What your cro doesn t Know could hurt you. How to leverage Canada for Study Expansion & Recruitment

Transcription

1 What your cro doesn t Know could hurt you How to leverage Canada for Study Expansion & Recruitment

2

3 Patient 001 ADC

4 Scimega s mission: To attract cutting-edge oncology trials to Canada and to connect sponsors with a network of highly motivated investigators and their patients.

5 summary A Look Under The Hood of the Reverse Feasibility Program - REB Strategy - Site Contract Execution - Regulatory Strategy Keys to Accelerating Site Performance Real-life Canadian Expansion Success Stories & Results

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7 Est The Reverse Feasibility Program

8 step 1 a Continuous survey of Canadian investigator needs and interests

9 step 1 b Engagement and input from patient advocacy groups

10 step 1 c Find U.S. biotech sponsors in need of oncology study expansion

11 step 2 Sponsor compounds/studies matched to needs of Canadian sites

12 step Approach select sites with 3 summary of criteria

13 step Introduce sponsor to sites and 4 discuss viability & feasibility

14 step 5 Identify best fit sites

15 step Start-up & FPI using Master CTA 6 & Regulatory expertise

16 What are investigators looking for?

17 motivated disinterested

18 18

19 Knowing investigators Isn t enough What else drives Reverse Feasibility Performance?

20 start-up strategy REB Strategy

21 start-up strategy Site Contract Strategy Scimega model Clinical Trial Agreement Process 21

22 start-up strategy Regulatory Strategy Parallel REB / HC Review Openness of HC Reviewers (official / unofficial discussions) When to hold a HC pre-cta meeting 22

23 Average Site Start-Up time in Canada» 36 weeks Scimega Site Start-Up time using Reverse Feasibility» 14 weeks

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25 Canadian Expansion CASE STUDIES

26 case study 1 Situation: Phase 1 dose finding HER2+ BrCa study looking at oral HER2 inhibitor in combination with T-DM1 Trial had been ongoing for six months at 7 sites in the U.S. Target end of recruitment by July 2015

27 case study 1 challenge reason Action taken Slow Enrolment 0.1 pts/month Scarcity of comparator arm naïve subjects (comparator drug in wide use in US) 3x Repeat customer: Came to Canada after last study was completed 3 months ahead of schedule

28 case study 1 START- UP METRICS Introduced Sponsor to select Reverse Feasibility Champions Confirmed Investigator Interest (comparator arm approved but not yet covered for 2nd line) results Identified 5 sites in less than two weeks Selected 4 sites Average Start-Up: 14 weeks from CPS to SI Study closed to enrolment in April 2015

29 case study 1 Enrolment Performance SITES 33% Canada vs. 67% US Patients 55% Canada vs. 45% US CAN US CAN US

30 Thanks to the Reverse Feasibility Program and Scimega s ability to attract pertinent clinical trials to Canada, several of my patients were able to LIVE significantly longer. Dr. Cristiano ferrario Montreal Jewish General hospital 2015 reverse feasibility champion

31 case study 2 Situation: Sophisticated Phase III Immuno-Oncology study in mrcc Global trial ongoing for 14 months Recruitment at risk Minimize logistical complexity

32 case study 2 challenge reason Action taken Slow Enrolment Logistical Complexity (required fresh tumor sample collection and access to leukapheresis lab) Site Expansion : Were told by existing CRO that Europe was the option; not Canada due to lack of PI interest & sites with limited capabilities

33 case study 2 START- UP METRICS results Introduced Sponsor to select Reverse Feasibility Champions Confirmed Within 2 weeks Investigator we had Interest confirmed (comparator 6 sites arm approved but not yet covered for 2nd line) Sponsor selected top 5 sites to add to existing four; In the end we doubled the # of sites in Canada Average Start-Up: 9.3 weeks from CPS to SIV

34 case study 2 START- UP METRICS results Introduced Sponsor to select Reverse Feasibility Champions Scimega Existing CRO in Canada Confirmed Investigator Interest (comparator arm approved but not yet covered for 2nd line) IRB TYPE Local Local # sites 5 4 Time from CPS IRB app 7.8 weeks 14.1 weeks Time from IRB app SIV 1.5 weeks total: 9.3 weeks 18.7 weeks total : 32.8 weeks

35 case study 2 Enrolment Performance

36 Scimega managed to expedite EC/IRB regulatory submissions at the site level, and accomplished in a much faster time frame in our p3 study than our global CRO. They are nimble, attentive and have an experienced oncology team that can handle all aspects of study operations and site level needs VP, Clinical and medical affairs

37 Subscribe to our blog to follow the progress of this ongoing clinical trial.

38 disclaimer NO U.S. CROs WERE HARMED DURING THE CONDUCT OF THESE TRIALS.

39 conclusion Mobilizing an expert canadian team significantly enhances study start- up & overall performance

40 UPDATE ON Patient 001 ADC

41 PATIENT A.D.C ALDO DEL COL

42 MCRN MISSION To conduct innovative Phase I & II clinical trials and translational research in a collaborative manner across Canada to improve patient outcomes in myeloma To publish evidence-based and peer-reviewed national consensus statements on the diagnosis and treatment of myeloma To develop a nationwide myeloma patient database

43 More early-phase trials with promising new therapies How PATIENTS BENEFIT Wider availability of new treatment options Enhanced access to an expanded clinical trial network Patient involvement

44 PRESENT & FUTURE COLLABORATIONS Celgene Otsuka Karyopharm Janssen Onyx Amgen The Binding Site NCIC Clinical Trials Group CellCAN (Regenerative Medicine & Cell Therapy Network) IMF Black Swan Research Initiative Cancer Research Society

45 MCRN ADVANTAGES & BENEFITS One-stop access to Canada s network of myeloma investigators and academic centres Rapid accrual Cost effectiveness Quality of results Collaboration with international experts Patient-centric

46 16 CENTRES IN 9 PROVINCES

47 OUR FIRST MEETING ASH 2009

48 2014

49 conclusion Mobilizing an expert canadian team significantly enhances study start- up & overall performance

50 conclusion Mobilizing an expert canadian team significantly enhances study start- up & overall performance

51 conclusion Mobilizing an expert canadian team significantly enhances study start- up & overall performance