Collaboration and chemical information data exchange with partners and CROs is hampered when different ELNs are in use. • No common data model to describe chemical reactions • Thwarting the development/sharing of business rules for consistent representation of reactions and IP capture VARIATIONS STAGES+ + 5 Standards •UDM Data sharing Best practices
- 6. ©PistoiaAlliance Unified chemistry data model 6 • Status – Community of interest established – Excellent example of cross-community involvement – Introductory materials posted on IP3 – Domain-aware, experienced PM hired – Biz case underway • Jarek Tomczak beginning interviews with stakeholders • Next steps – Complete biz case – Establish budget req. – Fundraise • Estimate $150K required • Several pledges in process • If this is of interest to you: • Join the CoI • Contribute use-cases • Make a pledge! Standards •UDM Data sharing Best practices
- 7. ©PistoiaAlliance User experience/User centered design 7 Standards Data sharing Best practices •UXUCD Problem Statement: “R&D in Pharma is quite hard enough without R&D IT getting in the way!” (personal communication from a senior leader in R&D from a major biopharma company)
- 8. ©PistoiaAlliance User experience/User centered design 8 • Status – Active CoI – ~40 people/20 companies at F-2-F joint EMBL-EBI workshop (Sep-16) – 1st round fund-raising in process. $25K raised from: • Bayer • GSK • Novartis • Roche • quattro research • (still in discussion with others) • Next steps – Contract a domain-aware, experienced PM. – Complete fundraising • Looking for $5K/co. – Launch Phase 1 • Build 3 high-priority UX/UCD tools, • If this is of interest to you: • Join project team • Make a pledge! Standards Data sharing Best practices •UXUCD
- 9. ©PistoiaAlliance Sequence analysis in regulated domain 9 Standards Data sharing Best practices • Seq analysis (reg domain) Problem Statement: As sequence analysis becomes increasingly a part of clinical trials - so sequence analysis enters the realms of GCP, and must become compliant with all the concomitant regulations controlling the use of computer-based technologies, including 21 CFR Part 11 and Computer Systems Validation.
- 10. ©PistoiaAlliance Sequence analysis in regulated domain • Status – Idea entered into IP3 – CoI emerging – Webinar on topic presented in Sept 2016 – $20K seed money contributed by Roche to support concept development • Next steps – Contract a domain-aware, experienced PM. – Identify needs and develop business case • If this is of interest to you: – Join the CoI – Help refine/prioritize the needs – Make a pledge! 10 Standards Data sharing Best practices • Seq analysis (reg domain)
- 11. ©PistoiaAlliance Emerging Portfolio Standards • Wearables Data sharing • RWD platforms • IoT Best practices 11
- 12. ©PistoiaAlliance Wearables 12 Problem Statement: There is an increasing use of wearables to collect phenotypic data in clinical trials. However, there are few standards to harmonise the data formats for transmission and storage of such data in clinical trials databases. This Community of Interest is working to understand how the Pistoia Alliance can identify best practices and “signpost” appropriate data and information standards. Standards •Wearables Data sharing Best practices
- 13. ©PistoiaAlliance Wearables 13 • Status – Wearables are a hot topic our members are highlighting – Conference session at PA 2016 conference London – 2 webinar hosted in 2016 • Smart glasses • Clinical trials& wearables – Initial idea entered into IP3 • Next steps – Develop the CoI – Submit idea to investment committee • Seed $ to hire PM • If this is of interest to you: – Join the CoI – Make a pledge! Standards •Wearables Data sharing Best practices
- 14. ©PistoiaAlliance Real-world data 14 Problem Statement: The need for real world data (RWD) means a need for rapid integration of structured, semi-structured and unstructured data. Individual approaches are suboptimal. This community of interest will explore what is needed to create a more shared RWD environment, to improve access and mining of such data. Standards Data sharing • RWD platforms Best practices
- 15. ©PistoiaAlliance Real-world data 15 • Status – Idea submitted to IP3 – Preliminary polling of PA members suggests broad interest in topic – New position paper submitted to PA comms company • Next steps – Organize a PA debates webinar – Establish a CoI • Share case studies • Discuss requirements • Identify best practices and • opportunities for precompetitive collaboration – Submit idea to investment committee • If this is of interest to you: – Join the CoI – Comment on IP3 to help focus the discussion – Make a pledge! Standards • Wearables Data sharing • RWD platforms • IoT Best practices
- 16. ©PistoiaAlliance Internet of Things (IoT) 16 Problem Statement: Internet of Things is still an immature field within Pharma. This community of interest will share use cases and identify tangible, common opportunities, including those in the laboratory, that could be addressed with a pre-competitive model. Standards Data sharing •IoT Best practices
- 17. ©PistoiaAlliance Internet of Things (IoT) 17 • Status – Preliminary idea entered into IP3 – Session at 2016 PA conference in Boston • Next steps – Establish CoI • Share case studies • Identify best practices & • opportunities for precompetitive collaboration – Submit idea to investment committee • If this is of interest to you: – Join the CoI – Share case studies – Make a pledge! Standards Data sharing •IoT Best practices
- 18. ©PistoiaAlliance Other discussion topics Standards Data sharing • Non-clinical development Best practices • IDMP • Blockchain 18
- 19. ©PistoiaAlliance IDMP 19 Problem Statement: Mandatory implementation of IDMP (identification of medicinal products - the ISO standard) is upon us. The Pistoia Alliance has the capability to identify pre-competitively and define best practices to implement this standard across the R&D pipeline through establishment of a Community of Interest. Standards Data sharing Best practices •IDMP
- 20. ©PistoiaAlliance IDMP 20 • Status – Personal communication with a regulatory agency official... “What is the Pistoia Alliance doing about IDMP?” – Write-up being prepared • Next steps – Establish CoI – Submit idea to investment committee • If this is of interest to you: – Consider championing the idea! – Submit comments to IP3 – Join the CoI – Make a pledge! Standards Data sharing Best practices •IDMP
- 21. ©PistoiaAlliance Non-clinical development CoI (NCD CoI) 21 Problem Statement: Currently, there is no cross-industry community of interest focusing on optimizing non-clinical development processes. For example, Much time and money is expended by NCD functions replicating protocol creation and validation. Collaborating in this area could save time, decrease costs and increase quality. Standards Data sharing •Non-clinical development Best practices
- 22. ©PistoiaAlliance Non-clinical development CoI 22 • Status – Initial IP3 idea submitted – F2F discussion planning underway • Next steps – Hold first CoI meeting in November – Submit idea to investment committee • If this is of interest to you: – Join the CoI – Submit discussion topics on IP3 – Make a pledge! Standards Data sharing •Non-clinical development Best practices
- 23. ©PistoiaAlliance Blockchain 23 Problem Statement: Blockchain has come on our radar recently, but we don’t know enough about it yet. For example can it enhance compliance in clinical trials and the clinical trials supply chain? If this topic is of interest to you, please let us know and consider entering your thoughts into IP3. Standards Data sharing Best practices •Blockchain