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CPTR Overview

CPTR 2012 Workshop October 2-4, 2012. CPTR Overview. The Challenge. CPTR Mission. Accelerate the development of new, safe, and highly effective regimens for TB by enabling early testing of drug combinations. CPTR Working Group Structure. Clinical Trials I nfrastructure WG. Data

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CPTR Overview

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  1. CPTR 2012 WorkshopOctober 2-4, 2012 CPTR Overview

  2. The Challenge

  3. CPTR Mission Accelerate the development of new, safe, and highly effective regimens for TB by enabling early testing of drug combinations.

  4. CPTR Working Group Structure • Clinical Trials Infrastructure WG • Data • Standards & Integration • WG • Biomarkers & Clinical Endpoints • WG • Preclinical & Clinical Sciences WG • Modeling and Simulation WG • Health Authorities Submission WG Regulatory Science Consortium Research Resources Group • Global Regulatory Pathways WG • Stakeholder & Community Engagement WG • Access & Appropriate Use WG Integrated Sciences Team Drug Development Coalition [Enter Presentation Title in Insert Tab > Header & Footer

  5. CPTR Structure Research Resources Group Regulatory Science Consortium ADVISORY PANEL Drug Development Coalition

  6. CPTR 2012 WorkshopOctober 2-4, 2012 CPTR Key Accomplishments:Regulatory Science Consortium

  7. CPTR Regulatory Science Consortium Governance Coordinating Committee Regulatory Science Consortium Research Resources Group Drug Development Coalition [Enter Presentation Title in Insert Tab > Header & Footer

  8. Regulatory Science Consortium Members and Partners Government/Regulatory participants Industry members Non-profit research members

  9. Regulatory Science Consortium Regulatory Science Consortium Research Resources Group • Our role in accelerating the process includes : • Identify tools and methods that can bring the most value • Reach scientific consensus through sharing of expertise, information and data • Proceed to regulatory qualification when appropriate as an outcome Drug Development Coalition

  10. Regulatory Sciences Structure and Role Biomarkers and Clinical Endpoints TB Data Standards and Integration Modeling and Simulation Regulatory Science Consortium Pre-Clinical and Clinical Sciences Health Authority Submissions Regulatory Authority Input

  11. Key Accomplishments • TB Data Standard Version 1.0 launched and available for use on CDISC site (3Q2012) • TB data repository developed and launched (3Q2012) for remapping of key data sets to the new standard • Liquid Culture to be proposed as a predictive or prognostic biomarker for clinical outcome (2Q2012) • Letter of Intent submitted to FDA (3Q2012) • Evaluation of key pre-clinical efficacy models for early selection of combination partners complete (2Q2012) • In vitro hollow fiber model selected and context of use for this tool is under development(3Q2012) • Existing TB progression models evaluated and review manuscript submitted (2Q 2012) • Develop a PBPK module to evaluate drug distribution in the infected lung [2Q2013 and ongoing] TB Data Standards and Integration Biomarkers and Clinical Endpoints Pre-Clinical and Clinical Sciences Modeling and Simulation [Enter Presentation Title in Insert Tab > Header & Footer

  12. TB Data Standard • Clinical data standard used/preferred by FDA review divisions • Enable data sharing between organizations • Enable aggregation and querying of data • When implemented from the start, can lower costs acquiring and analyzing data [Enter Presentation Title in Insert Tab > Header & Footer

  13. Key Accomplishments • TB Data Standard Version 1.0 launched and available for use on CDISC site (3Q2012) • TB data repository developed and launched (3Q2012) for remapping of key data sets to the new standard • Liquid Culture to be proposed as a predictive or prognostic biomarker for clinical outcome (2Q2012) • Letter of Intent submitted to FDA (3Q2012) • Evaluation of key pre-clinical efficacy models for early selection of combination partners complete (2Q2012) • In vitro hollow fiber model selected and context of use for this tool is under development(3Q2012) • Existing TB progression models evaluated and review manuscript submitted (2Q 2012) • Develop a PBPK module to evaluate drug distribution in the infected lung [2Q2013 and ongoing] TB Data Standards and Integration Biomarkers and Clinical Endpoints Pre-Clinical and Clinical Sciences Modeling and Simulation [Enter Presentation Title in Insert Tab > Header & Footer

  14. Modeling and Simulation Work Group Vision: More efficient translation between each stage of drug development Continuously revise and refine with relevant data (summary and subject-level) Preclinical PKPD Right Molecule Pharmacology Right Target Pharmaco- metrics Right Patients Network Biology Right Pathway Clinical Pharmacology Right Dose Disease Drug Target Pathway Clinical trial simulation tools (drug-disease-trial models) Physiologically-based PK models Hollow fiber model

  15. Milestone Horizon Today: CPTR 2012 Workshop CPTR 2013 Workshop Publish DPM-WG papers TB Data Standards Repository Launched Submit LOIto FDA for Hollow Fiber Qualification Begin Briefing Package for Hollow Fiber Qualification Identify Next Set of DDTs for Qualification Submit LOI to FDA for Liquid Culture Qualification TB Data Standards v 1.0 Published Publish Preclinical Sciences Papers Remap TB Data & Load to Repository S22, 27, 28 Begin Briefing Package for Liquid Culture Qualification

  16. Research Resources [Enter Presentation Title in Insert Tab > Header & Footer

  17. CPTR Structure Research Resources Group Regulatory Science Consortium Drug Development Coalition

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