The secret to successful early phase study expansions in

Canada

   

The Rise of Targeted Therapies

   

benefits

BETTER SCIENCE (and investigators with a clear understanding of said science)

= BETTER MEDICINE

   

benefits5-year survival rate for all cancers*

*according to American Cancer Society

68% 2004-201049%

1975-1977

Estimated cancer prevalence by age in the U.S. population from 1975 (216 M) to 2040 (380 M).

Shirley M. Bluethmann et al. Cancer Epidemiol Biomarkers Prev 2016;25:1029-1036

©2016 by American Association for Cancer Research

   Site 1

20 patients 5 patients

5 patients 5 patients

5 patients

   

Study complexity

Oncology Experts Needed

Regulatory Pressure

Efficacy Early on

   The Typical Response To These Operational Challenges

In an attempt at Lowering Direct Costs And mitigate issues regarding •  Quality; •  SOC (standard of care); •  Characterization of Patient Population

(different from North America)

“Off-Shoring”  

Ultra-Restrictive Eligibility Criteria Poor Quality + Time Delays Higher Overall Costs and missed milestone objectives Additional Logistical Challenges Language, Time Zones, Customs, Regulatory

The Typical Results From These Initiatives

   

Source:  Tu*s  CSDD  

   

FASTER GO/NO-GO DECISIONS Much earlier in the development process

   Enrollment Timelines are 71%

longer than planned*

71% 6.7 yearsTime to develop

a new drug

$2.6 billionTotal cost to develop

a new drug

$560 millionCosts from clinical through

regulatory approval

Source:  Tu*s  CSDD    

   

What sponsors look for

Disease Incidence / Prevalence Comparative SOC (standard of care) Minimal logistical Barriers

Language Time Zones Borders

    US EXPANSION PROJECTS

IN THE LAST 18 MONTHS WE’RE ON TO SOMETHING

WHY CANADA?

Key issues

   Any sponsor may submit a CTA to Health Canada. A Representative, residing in Canada must sign the administrative form and certify that the information is complete. Scimega can act as your Canadian representative for all trials.

   

Advantages of Regulatory Landscape in Canada

30-day default approval period FAST-TRACK APPROVALS (NOC/c) For compounds that demonstrate efficacy in early phase trials

VS1-3 month to prepare

CTA with Health Canada

1 week

It  should  not  take  more  than  10  BUSINESS  DAYS  if  your  CRO  is  prepared  and  knows  what  to  expect.  

   

50% quicker site start-up

Average Site Start-Up time

36 weeks

Scimega Site Start-Up time in Canada using Reverse

Feasibility

14 weeks

»   »  

Drug Reimbursement in Canada

DO NOT NEED A DRUG DEPOT PAYERS - EVEN WHEN COMPARATOR ARM NOT ON THE PROVINCIAL FORMULARIES:

•  INCREASED PATIENT ENROLLMENT POTENTIAL;

•  ENHANCED SCIENTIFIC INTEREST MAY OUTWEIGH THE COST.

   

14%at leading centers

VS

Canada’s healthcare system

Participation rates in clinical trials are HIGHER

1 to 5%in U.S

   

Despite these factors, Canada

is still not top of mind for drug developers.

Consider this:

E a r l y p h a s e ( 1 a n d 2 ) "interventional industry-led cancer” trials registered in the US from :

June 2015 to July 2016

712 And yet only 11% (79) of those programs also made it to Canada

Per clinicaltrials.gov

   

   

What’s Your Critical Number?

Inactive sites Out of Scope

costs

Drugcosts

   

   Commit to enrolment milestones

Refuse Under-performing

Studies

Streamline Activation Processes

   Specialized Sub-Units

Activation/ Regulatory

requirements

Patient enrollment

Data collection & monitoring

Pathology & specimens

Scimega’s goal is to leave no site behind and to help find creative ways to ease the burden of clinical trials. Knowing where to look is the key.

   Real-time notification system that alerts you to recruitment opportunities

solution

Scientific interest + Critical Numbers = highly engaged investigators

   

JUST 3 MONTHS = $17.8 MILLION In direct cost savings to drug developers

highlights  a  need  in  Canada  for  an  Ovarian  Cancer  clinical  trial.        

reverse feasibility needs report

Q1 2015

Marketing campaign to target drug developers in Ovarian Cancer

Sponsor with

Ovarian Clinical Trial

Q1 2015

Q2 2015

Match Made

Boston  area  Biopharma  conducDng  Phase  1b  &  Phase  2  trials  in  Ovarian  Cancer    18  Canadian  sites  idenDfied  with  an  acDve  clinical  need  for  the  study    

Q2 2015

Sponsor meets 5 Canadian Investigators at ASCO

Q3 2015

Sponsor agrees to expand trials to Canada but MTD cannot be established due to enrollment delays at U.S. sites

   Canadian sites start calling to ask if they can help expedite start-up

Q4 2015

Q1 2016

Cohort Expansion Confirmed

Canadian sites given the green light!

Study start-up metrics

Q2 2016

US CRO Scimega

MulDple    U.S.  sites  

 

24 weeks

One  Canadian  site  

72 weeks

5  Canadian  sites  

13 weeks

Q2 2016

Scimega 13 weeks

From  complete  Study  Package  Sent  to  Site  iniDaDon  Visit:  

From  SIV  to  First  PaDent-­‐In:  

Lead  Site:  

11.5 weeks

1.5 weeks

3 subjects enrolled in

4 weeks and

2 more in screening

Other Active Clinical Trial Needs in Canada

•     Colorectal  Cancer  •     Gastric  Cancer  •     Liver  Cancer  •     So*  Tissue  Sarcoma  •     NSCLC  •     SCLC  •     Triple  NegaDve  Breast  Cancer  

•     NHL/DLBCL  •     AML  •     ALL    

Solid TumorS

Hematologicalmalignancies

   

Case Study Proof

They had interesting science with good protocol design and great data and yet

Canadian sites still weren’t interested due to the economic burden

of start-up

   5 sites

55%

in less than 2 weeks

of the patients recruted in Canada

       

15 weeks

Dr. Ferrario

Average Start-Up from CPS to SIV

Was top enroller and 1st author

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

hXp://www.scimega.com/blog  

   

Local Knowledge & Relationships in the Oncology World are needed to

Accurately Predict Performance.

Creation of a new drug involves patients, doctors, regulators, payers, sponsors, and CROs.