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

2 © Roche th September, 2012

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

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

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

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 and 30 June 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).

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

COST: High cost of Australian research

9 © Roche Roche data: High cost of Australia research

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, Vic15$13, Vic15$32, Vic20$33, Vic20$11, Vic20$15, WA40$40, NSW15$7, NSW40$26, Vic20$8, Vic20$27, Vic20$39, SA20$20, Vic20$24,050 Total$437,499 COST

13 © Roche “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 © Roche “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.

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