ONLINE REGISTRATION www.nzacres2015.org.nz

NZACRes

2015CONFERENCE 2021 AUGUST 2015 THE HERITAGE HOTEL AUC KLAND , N E W Z E AL AND

TH ANNUAL CONFERENCE 11 www.nzacres2015.org.nz CONFERENCE ORGANISER — / Donna Clapham

CONFERENCE AND EVENTS MANAGEMENT PO Box 90641, Victoria Street West, 1142, t: +64 9 917 3653 / e: [email protected] / w: www.w4u.co.nz Invitation to attend

ORGANISING COMMITTEE —

Kevin Sheehy Associate, Health Lead, Navigator Ltd - NZACRes President & 2015 Convenor

Maria Carney Research Administrator, Oncology & Haematology Clinical Trials Units, Canterbury Regional Cancer & Haematology Service, Hospital

Rebecca Coombes Research & Development Manager, Canterbury DHB & University of , Christchurch

Murray Farnsworth Clinical Trials Business Consulting (CTBC)

Matt Kepple Director, Primorus Clinical Trials

Julian Abeysundera Clinical Operations Manager, Novotech

NZACRES EXECUTIVE COMMITTEE 2015 — The NZACRes 2015 Executive Committee invites you to attend our annual conference.

The New Zealand Association of Clinical Research use in local research and this year we are launching the (NZACRes) represents clinical researchers across New standardised Clinical Trial Research Agreement (sCTRA) Zealand in enhancing the environment for research here for Collaborative Research Groups. We hope that this and supports better delivery of high quality research for will streamline the setting up of collaborative research participants. groups and there will be a session on this presented at the conference. Last year our tenth anniversary looked back at the progress made in local research, this year the focus is on We are putting together an influential and informative the future and how to ensure our research networks are group of speakers to ensure this year’s conference delivers optimally connected and highly skilled for what research on what people have come to expect from the premier looks in the future. clinical research conference in New Zealand.

The NZACRes membership represents the largest Our venue this year will again be the beautiful Heritage independent group of researchers from across New Hotel Auckland. Zealand and we intend to continue advocating for what the research community needs to thrive. One of the We welcome you to the conference to update your many ways that NZACRes adds value to the research connections and share in the latest knowledge and community is by generating standard documents for expertise.

THANK YOU TO OUR SPONSORS

Silver Sponsor Supporting Sponsor

New Zealand Association of Clinical Research 2 Benefits of attending

Benefits of Attending Improve Your Performance in the Conduct of Clinical Trials The NZACRes Annual Conference & Exhibition is uniquely focused on supporting the professional growth and development of individuals involved in clinical trials in New Zealand through education, exchange, and peer-to- peer engagement. Our conference includes opportunities such as: • Educational Sessions uniquely tailored to professionals conducting clinical trials • Networking Opportunities for peer-to-peer exchange and engagement • Access to speaker presentations post conference (subject to speaker approval) for continuing education • Make lasting connections with our industry Association The opportunity to learn new skills and to stay up to date with trends and changes affecting the clinical research industry are key reasons NZACRes Members and others attend the NZACRes Annual Conference & Exhibition. The opportunity to spend quality time with other members helps build community, a sense of purpose and a network of colleagues to lean on for professional support.

CRITICAL DATES — Who will be there?

Call for Abstracts Live Estimated number of delegates: 180 - 220 Monday 13 April 2015 • Investigators, Study Coordinators, Physicians, Registration Live Clinical Research Nurses, University and Monday 27 April 2015 Hospital based research personnel Abstract Submission Close-off • Clinical Research Managers, Clinical Research Monday 8 June 2015 Associates, Regulatory Specialists and personnel Earlybird Registration Deadline from research institutes Monday 29 June 2015 • Pharmaceutical, Biotechnology and Medical Device Accommodation Deadline research personnel Monday 20 July 2015 • Pharmacists and Laboratory personnel Cancellation Deadline • Health Economists, Biostatisticians and Data Managers Monday 20 July 2015 • Medical Writers and Industry Consultants Online Registration Deadline Monday 17 August 2015 NZACRes is a non-profit scientific educational organisation. It is run by an elected team of volunteer officers from amongst its members.

3 Register online at www.nzacres2015.org.nz Our Programme

New Zealand Association of Clinical Research 4 Keynote Speakers

Dr Elliott C. Kulakowski PHD, MBA

Dr Elliott Kulakowski, has over 30 years of experience in research and research management. In positions of increasing responsibility, he has worked for the federal government, Carnegie Research Intensive Universities, and directed research activities at internationally recognized universities and academic medical centers. Dr Kulakowski’s primary focus in research management is benchmarking, performance management and building research programs while serving at the interface between research and its management. In particular, he is involved in strategic planning for the growth of CEO, Society of Research research, reviewing research operations, benchmarking, establishing clinical trials research programs, Administrators International, working with governmental agencies and legislatures on support of research funding, developing Virginia, USA institutional policies, procedures and regulatory compliance programs, overseeing technology transfer operations, establishing spin-out companies from university technologies and conducting related training. Dr Kulakowski began his professional career at the NIH where he served as a researcher, program administrator and Senior Scientific Advisor for the National Heart, Lung and Blood Institute. He subsequently moved to academia where he assumed positions as Associate Vice Provost for Health Sciences Research Development, Director of a State Sponsored Centers of Excellence, directed programs related to technology development and economic impact, established clinical trials research units, and headed up university based spin out companies. He received funding from the NIH, various non-profit funders, and foundations. Dr Kulakowski is a past president of SRA International. He also is recipient of the Excellence Award, Herbert Chermside Award and is a member of the Distinguished Faculty. He is an invited speaker at international meetings and publishes on issues of research management. Dr Kulakowski is co-author of the book “Research Administration and Management,” the first such book in nearly 25 years. He also appeared on a PBS special about biomedical research ethics and participated in nationally televised satellite conferences on research issues. Dr Kulakowski has a BS in Biology, MS in Medical Biology, PhD in Biochemistry and MBA.

Pramod K. Gaur

Pramod Gaur is a TeleHealth Subject Matter Expert (SME) and Adjunct Professor at Pace University. Most recently, Dr Gaur was responsible for the enterprise level coordination of TeleHealth at UnitedHealth Group for the continuum of care delivery. Prior to that, he was the founding President and CEO of two TeleHealth companies (Viterion and Healthanywhere). Dr Gaur’s activities as an industry advocate include demonstrations to the US Presidential Advisor, US Congress, The White House Conference on Aging and to International Delegates at the United Nations. Dr Gaur has served the American PhD, Adjunct Professor, Pace Telemedicine Association (ATA) in various capacities since 2003. He was inducted to the 2013 ATA Class of University, Seidenberg School of Fellows and is currently serving as Vice Chair of ATA mHealth SIG. Dr Gaur received his doctoral degree CS & IS, White Plains, NY, USA from the University of Kansas and received his postdoctoral training at the University of Wisconsin in Madison, Wisconsin and the University of Maryland, School of Medicine located in Baltimore, Maryland. http://csis.pace.edu/~pgaur/ http://www.pace.edu/seidenberg/corporate/executive-seminars

Mark Hochman

Mark Hochman gained a PhD in science (geology) in 1991 and has been in research management for more than 25 years including a period of 20 years as Director of the Research and Innovation Services Office at the University of South Australia. He is a foundation member of the Australasian Research Management Society (ARMS) and served on the ARMS executive for six years, including a period as President in 2007/2008. He has served on the Board of SRA International including a two year period as president of the International Section. He is currently co-Chair of SRA’s Education and Professional Senior Advisor in Research Development Committee and chairs SRA’s Governance Sub-committee. Mark currently works part- Policy and Strategy, University of time at the University of Tasmania as a Senior Advisor in Research Policy and Strategy and consults Tasmania, Australia in research management and strategy for the remainder of his time. As a consultant he has been Program Manager overseeing development of an accreditation program for ARMS which provides the foundation level learning and skills for those who are new in the research management profession. He also acted as Program Manager for a 2012 national pilot program in Australia examining the case study approach to assessing research impact. Since 2011 he has conducted research management reviews of Research Offices, research policies and strategies in 12 Australian universities. In 2014 Mark was awarded the inaugural Janet-Dibb-Leigh Award for distinguished service to the Australasian research management community.

5 Register online at www.nzacres2015.org.nz Invited Speakers

Maria Carney Maria has had over 25 years administration and clerical experience, ranging from retail administration, to education to PA/marketing, temp work to warehouse stocking. Industries range from preschool education, flooring and carpets to cremation. In these years she has managed to create systems, databases and ideas for office systems. If an idea doesn’t work or could be better utilised she comes up with a plan or idea to improve the system. She has been “thrown in the deep end” on occasion and has always come to the surface. Her attributes are not to let a hard job conquer you, but for you to conquer it. Setting up and coordinating a Research Administrators Network for non-clinical research Staff in Research Administrator, Oncology New Zealand. New Zealand wide hospitals, research organisations and universities were approached & Haematology Clinical Trials to find out whether interest to encourage the beginnings of a research administrator’s network in New Units, Canterbury Regional Zealand would be viable. Interest was received from administrators working in various areas of health/ Cancer & Haematology Service, medical research resulting in the network moving forward. Amongst the most valuable administrators in Canterbury District Health Board, New Zealand are those who work within the health research industry. These professionals are identified Christchurch, NZ as research managers, clinical trial assistants, research administrators, research clerical support, data managers, data coordinators, personal assistants, project managers, research finance and legal plus many more. Clinical trials and health research are highly regulated and thoroughly monitored which require significant record keeping, compliance and legal burdens, high level management responsibilities and an understanding of the research process.

Marina Dzhelali

Marina Dzhelali works as a Research Service Leader and is in charge of the Capital and Coast District Health Board Research Office. Born in Russia, raised in Ukraine and having worked professionally in USA and NZ for last 18 years, Marina has acquired nursing and research experience in many clinical areas and has been on NZACRES CTA working group since 2011. Living in one of the suburbs allows her to enjoy combination of suburban and semirural life style, with husband, kids and animals around. Favourite past time to curl on the sofa with Agata Christie book and an apple! Research Service Leader, Research Office, Capital & Coast DHB, Wellington, NZ

Professor Valery Feigin MD, PhD, FAAN

Professor Feigin is an internationally recognized expert in stroke and traumatic brain injury epidemiology, prevention and management. He has published over 400 research articles in medical journals (including 25 papers in The Lancet and The Lancet Neurology), 11 stroke handbooks and 15 book chapters (his publications have been cited over 13,500 times with h-index 40). Professor Feigin leads the Stroke Experts Panel of the Global Burden of Disease Project contributing data to the World Health Organization’s (WHO) reports which are distributed worldwide. He is on the Board of Directors Professor of Neurology and of the World Stroke Organization, Chair of the Global Burden of Disease Neurology Section, and a Epidemiology; Director, National member of the Advisory Working Group on Stroke for the WHO ICD-11 version. He is Editor-in-Chief of Institute for Stroke & Applied the journal Neuroepidemiology (impact factor 2.3) and a member of Editorial Boards on 10 international Neurosciences, AUT University, medical journals. He and his team at AUT University recently developed a unique Stroke RiskometerTM Auckland, NZ App to help to reduce the burden of stroke and other non-communicable disorders (NCD) worldwide. International collaborative epidemiological studies of stroke and other major NCD based on this app are expected to be the largest in the world and to significantly improve our knowledge on the prevalence and determinants of NCD across the world.

Professor Mary Galea, BAppSc (Physio) BA, PhD

Professor Mary Galea is a physiotherapist and neuroscientist whose research program includes both laboratory-based and clinical projects with the overall theme of control of voluntary movement by the brain, and factors that promote recovery following nervous system damage. She is currently Professorial Fellow in the Department of Medicine (Royal Melbourne Hospital) at the University of Melbourne, and previously Foundation Professor of Clinical Physiotherapy and Director of the Rehabilitation Sciences Research Centre at the University of Melbourne and Austin Health. She has had numerous awards, Professorial Fellow, including the Australian Physiotherapy Association (Vic Branch) Achievement Award, a Churchill The University of Melbourne, Fellowship, the Distinguished Scientist Award at Austin Health, and induction to the Victorian Honour Victoria, Australia Roll of Women. Professor Galea is the lead investigator on a large multi-site program of research, SCIPA (Spinal Cord Injury and Physical Activity), investigating the clinical and health economic impact of exercise after spinal cord injury from acute care to the community. This program involved all Spinal Units in Australia and New Zealand. She is also principal investigator for studies of nutrition after spinal cord injury and nerve transfer surgery to improve arm and hand function in patients with tetraplegia. Professor Galea has also been at the forefront of using technology for rehabilitation of neurologically impaired patients, including those with stroke and spinal cord injury.

New Zealand Association of Clinical Research 6 Invited Speakers

Dr Patrick Gladding

Patrick Gladding is a specialist in both general cardiology and internal medicine. He is currently employed as a cardiologist at North Shore Hospital and has expertise in echocardiography and personalized medicine. Patrick trained in cardiology at the Greenlane Cardiovascular Service, and completed a fellowship in advanced cardiac imaging at the Cleveland Clinic. His clinical interests are in preventative cardiology and an individualized approach to healthcare using genomic medicine and imaging. He received an inventor’s award from the Cleveland Clinic in 2010 and has two patents Cardiologist, North Shore Hospital, on technology related to this field. He is the Chief Technology Officer for Nanobeak Inc. and also the Auckland, NZ founder of Theranostics Laboratory.

Anna Guenther

Anna Guenther is the co-founder and CEO of PledgeMe, New Zealand’s first crowdfunding platform. Since launching 3 years ago, over 840 creative, community and entrepreneurial projects have raised almost $6 million through PledgeMe. Anna has also worked for the New Zealand Government, MIT and Harvard, and completed her Masters in Entrepreneurship with a focus on crowdfunding. In her day job, she focusses on building the crowdfunding community in New Zealand - and is constantly amazed by the passionate people she gets to play with. Half Kiwi, half American, she has travelled around the world Co-Founder and CEO, PledgeMe, for work – but always comes back to call New Zealand home. Wellington, NZ

Dr Shaun Holt

Dr Shaun Holt is an Adjunct Professor at Victoria University of Wellington, has started two clinical trials organizations and formed Research Review, a company that produce reviews of medical research. Shaun holds Pharmacy and Medicine degrees, has been the Principal Investigator in over 50 clinical trials and has over 180 publications in the medical literature. He is the Scientific Director and a founder of HoneyLab, and an advisor to the Asthma Foundation, Natural Products NZ and several pharmaceutical companies. Shaun has been a regular contributor on TV1’s Breakfast programme and national radio HoneyLab & Victoria University of shows and is the author of 6 books including the bestseller “Natural Remedies That Really Work”. He Wellington, Wellington, NZ was a finalist for the New Zealander of the Year, Innovator of the Year award 2015. More info at www. flavors.me/shaunholt

Dr Maui Hudson

Maui Hudson is a Senior Research Fellow and Research Developer (Vision Matauranga/Maori Partnerships) at the University of . He is an interdisciplinary researcher with extensive experience across a diverse range of research areas including traditional medicine, indigenous research ethics, interface between indigenous knowledge and science, Maori economic development and Maori health. Maui has been a member of a number of national and institutional ethics committees and was part of the team that developed Te Ara Tika: Guidelines on Maori Research Ethics – A framework for Senior Research Fellow and researchers and ethics committee members. In his research developer role he provides scientists and Research Developer, researchers with advice to strengthen their projects/proposals around research design, engagement University of Waikato, Hamilton, NZ with Maori stakeholders, and cultural/ethical components. Maui currently holds Senior Research Fellow roles in the Maori and Indigenous Governance Centre, and the Environmental Research Institute at the University of Waikato. He is the principal investigator for HRC funded Te Mata Ira exploring Maori views on biobanking and genomic research.

Andrea Miller

With an interest and involvement in CF for over twenty five years, Andrea Miller knows full well the personal and emotional effect of this illness. Her knowledge has been developed from grass roots experience of having a daughter with CF, a Board member of CF New Zealand, a past chairman of the CF New Zealand Research Fund, and life member of the Australian Capital Territory CF Association. In addition, she has a wealth of medical and scientific knowledge and has developed networks related to CF therapeutic development which stem from her internship at the CF Foundation in Bethesda, Maryland ED, BBS, PG Dip in 2010. Her leadership and business skills have been acquired through her previous roles: as a senior CEO, Breathe Easy Limited, officer in the NZ Army (including peacekeeping with the United Nations), a leadership role in the public Auckland, NZ service, and as a business development manager in a provincial economic development agency.

7 Register online at www.nzacres2015.org.nz Invited Speakers

Archana Nair

Archana is responsible for the management of follow-up trials, processing and shipping of blood samples for various current oncology clinical trials according to trial protocol, maintaining kit inventory and sample log, keeping up-to-date with laboratory flow charts for current trials, accreditation certificates and reference ranges for local labs, assisting in the development of standard operating procedures, monthly statistics, data entry for current trials etc. She has experience in assisting in-house audits of local investigator led studies to ensure robust data collection to meet external Data Manager, audit requirements, designing work sheets and compiling statistics for in-house studies. Archana is Oncology Clinical Trials, a recipient of Scholarship Award jointly provided by Victoria University of Wellington and NZACRes Waikato Hospital, Hamilton NZ towards completing a PostGraduate Diploma in Clinical Research for the year 2015. She is a member of Research Administrators Network (RAN) and a graduate in Biochemistry with Chemistry and Zoology as subsidiary subjects. Archana is currently doing PGDip in Clinical Research at Victoria University of Wellington. Archana worked at research laboratories as part of graduation assisting research students in India and has worked in biochemistry lab, part of Regional Cancer Centre, TVM, India for project submission as part of graduation. She is interested in gaining more experience and education with the aim of attaining specialised qualification in the field of clinical research, and to constantly upgrade knowledge where opportunities are given. Archana is experienced and certified in the field of medical typing. Born in India, the colourful country rich with culture and heritage, Archana migrated to New Zealand in 2008 and is married with an 11-year-old daughter.

Dr Greg Pringle

Greg was a full-time horticultural researcher in a Crown Research Institute for 16 years prior to starting up a new research office at New Zealand’s leading polytechnic in 1998. Late in 2004 he set up his own company specialising in research management, through which he held long term contracts in Australia and New Zealand in the hospital and IT sectors. From 2012 he hosted research management training workshops and associated services in both countries, serving a wide range of R&D intensive clients (CRIs, universities, polytechnics). In 2013 took on a fixed-term appointment as General Manager for the Business Development Manager, $3m p.a. ‘Nutrigenomics NZ’ programme which studied the link between food, genes and health. He The NZ Institute for Plant and has since taken a wider role in business development at Plant & Food Research while maintaining an Food Research Ltd, Auckland, NZ interest in food, nutrition and health.

Audrey Shearer

Audrey Shearer is the CEO of Spiral a Wellington software company. Spiral develop cloud-based software for collection and management of data in clinical trials. More than 25 hospitals across New Zealand and Australia are using Spiral’s software to collect data and help manage clinical trials. This number is growing with new trials going into Singapore and Ireland this year. Audrey has over 30 years programming and database experience. She believes in working smarter, not longer, being adaptable, not rigid, and in keeping it simple. This translates into a unique approach to data and CEO, Spiral, Wellington, NZ delivery of software that meets the idiosyncratic needs of both traditional and novel trial projects.

Dr Diana Siew

Diana Siew’s role in the NZ Innovation environment is to support and help develop NZ’s medical technology sector to grow the economy through partnerships and collaborations between firms, researchers, clinicians/end-users and government. Two complementary initiatives in NZ that underpin her Sector Manager role are the Consortium of Medical Device Technologies (CMDT - www.cmdt.org. nz) and the MedTech Centre of Research Excellence (MedTech CoRE). Diana co-chairs the CMDT and is an Associate Director of the MedTech CoRE, responsible for strategy and industry relationships. National MedTech Sector Manager, Diana previously held senior science management roles at Industrial Research Limited and Callaghan Callaghan Innovation Innovation, becoming involved in the commercialisation of early stage technologies. This sparked her interest in developing the ecosystem to support start-ups into sustainable entities. She has worked closely with the Medical Technology Association NZ for the last 10 years to develop an industry network supporting emerging medtech companies.

New Zealand Association of Clinical Research 8 Invited Speakers

Dr Barry Smith QSM, PhD

Of Te Rarawa and Ngāti Kahu descent, Barry has a PhD in sociology and degrees in science and music. He has worked in tertiary education and social and health research and is currently employed as a Population Health Analyst with the Lakes District Health Board. His key interests are in health inequality and Maori ethics frameworks where he was a co-author of the much cited guidelines on Maori ethics Te Ara Tika (HRC, 2010). He is involved with Health Research Council of New Zealand (HRC) supported research on attitudes of Maori to genomic research and bio-banking and has just completed Population Health Analyst, a three year Marsden Fund supported project culminating in a book with Martin Tolich entitled The Planning and Funding; Chair, Politicisation of Ethics Review in New Zealand (Dunmore Publishing, 2015). A previous Health and Research Committee, Disability Ethics Committee (HDEC) chair, he now leads the Health Research Council Ethics Committee Lakes DHB, Rotorua (HRCEC) and sits on a number of its science assessing committees. Other current memberships include the Advisory Committee on Assisted Reproductive Technology (ACART), the Auckland Regional Biobank Advisory Committee, the New Zealand Ethics Committee (NZEC) the Podiatrist Board of New Zealand, the Lakes DHB Research and Ethics Committee (which he chairs) and a number of university and government academic and policy advisory groups. He contributes to courses run by the University of Otago Bioethics Centre and teaches on Victoria University of Wellington’s Postgraduate Diploma of Clinical Research. A ‘gigging’ classical and jazz guitarist, he received the QSM in 2008 in recognition of his input to both ethics and the performing arts.

Isobel Smith

Isobel is a qualified pharmacist with more than 20 years’ experience in clinical trials in NZ, Australia and the United Kingdom. She is currently the country manager for PPD in New Zealand. Isobel has a wealth of industry experience including working as a Clinical Trial Monitor, Clinical Trainer and Manager.

Senior Clinical Manager (CRA) – NZ, PPD, Auckland, NZ

Richard S. Stubbs MD FRCS FRACS

Richard is an Otago graduate who completed surgical training in the UK, and a period of fulltime research in the US, before joining The University Department of Surgery in Wellington in 1986. In 1991 he established the Wakefield Gastroenterology Centre at Wakefield Hospital in Wellington, which became a referral centre for both the medical and surgical management of Gastrointestinal diseases. There he developed a busy career encompassing clinical practice as an upper GI and hepatobilary surgeon, clinical research, and basic science research. His own particular interests revolved around Managing Director the treatment of liver tumours, bariatric surgery and diabetes. In 2008 he was appointed to an Adjunct P3 Research Ltd Professor position within the University of Otago in recognition of his professional standing and Hepatobiliary and Upper GI the importance of his research program. More recently he has let lapse this involvement with the surgeon, Wakefield Hospital, University and has reduced his clinical workload in order to devote more time to the clinical trials Wellington industry in NZ, through the position he took up in 2010, as Managing Director of P3 Research Ltd.

Helen Teale

Helen Teale is the founder and director of Cameron Healthcare Ltd. A clinical research organisation founded in NZ, which runs clinical trials in NZ and Australia and offers a full consultancy service to pharmaceutical, device and life science companies. Cameron Healthcare recently celebrated their 5th birthday. Helen started her clinical research career in the UK in 1990 working initially for Bristol-Myers Squibb and Glasgow University on the now world renown West of Scotland Coronary Prevention Study (WOSCOPS) and then on to the respiratory division of Glaxo Wellcome plc. Before being approached Director, Cameron Healthcare, by former colleagues, to project manage SmithKline’s first pivotal study in South East Asia for a new Auckland, NZ anti-infective. Based in Singapore as the Clinical Operations Manager from 1996, Helen developed and managed Quintiles’ first clinical team in South East Asia. Quintiles was the first international CRO to open offices in Asia, Helen was their 5th member of staff! Helen moved to Auckland, New Zealand in 2005, where she originally worked for the former biotechnology company Protemix, on a large diabetes/cardiovascular programme, in association with the University of Auckland. She then managed a large CRO before setting up Cameron Healthcare, further information can be found on www. cameronhealthcare.co.nz and by talking to Helen at the conference.

9 Register online at www.nzacres2015.org.nz Programme

th 2015 NZACRES 11 Annual Conference CON FERE NCE 2021 AUGUST 2015, THE HERITAGE HOTEL AU CKLAND, NEW ZE AL AND

THURSDAY 20 AU GUST 2015

1200 © 1300 Registration Desk Open Pre Function

1300 © 1315 WELCOME Robert Laidlaw 1&2

1315 © 1400 Plenary Session Dr Kathryn McPherson, Chief Executive, Health Research Council of New Zealand, Auckland, NZ

1400 ©1430 New Mobile & Wearable Technologies Changing Connected Healthcare Models Clinical Research Prof Pramod K. Gaur, Adjunct Professor, Pace University, NY, USA

1430 © 1500 What Does Pharma Want from Clinical Trial Sites? Dr Elliott Kulakowski, CEO, Society of Research Administrators International, Virginia, USA

1500 © 1530 Afternoon Tea Pre Function

1530 © 1600 Mary Galea, Professorial Fellow Dept of Medicine, The University of Melbourne, Australia

1600 © 1630 Maori Ethics Frameworks: The Implications for Researcher Behaviour Dr Barry Smith, Population Health Analyst, Planning & Funding; Chair, Research Committee, Lakes DHB, Rotorua

1630 © 1700 (C)ELSI & Clinical Research - Addressing the (C)ultural Dimension Dr Maui Hudson, Senior Research Fellow and Research Developer, University of Waikato, Hamilton, NZ

1700 © 1730 Becoming a Professional Research Manager – Building your Skills and your Team Dr Mark Hochman, Senior Advisor in Research Policy and Strategy, The University of Tasmania, Australia

1730 © 1900 Welcome Reception Pre-Function

Grand Tearoom, 1900 © 2300 Conference Dinner The Heritage Hotel

Silver Sponsor Supporting Sponsor New Zealand Association of Clinical Research 10 Programme

th 2015 NZACRES 11 Annual Conference CON FERE NCE 2021 AUGUST 2015, THE HERITAGE HOTEL AU CKLAND, NEW ZE AL AND

FRIDAY 21 AU GUST 2015

0800 © 0900 Registration Desk Open, Arrival Tea & Coffee Pre Function

Stream A Robert Laidlaw 1 Stream B Robert Laidlaw 2 Stream C Tass Williamson

0900 © 0945 0900 © 0945 0900 © 0945 New Approach to Primary Global Stroke See Through the Cloud of Data GCP Prevention and Audrey Shearer, CEO, SPIRAL Wellington, NZ Helen Teale, Director, Cameron Healthcare, Epidemiological Research of Auckland, NZ Stroke and other Major NCDs Professor Valery Feigin, Professor of Neurology and Epidemiology; Director, National Institute for Stroke & Applied Neurosciences, AUT University, Auckland, NZ

0945 © 1030 0945 © 1030 New Technology into Human Trials and The Company Story - Therapeutic Clinical Use in New Zealand Development from the Edge of the World Dr Patrick Gladding, Cardiologist, Andrea Miller, CEO, Breathe Easy Therapeutics, North Shore Hospital, Auckland, NZ Auckland, NZ

1030 © 1100 Morning Tea Pre Function

Stream A Robert Laidlaw 1 Stream A Robert Laidlaw 2 Stream A Tass Williamson

1100 © 1145 1100 © 1130 1100 © 1145 Nutrition and Disease-related research Clinical Research Trials in Primary Health Relation to investigator led trials, which including clinical trials in a CRI Care through inadequate attention to design Dr Greg Pringle, Business Development Manager, Dr Simon Carson & Julia Mathieson, and analysis The NZ Institute for Plant and Food Research Ltd, Southern Clinical Trials, Christchurch, NZ Professor Chris Frampton, Auckland, NZ Biostatistics, Department of Medicine/ 1130 © 1145 Psychological Medicine, University of Otago, Free Paper Presentation Christchurch, NZ Investing in Clinical Research – the Role of the Health Research Council (HRC) Lucy Pomeroy, Project Manager, Clinical Investment Processes, Health Research Council of New Zealand

1145 © 1230 1145 © 1230 1145 © 1230 Research and Contracts, Growing the Clinical Trials Industry in What Capabilities New Zealand Problems and Solutions NZ – Why and H ow? Needs to be an A ttractive Place to do Marina Dzhelali, Service Leader, Research Office, Professor Richard Stubbs, Managing Director, P3 Commercial Research Capital & Coast DHB, Wellington, NZ Research, Auckland, NZ Edward Watson, South Pacific Clinical Trials, Auckland, NZ

1230 © 1330 Lunch Pre Function

1330 © 1400 Crowd Funding Website in NZ Robert Laidlaw 1&2 Anna Guenther, Co-Founder and CEO, PledgeMe, Wellington, NZ

Silver Sponsor Supporting Sponsor Register 11 online at www.nzacres2015.org.nz Programme

th 2015 NZACRES 11 Annual Conference CON FERE NCE 2021 AUGUST 2015, THE HERITAGE HOTEL AU CKLAND, NEW ZE AL AND

FRIDAY 21 AU GUST 2015

1400 © 1415 Rosemary Hall, Endocrinology Capital & Coast DHB, Wellington, NZ

1415 © 1445 The Research Administrators Network & NZACRes Scholarship Update Maria Carney, Research Administrator Christchurch Hospital, Christchurch, NZ & Archana Nair, Data Manager, Oncology Clinical Trials, Waikato Hospital, Hamilton NZ

1445 © 1515 Medicines from the Beehive Dr Shaun Holt, HoneyLab & Victoria University of Wellington, Wellington, NZ

1515 © 1545 Afternoon Tea Pre Function

1545 © 1615 Isobel Smith, Senior Clinical Manager (CRA), PPD, Auckland, NZ

1615 © 1645 Dr Diana Siew, National MedTech Sector Manager, Callaghan Innovation, Auckland, NZ

1645 © 1715 Mrs Anne Kolbe, Chair, National Health Committee, Auckland, NZ supported by Peter Guthrie, General Manager, National Health Committee, Auckland, NZ

1715 © 1730 Conference Close

Silver Sponsor Supporting Sponsor New Zealand Association of Clinical Research 12 Social Programme

Social Programme

Welcome Reception Date – Thursday 20 August 2015 Time – 1730 – 1900 hours Venue– Exhibition Hall, Pre-Function Area, The Heritage Hotel, Auckland Dress – Smart Casual Cost – One ticket is included in the Full Delegate Registration. Additional guest tickets can be purchased for $65.00 inclusive of GST. Please indicate your intention to attend when registering for the Conference.

Conference Dinner Date – Thursday 20 August 2015 Time – 1900 - 2300 hours Venue – Grand Tearoom, The Heritage Hotel, Auckland 35 Hobson St entrance Dress – Cocktail Cost – Registered Delegates $95 inclusive of GST. Additional guest tickets can be purchased for $145.00 inclusive of GST. Please indicate your intention to attend when registering for the Conference.

13 Register online at www.nzacres2015.org.nz Registration Information

Registration Information

Register online at www.nzacres2015.org.nz Cheque/Money Order/Bank Draft. Please make Acknowledgement payable to “Workz4U Conference Account”. All payments MUST BE IN NEW ZEALAND DOLLARS. All registrations received prior to Monday 17 August 2015 will be acknowledged in writing. Registrations received Credit Cards. Amex, Mastercard and Visa are after this date will be processed on the day you arrive at accepted. Credit Card payments will appear as the Conference. Online registrations will be acknowledged Workz4U Limited on your statement. with an automated email response and a tax invoice. If Online Banking. Please use delegates surname as you have any questions about your registration please a reference when transferring funds electronically. contact Workz4U Limited, [email protected] If transferring funds from overseas please ensure that you transfer the full amount including an Alterations international transaction fee of NZ$25. Alterations to your registration must be in writing via: Bank: Email: [email protected] ANZ Bank, Pukekohe Branch, 110 King Street, Post: Workz4U Limited, PO Box 90641, Victoria Street Pukekohe, New Zealand West, Auckland 1149, New Zealand Name of Account : Cancellation and Refund Policy Workz4U Conference Trust Account – NZACRes15 All cancellations must be made in writing to the Account # : 06-0293-0099402-65 Conference Managers. Cancellations made by Monday Swift Code : ANZBNZ22 20 July 2015 will be refunded, less a $125 administration Please use the following as a reference: fee to cover administration costs. After this date, no NZACRes15 refunds will be made. All refunds will be processed after Onsite Registration the Conference. Refunds will only be made by the same If you have not registered by Monday 17 August 2015, method as payment was received. If, for reasons beyond you can register on-site. The Registration Desk will be the control of the Organising Committee, the Conference open from 12:00 hrs on Thursday 20 August 2015. On-site is cancelled, registration fees will be refunded after delegates are not guaranteed Meeting documentation, deduction of expenses incurred. a Conference satchel or any inclusive social function Payment tickets. All prices are quoted in New Zealand dollars (inclusive of Registration Desk GST). Registration cannot be confirmed until full payment The registration desk will be open as follows. Our team is received. Credit card payment is not compulsory for will be happy to assist with any queries. online registration as you will receive a tax invoice with your registration confirmation. All registration fees must Thursday 20 August 2015 1200 – 1900 hours be paid prior to the commencement of the conference Friday 21 August 2015 0800 – 1730 hours either by direct credit, cheque or credit card.

New Zealand Association of Clinical Research 14 Registration Fees

Registration Fees (New Zealand dollars and inclusive of GST´

Full Conference Registration

NZ$ NZACRes Member ...... 445 INCLUDES — Early by 29 June 2015  Entry to all NZ$ NZACRes Member ...... 550 Conference sessions Standard after 29 June 2015  Conference Programme NZ$ Non Member ...... 605  Conference Early by 29 June 2015 Handbook - will NZ$ Non Member ...... 710 only be provided if requested during Standard after 29 June 2015 registration NZ$ Student ...... 285  Entry to Exhibition Evidence of full time course is required.  One ticket to the Welcome Reception No social functions are included in the student registration.

Day Conference Registration – Thursday

NZ$ NZACRes Member ...... 310 INCLUDES — Early by 29 June 2015  Entry to all NZ$ NZACRes Member ...... 385 Conference sessions Standard after 29 June 2015 on the day of registration only NZ$ Non Member ...... 465  Conference Early by 29 June 2015 Programme NZ$  Conference Handbook Non Member ...... 545 - will only be provided Standard after 29 June 2015 if requested during NZ$ Student ...... 185 registration Evidence of full time course is required.  Entry to Exhibition on the day of registration No social functions are included in the student registration.

Day Conference Registration – Friday

NZ$ NZACRes Member ...... 415 INCLUDES — Early by 29 June 2015  Entry to all NZ$ NZACRes Member ...... 495 Conference sessions Standard after 29 June 2015 on the day of registration only NZ$ Non Member ...... 570  Conference Early by 29 June 2015 Programme NZ$  Conference Handbook Non Member ...... 650 - will only be provided Standard after 29 June 2015 if requested during NZ$ Student ...... 235 registration Evidence of full time course is required.  Entry to Exhibition on the day of registration No social functions are included in the student registration.

15 Register online at www.nzacres2015.org.nz Conference Venue

The Heritage Hotel Conference Centre

Rooms to be used at the Heritage Hotel are as follows: • Registration Area Pre Function Area, Conference Centre • Plenary Sessions Robert Laidlaw 1&2 • Concurrent Sessions Robert Laidlaw 1 Robert Laidlaw 2 Tass Williamson • Exhibition Area Pre Function Area, Conference Centre

Entrance via • Catering 11 Wyndham Street, Auckland City, New Zealand Pre Function Area, Conference Centre PO Box 105-326 Auckland, New Zealand • Welcome Reception Ph +64 9 379 8553 Pre Function Area, Conference Centre Fax +64 9 979 7479 • Conference Dinner www.heritagehotels.co.nz The Grand Tea Room, Heritage Hotel

Exhibition Floorplan

Entry from Wyndam St T&C

T&C Note, coffee Coffee Coffee Registration DeskRegistration Cart cart will only be available if it is sponsored 9 Catering 8 Conference Catering Sessions T&C 7 6

5 T&C

2 1 4 3

Note: Coffee cart will only be available if it is sponsored

New Zealand Association of Clinical Research 16 Accommodation

Accommodation

Accommodation has been reserved at special rates for guaranteed check in and required check out times. delegates at the Conference venue. Please book your Should you wish to guarantee your room is ready before accommodation through the Conference Managers the hotel check in time please book and pay for the as part of the online registration process via www. room for the evening prior to your arrival. Failure to nzacres2015.org.nz. Please direct all accommodation advise your arrival time may mean that your room will be enquiries and changes in writing to the Conference released. Managers. The accommodation venues will not accept direct bookings. Room rates don’t include breakfast. To Secure Accommodation Delegates are responsible for covering all costs related To secure accommodation please book prior to the to their accommodation. If you have any queries please closing date of Monday 20 July 2015. A deposit may be contact the Conference Managers +64 9 917 3653 or email charged at the time of booking and will be taken from [email protected]. your credit card. Your account is to be settled directly The Heritage Hotel, Auckland with the hotel upon checkout. Any no-show fees will 35 Hobson Street, Auckland City, New Zealand be charged to your credit card. Room Rates quoted are per room per night in $NZD and include 15% GST unless PRICES ARE INCLUSIVE OF GST — otherwise specified. Reservations are taken on a first Superior & Deluxe Rooms ...... NZ$179.00 come, first served basis. One Bedroom Executive Room ...... NZ$229.00 Change of Booking Cancellation policy: Alterations to your accommodation booking must Any cancellations notified less than 30 days prior be advised in writing to the Conference Managers, to arrival may incur a charge equal to one night’s [email protected] accommodation. Cancellation of Booking No Shows – if a guest fails to arrive on the due date the hotel will charge for the entire accommodation Cancellations must be advised in writing to the booked. Conference Managers. Please check the individual hotel information for cancellation policies. Other information:

Check-in: 1400hrs Check-out: 1000hrs Sharing Accommodation Rates DO NOT include breakfast. Breakfast is Delegates who intend to share a room should indicate available from $25Map per person with per Parking room Buildingthe nameLocations of the person with whom they wish to share, during the registration process under the Arrival Time and Late Arrivals accommodation section. Only ONE of the sharing Please check the individual hotel information for delegates should submit the accommodation booking.

17 Register online at www.nzacres2015.org.nzA = Heritage Auckland

Heritage Hotel Auckland 35 Hobson Street, PO Box 105-326 AUCKLAND 1010 Phone +64 9 379 8553 Fax: +64 9 979 7476 Web: www.heritagehotels.co.nz General Information

General Information

Auckland Conference Account”, or directly into our bank account: New Zealand’s largest city, Auckland, is located in ANZ Bank, Pukekohe Branch, 110 King Street, the upper North Island. The ‘City of Sails’ is truly Pukekohe, New Zealand cosmopolitan. From the stunning Waitemata Harbour and Name of Account: the 50-plus islands making up the Hauraki Gulf to the Workz4U Conference Trust Account – NZACRes15 colourful mix of cultures that call Auckland home, the Account #: 06-0293-0099402-65 city has the people and the places to make any event a Swift Code: ANZBNZ22 success! See www.aucklandnz.com for more information Please use the following as a reference: about Auckland. NZACRes15

Airport All fees quoted are in New Zealand Dollars and are inclusive of GST. Payment for registration must be Auckland Airport: www.auckland-airport.co.nz received prior to the commencement of the Conference. Tel: +64 9 275 0789 or 0800 247 767 [email protected] Facilities for People with Disabilities The Heritage Auckland is a 40 minute drive from Auckland Please indicate as part of your online registration if you International Airport. The average taxi fare from the require disabled facilities. airport to Auckland CBD is NZ$85 depending on traffic. Please allow for extra travel time in peak hours. Goods and Services Tax Goods and services in NZ are subject to a 15% tax (GST). Air Travel This is usually included in the price, but if not, is clearly To obtain the best rates for international and domestic stated. air travel, it is essential to book airfares early. Air New Zealand flights can be booked via www.airnz.co.nz. Industry Exhibition Please arrange your own transport from the airport. A wide and varied Exhibition will be co-ordinated by Car Parking the Conference Managers. The Exhibition will be held in the Pre-Function Area of The Heritage Hotel Conference Casual valet parking is available for a reduced rate of Centre. Morning teas, lunches and afternoon teas, as $25.00 per vehicle per day (normally $35.00 per day), scheduled in the programme, along with the Welcome this is subject to availability. Parking is also available Reception will be held in the exhibition area. for conference attendees at Wilson Car Park (corner of Wyndham & Hobson Streets) which is directly across Expressions of interest in participating in the Exhibition the road from the Conference Centre entrance on 11 or Sponsoring the Conference are welcomed by Wyndham Street. Parking is at the guests’ own expense. the Conference Managers. If you are interested in participating as a sponsor or exhibitor, please contact Contact during the Conference Donna Clapham, Workz4U Limited on +64 9 917 3653 or As a courtesy to speakers, delegates are requested to [email protected] switch off mobile phones and pagers during sessions. Exhibition Opening Hours Messages can be left at the registration desk. Delegates will need to check with the registration desk if they are The Exhibition will be open as follows: expecting any messages. Thursday 20 August 2015 1200-1900hrs Friday 21 August 2015 0800-1730hrs Credit Cards Accepted cards are Visa and Mastercard. Payment may also be made by cheque, payable to “Workz4U

New Zealand Association of Clinical Research 18 Insurance or Exhibitor are welcomed. If you are interested please contact Donna Clapham, Workz4U Conference Delegates are advised to book comprehensive travel and Management on +64 9 917 3653 or [email protected] medical insurance and ensure that all possessions are adequately insured. The policy should include loss of Rental Cars fees/deposits through cancellation of your participation in the Conference. The Conference Managers will not accept any responsibility for delegates failing to arrange www.avis.co.nz www.hertz.co.nz insurance.

Liability Disclaimer www.budget.co.nz www.thrifty.co.nz The Organising Committee, including the Conference Managers, will not accept liability for damages of any Taxis and Shuttles nature sustained by participants or their accompanying persons or loss or damage to their personal property as a result of the meeting or related events. In the event of industrial disruption or other unforeseen circumstances, www.corporatecabs.co.nz www.supershuttle.co.nz the Conference Managers accepts no responsibility for loss of monies.

Name Badges All delegates will be given a name badge upon registration. This name badge is your official pass to www.greencabs.co.nz sessions, catering areas, the Welcome Reception and the Conference Dinner. It is necessary for delegates to wear WiFi their name badge at all time when on-site. WiFi is complimentary for delegates use over the period of the conference. If outside these hours delegates can No Smoking Policy purchase 1GB of wireless internet for $35.00 per day. This Smoking is banned in public buildings and many cannot be used in your accommodation rooms if staying hotels and restaurants in New Zealand, including the in-house. If staying in-house, you can purchase internet Conference venue. via your room which can also be used in the conference rooms. There are various options available for in-room Sponsorship and Exhibition access, please see the notices in your room. Expressions of interest in participating as a Sponsor

IF YOU HAVE ANY QUESTIONS AT ALL, PLEASE DO NOT HESITATE TO CONTACT OUR CONFERENCE MANAGERS: — / Donna Clapham

CONFERENCE AND EVENTS MANAGEMENT PO Box 90641, Victoria Street West, Auckland 1142, New Zealand t: +64 9 917 3653 / e: [email protected] / w: www.w4u.co.nz

19 Register online at www.nzacres2015.org.nz