Midyear Symposium & Live Webcast

Activity Overview

This educational activity will cover in depth the scientific and legislative issues associated with biosimilars, including patient safety concerns, such as immunogenicity, pharmacovigilance programs, substitution rules, and interchangeability.  Expert faculty will discuss pertinent issues for pharmacists such as the manufacturing and production process of biopharmaceuticals compared with traditional chemical drugs; EMEA’s 2003 guidelines and lessons learned from biosimilar approvals in Europe; current U.S. legislation and updates on FDA regulations regarding biosimilars.

The activity will discuss the importance of pharmacovigilance programs and the role of providers in that process. The activity will conclude with a review of risks and benefits as they relate to patients and providers and important clinical information that will be required when presenting biopharmaceuticals and biosimilars to decision-making groups, such as the pharmacy & therapeutics committee.

Learning Objectives

After attending this application-based educational activity, participants should be able to

  • Review the intricate scientific process used to produce biopharmaceutical agents and compare it with the process used to create traditional chemical drug products.
  • Discuss the development of the European Union and the U.S. biosimilar regulatory pathway and the impact of emerging FDA guidance on the evaluation and approval of biosimilars in the U.S.
  • Examine potential approaches to monitoring and identifying unique adverse events that could emerge with biosimilars.
  • Review key information that will be needed to evaluate biosimilars for formulary consideration.
  • Develop a plan for the introduction of biosimilars into routine health system practice, including an approach to transitions of care.

Activity Agenda

11:30 am – 11:40 am Welcome and Introductions
James M. Hoffman, Pharm.D., M.S., BCPS,  Program Chair
11:40 am – 12:15 pm The Role of Biologics in Patient Care and an Overview of Biosimilar Science
Edward Li, Pharm.D., BCOP
12:15 pm – 12:45 pm Developing the Biosimilar Pathway in the United States
James M. Hoffman , Pharm.D., M.S., BCPS
12:45 pm – 1:15 pm Introducing Biosimilars to the Health System:  The Pharmacist's and P&T Committee's Leadership Roles
James G. Stevenson, Pharm.D., FASHP
1:15 pm – 1:30 pm Discussion/Questions and Answers

A box lunch will be provided.

Continuing Education Information

ACPE

The American Society of Health-System Pharmacists is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. This activity provides 2 hours (0.2 CEUs) of continuing pharmacy education credit (ACPE activity# 0204-0000-12-437-L01-P).

Attendees must complete a Continuing Pharmacy Education Request online and may immediately print their official statements of continuing pharmacy education credit at the ASHP CE Center at http://ce.ashp.org following the activity.

Target Audience

This continuing pharmacy education activity was planned to meet the needs of pharmacists in a variety of practice settings, and it would be particularly beneficial for pharmacists, clinical specialists, pharmacy managers, leaders, and educators who are interested about the science, legislative status, and patient safety concerns of biosimilars.

Onsite Information

Monday, December 3, 2012   •   11:30 a.m. – 1:30 p.m. PST
Mandalay Bay Hotel   •   Islander Ballroom H, Lower Level, North Convention Center   •   Las Vegas, Nevada

There is no registration for this Midday Symposia. Seating at this activity is on a first-come, first-served basis. Please plan to arrive early. There is no fee to attend this continuing education activity.

Arrangements for Special Assistance

If you have any disability for which you may require an auxiliary aid or special service while participating in this activity, please contact support@ashpadvantage.com.

Faculty

James M. HoffmanJames M. Hoffman, Pharm.D., M.S., BCPS, Program Chair
Medication Outcomes and Safety Officer
St. Jude Children’s Research Hospital
Associate Professor of Clinical Pharmacy
College of Pharmacy
University of Tennessee Health Science Center
Memphis, Tennessee

Dr. James M. Hoffman, Pharm.D., M.S., BCPS,  is Medication Outcomes and Safety Officer and Associate Member in Pharmaceutical Sciences at St. Jude Children’s Research Hospital in Memphis, Tennessee. Dr. Hoffman is also an associate professor of clinical pharmacy at the University of Tennessee Health Science Center. In his position at St. Jude, Dr. Hoffman leads medication use policy, medication safety, and research pharmacy services.

Dr. Hoffman received both his Bachelor of Science in Pharmacy and Doctor of Pharmacy degrees from the Philadelphia College of Pharmacy. In addition, he received a Master of Science degree in pharmacy administration from the University of Wisconsin-Madison. He also completed a residency in pharmacy administration and a fellowship in outcomes research at the University of Wisconsin Hospital and Clinics.

Dr. Hoffman is a Board Certified Pharmacotherapy Specialist (BCPS). He is an active member of the American Society of Health-System Pharmacists (ASHP), including serving on the Council on Pharmacy Practice, in the ASHP House of Delegates, and on the editorial board of the American Journal of Health-System Pharmacy (AJHP).  He is currently a Director-at-Large for the Section of Pharmacy Practice Managers Executive Committee. Additionally, he has served on committees for other national organizations, including the National Quality Forum and the National Comprehensive Cancer Network (NCCN).  In 2011, he served on the NCCN biosimilars work group, and he was the senior author of the group’s white paper on biosimilars published in the Journal of the National Comprehensive Cancer Network. Dr. Hoffman also has extensive experience analyzing various aspects of medication use and policy.  Since 2004, he has been a lead author of the annual special feature in AJHP  that projects medication expenditures.

Edward LiEdward Li, Pharm.D., BCOP
Associate Professor
Department of Pharmacy Practice
University of New England College of Pharmacy
Portland, Maine

Edward Li, Pharm.D., BCOP,  is Associate Professor in the Department of Pharmacy Practice at the University of New England (UNE) College of Pharmacy in Portland, Maine.  Dr. Li earned his Doctor of Pharmacy degree from the Philadelphia College of Pharmacy.  He also completed a pharmacy practice residency at the University of Wisconsin Hospital and Clinics in Madison, and an oncology pharmacy practice residency at the University of Maryland School of Pharmacy in Baltimore.  He is also a board-certified oncology pharmacist.

Before joining UNE, Dr. Li was a member of the faculty at Wilkes University, Nesbitt College of Pharmacy and Nursing in Wilkes-Barre, Pennsylvania, and most recently was Oncology Pharmacy Manager at The National Comprehensive Cancer Network, a not-for-profit alliance of 21 of the world's leading cancer centers, that is dedicated to improving the quality and effectiveness of care provided to patients with cancer.

Dr. Li’s research interests include public health policy issues relating to oncology practice, such as comparative effectiveness and Risk Evaluation and Mitigation Strategies (REMS), as well as utilization of secondary data sources to analyze practice trends and outcomes. 

James StevensonJames G. Stevenson, Pharm.D., FASHP
Chief Pharmacy Officer
University of Michigan Health System
Professor and Associate Dean for Clinical Sciences
University of Michigan College of Pharmacy
Ann Arbor, Michigan

James G. Stevenson, Pharm.D., FASHP, is Chief Pharmacy Officer at the University of Michigan Health System, as well as Professor and Associate Dean for the Department of Clinical Sciences at the University of Michigan College of Pharmacy.

Dr. Stevenson received his Bachelor of Science and Doctor of Pharmacy degrees from Wayne State University in Detroit, Michigan.  He then joined the faculty at the West Virginia University School of Pharmacy in Morgantown.

Dr. Stevenson’s previous appointments include  Assistant Director for Clinical Services, and subsequently Associate Director for Patient Care, Education and Research Services in the Department of Pharmaceutical Services at West Virginia University Hospitals, before being appointed Director of Pharmaceutical Services.   He has also served as Director of Pharmacy Services at Detroit Receiving Hospital and University Health Center, Director of the Graduate Program in Health Systems Pharmacy Management in the Wayne State University College of Pharmacy, and Executive Director of Pharmacy Services for the Detroit Medical Center.

He is a Fellow of the American Society of Health-System Pharmacists (ASHP) and has been recognized as Pharmacist of the Year by both the Michigan Society of Health-System Pharmacists and the Michigan Pharmacists Association.   He has also been honored with the Distinguished Alumnus Award by the Wayne State University College of Pharmacy and the Joseph Oddis Leadership Award by the Michigan Society of Health-System Pharmacists.   He recently completed a term of service on the ASHP Board of Directors and received the John W. Webb Lecture Award in 2010. In 2012, Dr. Stevenson was appointed to the Michigan Board of Pharmacy.

Dr. Stevenson's major research interests include pharmacy practice management, pharmacoeconomics, pharmacy informatics, and medication safety.

Live Webcast

This symposium will be broadcast live from Las Vegas, Nevada, as a webcast so that pharmacists unable to attend this year’s ASHP Midyear Clinical Meeting can participate.

Register for Webcast

After registration, you will receive an e-mail confirmation with instructions for joining the webcast.

Download Handout

Frequently Asked Questions for Webcasts

What is a live webcast? A live webcast brings the presentation to you – at your work place or in your home. You view and hear the presentations in “real time” complete with slides and video of the speakers and have the opportunity to ask questions at the end of the activity. Continuing pharmacy education (CPE) credits earned through participation in webcasts qualify as live CPE credit.  Please join the webcast at least 5 minutes before the scheduled start time for important activity announcements.

How do I register? Click the Register for Webcast button. You will be emailed a confirmation with webcast connection information.

How do I process my CPE? After completion of this webcast, you will process your CPE online and print your statement of credit at http://ce.ashp.org. You will need the Activity and Session Codes that will be announced at the end of the webcast. Complete CPE processing instructions will be included in your handout. If you have questions about processing CPE online, contact support@ashpadvantage.com.

What if I would like to arrange for my colleagues to participate in this webcast as a group? One person should register for the webcast and will receive the webcast linking instructions via email. Each participant processes his or her CPE statement online at the conclusion of the activity.

How do I ask a question of the presenters during the webcast?
Click the “Ask a Question” bubble iconChat Icon to type a question and your email. The speakers will answer as many questions as possible at the conclusion of the activity. Responses to technical questions will be sent to the email address you provided.

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  • Player volume: look for volume icon inside the player.
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What do I need to participate in the webcast?
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Microsoft® Windows®

Mac®

Linux

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  • Internet Explorer® 7.0 or later, Firefox® 3.6 or later or Google Chrome™
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  • Broadband Internet connection
  • Mac OS® X 10.4.8 or later
  • Safari® 2.0.4 or later or Firefox 3.6 or later
  • Microsoft Silverlight 5*
  • Broadband Internet connection
  • SUSE Linux Enterprise Desktop 10, openS USE 11.0 or later, Ubuntu 8.04 or Fedora Core 9
  • Firefox 2.0 or 3.0 depending on Linux operating system
  • Moonlight™ 1.0
  • Microsoft Media Pack for Moonlight
  • Broadband Internet connection (256Kbps or more)
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* If Silverlight is not detected on your computer when viewing a presentation, you will be automatically prompted to install the plug-in. Silverlight only needs to be installed once and will then be available for watching any other presentations.

Classic Player Option
If you are unable to install Silverlight or your bandwidth speed is slower than required, another version of the webcast is available.  The requirements are as follows:

Microsoft® Windows®

Mac®

Linux

  • Microsoft® Windows 7, Windows Vista, Windows XP, Windows Server 2008
  • Windows Server 2003
  • Internet Explorer 6.0 SP1 or later, Firefox® 2.0 or later, or Google™ Chrome 1.0
  • Windows Media® Player 9.0 or later
  • Broadband Internet connection (256Kbps or more)
  • Mac OS X 10.4.8 or later
  • Safari™ 2.0.4 or later or Firefox 2.0 or later
  • Microsoft Silverlight 1.0 or later*
  • Broadband Internet connection (256Kbps or more)
  • SUSE Linux Enterprise Desktop 10, openSUSE 11.0 or later, Ubuntu 8.04, or Fedora Core 9
  • Firefox 2.0 or 3.0 depending on Linux operating system
  • Moonlight™ 1.0
  • Microsoft Media Pack for Moonlight
  • Broadband Internet connection (256Kbps or more)

* If Silverlight is not detected on your computer when viewing a presentation, you will be automatically prompted to install the plug-in. Silverlight only needs to be installed once and will then be available for watching any other presentations.

iPad

iPhone and iPod

Android

BlackBerry

  • iOS 4.3 or later
  • Mobile Safari™
  • Wi-Fi or cellular data connection (3G or higher)
  • iPhone 4 or later
  • iPod 4th generation or later
  • iOS 4.3 or later
  • Mobile Safari
  • Mediasite Mobile app (free download available from the Apple® App Store)
  • Wi-Fi connection
  • Android 4.0 or later
  • On-demand playback only
  • Wi-Fi or cellular data connection (3G or higher)
  • BlackBerry OS 7.0 or later
  • On-demand playback only
  • Wi-Fi or cellular data connection (3G or higher)
Symposium Handout
CE Processing
Instructions

Las Vegas Participants
Webcast Participants