Reducing the Risk of Pathogens in the Blood Supply

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Reducing the Risk of Pathogens in the Blood Supply

Monday, March 4, 2013

The New York Academy of Sciences

In 2011, an Academy symposium examined the nature of pathogens in the blood supply. While the speakers agreed that in developed countries the blood supply was very safe, there was concern expressed that emerging infections and diseases entering the blood supply from developing countries posed new risks. In this symposium, we will discuss major pathogens that are now being monitored more closely, and the measures being taken to keep them out of the blood supply. We will also provide an update on progress that has been made on several fronts, including an examination of strategies for defending the blood supply against emerging pathogens. Another strategy, pathogen inactivation, will be discussed, with the presentation of new technologies and a case study.

*Reception to follow.

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The Microbiology & Infectious Diseases Discussion Group is proudly supported by




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Agenda

* Presentation times and titles are subject to change.


Monday, March 4, 2013

12:00 PM

Welcome and Introduction
Jennifer Henry, PhD, The New York Academy of Sciences
Lorrence H. Green, PhD, Westbury Diagnostics

12:10 PM

Perspectives for New Technologies in Transfusion Medicine
Christopher D. Hillyer, MD, New York Blood Center

12:50 PM

Mosquito-borne Infections: Continual Evolution of Risks
Lyle R. Petersen, MD, MPH, Centers for Disease Control and Prevention

1:30 PM

Babesia Risk and Transfusion Safety
Jeanne V. Linden, MD, MPH, New York State Department of Health

2:10 PM

Coffee Break

2:40 PM

Safety and Efficacy of Blood Pathogen Inactivation Systems: Recent Data and Clinical Developments
Jeffrey McCullough, MD, University of Minnesota Medical School

3:20 PM

Case Study: The INTERCEPT System in Routine Use — A Blood Center's Experience
Andreas S. Buser, MD, University Hospital, Basel, Switzerland

4:00 PM

Networking Reception

5:00 PM

Close

Speakers

Organizers

Lorrence H. Green, PhD

Westbury Diagnostics

Dr. Lorrence H. Green earned a PhD in Cell and Molecular Biology from Indiana University. He subsequently completed a three-year postdoctoral research fellowship at Harvard University which focused on recombinant DNA and genetics. Dr. Green joined Analytab Products, a subsidiary of Wyeth Pharmaceutical and a major manufacturer of in vitro diagnostic test kits. During the next twelve years he invented, developed and manufactured over 40 diagnostic test kits, eventually becoming the Director of New Product Development and Product Support. Dr. Green is currently the President of Westbury Diagnostics, Inc. a contract research and development company, which he founded in 1993. He has worked on projects ranging from susceptibility testing of microorganisms, to manufacturing monoclonal antibodies. Dr. Green routinely lectures at four different colleges, and in addition to published peer reviewed articles, he co-edited the 2009 CRC Practical Handbook of Microbiology, second edition. He is a Director of the Fundamentals of the Bioscience Industry Program at Stony Brook University, and is a frequent speaker on the topic of Scientist/Entrepreneurs.

George Zavoico, PhD

MLV & Co.

George B. Zavoico, PhD, is Managing Director, Research, and a Senior Equity Research Analyst at MLV, a boutique investment bank and institutional broker-dealer based in New York. He has over 6 years of experience as a life sciences analyst writing research on publicly traded equities. Prior to MLV, he was an equity analyst with Westport Capital Markets and Cantor Fitzgerald. Prior to working as an analyst, Dr Zavoico established his own consulting company serving the biotech and pharmaceutical industries by providing competitive intelligence and marketing research, due diligence services, and guidance in regulatory affairs. He also wrote extensively on healthcare and the biotech and pharmaceutical industries for periodicals targeting the general public and industry executives. Dr Zavoico began his career as a Senior Research Scientist at Bristol-Myers Squibb Co., moving on to management positions at Alexion Pharmaceuticals, Inc. and T Cell Sciences, Inc. (now Celldex Therapeutics, Inc.). He has a BS in Biology from St. Lawrence University and PhD in Physiology from the University of Virginia and has held post-doctoral positions at the University of Connecticut Health Sciences Center and Brigham and Women's Hospital and Harvard Medical School.

Jennifer Henry, PhD

The New York Academy of Sciences

Speakers

Andreas Buser, MD

University Hospital, Basel, Switzerland

Andreas S. Buser, MD is the director of the Regional Blood Transfusion Service of the Swiss Red Cross in Basel, Switzerland. He is also attending physician for clinical and laboratory haematology at the University Hospital Basel and is head of the stem cell collection facility of the University Hospital Basel. He received his training at the University Hospital of Basel and at the Department of Immunohematology and Blood Transfusion of the Leiden University Medical Centre, the Netherlands. He has authored or co-authored over 60 medical and scientific articles. His research focuses on blood donor and blood product safety. He is a member of the emergency task force of the Blood Transfusion Service of the Swiss Red Cross.

Christopher D. Hillyer, MD

New York Blood Center

Christopher D. Hillyer, MD, is President and CEO of New York Blood Center and Professor, Department of Medicine, Weill Cornell Medical College, New York, New York. Previously, he was the tenured, endowed Distinguished Service Professor, Department of Pathology and Laboratory Medicine, Emory University School of Medicine and served as director of the Emory Center for Transfusion and Cellular Therapies with responsibility for all aspects of clinical and academic transfusion medicine at Emory's seven principle hospitals. Dr. Hillyer is an editor of eight textbooks in transfusion medicine including the 16–18th editions of the AABB Technical Manual, author of over 120 articles pertaining to transfusion, human immunodeficiency virus, and herpes viruses, most notably cytomegalovirus. Nationally recognized as an expert in hematology and blood transfusion, Dr. Hillyer is also a past-president, board of directors of AABB and a former trustee of the National Blood Foundation. Dr. Hillyer has been awarded many million dollars in research funding from the National Institutes of Health, the Centers for Disease Control and Prevention and other agencies. He is an associate editor of Transfusion and serves on several other editorial boards. Dr. Hillyer was formally recognized for his work in Africa as part of the AABB/Emory cooperative agreement from the President's Emergency Plan For AIDS Relief (PEPFAR), and is a recipient of two Tiffany Awards from the American Red Cross where he also served as a medical director and a member of their national Medical Advisory Board. He is a co-founder of Transfusion & Transplantation Technologies, Inc. (3Ti) and holds over 20 patents or patents pending. Dr. Hillyer is board certified in transfusion medicine, hematology, medical oncology and internal medicine. He received his BS from Trinity College, and his MD from the University of Rochester School of Medicine, with postgraduate training and fellowships in hematology-oncology, transfusion medicine and bone marrow transplantation at Tufts-New England Medical Center.

Jeanne V. Linden, MD, MPH

New York State Department of Health

Jeanne V. Linden, MD, MPH, FCAP is Director of Blood and Tissue Resources for the New York State Department of Health. In that capacity, she oversees development and implementation of standards for the more than 1,200 blood banks and tissue banks holding New York licenses, and also directs the Immunohematology Laboratory and Proficiency Testing Program. Dr. Linden has served on the federal HHS Advisory Committee on Blood Safety and Availability and is currently serving her second term on the FDA Blood Products Advisory Committee. She served as associate editor for the 15th edition of the AABB Technical Manual and has served for many years on American Association of Tissue Banks Standards Committee. She is a past president of the Blood Banks Association of New York State and served as editor of the BBANYS Quarterly for 15 years. Dr. Linden has received lifetime achievement awards from the American Association of Tissue Banks, the Blood Banks Association of New York State, and New York governor Andrew M. Cuomo. She is a recognized authority on transfusion-associated babesiosis and transfusion-related errors, with many publications and presentations. Board certified in clinical pathology and transfusion medicine, Dr. Linden received her medical and public health degrees from the University of Connecticut School of Medicine, where she also completed a residency in clinical pathology and a fellowship in transfusion medicine.

Jeffrey McCullough, MD

University of Minnesota Medical School

Dr. McCullough is one of the US leaders in Transfusion Medicine and Blood Banking. He has published more than 280 medical and scientific articles including his own text Transfusion Medicine (3rd Edition), has been a recipient of multiple NHLBI and CDC grants and contracts, has served on Federal advisory groups for FDA and NIH including the NHLBI Council, the Blood and Stem Cell Transplant Advisory Council to the Secretary of HHS, and the Scientific Advisory Board to the Canadian National Blood Service.

Dr. McCullough was the founder and first President of the United States National Marrow Donor Program and for 15 years, he served as Editor of the journal Transfusion. He has chaired multiple national symposia and ad hoc advisory committees to blood bank organizations and has been the recipient of multiple awards and named lectureships from the AABB, American Red Cross, NIH, and Blood Systems Inc. recognizing outstanding achievements. Recently he has worked with the National Blood Services in Tanzania and Afghanistan to strengthen and improve their operations.

Lyle R. Petersen, MD, MPH

Centers for Disease Control and Prevention

Lyle R. Petersen, MD, MPH, has served as the director of the Division of Vector-Borne Diseases since 2004. Dr. Petersen began his training at the University of California, San Diego where he received an undergraduate degree in biology. He then studied medicine at the University of California, San Francisco. After medical school, Dr. Petersen completed an internship and residency in internal medicine at Stanford University, CDC's Epidemic Intelligence Service (EIS) applied epidemiology training program, CDC's Preventive Medicine Residency Program, and a masters of public health program at Emory University. He served in several positions at CDC before joining the Division of Vector-borne Diseases, first as Deputy Director for Science and then Director. He is the author of more than 175 scientific publications. His current research focuses on the epidemiology of arboviral and bacterial vector-borne zoonoses, including assessment of transfusion transmission risks of emerging viral vector-borne pathogens.

Sponsors

Academy Friend

New York Blood Center


The Microbiology & Infectious Diseases Discussion Group is proudly supported by




Mission Partner support for the Frontiers of Science program provided by Pfizer

Abstracts

Case Study: The INTERCEPT System in Routine Use — A Blood Center's Experience
Andreas S. Buser, MD, University Hospital, Basel, Switzerland

In a single centre study from 2008 to 2010, we compared gamma-irradiated single donor platelet components in platelet additive solution (PAS) with pathogen reduced single donor platelet components, also in PAS. During that study we did not see a significant difference in the efficacy of transfusion of these compounds when assessing post transfusion platelet increments. No increased use of other blood products has occurred. In 2009, Swiss competent authorities (Swissmedic) approved the amotosalen based pathogen reduction technique Intercept. In the same year, the Blood Transfusion Service of the Swiss Red Cross and Swissmedic made a joint decision to implement pathogen reduction (PR) nationwide for platelet components. Deployment started in January 2011 and at the end of 2011 all platelet compounds in Switzerland were pathogen reduced, 2011 being a year when both conventional and pathogen inactivated platelets were used in parallel. National haemovigilance data from Swissmedic (2011 and 2012) indicate that PR is effective in preventing septic transfusion reactions. Non-infectious transfusion reactions and especially severe events are less frequent than before the implementation. No increased incidence of pulmonary adverse transfusion reactions following platelet transfusion - a presumed association with the pathogen reduction technique - was reported. As in the 5 years before implementation of PR, an annual increase of 10% of platelet usage has been observed, and as an indirect measure of transfusion efficacy, no increase in the use of red blood cell concentrates was noted. The haemovigilance data that continue to be collected in Switzerland, are comparable to the ones collected in France and other parts of Europe where the product is used in routine since 2006.
 

Perspectives for New Technologies in Transfusion Medicine
Christopher D. Hillyer, MD, New York Blood Center

Innovation, invention and institution of new technologies in the field of blood banking and transfusion medicine appear to lag other industries and may come predominately from those outside the disciplines. These three critical elements to the advancement of the field—innovation, invention and institution of new technologies—require significant investment either by the blood industry comprised of vendors to blood centers and the blood centers themselves; biotech and/or corporations; and/or the government, predominately via the NIH, or other nongovernmental agencies/foundations. Indeed, the blood industry as currently configured may risk extinction due to systemic conditions that include the inability to make adequate investment and garner return for reinvestment, a disjointed infrastructure, and high regulatory requirements especially in the United States. As blood is priced as a commodity and is thus extremely sensitive to market conditions, recent and likely long-lasting changes in supply and demand have led to a significant deflationary cycle and thus revenues from the procurement and provision of blood products no longer provide any foundation on which to invest in innovation, invention or institution of new technologies. In addition, the significant regulatory burden for market entry make the approval hurdles for new technologies even more costly and increase the risk for innovation and invention investment by increasing the amount needed, the time required and the limited ROI, all in a difficult market and a mature industry. Moreover, the patient as the ultimate consumer of new technologies in the field is very remote to those who make the decision for purchase or adoption. All of these forces make the likelihood for improvements in the safety and efficacy of the blood supply including pathogen reduction technologies less likely despite possible or even probable enhancements in patient care.
 

Babesia Risk and Transfusion Safety
Jeanne V. Linden, MD, MPH, New York State Department of Health

Babesiosis is a potentially life-threatening disease caused, in the northeastern US, by the intraerythrocytic parasite, Babesia microti. Parasites are usually transmitted to humans through a tick bite, but are also transmissible via blood transfusion. Recipients who are immunocompromised are most likely to develop symptomatic disease, while healthy blood donors may be parasitemic, but asymptomatic year round. In the absence of a licensed donor screening test, efforts to reduce risk have relied on donor health history interview, limited physical exam, and some geographic selection, along with public health measures intended to facilitate early diagnosis and intervention. As endemic zones in New York and other high-incidence states have expanded, the incidence of reported disease has continued to grow at an alarming rate, underscoring the need for other mitigation measures, such as high throughput donor screening assays.
 

Safety and Efficacy of Blood Pathogen Inactivation Systems: Recent Data and Clinical Developments
Jeffrey McCullough, MD, University of Minnesota Medical School

Multiple techniques are in use to inactivate pathogens in blood products. These include 5 methods for plasma, 2 for platelets and 2 under development for red cells or whole blood. The Intercept system for treatment of plasma or platelets uses a psoralen compound with UV light. The Mirasol system uses riboflavin and UV light. These plasma and platelet systems are in use to various degrees in many parts of the world outside the US. Thus there is extensive in vitro and in vivo clinical use data about pathogen inactivation of these two blood products. Most of the studies of pathogen inactivated plasma have reported post-transfusion improvements in coagulation factors. Three studies of Intercept plasma have had clinical endpoints and in all three studies Intercept plasma was equally effective as usual fresh frozen plasma in controlling or preventing bleeding. The clinical situations studied were thrombotic thrombocytopenic purpura, congenital coagulation factor deficiency and acquired coagulation factor deficiency. A clinical trial of Mirasol plasma showed improvement in coagulopathy but no clinical bleeding endpoint was reported. Five clinical trials of Intercept Platelets have demonstrated slight reduction in the post-transfusion platelet count but equal effect in treatment or prevention of bleeding. No increased use of other blood products has occurred when Intercept platelets have been implemented into routine use. One clinical trial of Mirasol platelets has also demonstrated a slight decrease in post-transfusion platelet increment and no statistically significant difference in effectiveness or prevention or treatment of bleeding. Two methods are well along in development for pathogen inactivation of whole blood (riboflavin and UV light) or packed cells (S-303, an alkylator). In patients undergoing cardiovascular surgery, a previous version of the S-303 treated red cells was equally effective as traditional red cells. Developmental studies of the riboflavin method continue and two clinical trials of the S-303 method are underway in Europe.
 

Mosquito-borne Infections; Continual Evolution of Risks
Lyle R. Petersen, MD, MPH, Centers for Disease Control and Prevention

Arthropod-borne diseases are numerous; the arthropod-borne viruses alone account for approximately 40% of all viruses pathogenic to man. They are amongst the fastest growing in incidence and distribution globally. West Nile virus heralded a new paradigm for a new class of transfusion-transmissible viral diseases: one based on high incidence of new infections of short duration rather than pathogen chronicity. The irreversible, accelerating, and intertwined etiologies underlying the emergence of these pathogens include human population growth and migration, globalization, and environmental perturbation. The future outlook of these newly emerging vector-borne pathogens threatening transfusion safety and the implications for other emerging infections will be discussed.
 

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