Early Phase Oncology Clinical Trials World class clinical trial expertise in new Zealand

World class clinical trial expertise in New Zealand
Early Phase
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
• 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
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
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development company of its kind in the Southern Hemisphere and a
wholly owned company of The University of Auckland.
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minds, UniServices provides commercial organisations the
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and is responsible for all research-based consultancy partnerships
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UniServices’ open innovation and world-class thinking can change
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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]
Auckland UniServices Limited
Level 10, UniServices House
70 Symonds Street, Auckland
Private Bag 92019 AMC
Auckland 1142, New Zealand
Phase I, II & III
Phase II & III