1. WELCOME.

2. FUNDERS

3. FEATURES Strategy 1: Establish short and longer term implementation capacity for this action plan and coordination of other clinical trial improvement activities. Strategy 2: Improve business operations through better cost, quality, and speed of clinical trial start up times. Strategy 3: Shape a positive future business environment and signal Canada’s interest globally with information and incentives.

4. Background Executive Committee ◦CIHR – Jane Aubin ◦Rx&D – Shurjeel Choudhri ◦HealthCareCAN – Duncan Stewart ◦Advisory Chair – Lawrence Korngut Executive Committee Support Team ◦CIHR – Diane Forbes, Erica Dobson ◦Rx&D – Alison Sargent, Elena Aminkova ◦HealthCareCAN – Tina Saryeddine, Claire Samuelson Staff ◦Director, Implementation – Belinda Vandersluis ◦Coordinator, Communications and Strategy – Leyla Di Cori Executive Committee Advisory Group Director Implementation Staff, Consultants Working Groups Secretariat

5. Dr. Lawrence Korngut (Chair), University of Calgary Laura Accetola, Amgen Canada Karen Arts, OICR, 3CTN, N2 Dr. John Cairns, University British Columbia, CAHS John Coderre, Patient Advocate, Canadian Arthritis Network Sharon Freitag, Ethics, St. Michael’s Hospital Dr. Karen Lee, MS Society Canada Susan Marlin, Clinical Trials Ontario Dr. Robert McMaster, Vancouver Coastal Health RI, BCCRIN Dr. Peter Monette, Strategic Policy Branch, Health Canada Dr. Jean Rouleau, CIHR ICRH Dr. Pamela Valentine, Alberta Innovates Health Solutions National Advisory Group

6. Progress 2014 Strategy 1 Establish short and longer term implementation capacity Strategy 2 Improve business operations Strategy 3 Signal Canada’s interest globally  Establish headquarters  Metrics, measuring performance  Infrastructure, SPOR  REB efficiencies  Patient registries and recruitment  SOPs and tools  Improve and use mCTA  IP and SR&ED tax credits  CCTAM / Asset Map

7. Plan 2015 Strategy 1 Establish short and longer term implementation capacity Strategy 2 Improve business operations Strategy 3 Signal Canada’s interest globally National Advisory Group engagement Metrics working group to measure Canada’s performance REB accreditation working group Patient registries working group N2 synergies Industry engagement and advancing mCTA CCTAM rollout and continued development

8. REC’Ms Operationalized in 2014, announced by Federal Minister of Health; April 2014 Executive Committee and support team in place, meets monthly National Advisory Group formed n=12, meets quarterly –Dr. Lawrence Korngut, Calgary joins Executive Committee; completed Web and news tools at www.cctcc.ca and www.cccec.ca ; completedwww.cctcc.cawww.cccec.ca REC #1 – National Headquarters

9. REC’Ms Update 2010 Industry Benchmarking survey (Rx&D); Q2-3 2015 Cost and start up times benchmarking w/ IMS Brogan Q1-2 2015 First year evaluation of CCTCC; ~mid 2015 –Investment in Canada $, international ranking –Short term milestones set and goals met –Future year(s) strategy and plans REC #2 – Measure Results

10. REC’Ms Strategy for Patient Oriented Research Funders strategic plans REC #3 – Integrate

11. REC #4 – Ethics Review Efficiencies SHRER Working Group common documents; completed. Canadian Standards Board REB standards; completed. Health Canada + CIHR creating an option for Canadian REB’s to seek accreditation. *Senate Committee recommendation –CCTCC Working group ‘what would accreditation look like’; Jan-Sept 2015 REC’Ms

12. Patient registries database. –Working initially to define ‘patient registry’, then develop a database of current patient registries; potentially national meeting; developing plans for 2015 Patient information, educational sessions for health charities and patient advocates; Q1-4 2015 REC #5 – Patient Registries and Recruitment

13. REC #6 – Common Tools and Site Certification Common Tools: Encouraging membership in N2: SOPs, GCP Training, Common Forms and Tools Site Certification: Quantify ‘Clinical Trial Sites’ in Canada; working with Health Canada CTSI & inspections databases; Q1-2 2015 Future working group: Is ‘site certification’ important/valuable? 2016 REC’Ms

14. REC #7 – mCTA Model CT Agreement Pilot phase completed, provincial reviews completed. mCTA available. Current: Industry endorsement, review with ~10 companies; Feb 2015 - >. Next steps: Communications strategy Q2-3 2015 CRO engagement in 2015-16 (after industry review) Future steps: development of other agreements - data sharing, confidentiality and non disclosure, etc. 2016 REC’Ms

15. REC #9 – Signaling our Interest Globally CCTAM: Canadian Clinical Trial Asset Map www.cctam.cawww.cctam.ca –Communications packages (eng/fr) available –‘Go Live” & rollout date June 2015 New “Business Case” for clinical trials in Canada with DFAT Investment Services, used to engage global investors. Completed. REC’Ms

16. CCTAM www.cctam.ca |cctam@cctcc.ca

17. Additional Slides Addt’l

18. Outside of the US, Canada is top in the number of active clinical trials 18 Industry Overview Source: clinicaltrials.gov (Accessed 6 Oct 2014)

19. Canada has the highest number of active clinical trials per capita among G7 nations 19 Industry Overview Source: clinicaltrials.gov (Accessed 6 Oct 2014)

20. The majority of clinical trials are performed in ON, QC, BC and AB, but all provinces have experience in clinical trials 20 *Some trials are counted multiple times when examining trials by province Source: clinicaltrials.gov (Accessed 6 Oct 2014) Canadian clinicians are experienced in all major therapeutic area, and across the country Industry Overview Inflammation 1% Immunology 2% Central Nervous System (CNS) 8% Total Active Trials in Canada: 2,971

21. Canada has the 2 nd lowest cost among G7 nations in the design, management and coordination of global clinical trials 21 Source: KPMG Competitive Alternatives – Highlights (2014) Efficient Clinical Trial Environment The KPMG Cost Index considers a clinical trial design center: A 10,000 sq. foot facility 50 employees Investment in tax-eligible research

22. The world’s top 10 pharmaceutical companies regularly conduct clinical trials in Canada 22 Source: clinicaltrials.gov (Accessed 6 Oct 2014) Companies Choosing Canada

23. Canada has an efficient regulatory process that fosters the prompt setup of clinical trials 23 Efficient Regulatory Review Process Health Canada Target is 30 days to review clinical trial applications 1 In 2013, Health Canada achieved their target in 99% of all applications received 1 Provinces have engaged in their own initiatives to streamline clinical trial processes for REBs Clinical Trials Ontario is harmonizing a streamlined research ethics review system and will implement this program in 2014 2 In BC, mutual recognition of Research Ethics Boards across the BC government, University of British Columbia and BC Cancer Agency 3 is streamlining the process Quebec has implemented new law for harmonization of reviews, Feb ‘15 Efficient Clinical Trial Environment Sources: 1 - Health Canada website (Accessed 16 Oct 2014); 2 - Biotechnology Focus, June/July 2014 ed; 3 - Clinicall Trials and Preclinical infrastructure Asset Map. Genome British Columbia (Accessed 16 Oct 2014)

24. CONTACT US. WE ARE ACCESSIBLE. www.cctcc.cawww.cctcc.ca info@cctcc.cainfo@cctcc.ca 613-234-2345 or 613-234-5678 116 Albert Street, Ottawa Ontario Belinda Vandersluis, Director Implementation bvandersluis@cctcc.cabvandersluis@cctcc.ca Leyla DiCori, Communications and Strategy Coordinator ldicori@cctcc.caldicori@cctcc.ca General info: info@cctcc.cainfo@cctcc.ca CONTACT

25. THANK YOU.