FINAL AGENDA

Toward Consensus on "Best Practices" for the Generation, Analysis, and
Application of Microarray Data in the Discovery, Development, and Review
of FDA-regulated Products

**The 7^th^ Meeting**

**MicroArray Quality Control (MAQC) Project**

**Development and Validation of Predictive Models**

**Thursday-Friday**

**May 24-25, 2007**

**9:00 am -- 6:00 pm EDT**

SAS Institute Inc.

Building V

100 SAS Campus Drive

Cary, NC 27513, USA

http://www.sas.com/; http://www.jmp.com/

http://edkb.fda.gov/MAQC/

![](media/image1.png){width="1.0416666666666666e-2in"
height="1.0416666666666666e-2in"}

-   MAQC contact: Leming.Shi@fda.hhs.gov, Tel : +1-870-543-7387

-   Participants are expected to be familiar with the "MAQC-II Research
    Plan". Contact Leming.Shi@fda.hhs.gov if you do not have it.

-   Participants should consider information exchanged during the MAQC
    meeting as confidential.

![](media/image2.png){width="0.9347222222222222in"
height="0.43680555555555556in"}

**Thursday, May 24, 2007 (Day One)**

+-------+------------------------------------------+------------------+
| **Se  |                                          |                  |
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| MA    |                                          |                  |
| QC-II |                                          |                  |
| Ove   |                                          |                  |
| rview |                                          |                  |
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| Group |                                          |                  |
| Up    |                                          |                  |
| dates |                                          |                  |
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| hair: |                                          |                  |
| *     |                                          |                  |
| *Russ |                                          |                  |
| W     |                                          |                  |
| olfin |                                          |                  |
| ger** |                                          |                  |
| (SAS) |                                          |                  |
+-------+------------------------------------------+------------------+
| 9:00  | Welcoming Remarks                        | John Sall        |
| am    |                                          |                  |
|       |                                          | Co-founder of    |
|       |                                          | SAS              |
+-------+------------------------------------------+------------------+
| 9:05  | Overview of MAQC-II and Meeting Agenda   | Leming Shi       |
| am    |                                          | (NCTR)           |
+-------+------------------------------------------+------------------+
| 9:20  | Clinical Working Group                   | Wendell Jones    |
| am    |                                          | (EA)             |
+-------+------------------------------------------+------------------+
| 9:35  | Toxicogenomics Working Group             | Federico         |
| am    |                                          | Goodsaid (CDER)  |
+-------+------------------------------------------+------------------+
| 9:50  | Titration Working Group                  | Rich Shippy      |
| am    |                                          | (Affymetrix)     |
+-------+------------------------------------------+------------------+
| 10:05 | Regulatory Biostatistics Working Group   | Greg Campbell    |
| am    | (RBWG)                                   | (CDRH)           |
+-------+------------------------------------------+------------------+
| 10:20 | Performance Metrics to be used by        | Lakshmi          |
| am    | MAQC-II for Evaluating Predictive        | Vishnuvajjala    |
|       | Classifiers/Models                       | (CDRH)           |
+-------+------------------------------------------+------------------+
| 10:30 | Discussion                               | All              |
| am    |                                          |                  |
+-------+------------------------------------------+------------------+
| 10:40 | Coffee break                             |                  |
| am    |                                          |                  |
+-------+------------------------------------------+------------------+
| **Se  |                                          |                  |
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| lysis |                                          |                  |
| Re    |                                          |                  |
| sults |                                          |                  |
| from  |                                          |                  |
| the   |                                          |                  |
| Titr  |                                          |                  |
| ation |                                          |                  |
| and   |                                          |                  |
| Cli   |                                          |                  |
| nical |                                          |                  |
| Wo    |                                          |                  |
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| G     |                                          |                  |
| roups |                                          |                  |
|       |                                          |                  |
| C     |                                          |                  |
| hair: |                                          |                  |
| **Jim |                                          |                  |
| Fus   |                                          |                  |
| coe** |                                          |                  |
| (NCTR |                                          |                  |
| /FDA) |                                          |                  |
+-------+------------------------------------------+------------------+
| 11:00 | Analysis Results from the Titration      | Marc Salit       |
| am    | Working Group:                           | (NIST)           |
|       |                                          |                  |
|       | What are we learning from the MAQC       |                  |
|       | titration study?                         |                  |
+-------+------------------------------------------+------------------+
| 11:45 | Analysis Results from the Clinical       | Wendell Jones    |
| am    | Working Group:                           | (EA)             |
|       |                                          |                  |
|       | Array QC: breast cancer and              | Wendell Jones    |
|       | neuroblastoma (8 mins)                   | (EA)             |
|       |                                          |                  |
|       | Hold-out set for UAMS multiple myeloma   | Jim Willey       |
|       | data (2 mins)                            | (Univ. Toledo)   |
|       |                                          |                  |
|       | Gene-by-gene array quality analysis (5   | Roger Perkins    |
|       | mins)                                    | (NCTR)           |
|       |                                          |                  |
|       | Summary of classifiers: breast cancer    | Weiwei Shi       |
|       | data (5 mins for each                    | (GeneGo)         |
|       |                                          |                  |
|       | presenter)                               | Russ Wolfinger   |
|       |                                          | (SAS)            |
|       | Discussion (10 mins)                     |                  |
|       |                                          | John Zhang (SAI) |
+-------+------------------------------------------+------------------+
| 12:30 | Lunch                                    |                  |
| pm    |                                          |                  |
+-------+------------------------------------------+------------------+
| **Se  |                                          |                  |
| ssion |                                          |                  |
| I     |                                          |                  |
| -C**: |                                          |                  |
| Ana   |                                          |                  |
| lysis |                                          |                  |
| Re    |                                          |                  |
| sults |                                          |                  |
| from  |                                          |                  |
| the   |                                          |                  |
| Toxi  |                                          |                  |
| cogen |                                          |                  |
| omics |                                          |                  |
| Wo    |                                          |                  |
| rking |                                          |                  |
| Group |                                          |                  |
| --    |                                          |                  |
|       |                                          |                  |
| A     |                                          |                  |
| Pilot |                                          |                  |
| Exe   |                                          |                  |
| rcise |                                          |                  |
| for   |                                          |                  |
| MA    |                                          |                  |
| QC-II |                                          |                  |
| Data  |                                          |                  |
| Ana   |                                          |                  |
| lysis |                                          |                  |
|       |                                          |                  |
| C     |                                          |                  |
| hair: |                                          |                  |
| *     |                                          |                  |
| *Greg |                                          |                  |
| Campb |                                          |                  |
| ell** |                                          |                  |
| (CDRH |                                          |                  |
| /FDA) |                                          |                  |
+-------+------------------------------------------+------------------+
| 2:00  | Coordination of Data Analysis Effort --  | Weida Tong       |
| pm    | The Hamner Data Set                      | (NCTR)           |
+-------+------------------------------------------+------------------+
| 2:20  | Summary of Classifiers -- NIEHS/NIH      | Pierre Bushel    |
| pm    |                                          | (NIEHS)          |
+-------+------------------------------------------+------------------+
| 2:30  | Summary of Classifiers -- Swiss          | Mauro Delorenzi  |
| pm    | Institute of Bioinformatics              | (SIB)            |
+-------+------------------------------------------+------------------+
| 2:40  | Summary of Classifiers -- University of  | Youping Deng     |
| pm    | Southern Missouri                        | (USM)            |
+-------+------------------------------------------+------------------+
| 2:50  | Summary of Classifiers -- NCTR/FDA       | Roger Perkins    |
| pm    |                                          | (NCTR)           |
+-------+------------------------------------------+------------------+
| 3:00  | Summary of Classifiers -- Chinese        | Tieliu Shi (CAS) |
| pm    | Academy of Sciences                      |                  |
+-------+------------------------------------------+------------------+
| 3:10  | Summary of Classifiers -- SAS Institute  | Russ Wolfinger   |
| pm    | Inc.                                     | (SAS)            |
+-------+------------------------------------------+------------------+
| 3:20  | Summary of Classifiers -- Systems        | John Zhang (SAI) |
| pm    | Analytics Inc.                           |                  |
+-------+------------------------------------------+------------------+
| 3:30  | RBWG Review of Statistical Analysis      | Tim Davison      |
| pm    | Plans (SAPs)                             | (Asuragen)       |
+-------+------------------------------------------+------------------+
| 3:40  | Coffee break                             |                  |
| pm    |                                          |                  |
+-------+------------------------------------------+------------------+
| **Se  |                                          |                  |
| ssion |                                          |                  |
| I     |                                          |                  |
| -D**: |                                          |                  |
| Av    |                                          |                  |
| ailab |                                          |                  |
| ility |                                          |                  |
| of    |                                          |                  |
| Tissu |                                          |                  |
| e/RNA |                                          |                  |
| Sa    |                                          |                  |
| mples |                                          |                  |
| and   |                                          |                  |
| Gener |                                          |                  |
| ation |                                          |                  |
| of    |                                          |                  |
| New   |                                          |                  |
| Data  |                                          |                  |
|       |                                          |                  |
| Co-Ch |                                          |                  |
| airs: |                                          |                  |
| **F   |                                          |                  |
| raser |                                          |                  |
| Symm  |                                          |                  |
| ans** |                                          |                  |
| (MD   |                                          |                  |
| And   |                                          |                  |
| erson |                                          |                  |
| C     |                                          |                  |
| ancer |                                          |                  |
| Ce    |                                          |                  |
| nter) |                                          |                  |
| and   |                                          |                  |
| **Fed |                                          |                  |
| erico |                                          |                  |
| Goods |                                          |                  |
| aid** |                                          |                  |
| (CDER |                                          |                  |
| /FDA) |                                          |                  |
+-------+------------------------------------------+------------------+
| 4:00  | Breast Cancer: Institut Bordet           | Desmedt          |
| pm    |                                          | Christine        |
|       | Eppendorf                                | (Bordet)         |
|       |                                          |                  |
|       |                                          | Peter Herzer     |
|       |                                          | (Eppendorf)      |
+-------+------------------------------------------+------------------+
| 4:25  | Multiple Myeloma: University of Arkansas | Wendell Jones    |
| pm    | for Medical Sciences                     | (EA)             |
|       |                                          |                  |
|       | Millennium Pharmaceuticals Inc.          | George Mulligan  |
|       |                                          | (MPI)            |
+-------+------------------------------------------+------------------+
| 4:45  | Neuroblastoma: University of Cologne     | André Oberthür   |
| pm    |                                          | (Cologne)        |
+-------+------------------------------------------+------------------+
| 5:00  | Toxicogenomics: The Hamner Institutes    | Rusty Thomas     |
| pm    | for Health Sciences                      | (Hamner)         |
+-------+------------------------------------------+------------------+
| 5:10  | Cross-laboratory and cross-platform      | Fraser Symmans   |
| pm    | reproducibility of model                 | (MDACC)/         |
|       |                                          |                  |
|       | prediction results                       | Christos Hatzis  |
|       |                                          | (Nuvera)         |
+-------+------------------------------------------+------------------+
| 5:25  | Microarray Platforms                     | Confirmation of  |
| pm    |                                          | support from     |
|       | Affymetrix Agilent Eppendorf Illumina    | representatives  |
|       |                                          | of platform      |
|       | NimbleGen PhalanxBiotech TeleChem        | providers        |
|       | ArrayIt                                  |                  |
|       |                                          |                  |
|       | Alternative Platforms                    |                  |
|       |                                          |                  |
|       | Applied Biosystems Gene Express Panomics |                  |
|       | SuperArray                               |                  |
+-------+------------------------------------------+------------------+
| 5:40  | Prioritizing Studies for the Generation  | All              |
| pm    | of New Data                              |                  |
+-------+------------------------------------------+------------------+
| 5:55  | Summary of Day One                       | Leming Shi       |
| pm    |                                          | (NCTR)           |
+-------+------------------------------------------+------------------+
| 6:00  | Adjourn Day One                          |                  |
| pm    |                                          |                  |
+-------+------------------------------------------+------------------+
| 6:15  | Bus Tour of SAS Campus                   |                  |
| pm    |                                          |                  |
+-------+------------------------------------------+------------------+
| 6:45  | ![](media/                               | All participants |
| pm    | image4.png){width="0.5423611111111111in" | are invited.     |
|       | height="0.35138888888888886in"}Dinner at | Kindly sponsored |
|       | Prestonwood Country Club, Salon B & C    | by JMP.          |
|       |                                          |                  |
|       | 300 Prestonwood Parkway, Cary, NC 27513  |                  |
|       |                                          |                  |
|       | Tel: 919-467-2566,                       |                  |
|       | http://www.prestonwoodcc.com/            |                  |
+-------+------------------------------------------+------------------+

Friday, May 25, 2007 (Day Two)

+-------+------------------------------------------+------------------+
| **Se  |                                          |                  |
| ssion |                                          |                  |
| II    |                                          |                  |
| -A**: |                                          |                  |
| FDA   |                                          |                  |
| Regul |                                          |                  |
| atory |                                          |                  |
| Pe    |                                          |                  |
| rspec |                                          |                  |
| tives |                                          |                  |
| on    |                                          |                  |
| Gen   |                                          |                  |
| omics |                                          |                  |
|       |                                          |                  |
| Co-Ch |                                          |                  |
| airs: |                                          |                  |
| **Uwe |                                          |                  |
| Sch   |                                          |                  |
| erf** |                                          |                  |
| (CDRH |                                          |                  |
| /FDA) |                                          |                  |
| and   |                                          |                  |
| *     |                                          |                  |
| *Rick |                                          |                  |
| Jen   |                                          |                  |
| sen** |                                          |                  |
| (Vir  |                                          |                  |
| ginia |                                          |                  |
| Bioi  |                                          |                  |
| nform |                                          |                  |
| atics |                                          |                  |
| Insti |                                          |                  |
| tute) |                                          |                  |
+-------+------------------------------------------+------------------+
| 9:00  | MammaPrint: The FDA Review and Approval  | Reena Philip     |
| am    | Process                                  | (CDRH)           |
+-------+------------------------------------------+------------------+
| 9:25  | Companion Guidance to the FDA            | Federico         |
| am    | Pharmacogenomics Guidance                | Goodsaid (CDER)  |
+-------+------------------------------------------+------------------+
| 9:45  | Uncertainties in the Multiple-Biomarker  | Bob Wagner       |
| am    | Classifier Problem                       | (CDRH)           |
+-------+------------------------------------------+------------------+
| 10:20 | Discussion                               | All              |
| am    |                                          |                  |
+-------+------------------------------------------+------------------+
| 10:40 | Coffee break                             |                  |
| am    |                                          |                  |
+-------+------------------------------------------+------------------+
| **Se  |                                          |                  |
| ssion |                                          |                  |
| II    |                                          |                  |
| -B**: |                                          |                  |
| G     |                                          |                  |
| enome |                                          |                  |
| -Wide |                                          |                  |
| A     |                                          |                  |
| ssoci |                                          |                  |
| ation |                                          |                  |
| Wo    |                                          |                  |
| rking |                                          |                  |
| Group |                                          |                  |
| (G    |                                          |                  |
| WAWG) |                                          |                  |
|       |                                          |                  |
| Co-Ch |                                          |                  |
| airs: |                                          |                  |
| **Fed |                                          |                  |
| erico |                                          |                  |
| Goods |                                          |                  |
| aid** |                                          |                  |
| (CDER |                                          |                  |
| /FDA) |                                          |                  |
| and   |                                          |                  |
| **L   |                                          |                  |
| eming |                                          |                  |
| Shi** |                                          |                  |
| (NCTR |                                          |                  |
| /FDA) |                                          |                  |
+-------+------------------------------------------+------------------+
| 11:00 | Genome-Wide Association Studies: New     | Teri Manolio     |
| am    | Paradigm or the Same Old Genes?          | (NHGRI)          |
+-------+------------------------------------------+------------------+
| 11:45 | Genome-Wide Association Studies and      | Federico         |
| am    | FDA's Voluntary eXploratory Data         | Goodsaid (CDER)  |
|       | Submission (VXDS)                        |                  |
+-------+------------------------------------------+------------------+
| 12:00 | Proposal and Discussion: Genome-Wide     | Federico         |
| pm    | Association Working Group (GWAWG) under  | Goodsaid (CDER)  |
|       | MAQC-II                                  |                  |
|       |                                          | Nick Xiao        |
|       |                                          | (SAIC/NCI)       |
+-------+------------------------------------------+------------------+
| 12:30 | Lunch                                    |                  |
| pm    |                                          |                  |
+-------+------------------------------------------+------------------+
| **Se  |                                          |                  |
| ssion |                                          |                  |
| II    |                                          |                  |
| -C**: |                                          |                  |
| Data  |                                          |                  |
| Ana   |                                          |                  |
| lysis |                                          |                  |
| Strat |                                          |                  |
| egies |                                          |                  |
|       |                                          |                  |
| C     |                                          |                  |
| hair: |                                          |                  |
| **Tim |                                          |                  |
| Davi  |                                          |                  |
| son** |                                          |                  |
| (Asur |                                          |                  |
| agen) |                                          |                  |
+-------+------------------------------------------+------------------+
| 2:00  | General Principles on the Development    | Kenneth Hess     |
| pm    | and Validation of Predictive Models      | (MDACC)          |
|       | based on Microarray Data                 |                  |
+-------+------------------------------------------+------------------+
| 2:20  | Logistic Considerations in Data          | Weida Tong       |
| pm    | Distribution and Data Analysis           | (NCTR)           |
+-------+------------------------------------------+------------------+
| 2:40  | Experimental Design for Data Analysis    | Russ Wolfinger   |
| pm    | Combinations                             | (SAS)            |
+-------+------------------------------------------+------------------+
| 3:00  | Percellome: "Per Cell" Normalization     | Jun Kanno        |
| pm    | Method for mRNA Measurement by           | (National        |
|       | Quantitative PCR and Microarrays         | Institute of     |
|       |                                          | Health Sciences) |
+-------+------------------------------------------+------------------+
| 3:20  | Discussion                               | All              |
| pm    |                                          |                  |
+-------+------------------------------------------+------------------+
| 3:40  | Coffee break                             |                  |
| pm    |                                          |                  |
+-------+------------------------------------------+------------------+
| **Se  |                                          |                  |
| ssion |                                          |                  |
| II    |                                          |                  |
| -D**: |                                          |                  |
| Data  |                                          |                  |
| Ana   |                                          |                  |
| lysis |                                          |                  |
| Teams |                                          |                  |
|       |                                          |                  |
| C     |                                          |                  |
| hair: |                                          |                  |
| **We  |                                          |                  |
| ndell |                                          |                  |
| Jo    |                                          |                  |
| nes** |                                          |                  |
| (     |                                          |                  |
| Expre |                                          |                  |
| ssion |                                          |                  |
| Anal  |                                          |                  |
| ysis) |                                          |                  |
+-------+------------------------------------------+------------------+
| 4:00  | Date Set (Disease) Specific Teams:       | Data Analysis    |
| pm    |                                          | Coordinators:    |
|       | Breast cancer                            |                  |
|       |                                          | Xutao Deng       |
|       | Neuroblastoma                            | (UCLA/CSHS)      |
|       |                                          |                  |
|       | Multiple myeloma                         | Russ Wolfinger   |
|       |                                          | (SAS)            |
|       | Hamner mouse-lung-tumor                  |                  |
|       |                                          | Roger Perkins    |
|       | Iconix-EPA liver carcinogenicity         | (NCTR)           |
|       |                                          |                  |
|       | Titration Data                           | Weida Tong       |
|       |                                          | (NCTR)           |
|       | Some Preliminary Proposals:              |                  |
|       |                                          | Richard Judson   |
|       | Effect of array data quality on model    | (EPA)            |
|       | prediction performance                   |                  |
|       |                                          | Marc Salit/Russ  |
|       | Cross-laboratory and cross-platform      | Wolfinger        |
|       | reproducibility of model                 |                  |
|       |                                          | Wendell Jones    |
|       | prediction results                       | (EA)             |
|       |                                          |                  |
|       | Batch effect on model prediction         | Fraser Symmans   |
|       | performance                              | (MDACC)/         |
|       |                                          |                  |
|       | RBWG "statistical methodologies"         | Christos Hatzis  |
|       |                                          | (Nuvera)         |
|       |                                          |                  |
|       |                                          | John Zhang (SAI) |
|       |                                          |                  |
|       |                                          | Lakshmi          |
|       |                                          | Vishnuvajjala/   |
|       |                                          |                  |
|       |                                          | Gene Pennello    |
|       |                                          | (CDRH)           |
+-------+------------------------------------------+------------------+
| 4:50  | Open Presentation/Discussion             |                  |
| pm    |                                          |                  |
|       | (limited to 5\~7 mins per presenter):    |                  |
|       |                                          |                  |
|       | Anne Bergstrom Lucas (Agilent)           |                  |
|       |                                          |                  |
|       | Xutao Deng (CSHS)                        |                  |
|       |                                          |                  |
|       | Guozhen Liu (SuperArray)                 |                  |
|       |                                          |                  |
|       | Jean & Danielle Thierry-Mieg (NCBI)      |                  |
|       |                                          |                  |
|       | Bill Worzel (Genetics Squared)           |                  |
|       |                                          |                  |
|       | Others                                   |                  |
+-------+------------------------------------------+------------------+
| 5:55  | Summary of the Meeting                   | Leming Shi       |
| pm    |                                          | (NCTR)           |
+-------+------------------------------------------+------------------+
| 6:00  | Adjourn the Meeting                      |                  |
| pm    |                                          |                  |
+-------+------------------------------------------+------------------+

**Reaffirmation of MAQC-II Goals**

We would like to remind all MAQC-II members that the main goal of
MAQC-II is to understand better the algorithms leading to classifiers
for the analysis of microarray data. The important goal of validation
for single classifier sets generated through internal validation drives
the initial schedule of this MAQC-II collaboration. However, each
analysis group is expected to include a report on the exploratory
performance in the test dataset for the other classifier candidates from
the internal validation stage. This will enable a comparison of the gap
between predicted performance from internal validation and actual
performance in the test dataset, even though these classifiers did not
undergo formal validation. The Clinical and Toxicogenomics Working
Groups will be responsible for collating the results of this exploratory
work.

**Disclaimer**

Participation in the MAQC project is completely voluntary. No fund
whatsoever is available from the MAQC to any participant. Participants
agree to cover all their own costs as a result of voluntary involvement
in the MAQC project. The US Food and Drug Administration (FDA) has
solicited DNA microarray gene expression data sets as well as proposals
to analyze these data sets in order to evaluate the impact of different
analysis protocols on the selection of genes and their associated
predictive models for biomarker pattern development (*Federal Register*,
71(77), 20707-8, April 21, 2006; available at
http://www.fda.gov/nctr/science/centers/toxicoinformatics/maqc/docs/FederalRegister_MAQC_FollowUp.pdf).
The MAQC project is being coordinated by the FDA, but there are no
regulatory rights conveyed to anyone by the participation of FDA
personnel in this project. Although FDA personnel are involved in the
MAQC project, the views expressed in the MAQC‑II Research Plan, at
face-to-face meeting or other circumstances are not FDA guidance and do
not necessarily represent FDA policy.

**Transportation**

The local airport is "RDU" (Raleigh/Durham International Airport).

Attendees driving themselves to the SAS Campus will need to stop at the
front security gate upon arrival and identify themselves as a
participant in the MAQC Meeting in Building V. Parking will be reserved
for the attendees in the lot at Building V.

SAS will have a bus to take people to and from lunch on Thursday and
Friday on the SAS campus. If the weather is nice, many people may decide
to walk since the Café is a very short (not even a block) distance from
Building V. After lunch, the bus will take people back to Building V for
the afternoon sessions. On Thursday (6:15 pm), SAS will offer people the
option of taking a brief (15 minutes) tour of the SAS campus.

**Hotel**

A list of SAS-recommended hotels:
http://support.sas.com/training/fyi/ca.html.

![](media/image4.png){width="0.5423611111111111in"
height="0.35138888888888886in"}

**Thursday Dinner**

All MAQC meeting participants are invited to a dinner kindly sponsored
by JMP at:

Prestonwood Country Club, Salon B & C, 300 Prestonwood Parkway, Cary, NC
27513.

Tel: 919-467-2566, http://www.prestonwoodcc.com/

**Dress Code**: "Gentlemen are expected to wear a collared shirt at all
times and denim blue jeans are not allowed throughout the club's
facilities."

**U.S. Federal Government Employees**: The U.S. FDA's Ethics and
Integrity Staff has determined that "all participants are allowed to
accept the free meal because this is considered to be a G-1 WAG \[Widely
Attended Gathering\] event".

There will be a SAS bus that can take you directly from the SAS campus
over to Prestonwood (\~6 miles) for dinner if you do not want to drive
yourselves. After the dinner, the bus can bring you back to the SAS
parking lot. You may also be taken back to your hotels directly if you
wish.

**Participation by Phone**

If you cannot physically attend the meeting, you may want to dial-in to
the meeting using the following access information through the entire
MAQC meeting:

USA Toll Free Number: 1-866-802-6141

International Callers: +1-210-453-1165

Passcode: 8698206#

We may be able to allow a few participants to join via WebEx. In
fairness to the expected large audience in the SAS conference room,
callers are asked to minimize the number and length of their
questions/comments because the audio quality may be less than
satisfactory. We reserve the right to disconnect the conference call if
the audience in the SAS conference room decides that there is too much
disruption by the calls. Thanks in advance for your understanding. If
you plan to attend by phone/WebEx, please e-mail leming.shi@fda.hhs.gov.

**SAS/JMP Contact**

Robin Hughes, JMP Marketing, 919-531-5806 (O), Robin.Hughes@jmp.com

**FDA/NCTR Contacts**

Leming Shi, 870-543-7387 (O), 501-258-3615 (C), Leming.Shi@fda.hhs.gov

Weida Tong, 870-543-7142 (O), 501-412-1749 (C), Weida.Tong@fda.hhs.gov

**List of Confirmed Participants** (As of May 18, 2007)

  --------- ------------- ------------------- --------- --------------- -------------------
  **No.**   **Name**      **Organization**    **No.**   **Name**        **Organization**

  1         Wenjun Bao    SAS Institute       56        Charles Ma      Phalanx Biotech
                                                                        Group

  2         William T.    Duke University     57        Sergei Makarov  Attagene
            Barry                                                       

  3         Anne          Agilent             58        Teri Manolio    NIH/NHGRI
            Bergstrom                                                   
            Lucas                                                       

  4         Vincent       Eppendorf Array     59        George J.       Millennium
            Bertholet     Technology                    Mulligan        Pharmaceuticals

  5         Norman        EPA                 60        Padraic Neville SAS Institute
            Birchfield                                                  

  6         Guy Bowman    InforSense, LLC     61        Paul E. Nisson  SuperArray

  7         Anne Bullard  SAS Institute       62        André Oberthuer University of
                                                                        Cologne

  8         Pierre Bushel NIH/NIEHS           63        Oluwole         Customized
                                                        Odujinrin       Therapeutics LLC

  9         Gregory       FDA/CDRH            64        Grier P. Page   University of
            Campbell                                                    Alabama

  10        Jennifer G.   FDA/CBER            65        Richard S.      NIH/NIEHS
            Catalano                                    Paules          

  11        Damien        Baylor Institute    66        Gene A.         FDA/CDRH
            Chaussabel    for Immunology                Pennello        
                          Research                                      

  12        Desmedt       Institut Jules      67        Edward J        US Army Engineer
            Christine     Bordet                        Perkins         Research and
                                                                        Development Center

  13        Tzu-Ming Chu  SAS Institute       68        Roger Perkins   FDA/NCTR (Z-Tech)

  14        Shannon       SAS Institute       69        Ron Peterson    Novartis
            Conners                                                     

  15        Michael B.    Duke University     70        Reena Philip    FDA/CDRH
            Datto         Medical Center                                

  16        Timothy S.    Asuragen            71        Laura H. Reid   Expression Analysis
            Davison                                                     

  17        Francoise de  Eppendorf Array     72        Todd Richmond   NimbleGen Systems,
            Longueville   Technology                                    Inc.

  18        Mauro         Swiss Institute of  73        Marc Salit      NIST
            Delorenzi     Experimental Cancer                           
                          Research                                      

  19        Adam Dempsey  XceedMolecular      74        John Sall       SAS Institute

  20        Xutao Deng    UCLA/Cedars-Sinai   75        Uwe Scherf      FDA/CDRH

  21        Youping Deng  University of       76        Banalata Sen    EPA
                          Southern                                      
                          Mississippi                                   

  22        David J. Dix  EPA                 77        Robert A.       Ambion
                                                        Setterquist     

  23        Pan Du        Northwestern        78        Imran Shah      EPA
                          University                                    

  24        Stephen W     EPA                 79        Joe Shambaugh   Genedata (USA) Inc.
            Edwards                                                     

  25        Meg G Ehm     GlaxoSmithKline     80        Leming Shi      FDA/NCTR

  26        Patton Fast   InforSense, LLC     81        Tieliu Shi      Chinese Academy of
                                                                        Sciences

  27        Kazuhisa      Yokogawa Electric   82        Weiwei Shi      GeneGo Inc.
            Fukushima     Corp.                                         

  28        Federico M.   FDA/CDER            83        Richard Shippy  Affymetrix
            Goodsaid                                                    

  29        Xu Guo        Affymetrix          84        Dave D. Smith   Luminex

  30        Paul K. Haje  TeleChem ArrayIt    85        W. Fraser       MD Anderson Cancer
                                                        Symmans         Center

  31        Christos      Nuvera Biosciences, 86        Tsetska Takova  NimbleGen Systems,
            Hatzis        Inc.                                          Inc.

  32        Yudong He     Rosetta             87        Pei-Yi Tan      SAS Institute
                          Inpharmatics                                  
                          (Merck)                                       

  33        Kenneth Hess  MD Anderson Cancer  88        Danielle        NIH/NCBI
                          Center                        Thierry-Mieg    

  34        Susan Hester  EPA                 89        Jean            NIH/NCBI
                                                        Thierry-Mieg    

  35        Lingkang      NIH/NIEHS           90        Venkata Thodima University of
            Huang                                                       Southern
                                                                        Mississippi

  36        Robin Hughes  SAS Institute       91        Russell S.      Hamner Institutes
                                                        Thomas          for Health Sciences

  37        Melody        Tecan               92        Guy Tillinghast Riverside Regional
            Humbles                                                     Medical Center

  38        Ansar Jawaid  AstraZeneca         93        Bernadette      GenomeWeb
                                                        Toner           

  39        Brandon D.    Iconix              94        Weida Tong      FDA/NCTR
            Jeffy                                                       

  40        Roderick V.   Virginia            95        Silvia Vega     Rosetta Biosoftware
            Jensen        Bioinformatics                                
                          Institute                                     

  41        Charles D.    Asuragen            96        Lakshmi         FDA/CDRH
            Johnson                                     Vishnuvajjala   

  42        Wendell D.    Expression Analysis 97        Juergen von     Almac Diagnostics
            Jones                                       Frese           

  43        Richard       EPA                 98        Robert F Wagner FDA/CDRH
            Judson                                                      

  44        Jun Kanno     National Institute  99        Stephen J.      Wake Forest
                          of Health Sciences            Walker          University

  45        Channa        EPA                 100       William Ward    EPA
            Keshava                                                     

  46        Nagalakshmi   EPA                 101       Jeffrey F       Abbott
            Keshava                                     Waring          

  47        Samir         FDA/CDRH            102       Liling L Warren GlaxoSmithKline
            Lababidi                                                    

  48        Ben Larman    tecnoparco.org      103       James C. Willey University of
                                                                        Toledo

  49        Dai J Li      FDA/CDRH            104       Russell D       SAS Institute
                                                        Wolfinger       

  50        Lei Li        Baylor University   105       Bill Worzel     Genetics Squared
                          Medical Center                                

  51        Wayne Liao    Phalanx Biotech     106       Shujian Wu      Bristol-Myers
                          Group                                         Squibb

  52        Simon Lin     Northwestern        107       Nianqing Xiao   NCI (SAIC)
                          University                                    

  53        Guozhen       SuperArray          108       George Yuan     Affymetrix
            (Gordon) Liu                                                

  54        Edward K.     Cogenics, a         109       John Zhang      Systems Analytics
            Lobenhofer    Division of                                   
                          Clinical Data                                 

  55        Jun Luo       Systems Analytics                             
  --------- ------------- ------------------- --------- --------------- -------------------