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Midterm Activities Breakout Discussion

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A breakout session at the Pistoia Alliance Information Ecosystem Workshop proposed several midterm activities the Alliance could undertake, including ways to improve interactions between CROs and pharma. The workshop was held in October 2011

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Page 1: Midterm Activities Breakout Discussion

Mid-Term ProjectsInformation Ecosystem Workshop (PA)

10.10.11

Monday, 10 October 2011

Page 2: Midterm Activities Breakout Discussion

People

• Henrik Seidel

• William Spooner

• Thomas Blackadar

• Ewan Hunter

• Bryn Williams-Jones

• Misha Kapushesky

Monday, 10 October 2011

Page 3: Midterm Activities Breakout Discussion

Mid-Term Project Ideas

• Improving CRO-pharma interaction

• “Common language” tools for integration

• Physical shipping logistics

• Sequence services phase three

Monday, 10 October 2011

Page 4: Midterm Activities Breakout Discussion

CRO-Pharma Environment

• Problem: there are increased costs to CROs and pharma in data round-tripping over QC evaluation rounds

• Short-term Assumption: a common standard can be defined for ELN data interchange

Monday, 10 October 2011

Page 5: Midterm Activities Breakout Discussion

CRO-Environment Mid-Term Project

• Implementation of ELN interchange standard

• Dev’p cloud environment for CRO/pharma

• Identity management and validation

• Timestamp, audit trails, verification

• Secure, validated, trusted (PA-approved)

Monday, 10 October 2011

Page 6: Midterm Activities Breakout Discussion

CRO-Environment Beyond Mid-Term

• Standard for protocol reporting with implementation and servicing

• Look for funding from PA and consider CROs, ELN developers as stakeholders

• ROI

• Better data quality

• Clearer IP ownership

• Lower total cost

• Improve quality control and reproducibility

Monday, 10 October 2011

Page 7: Midterm Activities Breakout Discussion

“Common Language” Tools Mid-Term Project

• Problem: there is no trusted resource for unambiguous resolution of named entities

• Short-term Assumption: an identifier mapping service will be created

Monday, 10 October 2011

Page 8: Midterm Activities Breakout Discussion

“Common Language” Tools Mid-Term Project

• Why? To enable data integration, “disease explorer”-like use cases

• A canonical, trusted, PA-approved repository of vocabularies/ontologies

• Collaborative ontology hosting, development and maintenance environment

Monday, 10 October 2011

Page 9: Midterm Activities Breakout Discussion

“Common Language” Tools Mid-Term Project

• Tools for annotation, tagging and integration of canonical ontologies/vocabularies into QC pipelines, ELN, LIMS, DBs and other systems

• Roles for Pistoia:

• Selection, approval: eg animal models ontol’s

• bring together key stakeholders in academia and industry to result in an SME, non-profit, or a workgroup to help build and maintain service and tools

Monday, 10 October 2011

Page 10: Midterm Activities Breakout Discussion

Physical Shipping Logistics

• Chemicals shipping: standards for labelling, pre- and post-shipping quality control, tracking, servicing

• Workgroup to mandate and approve standards, best practices

Monday, 10 October 2011

Page 11: Midterm Activities Breakout Discussion

Seq Services Phase 3

• Expanding tools and data types

• Expanding to sensitive data: patients, clinical

• Translational applications

• Healthcare

Monday, 10 October 2011