**Working with FDA: Biological Products and Clinical Development**

Rooms E1 and E2, Natcher Conference Center, NIH Campus, Bethesda,
Maryland

**Meeting Agenda**

+-----------------------------------------------------------------------+
| **May 14, 2007**                                                      |
|                                                                       |
| +-------+---------------------------------------------------------+   |
| | 8:30  | **Welcome**                                             |   |
| | a.m.  |                                                         |   |
| |       | -   **Jerry M. Collins, Ph.D.,** *Developmental         |   |
| |       |     Therapeutics Program, DCTD, NCI*                    |   |
| |       |                                                         |   |
| |       | -   **Raj K. Puri, M.D., Ph.D.,** *Center for Biologics |   |
| |       |     Evaluation and Research, FDA*                       |   |
| +-------+---------------------------------------------------------+   |
| | 8:40  | **Introductions**                                       |   |
| | a.m.  |                                                         |   |
| |       | Critical Path Initiatives                               |   |
| |       |                                                         |   |
| |       | -   **Patricia Keegan, M.D.,** *Center for Drug         |   |
| |       |     Evaluation and Research, FDA*                       |   |
| |       |                                                         |   |
| |       |     RAID Training for Investigators: Product and        |   |
| |       |     Regulatory Overview                                 |   |
| |       |                                                         |   |
| |       | -   **Eda T. Bloom, Ph.D.,** *Center for Biologics      |   |
| |       |     Evaluation and\                                     |   |
| |       |     Research, FDA*                                      |   |
| +-------+---------------------------------------------------------+   |
| | 9:00  | **Practical and Organizational Issues for PI-Initiated  |   |
| | a.m.  | Projects**                                              |   |
| |       |                                                         |   |
| |       | Factors in the Development of Academic GMP Projects:    |   |
| |       | Looking\                                                |   |
| |       | Beyond the FDA                                          |   |
| |       |                                                         |   |
| |       | > ► **Stephen Creekmore, M.D., Ph.D.,** *Biological     |   |
| |       | > Resources Branch,\                                    |   |
| |       | > DTP, DCTD, NCI*                                       |   |
| |       | >                                                       |   |
| |       | > NCI Technology Transfer Branch: RAID, Intellectual    |   |
| |       | > Property, and Technology Transfer Agreements          |   |
| |       | >                                                       |   |
| |       | > ► **Donna L. Bialozor,** *Technology Transfer Branch, |   |
| |       | > NCI*                                                  |   |
| +-------+---------------------------------------------------------+   |
| | 9:30  | **Regulatory Requirements and Recommendations**         |   |
| | a.m.  |                                                         |   |
| |       | What is an IND?                                         |   |
| |       |                                                         |   |
| |       | ► **Keith Wonnacott, Ph.D.,** *Center for Biologics     |   |
| |       | Evaluation and Research, FDA*                           |   |
| |       |                                                         |   |
| |       | > IND Regulatory Requirements and Recommendations       |   |
| |       |                                                         |   |
| |       | ► **Karen D. Jones,** *Center for Drug Evaluation and   |   |
| |       | Research, FDA*                                          |   |
| +-------+---------------------------------------------------------+   |
| | 10:30 | **BREAK**                                               |   |
| | a.m.  |                                                         |   |
| +-------+---------------------------------------------------------+   |
| | 10:45 | **Major Clinical and Scientific Components of the IND** |   |
| | a.m.  |                                                         |   |
| |       | *Preclinical and Nonclinical Testing*                   |   |
| |       |                                                         |   |
| |       | Nonclinical Safety Testing for Biological Therapeutics  |   |
| |       | for Cancer Treatment                                    |   |
| |       |                                                         |   |
| |       | -   **Anne M. Pilaro, Ph.D.,** *Center for Drug         |   |
| |       |     Evaluation and Research, FDA*                       |   |
| |       |                                                         |   |
| |       | > Perspective on Pharm/Tox Assessment for Cell and Gene |   |
| |       | > Therapy Products                                      |   |
| |       |                                                         |   |
| |       | -   **Ying Huang, Ph.D.,** *Center for Biologics        |   |
| |       |     Evaluation and Research, FDA*                       |   |
| +-------+---------------------------------------------------------+   |
| | 11:45 | **NETWORKING LUNCH** *(Please purchase your lunch from  |   |
| | a.m.  | the Natcher cafeteria and bring it back to the meeting  |   |
| |       | room)*                                                  |   |
| +-------+---------------------------------------------------------+   |
| | 1:15  | **Major Clinical and Scientific Components of the IND   |   |
| | p.m.  | *(continued)***                                         |   |
| |       |                                                         |   |
| |       | *Clinical Trials*                                       |   |
| |       |                                                         |   |
| |       | An Introduction to FDA's Clinical Trial Review          |   |
| |       |                                                         |   |
| |       | -   **Ke Liu, M.D., Ph.D.,** *Center for Biologics      |   |
| |       |     Evaluation and Research, FDA*                       |   |
| |       |                                                         |   |
| |       | > RAID Investigator Training---Clinical Trial Section   |   |
| |       | > II May 2007                                           |   |
| |       |                                                         |   |
| |       | -   **Hong Zhao, Ph.D.,** *Center for Drug Evaluation   |   |
| |       |     and Research, FDA*                                  |   |
| +-------+---------------------------------------------------------+   |
| | 2:15  | *Manufacturing*                                         |   |
| | p.m.  |                                                         |   |
| |       | Manufacturing of Cellular & Gene Therapies: Ensuring    |   |
| |       | Product Safety and Quality                              |   |
| |       |                                                         |   |
| |       | -   **Dan Takefman, Ph.D.,** *Center for Biologics      |   |
| |       |     Evaluation and Research, FDA*                       |   |
| |       |                                                         |   |
| |       | > Chemistry, Manufacturing and Control Issues in        |   |
| |       | > Production of Therapeutic Biologic Protein Products   |   |
| |       |                                                         |   |
| |       | -   **Ingrid Markovic, Ph.D.,** *Center for Drug        |   |
| |       |     Evaluation and Research, FDA*                       |   |
| +-------+---------------------------------------------------------+   |
| | 3:15  | **BREAK**                                               |   |
| | p.m.  |                                                         |   |
| +-------+---------------------------------------------------------+   |
| | 3:30  | **Major Clinical and Scientific Components of the IND   |   |
| | p.m.  | *(continued)***                                         |   |
| |       |                                                         |   |
| |       | *Case Studies: The Good, the Bad, and the Ugly*         |   |
| |       |                                                         |   |
| |       | RAC: IND Case Studies                                   |   |
| |       |                                                         |   |
| |       | -   **Deborah Lavoie, J.D.,** *Center for Biologics     |   |
| |       |     Evaluation and Research, FDA*                       |   |
| |       |                                                         |   |
| |       | > IND Case Studies                                      |   |
| |       |                                                         |   |
| |       | -   **Karen D. Jones,** *Center for Drug Evaluation and |   |
| |       |     Research, FDA*                                      |   |
| +-------+---------------------------------------------------------+   |
| | 4:15  | **QUESTIONS FROM THE FLOOR**                            |   |
| | p.m.  |                                                         |   |
| +-------+---------------------------------------------------------+   |
| | 5:00  | **ADJOURN**                                             |   |
| | p.m.  |                                                         |   |
| +-------+---------------------------------------------------------+   |
+-----------------------------------------------------------------------+