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 research in HIV, chronic viral hepatitis, haematological malignancies, NASH, inflammatory diseases, invasive fungal infections and COVID-19 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 outcomes in the specific disease areas of HIV, chronic viral hepatitis, haematological oncology, NASH, inflammatory diseases, invasive fungal infections and COVID-19.

Similar programs have been running successfully for several years here and 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 people living with HIV and/or chronic viral hepatitis, haematological malignancies, NASH, inflammatory diseases, invasive fungal infections and COVID-19. 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, carceral system, primary and secondary care awareness, interest and uptake of screening to identify undiagnosed people living with HIV and/or chronic viral hepatitis in high prevalence and/or under‑served populations
  • Reducing late diagnosis of HIV and/or chronic viral hepatitis in high prevalence and/or under-served populations
  • Improving access, uptake and adherence to medication for HIV and/or chronic viral hepatitis, with emphasis on marginalised and/or under-served populations 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 people living with HIV and/or chronic viral hepatitis being lost to follow-up
  • Improving adherence to long-term medication through innovative programs
  • Describing the impact of nurse practitioners on the delivery of care to patients living with HIV and chronic viral hepatitis

Haematological malignancies

  • Improving care and outcomes of people living with lymphoma and/or leukaemia

Non-alcoholic steatohepatitis (NASH)

  • Developing and validating non-invasive tests in the diagnostic, predictive, and/or prognostic pathways in managing NASH
  • Improving outcomes of people living with advanced fibrosis due to NASH

Inflammatory diseases

  • Improving the care and outcomes of people living with:
  • inflammatory arthropathies
  • inflammatory bowel disease
  • Sjogren’s syndrome
  • cutaneous lupus erythematosus.

Invasive fungal infection

  • Improving patient care, quality and safety by investigating:
  • antifungal resistance
  • breakthrough fungal infections, including incidence, risk factors, populations at risk and management strategies
  • optimisation of antifungal use and prevention of unnecessary exposure
  • appropriate sequencing of antifungals.

Emerging viruses

  • Improving care and outcomes of people with COVID-19

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.

Basic research projects

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

For the 2021 research grants, preferred projects will also demonstrate engagement with local communities

FUNDING AVAILABLE

How much funding is available for projects?

The total funding available for the 2021 Research Grants Program is $300,000.

The requested level of funding should be stated at the time of application.

Funding is contingent on the project:

  • being granted ethics approval (if required)
  • being solely funded by a Gilead Australia fellowship grant of up to $60K*
  • concluding in no more than 18 months after execution of agreement.

* The exact amount of funding allocated to each project may vary depending on the nature of the project. Funding is entirely independent of the use of any particular therapeutic agent.

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 July 2022 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 2021 and all projects must be completed by July 2022. 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 1 June 2020 to 23:59 AEST on 7 August 2020. 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; 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. by July 2022)
  • 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 the ethics requirements of primary care research, please review the information from the NHMRC at https://www.nhmrc.gov.au/research-policy/ethics-and-integrity and the RACGP at https://www.racgp.org.au/the-racgp/governance/committees/national-committees/ethics-committee 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 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 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.

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.

Professor Suzanne Crowe AM Program Director, Healthy Ageing (Expansion Program) and NHMRC Principal Research Fellow at the Burnet Institute in Melbourne

Professor James Ward Director, University of Queensland Poche Centre for Indigenous Health
Professor, University of Queensland School of Public Health

Professor James Ward is a Pitjantjatjara and Narungga man, and a national leader in Aboriginal and Torres Strait Islander research.

He is currently the Director of the Poche Centre for Indigenous Health and Professor within the School of Public Health at the University of Queensland.

James has a long history working in Aboriginal communities, beginning as a men's health educator for 29 remote communities in central Australia. Having held various roles in Aboriginal public health policy for both government and non-government organisations, in 2007 he was appointed as the Inaugural Program Head of the Aboriginal Program at the Kirby Institute, University of New South Wales. In 2012 he moved to Alice Springs to become Deputy Director of the Baker Institutes' Aboriginal Health Program, after which he joined the South Australian Health and Medical Research Institute. In 2016 he completed his PhD focused on epidemiology of sexually transmissible infections in Aboriginal communities.

James has been awarded funding applications totalling $23M since 2013; including $7.14M as CIA on NHMRC funded grants and has authored 100 publications. He has led national research projects in sexually transmissible infections and blood borne viruses, including issues surrounding injecting drug use. His work has influenced policy and practice significantly over the last five years contributing to national guidelines, and policy and practice. He has been instrumental in initiating and advocating for action to address an ongoing syphilis outbreak that affects predominantly young people living in remote communities which has resulted in $8.8M being allocated to address the outbreak.

Associate Professor Stephen Hall Clinical Professor of Medicine, Monash University and Medical Director of Emeritus Research

Stephen Hall is an Associate Professor of Medicine at Monash University based at Cabrini Health in Melbourne.

He trained in rheumatology at the Mayo Clinic and has been in private practice since 1984. Having been a consultant at a number of hospitals, including Head of Unit at Box Hill Hospital for a number of years, his primary commitment has been to clinical practice.

In addition to maintaining normal clinical practice, he also serves as Medical Director of Emeritus Research a private Clinical Trials centre where he has conducted more than 250 trials including most of the biological drugs currently available and many which have not yet been released in rheumatology.

Dr Heshaam Mir Medical Director, Gilead Sciences Pty Ltd
As a graduate of Boston University College of Arts & Sciences (BA), American University School of Medicine (MD), and University of Melbourne Business School (MBA), Dr Mir has worked in a variety of research, academic, and industry positions in the US, UK, and Australia.

After completing medical school that included time in the UK NHS, Dr Mir led the Clinical Research Unit at Inova Fairfax Hospital in Washington DC and conducted over 45 industry-sponsored studies in hepatology and infectious diseases. He was appointed Affiliate Faculty at George Mason University and authored 9 articles and 17 presentations published in peer-reviewed international journals and congresses.

For the last 7 years, Dr Mir been part of Medical Affairs organisation at Gilead Sciences and has held positions of increasing responsibility in the United States and Australia.

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 July 2022)
  • 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 2020 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 July 2022.

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 2021 Program can apply for funding for the 2022 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, please contact Dr Heshaam Mir, Medical Director at Gilead Sciences at heshaam.mir@gilead.com.

For technical support please contact Gilead Client Services at gilead@steeprockinc.com.

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