GUIDANCE FOR APPLICANTS

Gilead Sciences Pty Ltd is proud to work in partnership with the Australian research and clinical community to provide opportunities for investigation and research. Gilead has furthered its commitment to HIV, chronic viral hepatitis and haematological oncology research by establishing the Gilead Australia Fellowship: Research Grants Program, an Australian-specific initiative enabling researchers to apply for funding support for innovative projects with a clinical but 'real-world' focus.

Please read the following information to assist you with preparing your application.

  • AIM AND SCOPE
  • FUNDING AVAILABLE
  • APPLICATION PROCESS
  • JUDGING PANEL AND CRITERIA
  • APPLICANTS
  • FURTHER INFORMATION

AIM AND SCOPE

What is the aim of the Research Grants Program?

The aim of the Gilead Australia Fellowship: Research Grants Program is to support the development, exploration and implementation of best practice in enhancing patient care in the specific disease areas of HIV, chronic viral hepatitis and haematological oncology.

Similar programs have been running successfully for several years in the UK and Europe, where evidence generated from supported projects has provided the potential to generate new studies or joint ventures to shape clinical care pathways and inform public health policy.

What projects will be considered for funding by the Research Grants Program?

Financial grants will be awarded on a competitive basis to individuals, organisations or groups of healthcare providers within a locality whose proposals are focused on investigating solutions to improve care for patients with HIV and/or chronic viral hepatitis, and haematological malignancies. This includes clinical and academic staff at Australian hospitals, clinics, universities and research institutes, young investigators, nurses, GPs and other healthcare providers/researchers from professional organisations, in both urban and rural areas. Applications for community based projects that may not necessarily fall under traditional research grant criteria are welcome. In addition, projects may be based on sociological and epidemiological aspects of patient care in these three therapy areas, as well as practical aspects. A key focus for the judges is innovation, with projects driven by novel approaches particularly sought.

Research proposals are invited that explore and address the following issues and themes:

HIV/CHRONIC VIRAL HEPATITIS

  • Developing and/or evaluating novel ways to prevent new HIV and/or chronic viral hepatitis infections
  • Improving community and primary care awareness, interest and uptake of screening to identify undiagnosed people with HIV and/or chronic viral hepatitis in high prevalence populations
  • Reducing late diagnosis of HIV and/or chronic viral hepatitis in high prevalence groups
  • Improving access, uptake and adherence to medication for HIV and/or chronic viral hepatitis, with emphasis on marginalised groups such as Indigenous communities, drug users and immigrants
  • Developing strategies to support the management of long-term complications associated with HIV and/or chronic viral hepatitis infection and its treatment
  • Identifying the reasons for and strategies to reduce loss to follow-up for patients with HIV and/or chronic viral hepatitis
  • Improving adherence to long-term medication through innovative programs.

HAEMATOLOGICAL ONCOLOGY

  • Improving the care of patients with haematological malignancies

Please see below for additional guidance on the following project types:

Mobile applications

The Research Grants Program can only fund testing of completed mobile applications that have the potential to change clinical practice. Funding for the development of mobile applications is not within the remit of the Program.

Culturally and linguistically diverse (CALD) populations

Applications involving CALD communities should address novel research questions that have not been addressed in other communities.

Basic research projects

The Research Grants Program is unable to provide funding for basic research projects.

FUNDING AVAILABLE

How much funding is available for projects?

For the 2018 Research Grants Program, the total funding available is $250,000. It is anticipated that at least one project will be funded in each of the three therapeutic areas, subject to project proposals meeting the judging criteria. The requested level of funding should be stated at the time of application, although the exact amount of funding allocated to each project may vary depending on the nature of the project. Funding is contingent on ethics approval being granted (if required), and all projects must be completed by the end of 2018.

Dependent on ethics approval (please see further guidance below), funding will commence in January 2018 and all projects must be completed by the end of December 2018.

Can I apply for funding for more than one project at a time?

No. Each applicant can only apply for funding for one project during the course of any one Research Grants Program.

Can I apply for a grant on a currently ongoing project?

Yes, as long as the funding will be used to extend an existing project that will complete by the end of 2018 and the proposal meets the required criteria. The application must highlight and explain why additional funding is required for the completion of the project, and disclose whether the project has received/is receiving funding from other sources. Preference will be given to projects requiring full funding from the Research Grants Program.

What are the conditions of funding?

Projects should run during the calendar year (January–December) of 2018 and all projects must be completed by the end of 2018. Funding is dependent on the project adhering to this timeframe and applicants must confirm their ability to meet this requirement at the time of application.

Funding is also subject to ethics approval being granted, if required.

APPLICATION PROCESS

What is the application process for the Research Grants Program?

All applications must be submitted online via the dedicated Gilead Australia Fellowship website (www.gileadfellowship.com.au). The website will be accepting applications from 10 April 2017 to 23:59 AEST on 1 September 2017. All applicants will need to register on the website to gain access to the application portal. After starting an application online, the form can be saved and the application continued at a later date. All applications must be completed and submitted by the closing date of 1 September 2017; incomplete applications and applications submitted after this time will not be considered. Please note all correspondence and notifications to applicants will be via email where possible.

What are the key components that should be included in the application?

To assist you with completing your application, the following guidance outlines what should be considered for inclusion:

  • Objective(s) and overview of the project, including a description of specific goals to be achieved and the population to be targeted
  • Description of how the project is innovative
  • Information regarding your/your team’s capacity to initiate and implement the project in a timely manner and complete the project within the specified time frame (i.e. between January and December 2018)
  • Description of the sustainability of the project, including the potential for scaling up and reproduction in other settings
  • Current clinical or research activities related to the area of application
  • Relevant and project-specific data (i.e. evidence base) that support the need for the project
  • Specific, measurable, achievable, realistic and time-sensitive project milestones and action steps required to meet project goals
  • Process for data collection and analysis, including which staff members will analyse the data
  • Methodology for the collection and reporting of cost-effectiveness data and patient-related outcome data (which should ideally be measured using validated tools)
  • Clear details of the budget required and the amount of funding being requested
  • Disclosure of any other sources of funding applied for and/or granted
  • Confirmation of the need for ethics approval and estimated timelines for approval or evidence of approval
  • Name and contact details of the person within your organisation who is authorised to sign grant funding contracts.

No individual level data will be requested and no individual or aggregate data will be collected regarding prescribing patterns or treatment regimens, nor should any be submitted in response to a request for data. Organisations may collect and publish such data for their own purposes as per their internal policies.

Do applications need to include references?

References should be listed in the application where relevant. In addition, appropriate sources should be provided for all statistics cited in the application.

What ethics information should be included?

Obtaining ethics approval (if required) is a condition of funding being granted. Your application should indicate whether ethics approval is required and the estimated time of gaining this approval, confirming the body to which the application was made.

For further information on ethics requirements of primary care research, please visit the NHMRC Human Research Ethics Portal website (http://hrep.nhmrc.gov.au) or the RACGP ethics website (http://www.racgp.org.au/research/ethics) or contact your organisation’s research department for advice.

What information should be included in the budget?

All applications must include full budget details for the amount of funding being requested, providing a justification for all items. The budget should include:

  • Total project costs including supplies, staffing, supervision, quality assurance, overheads, etc
  • The amount of funding being requested
  • Disclosure of other sources of funding applied for and/or granted for the project.

The table below shows the level of detail for the budget required on the application form.

Project costs Details Total cost (AU $) Amount of funding being requested Justification for funding requested
Supplies        
Staffing        
Supervision        
Quality assurance        
Other (please specify)        
Other (please specify)        
Other (please specify)        
Other (please specify)        
Total        

Please note that the Research Grants Program will not provide funding for:

  • Supervisor and/or staff costs ordinarily provided by institutions or local health authorities
  • Testing and/or vaccination of whole populations – only pilot projects of this nature are eligible for funding.
  • Investment in medical equipment or medical hardware as one-off purchases
  • Operating expenses ordinarily provided by institutions or local health authorities

Can an application be recalled for changes?

All submissions will be reviewed by the Program Secretariat prior to judging, to ensure applications are complete and projects are within the specified themes. If, for any reason, further clarity needs to be sought on a submitted application before the closing date has been reached, an email will be sent to the applicant requesting resubmission before the closing date. After the closing date has been reached, applications cannot be resubmitted, so please ensure all relevant information is clearly included in your submitted application.

What is the process once applications have been submitted?

The flowchart below shows the Research Grants Program application and notification process. As outlined above, please note that once the application closing date has been reached, all applications will be screened by the Program Secretariat prior to review by the judging panel, to ensure applications are relevant and complete.

Please see below for more details on the information and feedback that can be expected once applications have been submitted.

JUDGING PANEL AND CRITERIA

Who are the members of the judging panel?

The applications will be reviewed by a judging panel made up of experts from across Australia recognised for their contributions to research in HIV, chronic viral hepatitis and haematological oncology, as well as senior Australian public figures. In addition to the Panel, a member of Gilead senior management will be present at the judging sessions. The following people have accepted a position on the Research Grants Program judging panel:

Professor David Cooper, AO Scientia Professor of Medicine, University of New South Wales, and Director, Kirby Institute, Sydney

David A Cooper AO, Scientia Professor of Medicine at the University of New South Wales and a Fellow of the Australian Academy of Science (FAA), is Director of the Kirby Institute for infection and immunity in society.

The Kirby Institute (until April 2011 known as the National Centre in HIV Epidemiology and Clinical Research or NCHECR), is funded by the Australian Government Department of Health to conduct research into the HIV/AIDS epidemic in Australia, with the ultimate aim of reducing the burden of HIV/AIDS for the affected community.

The major responsibilities of the Kirby Institute are the epidemiology and surveillance of HIV/AIDS, viral hepatitis and sexually transmissible infections in Australia, including research aspects and the coordination and conduct of clinical trials of innovative therapies and vaccines for HIV disease, as well as an active clinical research program with particular emphasis on HIV/AIDS. The 12 program areas include indigenous health and justice health as well as extensive laboratory research, clinical and behavioural research into viral hepatitis, HIV-related malignancies, an infection analytics program and surveillance evaluation. In addition to his role at the Kirby Institute, Professor Cooper is also a consultant physician to the HIV/immunology infectious diseases clinical services unit at St Vincent’s Hospital, Sydney.

Internationally, Professor Cooper is recognised as a leading HIV clinician and clinical investigator. He is a past President of the International AIDS Society and past Chairman of the World Health Organisation-UNAIDS HIV Vaccine Advisory Committee (VAC). In 1996, he co-founded HIV-NAT, a clinical research and trials collaboration based at the Thai Red Cross AIDS Research Centre at the Chulalongkorn University Hospital in Bangkok, Thailand. He is actively involved in studies of biomedical prevention and therapeutic optimisation strategies for HIV infection in the developing world.

Professor Cooper was awarded the Sir William Upjohn Medal for services to medicine in Australia for 2008. This medal is awarded every five years by the Faculty of Medicine of the University of Melbourne. Professor Cooper also received an Honorary Fellowship from The Royal College of Physicians in Thailand in April 2012 and became a Fellow of the Australian Academy of Health and Medical Science (FAHMS) in December 2014. In February 2015 at the Conference on Retroviruses and Opportunistic Infections Professor Cooper presented the N’Galy-Mann Lecture. In 2012 Professor Cooper became a member of the WHO HIV Guidelines Committee. He is a past President of the International AIDS Society (IAS).

He is an author on more than 800 published scientific papers and is on the editorial boards of several international journals.

Professor Ian Gust Professorial Fellow, Department of Microbiology and Immunology, The University of Melbourne

Professor Ian Gust is a medical virologist with a distinguished career in public health, including involvement in the development of vaccines against hepatitis A and human papillomavirus infection and membership of the International Task Force for Hepatitis B Immunization, which accelerated the introduction of the HB vaccine into routine immunisation programs. During his 20 years at Fairfield Hospital, he built an internationally renowned research team, founded and directed the Macfarlane Burnet Institute for Medical Research, established the National HIV Reference Laboratory and directed the NHMRC Special Unit for AIDS virology. During his subsequent period as R&D Director at CSL Ltd, he reorganised the research division, recruited high quality staff and laid the basis for the company’s new product portfolio. Professor Gust is the author of three books, more than 300 papers and has received several major awards for his work. Since ‘retirement’ in 2000, he has served as a Professorial Fellow in the Department of Microbiology and Immunology at the University of Melbourne. In addition to chairing Biomedical Research Victoria and the Victorian Biotechnology Advisory Council, he works with several biotech companies and is actively involved with the International AIDS Vaccine Initiative (New York), ICDDR (Bangladesh) and Hilleman Institute (Delhi).

Professor Jacob George Robert W Storr Professor of Hepatic Medicine, University of Sydney and Head of Department, Gastroenterology and Hepatology, Westmead Hospital

Jacob George is the Robert W Storr Professor of Hepatic Medicine at the Storr Liver Centre, Westmead Millennium Institute, University of Sydney and is Head of the Department of Gastroenterology and Hepatology at Westmead Hospital and Director of Gastroenterology and Hepatology Services for the Western Sydney Local Health Network. He undertakes basic and clinical research on hepatitis C, liver cancer, NASH and hepatic fibrosis. He is Associate Editor for J Hepatology. He is or has been on the editorial board of several journals including Hepatology, Liver International, Hepatology International and the World Journal of Gastroenterology. He was a member of the Executive Council of the Asian Pacific Association for the Study of the Liver and of the Gastroenterological Society of Australia.

Associate Professor Levinia Crooks A.M. CEO, Australasian Society for HIV, Viral Hepatitis and Sexual Health Medicine (ASHM), Adj A/Prof, Public Health and Human Biosciences, La Trobe University and Adj A/Prof, Centre for Social Research in Health, University of NSW

Levinia Crooks joined ASHM as CEO in November 1999. She has significant involvement in HIV, viral hepatitis and sexual health policy. She is a member of the Blood Borne Viruses and STI intergovernmental committee (BBVSS) and co-chair of the HIV Testing Policy Expert Reference Committee. In 2008 she was made a Member of the Order of Australia for her contribution to HIV policy, her care for people with HIV and her contribution to health generally.

She has used the experience she has learned in the HIV sector to push for change in the viral hepatitis area. Under her stewardship, ASHM has increased its involvement in the HIV, viral hepatitis and sexual health areas, particularly as a provider of high quality policy, resources and training. ASHM has also expanded its interest regionally and runs an international program that provides support to the Regional Network of Professional Societies working in HIV, viral hepatitis and sexual health.

She has worked in the HIV sector since 1986, at which time she was conducting social research to inform the development of counselling and support services for people living with HIV. She has been involved in the community response to HIV in Australia including regionally, and has served as President of the AIDS Council of NSW and Bobby Goldsmith Foundation HIV/AIDS charity. She has also served on the Board of the Australian Federation of AIDS Organisations. In 2015 she was awarded the ACON Presidents Honour for her contribution to the sector. Levinia has written a number of publications and educational resources for clinicians, people living with HIV and has been involved in many initiatives to increase access to HIV, viral hepatitis and sexual health treatment and prevention.

Professor John Zalcberg Professor of Cancer Research, School of Public Health and Preventive Medicine, Monash University

Professor John Zalcberg was the Director, Division of Cancer Medicine, at the Peter MacCallum Cancer Centre in Melbourne, Australia for 17 years prior to taking up the position of Professor of Cancer Research in the School of Public Health and Preventive Medicine in the Faculty of Medicine at Monash University in 2014.

After earning a Bachelor of Medicine and Bachelor of Surgery from the University of Melbourne and a PhD in cancer immunology, he served as Director of Medical Oncology at the Heidelberg Repatriation Hospital and as Director of Cancer Services at the Austin and Repatriation Medical Centre.

A founder of the Lorne Cancer Conference and the Australasian Gastrointestinal Trials Group (AGITG), he is immediate past Chair of the Board of AGITG after serving in this role for over 15 years and a past Board Member of Cancer Trials Australia. He is the current Co-Chair of the Cancer Drugs Alliance and Chair of the Australian Clinical Trials Alliance and a Board member of the Australian Red Cross Blood Service.

He is a past Board Member of Progen Industries and the NSW Cancer Institute, past President of the Clinical Oncological Society of Australia and a past Member of the Consultative Council of the Victorian Cancer Agency. He received a Medal of the Order of Australia Award (OAM) in 2007, the 2011 ‘Cancer Achievement Award’ from the Medical Oncology Group of Australia and was the recipient of the 2014 Clinical Oncological Society of Australia ‘Tom Reeve Award for Outstanding Contributions to Cancer Care’. In 2014, the AGITG introduced the annual ‘John Zalcberg OAM Award for Excellence’.

Professor Zalcberg’s clinical research interests include gastrointestinal cancer and healthcare outcomes. He has published more than 250 articles in peer-reviewed journals. He was a Principal Investigator for the EORTC advanced GIST trial in Australia and continues an active involvement in trials in this disease as well as other GI cancers. He continues an active clinical practice in GI cancer.

Dr Paul Slade Medical Director, Gilead Sciences Pty Ltd

The judges take their commitment to the Research Grants Program very seriously. Judges declaring a conflict of interest with a particular applicant during the review process will not be involved in the review of, or decision to fund, that application.

Please note that applicants may not contact the judges individually in relation to the Research Grants Program. All queries should be directed as below.

What are the judging criteria?

Project applications within the specified themes will be judged against the following criteria:

  • Innovative projects aimed at improving patient care and/or guiding healthcare policy
  • Clear demonstration of need and relevance to local clinical practice
  • Clarity and specificity of key steps involved
  • Measurable objectives and outcomes
  • Collection/reporting of actual project-related cost
  • Collection/reporting of patient-related outcomes
  • Demonstration of clear evaluation plans
  • Clear project timelines
  • Clear demonstration of ability to meet the required timelines
  • Clarity in the budget
  • High likelihood of appropriate ethics approval in the estimated time frame.

Greater consideration will be given to applications that:

  • Fit within the required project themes and satisfy the required criteria (in particular completion by the end of December 2018)
  • Are innovative or employ novel research approaches
  • Improve access to screening, support and/or medication for minority patient groups who would not necessarily have easy or consistent access to these services
  • Provide a detailed breakdown of exactly how the funds are to be used
  • Are not currently receiving or due to receive funding from other sources
  • Have been or will be granted ethics approval, if required.

Allocation of funding will be dependent on receipt of appropriate ethics approval. It is therefore essential that applicants are able to facilitate timely ethics approval so that the project can be completed in the assigned time frame. If for any reason ethics approval is not granted for a project, or if a project initially selected for funding is withdrawn from the Program before funding commences (e.g. due to securing funding from another source), where appropriate the judges reserve the right to select an alternative project to allocate funding to from a shortlist of the next highest-scoring projects.

The decision by the judges to award or not award funding to a project, or to allow flexibility as detailed above, is final and no correspondence will be entered into regarding this. Funding decisions by the judging panel are entirely unrelated to the use of any particular therapeutic agent.

SUCCESSFUL APPLICANTS

What can be expected if my application is successful?

All successful applicants will be notified in October 2017 and will be asked to sign a grant agreement. This will summarise the core requirements of the grant award, the amount of grant allocated and the responsibilities for each party. The grant agreement will also include a clause relating to the ethics approval of the project and the expectation of compliance with the relevant ethics guidelines. Legal liability and insurance requirements will also be confirmed for each project at the grant agreement stage.

Information and updates on progress from project leads will be required periodically and used to develop newsletters detailing those projects that have received funding, as well as to provide updates on the Gilead Australia Fellowship website.

What commitments must successful applicants make?

The commitments required of successful grantees are:

  • Successful applicants may be required to work in collaboration with Gilead to prepare a manuscript or publication on the project. Intellectual property rights would remain in the ownership of the project leads.

Evidence generated from project results may be shared on the Gilead Australia Fellowship website (www.gileadfellowship.com.au).

On a successful application, when does work for the project have to be completed?

Funding will only be awarded for projects that can be completed by the end of 2018.

When will funding be provided?

On the successful award of a grant, the grant agreement will state which items of the project are being supported and the total amount of funding that will be provided. Specific timings and levels of payment instalments will be agreed upon at the start of each individual project.

UNSUCCESSFUL APPLICANTS

Will unsuccessful applicants get feedback?

Unfortunately, the judging panel will be unable to enter into any correspondence regarding the outcome of their decisions on grant applications.

Can applicants who are unsuccessful this year reapply next year?

Yes. Applicants who are unsuccessful in securing funding for the 2018 Program can apply for funding for the 2019 Program, provided their projects fit within the required criteria for that year's Program.

FURTHER INFORMATION

Who do I contact with queries on my application?

If you have any questions regarding the Research Grants Program application process or requirements, please contact admin@gileadfellowship.com.au.

For more specific application queries, or if you would like to speak with someone in person to discuss your application, please contact the Medical Department at Gilead on 61 3 9272 4400.

Please note that all queries must be directed as above and applicants may not contact the judges individually.