CSL Behring Dialogue Series
CSL Behring is a biotherapy company committed to saving lives and improving the lives of people with rare and serious diseases worldwide. At CSL Behring, we occasionally invite thought leaders to participate in discussions or dialogues about important and emerging issues affecting people with the rare and serious conditions treated with CSL Behring biotherapies. These dialogues offer an exchange of information about the medical, social and political facets of biotherapies.
At CSL Behring, we are asking many of the same questions you are asking -- questions such as: Why does it often take several years or more to obtain an accurate diagnosis of a rare disease? At what point should an individual’s symptoms automatically prompt a physician to order diagnostic tests? Discussions about these questions and other pertinent concerns are featured throughout these dialogues. We thank you for your interest and look forward to receiving your feedback about our series.
Quality & Safety |
Download:
Quality & Safety Dialogue (PDF, 1.8MB) |
This dialogue explains the many quality and safety processes and procedures employed by CSL Behring to ensure the production of safe and effective biotherapies. We take the health of the people who use our lifesaving biotherapies very seriously. We meet or exceed the most stringent international standards for plasma product safety in accordance with regulatory agencies worldwide. Our dedication to collecting safe plasma and producing the highest quality products is well known in the plasma-protein therapies industry and throughout the patient communities we serve.
We believe our products have never been safer than they are today due to substantial investments in product safety, manufacturing facility enhancements, and research and development activities. In fact, during the past 25 years, the risk of virus transmission through plasma-derived products has been nearly eliminated.
To demonstrate all the measures we employ to ensure safety, we invited members of the bleeding disorders community to tour one of our three manufacturing facilities and one of our 73 plasma collection centers. After the tours, CSL Behring virologists, hematologists and plasma collection and manufacturing experts were on site to explain the company’s quality and safety paradigm and answer questions from patient representatives.
Participants representing the bleeding disorders community include:
- Mark Brooker, Senior Policy Officer, World Federation of Hemophilia
- Lew Collins, Member, Board of Directors, Hemophilia Federation of America
- Raymond C. Dattoli, Board Member, Committee of Ten Thousand
- Kimberly Haugstad, Executive Director, Hemophilia Federation of America
- David Page, Executive Director of the Canadian Hemophilia Society
- Michelle Rice, Regional Director for Chapter Services, National Hemophilia Foundation
- Bob Robinson, Executive Director, Hemophilia Foundation of Illinois
- Raymond Stanhope, Chair, Board of Directors, National Hemophilia Foundation
Participants representing CSL Behring include:
- Dr. Garrett E. Bergman, Senior Medical Director, U.S. Commercial Operations
- Wally Casey, Senior Vice President and General Manager, Kankakee Plant
- Patrick Collins, Director, Public Affairs
- Dan Ferris, Director of Manufacturing, Kankakee, IL
- Dr. Albrecht Gröner, Head of Pathogen Safety
- Dennis Jackman, Senior Vice President, Public Affairs
- Gordon Naylor, Executive Vice President, Plasma, Supply Chain and Information Systems
VWD
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Download:
VWD Dialogue (PDF, 1.1MB) |
This dialogue is about
von Willebrand Disease
(VWD), the most common bleeding disorder. People with VWD take longer to stop bleeding than is normal. VWD affects both men and women, although women are at risk for bleeding specifically due to menstrual periods and childbirth. Topics in this dialogue include the patient care guidelines established by the
National Heart, Lung, and Blood Institute
(NHLBI) and the impact on physicians making diagnoses of VWD. Access to care, reimbursement, and treatment centers are also discussed. The participants talk about how best to share information about VWD with the public and healthcare providers.
Broad topics about VWD include the difficulty in making a diagnosis, the need to accumulate clinical data to track trends and the role of advocacy organizations in public and community education. Participants also discussed the
National Hemophilia Foundation's (NHF) support of people with VWD in addition to their primary focus on hemophilia. The progress made in NHF’s public awareness campaign, "
Project Red Flag," is also discussed.
Participants include:
Garrett E. Bergman, M.D., is the Medical Director for CSL Behring. A pediatric hematologist, Dr. Bergman provides scientific and medical support to the commercial operations of the company.
Craig M. Kessler, M.D., MACP, is Professor of Medicine and Pathology and Chief of the Division of Coagulation at the Georgetown University School of Medicine. Dr. Kessler has been active in hemophilia care and research throughout his career and is currently the Chair of the Medical and Scientific Advisory Council of the National Hemophilia Foundation.
Robert R. Montgomery, M.D., is Professor of Pediatric Hematology at the Medical College of Wisconsin and the Senior Investigator at the Blood Research Institute of the Blood Center of Wisconsin. Dr. Montgomery served on the NHBLI’s expert panel that developed the guidelines for VWD.
Ann-Marie Nazzaro, Ph.D., is Vice President for Education at the National Hemophilia Foundation of the U.S. She is responsible for consumer education and training, and is a key member of the medical education team.
Sally Owens, R.N., BSN, joined the Centers for Disease Control in June 1996 to coordinate the newly formed national Hemophilia Treatment Center program and now serves as director. She received a "Project Red Flag Visionary Award" in 2008 to celebrate 10 years of service on behalf of women with bleeding disorders.
Paul R. Perreault is the Executive Vice President of Worldwide Commercial Operations at CSL Behring. He is responsible for all sales, marketing and commercial development activities.
HAE in Europe
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HAE in Europe Dialogue (PDF, 1.3MB) |
This European-based dialogue about
Hereditary Angioedema
(HAE) discusses the challenges and advances in diagnosis and treatment. HAE is caused by a protein deficiency (C1-esterase inhibitor) and often involves painful and life-threatening symptoms. Topics include lack of awareness and education, which causes frequent misinterpretation of HAE symptoms.
Among the worldwide HAE topics discussed are: early diagnosis, reimbursement issues, the possibility of an EU-wide patient registry, centers of expertise and referral networks, and treatment guidelines.
Participants include:
Ursula Huffer is an executive committee member of the International HAE Patient Organization and board member of the German HAE Patient Association. She was born with HAE and suffered for many years before adequate treatments became available.
Lucia Schauf is president of the German HAE Patient Association and is the third generation in her family to be diagnosed with HAE. She is a staff nurse but is no longer able to work because of HAE.
Ingolf Sieper, M.D., J.D., is vice president and general manager for commercial operations in Central Europe for CSL Behring. Dr. Sieper has nearly 20 years' experience in the marketing and management of plasma-derived biotherapies.
Marco Cicardi, M.D., is a professor of internal medicine at Milan’s Luigi Sacco Hospital. He has cared for people with HAE for more than 35 years and is widely considered to be a leading HAE expert.
Rüdiger Gatermann is director, public affairs for CSL Behring in Europe, where he is responsible for the development and execution of policy strategies.
Standards of Care Legislation
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Standards of Care Dialogue (PDF, 1.76MB)
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This dialogue offers insight into the legislative process necessary to move Standard of Care bills through to becoming laws. The legislation relates to bleeding disorders and immune deficiencies. It includes standards for home care pharmacies and health plan requirements related to coverage of home health care, access to FDA-approved plasma-derived therapies and to treatment centers and laboratory services. Also included is a discussion about mandatory screening for von Willebrand disease for people with symptoms such as excessive menstrual or other bleeding, prior to certain surgical procedures. The issue of access to all brands of immunoglobulin at all care sites is also discussed.
Participants include:
Katherine Antilla is director of education and volunteer programs at the
Immune Deficiency Foundation. She became a tireless advocate for persons with primary immunodeficiency disease after her son was diagnosed with common variable immunodeficiency disease.
Val D. Bias is executive director of the Hemophilia Council of California, a non-profit dedicated to improving the quality of life of persons with coagulation disorders. He is a past chairman and legislative coordinator of the National Hemophilia Foundation. Mr. Bias also has a severe factor IX deficiency.
Jerry S. Powell, M.D., is director of the Division of Hematology and Oncology and of the Hemophilia Treatment Center at the University of California Davis Medical Center. Dr. Powell is board certified in internal medicine, oncology and hematology.
Ann E. Rogers is executive director of the Delaware Valley Chapter of the National Hemophilia Foundation, representing patients affected by bleeding disorders. She is the mother of three sons, two with hemophilia.
Patrick Collins is Senior Manager for Public Affairs at CSL Behring. He is the past Director of Government Affairs at the National Hemophilia Foundation.
Kim Isenberg is Manager for State Government Affairs at CLS Behring. She is the past regional director for government affairs at PhRMA.
ITP
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ITP Dialogue (PDF, 1.33MB)
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This dialogue is about Idiopathic Thrombocytopenic Purpura (ITP), a common autoimmune bleeding disorder caused by a reduction in platelets. Platelets are the circulating blood cells that prevent bleeding. ITP is manifested by a low platelet count and red or purple skin discolorations. ITP is also used to abbreviate Immune Thrombocytopenic Purpura since most cases of ITP result from an antibody response against platelets.
Among the topics discussed are: when is a platelet count considered normal; the need to exclude other diagnoses, including leukemia, during medical evaluation for ITP; the possibility of an environmental trigger for ITP; treatment options and quality of life expectations for people with ITP. General topics include: the difficulty of developing an accurate count of people with ITP; private and government insurance reimbursement; public awareness and education and the overall need for better understanding of autoimmune disorders.
Participants include:
Douglas B. Cines, M.D., is a board-certified hematologist, professor of pathology and a vice-chair in the Department of Pathology and Laboratory Medicine at the Hospital of the University of Pennsylvania.
Joan Young is president and founder of the Platelet Disorder Support Association, an organization started in 1998 after she began a Web site for people with ITP.
Garrett E. Bergman, M.D., is senior director of U.S. Medical Affairs at CSL Behring. Dr. Bergman joined CSL Behring following a distinguished career in academic medicine.
Dennis Jackman is senior vice president of Public Affairs at CSL Behring where he is responsible for optimizing stakeholder impact on CSL Behring’s ability to provide lifesaving therapies worldwide.
HAE and PID
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HAE and PID Dialogue (PDF, 1.3M)
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This dialogue among three members of the primary immunodeficiency disorders (PID) community in the United Kingdom is intended to bring attention to these rare conditions. Topics include the need to flag recurrent infections as possible indicators of one of 80 PID conditions, the economic value of diagnosis and treatment, and how to get an accurate count of persons with PID.
Global PID issues discussed include patient referrals to specialists, reimbursement of healthcare costs, the shift toward subcutaneous treatment options, safety concerns about plasma-derived therapies, and helping individuals take better control of their quality of life.
Participants include:
Dr. Hilary Longhurst is an immunologist at Barts and the London NHS Trust, where she is an enthusiastic supporter of patient empowerment and helps enable people with PID to lead independent, productive lives.
Dr. Richard Herriot is an immunologist who provides specialty care for people with PID. He is chairman of the U.K. Primary Immunodeficiency Network.
Chris Hughan is the chief executive of the Primary Immunodeficiency Association, London, England.
Eddie Owens is general manager, CSL Behring, U.K. and Ireland.
Alpha-1
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Alpha-1 Dialogue (PDF, 1MB)
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This dialogue is about medical conditions related to Alpha1-antitrypsin (Alpha-1), a protein that protects the lungs. Normally, this protein prevents overactivity by an enzyme called neutrophil elastase which, if left unchecked, can attack healthy lung tissue. People who do not produce enough Alpha1-antitrypsin are often diagnosed with emphysema, chronic obstructive pulmonary disease (COPD), asthma and bronchitis. Some people with Alpha-1 antitrypsin develop cirrhosis of the liver or a skin condition called panniculitis.
Topics in this dialogue include: educating people diagnosed with COPD to seek further information about Alpha-1 antitrypsin and assess possible genetic risk factors; the importance of early detection to avoid lung transplantation if possible in severe cases; the identification of a flag to automatically prompt diagnostic testing and the benefits of subcutaneous treatment. In addition, the panel discusses the impediments to developing aerosol therapies and quality of life issues for people with Alpha-1 antitrypsin.
Broad topics about Alpha-1 antitrypsin in this dialogue include: the role of government in physician and public awareness; the safety and availability of blood products and research to further understand the role of Alpha-1 antitrypsin and to develop new treatments.
Participants include:
John W. Walsh is president and CEO of the Alpha-1 Foundation, where he leads an organizational investment in research on Alpha-1 antitrypsin. Mr. Walsh was diagnosed with Alpha-1 antitrypsin in 1989.
Steven D. Nathan, M.D., is director of the Advanced Lung Disease Program and Medical Director of the Lung Transplant Program at Inova Fairfax Hospital.
Robert D. Lefebvre is vice president and general manager of CSL Behring’s U.S. Commercial Operations.
Dennis Jackman is senior vice president of Public Affairs at CSL Behring where he is responsible for optimizing stakeholder impact on CSL Behring’s ability to provide lifesaving therapies worldwide.