Clinical Trials in Canada: Impact of Globalization

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Clinical Trials in Canada Impact of
Globalization

• Ghislain Boudreau, PhD
• Director Medical Affairs
• and Clinical Research
• Pfizer Canada Inc

2
RD in Canada

• Leading development pharmaceutical companies have
  used Canada strategically to reinforce their
  global development capacity.
• As a pivotal country to many development
  programs, Canadas contribution to RD Clinical
  Research has often been larger than its direct
  commercial contribution.

3
RD Expenditure in Canada
Applied research, represents approximately 62 of
current RD expenditure. Clinical trials
accounted for 76.9 of applied research
expenditure.
PMPRB Annual Report 2005 www.pmprb-cepmb.gc.ca/en
glish/
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Annual Drug Submission Performance Report 2006,
TPD www.hc-sc.gc.ca/dhp-mps/alt_formats/hpfb-dgpsa
/pdf/prodpharma/tpd_dpt_annual_annuel_05_e.pdf
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Current Environment

• Rising Costs of Development
• Pressure on RD Budgets
• An Industry under Pressure
• Limited Pool of Trained Investigators
• Global Competition

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Productivity Challenge
35
Total RD Investment (Billions)
30
25
20
15
10
5
0
2003
1970
1975
1980
1985
1990
1995
2000
Source 2004 PhRMA Annual Survey, 2003/2004
PAREXELS Pharmaceutical Industry Sourcebook
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Globalization
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Globalization

• The landscape is changing and clinical trials
  starting now are becoming more and more global
  with increase activities in the new emerging
  economies in Eastern Europe, Latin America and
  South Asia
• (Getz, K.A., Applied Clinical Trials, December 1,
  2005).

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Globalization of Clinical Trials

• The Globalization of Clinical Trials Where Are
  They Going and Why?Ernst R. Berndt, et al., Drug
  Information Association June 19, 2007
• Atlanta, Georgia

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Decision to place a clinical trial
Cost

• Research
• Balance

Speed
Quality
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Global Trial Placement Decision Making
Regulatory
Logistics
Disease
?
Subjects
Training
Infrastructure
Risk
Medical Practice
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Innovation in Canada
15
if Canada is not successful in rewarding
innovation, that innovation will be developed
elsewhere (Russell Williams, President of
Canadas Research Based Pharmaceutical Companies
(RxD), Statement PMPRB Report 2005, Canada
NewsWire, 23June 2006
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The Global Context Canada versus Comparator
Countries
PMPRB Annual Report 2005 www.pmprb-cepmb.gc.ca/en
glish
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RD-to-Sales Ratio in Canada
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Canadas contribution

• One of the largest contributor in clinical trials
  investment after the US
• Numerous advantages to conduct clinical trial in
  Canada
• Presence of Centres of Excellence
• Number of high quality clinical sites as measured
  by level of GCP training
• Experienced clinical trial and site management
  organizations
• Well-characterized patient populations
• Early-stage initiatives to create centralized IRB
• Cost advantage for biotech/biomedical RD

Clinical Trials in Canada Quality with Cost
Advantage, Government of Canada, 2003)
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Canadas contribution

• Numerous advantages to conduct clinical trial in
  Canada
• Lower diagnostic and interventional costs per
  patient through public healthcare
• Financial support for clinical trials on a
  selective basis from government sources, e.g.,
  Technology
• Partnerships Canada (http//tpc.ic.gc.ca),
  Canadian Institutes of Health Research (CIHR) and
  BioLevier
• Common standard-of-care which allows for easier
  integration of clinical trial data over many
  sites
• Competitive labour costs, especially for research
  nurses with good clinical practice (GCP) training
• Canadian reputation for high standards of
  reliability in clinical research

• Clinical Trials in Canada Quality with Cost
  Advantage, Government of Canada, 2003)

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Areas to explore

• Streamlining clinical trials (moving away from
  empirical design)
• Biomarker development
• Genomic
• Proteomic
• New technology (imaging techniques)
• Collaboration with Biotech
• Global Risk Management (Pharmacovigilance)
• Partnership with Academia, Government,
  Scientific/Medical Associations

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Canada A pivotal country

• As a pivotal country to many development
  programs, Canadas contribution to RD has often
  been larger than its direct commercial
  contribution. In order to maintain this pace, we
  will need to work collaboratively at aiming to
  accelerate development of safe and effective
  medicines, aiming to bring tangible benefits to
  Canadian patients and revitalize the
  biopharmaceutical research environment.