**FINAL AGENDA**

**The 6^th^ Meeting**

**MicroArray Quality Control (MAQC) Project**

**MAQC-II**

**Development and Validation of**

**Predictive Signatures and Classifiers**

**Tuesday, November 28, 2006, 3:00 pm -- 5:00 pm ET**

at

Washington Marriott Hotel

1221 22nd Street NW

Washington, DC 20037-1294

+1-800-393-3053, +1-202-872-1500

**Wednesday, November 29, 2006, 9:00 am -- 4:00 pm ET**

at

Room 2031, Central Shared Use Building

U.S. Food and Drug Administration

10903 New Hampshire Avenue

Silver Spring, MD 20903-0002

MAQC Phase II participants are encouraged to attend the
FDA/DIA/PhRMA/BIO co-sponsored workshop on "*Best Practices and
Development of Standards for the Submission of Genomic Data to the
FDA*", November 27-28, 2006, Washington Marriott Hotel
(<http://www.diahome.org/product/12225/06036.pdf>). Registration is
required.

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

> ![](media/image1.png){width="1.075in" height="0.5020833333333333in"}

**The 6^th^ MAQC Project Meeting**

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| Ch   |       |                                      |               |
| air: |       |                                      |               |
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| onne |       |                                      |               |
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| an** |       |                                      |               |
| (N   |       |                                      |               |
| CTR/ |       |                                      |               |
| FDA) |       |                                      |               |
+------+-------+--------------------------------------+---------------+
| > *  | 3:00  | Chair's remarks                      | Yvonne Dragan |
| *MAQ | pm    |                                      |               |
| C-II |       |                                      |               |
| >    |       |                                      |               |
| Prog |       |                                      |               |
| ress |       |                                      |               |
| >    |       |                                      |               |
| Repo |       |                                      |               |
| rt** |       |                                      |               |
+------+-------+--------------------------------------+---------------+
|      | 3:05  | MAQC: From Phase I to Phase II       | Leming Shi    |
|      | pm    |                                      |               |
|      |       |                                      | (NCTR/FDA)    |
+------+-------+--------------------------------------+---------------+
|      | 3:25  | Clinical Working Group               | Uwe Scherf    |
|      | pm    |                                      |               |
|      |       |                                      | (CDRH/FDA)    |
+------+-------+--------------------------------------+---------------+
|      | 3:40  | Toxicogenomics Working Group         | Federico      |
|      | pm    |                                      | Goodsaid      |
|      |       |                                      |               |
|      |       |                                      | (CDER/FDA)    |
+------+-------+--------------------------------------+---------------+
|      | 3:55  | MAQC Titration Working Group         | Rich Shippy   |
|      | pm    |                                      |               |
|      |       |                                      | (GE           |
|      |       |                                      | Healthcare)   |
+------+-------+--------------------------------------+---------------+
|      | 4:10  | Gene expression profiling and breast | Fraser        |
|      | pm    | cancer: state-of-the-art             | Symmans (MD   |
|      |       |                                      | Anderson      |
|      |       |                                      | Cancer        |
|      |       |                                      | Center)       |
+------+-------+--------------------------------------+---------------+
|      | 4:30  | Characteristics of toxicogenomic     | Kurt Jarnagin |
|      | pm    | biomarkers: the Iconix experiences   | (Iconix)      |
+------+-------+--------------------------------------+---------------+
|      | 4:50  | Open discussion                      | All           |
|      | pm    |                                      |               |
+------+-------+--------------------------------------+---------------+
|      | 5:00  | Adjourn                              |               |
|      | pm    |                                      |               |
+------+-------+--------------------------------------+---------------+
| > *  |       |                                      |               |
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| (N   |       |                                      |               |
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| FDA) |       |                                      |               |
+------+-------+--------------------------------------+---------------+
| > ** | 9:00  | Criteria for the selection of        | Wendell Jones |
| Clin | am    | clinical data sets                   |               |
| ical |       |                                      |               |
| >    |       |                                      |               |
| Data |       |                                      |               |
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| ts** |       |                                      |               |
+------+-------+--------------------------------------+---------------+
|      | 9:10  | Breast cancer                        | Fraser        |
|      | am    |                                      | Symmans       |
+------+-------+--------------------------------------+---------------+
|      | 9:40  | Multiple myeloma                     | John          |
|      | am    |                                      | Shaughnessy   |
|      |       |                                      |               |
|      |       |                                      | (UAMS)        |
+------+-------+--------------------------------------+---------------+
|      | 10:00 | Leukemia                             | Shujian Wu    |
|      | am    |                                      | (BMS)         |
+------+-------+--------------------------------------+---------------+
|      | 10:20 | Neuroblastoma                        | Andre         |
|      | am    |                                      | Oberthür      |
|      |       |                                      | (Univ.        |
|      |       |                                      | Cologne)      |
+------+-------+--------------------------------------+---------------+
|      | 10:40 | Coffee break                         |               |
|      | am    |                                      |               |
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| Co   |       |                                      |               |
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| *    |       |                                      |               |
| *Gre |       |                                      |               |
| gory |       |                                      |               |
| Ca   |       |                                      |               |
| mpbe |       |                                      |               |
| ll** |       |                                      |               |
| (C   |       |                                      |               |
| DRH/ |       |                                      |               |
| FDA) |       |                                      |               |
+------+-------+--------------------------------------+---------------+
| > ** | 11:00 | Development and evaluation of        | Richard Simon |
| Crit | am    | predictive classifiers               |               |
| eria |       |                                      |               |
| >    |       |                                      |               |
|  for |       |                                      |               |
| >    |       |                                      |               |
|  Per |       |                                      |               |
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| alua |       |                                      |               |
| tion |       |                                      |               |
| > of |       |                                      |               |
| > C  |       |                                      |               |
| lass |       |                                      |               |
| ifie |       |                                      |               |
| rs** |       |                                      |               |
+------+-------+--------------------------------------+---------------+
|      | 11:10 | Regulatory Biostatistics Working     | Gregory       |
|      | am    | Group                                | Campbell      |
+------+-------+--------------------------------------+---------------+
|      | 11:20 | Statistical goals of MAQC-II         | Gene Pennello |
|      | am    |                                      | (CDRH/FDA)    |
+------+-------+--------------------------------------+---------------+
|      | 11:30 | Glossary for classifiers and their   | Tim Davison   |
|      | am    | evaluation                           | (Asuragen)    |
+------+-------+--------------------------------------+---------------+
|      | 11:40 | **Open discussion**                  | *Wendell to   |
|      | am    |                                      | take notes*   |
|      |       | 1.  Prediction accuracy,             |               |
|      |       |     sensitivity, and specificity     |               |
|      |       |                                      |               |
|      |       | 2.  Robustness of signatures         |               |
|      |       |                                      |               |
|      |       | 3.  Mechanistic relevance            |               |
|      |       |                                      |               |
|      |       | 4.  Within a single data set         |               |
|      |       |                                      |               |
|      |       | 5.  Across multiple data sets        |               |
|      |       |                                      |               |
|      |       | 6.  Prospective data sets            |               |
+------+-------+--------------------------------------+---------------+
|      | 12:30 | Lunch (on your own)                  |               |
|      | pm    |                                      |               |
+------+-------+--------------------------------------+---------------+

+------+-------+--------------------------------------+---------------+
| Co   |       |                                      |               |
| -cha |       |                                      |               |
| irs: |       |                                      |               |
| **   |       |                                      |               |
| Fede |       |                                      |               |
| rico |       |                                      |               |
| Go   |       |                                      |               |
| odsa |       |                                      |               |
| id** |       |                                      |               |
| (C   |       |                                      |               |
| DER/ |       |                                      |               |
| FDA) |       |                                      |               |
| and  |       |                                      |               |
| **D  |       |                                      |               |
| avid |       |                                      |               |
| D    |       |                                      |               |
| ix** |       |                                      |               |
| (    |       |                                      |               |
| EPA) |       |                                      |               |
+------+-------+--------------------------------------+---------------+
| >    | 1:30  | Iconix                               | Donald        |
| **To | pm    |                                      | Halbert       |
| xico |       | CIIT                                 |               |
| geno |       |                                      | Rusty Thomas  |
| mics |       | EPA                                  |               |
| >    |       |                                      | David Dix     |
| Data |       | EBI                                  |               |
| > Se |       |                                      |               |
| ts** |       | NIEHS                                |               |
|      |       |                                      |               |
|      |       | ......                               |               |
+------+-------+--------------------------------------+---------------+
| >    | 2:30  | MAQC Main Study data set (ABCD)      | Rick Jensen   |
|  **T | pm    |                                      |               |
| itra |       | Titration Pilot data set (13         |               |
| tion |       | titration mixtures)                  |               |
| >    |       |                                      |               |
| Data |       | New mixtures?                        |               |
| > Se |       |                                      |               |
| ts** |       |                                      |               |
+------+-------+--------------------------------------+---------------+
| > *  | 2:45  | **Prospective studies**              | Fraser        |
| *Log | pm    |                                      | Symmans       |
| isti |       | Samples                              |               |
| cs** |       |                                      | John          |
|      |       | Arrays                               | Shaughnessy   |
|      |       |                                      |               |
|      |       | Timeline                             | Donald        |
|      |       |                                      | Halbert       |
|      |       |                                      |               |
|      |       |                                      | Array         |
|      |       |                                      | manufacturers |
|      |       |                                      |               |
|      |       |                                      | ......        |
+------+-------+--------------------------------------+---------------+
|      | 3:15  | Confidentiality                      | All           |
|      | pm    |                                      |               |
|      |       | Intellectual properties              |               |
+------+-------+--------------------------------------+---------------+
|      | 3:40  | **Action items/Timelines**           | All           |
|      | pm    |                                      |               |
|      |       | Biweekly conference call for each WG |               |
|      |       |                                      |               |
|      |       | Monthly conference call for the      |               |
|      |       | entire MAQC                          |               |
|      |       |                                      |               |
|      |       | Submission of raw data to NCTR by    |               |
|      |       | 12/15/06                             |               |
|      |       |                                      |               |
|      |       | Array QC team                        |               |
|      |       |                                      |               |
|      |       | Data distribution and CDA by 1/31/07 |               |
|      |       |                                      |               |
|      |       | Initial results discussed at FDA     |               |
|      |       | Science Forum, April'07              |               |
+------+-------+--------------------------------------+---------------+
|      | 3:55  | Closing remarks                      | Leming Shi    |
|      | pm    |                                      |               |
+------+-------+--------------------------------------+---------------+
|      | 4:00  | Adjourn                              |               |
|      | pm    |                                      |               |
+------+-------+--------------------------------------+---------------+

***Background:*** The MAQC Phase I (MAQC-I) has demonstrated the
technical reliability of microarray technology in detecting differential
gene expression. However, questions remain regarding the reliability of
the technology in clinical applications such as disease diagnostics or
prognostics, and for tailored treatment based on gene expression
profiles. To investigate the capabilities and limitations of microarray
technology in such real-life applications, the MAQC Phase II (MAQC-II)
has been launched to address technical and scientific issues involved in
the development and validation of predictive signatures and classifiers.
Multiple data sets will be collected and distributed to participating
organizations for independent analyses with available algorithms. The
resulting classifiers will be evaluated at three different levels:
within a single data set via cross-validation, validation across
multiple data sets from studies with the same study objectives, and
prospective validation with additional data from new samples. It is
anticipated that the MAQC project, through the community's active
participation, will help develop "best practices" for the generation,
analysis, and application of microarray data in the discovery,
development, and review of FDA-regulated products. For more information
about the MAQC project, please contact <Leming.Shi@fda.hhs.gov> and
visit <http://edkb.fda.gov/MAQC/>.

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