Key Insights: Biosimilars and Novel Targets in Inflammatory Bowel Disease

Key Insights: Biosimilars and Novel Targets in Inflammatory Bowel Disease

On-Demand Webcast
Chair

Marla Dubinsky, MD
Icahn School of Medicine at Mount Sinai
New York, New York

Faculty

David G. Binion, MD, FACG
UPMC Presbyterian Hospital,
University of Pittsburgh School of Medicine
Pittsburgh, Pennsylvania

Target Audience

This educational activity is designed for IBD specialists, gastroenterologists and other healthcare professionals (internists, primary care physicians, nurse practitioners, physician assistants, nurses, pharmacists, etc.) involved and/or interested in the therapeutic management of patients with IBD.

Overview

A wealth of new medications is available for the treatment of IBD, and these medications have greatly improved patient outcomes. However, clinicians are not always apprised of emerging data on late-phase clinical trials for potential new IBD medications and their possible role in the treat-to-target paradigm, nor do they always consider mechanisms of action of these newer medications. Further, with several biosimilar versions of existing biologics available for the management of IBD, clinicians are challenged to evaluate the rationale for biosimilar use and the potential safety and efficacy considerations related to their use in clinical practice. This Key Insights™ activity featuring Drs. Marla Dubinsky and David G. Binion provides expert review and guidance on both emerging targets and biosimilars for the treatment of patients with inflammatory bowel disease.

Objectives

Upon successful completion of this educational activity, participants should be better able to:

  1. Define “totality of evidence” as applied to the FDA evaluation and approval of biosimilars
  2. Discuss how biosimilars are evaluated and approved by the FDA based on extrapolation of indications
  3. Outline available data on the safety and efficacy of biosimilars approved for the treatment of IBD
  4. Assess the mechanisms of action and therapeutic potentials of evolving treatments in IBD
  5. Incorporate current knowledge on optimal treatment approaches and emerging therapies for patients with IBD into clinical practice
Provider

This activity is provided by Imedex®, LLC.
Imedex

Continuing Education

To be eligible for documentation of credit, participants must complete the educational activity, complete the 10-question post-test with a score of 70% or better, and complete the evaluation form. After successful completion of the post-test and evaluation form online at www.naccme.com, participants may immediately print their documentation of credit.

Physicians

  Imedex, LLC is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians.

Imedex, LLC designates this internet-based enduring educational activity for a maximum of 0.5 AMA PRA Category 1 Credit™. Physicians should claim only credit commensurate with the extent of their participation in the activity.

Physician Assistants

NACCME has been authorized by the American Academy of PAs (APA) to award AAPA Category 1 CME credit for activities planned in accordance with the AAPA CME Criteria. This activity is designated for 0.50 AAPA Category 1 credit(s). PAs should only claim credit commensurate with the extent of their participation.

Nursing

  In support of improving patient care, this activity has been planned and implemented by North American Center for Continuing Medical Education (NACCME) and the Imedex. NACCME 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.

This continuing nursing education activity awards 0.50 contact hours.

Pharmacy

  In support of improving patient care, this activity has been planned and implemented by North American Center for Continuing Medical Education (NACCME) and Imedex. NACCME 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.

This knowledge-based activity (JA0006201-9999-18-175-H01-P) is approved for 0.50 contact hours (0.005 CEUs) of continuing pharmacy education. Participants must attend sessions and complete an evaluation in order to claim credit. Participants will have only 60 days following the activity to claim credit (Deadline: October 31, 2019.)

Release Date: August 31, 2018

Expiration Date: August 31, 2019

Faculty Disclosure

As a provider accredited by the Accreditation Council for Continuing Medical Education (ACCME), Imedex, LLC must ensure balance, objectivity, independence, and scientific rigor in its educational activities. Faculty are instructed to provide a balanced view of therapeutic options by utilizing generic names to ensure impartiality.

All faculty participating in an Imedex activity are required to disclose relevant financial relationships that may be considered to be related to the subject matter of the educational activity. Disclosure of these commitments and/or relationships is included in these course materials so that participants in the activity may formulate their own judgments in interpreting its content and evaluating its recommendations.

The following indicates the faculty disclosure declaration information and the nature of those commercial relationships.

1=grant/research support 2=consultant 3=speaker’s bureau 4=stock shareholder 5=other support

David G. Binion, MD, FACG AbbVie1,2; Janssen Biotech2; Merck2; Shire1; Takeda1
Marla Dubinsky, MD AbbVie2; Boehringer Ingelheim2; Celgene2; Eli Lilly2; Genentech2; Janssen2; Prometheus2

All materials are included with the permission of the authors

Planning Staff Disclosure

The planning staff comprises Chris Bolwell, Donna Brophy, Kristin Ciszeski, Amy Ghiretti, Mary Johnson, Randy Robbin, and Susan Yarbrough.

All Imedex and NACCME staff members who are in a position to control content of this activity have no financial relationships with any commercial interests, except for the following individuals:

   Chris Bolwell owns shares of stock of GlaxoSmithKline.

Unapproved Uses

This activity may contain information about experimental and other uses of drugs or devices that are not currently approved by the US Food and Drug Administration (FDA) and/or other national regulatory agencies in the United States and other countries. Participants in the United States are encouraged to consult the FDA-approved product labeling for any drug or device mentioned in this program before use. Participants from other countries should consult with their respective regulatory authorities.

The opinions expressed in this webcast are the opinions of the authors and do not necessarily reflect the opinions of Imedex.

Disclaimer

The material presented and related discussions are not intended to be medical advice, and the presentation or discussion of such material is not intended to create and does not establish a physician-patient relationship. Medical advice of any nature should be sought from an individual’s own physician.

About Imedex

Imedex is a brand and assumed name used by Imedex, LLC (hereby referred to as Imedex). Imedex is solely responsible for this agenda’s content. Although Imedex attempts to ensure that the information in our program is accurate and timely, matters and opinions discussed and/or presented with respect to clinical matters are those of the discussion participants only, and not necessarily those of Imedex. Moreover, although Imedex attempts to identify and integrate the most qualified medical professionals in our program, TO THE FULLEST EXTENT PERMITTED BY LAW, IMEDEX EXPRESSLY DISCLAIM ALL WARRANTIES, EITHER EXPRESS OR IMPLIED, STATUTORY OR OTHERWISE, INCLUDING BUT NOT LIMITED TO THE IMPLIED WARRANTIES OF MERCHANTABILITY, NON-INFRINGEMENT OF THIRD PARTIES’ RIGHTS, AND FITNESS FOR A PARTICULAR PURPOSE, WITH RESPECT TO THE CONTENT PRESENTED. IMEDEX FURTHER MAKES NO REPRESENTATIONS OR WARRANTIES ABOUT THE ACCURACY, RELIABILITY, COMPLETENESS OR TIMELINESS OF THE CONTENT OR ANY MATERIAL PRESENTED.

© 2018 Imedex, LLC. All rights reserved. Reproduction in whole or part is prohibited without prior written consent from Imedex and contributing faculty.

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Support

Supported by educational grants from: Gilead Sciences, Inc. and Merck & Co., Inc.