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Faculty

Cliff Takemoto, MD
Cliff Takemoto, MD (Activity Director)
Associate Professor
Division of Pediatric Hematology
Associate Director, Hemophilia Treatment Center
Johns Hopkins University School of Medicine
Baltimore, Maryland

Dr Takemoto reports receiving grants/research support from
Baxalta US Inc, Mast Therapeutics, and Novo Nordisk;
and receiving honorarium from the American Board
of Pediatrics and Medicusworks.


Margaret V. Ragni, MD, MPH
Margaret V. Ragni, MD, MPH
Professor of Medicine and Clinical Translational Science
Division of Hematology/Oncology
Director, Hemophilia Center of Western PA
University of Pittsburgh
Pittsburgh, Pennsylvania

Dr Ragni reports receiving grants/research support from Biogen;
and serving as a consultant for and receiving honoraria from Biogen,
Medscape, and WebMD.


Guy Young, MD
Guy Young, MD
Director, Hemostasis and Thrombosis Center
Attending Physician in Hematology and Oncology
Children’s Hospital Los Angeles
Professor of Clinical Pediatrics
University of Southern California Keck School of Medicine
Los Angeles, California

Dr Young reports serving as a consultant for and receiving honoraria
from Baxalta US Inc, Bayer, and Novo Nordisk.


Planner Disclosures

Cliff Takemoto, MD, reports serving as the Principal Investigator for and receiving grants/research support from Baxalta US Inc, Mast Therapeutics, and Novo Nordisk; and receiving honorarium from the American Board of Pediatrics and Medicusworks.

No other planners have indicated that they have any financial interests or relationships with a commercial entity.

Note: Grants to investigators at The Johns Hopkins University are negotiated and administered by the institution which receives the grants, typically through the Office of Research Administration. Individual investigators who participate in the sponsored project(s) are not directly compensated by the sponsor, but may receive salary or other support from the institution to support their effort on the project(s).

OFF-LABEL PRODUCT DISCUSSION – The following speakers have disclosed that their presentation will reference unlabeled/unapproved uses of drugs or products:

Dr Takemoto – Antihemophilic factor (recombinant) PEGylated (Adynovate; Westlake Village, CA; Baxalta Inc) and pegylated lyophilized powder for solution for intravenous injection and antihemophilic factor (recombinant) (Eloctate; Cambridge, MA; Biogen).

Dr Ragni – Pegylated lyophilized powder for solution for intravenous injection and antihemophilic factor (recombinant) (Eloctate; Cambridge, MA; Biogen).

All other speakers have indicated that they will not reference unlabeled/unapproved uses of drugs or products.


Presented by the Johns Hopkins University School of Medicine.

Activity Details

Credit Type: ACCME
Credit Amount: 1.5
Release Date: July 6, 2016
Expiration Date: July 6, 2018
Estimated Time to Complete Activity: 90 minutes
Registration Required: No
Fee for Activity: There is no fee for this educational activity.

Activity Description

A web-based archived live symposium

Statement of Educational Need

OVERVIEW
The Medical and Scientific Advisory Council (MASAC) of the National Hemophilia Foundation has recommended that prophylaxis for patients with hemophilia A be implemented early, before frequent bleeds occur. The recent introduction of new bioengineered FVIII replacement therapies with longer half-lives is expected to have profound implications on prophylaxis treatment regimens, which have been notoriously associated with poor adherence. The decreased frequency of infusions with the newer products is expected to facilitate individualized therapies that will incorporate patient-specific targeted trough levels, ultimately reducing the risk of breakthrough bleeds. Without specific guidelines on the use of these new treatments and their role relative to more established agents, treating physicians need to understand the clinical implications of joint pain/damage as well as the emerging research surrounding new regimens. This archived symposium will compare and contrast Fc fusion therapies with PEGylated therapies for prophylaxis treatment in patients with hemophilia A. For each class of products, presenters will review the technologies involved, available efficacy data, and information on toxicity and inhibitor formation. A discussion of which patients are appropriate for each type of therapy will also be included.

Agenda

Preassessment and Activity Goals
Cliff Takemoto, MD

Fc Fusion Products: Is It Right for Your Patient?
Margaret V. Ragni, MD, MPH

PEGylated Products: Is It Right for Your Patient?
Guy Young, MD

Summary and Comparison
Cliff Takemoto, MD

Question & Answer Session
Faculty Panel

Postassessment and Evaluation

Cliff Takemoto, MD

Goals (Purpose) of Program

This archived symposium will provide clinicians who treat patients with hemophilia A with current information on Fc-fusion and PEGylated Factor VIII replacement therapies as prophylaxis treatment, to help determine which patients are most appropriate for each type of therapy.

Learning Objectives

After participating in this activity, the participant will demonstrate the ability to:

  • DESCRIBE the Fc fusion and PEGylated technologies used to extend factor half-life for hemophilia treatments.
  • COMPARE the efficacy between Fc fusion and PEGylated factor products used for hemophilia treatments.
  • ANALYZE the toxicities associated with Fc fusion and PEGylated factor products for pharmacotherapies.
  • DETERMINE the appropriate patient candidates for Fc-fusion vs PEGylated hemophilia treatments.

The Johns Hopkins University School of Medicine takes responsibility for the content, quality, and scientific integrity of this CME activity. 

Target Audience

This activity has been designed to meet the needs of adult and pediatric physicians in hematology settings, as well as other appropriate healthcare providers (including orthopedists, dentists, nurse practitioners and physicians’ assistants) who care for patients with hemophilia. There are no prerequisites.

Requirements for Successful Completion

In order to receive credit, participants must complete the pre-test, review the online activity, complete the post-test and receive a score of at least 70%, and complete the evaluation. A certificate of participation will be available online immediately following successful completion of the activity.

Media

Online Activity

Conflict of Interest Policy / Disclosure Statement

Full Disclosure Policy Affecting CME Activities
As a provider approved by the Accreditation Council for Continuing Medical Education (ACCME), it is the policy of the Johns Hopkins University School of Medicine Office of Continuing Medical Education (OCME) to require signed disclosure of the existence of financial relationships with industry from any individual in a position to control the content of a CME activity sponsored by OCME. Members of the Planning Committee are required to disclose all relationships regardless of their relevance to the content of the activity. Faculty are required to disclose only those relationships that are relevant to their specific presentation. 

Accreditation Statement

The Johns Hopkins University School of Medicine is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians.

Designation of Credit

The Johns Hopkins University School of Medicine designates this enduring material for a maximum of 1.5 AMA PRA Category 1 Credit(s)™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

Statement of Commercial Support

Supported by an educational grant from Baxalta US, Inc.

Disclaimer Statement / Disclosure of Unlabeled Use

Off-Label Product Discussion
No speaker has indicated that he/she will reference unlabeled/unapproved uses of drugs or products.

DISCLAIMER
The opinions and recommendations expressed by faculty and other experts whose input is included in this program are their own. This enduring material is produced for educational purposes only. Use of Johns Hopkins University School of Medicine name implies review of educational format design and approach. Please review the complete prescribing information of specific drugs or combination of drugs, including indications, contraindications, warnings and adverse effects before administering pharmacologic therapy to patients.

CONFIDENTIALITY DISCLAIMER FOR CME ACTIVITY PARTICIPANTS
I certify that I am attending a Johns Hopkins University School of Medicine CME activity for accredited training and/or educational purposes.

I understand that while I am attending in this capacity, I may be exposed to "protected health information," as that term is defined and used in Hopkins policies and in the federal HIPAA privacy regulations (the “Privacy Regulations”). Protected health information is information about a person's health or treatment that identifies the person. 

I pledge and agree to use and disclose any of this protected health information only for the training and/or educational purposes of my visit and to keep the information confidential. I agree not to post or discuss this protected health information, including pictures and/or videos, on any social media site (eg, Facebook, Twitter, etc), in any electronic messaging program or through any portable electronic device.

I  understand that I may direct to the Johns Hopkins Privacy Officer any questions I have about my obligations under this  Confidentiality  Pledge or under any of the Hopkins policies  and procedures  and  applicable  laws  and  regulations  related  to  confidentiality. The contact information is: Johns Hopkins Privacy Officer, telephone: 410-735-6509, e-mail: HIPAA@jhmi.edu.

“The Office of Continuing Medical Education at the Johns Hopkins University School of Medicine, as provider of this activity, has relayed information with the CME attendees/participants and certifies that the visitor is attending for training, education and/or observation purposes only.”

For CME Questions, please contact the CME Office at 410-955-2959 or e-mail cmenet@jhmi.edu. For CME Certificates, please call 410-502-9634.

Johns Hopkins University School of Medicine Office of Continuing Medical Education
Turner 20/720 Rutland Avenue
Baltimore, Maryland
21205-2195

Reviewed & Approved by:
General Counsel, Johns Hopkins Medicine (4/1/03)
(Updated 4/09 and 3/14)

Contact Information for Questions about the Activity

webmaster@asimcme.com

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