Category: <span>Quality Activities</span>

Thurs 7 April – The Science Exchange, Adelaide

Around 61 people including several members from interstate attended this interesting and informative event. The two presentations generated discussion on first in human studies utilizing the incident in the BIAL/Biotrial Phase 1 trial in France early in January as a case study. The event was very well received and a range of interesting questions were raised. Our Education evenings are part of our ongoing commitment to the continuing professional development of our HREC members. We believe that on-going education is a fundamental requirement in the delivery of a high quality ethics review service to the human research community. Bellberry wishes to thank our excellent speakers and everyone else who attended for their input and discussion. We look forward to the next event.

7-10 October 2015, Sydney

The theme of this year’s meeting is Better Evidence, Better Health and it aims to bring together a broad range of local and international experts in the design and conduct of clinical trials, clinical data and registry custodianship, healthcare funding, policy and regulation, healthcare service delivery, health information technology and patient advocacy to:

Bellberry will again be attending this event and hosting a stand so please come along and find out who we are and what we do or just to say hello!

PRAXIS_opt

Bellberry are delighted to announce the launch of the PRAXIS Australia website at http://www.praxisaustralia.com.au/

PRAXIS Australia Ltd promotes the understanding and practice of ethical human research in Australia and internationally, to enhance the welfare of research participants and the quality and effectiveness of research.

Over the next few weeks PRAXIS will expand their online services with resources and a communication forum that promotes the exchange of ideas and facilitates discussion around matters of interest to the research ethics and research communities.

Please visit the PRAXIS site to register for courses, subscribe for updates or simply ask a question about PRAXIS services or other tailored training needs.

Bellberry is a Member Organisation of PRAXIS and fully support this initiative.

e: info@praxisaustralia.com.au

Clinical Trends and New Approaches

Wed 6 May, The Royal Australasian College of Surgeons, Melbourne

Simon Windsor and Trina O’Donnell attended this event held at the Royal Australasian College of Surgeons in May. Simon presented a session to over 200 people at this popular workshop which is organised by Victoria Health.

The workshop addressed current issues and use of electronic approaches. There were sessions on participant consent including e-consent, personalised medicine and developments in investigator initiated projects, industry related topics including online monitoring and social media surveillance

Simon presented a session on the National PICF Project, A Participant-focused Approach. The session was very well received and many thought provoking questions were raised.

All presentations from this workshop will be available to view on the Victoria Health website.

Thurs 30 April – The Science Exchange, Adelaide

Around 45 people with several members from interstate attended this interesting and informative event. The two topics presented were ‘Ethical and regulatory challenges generated by surgical innovation’ and ‘Procedures and Devices.’

The event was very well received and a range of interesting questions were raised. Our Education evenings are part of our ongoing commitment to the continuing professional development of our HREC members. We believe that on-going education is a fundamental requirement in the delivery of a high quality ethics review service to the human research community.

Bellberry wishes to thank our excellent speakers and everyone else who attended for their input and discussion. We look forward to the next event.

ARCS Scientific Congress, Sydney

5-7 May 2015

This year ARCS are running a combined congress for those working in the development of medicines and medical technologies including clinical research, regulatory affairs, quality/GMP, medical devices, reimbursement, pharmacovigilance, medical information, medical affairs, and workplace management.

This year Bellberry are delighted to be presenting at two sessions. Our Project Officer Simon Windsor will be speaking on Tues May 5 at the Improving Investigational Site Operations session. Simon will be presenting information about the National PICF Project and providing pilot data from the project.

On Wed May 6 Melanie Gentgall will be talking at the Trends in Clinical Research Governance session which will be chaired by Bellberry CEO Kylie Sproston.

We will also have our usual booth at the conference so please feel free to come along for further information on Bellberry and our ethics Committee’s or just to say hello! We look forward to meeting new friends and catching up with old acquaintances.

AusBiotech Image

Australian and international biotech leaders and stakeholders will gather on the Gold Coast from 29 to 31 October for the AusBiotech 2014 national conference. The conference theme ‘Life Sciences = Future. Jobs. Exports.’ brings the focus to the developments in biotechnology and the life sciences industry that will significantly boost Australia’s economic performance and build our nation.

Bellberry CEO Kylie Sproston will be attending this years conference and looks forward to the opportunity of creating new partnerships and catching up with you all.

With just two weeks to go until we host the International Scientific Congress into the Challenges of Early Crossover in Clinical Trial Design for Oncology, time is running out to book your place!

Confirmed speakers include:

E/Prof Lloyd Sansom AO
Prof Davina Ghersi (NHMRC)
Prof Francesco Pignatti (EMA)
A/Prof Michael Coory (TGA)
Prof Andrew Mitchell (NHMRC)
Dr Kathy Soltys (Health Canada)
Rebecca Trowman (NICE)
Dr Anthony Fields (CADTH)
Dr Beate Wieseler (IQWiG)
Dr Sean Tunis (CMTP (USA)
Dr Dane Dickson (MoIDX, Palmett GBA )

The panels will cover the range of perspectives around this issue: from the needs of clinical trial participants; to practical considerations of treating oncologists. From the analytical considerations of the regulatory agencies; to the data set conundrums facing the Health Technology Assessment agencies. Supported by leading academics in biostatistics and health economics. Sessions will be fully interactive, offering the audience the opportunity to give feedback direct to the agencies on proposed guidelines around how to handle these growing challenges.

Further Conference Information and Agenda

Challenges of Early Crossover in Clinical Trial Design for Oncology

On Wednesday 22 October 2014, Bellberry will host a conference in Adelaide on the Challenges of Early Crossover in Clinical Trial Design for Oncology. At this important event, we will launch guidelines in this area which have been consolidated by an international panel of experts at a workshop overseen by a Scientific Advisory Committee, chaired by Emeritus Professor Lloyd Sansom AO.

The workshop will result in the development of an agreed statement of good practice, guidelines on approaches and clear agreement on any required next steps, all of which will be presented and debated at the conference.

Dr Shayne Bellingham, University of Melbourne and Alison Gibberd, University of Sydney both received donations in 2013 as part of the Bellberry donation scheme. Below is an update on both awards.

Inaugural Bellberry Indigenous Health Fellow

Dr Shayne Bellingham was awarded the inaugural Bellberry Indigenous Health Fellow at the Department of Biochemistry and Molecular Biology, University of Melbourne in 2013 to support indigenous research. One year on Dr Bellingham reflects on the impact that the fellowship has made on his ongoing research. ‘The Bellberry Indigenous Health Research Fellowship is a wonderful initiative to support indigenous Australians for a career in medical research. Importantly without such generous support it is more than likely I would not have been able to continue my research career. The fellowship, thus far, has provided the opportunity for me to expand research skills into animal models of disease for development of clinical diagnostic tests; witness my first PhD student graduate; and consolidate several research papers that will strengthen my NHMRC Project Grant application in the next funding round. The fellowship has also allowed me to engage with Indigenous leaders within the University of Melbourne and undergraduate students through Ormond College. The Bellberry Indigenous Health Fellowship has also fuelled a passion for me to develop my research career so that it has a direct benefit for indigenous Australians. Long term, I plan to head my own research team to investigate Alzheimer’s disease and end-stage chronic kidney in the field of early diagnosis and preventative medicine. The prevalence of dementia is 12.4% higher in Indigenous Australians and the incidence rate for end-stage renal disease for Indigenous Australians has more than doubled between 1991 and 2008, from 31 to 76 per 100,000 population. Since “closing the gap” is predicted to increase the life expectancy of Indigenous Australian, then the onset of dementia and development of chronic kidney disease will no doubt have a major cultural impact. I would like to thank the board of Bellberry Pty Ltd for the opportunities they have afforded me through the establishment of this Fellowship, and to commend them for their philanthropy and support for medical research and Indigenous researchers.’

The University of Sydney

The Bellberry Scholarship in Indigenous Health and Biostatistics was established in 2012 to offer a suitably qualified candidate with a Masters degree in Biostatistics to undertake research studies leading to a PhD in Biostatistics, in the field of Indigenous health. In March 2013, Alison Gibberd was excited to be awarded the inaugural Bellberry Scholarship in Indigenous Health and Biostatistics: ‘For almost 3 years, I worked on a project exploring reasons for poorer survival from cancer and patterns of care for Aboriginal people in NSW. During this period, my interest in Indigenous health was strengthened and I saw the Bellberry Postgradu¬ate Scholarship in Indigenous Health and Biostatistics as a fantastic opportunity to examine interesting questions in an area of great need. Disparities in the health of Indigenous and non- Indigenous Australians begin at birth, with higher rates of preterm birth, stillbirth and low birth weight in Aboriginal people, and continue across the life course. For my PhD, my supervisors, Judy Simpson and Sandra Eades, and I will investigate relationships between perinatal outcomes and subsequent health throughout the life course, as well as associations across generations, using birth and health data for all Indigenous people born in Western Australia over a 30 year period. I am very grateful to Bellberry Limited for the opportunity to work on this project.’ During her PhD, Alison is being supervised by Professor Judy Simpson and Professor Sandra Eades. ‘The Bellberry Scholarship in Indigenous Health and Biostatistics has enabled us to recruit Alison, an outstanding young biostatistician to work with us to understand intergenerational pathways to poor fetal growth among Aboriginal infants’ – Professor Sandra Eades

As we have mentioned in previous updates, Bellberry Ltd is committed to contributing to the current national aim of streamlining of current ethics review processes. This is in conjunction with our core aims of promoting and improving the welfare of research participants and promoting quality, efficiency and effectiveness of research across Australia.

The need for increased education services to the broader research sector has been identified by many key stakeholders as an important element of the streamlining objective, with an end goal of promoting and retaining a skilled and informed workforce. We are excited to announce our plans to deliver VET accredited education to the Human Research Ethics sector, with a planned implementation internally later this year and then nationally in early 2015. This will be closely followed by accredited education to the broader research sector , focusing on education and support for researchers and research site support staff.

Importantly, we recognise that affordability, accessibility and quality are inherent design elements. All education services will be conducted in partnership with an academic tertiary institution /professional body, with support and guidance on design, content and delivery from key experts around the nation, including industry, regulators and representatives of all of the target audience groups. One important goal of this project is to ensure that the services can be readily accessed by all, with an aim to ensuring portability of acquired skills and recognition amongst the sector of accredited training as an accepted standard. This would ultimately reduce the current burden of repetition of training that impacts time and costs related to research.

If you would like to know more about this project or would like to know how you can be involved, please contact Melanie Gentgall, Bellberry Education Project Manager at melaniegentgall@bellberry.com.au

Bellberry HREC will once again be attending the ARCS Scientific Congress in Sydney on the 3rd-4th June 2014. The ARCS congress brings together the Australian therapeutics community for education and networking. We look forward to this event as an opportunity to meet with Investigators, Institutions, research organisations, and HREC members. Bellberry will also be presenting on innovations in the Ethics arena.