What your cro doesn t Know could hurt you How to leverage Canada for Study Expansion & Recruitment
Patient 001 ADC
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.
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
Est. 2008 The Reverse Feasibility Program
step 1 a Continuous survey of Canadian investigator needs and interests
step 1 b Engagement and input from patient advocacy groups
step 1 c Find U.S. biotech sponsors in need of oncology study expansion
step 2 Sponsor compounds/studies matched to needs of Canadian sites
step Approach select sites with 3 summary of criteria
step Introduce sponsor to sites and 4 discuss viability & feasibility
step 5 Identify best fit sites
step Start-up & FPI using Master CTA 6 & Regulatory expertise
What are investigators looking for?
motivated disinterested
18
Knowing investigators Isn t enough What else drives Reverse Feasibility Performance?
start-up strategy REB Strategy
start-up strategy Site Contract Strategy Scimega model Clinical Trial Agreement Process 21
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
Average Site Start-Up time in Canada» 36 weeks Scimega Site Start-Up time using Reverse Feasibility» 14 weeks
Canadian Expansion CASE STUDIES
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
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
case study 1 START- UP METRICS 1 2 3 4 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
case study 1 Enrolment Performance SITES 33% Canada vs. 67% US Patients 55% Canada vs. 45% US CAN US CAN US
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
case study 2 Situation: Sophisticated Phase III Immuno-Oncology study in mrcc Global trial ongoing for 14 months Recruitment at risk Minimize logistical complexity
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
case study 2 START- UP METRICS 1 2 3 4 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
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
case study 2 Enrolment Performance
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
Subscribe to our blog to follow the progress of this ongoing clinical trial. http://www.scimega.com/blog
disclaimer NO U.S. CROs WERE HARMED DURING THE CONDUCT OF THESE TRIALS.
conclusion Mobilizing an expert canadian team significantly enhances study start- up & overall performance
UPDATE ON Patient 001 ADC
PATIENT A.D.C ALDO DEL COL
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
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
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
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
16 CENTRES IN 9 PROVINCES
OUR FIRST MEETING ASH 2009
2014
conclusion Mobilizing an expert canadian team significantly enhances study start- up & overall performance
conclusion Mobilizing an expert canadian team significantly enhances study start- up & overall performance
conclusion Mobilizing an expert canadian team significantly enhances study start- up & overall performance