Research & Development Updates

PT BLC Meeting April 2014

Canadian Blood Services Dr. Dana Devine

Chief Medical & Scientific Officer

Update: Establishment of the Centre for Innovation

Highlights of key research & development outcomes

Highlights of key knowledge mobilization and educational programs

Centre for Innovation Centre for Innovation

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Governance Centre for Innovation

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Board of Directors

Chair: Leah Hollins

Safety, Science & Ethics Committee

Chair: Dr. Gary Glavin

Chief Executive Officer

Dr. Graham Sher

CBS Research Ethics Board

Chair: Dr. Francis Rolleston

Scientific & Research Advisory

Committee

CBS Centre for Innovation Centre Grant Review Panel

Chair: Dr. Ralph Vassallo

Chief Medical & Scientific Officer

Dr. Dana Devine

Centre for Innovation Core Team: Discovery Research

Donald Branch Dana Devine Anna Janowska-Wieczorek

Alan Lazarus

Heyu Ni Ed Pryzdial Mark Scott Bill Sheffield

Red cells, Platelets, Plasma, Coagulation, IVIG replacement, Immunology, Fibrinolysis, Hemolysis, Serology, Virology, Hematopoietic stem cells, Regulatory science

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Centre for Innovation Core Team: Development Research

Jason Acker John Blake Nicolas Pineault Sandra Ramirez-Arcos

Red cells, Cryopreservation, Bacteriology Hematopoietic stem cells, Process engineering

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Centre for Innovation

Core Team: Medical microbiology, Donor Research & Epidemiology

Infectious Diseases, Epidemiology, Donor safety, criteria & screening

Sheila O’Brien Mindy Goldman Margaret Fearon

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Key Partnerships & Collaborations

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Industry

Federal Government

Academic Institution

Not-for-Profit

Centre for Innovation

R&D Leadership group ABO collaboration focused on • research program operation and management, • international research collaborations, • increasing research efficiency, productivity, and • horizon scanning in the area of new scientific developments

Risk-based Decision Making Project

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Key International Collaborations Centre for Innovation

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Key International Collaborations

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Centre for Innovation

The Biomedical Excellence for Safer Transfusion (BEST) Collaborative is an international research organization that works collaboratively to explore ways to improve transfusion-related services through standardization of analytic techniques, development of new procedures, systematic review of evidence, and execution of clinical and laboratory studies.

• Dr. Devine – Team Leader for the Conventional Components area • Dr. Goldman – Blood Services Member • Dr. Acker – Blood Services Associate Member • CBS researchers involved in numerous BEST studies

Update: Establishment of the Centre for Innovation

Highlights of key research & development outcomes

Highlights of key knowledge mobilization and educational programs

Red Blood Cells (RBC)

Developing evidence around the impact of irradiation on RBC quality A study was conducted which demonstrated that current Canadian guidelines on irradiation of RBC units may not be enough to ensure transfusion of high quality units - depending on when irradiation takes place, irradiated units may show higher than acceptable levels of red blood cell damage.

Developing evidence around the impact of manufacturing methods on RBC quality A study was conducted, in partnership with Blood Systems, which determined that in vitro RBC quality attributes are dependent on the collection and/or whole blood manufacturing method used and thus suggesting that not all RBC products are equivalent. The impact of the manufacturing method on product quality should therefore be carefully considered when making process changes and in the interpretation of transfusion outcomes.

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Red Blood Cells (RBC)

Developing evidence to inform changes to the 30-minute rule for RBC Initiated extended bacterial testing to fill gaps of previous studies with the view to propose changes to CSA Standards (study in collaboration with Héma-Québec).

Understanding the impact of a shorter RBC shelf-life Developed a generic model to simulate blood products supply and demand, and to evaluate how much inventory to hold in the system and where (at CBS distribution site or at hospitals). The model was used to evaluate the impact of a shorter shelf life for RBC and it was found that it could be shortened from 42 to 21 days without significantly affecting hospital or blood product supply chain. Below 21 days, there would be significant increase in RBC outdates and shortages. The model is now used to optimize transfers between distribution centres to improve network inventory.

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Red Blood Cells (RBC)

Implementation of a new RCC washing technology Health Canada approval for washing RBCs with the ACP-215 was obtained in Q1 and the first units was washed for patient use in Q3.

Currently completing pre-and post implementation monitoring with a cohort of hereditary thalassemia patients at UHN. Outcomes studies are:

Transfusion Safety (6 mths before and after implementation)

Primary endpoint : frequency of transfusion reactions

Data to date: No reactions reported, No new antibodies reported

Transfusion Efficacy (3 mths before and after implementation)

Primary endpoints: change in pre-transfusion hemoglobin and

frequency between transfusions

Data to date: 3 mths pre (94 transfusion episodes) and 3 mths

post (88 transfusion episodes)

First units washed in Brampton 2013-10-08

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Platelets

Evaluating new technology for bacterial testing in platelets In collaboration with industry, the pH SAFE product [Blood Cell Storage, Inc.] was evaluated for its efficacy to identify bacterial contamination in platelet units. pH SAFE is a rapid, non-invasive method for quality control pH measurement of platelet concentrates. The results are being prepared for publication.

Assessing risks associated with bacterial biofilms The formation of surface-attached bacterial aggregates during platelet storage poses an increased danger in transfusion medicine. Several studies were conducted demonstrating:

• Bacterial biofilms are more likely to escape detection during screening.

• Biofilms have increase pathogenicity.

• Anaerobic bacteria cannot replicate during platelet storage but can survive in the presence of oxygen likely due to biofilm formation.

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Platelets

Evaluating pathogen reduction technology Continued efforts to contribute to the Canadian arm of the PREPAReS clinical trial (Mirasol), in partnership with Sanquin and Norway.

In addition, efforts are ongoing to use proteomic profiling to identify critical changes in Mirasol treated blood products which may provide information about product quality.

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Plasma and Plasma Products

Providing evidence to inform cryosupernatant plasma regulations A study was conducted to determine the impact on quality of extending the storage period of thawed cryosupernatant plasma. While current Canadian regulations require that cryosupernatant plasma must be transfused within 24 hours of thawing, the study demonstrated that it could be refrigerated for up to 5 days without compromising the safety and quality of the product.

Furthering our understanding of IVIg mechanism of action Continued efforts were made using animal models to shed some light on the mechanism of action of IVIg as well as to develop alternative drug to IVIg.

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Cord Blood Stem Cells

Validating sterility testing of cord blood units for the National Public Cord Blood Bank Developed and executed a validation protocol to perform sterility testing on cord blood collected by CBS National Public Cord Blood Bank. Impact on the safety of cord blood transplantation.

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Transmissible Diseases

Evaluating the prevalence of hepatitis E and Babesia in Canada Studies are underway to determine the prevalence rates of hepatitis E and Babesia in Canadian donors. The studies aim to test 10,062 donors from collection sites in South Central Ontario, Nova Scotia and New Brunswick, and Winnipeg. The studies results will inform policy development.

Babesia study is now completed and there has been no antibody detected.

Hepatitis E study is ongoing, ~4,000 donors have been tested to date using NAT and no positive has been found.

Blacklegged tick

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Donor Safety

Iron management in Canadian blood donors A prospective cohort study was performed on blood donors to

determine donor iron deficiency. The study determined that iron deficiency was frequent, particularly in female donors and frequent donors. The study recommended that donors and physicians need to be more aware of iron needs associated with blood donation and appropriate treatment for low iron stores.

The group developed tools to enhance education of donors regarding iron deficiency.

Now conducting a larger study in 10,000 donors to assess the operational feasibility of ferritin testing in donors. The study findings will inform policy development.

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Impact and Value

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Centre for Innovation

• e.g. protein profiling to predict platelet quality; understanding immune system platelet destruction; assessing post-chemo bleeding; clin. guidelines

Improved Health Outcomes

• e.g. optimized distribution network for CBS in the Atlantic provinces, QMP, trouble-shooting for cord blood bank

Improved Products and Processes -

Operational Excellence

• e.g. IVIG alternatives; elimination of B1 mixing step; 30min rule for RBC’s Increased Value

Positive patient impact

Positive system impact

Demonstrated value of current and future

investments

Number of Publications 188

Peer-Reviewed Publications 136

Journal Articles 49

Review Articles 9

Letters/Comments 5

Published Abstracts 66

Books/Book Sections 7

Non-Peer-Reviewed Publications 52

CBS Website Publications 12

Technical Reports 35

Theses 5

Knowledge Products (FY2013-14 not final)

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Centre for Innovation

Mean H-Index for CBS researchers (2014-03)

H-Index 24 (13 – 42)

H-Index (Past 5 Years only) 17 (9 – 31)

*Compared with 10.6 - 2012 mean H-Index of Canadian researchers in the field of Science

Knowledge Products Impact Centre for Innovation

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Update: Establishment of the Centre for Innovation

Highlights of key research & development outcomes

Highlights of key knowledge mobilization and

educational programs

Mobilizing Research Conference Reports

& Knowledge to Munch On

Conference Reports & Knowledge to

Munch On

Mobilizing Research

Mobilizing Research Surveillance

Report

History of Surveillance Reporting Canadian Red Cross Blood Transfusion Service, Demographic Report 2002: First CBS Surveillance Report produced by the Epidemiology Department 2012: First CBS Surveillance Report published on www.blood.ca

Knowledge Exchange Mechanisms (FY2013-14 not final)

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Number of National/International Conference

Presentations

92

Oral Presentations 50

Poster Presentations 42

Number of Knowledge Exchange Events 70

Symposia 5

LearnTransfusion.ca Webinars 35

CBR Seminars 30

Centre for Innovation

Education

Website designed to share CBS educational tools with the transfusion community and to act as a “clearing house” of trustworthy content

Centre for Innovation

Education

18 Chapters Free on-line edition at

www.transfusionmedicine.ca

“…An excellent and very practical summary of our current knowledge of

blood components and transfusion medicine practices. ...this Guide will help

to increase safety for those Canadians who require blood products and add

confidence for those who provide services.”

Education

Transfusion Medicine Fellowship Program

University of Toronto

Dr. Wendy Lau

University of British

Columbia Dr. Tanya Petraszko

McMaster University

Dr. Donald Arnold

University of Ottawa/Queen’s

University Dr. Antonio Giulivi

Dalhousie University

Dr. Irene Sadek

Diploma guidelines, review and accreditation

Transfusion Medicine Advisory group

CBS MSI Dr. Robert Skeate

Advise on Diploma content

Education

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Building Capacity Through Trainee Awards

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Trainee Category Number fully or partially supported by C4I

Summer Students 8

Graduate Students 17

Post-doctoral Fellows (PhD)

8

Transfusion Medicine Residents (MD)

9

Total 42

Centre for Innovation

Clinical Guidelines

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Aims 1. To establish evidence based transfusion medicine guidelines to optimize transfusion care,

2. To enable more timely, and cost effective creation of transfusion medicine guidelines, 3. To increase the credibility of guideline development for transfusion medicine by using a widely collaborative effort and consistent up-to-date methodology To date 2 systematic reviews published 1 clinical guideline submitted Topic: Platelet Transfusion Therapy in Hypoproliferative Thrombocytopenia

Achieving Our Mission Centre for Innovation

To facilitate the creation, translation and application of new knowledge in the support of a safe, effective and responsive blood and transplantation systems for Canada.

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Annual Report Centre for Innovation

The Centre for Innovation Annual Report will include a comprehensive list of publications and additional details around performance metrics. The Annual Report will be completed and approved by the CBS Board of Directors in June 2014. It will be provided to PTBLC members once finalized.

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Thank You

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