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A Novel Therapeutic Approach in Myeloid Malignancies: Targeting the Neddylation Pathway

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A Novel Therapeutic Approach in Myeloid Malignancies: Targeting the Neddylation Pathway

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Chapter 1
A Novel Therapeutic Approach in Myeloid Malignancies: Targeting the Neddylation Pathway
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Chapter 2
video Investigational Clinical Research on NAE Inhibition in MDS, CMML, and AML for Segment 11694
Investigational Clinical Research on NAE Inhibition in MDS, CMML, and AML
Chapter 3
video What Does the Future Hold for the Management of MDS, CMML, and AML? for Segment 11694
What Does the Future Hold for the Management of MDS, CMML, and AML?
Chapter 4
video Impact of COVID-19 on the Management of Hematologic Malignancies for Segment 11694
Impact of COVID-19 on the Management of Hematologic Malignancies
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  • Overview

    There is a lack of available therapeutic options for the management of patients with myeloid malignancies, including myelodysplastic syndromes (MDS), chronic myelomonocytic leukemia (CMML), and acute myeloid leukemia (AML). Novel therapeutic approaches are being evaluated, particularly those that target the NEDD8-activating enzyme (NAE). Evaluating the rationale for NAE inhibition, assessing emerging safety and efficacy data on use of NAE inhibitors in myeloid malignancies, and developing strategies based on the evolving implications of this research will allow for greater understanding of their potential impact on management and health outcomes of patients with MDS, CMML, and AML.

  • Disclosure of Conflicts of Interest

    Conflict of Interest Statement
    The “Policy on Collection of Relevant Financial Relationships and Resolution of COI” of Albert Einstein College of Medicine-Montefiore Medical Center requires that faculty participating in any CME activity disclose to the audience any relevant relationship(s) with a pharmaceutical or equipment company.* Any presenter whose disclosed relationships prove to create a conflict of interest, with regard to their contribution to the activity, will not be permitted to present.

    Albert Einstein College of Medicine-Montefiore Medical Center also requires that faculty participating in any CME activity disclose to the audience when discussing any unlabeled or investigational use of any commercial product or device not yet approved for use in the United States.

    *The ACCME defines a Commercial Interest as an entity producing, marketing, re-selling or distributing health care goods or services consumed by or used on, patients. The ACCME does not consider providers of clinical service directly to patients to be commercial interests - unless the provider of the clinical service is owned, or controlled by, an ACCME-defined commercial interest.

    Faculty

    Mikkael A. Sekeres, MD, MS
    Consulting Fees: Celgene/Bristol-Myers Squibb; Takeda/Millennium 

    Sara M. Tinsley, PhD, ARNP, AOCNP
    Consulting Fees: Agios Pharmaceuticals Inc; Celgene Corp; Incyte Corp; Jazz Pharmaceuticals Inc; Novartis Pharmaceuticals Corp
    Speakers Bureau: Astellas Pharma US Inc; Celgene Corp; Incyte Corp; Jazz Pharmaceuticals Inc; Novartis Pharmaceuticals Corp  

    The faculty have indicated that their financial relationships will not impact their ability to discuss material that is balanced, non-biased, accurate, current and scientifically rigorous.

    Disclosure of Unlabeled Use and Investigational Product

    This educational activity contains discussion of the unlabeled/unapproved use of NAE inhibitors for treatment of myeloid malignancies. The planners of this activity do not recommend the use of any agent outside of the labeled indications. 

    The opinions expressed in the educational activity are those of the faculty and do not necessarily represent the views of the planners. Please refer to the official prescribing information for each product for discussion of approved indications, contraindications, and warnings.

    Reviewer Disclosures:
    Albert Einstein College of Medicine
    Amit K. Verma, MBBS (Peer Reviewer)
    Professor, Department of Medicine (Oncology)
    Professor, Department of Developmental & Molecular Biology
    Director, Division of Hemato-Oncology, Montefiore Department of Oncology
    Albert Einstein College of Medicine
    Montefiore Medical Center
    Bronx, NY

    Dr. Verma has no relevant conflicts of interest with any ACCME-defined commercial interest.

    Victor B. Hatcher, PhD (CE Reviewer)
    Associate Dean, Continuing Professional Development
    Albert Einstein College of Medicine
    Montefiore Medical Center
    Bronx, NY

    Dr. Hatcher has no relevant conflicts of interest with any ACCME-defined commercial interest.

  • Target Audience

    This activity is designed to meet the educational needs of hematologists/oncologists, hematology/oncology nurse practitioners (NPs), and hematology/oncology physician assistants (PAs).

  • Learning Objectives

    After participating in this educational activity, participants should be better able to:

    • DESCRIBE treatment-related adverse events associated with conventional therapy for myeloid malignancies to better educate patients
    • EXPLAIN the role of targeting NEDD8-activating enzyme (NAE) in myelodysplastic syndromes (MDS), chronic myelomonocytic leukemia (CMML), and acute myeloid leukemia (AML)
    • ASSESS efficacy and safety data regarding NAE inhibition in MDS, CMML, and AML
    • DESCRIBE clinical implications and potential place in therapy of NAE inhibitors in MDS, CMML, and AML 
  • Accreditation and Credit Designation Statements

    In support of improving patient care, this activity has been planned and implemented by Albert Einstein College of Medicine-Montefiore Medical Center and Spire Learning. Albert Einstein College of Medicine-Montefiore Medical Center is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.

    Credit Designation Statements
    PHYSICIANS
    Albert Einstein College of Medicine-Montefiore Medical Center designates this enduring material for a maximum of 0.5 AMA PRA Category 1 Credit(s)™. Physicians should claim only the credit commensurate with the extent of their participation in the activity. 

    NURSES
    Albert Einstein College of Medicine-Montefiore Medical Center designates this activity for 0.5 nursing contact hours. Nurses should claim only the credit commensurate with the extent of their participation in the activity. 

    IPCE
    This activity was planned by and for the healthcare team, and learners will receive 0.5 Interprofessional Continuing Education (IPCE) credit for learning and change.

    LEVELS OF EVIDENCE
    Levels of evidence are provided for any patient care recommendations made during this activity.

    • Level A (randomized controlled trial/meta-analysis): High-quality, randomized controlled trial (RCT) that considers all important outcomes. High-quality meta-analysis (quantitative systematic review) using comprehensive search strategies
    • Level B (other evidence): A well-designed, nonrandomized clinical trial. A nonquantitative systematic review with appropriate search strategies and well-substantiated conclusions. Includes lower-quality RCTs, clinical cohort studies, and case-controlled studies with nonbiased selection of study participants and consistent findings. Other evidence, such as high-quality, historical, uncontrolled studies, or well-designed epidemiologic studies with compelling findings, is also included
    • Level C (consensus/expert opinion): Consensus viewpoint or expert opinion

    Each rating is applied to a single reference in the activity, not the entire body of evidence on the topic.

    Disclaimer
    Participants have an implied responsibility to use the newly acquired information to enhance patient outcomes and their own professional development. The information presented in this activity is not meant to serve as a guideline for patient management. Any procedures, medications, or other courses of diagnosis or treatment discussed or suggested in this activity should not be used by clinicians without evaluation of their patients’ conditions and possible contraindications and/or dangers in use, review of any applicable manufacturer’s product information, and comparison with recommendations of other authorities.

    Privacy Policy:
    Albert Einstein College of Medicine-Montefiore Medical Center, Center for Continuing Professional Development (Einstein) protects the privacy of personal and other information regarding participants and educational collaborators. Einstein will not release personally identifiable information to a third party without the individual's consent, except such information as is required for reporting to the ACCME.

    Einstein maintains physical, electronic, and procedural safeguards that comply with federal regulations to protect against the loss, misuse, or alteration of information collected from you.

    Additional information regarding Albert Einstein College of Medicine-Montefiore Medical Center's Privacy Policy can be viewed at https://www.mecme.org/PrivacyStatement.aspx.

    Copyright Information
    Copyright © 2020 by Spire Learning, LLC and its Licensors. All rights reserved. No part of this publication or activity may be reproduced or transmitted in any form, by any means, without prior written permission of Spire Learning, LLC. Spire Learning, LLC and Albert Einstein College of Medicine-Montefiore Medical Center, Center for Continuing Professional Development (Einstein) will not assume responsibility for damages, loss, or claims of any kind arising from or related to the information contained in this publication or activity, including any claims related to the products, drugs, or services mentioned herein.

  • Provider(s)/Educational Partner(s)

    This activity is jointly provided by Albert Einstein, Montefiore, and Spire.

  • Commercial Support

    This activity is supported by an independent educational grant from Takeda Oncology.

  • System Requirements

    Our site requires a computer, tablet or mobile device and a connection to the Internet. For best results, a high-speed Internet connection is recommended (DSL/cable). We also recommend using the latest version of your favorite browser to ensure compliance with W3C standards, such as Internet Explorer, Microsoft Edge, Chrome, Firefox or Safari. Users accustomed to IE8, IE9 IE10 are advised to update their browsers for the best experience.

  • Publication Dates

    Release Date:

    Expiration Date:

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Comments
  • Overview

    There is a lack of available therapeutic options for the management of patients with myeloid malignancies, including myelodysplastic syndromes (MDS), chronic myelomonocytic leukemia (CMML), and acute myeloid leukemia (AML). Novel therapeutic approaches are being evaluated, particularly those that target the NEDD8-activating enzyme (NAE). Evaluating the rationale for NAE inhibition, assessing emerging safety and efficacy data on use of NAE inhibitors in myeloid malignancies, and developing strategies based on the evolving implications of this research will allow for greater understanding of their potential impact on management and health outcomes of patients with MDS, CMML, and AML.

  • Disclosure of Conflicts of Interest

    Conflict of Interest Statement
    The “Policy on Collection of Relevant Financial Relationships and Resolution of COI” of Albert Einstein College of Medicine-Montefiore Medical Center requires that faculty participating in any CME activity disclose to the audience any relevant relationship(s) with a pharmaceutical or equipment company.* Any presenter whose disclosed relationships prove to create a conflict of interest, with regard to their contribution to the activity, will not be permitted to present.

    Albert Einstein College of Medicine-Montefiore Medical Center also requires that faculty participating in any CME activity disclose to the audience when discussing any unlabeled or investigational use of any commercial product or device not yet approved for use in the United States.

    *The ACCME defines a Commercial Interest as an entity producing, marketing, re-selling or distributing health care goods or services consumed by or used on, patients. The ACCME does not consider providers of clinical service directly to patients to be commercial interests - unless the provider of the clinical service is owned, or controlled by, an ACCME-defined commercial interest.

    Faculty

    Mikkael A. Sekeres, MD, MS
    Consulting Fees: Celgene/Bristol-Myers Squibb; Takeda/Millennium 

    Sara M. Tinsley, PhD, ARNP, AOCNP
    Consulting Fees: Agios Pharmaceuticals Inc; Celgene Corp; Incyte Corp; Jazz Pharmaceuticals Inc; Novartis Pharmaceuticals Corp
    Speakers Bureau: Astellas Pharma US Inc; Celgene Corp; Incyte Corp; Jazz Pharmaceuticals Inc; Novartis Pharmaceuticals Corp  

    The faculty have indicated that their financial relationships will not impact their ability to discuss material that is balanced, non-biased, accurate, current and scientifically rigorous.

    Disclosure of Unlabeled Use and Investigational Product

    This educational activity contains discussion of the unlabeled/unapproved use of NAE inhibitors for treatment of myeloid malignancies. The planners of this activity do not recommend the use of any agent outside of the labeled indications. 

    The opinions expressed in the educational activity are those of the faculty and do not necessarily represent the views of the planners. Please refer to the official prescribing information for each product for discussion of approved indications, contraindications, and warnings.

    Reviewer Disclosures:
    Albert Einstein College of Medicine
    Amit K. Verma, MBBS (Peer Reviewer)
    Professor, Department of Medicine (Oncology)
    Professor, Department of Developmental & Molecular Biology
    Director, Division of Hemato-Oncology, Montefiore Department of Oncology
    Albert Einstein College of Medicine
    Montefiore Medical Center
    Bronx, NY

    Dr. Verma has no relevant conflicts of interest with any ACCME-defined commercial interest.

    Victor B. Hatcher, PhD (CE Reviewer)
    Associate Dean, Continuing Professional Development
    Albert Einstein College of Medicine
    Montefiore Medical Center
    Bronx, NY

    Dr. Hatcher has no relevant conflicts of interest with any ACCME-defined commercial interest.

  • Target Audience

    This activity is designed to meet the educational needs of hematologists/oncologists, hematology/oncology nurse practitioners (NPs), and hematology/oncology physician assistants (PAs).

  • Learning Objectives

    After participating in this educational activity, participants should be better able to:

    • DESCRIBE treatment-related adverse events associated with conventional therapy for myeloid malignancies to better educate patients
    • EXPLAIN the role of targeting NEDD8-activating enzyme (NAE) in myelodysplastic syndromes (MDS), chronic myelomonocytic leukemia (CMML), and acute myeloid leukemia (AML)
    • ASSESS efficacy and safety data regarding NAE inhibition in MDS, CMML, and AML
    • DESCRIBE clinical implications and potential place in therapy of NAE inhibitors in MDS, CMML, and AML 
  • Accreditation and Credit Designation Statements

    In support of improving patient care, this activity has been planned and implemented by Albert Einstein College of Medicine-Montefiore Medical Center and Spire Learning. Albert Einstein College of Medicine-Montefiore Medical Center is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.

    Credit Designation Statements
    PHYSICIANS
    Albert Einstein College of Medicine-Montefiore Medical Center designates this enduring material for a maximum of 0.5 AMA PRA Category 1 Credit(s)™. Physicians should claim only the credit commensurate with the extent of their participation in the activity. 

    NURSES
    Albert Einstein College of Medicine-Montefiore Medical Center designates this activity for 0.5 nursing contact hours. Nurses should claim only the credit commensurate with the extent of their participation in the activity. 

    IPCE
    This activity was planned by and for the healthcare team, and learners will receive 0.5 Interprofessional Continuing Education (IPCE) credit for learning and change.

    LEVELS OF EVIDENCE
    Levels of evidence are provided for any patient care recommendations made during this activity.

    • Level A (randomized controlled trial/meta-analysis): High-quality, randomized controlled trial (RCT) that considers all important outcomes. High-quality meta-analysis (quantitative systematic review) using comprehensive search strategies
    • Level B (other evidence): A well-designed, nonrandomized clinical trial. A nonquantitative systematic review with appropriate search strategies and well-substantiated conclusions. Includes lower-quality RCTs, clinical cohort studies, and case-controlled studies with nonbiased selection of study participants and consistent findings. Other evidence, such as high-quality, historical, uncontrolled studies, or well-designed epidemiologic studies with compelling findings, is also included
    • Level C (consensus/expert opinion): Consensus viewpoint or expert opinion

    Each rating is applied to a single reference in the activity, not the entire body of evidence on the topic.

    Disclaimer
    Participants have an implied responsibility to use the newly acquired information to enhance patient outcomes and their own professional development. The information presented in this activity is not meant to serve as a guideline for patient management. Any procedures, medications, or other courses of diagnosis or treatment discussed or suggested in this activity should not be used by clinicians without evaluation of their patients’ conditions and possible contraindications and/or dangers in use, review of any applicable manufacturer’s product information, and comparison with recommendations of other authorities.

    Privacy Policy:
    Albert Einstein College of Medicine-Montefiore Medical Center, Center for Continuing Professional Development (Einstein) protects the privacy of personal and other information regarding participants and educational collaborators. Einstein will not release personally identifiable information to a third party without the individual's consent, except such information as is required for reporting to the ACCME.

    Einstein maintains physical, electronic, and procedural safeguards that comply with federal regulations to protect against the loss, misuse, or alteration of information collected from you.

    Additional information regarding Albert Einstein College of Medicine-Montefiore Medical Center's Privacy Policy can be viewed at https://www.mecme.org/PrivacyStatement.aspx.

    Copyright Information
    Copyright © 2020 by Spire Learning, LLC and its Licensors. All rights reserved. No part of this publication or activity may be reproduced or transmitted in any form, by any means, without prior written permission of Spire Learning, LLC. Spire Learning, LLC and Albert Einstein College of Medicine-Montefiore Medical Center, Center for Continuing Professional Development (Einstein) will not assume responsibility for damages, loss, or claims of any kind arising from or related to the information contained in this publication or activity, including any claims related to the products, drugs, or services mentioned herein.

  • Provider(s)/Educational Partner(s)

    This activity is jointly provided by Albert Einstein, Montefiore, and Spire.

  • Commercial Support

    This activity is supported by an independent educational grant from Takeda Oncology.

  • System Requirements

    Our site requires a computer, tablet or mobile device and a connection to the Internet. For best results, a high-speed Internet connection is recommended (DSL/cable). We also recommend using the latest version of your favorite browser to ensure compliance with W3C standards, such as Internet Explorer, Microsoft Edge, Chrome, Firefox or Safari. Users accustomed to IE8, IE9 IE10 are advised to update their browsers for the best experience.

  • Publication Dates

    Release Date:

    Expiration Date:

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