OUTSOURCING
success. For example, academic reviewers do not often have first-hand experience in the regulatory process and can be more interested in scientific findings than what is on the critical path to approval by the FDA. Nevertheless, it’s important to get a feel for what reviewers want; applicants also have some say in who is on the review panel, which can make a big difference. First-time application success rate for NIH grants is 11%; a resubmission has a 20% success rate and another 12-month application and review cycle. The authors have applied for a series of NIH
grants and have had considerable success, but not without a steep learning curve. There is a certain element of ‘grantsmanship’ required in the preparation of a successful grant. The authors have built up a network of experts to maximise the fundability of a range of assets, including a virtual network of drug and device development strategists, commercial value appraisers, grant writers and individuals with experience on grant review panels. These capabilities are applicable to not only NIH, Department of Defense (DOD), and NSF International funding opportunities, but also to applications to research foundations, family offices, angel networks and venture groups. All potential investors want to see a complete appraisal of market potential, regulatory pathway, development strategy, and an experienced team and contractors to execute the plan.
Things to consider As has been well documented by a number of fundraising advisers, there are several factors to consider when preparing a funding application, whether for non-dilutive or equity financing:
to a value influx or return on investment (ROI) in the time proposed. The authors have determined that a well-resourced commercialisation plan and development strategy – backed by a credible development team – is critical for success. Many valuable assets have not advanced to the clinic because of management’s reluctance to invest the initial capital to de-risk the project before requesting additional funding. A funding strategy with input from all these professionals is essential – an enthusiastic endorsement by the founding scientist is reassuring but not sufficient.
“There is a certain element of ‘grantsmanship’ required in the preparation of a successful grant. The authors have built up a network of experts to maximise the fundability of a range of assets, including a virtual network of drug and device development strategists, commercial value appraisers, grant writers and individuals with experience on grant review panels.”
The following points are important when
Timing is important – some assets are too early for venture investment and are better suited to grant, angel or foundation funding. It is, therefore, important to assess the stage of the asset and direct it to the appropriate body.
The pitch/business plan/grant application needs to be tailored to the requirements of the funding institution. In all cases, it’s important to introduce the opportunity in a very uncomplicated and concise manner – whether it’s to a venture fund manager or grant reviewer, the introduction to the presentation must outline the opportunity to immediately interest the reviewee.
It’s crucial to have a development plan that convinces the reviewer that it can lead
requesting funding for clinical trials from non- dilutive as well as equity sources: It is very important to demonstrate that the clinical site principal investigator (PI) has relevant experience, the site has a good patient enrolment history and that the site has a strong commitment – for example, letters of support from all the involved key personnel and head/director of facilities at the site.
The budget should be accurate and supported by site metrics, cost-sharing and should have provided for the possibility of any cost overruns.
The clinical trial for which funding is sought should be clearly shown to be on the critical path to an ROI.
As mentioned above, most authors have typically started out with friends and family
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