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What we want from Early Phase Groups & What are the metrics we use?

What we want from Early Phase Groups & What are the metrics we use?. David Fuller MBBS, B.Pharm (Hons) INC Oncology March 2017. What do we want? And key metrics. The Environment we work in What does the Industry want ? Key metrics

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What we want from Early Phase Groups & What are the metrics we use?

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  1. What we want from Early Phase Groups & What are the metrics we use? David Fuller MBBS, B.Pharm (Hons) INC Oncology March 2017

  2. What do we want? And key metrics • The Environment we work in • What does the Industry want ? • Key metrics “An experiment is a question which science poses to Nature and a measurement is the recording of Nature's answer.” Max Planck, Scientific Autobiography and Other Papers

  3. What do we want ? The cure…

  4. The Oncology Therapeutic Area is increasingly…. • Life saving / extending • Shift from Phase I  Phase II & III available? • Competitive and crowded • Increased choice • Complex  infrastructure & staff needs • Challenging • Personalised / targeted • Expensive for developer & payer / end user • Big Business

  5. Some Industry Metrics…

  6. Some Industry Metrics • 70 new oncology approvals for • 20 new indications over • 5 past years • > 500 oncology companies • >586 oncology products in late phase • 130 concentrated in 10 pharma companies • Median approval time is 9.5 years  patent life10 years • ~ $950 million out of pocket clinical spend per molecule • One month delay in trial  $> $40 million potential lost sales

  7. Why Australia ? • High quality / reputation – 1st world standards • Regulatory “light” • Clinical Trial Notification • Need protocol and Investigator Brochure • No IND needed • Private sites for fast Ethics & Governance approval, with high quality academic slights (slower start-up) • Financial Incentives: R&D Tax – non-dilutive finance !! • Exchange rate advantages

  8. Interventional Industry Sponsored Oncology

  9. Interventional Industry Sponsored OncologyAU = 13.5 vs US 7.57 per million population

  10. Our large clients want this….

  11. Our small clients want this….

  12. Likelihood of Approval (from Phase 1) • Source bio.org

  13. Where does INC fit in ? • 15th March: Our pharma or biotech client needs a proposal to run a 30 patient dose escalation 3+3 / dose expansion study in advanced cancers with first patient in by 30th June and recruitment complete within 12 months

  14. Rarely happens the other way…

  15. What we want – Time, Cost, Quality....

  16. And risk managed……

  17. What The Industry want … • Strong Relationships • Good infrastructure • Timeliness • Quality • Cost competitiveness • Predictability • Timely start-up • Recruitment • Reliable Feasibility Data • Reliable Study Data

  18. What we want / Wish List • Strong Relationships • Good infrastructure • Timeliness • Quality • Cost competitiveness • Predictability • Timely start-up • Recruitment • Reliable Feasibility Data • Reliable Study Data Wish List….. • No CDAs • Improved Feasibility • Integrated PK/PD Labs • Centralised Ethics Approval for Australia • Streamlined Governance

  19. Key Metrics …

  20. Key Metrics …Time, Cost, Quality • Time to • Study Initiation Visit • First patient / first visit • Last patient out • Database lock • Recruitment – patients / site / month • Average cost / completed patient • Initial budget to final budget (forecast vs actuals) • Quality • Query rate – from CRA visits • Query rate – from database review • Significant audit findings

  21. Site Start Up & Regulatory Country metrics and start up considerations • Parallel or sequential submissions (CIRB or LIRB) • Academic institutions often require sequential submission, include secondary review committees, complex site contract language negotiation United States FSA: Jul 2017 • Parallel or sequential submissions (CREB or LREB) • Academic institutions often require sequential submission, include secondary review committees, complex site contract language negotiation Canada • FSA: • Jul 2017 • Final site selection and identify the lead site key for success • National country contract template language without any changes is highly recommended. • Budget to be available for (c / l) EC submission • Watch potential risk of EC escalation to the TGA fro full review and approval vs. only acknowledgement Australia • FSA: • Sept 2017

  22. Recruitment Rate – The Key MetricPatients / Site / Month

  23. Our Math (s) The client wants a 160 patient study completed in newly dx glioblastoma Current median recruitment rate 0.13 i.e. the average site will deliver 1-2 pats / year • We use ~ 0.5 for advanced solid tumours Recruitment time 18 months So required sites will be 160 patients / 18months / 0.13 = 70 sites However if the actual rate is 0.1 psm then we need: • 88 sites or • An extra 6 months recruitment

  24. Rarely happens the other way…

  25. What The Industry want … • Strong Relationships • Timeliness • Quality • Cost competitiveness • Predictability • Timely start-up • Recruitment • Reliable Feasibility Data • Reliable Study Data

  26. What The Industry want … • Strong Relationships • Timeliness • Quality • Cost competitiveness – per patient cost • Predictability • Timely start-up – days to FPI • Recruitment – p/s/m • Reliable Feasibility Data • Reliable Study Data

  27. Any questions?

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