Donation & Transplantation at Canadian Blood Services

Jillian Adler Senior Program Manager Donation & Transplantation November 6, 2015 Disclosure

• I have no involvement with the industry and therefore I have nothing to disclose nor can I identify any potential conflicts of interest.

2 Donation & Transplantation Agenda 1. Overview of Canadian Blood Services 2. Donation & Transplantation a) Organ Donation & Transplantation b) OneMatch Stem Cell & Marrow Network 3. National Public Cord Blood Bank 4. Questions

3 About Canadian Blood Services Programs and services

Programs and services Red blood cells, platelets, plasma, stem cells Stem cell and organ registries Medical services Knowledge, tools and expertise

Bulk purchasing and distribution of pharmaceutical plasma protein products

Insurance captives: $1 billion comprehensive coverage

4 About Canadian Blood Services Our business by the numbers

Operations People

Budget: ~$1B ~3,700 employees 41 static collection sites 17,000 volunteers 6,500 mobile collection sessions

2 testing/ 8 processing sites 412,000 blood donors ~700 hospitals served

5 About Canadian Blood Services What we do: The heart of our strategy

Manufacturing biological products Providing clinical services Including red blood cells, platelets, plasma, stem cells Including registries, medical services, knowledge, tools, expertise

SUPPLY CHAIN MANAGEMENT CLINICAL AND MEDICAL SERVICES Planning, collection, manufacturing, testing and distribution From registry management to diagnostic services to hospital of biologics products – to the right place at the right time. relationships.

RECRUITMENT INNOVATION Identifying and attracting potential donors for all products Research, knowledge creation/exchange, education and new and services, from blood to stem cells to organs. product development.

6 Medical Services & Innovation

Donation Donor and Clinical Medical Strategic And Utilization Innovation Services Microbiology Performance Transplantation

CTR SCNSS Operations Operations

Advisory Transplant Professional Committees Listing & Education / Search Integration Allocation Support

Organs & Tissues OneMatch

Data & Living Advisory Donor Analytics Dx & Tx Committees Activation

Deceased Case Donation Management TX

Organ and Tissue Donation & Transplantation

8 Organ and Tissue Donation & Transplantation Programs and Services in CBS Areas of Focus

Clinical Governance Develop leading Quality Management practices & provide System to guide Strategic Plan national programs awareness & Development & Leading Practices, and services education services Professional & Public Implementation Integrated Planning Education Clinical Governance, and Policy

System Performance Canadian Transplant KPD Program Timely & accurate Improvement: Data, Registry HSP Program Analytics data for reporting & Patient Programs & NOW Program system improvement Services CTR Services OM Program SCNSS Services Strategic Plan

Call to Action A strategic plan to improve organ and tissue donation and transplantation performance for Canadians.

Strategic Plan Development & Leading Practices, Implementation Professional & Public Education Clinical Governance, and Policy

System Canadian Performance Transplant Improvement: Registry Data, Analytics Patient Programs & Services 10 Strategic Plan

Call to Action Recommendations • Formal Accountability Framework

• ODT Committees IMPROVE ACCOUNTABILITY • Mandatory Data Reporting • Auditing • Donation Physicians INCREASE DONATION • National Public Awareness Strategy • Intent-to-Donate Registries

IMPROVE ACCESS TO • Comprehensive, Integrated, Inter-Provincial Patient Registries TRANSPLANTATION

• Leading Practices INCREASE COLLABORATION • Research and Innovation

• Data Management and Analytics IMPROVE INFRASTRUCTURE AND • Professional Awareness and Education CAPABILITIES • Financial Resources for Frontline ODT Service Providers Strategic Plan Development Leading & Practices, Implementati Professional on & Public Education Clinical Governance, System Canadian and Policy Performance Transplant Improvement Registry : Data, Patient Analytics Programs & Services Donation & Transplantation Program

Advancing the System Network with Collaboration

Organ Donation & Canadian Blood Transplantation Expert Services Advisory Council (ODTEAC)

Kidney Transplant Deceased Donation Advisory Committee Advisory Committee “Interim” Governance Deceased Donation Administrators Heart Transplant Committee Advisory Committee

Living Donation Liver Transplant Advisory Committee Advisory Committee

Information Strategy Lung Transplant Advisory Committee Advisory Committee

Data & Research Strategic Plan Pancreas Transplant Leading Practices, Development & Management Advisory Committee Professional & Implementation Committee Public Education Clinical Governance, and Policy

National HLA System Canadian A hoc Working Performance Advisory Committee Transplant Registry Groups Improvement: Data, Analytics Patient Programs & Services Donation & Transplantation OTDT Areas of Focus

Develop leading Policies review & practices & provide Leading feedback to guide awareness & Practices, Strategic Plan national programs education services Professional & Development & and services Public Implementation Education

Canadian System Transplant KPD Program Timely & accurate Performance Registry HSP Program data for reporting & Improvement Programs & NOW Program system improvement Services CTR Services

13 Canadian Transplant Registry Clinical Programs

Enables matches among multiple donor–recipient pairs and anonymous non- paired donors, expanding the transplant possibilities for prospective kidney KPD recipients who have willing but incompatible donors Increases the number of transplants and number of low risk transplants Creates a societal benefit from cost avoidance • Removes patients from provincial waitlist • • Program for highly sensitized patients; opens up a national pool of donors for HSP the hard-to-match Increases equity of access to transplants Increases overall life-span of the transplant due to the low rejection rates • • Real-time listing data source, replacing the antiquated paper-based waitlist, for NOW all non-renal patients throughout Canada Makes it possible to obtain a true national picture of current wait times and access to organs for transplantation • Canadian Transplant Registry

Kidney Paired Donation (KPD) Program Performance KPD Program Performance Activity to Date

Match Cycles Executed 22 (June 2015) Pairs Registered 763 (184 in last MC) Recipients Registered 707 (162 in last MC) NDADs Registered 91 (8 in last MC)

Match Cycles Completed 21

Transplants Completed 361 Registered Recipient Transplants 295 Wait List Transplants 66

Strategic Plan Leading Development & Practices, Implementation Professional & Public Clinical Education Governance, and Policy Canadian System Transplant Performance Next Match Cycle: October 2015 Registry Improvement: Data, Analytics Patient Programs & Services Canadian Transplant Registry Highly Sensitized Program (HSP) Performance HSP Performance Transplant for cPRA

45 48% 40 959 HSP Registered 24% 35 148 HSP Transplanted 30

25 4% 41% 20 53% 50% 15

10 5 18 14 19 39 35 23 0 cPRA 95 cPRA 96 cPRA 97 cPRA 98 cPRA 99 cPRA 100

Strategic Plan Leading Development & Practices, Implementation Professional & % is the proportion of those registered with the specified cPRA whom received transplants through HSP Public Clinical Education Governance, and Policy Canadian System Transplant Performance Registry Improvement: Data, Analytics Patient Programs & Services Canadian Transplant Registry National Organ Waitlist (NOW) Performance NOW Performance NOW & HSP Kidney Candidates Organ Demand from Active Candidates

Liver Pancreas There are also 492 HSP Kidney 386 96 Islets (Pancreas) 47% 12% 7 Candidates, four of whom are also 1% awaiting pancreas transplants. Multiple Heart 0 11 132 0% 1% 16% Lung 191 23%

These four candidates are included in the “Multiple” category above; however, candidates who were identified as requiring a kidney without being in the HSP category (cPRA >=95) for that organ are represented as single-organ candidates. Donation & Transplantation OTDT Areas of Focus

Canadian System Transplant KPD Program Timely & accurate Performance Registry HSP Program data for reporting & Improvement Programs & NOW Program system improvement Services CTR Services

21 Leading Practices Timeline Kidney Paired Assessment and Donation Protocol for Management of Donation after Participating Donors. Immunologic Risk in Cardiocirculatory Death Transplantation. 2005 2015 (DCD). 2005 End-of-Life Conversations Enhancing Living with Families of Potential Severe Brain Injury to Donation. 2006 Donors: Leading Practices Neurological Eye and Tissue Banking Determination of Death Kidney Allocation in in Canada: A Leading in Offering the Opportunity (NDD). 2003 Canada: A Canadian Practices Workshop. for Donation. 2014 Forum. 2007 2012

2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015

Medical Management to Brain Blood Flow in the Bioburden Reduction Optimize Donor Organ Neurological International and Control Leading Potential. 2004 Determination of Death. Guidelines for the Practices. 2015 2007 Determination of Death. Canadian Highly 2012 Sensitized Patient and Living Donor Paired Leading Practices for the Exchange Registries. Allocation of Organs for 2005 Combined Transplantation. 2015 22

Leading Practices, Professional & Public Education KPD Donation Protocol and Knowledge Translation

Strategic Plan Leading Development & Practices, Implementation Professional & Public Clinical Education Governance, and Policy

Canadian System Transplant Performance Registry Improvement: Data, Analytics Patient Programs & Services Professional Education Engaging Medical Examiners and Coroners

• Collaborating with the Canadian Conference of Chief Coroners and Chief Medical Examiners to develop a Canadian Reference Donation Manual for coroners, medical examiners and pathologists Professional Education

On-Line Donation Course for:

• Medical Examiners and Coroners • Pathologists and Death Investigators • Funeral Professionals • Donation Organizations Canadian Blood Services will be launching • Eye and Tissue Banks this course in April 2015. With completion of the course participants will receive documentation to support submission for CEU’s. Public Education Public Education Materials

Online Advertising Campaigns

Kidney Donor and Recipient Posters Infographic Doodle Video “Think, Act, Talk” sell sheet

“Think, Act, Talk” public presentation NWT Donor Family Video Public Education & Awareness Public Education Materials In Development 30 Second Versions

28 OneMatch Stem Cell & Marrow Network OneMatch About OneMatch

• Only 25% of patients will find a related donor

• Established in 1988 (formerly known as the Unrelated Bone Marrow donor Registry UBMDR)

• Canadian Blood Services Program dedicated to recruiting and finding healthy, committed volunteer donors for Canadian and International patients in need of hematopoetic stem cell (HSC) transplants

• Re-branded in October 2007

• 10th largest registry in the world National Public Cord Blood Bank OneMatch Areas of Focus - OneMatch

Donor Post-Donation Search Workup Activations Post-Transplant OneMatch 364,317 • Just over 360,000 searchable donors willing to give their stem cells to any patient in need anywhere in the world OneMatch 26 million donors in global database

• OneMatch linked internationally to 75 registries in 53 countries OneMatch 677,802 cord blood units

International Cord Banks: 53 in 36 countries

• OneMatch

OneMatch Program Performance

Program Performance

Canadian Patient Searches 898 896 900 815 770 800 745 does not include Quebec Patients 716

700 624 600 541

500

400

Number of Patients Number 300

200

100

0 2008/2009 2009/2010 2010/2011 2011/2012 2012/2013 2013/2014 2014/2015 2015/2016 (YTD) Total Program Performance

Products Collected from OneMatch Donors -Marrow, PBSC, DLI-

120

100

69 62 80 57 57 45 53 60 44

40 38 Number of Products Number 50 51 54 46 43 46 20 34 19 0 2008/2009 2009/2010 2010/2011 2011/2012 2012/2013 2013/2014 2014/2015 2015/2016 (YTD) Fiscal Year

Canadian Patient International/Hema-Quebec Patient Program Performance

Canadian Unrelated Transplants -Bone Marrow & PBSC- does not include Transplants for Quebec Patients

350

300

250

200 256 240 230 240 150 153 167 150 100 Number of Transplants Number 145

50 44 42 43 47 50 52 33 19 0 2008/2009 2009/2010 2010/2011 2011/2012 2012/2013 2013/2014 2014/2015 2015/2016 (YTD) Fiscal Year

Canadian Donor International/Hema-Quebec Donor Program Performance

Cord Units Procured for Canadian Patients does not include procurement for Quebec Patients

30 54 52 50 48 20 32 35 23 Number of Cord Units Procured Units of Cord Number 10 14

0 2008/2009 2009/2010 2010/2011 2011/2012 2012/2013 2013/2014 2014/2015 2014/2015 (YTD) Fiscal Year

International Cords Program Performance

Where Canadian donations go

Italy 8% Canada France Australia 10% 6% 6% United Kingdom Spain 5% 10% Netherlands 3%

Turkey 2% Germany Switzerland 2% 14% Finland 1% Hungary Poland 1% USA 1% 27% Slovenia Ireland 1% 1% Program Performance

Where International products come from

United Kingdom 4% United States Australia Canada (Quebec) Poland 1% 29% China Israel 11% 2% 1% 1% Portugal Finland 1% Spain 0% 0% Switzerland Italy 0% 0%

Germany Argentina 51% Taiwan 0% 0% Brazil 0% Program Performance

Ethnic Composition of OneMatch Database

First Nations Central Asian Filipino 1% 0% 1% Hispanic Chinese 1% Inuit 7% 0% Métis Northeast Multiple 0% Other Asian Ethnicity 6% Pacific 0% 2% Caucasian Islander Southeast Asian North Asian 70% 0% 1% 0% South Jewish-Sephardic Unknown Asian 0% 2% 5% Jewish- Ashkenazi Arab 0% Black - 1% Black - Other Caribbean Black - African 1% 0% 0% Program Performance

Age Composition of OneMatch

Male, 36+ 22% 0% Male, U36 Ethnic 8%

Female, 36+ Male, U36 35% 18% Male, U36 Caucasian 10%

Female, U36 25%

National Public Cord Blood Bank

44 Objective Build a national, public inventory of high quality, ethnically diverse stem cells from umbilical cord blood to increase transplant opportunities in Canada and worldwide.

Maximizing Opportunities for Stem Cell Transplant Model Fully Established September 30, 2013 The approved model of the original business case for the Cord Blood Bank has been fully implemented, nationally. The following collection sites were established July 7, 2014 Additionally, stem cell manufacturing and storage facilities were implemented in Ottawa, September 30, 2013, and Edmonton, January 26, 2015 January 26, 2015. 46

January 26, 2015 Maximizing Opportunities for Stem Cell Transplant Model: National Public Cord Blood Bank Five collection sites and two manufacturing facilities for processing, storage and distribution. Canadian Blood Services

Medical and OTTAWA EDMONTON Many CBS Scientific Searching, Manufacturing Manufacturing Support Areas: CBS Research Ethics Committee Facility Facility eg., HLA & Advisory Matching (units unsuitable (Sep. 2013) (Jan. 2015) Transmissible Committee Disease Testing, for transfusion) Marketing, Logistics, Shipping

Canadian OTTAWA EDMONTON Canadian Collection Sites Collection Site Transplant Research (2) (1) Programs (Sep. 2013) (Jan. 2015) Scientists

BRAMPTON VANCOUVER International Collection Site Collection Site Registries (1) (1) (Jul. 2014) (Jan. 2015) Maximizing Opportunities for Stem Cell Transplant Operations to Date As of October 19, 2015:

• 6,518 mothers have donated their baby’s cord blood

• 1,161 cord blood units have been banked

• 502 cord blood units are listed nationally and internationally for searching and matching

• Cost per cord blood unit: – No charge to Canadian transplant centres – $40,000 USD to international transplant centres – Transplant inquiries are occurring Maximizing Opportunities for Stem Cell Transplant

Quality Driven

• Accreditation: To ensure the safety and efficacy of the cord blood stem cell product for therapeutic use, CBS complies with Canadian regulatory requirements, and is seeking accreditation from AABB (American Association of Blood Banks) which is recognized, internationally. The cord blood bank is being inspected by AABB in November 2015 and anticipates receiving accreditation in Q4.

• Ethnically diverse inventory: There is a direct link between stem cell donations and matching to a patient based on ethnicity. The CBB focus is to build a highly diverse inventory to help offset the OneMatch registry. Maximizing Opportunities for Stem Cell Transplant

Quality Driven – Impact of TNC cut off

• High TNC cut-off was established, as the higher TNC tends to result in a better outcome for the patient and shorter hospital recovery times, therefore, reducing healthcare costs:

– 1.5 X 109 – Caucasian – 1.3 X 109 – Non-Caucasian

Maximizing Opportunities for Stem Cell Transplant

Ethnicity of CBUs Listed Filipino 1%

Goal of Cord Blood Bank is to offset First Nations <1% composition of OneMatch registrants. Chinese 1% Hispanic 1% Inuit <1% Métis <1% Target: 60/40, Non-Caucasian/Caucasian

Currently: Northeast Asian 49/51, Non-Caucasian/Caucasian, but <1% Multiple Ethnicity trending toward 60/40, as more cord blood 26% North units from more highly diverse collection Asian <1% sites such as Brampton and Vancouver are Caucasian 51% Other <1% released into inventory and listed for Pacific Islander <1% transplant. Jewish- Southeast Asian Sephardic 1% <1% Arab 5% Unknown 1% Jewish-Ashkenazi <1% Black-African 4% South Asian 5% Black- Black-other <1% Caribbean 2%

Maximizing Opportunities for Stem Cell Transplant

Ethnicity of CBUs Collected First Nations 55% Aboriginal 0.5% Target: Inuit 24% Métis 21% 60/40, Non-Caucasian/Caucasian Central Asian 4% Chinese 17% 60% Filipino 8% Asian 16% North Asian 1% Northeast Asian 3% 50% 43% South Asian 52% Southeast Asian 15% 40% African 57% Black 5% Caribbean 37% 30% Other 5% Caucasian 43% Multi-ethnic 17% 20% 16% 17% 11% None Listed 11%

10% 5% 6% Arab 62% 0.5% Hispanic 20% Jewish-Ashkenazi 4% 0% Other 6% Aboriginal Asian Black Caucasian Multi-ethnic None Listed Other Jewish-Sephradic 0.3% Pacific Islander 1% Other 13% Program Performance

Cord Units Procured for Canadian Patients does not include procurement for Quebec Patients

30 54 52 50 48 20 32 35 23 Number of Cord Units Procured Units of Cord Number 10 14

0 2008/2009 2009/2010 2010/2011 2011/2012 2012/2013 2013/2014 2014/2015 2014/2015 (YTD) Fiscal Year

International Cords Questions? 55