1. Developing a Canadian
Clinical Research
Asset Map
Shurjeel H Choudhri MD, FRCPC
Senior Vice President & Head, Bayer Inc

2. Clinical Research:
Canada is losing its edge
Cost/Performance Operational environment
(value for money) (public/private
partnerships)
Canada’s
Competitiveness
Recruitment Reliability (lost opportunity)

3. Clinical
Trials
by
Country:
Percent
Change
from
2005
to
2010
180% Japan
160% China
140%
Percentage of Change
Russian Confederation
120%
Poland
100%
Australia
80% CANADA
60% Argentina
40% Germany
20%
France
0% 3 4 5 6 7 8 9 10 11
12 13
2 14 15
16
Brazil
-20% 1
India
Country by Rank from 1 to 16

4. Clinical
Trial
Sites
by
Country:
Percent
Change
from
2005
to
2010
250%
Japan
200% India
Percentage of Change
China
150% Russian Confederation
Argentina
100%
Poland
Brazil
50% CANADA
Australia
South Africa
0% 5 6 7 8
4
1 2 3 United Kingdom
9 10 11 12 13 14 15
16 Spain
-50%
France
Country by Rank 1 to 16

5. Clinical
Trial
Subjects
by
Country:
Percent
Change
from
2005
to
2010
300%
India
250%
Japan
Percentage of Change
200% China
Spain
150%
Russian Confederation
100%
Brazil
50% CANADA United States of America
Australia
0% 4 5
1 2 3 6 7 8 9 Poland
10 11 12 13 14 15 16
-50% France
Germany
-100%
Argentina
Country by Rank from 1 to 16

6. Average
Recruitment
Reliability
(AvRR):
From
2005
to
2010
1.6
1.4
1.2
1
AvRR
0.8
Canada
0.6
Global
0.4
0.2
0
2005 2006 2007 2008 2009 2010
Year

7. Per-­‐Patient
Cost
by
Country:
2006
to
2010
25,000
CANADA
CANADA
Per-Patient Cost (CAN$)
20,000
15,000 Canada
France
10,000 Germany
Spain
5,000 United Kingdom
United States
0
2006 2007 2008 2009 2010
Year

8. Per-­‐Patient
Cost:
International
Comparators
Canada
United States
Comparison Country
Canada
United Kingdom
Canada
Spain
Canada
Germany
Canada
France
$0 $5,000 $10,000 $15,000 $20,000 $25,000
Per-Patient Cost (CAN$)

9. Time
to
First
Patient
In
(FPI)
by
Year
250
200
Time to FPI (DAYS)
150
Canada
100
United States of America
Global
50
0
2005 2008 2010
Year

10. ….but
we
are
still
in
the
game
• Well-characterized and well managed patient population
• We must compete globally
• Understand the global clinical research landscape
• Understand our patient population (strategic choices)
• Create research infrastructure for trials of the future
• Be fast, efficient and reliable (get results)
• Create a favorable business environment (IP-Access-Price)
• Innovation Strategy/Knowledge Based Economy

11. Clinical
Trials
Summit
2011
• The first ever clinical trial steering committee meeting on
September 15, 2011
• 150 experts from Government, Academia, Clinical Sites and
Industry
• The Summit addressed topics of critical importance to the
Canadian clinical trial environment, including:
• Ethics review process
• Recruitment, patient retention and follow-up (administrative databases, e-
records)
• Cost structure
• Administrative (contracts, standard operating procedures, education,
training)
• Future – what strengths can Canada develop that would make a difference in

12. Clinical
Trials
Action
Plan
http://www.acaho.org/?policy_2012

13. To Your Health & Prosperity…An Action Plan to help attract more clinical trials to Canada
The Vision is for Canada to become a premier country globally for conducting industry led clinical trials (CTs)
The Goals are to help (1) reverse or halt a downward CT investment trend; (2) improve business operations;
(3) create a positive forward looking opportunity.
Strategy 1: Establish short & longer term Strategy 2: Improve business operations through better Strategy 3: Shape a positive future business
implementation capacity for this action plan & cost, quality, and speed of clinical trial start up times. environment & signal Canada’s interest
coordination of other CT improvement activities globally with information& incentives.
Recommendation Details Recommendation Details Recommendation Details
Recommendation 1. Establish Coordination & Recommendation 4. Leveraging appropriate Recommendation 8. We can improve the
an implementation implementation focus & Improve efficiencies of ethics expertise, common consent & Optimize intellectual attractiveness of
headquarters & resources to resource are required as reviews-common forms and ethics application property protection policy Canada as an
implement action plan & to is coordination of metrics and advance forms will be developed to & SR&ED Tax Credits investment partner
coordinate existing clinical existing CT initiatives. strategic considerations like reduce confusion and cost. It will by adjusting IP and
trial improvement activity. SPOR to be accreditation & begin with feasibility & option SR&ED policy.
approached. harmonization. assessment. Strategic issues like
accreditation also require
detailing.
Recommendation 2. As the intent of the plan Recommendation 5. Using appropriate privacy Recommendation 9. Beginning on a small
Measure, monitor, manage is to attract business, Develop a database of considerations, improve Signal our interest globally scale, communicate
and market CT performance results need to be registries to identify eligible recruitment by focussing on the - open a concierge CT assets &
improvements measured & patients & consider national use of registries & a national (storefront) service for improvements to
communicated. recruitment strategy. recruitment strategy. investors global companies.
Consider concierge
Recommendation 3. A bold long term vision Recommendation 6. Adopt Resources will be sought for or
Integrate health system and is needed for issues common SOPs, training and broader use of N2’s common storefront for
research infrastructure to impacting health care certification that are already SOPs, training & certification to investors.
address issues which affect & research & thereby available. increase trust & efficiency.
CTs because of the impact CTs. This will enable cost
on research and healthcare. containment Recommendation 7. Upon pilot completion, adjust Full action plan: ACAHO, Rx&D, CIHR, 2012. To
considerations and Improve and use the model the mCTA as needed & Your Health & Prosperity…An action plan to help
sustainability. clinical trials contract (mCTA) communicate use to global attract more clinical trials to Canada. See:
offices. www.acaho.org or www.canadapharma.org

14. To Your Health & Prosperity…An Action Plan to help attract more clinical trials to Canada
The Vision is for Canada to become a premier country globally for conducting industry led clinical trials (CTs)
The Goals are to help (1) reverse or halt a downward CT investment trend; (2) improve business operations;
(3) create a positive forward looking opportunity.
Strategy 1: Establish short & longer term Strategy 2: Improve business operations through better Strategy 3: Shape a positive future business
implementation capacity for this action plan & cost, quality, and speed of clinical trial start up times. environment & signal Canada’s interest
Recommendation 9.
coordination of other CT improvement activities Beginning on a globally with information& incentives.
Recommendation Signal our interest
Details Recommendation small Details scale, Recommendation Details
implementation focus - open a
globally & Improve efficiencies of ethics communicate CT intellectual
Recommendation 1. Establish Coordination & Recommendation 4. Leveraging appropriate Recommendation 8. We can improve the
an implementation expertise, common consent & Optimize attractiveness of
headquarters & resources to
implement action plan & to concierge metrics and advance
is coordination of (storefront)
resource are required as reviews-common forms and
assets &
ethics application
forms will be developed to
property protection policy
& SR&ED Tax Credits
Canada as an
investment partner
coordinate existing clinical existing CT initiatives. strategic considerations like reduce confusion and cost. It will by adjusting IP and
trial improvement activity. service for accreditation &
SPOR to be
approached.
investors
harmonization.
improvements to
begin with feasibility & option
assessment. Strategic issues like
SR&ED policy.
global companies.
accreditation also require
detailing.
Consider
considerations, improve or
concierge
Recommendation 2. As the intent of the plan Recommendation 5. Using appropriate privacy Recommendation 9. Beginning on a small
Measure, monitor, manage is to attract business, Develop a database of Signal our interest globally scale, communicate
and market CT performance results need to be registries to identify eligible recruitment by focussing on the - open a concierge CT assets &
improvements measured &
communicated.
patients & consider national
recruitment strategy.
storefront for
use of registries & a national
recruitment strategy.
(storefront) service for
investors
improvements to
global companies.
Recommendation 3. A bold long term vision Recommendation 6. Adopt
investors. for
Resources will be sought
Consider concierge
or
Integrate health system and is needed for issues common SOPs, training and broader use of N2’s common storefront for
research infrastructure to impacting health care certification that are already SOPs, training & certification to investors.
address issues which affect & research & thereby available. increase trust & efficiency.
CTs because of the impact CTs. This will enable cost
on research and healthcare. containment Recommendation 7. Upon pilot completion, adjust Full action plan: ACAHO, Rx&D, CIHR, 2012. To
considerations and Improve and use the model the mCTA as needed & Your Health & Prosperity…An action plan to help
sustainability. clinical trials contract (mCTA) communicate use to global attract more clinical trials to Canada. See:
offices. www.acaho.org or www.canadapharma.org

16. Why Create a New Asset Map?
Limitations of existing asset maps include:
— Most are promotional brochures and represent only a snapshot of clinical
research in a particular region, disease area or time period
— Focus is on academic or institutional sites with a gap in information for
private, non-institutional research sites
— Information available is of variable age with some being current while many
others appear not to have been updated frequently, being up to 5 years old.
— Highly variable content with some asset maps providing very general
information and others being specific.

17. What is the Canadian Clinical Trials
Asset Map?
— Inspired by the Clinical Trials Summit Action Plan
— Project to develop a web-based, “living”, easily
searchable, interactive, database of Canadian
clinical research capabilities
— Broad umbrella of working group members from
Rx&D and member companies, CIHR, DFAIT, HC, IC,
ACAHO, BCCRIN, CTO, N2, etc.

18. Canadian Clinical Trials Asset Map
Objectives
— Improve capacity for both academic and
commercial sectors to conduct clinical studies in
Canada;
— Position Canada globally as an attractive
destination for clinical trial investments.

19. Current Status

21. Value of Clinical Trial Investment =
Costs (procedural + IRB + start-up + overhead + lost
opportunity + complexity – SR&ED credits)
+
Quality
+
Efficiency (regulatory approval timelines + speed of
establishing contract + IRB approval + trial complexity +
trial initiation + enrollment)

22. Asset Map Working Group Members
Alison Orth BCCRIN, Clinical Research Consultant,
Barbara Nicholls GSK
Bradley Millson Foreign Affairs & Intl Trade Canada
Celia Lourenco Health Canada, Office of Clinical Trials
Christophe Ledent Industry Canada
Farida Dabouz FB2D Clinical Research Consulting
Geoffrey Hynes CIHR
Heather Dunster Rx&D
Heather Harris BCCRIN
Janette Panhuis Population Health Research Institute
Joanna O'Reilly Health Canada, Office of Clinical Trials
Karen Arts Ontario Institute of Cancer Research
Keith Francis Bayer
Ken Hughes Rx&D
Linda Assouline Abbott
Linda Bennett Cdn Rheumatology Research Consortium
Marielle Métrailler Rx&D
Mark Ferdinand Rx&D
Muhammad Mamdani St. Michaels Hospital - Li Ka Shing Knowledge Institute
Nadia Lise Tanel Bloorview Research Insitute, Holland Bloorview Kids Rehab Hospital
Natasha Georgijev EMD Serono
Rohinish Gunadasa Syreon Corporation
Ron Heslegrave CT Ontario
Sandra Gazel Abbott
Shurjeel Choudhri Bayer
Tina Saryeddine ACAHO

24. Thanks!
Questions?