PACT Workshops
*This workshop was organized by NIH/NHLBI and PACT in collaboration with:
AABB, ISCT, ISBTc & FDA/CBER |
Presentations for prior workshops are posted below in PDF. Full slides are posted in color and Handouts are posted in black & white unless otherwise noted.
Disclosure: The views of the speakers represent scientific opinion and are not to be construed as opinion or policy of the Production Assistance for Cellular Therapies (PACT) Group or the US Food and Drug Administration (FDA).
| NHLBI PACT Workshop |
| University of Pittsburgh |
| University of Minnesota MCT |
| Baylor College of Medicine |
NHLBI PACT Workshop "Converging Concepts in Cell Therapy"
April 23-24, 2009
Natcher Conference Center
National Institutes of Health
Bethesda, Maryland
Day 1 – April 23, 2009
Session 1: T-Regulatory Cells
- David H. McKenna, Jr., MD - Considerations for Clinical Manufacture of T Regulatory Cells (View Presentation)
- Bruce L. Levine, PhD - Engineering Artificial Antigen Presenting Cells for Efficient Expansion of Regulatory T Cells
(View Presentation) - Claudio G. Brunstein, MD - (Presentation not available)
Session 2: Mesenchymal Stem Cells
- Adrian P. Gee, MI Biol., PhD - Opening Presentation (View Presentation)
- Ian K. McNiece, PhD - Mesenchymal Stem Cells (View Presentation)
Mesenchymal Stem Cell Transplantation for Heart Failure (View Presentation) - Katarina Le Blanc, MD, PhD - (Presentation not available)
Session 3: Antigen-Specific T Cells
- Shelly Heimfeld, PhD - Banking and Qualification of Feeder Cells for Clinical Production of Antigen-Specific T Cells
(View Presentation) - Philip D. Greenberg, MD - (Presentation not available)
- Cliona M. Rooney, PhD - Antigen-Presenting Cells (APCs) for T Cell Activation (View Presentation)
Session 4: Engineered T Cells
- Bernard A. Fox, PhD - Cell Processing Related Issues: Adoptive T Cell Immunotherapy (View Presentation)
- Carl H. June, MD - Engineered T Cells for HIV/AIDS (View Presentation)
- Steven A. Rosenberg, MD, PhD - Cell Transfer Therapy for Patients with Cancer
(View Presentation)
Session 5: Natural Killer Cells
- David Stroncek, MD - NK Cell Therapy: Cell Processing Considerations (View Presentation)
- Jeffery S. Miller, MD - The Role of Haploidentical NK Cells in Cancer and Transplantation (View Presentation)
- Richard W. Childs, MD - In Vitro Expansion of Human NK Cells for Adoptive Cancer Immunotherapy (View Presentation)
Day 2 – April 24, 2009
Session 6: Dendritic Cells
- Theresa L. Whiteside, PhD - Dendritic Cells for Therapy: Production, Maturation and Potency (View Presentation)
- Sharon A. Riddler, MD, MPH - Therapeutic Vaccination with Autologous Dendritic Cells in HIV Infection (View Presentation)
- Pawel Kalinski, MD, PhD - Dendritic Cells in Cancer Immunotherapy: Induction of Tumor-homing Effector-type T cells
(View Presentation)
Session 7: Cell Trafficking and Imaging Techniques
- Marianna Sabatino, MD - Imaging and Cell Therapy (View Presentation)
- Erin F. Simonds, PhD Candidate - - (Presentation not available)
- Zhenghong Lee, PhD - (Presentation not available)
- Eric T. Ahrens, PhD - (Presentation not available)
Innovative Cellular Therapies and Methods at GMP Cell Therapy Facilities
May 5-6, 2008
University of Pittsburgh Cancer Institute
Immunological Monitoring and Cellular Products Laboratory
Hematopoietic Stem Cell Laboratory
Herberman Conference Center
Pittsburgh, Pennsylvania
Day 1 – 5/6/2008
Day 2 – 5/7/2008
-
Lab Practical - CD34 Single Platform Enumeration | Deborah Griffin, MS – (Handouts)
-
Lab Practical - Endotoxin and Mycoplasma | Joanna Stanson, MS – (Handouts)
Design and Operation of GMP Cell Therapy Facilities
April 11-12, 2007
University of Minnesota
Molecular and Cellular Therapeutics
Earle Browne Continuing Education and Conference Center
St. Paul, Minnesota
Day 1 – 4/11/2007
- Meeting Objectives | Debbie Wood, BS, MT(ASCP) – (PDF)
- Facility Design-University of Minnesota | Diane Kadidlo, MT(ASCP), SBB – (PDF)
- Facility Design-University of Pittsburgh | Deborah Griffin, BA – (PDF)
- Facility Design-Baylor College of Medicine | Adrian Gee, MIBiolo, PhD –
(PDF with linked .mpg files)
(PDF without .mpg files)
Slide 24 movie clip (.mpg file)*
Slide 26 movie clip (.mpg file)*
*Please note that these .mpg files play best in Windows Media Player. If clicking on the link does not automatically launch a viewer that supports these files, open Windows Media Player and copy the link into it (Right click on the .mpg file link, choose "Copy Shortcut". Then open Windows Media Player, go to File/Open URL and paste the shortcut into the dialog box.) As these media files are large, you may find a delay before they begin to play.
- Facility Design-Mayo Clinic | Doug Padley, MT(ASCP) – (PDF)
- Facility Cleaning & Environmental Monitoring | Adrian Gee, MIBiolo, PhD – (PDF)
- Supplies and Reagents | Lisa Van Orsow, BS – (PDF)
- Staff Training | Deborah Griffin, BA – (PDF)
- Documentation and Batch Records | Joanna Stanson, MS – (PDF)
- CMC Writing | Dave McKenna Jr., MD – (PDF)
- Product Development | Karen Prezioso, MS – (PDF)
Day 2 – 4/12/2007
- Cryopreservation | Allison Hubel, PhD – (PDF)
- Data Management - Deviations & Processing | Darin Sumstad, CLS (NCA, ASCP) – (PDF)
- Lot Release | Diane Kadidlo, MT(ASCP), SBB – (PDF)
- IND - Cell Therapy | Robert Lindblad, MD, FACEP – (PDF)
Design and Operation of GMP Cell Therapy Facilities
April 4-5, 2006
Baylor College of Medicine
Houston, Texas
Day 1 – 4/4/2006
- Meeting Introduction & Objectives | Debbie Wood, BS, MT(ASCP) – (Slides) (Handouts)
- Facility Design-University of Pittsburgh | Deborah Griffin, BA – (Slides) (Handouts)
- Facility Design-University of Minnesota | Diane Kadidlo, MT(ASCP), SBB – (Slides) (Handouts)
- Facility Design-Baylor College of Medicine | Adrian Gee, MIBiolo, PhD – (Slides) (Handouts)
- Facility Design-MD Anderson Cancer Center | John McMannis, PhD – (Slides) (Handouts)
- Facility Cleaning & Monitoring | Adrian Gee, MIBiolo, PhD – (Slides) (Handouts)
- Facility and Equipment Maintenance | Deborah Griffin, BA – (Slides) (Handouts)
- Supplies and Reagents | Lisa Van Orsow, BS – (Slides) (Handouts)
- Documentation | Adrian Gee, MIBiolo, PhD – (Slides) (Handouts)
- Labeling | Jeff Wilson, BS – (Slides) (Handouts)
- Databases | Darin Sumstad, CLS (NCA, ASCP) and Jeff Wilson, BS – (Slides) (Handouts)
Day 2 – 4/5/2006
- Production Records & Documentation | Diane Kadidlo, MT(ASCP), SBB and Joanna Stanson, MS – (Slides) (Handouts)
- Product Testing & Release | Diane Kadidlo, MT(ASCP), SBB – (Slides) (Handouts)
- Staff Training | John McMannis, PhD – (Slides) (Handouts)
Please note that some files are large and may take longer to download than expected