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Tuesday, October 15th at 7:00 PM ET

Presenters: Ali McBride, PharmD, MS, BCOP, FAzPA, FASHP,
and John Valgus, PharmD, MHA, BCOP


This webcast will provide live credit (L) for those states requiring it.

Earn 1.5 contact hours of live (L) credit!


OVERVIEW
Biosimilar drugs offer the potential to foster significant improvements in oncology patient management by reducing healthcare costs and increasing patient access to treatment and supportive care. However, their use remains clouded by considerable uncertainty regarding how they fit appropriately into oncology practice. While mimicking the concept of generic small-molecule drugs and their branded agents, the association between biosimilars and their reference biological products is more complex, requiring unique considerations for development and regulatory approval. In this activity, we will review the following: key differences between biosimilars, generics, and reference biologics; US Food and Drug Administration regulatory requirements for their approval and interchangeability; considerations and implications for cancer treatment and supportive care; and pharmacist-led strategies to overcome administrative and educational barriers to biosimilar implementation.

GOAL
The goal of this educational activity is to provide an in-depth understanding of biosimilars in cancer treatment and supportive care, including their evaluation, regulation, and real-world use, as well as to discuss pharmacist-driven strategies to facilitate and optimize the use of oncology biosimilars in clinical practice.

INTENDED AUDIENCE
This activity is primarily intended for oncology pharmacists as well as other pharmacists (eg, specialty, managed care, community/retail, health-systems pharmacists) involved in the management of oncology patients. No prerequisites required.

AGENDA
  • Activity Overview and Goals
    Ali McBride, PharmD, MS, BCOP, FAzPA, FASHP

  • The Future of Value-Based Care: An Introduction to Biosimilars
    John Valgus, PharmD, MHA, BCOP

  • FDA Guidance and Abbreviated Approval Pathway for Biosimilars
    John Valgus, PharmD, MHA, BCOP

  • Practice Implications of Biosimilars: Perspectives for Oncology Pharmacists
    Ali McBride, PharmD, MS, BCOP, FAzPA, FASHP

  • Question and Answer Session Part 1
    Faculty Panel

  • Pharmacist-Led Strategies for Optimizing Biosimilar Use in Oncology Care
    Ali McBride, PharmD, MS, BCOP, FAzPA, FASHP

  • Question and Answer Session Part 2
    Faculty Panel

  • Conclusions and Postassessment
    Ali McBride, PharmD, MS, BCOP, FAzPA, FASHP
LEARNING OBJECTIVES
The University of Tennessee College of Pharmacy takes responsibility for the content, quality, and scientific integrity of this CPE activity. Upon the conclusion of this activity, the participant should be able to:
  • SUMMARIZE how the FDA uses a “totality of evidence” strategy to evaluate biosimilar compounds.
  • REVIEW current and emerging efficacy and safety data for biosimilar agents for the treatment of cancer.
  • SUMMARIZE current safety and efficacy data with supportive care biosimilars.
  • DISCUSS key clinical considerations associated with the use of biosimilars in the treatment of cancer.
  • REVIEW biosimilar implementation pathways in clinical practice.
PARTICIPATING FACULTY
Ali McBride, PharmD, MS, BCOP, FAzPA, FASHP (Course Director)
Clinical Coordinator
Hematology/Oncology Department of Pharmacy
University of Arizona Cancer Center
Tucson, Arizona

John Valgus, PharmD, MHA, BCOP
Assistant Professor of Clinical Education
UNC Eshelman School of Pharmacy
UNC School of Medicine
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina

CONTINUING EDUCATION INFORMATION
acpe logoThe University of Tennessee College of Pharmacy is accredited by the Accreditation Council for Pharmacy Education (ACPE) as a provider of continuing pharmacy education. Successful completion of this knowledge-based activity will provide a statement for 1.5 live contact hours of credit (0.15 CEUs) and will be available at the completion of the activity. Successfully completing the activity and receiving credit includes: 1) attending the session; 2) watching, listening to, and participating in the educational activity; 3) completing the self-assessment instrument with a score of at least 70%. UAN: 0064-9999-19-202-L01-P. CE credit will be submitted to the NABP CPE Monitor within 30 days. It is recommended that you check your NABP CPE Monitor e-profile database 30 days after the completion of any CE activity to ensure that your credits are posted.

NABP e-PROFILE ID NUMBER: Pharmacists or pharmacy technicians with questions regarding their NABP e-Profile or CPE Monitor should refer to the FAQ section on the NABP website: https://nabp.pharmacy/cpe-monitor-service/cpe-monitor-faqs/.
To receive credit for your participation in this activity, all pharmacists must include their CORRECT NABP e-Profile ID number, along with their month and date of birth. If incorrect information is provided, this will result in "rejected" status from the CPE Monitor. It is the responsibility of the participant to notify The University of Tennessee (within the 60 day submission timeframe) of their corrected information. Otherwise, the completed CE will not be accepted by the CPE Monitor.

Please allow up to 30 days for your credit to appear on CPE-Monitor.

POLICY ON FACULTY AND PROVIDER DISCLOSURE
It is the policy of The University of Tennessee College of Pharmacy that the faculty and provider disclose real or apparent conflicts of interest relating to the topics of this educational activity, and also disclose discussions of unlabeled/unapproved uses of drugs or devices during the presentation(s). Detailed disclosures will be made in the presentations.

GRIEVANCE POLICY
A participant, provider, faculty member, or other individual wanting to file a grievance with respect to any aspect of an activity provided or coprovided by The University of Tennessee College of Pharmacy may contact the Director of Continuing Professional Development in writing at jwheeler@utasip.com. The grievance will be reviewed and a response will be returned within 45 days of receiving the written statement. If not satisfied, an appeal to the Dean of the College of Pharmacy can be made for a second level review.

SYSTEM REQUIREMENTS
Operating System: Windows 98 or higher & Macintosh 2.2 or higher
Internet Browser (Mac &/Windows): Internet Explorer 6.0 or higher, Google Chrome, Safari 5.0.6 or higher, Firefox 3.0.3 or higher & Opera 5 or higher
Windows Media Player 9.0 or later Flash player, 128 MB of RAM Monitor settings: High color at 800 x 600 pixels, Sound card and speakers, Adobe Acrobat Reader.
Broadband Internet connection: Cable, High-speed DSL & any other medium that is internet accessible

FEE INFORMATION
There is no fee for this educational activity.

Supported by an educational grant from Pfizer Inc.

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University of Tennessee Advanced Studies in Pharmacy (ISSN-1558-0350), is published by ASiM CE, LLC, d/b/a ASiM, PO Box 340, Somerville, NJ 08876. (908) 253-9001. Copyright ©2017 by ASiM CE, LLC. All rights reserved. No part of this publication may be reproduced or transmitted in any form or by any means, electronic or mechanical, without first obtaining permission from the publisher. ASiM is a registered trademark of ASiM CE LLC.