Unlocking the Value of Biosimilar Therapies in IBD

Faculty

Miguel Regueiro, MD
Moderator
Chief, Digestive Disease Institute
Professor in the Department of Medicine
Cleveland Clinic Lerner College of Medicine of Case Western Reserve University
Cleveland, OH
Miguel Regueiro, MD
Moderator

Miguel Regueiro earned his bachelor’s degree at the University of Pennsylvania, his medical degree at Drexel (Hahnemann) University and completed his internal medicine internship, residency, and clinical and research fellowship training in gastroenterology at Harvard Medical School’s Beth Israel Hospital.

Dr. Regueiro was Professor of Medicine and Clinical and Translational Science at the University of Pittsburgh School of Medicine from 2000 to 2018. There he served as the IBD Clinical Medical Director, Senior Medical Lead of Specialty Medical Homes, was Professor with Tenure, and honored as the UPMC Endowed Chair for Patient Centered Care in Inflammatory Bowel Diseases.

Dr. Regueiro is currently the Chair of the Department of Gastroenterology and Hepatology and Chair of the Digestive Disease and Surgery Institute at Cleveland Clinic in Ohio. He serves as Medical Co- Chair of Digestive Disease and Surgical Institute Research Governance committee and is Professor of Medicine at the Lerner College of Medicine, Cleveland Clinic.

Dr. Regueiro’s main clinical and research interest is Inflammatory Bowel Diseases with a focus on the natural course of these diseases and postoperative prevention of Crohn’s disease. Recently, he has been involved in transformative medicine initiatives and developing new models of healthcare, including the first-of-its kind specialty medical home for IBD. Dr. Regueiro is investigating alternative models of care in population-based health that integrates patients, payers, providers, pharmaceutical industry, and other facets of healthcare delivery around these novel programs.

Christina Ha, MD, FACG, AGAF
Inflammatory Bowel Disease Center Mayo Clinic Scottsdale, AZ
Christina Ha, MD, FACG, AGAF

Christina Ha, MD, FACG, is an Associate Professor with the F. Widjaja Foundation Inflammatory Bowel Immunology Research Institute at Cedars-Sinai She received her BA from Harvard College and her MD from the Albert Einstein College of Medicine in New York. She completed an internal medicine residency and GI fellowship at the Washington University in St. Louis School of Medicine and as the Present-Levison Inflammatory Bowel Diseases Fellow at the Mount Sinai School of Medicine. After fellowship, Dr. Ha joined the faculty as Co-Associate Director of Clinical Research at the Meyerhoff Inflammatory Bowel Disease Center and Associate Fellowship Director for the Division of Gastroenterology and Hepatology at the Johns Hopkins School of Medicine. From there, she joined the Tamar and Vatche Manoukian Division of Digestive Diseases as the Associate Director of Clinical Programs for the Center for Inflammatory Bowel Diseases at the David Geffen School of Medicine prior to moving to Cedars-Sinai. Her clinical research interests focus on the impact of aging on the natural history of inflammatory bowel diseases, particularly with respect to therapeutics, morbidity, and mortality. Dr. Ha is the Director of the IBD Fellowship Program at Cedars-Sinai and has been involved in medical education initiatives locally and nationally.

Statement of Need

Over the years, biologic agents have proven their importance in the management of chronic autoimmune diseases including inflammatory bowel disease (IBD). Biosimilars are molecules highly similar to approved biologic medicines that have been developed to mitigate the high costs of biologics. Despite the fact that these therapies are tested to ensure non-inferiority to originator products, questions about appropriate use of biosiilars in IBD remain among clinicians and patients alike.

In this CME Outfitters webcast, expert faculty will focus on identifying key terminology related to biosimilar products, assessing evidence regarding the efficacy and safety of biosimilars in IBD, and improving patient-provider communication patterns on the topic of biosimilars.

Learning Objectives

At the end of this CME/CE activity, participants should be able to:

  • Identify the key terminology related to biosimilar products such as interchangeability, substitution, and switching.
  • Assess clinical trial and real-world evidence of efficacy and safety of biosimilars in IBD.
  • Improve patient-provider communication patterns regarding appropriate use of biosimilars.

The following learning objectives pertain only to those requesting CNE or CPE credit:

  • Identify the key terminology related to biosimilar products such as interchangeability, substitution, and switching.
  • Assess clinical trial and real-world evidence of efficacy and safety of biosimilars in IBD.
  • Explain how to improve patient-provider communication patterns regarding appropriate use of biosimilars.

Financial Support

This activity is supported by educational funding provided by Amgen.

Target Audience

Gastroenterologists, PAs, nurse practitioners, nurses, pharmacists.

Credit Information

Physicians (ACCME) 1.0

CME Outfitters, LLC, designates this enduring material for a maximum of 1.0 AMA PRA Category 1 Credit™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

Note to Nurse Practitioners

Nurse Practitioners can apply for AMA PRA Category 1 Credit through the American Academy of Nurse Practitioners (AANP). AANP will accept AMA PRA Category 1 Credit  from organizations accredited by the Accreditation Council for Continuing Medical Education. Nurse practitioners can also apply for credit through their state boards.

Pharmacists/Pharmacy Tech (ACPE) 1.0

This application-based activity is approved for 1.0 contact hour (0.10 CEUs) of continuing pharmacy credit.

ABIM MOC 1.0

Successful completion of this CME activity, which includes participation in the evaluation component, enables the participant to earn up to 1.0 medical knowledge MOC point in the American Board of Internal Medicine's (ABIM) Maintenance of Certification (MOC) program. Participants will earn MOC points equivalent to the amount of CME credits claimed for the activity. It is the CME activity provider's responsibility to submit participant completion information to ACCME for the purpose of granting ABIM MOC credit.

Royal College MOC

Through an agreement between the Accreditation Council for Continuing Medical Education and the Royal College of Physicians and Surgeons of Canada, medical practitioners participating in the Royal College MOC Program may record completion of accredited activities registered under the ACCME’s “CME in Support of MOC” program in Section 3 of the Royal College’s MOC Program.

MIPS Improvement Activity

Completion of this accredited CME activity meets the expectations of an Accredited Safety or Quality Improvement Program (IA_PSPA_28) for the Merit-based Incentive Payment Program (MIPS). Clinicians should submit their improvement activities by attestation via the CMS Quality Payment Program website.

Disclosure Declaration

It is the policy of AGA and 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 attempted to resolve any potential conflicts of interest through a rigorous content validation procedure, use of evidence-based data/research, and a multidisciplinary peer review process. The following information is for participant information only. It is not assumed that these relationships will have a negative impact on the presentations.


Dr. Regueiro reports that he receives research support from AbbVie Inc.; Janssen Pharmaceuticals, Inc.; and Takeda Pharmaceuticals U.S.A., Inc. He receives unrestricted educational grants from AbbVie Inc.; Janssen Pharmaceuticals, Inc.; Salix Pharmaceuticals; Shire; Takeda Pharmaceuticals U.S.A., Inc.; and UCB, Inc. He is on the advisory board or a consultant for AbbVie Inc.; Amgen Inc.; Celgene Corporation; Janssen Pharmaceuticals, Inc.; Miraca Laboratories; Pfizer Inc.; Seres Therapeutics; Takeda Pharmaceuticals U.S.A., Inc.; and UCB, Inc.


Dr. Ha reports that she receives grant support from Pfizer Inc. She receives research support from Eli Lilly and Company and Pfizer Inc. She is on the advisory board for AbbVie Inc.; Eli Lilly and Company; Ferring Pharmaceuticals; Genentech, Inc.; InDex Pharmaceuticals; Janssen Pharmaceuticals, Inc; Pfizer Inc.; Salix Pharmaceuticals; and Takeda Pharmaceuticals U.S.A., Inc.


Howard Bliwise, MD (peer reviewer) has no disclosures to report.

Mae Ochoa, RPh (peer reviewer) has no disclosures to report.

Olga Askinazi, PhD (planning committee) has no disclosures to report.

Jan Perez (planning committee) has no disclosures to report.

Susan Perry (planning committee) has no disclosures to report.

Sharon Tordoff (planning committee) has no disclosures to report.

Disclosures were obtained from the CME Outfitters, LLC staff: No disclosures to report.


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.

Additional Formats

Post-tests, credit request forms, and activity evaluations must be completed online (requires free account activation), and participants can print their certificate or statement of credit immediately (75% pass rate required). This website supports all browsers except Internet Explorer for Mac. For complete technical requirements and privacy policy, visit our Privacy & Confidentiality page.

 


NOTE: Pharmacist CE Universal Activity Number, Enduring: JA0007185-0000-21-109-H01-P.

Questions about this activity?

Call us at 877.CME.PROS (877.263.7767).

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Unlocking the Value of Biosimilar Therapies in IBD
Event Date: 02/04/2021