World class clinical trial expertise in New Zealand Early Phase Oncology Clinical Trials What you need to know.. Auckland’s medical oncology service Our catchment is the northern region of New Zealand (Auckland and Northland) whose population is 1.6 M, and we provide comprehensive treatment services seeing all types of cancer patients. We are the largest oncology service in Australasia with eighteen medical oncologists organised across tumour streams. Most standard approved therapies are funded/available, including rituzumab, imatinib, trastuzumab, erlotinib, sunitinib. Auckland’s Medical Oncology Service is aligned with corresponding haematology, paediatric, radiation and surgical oncology services organised within a Cancer Health Services Group. Clinical Trial Regulatory Approval in New Zealand Resources for oncology phase I trials in Auckland • G roup of principal investigators and support staff experienced in the broad range of oncology phase I and II trials • L arge referral-base of patients with solid and haematological malignancies (ca 3000/annum) • Access to imaging (CT, MRI, CT-PET) • Clinical trials pharmacy on-site • Prospective biomarker analysis • M anagement of the contracting, budgeting and financial processes • O btained prospectively for legal exemption from requirement for regulatory marketing approval • A pproval given by the Minister of Health via the drug regulatory agency (MedSafe) that acts on advice and recommendations of the Standing Committee of Therapeutic Trials (SCOTT) or GTAC • S COTT review carried out by 3 or more clinicians with relevant clinical research expertise • NZ requirements follow those of FDA, EMEA and TGA • P rocess complete within 14 to 18 days after the MOH have fee and documentation • Carried out separately but in parallel to ethical approval Ethical review in New Zealand Oncology clinical trial experts Associate Professor Mark McKeage Mark McKeage is an Associate Professor in Clinical Pharmacology at The University of Auckland and a Consultant Medical Oncologist at Auckland City Hospital. • National centralised ethical review process • One application only for multicentre trials • Ethics committee review – Committees meet every 2 weeks – Applications close two weeks prior to meeting – Notification obtained within 1-2 weeks of meeting – Applicants attend meeting and are able to address questions and concerns directly – Outstanding issues usually resolved by Chair sign-off • Ethical rather than scientific review (SCOTT) • P arallel review of cultural issues by Maori Research Review Committee Prior to establishing his career in academic medical oncology, Mark acquired qualifications in clinical medicine (MBChB, Otago), medical oncology (FRACP) and postgraduate research (MMedSc, Auckland; PhD, London), and gained relevant experience abroad in the United Kingdom and Australia. He has published over 75 journal articles, supervised over 20 graduate students and received numerous research grants, awards and prestigious appointments relating to his work on novel anticancer drugs. He has successfully guided the development of several novel anticancer drugs through their early-phase clinical trials onto late-phase clinical development, including satraplatin (JM216) and vadimezan (ASA404, DMXAA). Mark is dedicated to reducing mortality and morbidity from cancer through patient care, education and research that transforms scientific discoveries into clinical interventions. ... Professor Peter Browett Professor Michael Findlay Peter Browett is a Consultant Haematologist at Auckland City Hospital, and Professor of Pathology and Head of the Department of Molecular Medicine and Pathology, University of Auckland. Michael Findlay works as Consultant Medical Oncolgist at Auckland City Hospital. He is also the Director of Cancer Trials New Zealand and Professor of Oncology at The University of Auckland Professor Browett is a graduate of the University of Otago School of Medicine and has worked at the Royal Free Hospital School of Medicine as a research fellow in the Academic Department of Haematology. Peter is a Fellow of the Royal Australasian College of Physicians and the Royal College of Pathologists of Australasia, and is currently Vice-President of the Haematology Society of Australia and New Zealand (HSANZ). His clinical interests include the management of patients with haematological malignancies, including blood cell and bone marrow transplantation. In the laboratory, he has an interest in cell marker and molecular studies in the diagnosis and monitoring of patients with leukaemias, lymphomas and inherited blood disorders. Professor Peter C. Fong Peter C. Fong is a Medical Oncologist at Auckland City Hospital, Auckland, New Zealand since 2008. He is also an Honorary Clinical Senior Lecturer with the Auckland University Faculty of Health and Medical Sciences. Michael Findlay completed his undergraduate studies at the University of Otago. He was awarded his Fellowship of the Royal Australasian College of Physicians in 1990 after training in Wellington and Sydney. His post-Fellowship research in the treatment of gastro-intestinal cancers at the Royal Marsden Hospital in London resulted in the awarding of the degree of Doctor of Medicine in 1995. After appointments at Sydney Cancer Centre and Wellington Cancer Centre between 1994 and 2002, he was appointed as the foundation Professor in Oncology at the University of Auckland. During his appointment he established Cancer Trials New Zealand, a clinical trials coordinating centre engaged in the design and conduct of clinical and translational trials in a wide range of cancer types – trials that are considered to be of particular significance to New Zealanders. Other current activities related to cancer and cancer research include: board director and deputy-chairman of the Australasian GastroIntestinal Trials Group and its Scientific Advisory Committee; member of the Genesis Oncology Trust Scientific Evaluation Committee; board member of the Auckland Division of the New Zealand Cancer Society; and member of the National Ethics Advisory Committee. Professor Reuben Broom Peter’s interests are in Drug Development, Genitourinary and Gynaecological cancers especially castrate resistant prostate cancer and ovarian cancer trials and research. He graduated with first class honours from Queensland University, Australia before working in Australia and New Zealand. Peter completed his medical oncology training at Auckland including a 6 month elective in the Bone Marrow Transplant unit before taking up a locum consultant post at Auckland Hospital in 2003. From 2004 to 2008, he undertook a clinical and laboratory fellowship at the Royal Marsden Hospital and the Institute of Cancer Research in London, UK. During this time, he worked at the Drug Development Unit (with Stan Kaye and Johann de Bono)engaged in running over 20 phase I trials concurrently. Examples of these include the PARP inhibitor, olaparib, various HDAC inhibitors and the IGF1-R inhibitor, figitumumab. Peter spent 2 years in postgraduate’s studies in the Cancer Research UK section of Cancer Therapeutics Laboratory in translational research of novel biomarkers of histone deacetylase inhibitors including high throughput ELISA validation and circulating tumour cells. Subsequently he worked in the Prostate Drug Development Unit running Phase I to III trials, including abiraterone. He has authorednumerous abstracts and has published in various peer-reviewed journals. Reuben Broom is a Medical Oncologist at Auckland City Hospital and an honorary clinical lecturer in oncology at the University of Auckland. He graduated from medical school, University of Auckland in 1999 and became a Fellow of the Royal Australasian College of Physicians in 2006. Between 2006 – 2008 he completed a clinical research fellowship at Princess Margaret Hospital, Toronto, Canada, focusing on renal and breast malignancies before returning to New Zealand. Reuben is an active researcher in both breast and renal cancers. He is an investigator on multiple phase II and III clinical trials, including leading investigator initiated trials. He is also conducting translational research in these malignancies in collaboration with several Auckland based laboratories. The main focus of his renal cancer research is the issue of bone metastases – a common site of spread in this disease associated with significant morbidity. He is currently running a phase II trial in this specific population which includes bone-specific end-points. Experts’ Specialities Overarching speciality(s)Sub-speciality(s)Type (phase) of trials Mark McKeage Oncology - translational and clinical research Head and neck cancer, clinical pharmacology and development of anticancer drugs, drug transport, platinum drugs, chemotherapy neurotoxicity, tumour vascular disruption, lung cancer Peter Browett Haematology research Malignant haematology, bone marrow transplantation, laboratory diagnosis of haematological disorders Phase II Mike Findlay Oncology clinical research Gastrointestinal cancers, clinical trials, expertise across most types of cancers through national collaborators Phase II, III & IV Peter Fong Oncology - translational and clinical research Prostate, bladder, testicular, ovarian, endometrial Phase I, II & III Reuben Broom Oncology - translational and clinical research Renal and breast cancers, bone metastases Auckland UniServices Ltd Auckland UniServices Limited is the largest research and development company of its kind in the Southern Hemisphere and a wholly owned company of The University of Auckland. By connecting its clients with The University’s brightest academic minds, UniServices provides commercial organisations the innovative technologies they seek, and governments the national programmes they need. The results can mean huge strides in a company’s international competitive edge, or in a country’s health, education and welfare capability. UniServices manages all of The University’s intellectual property and is responsible for all research-based consultancy partnerships and commercialisation. UniServices’ open innovation and world-class thinking can change the world. Contacts Cushla Currie Business Manager - Medicine & Health +64 9 923 2585 or 021 859 188 [email protected] Andrew Palairet Business Manager - Biomedical Sciences +64 9 923 8245 [email protected] SEPTEMBER 2010 Auckland UniServices Limited Level 10, UniServices House 70 Symonds Street, Auckland Private Bag 92019 AMC Auckland 1142, New Zealand www.uniservices.co.nz Phase I, II & III Phase II & III