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Drug Development 2017: Advancing early phase clinical trials through collaboration

Drug Development 2017: Advancing early phase clinical trials through collaboration. The Austin Health Experience. Qualifications and Career. 2008-2009. 2003-2007. 2010 to current. 2002. FRACP. PhD (Ludwig Institute for Cancer Research). Director, CCTC, Austin Health

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Drug Development 2017: Advancing early phase clinical trials through collaboration

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  1. Drug Development 2017: Advancing early phase clinical trials through collaboration The Austin Health Experience

  2. Qualifications and Career 2008-2009 2003-2007 2010 to current 2002 FRACP PhD (Ludwig Institute for Cancer Research) • Director, CCTC, Austin Health • Oncologist (ONJCWC) • Senior Research Fellow (ONJCRI) Fellowship (Princess Margaret Hospital, Toronto) • H&N • CNS • Genito-urinary • Phase 1 • H&N • Trials with AbbVie, Merck, AZ, Exelixis, TROG, Eisai • CNS • Trials with Abbvie, BMS, Medimmune, Engenics, Novartis, EORTC, COGNO. Lilly) • Phase 1 • Beigene, GSK, Daichii-Sankyo, Atridia-Incyte, Engenics, Hutchison, AbbVie,BMS, Roche) • Cancer Trials Australia • Associate director (till 2015), Brain Group (chair), Phase 1 Group (member), • Characterisation & development of mAb806 • Epitope mapping • Mechanism of action • Combination therapy • Clinical development of ABT806 (Abbvie) • Naked antibody (Phase 1&2) • Antibody-drug conjugates (Phase 1)

  3. Qualifications and Career 2008-2009 2003-2007 2010 to current 2002 FRACP PhD (Ludwig Institute for Cancer Research) • Director, CCTC, Austin Health • Oncologist (ONJCWC) • Senior Research Fellow (ONJCRI) Fellowship (Princess Margaret Hospital, Toronto) • H&N • CNS • Genito-urinary • Phase 1 • H&N • Trials with AbbVie, Merck, AZ, Exelixis, TROG, Eisai • CNS • Trials with Abbvie, BMS, Medimmune, Engenics, Novartis, EORTC, COGNO. Lilly) • Phase 1 • Beigene, GSK, Daichii-Sankyo, Atridia-Incyte, Engenics, Hutchison, AbbVie,BMS, Roche) • Cancer Trials Australia • Associate director (till 2015), Brain Group (chair), Phase 1 Group (member), • Characterisation & development of mAb806 • Epitope mapping • Mechanism of action • Combination therapy • Clinical development of ABT806 (Abbvie) • Naked antibody (Phase 1&2) • Antibody-drug conjugates (Phase 1)

  4. Austin Health and ONJCWC The Oncology Unit at Austin Health: is a large quaternary cancer service in Victoria (Australia), serving a quarter of the population A major contributor to rural cancer services, in particular as a provider of radiation oncology through the Ballarat Regional Integrated Cancer Centre (BRICC) provides specialist cancer surgery, medical oncology, radiation oncology, cancer genetics, clinical haematology, wellness, supportive care and palliative medicine. has a strong and established culture of research All clinicians & researchers have dual appointments with Olivia Newton-John Cancer Research Institute and/or University of Melbourne A founding member of Cancer Trials Australia (CTA) One of the two largest clinical trial centres in the state Cancer Care at Melbourne Centre (Clinical activity, Dept Health bed occupancy)

  5. Austin Health and ONJCWC The Olivia Newton-John Cancer and Wellness Centre (ONJCWC) opened in 2012 and is a purpose built 25,000 m2 facility which: Integrates the clinical needs of cancer patients at Austin Health including their wellness & supportive care needs facilitates and optimises clinical and laboratory research focuses on wellness and supportive care, particularly in collaboration with the school of nursing, La Trobe University.

  6. Olivia Newton-John Cancer & Wellness Centre:An integrated cancer centre Radiation Oncology (2nd floor*) 3 linear accelerators Ambulatory care (3rd floor) 25 chair day oncology suite Outpatient clinics Wellness Centre Cancer Clinical Trials(4th Floor) ONJ Cancer Research Institute (4th,5th& 6th Floors) 5,670 m2 of laboratory space, including PC2 and PC1 labs Capacity for 220 scientists Wards (6th & 7th Floors) 64 inpatient beds Palliative Care (8th Floor) 28 inpatient beds * Level 2 is the lowest level in the ONJCWC

  7. Austin Health Cancer Clinical Trial Centre >100 open trials in brain, breast, colorectal, esophago-gastric, haematological, liver, lung, melanoma, prostate, genito-urinary and head&neck. Staffing Director (Gan) and Manager (Hakanson) 24 Clinical Trial Coordinators 5 Fellows 3 Research Admin Assistants Administration Assistant Data Manager Ethics coordinator Finance officer

  8. Coming back to the Austin in 2010 • No local profile • Not recognised as a phase 1 centre per se • Relevant experience • Well established cancer centre

  9. A slow beginning

  10. Support from professional/craft networks CTA Phase 1(Mark Rosenthal, Jayesh Desai) Forming collaborations Clinical Networks Nucleus/Linear (Michael Millward, Lisa Nelson, Jason Lickliter) NEMICS Funding bodies VCA Research Fellowship 2012-2013 (Developing a Phase 1 Network in NEMICS) Mentors/Peers

  11. Raising profile with pharma General demonstrating good record as a trialist generally Highlighting robust Phase 1 clinics/processes Taking what comes your way but doing it well Meeting with key/senior pharma at every opportunity Opportunities arising from LICR/ONJCRI relationship

  12. Phase 1 history at Austin since 2010 • Multiple phase 1 studies • Roche, GSK, Abbvie, Novartis • Ludwig Institute for Cancer Research • Diachii- Sankyo • Australian biotechnology • Starpharma, • Asian Biotechology • Beigene, Hutchison, Atridia-Incyte • Both FTIH and Phase 1b • Phase 1B:Drug-drug, drug-radiation, • Also tumour specific phase 1 studies • Phase 1 biodistribution studies

  13. Future plans Increasing size of team Second Phase 1 specialist (A/Prof Andrew Weickhardt) Dedicated Phase 1 Fellow Enlarged Phase 1 team Continue to collaborate Continue to build/maintain pharma relationships Prioritise strategically important studies ONJCRI Investigators ? Victoria/Australia

  14. Conclusions “How we did it”: Necessary infrastructure Medical and non-medical Medical and scientific facilities and capabilities Form relations with professional/craft groups Mentoring Forming long term relationships with pharma Doing each study well

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