Icon Research and Clinical Trials Capability Handbook

ICON RESEARCH AND CLINICAL TRIALS

CAPABILITY HANDBOOK

INTRODUCTION

Icon Group operates Australia’s largest private cancer clinical trials program with a growing reach into Asia and New Zealand. Icon brings together over 35 years’ experience in research and has an unwavering commitment to providing access to clinical trials to as many people as possible, as close to home as possible.

Research is part of Icon’s DNA, and our international network of clinicians believe clinical trials are critical to the provision of exceptional cancer care. Within the private healthcare setting, Icon has an unparalleled track record of participating in national and international clinical trials across Phase I to IV and lead the way in providing a quality, robust and efficient global clinical trials program.

Icon’s long-term commitment to clinical trials and emerging treatments is backed by peak industry partnerships. Research at Icon aims to provide more patients with opportunities previously not available to them by bringing tomorrow's treatments closer to today.

We deliver a true end-to-end trials service, leading a comprehensive clinical trials and research program in partnership with our compounding and pharmacy teams at Icon.

MEDICAL ONCOLOGY

PHARMACY COMPOUNDING

HAEMATOLOGY THERANOSTICS

RADIATION ONCOLOGY

Across Australia, New Zealand and Asia, Icon is dedicated to delivering the best care possible, to as many people as possible, as close to home as possible.

OVER 50 CANCER CENTRES GLOBALLY

730 360+

PATIENTS ACTIVE ON CLINICAL TRIALS

PATIENTS RECRUITED TO CLINICAL TRIALS / RESEARCH PROJECTS

Five cancer centres

MAINLAND CHINA HONG KONG

Management service agreement

VIETNAM

Two cancer centres

SINGAPORE

Three centres delivering research

Six cancer centres including flagship Mt Alvernia integrated centre Management of 70+ pharmacies

AUSTRALIA

Four TGA licensed compounding facilities

17 centres delivering research

Over 38 cancer centres

Drug stability and research lab

One cancer centre

One GMP licensed compounding facility

NEW

OUR LEADERS

OUR RESEARCH TEAM

Icon’s research team is made up of highly experienced and dedicated team members committed to delivering exceptional, quality clinical trials and research. Our expert team consists of clinical research assistants, clinical research coordinators, research quality managers, specialised pharmacists, state leads, project managers and centralised global operations and executives working alongside a global network of clinicians to provide a comprehensive and robust trials portfolio.

Click here for a full organisational chart

MARK MIDDLETON Icon Group Chief Executive Officer

SOPHIE MEPHAM PHD Group Executive - Research Global

Co-Director of Research (Radiation Oncology / Radiation Medicine)

A/PROF JONATHAN RAMSAY

GLOBAL RESEARCH COMMITTEES

A/PROF JIM COWARD Medical Oncology Research Committee Chair

DR JASON BUTLER Haematology Research Committee Chair

PROF SANDRO PORCEDDU Radiation Medicine Research Committee Chair

DR HSIEH WEN-SON Singapore Research Committee Chair

OUR IMPACT AT A GLANCE

AUSTRALIA'S LARGEST PROVIDER OF CANCER CLINICAL TRIALS

35+ years' experience in delivering oncology clinical trials

TRIALS CONDUCTED IN:

- Australia

- Hong Kong

- New Zealand

- Singapore

NATIONAL LEADER OF PRIVATE PHASE I CLINICAL TRIALS

135 18%

Phase I trial patients of studies are Phase I trials

300+ 120

ACTIVE CLINICAL TRIALS / RESEARCH PROJECTS

30

trials / research projects closed to accrual with patients still on treatment or in follow-up

30 trials / research projects selected for participation and undergoing start-up at Icon

700+

trials / research projects in development or undergoing feasibility

PATIENTS ON ACTIVE TRIALS

500+

COMPOUNDING AND PHARMACY

active trials *including trials external to Icon Group

CLINICAL RESEARCH TEAM TRAINED IN TransCelerate accredited GCP

90+ active Principal Investigators

State-of-the-art

RESEARCH STABILITY LAB an Australian first 200+ industry collaborators

OPERATIONAL EXCELLENCE

Icon operates a true end-to-end clinical trials and research program supporting clinicians and patients with access to the latest in treatments and techniques. As pioneers of private clinical trials and a mature research infrastructure, Icon delivers unparalleled research operations.

To learn more about Icon’s research operations, please contact research@icon.team for a copy of our detailed Icon Group Research Operations Manual.

Leaders in Phase I-IV oncology trials

¬ Over 300 active trials across medical oncology, haematology, radiation medicine and theranostics

¬ Operates Australia’s largest private Phase I clinical trials program

¬ Over 50% growth in Phase I trials in the last year, contributes approximately 38% of annual research patient accrual

¬ Wide network of international sponsors and long-term research and industry partners

¬ Highest recruiter track records

¬ Involvement in ground-breaking clinical trials improving patient outcomes across oncology and a wide range of medical conditions

Investigator Initiated Trials

¬ Dedicated Icon Investigator Initiated Trials (IIT) team to initiate, develop and manage unique and multidisciplinary IITs

¬ Established Icon IIT Framework

¬ Experienced development and management of quality IITs

¬ Quality electronic database design and development

¬ Radiation therapy quality assurance

¬ Manuscript preparation expertise

Contact:

MEL GRAND

Investigator Initiated Trials and Grants Manager

E: mel.grand@icon.team

Global Research Operations (Governance, Quality, and Systems and Innovations teams)

Governance

¬ Global dedicated Research Governance team, centrally managing new trials from feasibility, through to study start up, ethics, contracts, budget to SIV

¬ Site selection and capabilities of research ready centres mapped for patient population, investigator interests and clinical services

¬ Centralised team for any research expressions of interest from sponsors and CRO

Quality

¬ Industry leading Good Clinical Practice (GCP) compliance and trainers

¬ Established global standard operating procedures and policies

¬ Alignment with National Clinical Trials Governance Framework as a global standard

¬ Unified regulatory management

Systems and Innovations

¬ Global, cloud-based secure Clinical Trials Management System – RealTime CTMS

¬ Global, cloud-based secure Investigator Site File – TrialDocs International

¬ Streamlined implementation, uptake and maintenance of technological solutions

¬ Efficient deployment of innovative applications and vendor partnerships

¬ Partnering with sponsors, CROs and Real-World Evidence vendors in the provision of high-quality Real-World Data / Real-World Evidence initiatives

¬ Access to the Icon Group data warehouse sources to identify potential Real-World Evidence opportunities

¬ Dedicated resource within team to query the Icon Group data warehouse using Power BI

¬ Centralised administrative oversight and protocol compliance

Research team national support

¬ Extensive national network of clinical research staff supporting clinicians to deliver high level quality results for trials

¬ Highly experienced clinical research staff from a variety of multi-disciplinary backgrounds, including nursing, radiation therapy, pharmacy and science

¬ Dedicated research staff supporting administration of trials and documentation for the entirety of the trial

¬ On demand dedicated operational support across Australia, New Zealand, Singapore and Hong Kong

Contacts:

ADAM STONELEY

Global Research Operations Manager

E: adam.stoneley@icon.team

JENNIFER PAVLIDES

Global Research System and Innovations Manager

E: jennifer.pavlides@icon.team

TENILLE BAKER

Global Research Governance Manager

E: tenille.baker@icon.team

REBECCA CLARKE

Senior Operations Manager Research Coordination AU/NZ

E: rebecca.clarke@icon.team

JOANNE CHIO

Director of Clinical Trials (ASEAN)

E: joanne.chio@icon.team

Compounding

¬ Four TGA-licensed facilities, compliant with Good Manufacturing Practice (GMP)

¬ State-of-the-art stability and research lab

¬ Dedicated pharmacy clinical trials staff oversee management of clinical trial drugs and equipment for over 240 clinical trials

¬ Experience across Phase I-IV trials primarily in oncology and haematology

¬ Secure administrative support of manufacturing records and documentation

¬ Validated couriers assuring safe and secure cold chain of clinical trial products

Contact:

MARK MCARTHUR

Chief Operating Officer (Compounding)

E: mark.mcarthur@icon.team

Pharmacy

¬ Experienced management of pharmaceutical components associated with investigational drugs and research

¬ Supports over 490 clinical trials across Icon Group and hospital partners

¬ Experience in Phase I-IV trials covering a wide-range of clinical indications including solid tumours, cardiovascular, neurological and gastrointestinal disorders

¬ Centralised Icon Pharmacy Practice Unit (PPU) providing quality assurance, training, audits and quality trial documentation

¬ All pharmacies and pharmacy staff are GCP compliant and follow the Society of Hospital Pharmacists’ Standard of Practice in clinical trials

Contact:

RUSSELL HILL

Director Pharmacy Practice Unit

E: russell.hill@icon.team

FUTURE DIRECTION

Icon will continue to invest in clinical trials and research and lead the way in providing access to new and emerging treatments to turn the dial on oncology treatment and reduce the growing global cancer burden. Future direction will continue to see the expansion of our international trials portfolio and see a focus on new treatments and revolutionary data.

Real-World Data (RWD) / Real-World Evidence (RWE)

¬ Exploration of RWD and RWE to contribute to best practice clinical trials and emerging treatments

¬ Use RWD and RWE to enhance capabilities for business decision making within Icon Group

¬ Leverage RWD to increase efficiencies and access to clinical trials and quality data

¬ Establish global partnerships

Theranostics

¬ Establishment of a new national theranostics program with comprehensive clinical trial and registry program

¬ Provider of choice for theranostics research initiatives alongside expansion of clinical trials and doctor growth

¬ Seek opportunities to establish clinical and technical experience in physics, dosimetry, radiochemistry and operations to support theranostics services

¬ Set the agenda for efficient and high-quality theranostics trials operations globally, supported by in-house radio-pharmacy strategy

Contact:

JULIE CROUCH

Group Director Molecular Oncology

E: julie.crouch@icon.team

Julie Crouch confidently leads the strategic development of Icon’s global theranostics program with extensive experience in the healthcare industry and is committed to improving patient outcomes through research and evidence-based medicine.

She has management experience across the public and private sectors, start-ups, and multinationals, including WA Health Department Representative for The Australian Organ and Tissue Authority, former Director of Oceanic Medical Imaging and Chair of the Australian and New Zealand Society of Nuclear Medicine Accreditation Board.

Professional areas of interest include molecular imaging and therapy, innovative therapies and research including the development of new techniques. Julie recently established a global network of sites delivering both clinical and research theranostics including the first FDA approved fluorinated prostate-specific membrane antigen PET scan (F- PSMA; trade name PYLARIFY) and 177Lutetium-PSMA-617 therapy (Lu-PSMA; trade name Pluvicto) for advanced prostate cancer in the US.

National skin program

¬ Establish an extensive skin research program across Australia to improve patient access to skin cancer trials, as close to home as possible

¬ Develop investigator-initiated benign, non-melanoma and melanoma clinical research

¬ Source commercially sponsored skin research opportunities across Icon’s global network

¬ Establish skin research that will inform Australian and international treatment guidelines

New geographies

¬ Continual expansion of clinical trials in all Icon Group regions and beyond

RESEARCH PARTNERS

Abbisko Therapeutics Australia Pty Ltd

Abbvie

Accendatech

Acerta Pharma LLC

Adagene

Agenus Inc

Akeso BioPharma Co

Alexion Pharmaceuticals

Alkermes, Inc.

Alphamab Oncology

ALX Oncology Holdings

Amgen Inc

Antengene Corp

Arcus Biosciences

Astellas Pharma Inc

AstraZeneca

Atomic Oncology Pty Limited

Atridia Pty Ltd

Australasian Gastro-Intestinal Trials Group (AGITG)

Australasian Leukaemia & Lymphoma Group (ALLG)

Australasian Myeloma Research Consortium (AMaRC)

Australia New Zealand Gynaecological Oncology Group (ANZGOG)

Australian and New Zealand Urogenital and Prostate Cancer Trials Group (ANZUP)

Australian Clinical Labs

Avance Clinical

AVEO Pharmaceuticals, Inc

Bayer AG

BeiGene

Bellberry Limited

BioAtla Inc

Boehringer Ingelheim

Boston Scientific

Breast Cancer Trials (BCT)

Bristol Myers Squibb (BMS)

Cancer Council

Cascadian Therapeutics, Inc

Celgene Corporation

Checkmate Pharmaceuticals, Inc.

Clinical Network Services (CNS) Pty. Ltd

Clinipace

ClinPath Pathology

Clintec

Concord Hospital

Constellation Pharmaceuticals

CSL Limited

CStone Pharmaceuticals

Daiichi Sankyo Company, Limited

Debiopharm Group

DocuSign

DrugDev, Inc.

Eisai Co., Ltd

Eli Lilly and Company

Epworth HealthCare

Eucure (Beijing) Biopharma Co., Ltd

Exelixis, Inc

F. Hoffmann-La Roche AG (Roche)

Five Prime Therapeutics, Inc.

Gallipoli Medical Research Foundation

Genentech, Inc

Genmab A/S

Genomics for Life

Genzyme

George Clinical

Ghent University

Gilead Sciences, Inc.

GlaxoSmithKline plc (GSK plc)

GreenLight Clinical

Hangzhou TigerMed

Hinova Pharmaceuticals Inc

Hobart Pathology

Hutchison MediPharma Limited

ICON plc

Idera Pharmaceuticals, Inc.

I-MED Radiology Network

ImmunoGen, Inc

Immunomedics

INC Research

Incyte Corporation

INmune Bio Inc

IQVIA

Janssen Pharmaceuticals

Jiangsu Hengrui Medicine

Johnson & Johnson

Jones Radiology

Kartos Therapeutics

Karyopharm Therapeutics Inc.

Kazia Therapeutics Limited

Labcorp

Icon is proud to work with over 200 collaborators including Clinical Research Organisations (CROs), commercial and non-commercial organisations (including the pharmaceutical industry, hospitals, and universities), industry vendors and service providers. We understand that making a difference in reducing the global cancer burden is a collaborative effort and we continue to partner with leading organisations to contribute to the future of cancer care.

Laboratoires Servier (Servier)

LaNova Australia Pty Ltd

London Regional Cancer Program

Loxo Oncology, Inc.

Lucence

Lumus Imaging

MacroGenics, Inc

Mater Health

Mater Research

MaxiNovel Pharmaceuticals Co.,Ltd

Medicenna Therapeutics Corp

MedImmune, LLC

Medivation, Inc.

Medpace Holdings, Inc.

Melanoma and Skin Cancer Trials (MASC Trials)

Melbourne Pathology

Merck KGaA

Merck Sharp & Dohme (Australia) Pty. Ltd (MSD)

Mersana Therapeutics, Inc

Metagone Biotech Inc.

Microba Life Sciences

Millenium Pharmaceuticals

Mirati Therapeutics Inc

Molecule2Market

Monash University

MorphoSys AG

Morphotek, Inc.

Myeloid Therapeutics

Myovant Sciences

Nektar Therapeutics

North Eye Specialists

Novartis AG

Novogen Research Pty Ltd

Novotech (Australia) Pty Limited

Nucleus Network

Olema Oncology Australia Pty Ltd

OncoC4, Inc.

Onconova Therapeutics Inc.

Outlook Eye Centre

Parexel International

Peter MacCallum Cancer Institute

Pfizer, Inc.

Pharmaceutical Product Development, Inc. (PPD)

Pharmaceutical Solutions Limited (PharmaSols)

Pharmacyclics LLC

Pharm-Olam LLC

Pharos I&BT Co., LTD.

PRA Health Sciences

PSI CRO AG

QIMR Berghofer Medical Research Institute

Qscan

Queensland Cardiovascular Group

Queensland Eye Institute

Queensland University of Technology

Queensland X-Ray

RealTime Software Solutions, LLC

Regeneron Pharmaceuticals

Sanofi S.A.

Seagen Inc.

Shanghai Henlius Biotech

Sierra Oncology, Inc.

Sonic HealthCare

South Coast Radiology

Sullivan Nicolaides Pathology

Supportive Therapeutics, LLC

Suzhou Sinovent Pharmaceuticals Co., Ltd. (Sinovent)

Symvivo Corporation

Syneos Health

Takeda Oncology

Telios Pharma, Inc.

Telix Pharmaceuticals

TG Therapeutics, Inc.

Translational Research In Oncology

Translational Research Institute

Trans-Tasman Radiation Oncology Group (TROG)

TrialDocs International Pty Ltd

TriNetX, LLC

Turning Point Therapeutics, Inc.

UnitingCare Health

University of Queensland

University of Sydney

Varian

Worldwide Clinical Trials

Y-mAbs Therapeutics Inc

Ziopharm Oncology, Inc.

RESEARCH ORGANISATIONAL STRUCTURE

ICON CANCER FOUNDATION

Icon Cancer Foundation (ICF) is an independent not-for-profit registered charity whose mission is to promote, initiate and support clinical trials and research, striving towards a brighter future for cancer patients and communities. ICF is committed to improving patient access to new and emerging treatments by raising awareness of and sponsoring Investigator Initiated Trials (IITs) run by Icon Group. Learn more about Icon Cancer Foundation at iconcancerfoundation.org.au

Contact:

E: foundation@iconcf.org.au