Normand Laberge Vice-President Regulatory & Scientific Affairs Rx&D. Globalization of Clinical Research: Trends & Implications for Canada

Transcription

1 Normand Laberge Vice-President Regulatory & Scientific Affairs Rx&D Globalization of Clinical Research: Trends & Implications for

2 Success Rates by Phase and Therapeutic Area Source: Nature Reviews Drug Discovery, vol. 3, issue 8, (August 2004), I. Kola and J. Landis: Can the Pharmaceutical Industry Reduce the Attrition Rate? Data from the top ten companies during as obtained by Datamonitor in the Pharmaceutical Benchmarking Study

3 Success Rate Compounds Discovered 1 Goes to Market

4 New Drug Discovery and Development Basic research Applied research Discovery Effective patent life Patent years

5 R&D Spending by Industry Source: Booz Allen Report: THE GLOBAL INNOVATION 1000: How the Top Innovators Keep Winning, 2010 Investments in Healthcare R&D were maintained

6 Biopharm R&D Investment (US$B) by Year Source: PhRMA Report: Profile Pharmaceutical Industry, 2010 Investments From PhRMA Slowed down

7 Evolution of Number of Trials 2011 MIT-NBER-ViS Analysis of clinicaltrials.gov data (Sep 2005 Sep 2010) Number of trials decreased

8 Percentage of Trials by Country % 14.04% 2010 Argentina 45.27% % 2.19% 45.68% % 5.07% 3.99% Australia Brazil China France Germany % India Japan 13.70% Poland 15.18% 8.94% 11.58% 4.50% 5.79% 7.14% % 4.37% % 4.24% 7.64% % Russian Confederation South Africa Spain Sweden United Kingdom United States of America

9 Trials by Country: Change from 2005 to % Japan 160% China Russian Confederation 140% Poland Percentage of Change 120% 100% 80% 60% 40% 20% CANADA Australia Argentina Germany France Brazil India United States of America Spain 0% -20% Country by Rank from 1 to South Africa United Kingdom Sweden

10 Evolution of Average Number of Sites per Trial in Phase III Trials 2011 MIT-NBER-ViS Analysis of clinicaltrials.gov data (Sep 2005 Sep 2010) Number of sites per trial decreased

11 Percentage of Sites by Country % 4% Argentina 25% 4% 9% 29% 7% Australia Brazil China France 4% 6% Germany India Japan Poland Russian Confederation South Africa Spain Sweden 37% 30% United Kingdom United States of America Other

12 Percentage of Sites by Country % 4% Argentina Australia 25% 4% 29% 7% Brazil China 9% France Germany India 4% 6% Japan Poland Russian Confederation South Africa Spain 37% 30% Sweden United Kingdom United States of America Other

13 Sites by Country: Change from 2005 to % 200% Japan India China Percentage of Change 150% 100% 50% CANADA Russian Confederation Argentina Poland Brazil Australia South Africa United Kingdom Spain France 0% -50% United States of America Germany Sweden Country by Rank 1 to 16

14 Percentage of Subjects by Country % 4% 4% 2010 Argentina Australia 38% 7% 4 6% Brazil China France Germany India Japan Poland Russian Confederation South Africa Spain 24% 2 Sweden United Kingdom United States of America Other

15 Subjects by Country: Change from 2005 to % 250% India Japan 200% China Spain Percentage of Change 150% 100% 50% CANADA Russian Confederation Brazil United States of America Australia Poland France Germany 0% -50% Argentina Sweden South Africa United Kingdom -100% Country by Rank from 1 to 16

16 Average Recruitment Reliability (AvRR): From 2005 to AvRR Spain Global Year

17 Per-Patient Cost by Country: For 2006 to ,000 20,000 Per-Patient Cost (CAN$) 15,000 10,000 5,000 France Germany Spain United Kingdom United States Year

18 Per-Patient Cost Comparing Same Trials United States Comparison Country United Kingdom Spain Germany France $0 $5,000 $10,000 $15,000 $20,000 $25,000 Per-Patient Cost (CAN$)

19 Opportunity Loss by Year $ $ $ AvOL (CAN$) -$ $ $ $ Year

20 WHAT TO MAKE OF ALL THIS DATA: Where does stand?

21 Where does stand? We are still in the race Patient availability (quality of our research) We have lost our edge Cost/Performance (value for money) Operational environment (public/private partnerships) Recruitment Reliability (lost opportunity)

22 Where does stand? Emerging markets not our competitors Spain, UK, Australia, Argentina and US (competitive edge) Policy framework (clinical research and regulatory) Market attractiveness (business environment) Availability of comparator drug (standard of care)

23 How can prepare to host global pharmaceutical clinical trials?

24 Compete Globally Understand the global clinical research landscape Understand our patient population (strategic choices) Create research infrastructure for trials of the future Fast, efficient and reliable (get results) Create a favorable business environment (IP Access Price) Collaborate with your industry!!!

25 Thank you