Deciphering the Clinical Clues: Updates to Protocols and Procedures for Anti-CD47 Agents in Clinical Laboratories

Faculty

David Sallman, MD
Leukemia and Myelodysplastic Syndrome (MDS) Section Head
Associate Member, Department of Malignant Hematology
H. Lee Moffitt Cancer Center & Research Institute
Associate Professor, Department of Oncologic Sciences
University of South Florida
Tampa, FL
David Sallman, MD

David Sallman, MD, is an associate member in the Department of Malignant Hematology at Moffitt Cancer Center and associate professor in the Department of Oncologic Sciences at the University of South Florida, both in Tampa. Dr. Sallman is the myeloid section head of the malignant hematology department. He earned his medical degree from the University of South Florida College of Medicine and completed an internal medicine residency at Massachusetts General Hospital before completing a hematology/oncology fellowship at Moffitt Cancer Center. He is board certified in medical oncology, hematology, and internal medicine.

Dr Sallman’s clinical interests are myelodysplastic syndromes (MDS), acute myeloid leukemia (AML), and myeloproliferative neoplasms. His research interests focus on the development of novel targeted therapeutic strategies (phase 1 and 2 clinical trials) for patients with MDS and AML, based on the underlying mutational drivers of each disease. Specifically, he studies the genetic drivers of myeloid diseases to improve prognostication for patients and to allow for more personalized treatment. He has published significantly on this topic, including recently in highly regarded journals such as Leukemia and Haematologica, and these works are the foundation of clinical trials/translational studies designed to improve the quality of life and survival of patients with MDS. He is the principal investigator for multiple ongoing studies focused on higher-risk MDS. Furthermore, his recent work has focused on TP53-mutant MDS, where he and his team identified and validated that the clonal burden of TP53 mutation is strongly concordant with patient outcomes and are intimately tied with the clinical trajectory of these patients. Additionally, they have identified that serial next-generation sequencing has significant prognostic value and can be an early biomarker of outcome with novel agents. He has been the lead principal investigator (PI) for phase 1-3 trials TP53-mutant MDS and AML patients.  Additionally, Dr. Sallman serves as lead PI for multiple cellular therapy trials including CAR-T and TCR therapies.

Dr Sallman has authored and coauthored numerous articles, books, book chapters, and abstracts, and serves as reviewer for multiple journals. He received the Young Investigator Grant from the MDS Foundation in 2017 and the Dresner Foundation Career Development award in 2018.

Christine Lomas-Francis, MSc, FIBMS
Scientist Emeritus
Lindsley F. Kimball Research Institute (LFKRI)
Highland, NY
Christine Lomas-Francis, MSc, FIBMS

Christine Lomas-Francis, MSc, FIBMS, recently retired as the technical director of the Laboratory of Immunohematology and Genomics at the New York Blood Center, where she was involved in the resolution of many complex antibody investigations and discoveries of new blood group antigens. She is a Fellow of the Institute of Biomedical Science and gained her master’s degree in applied immunology from Brunel University in England. Ms. Lomas-Francis received her training at the Blood Group Unit of the Medical Research Council in London, England, and originally relocated to the United States to join the consultation and education department at Gamma Biologicals in Houston, Texas.

Ms. Lomas-Francis is a member of the Association for the Advancement of Blood & Biotherapies (AABB), the British Blood Transfusion Society (BBTS), and the International Society of Blood Transfusion (ISBT), among others. She serves on the ISBT working parties for Red Cell Immunogenetics and Blood Group Terminology, and is past chair of the working party for Rare Donors. She has coauthored many peer reviewed publications and three editions of The Blood Group Antigen FactsBook.

Lynsi Rahorst, MHPE, MLS(ASCP)SBBCM
Manager, Education and Training, Immunohematology Reference and Genomics Laboratories
New York Blood Center Enterprises
Kansas City, MO
Lynsi Rahorst, MHPE, MLS(ASCP)SBBCM

Lynsi Rahorst, MHPE, MLS(ASCP)SBBCM, spent several years in the Immunohematology Reference Laboratory at Community Blood Center in Kansas City, before assuming the role of manager of education and training for IRL/Genomics for New York Blood Center Enterprises (NYBCe). In this role, she supports training of laboratory staff and coordinates educational programs and content offered by NYBCe for the greater transfusion medicine community. She earned a masters of health professions education from the University of Missouri–Kansas City and is American Society for Clinical Pathology (ASCP)-certified as a Specialist in Blood Banking (SBB).

Ms. Rahorst has been active in the Heart of America Association of Blood Banks (HAABB), as both a speaker and by serving on the board of directors, including serving as president in 2017. She has served on multiple AABB committees, including the Annual Meeting Education Committee and the eLearning Committee, and is an AABB assessor in training. Additionally, she is active in the AABB Spanish-language section, where she coordinated the translation of the Fundamental Standards for Blood Collection and Transfusion and assists in training for the AABB Quality Certificate Program in Latin America.

Ms. Rahorst is passionate about educating and training the next generation of leaders in immunohematology and genomics, as well as supporting blood banking educational initiatives in Spanish-speaking countries.

Statement of Need

Because hematologic cancers are often associated with poor prognosis, the development of new and efficacious treatments has become a national health care imperative. Recent trials of a humanized anti-CD47 monoclonal antibody (mAb) in lymphoma, multiple myeloma (MM), and other hematologic malignancies has shown great promise. However, it is also expressed on red blood cells (RBCs), thereby creating a significant impact on blood bank testing and transfusion management.

In anticipation of new anti-CD47 therapies in practice, clinical laboratory and blood bank personnel including pathologists, phlebotomists, technologists, nurses, and collections managers need to prepare for strategies that address the effects of anti-CD47 mAb therapy on RBCs, compatibility testing, and transfusion requirements.

Learning Objectives

  • Evaluate the impact of anti-CD47 agents on blood compatibility testing.
  • Implement detailed laboratory protocols and procedures to facilitate timely transfusion support for patients taking anti-CD47 agents.
  • Utilize collaborative care strategies to ensure patients receive timely transfusions as part of supportive care.

Financial Support

This program has been supported by an independent educational grant from Gilead Sciences, Inc.

Target Audience

Clinical laboratory clinicians (pathologists) and blood bank personnel including phlebotomists, technologists, nurses, and collections managers

Credit Information

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Nurses (ANCC) 1.0

This activity is designated for 1.00 contact hours.

ABIM MOC 1.0

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Disclosure Declaration

It is the policy of CME Outfitters, LLC, to ensure independence, balance, objectivity, and scientific rigor and integrity in all of their CE activities. Faculty must disclose to the participants any relationships with commercial companies whose products or devices may be mentioned in faculty presentations, or with the commercial supporter of this CE activity. CME Outfitters, LLC, has evaluated, identified, and mitigated any potential conflicts of interest through a rigorous content validation procedure, use of evidence-based data/research, and a multidisciplinary peer review process.

Dr. Sallman reports the following financial relationships:

Advisory Board: AvenCell Therapeutics, Inc.; bluebird bio, Inc.; Bristol Myers Squibb Company; Intellia Therapeutics, Inc.; Jasper Therapeutics, Inc.; Kite; Magenta Therapeutics; Nkarta, Inc.; Novartis Pharmaceuticals Corporation; Orbital Therapeutics; Shattuck Labs, Inc.; Servier; Syndax; and Syros Pharmaceuticals, Inc.

Consultant: AbbVie Inc.; Affirmed Pharma; Gilead Sciences, Inc.; Incyte; Intellisphere, Inc.; LLC; Molecular Partners AG; PGEN Therapeutics, Inc.; Takeda Pharmaceuticals U.S.A., Inc.; and Zentalis Pharmaceuticals

Research Support: Aprea Therapeutics and Jazz Pharmaceuticals, Inc.

Ms. Lomas-Francis reports no financial relationships to disclose.

Ms. Rahorst reports no financial relationships to disclose.

Disclosures were obtained from the following peer reviewer and  CME Outfitters, LLC, staff, with no disclosures to report:

  • Jeffrey Helfand, DO (peer reviewer)
  • Albert Eubanks, Jr., RN
  • Nichole Lainhart (planning committee)
  • Warren Beckman (planning committee)
  • Susan H. Yarbrough, CHCP (planning committee)
  • Sandra Caballero, PharmD (planning committee)
  • Sharon Tordoff (planning committee)

Faculty of this CE activity may include discussions of products or devices that are not currently labeled for use by the FDA. The faculty have been informed of their responsibility to disclose to the audience if they will be discussing off-label or investigational uses (any uses not approved by the FDA) of products or devices.

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MMV-133-101423-47

Deciphering the Clinical Clues: Updates to Protocols and Procedures for Anti-CD47 Agents in Clinical Laboratories
Event Date: 12/04/2023