1. 1 © Roche 2012. ANZ Clinical trials – what is the future? 21 st March, 2013 Dr Dan Thurley MD Medical Director Australia & Asia Pacific, Roche picture placeholder

2. 2 © Roche 2012. 7 th September, 2012

3. A recent decrease in the number of new studies In 2012: Australia 18,000 vs Poland 34,000 participants to trials

4. WHY WORRY SO MUCH ABOUT AUSTRALIAN COMPETITIVENESS? CLINICAL TRIAL APPROVALS IN SINGAPORE, HONG KONG & TAIWAN Singapore Taiwan Hong Kong

5. KEY FOCUS AREAS FOR GLOBAL COMPETITIVENESS – AUSTRALIA  Speed to start trials  ethics and governance approval times  Subject recruitment  productivity and efficiency  Value and cost  total cost per patient visit (incl. internal and external costs) Quality  medical and scientific excellence  research standards

6. 2012 SURVEY OF RESEARCH GOVERNANCE TIMELINES IN AUSTRALIA Methodology Survey sent to 45 commercial sponsors of clinical research in Australia Data collected on studies commenced in Australia between 1 July 2011 - and 30 June 2012. Data Collected Milestone dates: HREC approval Last signature date on contract CTN certification dates: principal investigator HREC approving authority sponsor 19 companies responded, providing complete data on 271 CT sites (105 trials).

7. HREC Approval (HREC Approval Letter) to SSA Completion (Last Contract Signature) Calendar Days Best Practice Threshold – 30 calendar days SPEED: 2012 SURVEY OF RESEARCH GOVERNANCE TIMELINES IN AUSTRALIA

8. COST: High cost of Australian research

9. 9 © Roche 2012. Roche data: High cost of Australia research

10. SiteStateNo. Contract SubjectsSite Start Up fees [AUD] 1 Vic10$4,900 2 Vic20$17,162 3 NSW40$8,250 4 Vic20$41,418 5 Vic15$25,250 6 NSW20$12,750 7 WA20$6,600 8 NSW20$8,650 9 Vic20$11,900 10 Vic15$13,050 11 Vic15$32,125 12 Vic20$33,315 13 Vic20$11,917 14 Vic20$15,640 15 WA40$40,050 16 NSW15$7,950 17 NSW40$26,250 18 Vic20$8,982 19 Vic20$27,880 20 Vic20$39,110 21 SA20$20,300 22 Vic20$24,050 Total$437,499 COST

13. 13 © Roche 2012. “A PLAN FOR AUSTRALIAN JOBS” Government’s Industry and Innovation Statement 18 Feb, 2013 Joint Announcement by Ministers Plibersek and Combet One Focus on implementing the CTAG recommendations $9.9m funding “expediting clinical trial reform”

14. 14 © Roche 2012. “A PLAN FOR AUSTRALIAN JOBS” Creating standardised costs for items used by the clinical trials community Incorporating clinical research needs into the e-Health system Developing a conceptual design to enable clinical trials to link, on-site and remotely, with medical records of clinical trial participants A pilot project to develop a national interactive Clinical Trials Portal Education and training of staff and researchers to improve clinical trial conduct and timeliness of approvals Enhancing the ability of the NHMRC to work with states, territories and other stakeholders on a nationally consistent approach to clinical trials.

15. KEY FOCUS AREAS FOR GLOBAL COMPETITIVENESS – AUSTRALIA  Speed to start trials  ethics and governance approval times  Subject recruitment  productivity and efficiency  Value and cost  total cost per patient visit (incl. internal and external costs) Quality  medical and scientific excellence  research standards