Agenda

Monday, Dec 10 Tuesday, Dec 11

Monday, December 10, 2018

09:00 am - 09:15 am EST
Welcome and opening remarks

Ned Sharpless, Director, National Cancer Institute

09:15 am - 09:25 am EST
Goals of the Workshop

James Doroshow, Director, Division of Cancer Treatment and Diagnosis, NCI

                                                     SESSION 1

                                         CLINICAL PERSPECTIVE

09:25 am - 09:45 am EST
Keynote Presentation - Bit by Bit: Putting It Together

Malcolm Brenner, Baylor University

09:45 am - 10:05 am EST
Targeting Unique Somatic Mutations for the Immunotherapy of Solid Epithelial Cancers

 Steven Rosenberg, National Cancer Institute

10:05 am - 10:25 am EST
TCR Gene Therapy for Epithelial Cancers

Christian Hinrichs, National Cancer Institute

10:25 am - 10:40 am EST
COFFEE BREAK

(15 minutes)

10:40 am - 11:00 am EST
Successes and Challenges with CAR-T Cell Therapy for Hematologic Malignancies

Terry Fry, University of Colorado, Denver

11:00 am - 11:20 am EST
Insights into Toxicities of CD19 CAR-T Cells
11:20 am - 11:40 am EST
Opportunities and Challenges in Developing CAR-T Cells for Solid Tumors

Marcela Maus, Massachusetts General Hospital and Harvard University

11:40 am - 12:10 pm EST
PANEL DISCUSSION

(30 minutes), Terry FRY

12:10 pm - 01:10 pm EST
LUNCH BREAK

(60 minutes)

                                                        SESSION 2

                                               STATE OF THE SCIENCE

01:10 am - 01:30 am EST
CAR-T Cell Therapy for Solid Tumors: A Work in Progress

Steven Albelda, University of Pennsylvania

01:30 am - 01:50 am EST
Target antigen selection for solid tumor CAR T-cell therapy

Stephen Gottschalk, St. Jude Children’s Research Hospital

01:50 am - 02:10 am EST
An NIH Intramural/Extramural Collaboration to Target Renal Cell Carcinoma with TCR Transduced Autologous T Cells

Michael Nishimura, Loyola University of Chicago

02:10 am - 02:25 am EST
COFFEE BREAK

(15 minutes)

02:25 am - 02:55 am EST
Moving CARs Forward: Next Generation CAR-T Cells

Renier Brentjens, Memorial Sloan Kettering Cancer Center

02:55 am - 03:15 am EST
Switchable CARs: Targeting More Than One Antigen

Travis Young, California Institute for Biomedical Research

03:15 am - 03:35 am EST
Engineered Human Pluripotent Stem Cell-derived NK Cells with Improved Anti-Tumor Activity

Dan Kaufman, University of California San Diego

03:35 am - 04:05 am EST
PANEL DISCUSSION

(30 minutes), Steven ALBELDA

Tuesday, December 11, 2018

08:45 am - 09:00 am EST
Recap of Day 1 and Goals for Day 2

Rose Aurigemma, National Cancer Institute

                                                           SESSION 4

                                      FDA AND INDUSTRY PERSPECTIVE

09:00 am - 09:20 am EST
Overview of Steps in Manufacturing Genetically Engineered T Cells
09:20 am - 09:40 am EST
Replicating Virus Testing in Integrating Vectors: So Far So Good

Kenneth Cornetta, Indiana University

09:40 am - 10:10 am EST
Genome Editing in the Clinic for Cancer Indications: Status of the Field and General Considerations for IND-enabling Safety and Efficacy Studies

Fyodor Urnov, Altius Institute for Biomedical Sciences

10:00 am - 10:15 am EST
COFFEE BREAK

(15 minutes)

10:15 am - 10:35 am EST
Challenges of Expanding Tumor Infiltrating Lymphocytes (TIL) from Solid Tumors

Chantale Bernatchez, Baylor University

10:35 am - 11:15 am EST
Challenges in CAR-T Cell Manufacturing

Isabelle Riviere, Memorial Sloan Kettering Cancer Center

10:55 am - 11:15 am EST
Cellular Product Release and Potency Testing

Lisa Butterfield, Parker Institute and University of California San Francisco

11:15 am - 11:35 am EST
CAR-T Cell Therapy: Going Beyond the Test Drive

Nirali Shah, National Cancer Institute

11:35 am - 12:05 pm EST
PANEL DISCUSSION (30 MINUTES),

CHANTALE BERNATCHEZ

12:05 pm - 01:00 pm EST
LUNCH BREAK

(55 MINUTES)

                                                         SESSION 3

                      TECHNOLOGICAL CHALLENGES FOR CELL THERAPY

01:00 am - 01:20 am EST
Cell-based Immunotherapy for Solid Tumors: US FDA Regulatory Perspectives

Ke Liu, Food and Drug Administration

01:20 am - 01:40 am EST
Regulatory Considerations for Cell and Gene Therapy Manufacturing

Thomas Finn, Food and Drug Administration

01:40 am - 02:00 am EST
Cell-based Immunotherapy for Solid Tumors: The Role of Small Business

Jake Reder, Celdara Medical and Giesel School of Medicine at Dartmouth

02:00 am - 02:20 am EST
Partnering with the NCI: Intellectual Property Issues

Jason Cristofaro, National Cancer Institute

02:20 am - 03:00 am EST
PANEL DISCUSSION AND WRAP UP (40 MINUTES),

JAKE REDER