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Block 5: Convalescent Plasma, Cell Therapy & Apheresis May 19, 2021 3-4:30 EST (2-3:30 CST) 1.5 Contact Hour Recruitment, Collection & Testing of CCP-Blood Center Perspective from the COVID-19 Pandemic Bruce Sachais, MD, PhD Chief Medical Officer & VP, New York Blood Center Enterprises Objectives: 1. Explain what convalescent plasma is and why it is used. 2. Discuss how to build and grow a new program quickly, as exemplified by NYBCs CCP program. 3. Discuss some of the difficulties and challenges that may arise and how to overcome them when building a new program. Level of Instruction: Intermediate Blood Product Utilization During the COVID-19 Pandemic: Transfusion Service Perspective Robert DeSimone, MD, Assistant Professor of Pathology and Laboratory Medicine, Weill Cornell Medicine Objectives: 1. Describe hospital-wide trends in blood product utilization during the pandemic. 2. Review clinical factors associated with need for transfusion in COVID-19 patients. 3. Discuss the important role of randomized clinical trials in the evaluation of convalescent plasma. Level of Instruction: Basic May 26, 2021 3-4:30 EST (2-3:30 CST) 1.5 Contact Hours Overview of Cellular Therapy Joseph (Yossi) Schwartz, MD, Director FACT BOD, Past President, ASFA Objectives: Objectives not available Level of Instruction: Not available June 2, 2021 3-4:30 EST (2-3:30 CST) 1.5 Contact Hours Cellular Therapy Laboratories Rona Singer Weinberg, PhD, Executive Director, Comprehensive Cell Solutions, New York Blood Center Objectives: 1. Define regulatory requirements for manufacturing cellular therapy products. 2. Describe sources for obtaining and methods for processing and cryopreserving hematopoietic and mononuclear cell products. 3. Discuss purity and potency assays used for cellular therapy products. Level of Instruction: Basic Cell Therapy cGMP Yen-Michael S. Hsu, MD, PhD, FCAP, Director of Immunologic Monitoring and Cellular Products Laboratory and Associate Professor of Medicine, UPMC Hillman Cancer Center Objectives: 1. Describe cGMP in cellular therapy practices. 2. Explain why IND is important for enabling cell-based clinical trials using cell products. 3. Discuss the roles of cGMP facility and operation to support clinical trials. Level of Instruction: Intermediate

Block 5: Convalescent Plasma, Cell Therapy & Apheresis

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Page 1: Block 5: Convalescent Plasma, Cell Therapy & Apheresis

Block 5: Convalescent Plasma, Cell Therapy & Apheresis

May 19, 2021 3-4:30 EST (2-3:30 CST) 1.5 Contact Hour Recruitment, Collection & Testing of CCP-Blood Center Perspective from the COVID-19 Pandemic

Bruce Sachais, MD, PhD Chief Medical Officer & VP, New York Blood Center Enterprises Objectives:

1. Explain what convalescent plasma is and why it is used. 2. Discuss how to build and grow a new program quickly, as exemplified by NYBCs CCP program. 3. Discuss some of the difficulties and challenges that may arise and how to overcome them when building a new

program. Level of Instruction: Intermediate

Blood Product Utilization During the COVID-19 Pandemic: Transfusion Service Perspective

Robert DeSimone, MD, Assistant Professor of Pathology and Laboratory Medicine, Weill Cornell Medicine Objectives:

1. Describe hospital-wide trends in blood product utilization during the pandemic. 2. Review clinical factors associated with need for transfusion in COVID-19 patients. 3. Discuss the important role of randomized clinical trials in the evaluation of convalescent plasma.

Level of Instruction: Basic

May 26, 2021 3-4:30 EST (2-3:30 CST) 1.5 Contact Hours Overview of Cellular Therapy

Joseph (Yossi) Schwartz, MD, Director FACT BOD, Past President, ASFA Objectives:

Objectives not available Level of Instruction: Not available

June 2, 2021 3-4:30 EST (2-3:30 CST)

1.5 Contact Hours

Cellular Therapy Laboratories

Rona Singer Weinberg, PhD, Executive Director, Comprehensive Cell Solutions, New York Blood Center Objectives:

1. Define regulatory requirements for manufacturing cellular therapy products. 2. Describe sources for obtaining and methods for processing and cryopreserving hematopoietic and mononuclear

cell products. 3. Discuss purity and potency assays used for cellular therapy products.

Level of Instruction: Basic Cell Therapy cGMP Yen-Michael S. Hsu, MD, PhD, FCAP, Director of Immunologic Monitoring and Cellular Products

Laboratory and Associate Professor of Medicine, UPMC Hillman Cancer Center

Objectives: 1. Describe cGMP in cellular therapy practices. 2. Explain why IND is important for enabling cell-based clinical trials using cell products. 3. Discuss the roles of cGMP facility and operation to support clinical trials.

Level of Instruction: Intermediate

Page 2: Block 5: Convalescent Plasma, Cell Therapy & Apheresis

June 9, 2021 3-4:30 EST (2-3:30 CST) 1.5 Contact Hours Medical Issues and Transfusion Support for Cellular Therapy

Ljiljana V. Vasovic, MD, Associate Director of Cellular Therapy, New York Presbyterian Hospital- Weill Cornell Medicine Objectives:

1. Describe ABO-mismatched allogeneic hematopoietic stem cell transplant 2. Discuss the rules for blood product selection for transfusion of cellular therapy recipients. 3. Identify adverse events and critical medical issues after cellular therapy.

Level of Instruction: Intermediate NMDP Be the Match Program & Collecting HPC & MNC Products from Healthy Donors

Stephanie Dormesy, MHP, Senior Manager, Apheresis & Research, New York Blood Center Luzmary Alvarez, Manager of Special Donor Activities, New York Blood Center Objectives:

1. Explain how to join the Be the Match registry and why diversity is crucial. 2. Describe the steps to donate Peripheral Blood Stem Cells (PBSC) and marrow. 3. Discuss apheresis collection for NMDP donors.

Level of Instruction: Basic

June 16, 2021 3-4:30 EST (2-3:30 CST) 1.5 Contact Hours Overview of Therapeutic Apheresis

Sarah Vossoughi, MD, RN Medical Director of Apheresis, Assistant Director of Transfusion Medicine, Columbia University Irving Medical Center, Assistant Professor, Columbia University Objectives:

1. Describe the mathematical, mechanistic, and pathophysiologic mechanisms by which apheresis provides the intended effect.

2. Discuss the common adverse effects experienced and the points to cover during the informed consent process. 3. Predict what substances and medications may be removed as intended or unintended consequences of

therapeutic apheresis Level of Instruction: Basic

Applications of Therapeutic Apheresis

Patricia Shi, MD Medical Director, New York Blood Center Objectives:

1. Explain the major types of pathophysiologies addressed by therapeutic apheresis. 2. Describe the patient factors to consider when individualizing therapeutic apheresis orders. 3. Utilize the American Society of Apheresis Guidelines to optimize patient care.

Level of Instruction: Intermediate

New York Blood Center Enterprise is approved as a provider of continuing education programs in the clinical

laboratory sciences by the ASCLS P.A.C.E.® Program.