Melbourne University / Ventana collaboration

Jayesh Desai Medical Oncologist Head of Early Drug Development Trials PCCTU Peter MacCallum Cancer Centre/Royal Melbourne Hospital Walter and Eliza Hall Institute Outline Cancer Trials Australia (CTA) as a Collaborative Model Background Phase I/Early Drug Development Group Evolution of Phase I Group Successes and Challenges Next steps Applying this model elsewhere/in NSW? CTA- Background Member based organisation of 22 clinical and research sites Established as the CDCT 1993. RMH, PMCC, Austin, LICR, WEHI: Development of G-CSF Incorporated in 2003 as CTA, Not for Profit Company Underlying Principles

Academic network to facilitate clinical/translational research (trials) Operational: Central Infrastructure to maintain a clinical network to conduct clinical trials efficiently e.g. governance/contracts/ethics/budgets Act strategically as an enabler The Phase 1 group: Early phase cancer trial Your drug. Our expertise. specialists A successful combination to manage your clinical trials A single point of contact to a wide Phase 1 network Evolvement of CTA- Phase I Group Continued growth in activity Groups members conduct 50-60 Phase I trials 20 Haem, 15-20 FTIH. 80% big pharma Original 3 and 2 more recent Phase I clinical sites RMH: strong focus on Ph1 within units portfolio, translational drive though WEHI, strengths in Haem, Brain, CRC, Breast, strategic relationships/CoE PeterMac: focus on translation opportunities, strengths in melanoma, lung, haem, strategic relationships (eg. Pfizer........Roche/Genentech, BMS)

Combined program with approx 40 Phase I trials, I/O focus, evolve from Reactive to Pro-active Austin: (Hui Gan) Ludwig programs, strong drive in Solid tumours Monash: (Ben Markman) Steady growth over 6 years. 10-15 Ph1s. Evolvement of CTA- Phase I Group Underlying Principles Academically driven, high quality Phase Is. Not contract research Work closely with Biotech Assemble a large group as a One-Stop Shop following on from CDCT Signiifcant depth and breadth of expertise Clinical, drug-development expertise Translational/biology Other, eg. Pharmacodynamic, Molecular Path Operational: Regulatory guidance, budgets etc Partners included: Bionomics, Engeneic, UNSW (PENAO), Beigene Provides trials and opportunities, and Strong culture of providing mentorship to sites/investigators Information exchange/sharing of IP Strategic Initiatives Bre as l

g Lun k PhaseG 1 Brain d Mark Rosenthal Kate Drummond Hui Gan a He a Danny Rischin Linda Mileshkin Michael Quinn Anne Hamilton om

rc Danny Rischin Ben Soloman Hui Gan Ben Solomon Linda Mileshkin Paul Mitchell David Ball Hui Gan yn e cal cologi Sa & l a c i log Guy Toner Andrew Weickhardt

Lisa Horvath Shahneen Sandhu Mark Rosenthal Ben Tran Uro t Ne c Geoff Lindeman Richard de Boer Sherene Loi Jane Beith Andrew Roberts William Rennick John Seymour Simon Harrison David Ritchie Miles Prince Andrew Grigg Jeff Szer

He m at ol og ica Niall Tebbutt Peter Gibbs Melanoma ro l st i n a Ga st te In Translational and drug development Michael expertise Michael Jayesh Desai Grant McArthur

Andrew Haydon Jonathan Cebon Mark Shackleton Catriona McNeil Jayesh Desai Preclinical expertise and support G as Tony Burgess Matthias Ernst Wayne Phillips Rob Ramsay Oliver Sieber John Mariadason Jayesh Desai em H o t a

l a c i g o l g o l o r U ne co lo l a ic Brain

Gail Risbridger Patrick Humbert Lisa Horvath Ygal Haupt nt es tin al Andrew Roberts Nick Nicola Warren Alexander David Huang Andreas Strasser Kylie Mason Ricky Johnstone Mark Dawson Preclinical G y Breast Jane Visvader

Geoff Lindeman Ian Campbell Robin Anderson Sherene Loi tr oi Melanoma Grant McArthur Jonathan Cebon Mark Shackleton Terry Johns Mark Rosenthal Richard Shaffery Lung Neil Watkins Ben Solomon Tom John Marie-Liesse Asselin-Labat David Bowtell gi

ca Claire Scott lWayne Phillips Key Projects/Initiatives HRE Application FTIH Application FTIH Advice Key Projects/Initiatives HREC approval process/MAP ity to conduct FTIH trials without the need for an IND applica 60 days to HREC/Governance approval HREC ApplicationOne HREC application for all of CTAs clinical HRE Application sites CTA compiles HREC submission within 15 days Approval time can be reduced if no scientific or ethical queries are received

CTA assists with the preparation of FTIH submission FTIH Application FTIH Application Developed under the Clinical Trial Notification (CTN) scheme, no IND required FTIH Advice FTIH Advice 10 days to evaluate data within HREC approval period Preclinical data examined by independent expert panel Panel advise on data readiness for clinical trial to facilitate HREC approval FTIH: First time in human HREC: Human research ethics committee Key Projects/Initiatives Active input into the Regulatory Process: Personalised Medicine Molecular testing protocol (ALK and beyond), referral pathways Coordinated Grants

VCA and CCV: eg.TrialMatcher MGHA: solid tumours CRC/CTX2: Clinical partner Strategic Reviews Annual, + Extensive reviews Julian Clark/WEHI Bus Dev, Deloitte/CTA: trial costings Marketing efforts Educational programs and scholarships: Melb Uni, Mol to Medicines Trials App with CCV Next Steps Changes++ in Victoria VCCC, Monash, Austin Lifehouse Focus on consolidation of programs at a site level Sites are now mature and independent Network to continue to enhance activity, communication Initiatives around referral pathways, personalised medicine, I/O Summary: Value of Collaboration? Challenges Competing interests: investigator, site Managing expectations: from sites/investigators and from sponsors Collaboration requires give and take

Defining Phase I success requires a long-term view Sites need to invest in resources themselves Not an automatic way to get Phase I trials Summary: Value of Collaboration? Challenges Competing interests: investigator, site Managing expectations: from sites/investigators and from sponsors Defining Phase I success requires a long-term view Positives Mentorship and knowledge sharing has been outstanding Not only reliant on what our own institutions can provide Depth and breadth of expertise and resources offered through the network Sharing of platforms/expertise Facilitate Australian Biotech Ability to develop larger strategic initiatives, funding/grants Develop a more sophisticated operational model, educating HRECs Clearly generated more trials for us Summary: Value of Collaboration? Challenges Competing interests: investigator, site Managing expectations: from sites/investigators and from sponsors Collaboration requires give and take Defining Phase I success requires a long-term view

Positives Mentorship and sharing of our IP has been outstanding Not only reliant on what our institutions can provide Depth and breadth of expertise and resources offered through the network Sharing of platforms/expertise Ability to develop strategic initiatives, funding/grants Develop a more sophisticated operational model Clearly generated more trials for us

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