Upload
dandre
View
47
Download
0
Tags:
Embed Size (px)
DESCRIPTION
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 - PowerPoint PPT Presentation
Citation preview
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 & Footer 4
• 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 PAN
EL
5
CPTR Key Accomplishments:Regulatory Science Consortium
CPTR 2012 Workshop October 2-4, 2012
[Enter Presentation Title in Insert Tab > Header & Footer 7
CPTR Regulatory Science Consortium Governance
Regulatory Science Consortium
Research Resources Group
Drug Development Coalition
Coordinating Committee
Government/Regulatory participants
Non-profit research membersIndustry 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
outcome9
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 andSimulation
Regulatory Authority
Input
10
[Enter Presentation Title in Insert Tab > Header & Footer 11
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 Standardsand Integration
Pre-Clinical and Clinical Sciences
Key Accomplishments
[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
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 Standardsand 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)
PreclinicalPKPDRight
Molecule
Vision: More efficient translation between each stage of drug development
ClinicalPharmacology
RightDose
Pharmaco-metrics
RightPatients
Pharmacology
RightTarget
NetworkBiology
RightPathway
Pathway Target Drug Disease
14
Today:CPTR 2012
Workshop
CPTR 2013
Workshop
TB Data Standards
v 1.0 Published
TB Data Standards Repository Launched
Remap TB Data & Load to
RepositoryS22, 27, 28
Publish DPM-WG
papers
Publish Preclinical Sciences Papers
Submit LOIto 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
[Enter Presentation Title in Insert Tab > Header & Footer 16
Research Resources
CPTR Structure
Regulatory Science
Consortium
Research Resources Group
Drug Development
Coalition
17