NHMRC Development Grants David Grayden Biomedical Engineering With some slides borrowed from MDHS

Aims The aim of a Development Grant is to progress research to a stage where it can attract investment from industry development schemes or the private sector. Provide a potential mechanism through which projects may progress to a stage that makes them competitive to receive funding through business development programs within the Department of Industry, support from Commercialisation Australia or through private sector investment.

Overview Development Grants support the development of a product, process, procedure or service that if applied, would result in demonstrably improved health care or disease prevention, or provide health cost savings. The scheme focuses on health and medical research that has the potential for commercialisation to commence within five years. The most basic stages of research will be complete and ideally have preliminary data to demonstrate feasibility. A funding partner for the proposed research is beneficial; however, this is not essential.

Evaluation & Assessment Assessment Criterion 1 (40%, 8 pages) – Scientific merit of the proposal Significance: Does it address an important unmet health need? Approach: Will the experimental design, methods and analyses produce definitive answers and are they likely to demonstrate proof of principle? Feasibility: Do the applicants have the skills, commitment and resources to carry out the experimental plan and meet milestones? Scientific track record: Do the applicants’ publications or other scientific outputs demonstrate they can conduct the research program at a high scientific level?

Evaluation & Assessment Assessment Criterion 1 (40%, 8 pages) – Scientific merit of the proposal Score: 5 - Very Good (out of 7) The research plan: has sound, clear objectives has clarity of design and any reservations are relatively minor will likely be successfully achieved will likely successfully arrive at a proof of principle The scientific research team members, on average, have good research track records in the field of the proposed research contains most of the expertise needed for success

Evaluation & Assessment Assessment Criterion 2 (20%, 2 pages) – Track record of commercial achievements (relative to opportunity) Do the applicants or their identified partners have any previous experience in the commercialisation of research? Such experience may include: inventorship on patents; industry consulting; involvement in sponsored research programs; licensing of intellectual property; direct involvement in industry placements; involvement in a company ‘spun out’ of a university, hospital or research institution for the purpose of commercialising a product, process and or service; and involvement in taking research findings through to market.

Evaluation & Assessment Assessment Criterion 2 (20%, 2 pages) – Track record of commercial achievements (relative to opportunity) Score: 5 - Very Good (out of 7) The research team: has a solid record of research commercialisation achievement including patents, industry consultation, licensing of intellectual property has a commercial track record which is of a good national standard has some ability to promote a viable commercial outcome.

Evaluation & Assessment Assessment Criterion 3 (40%, 3 pages) – Commercial potential Applicants are expected to provide evidence of an understanding of the process and steps to move from research to outcomes that can be commercialised, including: the nature of the market and an initial assessment of the patent landscape, the milestones and risks of the venture and an understanding of methods for handling intellectual property connected with the project. an outline of the potential commercial development pathway that would be traversed should the development of the product, process or technology prove successful.

Evaluation & Assessment Assessment Criterion 3 (40%, 3 pages) – Commercial potential Score: 5 - Very Good (out of 7) The commercial proposal: is linked to a human health issue where the size of the potential market is large provides an outline of a feasible commercial development pathway should the product, process or technology prove to be successful will be conducted in an environment with access to commercial development support structures. The product, process or technology: has significant commercial potential nationally and internationally is linked to a strong or strongly developed IP position. Funding the project: may increase the interest of commercial partners would most likely bring economic benefit to Australia.

Evaluation & Assessment Assessment Criterion 3 (40%) – Commercial potential The following questions must be addressed: How can the intellectual property underpinning the project, process or technology be protected? Is the product, process or technology completely new, or is it a replacement for an existing product, process or technology? What qualities of the product, process or technology make it unique or provide a competitive edge over existing technologies in the market place? What are the national and international, current and future market opportunities? Has the research advanced past the basic research phase? If not, the Development Grants Scheme may not be appropriate.

Evaluation & Assessment Assessment Criterion 3 (40%) – Commercial potential The following questions must be addressed: Have funding partners or reputable venture capital backing been identified, or is there evidence of a substantial commitment (including funding input) to the project by an appropriate industry alliance? How does the proposal fit within the strategic plan of the partner company?. Venture capital firms, business angels or philanthropic organisations must have a bona fide track record of commercial development of innovation, nationally or internationally. A letter of support will be required where a funding partner is listed on an application. Does the proposed project provide a credible route to commercial proof-of-principle? Are the proposed milestones and deliverables appropriate, and precisely enunciated? And are they likely to be achievable?

My experience Prior successful applications 2014 – 2016: T. Oxley, A.N. Burkitt, T. O’Brien, D.B. Grayden, S. Davis, N. Opie, J. Harcourt, Developing a prototype of a next generation brain computer interface, three year project, $810,382 – MDHS – 2016: C. Williams, M.J. Cook, P. Seligman, D.B. Grayden, Black out advisory system – development of an implantable sub-scalp seizure monitor, three year project, $840,715 – Bionics Institute – 2011: M.J. Cook, P. Blamey, C. Williams, D.B. Grayden, Prototype medical device for the automatic detection and suppression of epileptic seizures and ex vivo studies in humans, two year project, $415,700 – Bionic Ear Institute – 2004: D.B. Grayden, O.P. Kenny, R.C. Dowell, G.M. Clark, Development and evaluation of a new cochlear implant sound processing strategy that mimics the behaviour of the inner ear and auditory nerve, one year project, $98,000 – Bionic Ear Institute. Plus one unsuccessful attempt

My experience Reviewers’ comments on successful applications This application is for the further development of… The budget is probably reasonable. The device is in early stage of development but has great potential… The research team has a very strong research commercialisation track record. This seems to be the construction of a piece of scientific apparatus and not the development of a product for commercialization. However, the CIs address this issue early in the application and provide adequate evidence to the contrary. The CIs are experienced scientists who are well qualified for their role in the project. Substantial experience taking products to market that have direct relevance to proposed work.

My experience Reviewers’ comments on the unsuccessful application The applicant team has a very strong track record in this area, and have both technical and clinical skills appropriate to achieving success. The team has proven international track record of commercial achievement and engagement. The commercialisation path is well articulated and appears achievable. It would be helpful if the applicants could provide clarification on the following important aspects of their proposal… Many sections for assessor comments had “None provided.”