CDER FDA Initiatives. Lilliam Rosario, Ph.D. . Pharmacology/Toxicology Subcommittee on Pharmacogenomics under the Advisory Committee for Pharmaceutical Sciences. CDER FDA Initiatives. A. Formation of Non-Clinical Pharmacogenomics Subcommittee B. Regulatory Research-Lab Based Initiatives
Lilliam Rosario, Ph.D.
Pharmacology/Toxicology Subcommittee on Pharmacogenomics
under the Advisory Committee for Pharmaceutical Sciences
ODE I ODE V
Patricia Harlow, Cardio-RenalPaul Brown, Dermal/Dental
John Leighton, Oncology Maria Rivera, Anti-Inflammatory
Lilliam Rosario, Oncology Josie Yang, Anti-Inflammatory
ODE II OTR
Wafa Harrouk,Metabolic/Endocrine Frank Sistare, Applied Pharm. Research
Timothy Robison, Pulmonary Barry Rosenzweig, Applied Pharm Research
Scott Pine, Applied Pharm Research
ODE III Karol Thompson, Applied Pharm Research
Lynnda Reid, Reproductive/Urologic
Siham Biade, Imaging/Radiopharm CBER
David Essayan, Clin. Pharm. Tox
Hao Zhang, Anti-Virals Co-Chairs
“Evaluation of Performance Standards and Statistical Software for Regulatory Toxicogenomic Studies”
Goal is to generate and evaluate a complex mixed tissue standard’s utility for assessing platform features…..
Conduct a mock submission of microarray data
1. Concept Definition and Refinement of Scope
May 5, 2003
2. Recommendations/Aims/Approach Document Development and Review
3. Pilot Submission
4. Intermediate Stakeholder Review and Feedback
5. Incorporation of Further Refinements and Iterations
6. Completion of Mock Submission
7. Final Stakeholder Discussion Forum
8. Development of Summary Report
Animal line listings as datasets
“Animal line listings that you would provide on paper or in PDF format may be provided as datasets. Just as you provide data for each domain (e.g., body weights, clinical signs) as a table in a paper or PDF submission, with electronic datasets, each domain should be provided as a single dataset”.
Federal Register / Vol. 68, No. 17 / January 27, 2003
[Docket No. 02N – 0532]
“This pilot project is part of an effort to improve the process for submitting nonclinical data. Eventually, FDA expects to recommend detailed data standards for the submission of nonclinical data”.
FDA received recommendations for a standard presentation of certain clinical data from the Clinical Data Interchange Standards Consortium, Inc. ( CDISC).
CDISC is currently facilitating the work on similar standards for nonclinical data sets.
Experimental information (sample, array, fluidics/scanner). Readable in a text editor.
Raw image of the scanned GeneChip array. Only readable in MAS software.
Cell intensity file; (x,y) coordinates for each cell (i.e. probe) with the intensity of each. Can be used to re-analyze data with different expression algorithm parameters. Readable in a text editor.
Quantifies (signal) and qualifies (presence or absence) each transcript and its relative expression level. Text versions creatable.
Text file containing quality control information.
Probe Set ID
Stat Pairs Used
Cluster Incl AW122482:UI-M-BH2.2-ao...
Cluster Incl D85904:Mouse mRNA for ...
Cluster Incl AI509617:vx14h07.y1 ...
Cluster Incl AB021743:Mus musculus ...
Cluster Incl AI851046:UI-M-BH0-ajv-..