About This CME/CNE Activity

About This CME/CNE Activity

RATIONALE AND PURPOSE
Hemophilia, an X-linked recessive bleeding disorder, affects more than 400,000 people worldwide. Internal bleeding related to the disorder spans the gamut from spontaneous hemarthroses resulting in chronic, disabling joint pain and swelling to deep-muscle, central nervous system, and gastrointestinal bleeding. This inaugural issue of The Hemophilia Report explores the genetic foundation of hemophilia, differentiates between its two major types (A and B), and reviews the current management of this hematologic disease, as well as recent advances in preventing bleeding and reducing the development of autoimmune inhibitors to coagulation replacement factor therapy.

Among the many topics discussed by the authors are advances in synthetic blood-coagulation factors that promise to improve patient outcomes with more effective bleeding control and preservation of joint function; reducing the burden of prophylactic replacement therapy by extending the half-life of bioengineered coagulation factors; personalizing treatment based on the pharmacokinetics of replacement factors, bleeding phenotypes, and lifestyle; identifying, monitoring, and preventing age-related comorbidities; and potentially developing a cure for hemophilia through gene therapy. The articles in this issue are based upon presentations delivered during the 65th Annual Meeting of the National Hemophilia Foundation, held in Anaheim, California, October 3–5, 2013, and the 55th Annual Meeting of the American Society of Hematology, convened in New Orleans, Louisiana, December 7–10, 2013.

The articles in this issue, written from the academic perspective of physicians-in-training at leading medical institutions, summarize the import of these new findings and place them into clinical context. This activity has been developed and approved by a planning committee of nationally recognized thought leaders to meet a perceived educational need to provide hematologists, other physicians, and nurses with diagnostic and therapeutic strategies to help them perform their clinical roles.

LEARNING OBJECTIVES
After studying this issue of The Hemophilia Report, participants in this educational activity should be able to:

  • Outline the genetic basis of hemophilia A and B and differentiate between the two types.
  • Review the history of hemophilia management, discuss current best practices in children and adults, and explain the goals of ongoing research to better understand the disease.
  • Summarize the developments being made in the laboratory and currently being tested in clinical trials to produce synthetic coagulation factors with longer half-lives than those of present blood products for treating hemophilia or that are less prone to stimulate the production of neutralizing antibodies (inhibitors).
  • Discuss the advantages and drawbacks of prophylactic versus on-demand therapy, the controversies over therapeutic timing and individualizing therapy for different patients, the factors affecting patient compliance, and the promise of bioengineering and pharmacokinetic strategies to individualize patient management.

TARGET AUDIENCE
Hematologists, other physicians, and nurses significantly involved in the management of hemophilia should find participating in this educational activity valuable.

ACCREDITATION AND CREDIT DESIGNATION
Physicians: This activity has been planned and implemented in accordance with the accreditation requirements and policies of the Accreditation Council for Continuing Medical Education (ACCME) through the joint providership of the University of Cincinnati and Direct One Communications, Inc. The University of Cincinnati is accredited by the ACCME to provide continuing medical education for physicians.

The University of Cincinnati designates this Enduring Material Activity for a maximum of 3.5 AMA PRA Category 1 Credits™. Physicians should only claim credit commensurate with the extent of their participation in the activity.

Nurses: A total of 3.5 continuing education contact hours for nurses are approved by the Ohio Board of Nursing through the OBN Approver Unit at the University of Cincinnati College of Nursing, Continuing Education Program (OBN-011-93). Contact hours are valid in most states. Program #140505-1.

CREDIT AVAILABILITY
Activity release date: April 30, 2014
Expiration date: May 1, 2015 (for CME credit); May 1, 2016 (for CNE credit)

METHOD OF PARTICIPATION
This Enduring Material Activity is available in print and online at www.HemophiliaReport.com and consists of an introduction, seven articles, a postactivity assessment, and an evaluation. Estimated time to complete the activity is 3.5 hours.

To receive credit, participants must read the CME information on these two pages, including the learning objectives and disclosure statements, as well as the full content of this monograph, and then complete the post test and evaluation form online at www.HemophiliaReport.com. Upon successful completion of the post test (80% correct) and evaluation form, a CME certificate of participation will be awarded automatically. The certificate may be printed directly from the Web site or e-mailed and printed later.

There are no fees for participating in or receiving credit for this activity.

CME REVIEWER
Rick Ricer, MD
Adjunct Professor of Family Medicine
University of Cincinnati
Cincinnati, Ohio

CME ACCREDITATION
Susan P. Tyler, MEd, CMP, CCMEP
Director, Continuing Medical Education
University of Cincinnati
Cincinnati, Ohio

FACULTY DISCLOSURES
All faculty members (or anyone else in a position to control content, such as activity planners) are required to complete a Disclosure of Commercial Interest and Resolution form and to cooperate with identified methods for resolving conflict of interest prior to participating in the activity. The University of Cincinnati requires disclosure to the learners of all relevant financial relationships and adheres strictly to the ACCME Standards for Commercial Support.

Steven W. Pipe, MD, is Professor of Pediatrics and Pathology, Division of Pediatric Hematology/Oncology, University of Michigan, Ann Arbor, Michigan. He is a consultant to Baxter BioScience, Biogen Idec, CSL Behring, Novo Nordisk, and Pfizer and has received research/grant support from Pfizer.

Duc Q. Tran, MD, a Fellow in Hematology at Winship Cancer Institute, Emory University, Atlanta, Georgia, has nothing to disclose.

Anthony Sung, MD, a Fellow in Hematology/Oncology at Duke University Medical Center, Durham, North Carolina, has nothing to disclose.

Anna Chalmers, MD, a Fellow in Hematology/Oncology at Rush University Medical Center, Chicago, Illinois, has nothing to disclose.

Holleh D. Husseinzadeh, MD, a Fellow in Hematology and Medical Oncology at the University of Pennsylvania, Philadelphia, Pennsylvania, has nothing to disclose.

Kerry Hege, MD, a Fellow in Pediatric Hematology/Oncology at Riley Hospital for Children, Indiana University Health, Indiana University School of Medicine, Indianapolis, Indiana, has nothing to disclose.

Noa Biran, MD, a Fellow in Hematology/Medical Oncology at Tisch Cancer Institute, Mount Sinai School of Medicine, New York, New York, has nothing to disclose.

Rick Ricer, MD, has nothing to disclose.

Susan P. Tyler, MEd, CMP, CCMEP, has nothing to disclose.

Jacqueline Keenan and Edwin Geffner of Direct One Communications, Inc., have nothing to disclose.

DISCLAIMER
This activity is an independent educational activity under the direction of the University of Cincinnati. The activity was planned and implemented in accordance with the accreditation requirements and policies of the ACCME, the Ethical Opinions/Guidelines of the American Medical Association, the US Food and Drug Administration (FDA), the Office of Inspector General of the US Department of Health and Human Services, and the Pharmaceutical Research and Manufacturers of America Code on Interactions With Healthcare Professionals, thus assuring the highest degree of independence, fair balance, scientific rigor, and objectivity.

However, the planning committee, faculty, University of Cincinnati, Biogen Idec, and Direct One Communications, Inc. shall in no way be liable for the currency of information or for any errors, omissions, or inaccuracies in this activity. The opinions and recommendations presented herein are those of the faculty and do not necessarily reflect the views of the provider, producer, or grantor. Participants in this activity are encouraged to refer to primary references or full prescribing information resources.

DISCLOSURE OF UNAPPROVED/OFF-LABEL USE
Discussions concerning drugs, dosages, devices, and procedures may reflect the clinical experience of the planning committee or faculty, may be derived from the professional literature or other sources, or may suggest uses that are investigational and not approved labeling or indications.

In this issue of The Hemophilia Report, Dr. Hege discusses the rationale for development of new, longer-acting coagulation replacement factors and what's in the pipeline. Dr. Biran describes a recombinant factor VIII crystallizable fragment (Fc) fusion protein currently under FDA review and the off-label use of a four-factor prothrombin complex concentrate (PCC) in patients requiring anticoagulant reversal before undergoing urgent surgical procedures. Dr. Chalmers refers to the potential of PEGylated and fusion protein replacement factors and gene therapy. Drs. Husseinzadeh and Sung discuss recent clinical trials of these and other investigational replacement factors, as well as novel bypassing agents, PCCs, and gene-transfer therapy. Dr. Tran also touches on the potential of gene therapy.

CONTACT INFORMATION
We would like to hear your comments regarding this or other educational activities produced by Direct One Communications, Inc. In addition, suggestions for future activities are welcome. Contact us at:

Direct One Communications, Inc.
1424 Ridge Road
Syosset, NY 11791
Phone: 516-364-1020
Fax: 516-364-4217
Website: www.CMEdirect.net

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