Genocea Biosciences Inc (GNCAQ)

[jondoeuk]

Day two https://nci.rev.vbrick.com/#/videos/7bf4d3df-bbf8-4712-8f29-fd7c51d0eb93

8:45am – 9:00am EST
Day 1 Recap
Marc Ernstoff, MD (NCI)

9:00am – 9:45am EST
Keynote Talk
Emerging Challenges and Strategies with CAR T Cells, Marcela Maus, MD, PhD (Harvard Medical School and Massachusetts General Hospital)

9:45am – 12:15pm EST
Alternative Approaches: Looking Beyond Traditional CAR-T Cells
Chair: Tonya Webb, PhD (University of Maryland)

9:45am – 10:15am, Cellular Therapy of Solid Epithelial Cancers Using Naturally Occurring or Genetically Modified Anti-Tumor T Cells, Steven Rosenberg, MD, PhD (National Cancer Institute)

10:15am – 10:45am, Looking Beyond Traditional CAR-T Cells: Unconventional T Cells, Stem Cell Engineering, and an Off-The-Shelf Cell Therapy, Lili Yang, PhD (University of California, Los Angeles)

10:45am – 11:15am, Dendritic Cells: Vaccines, Modulation of Tumor Microenvironment and Adoptive T Cell Therapies, Pawel Kalinski, MD, PhD (Roswell Park Comprehensive Cancer Center)

11:15am – 11:45am, Clinical and Immunologic Effects of Bispecific Antibody Targeted T Cells for Metastatic Breast and Pancreatic Cancer, Lawrence Lum, MD, DSC (University of Virginia)

Panel Discussion
Pawel Kalinski, MD, PhD (Roswell Park Comprehensive Cancer Center)
Dan Kaufman (University of California, San Diego)
Lawrence Lum, MD, DSC (University of Virginia)
Steven Rosenberg, MD, PhD (National Cancer Institute)
Tonya Webb, PhD (University of Maryland)
Lili Yang, PhD (University of California, Los Angeles)

12:15pm – 1:00pm EST
Break

1:00pm – 3:30pm EST
Cell Product Manufacturing and Characterization
Chair: Bruce Levine, PhD (University of Pennsylvania)

1:00pm – 1:30pm, The Role of Standards in Supporting Cell-Based Therapies & Genome Editing Technology, Samantha Maragh, PhD (National Institute of Standards and Technology)

1:30pm – 2:00pm, Design, Engineer, Validate, Build, Test: Manufacturing the Next Generation of Cell Therapies Targeting Solid Cancers, Bruce Levine, PhD (University of Pennsylvania)

2:00pm – 2:30pm, Manufacturing Matters: Population, Phenotype & Potency, Christine Brown, PhD (City of Hope)

2:30pm – 3:00pm, Considerations for Manufacturing an Allogeneic Cell Product, Barbra Sasu, PhD (Allogene Therapeutics)

Panel Discussion
Christine Brown, PhD (City of Hope)
Bruce Levine, PhD (University of Pennsylvania)
Samantha Maragh, PhD (National Institute of Standards and Technology)
Raj K. Puri, M.D., Ph.D. (Food and Drug Administration)
Tal Salz, Ph.D. (Food and Drug Administration)
Barbara Sasu, PhD (Allogene Therapeutics)
Anthony Welch, PhD (National Cancer Institute)

3:30pm – 4:00pm EST
Break

4:00pm – 6:00pm EST
Cell Therapies: The FDA Perspective
Chair: Elad Sharon, MD, MPH (National Cancer Institute)

4:00pm – 4:30pm, Regulatory Perspective on the Preclinical Development of Cell-Based Immunotherapies, Alyssa Galaro, PhD (Food and Drug Administration)

4:30pm – 5:00pm, Identification and Assessment of Critical Quality Attributes for Cell-Based Therapies, Irina Tiper, PhD (Food and Drug Administration)

5:00pm – 5:30pm, FDA Clinical Assessment for First-In-Human Studies of Cell Therapy in Solid Tumors, Yuxia Jia, MD, PhD (Food and Drug Administration)

Panel Discussion
Alyssa Galaro, PhD (Food and Drug Administration)
Yuxia Jia, MD, PhD (Food and Drug Administration)
Irina Tiper, PhD (Food and Drug Administration)
Tal Salz, Ph.D. (Food and Drug Administration)
Elad Sharon, MD, MPH (National Cancer Institute)

6:00pm – 6:15pm EST
Closing Remarks
Marc Ernstoff, MD (National Cancer Institute)