CPTR Overview CPTR 2012 Workshop October 2-4, 2012.

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Presentation transcript:

CPTR Overview CPTR 2012 Workshop October 2-4, 2012

The Challenge 2

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

CPTR Working Group Structure [Enter Presentation Title in Insert Tab > Header & Footer4 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 Drug Development Coalition Global Regulatory Pathways WG Stakeholder & Community Engagement WG Access & Appropriate Use WG Clinical Trials Infrastructure WG Integrated Sciences Team

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

CPTR Key Accomplishments: Regulatory Science Consortium CPTR 2012 Workshop October 2-4, 2012

CPTR Regulatory Science Consortium Governance [Enter Presentation Title in Insert Tab > Header & Footer7 Regulatory Science Consortium Research Resources Group Drug Development Coalition Coordinating Committee

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

Regulatory Science Consortium Regulatory Science Consortium Research Resources Group Drug Development Coalition 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 9

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

[Enter Presentation Title in Insert Tab > Header & Footer11 Biomarkers and Clinical Endpoints Modeling and Simulation 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 Pre-Clinical and Clinical Sciences Key Accomplishments

TB Data Standard [Enter Presentation Title in Insert Tab > Header & Footer12 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 & Footer13 Biomarkers and Clinical Endpoints Modeling and Simulation 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 Pre-Clinical and Clinical Sciences Key Accomplishments

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

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

Research Resources [Enter Presentation Title in Insert Tab > Header & Footer16

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