Title: International Meeting on Clinical and Laboratory Genomic Standards
1International Meeting on Clinical and Laboratory
Genomic Standards
- 3-5, May 2005
- Paris
- Janet A. Warrington, Ph.D.
- Vice President
- Affymetrix Inc.
2Planning Committee
- Joe Boone
- Jean Jacques Cassiman
- Philippe Corbisier
- Edison Liu
- Thane Kreiner
- Vincent L. Vilker
- Janet A. Warrington
- Robert Wells
- Kathy Zoon
3 Working together is success
- Pharmacogenomic and pharmacogenetic assays
- raise complex issues difficult for pharma
- and biotech to resolve (alone)
- Standardization requires community efforts
Ito R.I., and Demers L. M., 2004 Clin Chem.
501526-27
4Goals and outcomes
- Meeting goals
- Increase stakeholder interaction
- Accelerate development of guidelines, shared
materials - Desired outcomes
- Identify areas where harmonization is possible
and practical and areas where it is not - Identify initiatives that would benefit from the
international community - working together
- Identify areas that need to be addressed, where
new working - groups are needed
- Prioritize issues
- Identify next steps for moving forward
- Meeting summary Dr. Susan Aldridge
5 Meeting Overview
- Case study examples in rapidly developing areas
- Address current status
- Standard controls and reference materials
- Reporting standards
- Probabilistic outcome decision making
- Ethical and legal issues associated with
probabilistic outcome decision making - Panels to discuss key activities, challenges,
priorities - Working groups to identify priorities, next steps
6Agenda
- Wednesday, May 4, 2005
- Case Studies
- 900 AM High Complexity Gene Expression Based
Tests, Dr. Haferlach - 1000 AM Break
-
- 1015 AM Implementation of cyp450 Testing in a
Hospital-Based - Clinical Laboratory Setting, Dr. Farkas
- 1045 AM Molecular Karyotyping An Example of
a High Complexity DNA
Based Test, Dr.Vermeesch - 1115am The Cystic Fibrosis Model for Genetic
Test Result Reporting - Applicability to Clinical Direct Mutation
and Sequence - Analysis, Dr. Lubin
- 1215pm Lunch at the Hotel DAubusson
7Agenda
- Wednesday, May 4, 2005
- 145pm Roundtable Discussion Technical Panel
- Dr. OConnell, Dr. Foy, Dr.Elles, Dr. Ueda
- 330pm Break
-
- 345pm Roundtable Discussion Policy Panel Dr.
Ronchi, Dr. Sanne, Dr. Chan, Mr. Doheny - 530pm Free Time
- 640 pm Meet in lobby and walk to Lapérouse
- 700pm Dinner at Lapérouse
8Agenda
- Thursday, May 5, 2005
- 730am Breakfast in the Hotel DAubusson
- 845am Review agenda for the day
- 900am Working Groups
- Technical working groups Dr. Zoon, Dr. Barton
- Policy working groups Dr. Liu, Dr. Cassiman
-
- 1030am Break
- 1045am Continue discussion Panel chairs present
summaries - of next steps
- 1200pm Working lunch
- 100pm Adjourn
9Technical Working Groups
Group 1 Leader Dr.Zoon Dahlman-Wright Forrest F
urukawa Haferlach Landegren OConnell Parkes Reid
l
Group 2 Leader Dr.Barton Canneiux Corbissier Ell
es Foy Lubin Salit Ueda Tirrell
10Policy Working Groups
Group 3 Leader Dr. Cassiman Cao Chan Doheny Ibar
etta Kreiner Madej Rousseau Sun
Group 4 Leader Dr.Liu Carlstedt-Duke Farkas Mans
field Passioukov Ronchi Sanne Wells
11Definitions
- Pharmacogenetic Test (PGe)
- An assay intended to study interindividual
variations in DNA sequence related to drug
absorption and disposition (pharmacokinetics) or
drug action (pahrmacodynamics), including
polymorphic variation in the genes that encode
the functions of transporters, metabolizing
enzymes, receptors and other proteins. - Pharmacogenomic Test (PGo)
- An assay intended to study interindividual
variations in whole-genome or candidate genes,
SNP maps, haplotype markers, or alterations in
gene expression or inactivation that may be
correlated with pharmacological functionand
therapeutic response. In some cases, the pattern
or profile of change is the relevant biomarker,
rather than the changes in individual markers.
Attachment to Guidance on Pharmacogenomic Data
Submissions U.S. Dept. HHS, FDA, March 2005
12Rules of Engagement
- Opinions expressed represent individual expert
opinion and are not meant to represent the
official position of any organization unless
explicitly stated. - To indicate that you wish to participate in the
discussion please set your tent card on end.