Non dilutive R&D funding – mainly multibillion programs of Federal agencies – has become a major player in the life science finance industry. Today more than ever, NIH, DOD, NSF, CDC and dozens of other agencies, both federal and private, support biological and medical preclinical and clinical activities in all fields and scopes of research and development. Funds for individual projects range from <$150K for early stage research, through $1-2M for standard hypothesis-driven and product development grants, to large scale funding opportunities of up to $100M and more. The estimated total annual budget allocated for such funding opportunities is over $60B. Each year, these funding agencies release hundreds of solicitations, requesting applications in areas that address topics of importance to public health. In addition, most funds are granted to investigator-initiated, unsolicited research.

Grants and contracts have thus become a conceivable and often preferred option for translational research, product development, pipeline broadening, industry-academia collaborations, clinical trials and more. Their importance makes them a strategic source of funding for startup and mature companies, and even leading pharmaceutical companies. Accordingly, given the increased demand for such funds, a need for a professional and methodological approach that will allow every company to maximize its funding potential has arisen.

FreeMind Group, with its over 14 years of experience, highly motivated, skilled team, can help you make the most of this substantial opportunity. Our team helps you devise and execute a long term strategy to consolidate your research goals into distinct, focused projects and find the most appropriate opportunities to maximize your funding potential.

Over the past decade, the United States government has allocated nearly $55 billion on preparing the nation against biological threats. The Obama administration has maintained that momentum with a total biodefense budget of $6.05 billion for FY2012, going primarily to the NIH and DOD. Additional civilian biodefense funds have been budgeted to the DHS, USDA, EPA, NSF and Department of State.

Due to the focused interests and needs of the funding agencies and the complex nature of solutions in that arena, biodefense submission processes are highly demanding. FreeMind’s team is frequently invited to work closely with companies and research organizations that are either dedicated to biodefense or those who have more widely ranging research, with individual applications that may be relevant to the biodefense community. We have supported the submission of successful grant and contract applications, covering projects of basic research up to product development. These applications also, included late stage clinical research leading to later to procurement deals with the agencies that originally funded the research activity.

FreeMind has been particularly successful in submitting and winning biodefense grants and contracts. Whereas the biodefense budget represents 0.5% of the HHS annual budget, FreeMind has submitted applications for at least ten times that proportion in recent years for diagnostics and therapeutics for Ebola, Marburg, Anthrax, Botulism, and a wide range of pathogens that have a widespread epidemic potential through either accidental or intentional contamination. Our clients were awarded over $270 million for such projects (2005-2012).

One of the most common misperceptions relating to non-dilutive funding for life science R&D is that the SBIR/STTR program is the main and even only funding resource available for the life science industry. Companies and investors alike must know that although it is an important and sometimes relevant program, the SBIR/STTR program is a small, limited and limiting program. Also, it must be emphasized that programs thought to be focused solely on academic research (such as RO1, R21 and UO1) are open to all applicants, industry and academia alike; in fact the number of awarded industry R01 is increasing steadily every year.

The Small Business Innovation Research (SBIR) program is a set-aside program for domestic small business concerns to engage in Research/Research and Development (R/R&D) with commercial potential. The STTR program was established by the Small Business Technology Transfer Act of 1992. Federal agencies with extramural R&D budgets over $1 billion are required to administer STTR programs using an annual set-aside of 0.30%. Under the newly approved regulation (2010), SBIR funding has increased from $100K to $150K for an SBIR Phase I award; and from $750K to $1M for an SBIR Phase II award. Companies that are willing to apply to those mechanisms should take into account alternative sources of funding that might be more significant.

Writing proposals for Federal grants is a time consuming task that requires much planning and administration. This process typically takes 3-6 weeks to complete for a standard high quality application; more complex applications may take longer. However, the brief periods often allotted between release of a funding opportunity announcement and its deadline, as well as limited availability of research partners, may severely restrict the ideal timeframe.

When the deadline is rapidly approaching, an experienced team that is well prepared with a streamlined approach for submission can make this process flow smoothly. FreeMind’s experienced, methodological and highly motivated professional team have helped dozens of companies and academic groups to submit on time (and win) large scale applications in a process that started 14, 10, and even 7 days before the deadline.

Our templates structure the writing in such a way that the presentation is made easy, saving you the time of planning the structure. All that is left for you to do is to pour the scientific content into the pre-made mold. Our primary goal is not saving time but winning the award, nevertheless we are regularly able to significantly reduce the time allocated by our clients, and focus their attention to the scientific aspects of the application alone. We optimize the scientific presentation and structure, assist in finalizing the budget and all administrative cores, plan and complete flow of information aspects and finalize the compilation of the package and reduce the load of some of the more technical items.

We would, of course, prefer to have the time to complete a thorough and detail oriented application, and to perfect the application. For that purpose we would recommend an earlier start rather than a later one. However, if time does not allow the more optimal writing timeline, we will allocate as many individuals as necessary to complete the best quality application in the time available.

 

As life science research is becoming more complicated, requiring collaborative activity and significant resources, funding agencies, such as NIH and DOD, have shifted significant portions of their budgets towards supporting large scale, multi-project clinical activities of both academic institutions and companies. The funding agencies put forth great effort in creating and allocating budgets to programs and mechanisms that allow implementation of such scientific work. These include RFPs, U19s, grants and contracts solicited through Roadmap programs, and other opportunities, with fund proposals for over $5M. Such large scale solicitations fund advanced clinical trials, construction projects, product development, building centers of excellence, and more. In addition, in recent years, virtually all funding institutes within NIH allow for large scale projects to be submitted through the main unsolicited (investigator initiated) route, pending a brief institutional pre-approval process.

Being multi-project in nature, such applications require multidisciplinary collaborations with multiple laboratories and organizations, often bringing together academic and industry partners, and numerous commercial subcontractors. As such, creating an application can be a particularly daunting task, requiring a great deal of coordination between all partners, and skilled and experienced project management focus in order to integrate the scientific and technical sections for a single and coherent presentation. In addition, such large scale applications require submission of large and complex budgets for which detailed justifications must be added to complement the specific scientific and research plan presented. Lastly, these programs define very specific regulations that must be followed. The brief periods typically allotted between the dates of publication and submission add another source of pressure.

FreeMind’s team is particularly adept at large scale funding opportunities. We take it upon ourselves to devise a timeline for completion of the project, coordinate the specific tasks among all partners and collect all relevant scientific and technical sections in a timely manner. We ensure that all the components are integrated into a cohesive, focused, and competitive proposal. We follow the submission and post submission processes, and aid the clients in any negotiations that are necessary to get the award. Our expert consultants, analysts, managers and writers have extensive experience allowing them to identify the weakness, scientific or administrative, and strengthen them to produce a competitive and winning application.

FreeMind sustains a growing network of leading companies and organizations, all with a strong and common interest in assisting the life science market and creating a common ground and collaborative framework for academia-industry collaborations.
Our extensive and intimate understanding of the market, coupled with our designated knowledge of non dilutive funding sources and their promotion to a strategic position with many companies and investors a like, offers a great network that serves both our clients and partners. FreeMind is a leading tool for top tier service providers within the life science market that are willing to expand their services or to benefit their clients. FreeMind’s collaborative efforts with its partners include educational activities such as presentations, workshops, webinars, round tables and financial benefits to their clients.

Non dilutive funding is available for every conceivable kind of research or development effort, whether it is an academic or industry project. Government agencies, as well as state organizations and private foundations, release daily hundreds of different solicitations covering topics that are of interest to public health and medical and life science research. Although these are just a small portion of the total number of awards granted annually by NIH, DOD and other such organizations, they represent a great funding opportunity for researchers within industry and academia. A greater number of awards are granted to unsolicited investigator initiated projects, focusing on virtually every field and every stage of research and product development. Research funded covers all ranges of scientific endeavors, from basic science, whose applications are not yet known, to product-oriented and translational research, clinical trials, training grants, and construction projects to provide facilities for research and medical care.

Funding agencies cover very small to very large scopes of projects. The NIH has mechanisms to fund exploratory research, where only an initial direction is being investigated to see if it’s worth pursuing. These are typically of short duration and a more limited budget. Standard R01 grants are geared towards research in progress, driven by a hypothesis and supported by strong preliminary data. These projects typically last up to 5 years, with a budget of $1-3M. It is important to stress and clarify that ALL entities are eligible for funding from such sources and are eligible to receive such awards, including for-profit companies, foreign entities and academic research organizations. In addition to these, American small businesses are also eligible for SBIR and STTR grants, geared towards development of products with commercial potential. Large scale grants and contracts offer sizable sources of funding of greater than $5M to cover large scale clinical trials, major construction projects and more.

FreeMind Group helps researchers in every field, every stage, and every scope of biomedical research and development, and for all research entities, academic and industry alike. In many cases, a process that started in an early pre-clinical stage application and award has then grown to clinical stages awards.

Over the last decade, many academic institutions established specialized centers that articulate their expertise in specific fields. These centers have the advantage of highly specialized human and physical resources. By virtue of their specifically defined purpose, they bring together the top experts in the field, working in proximity to each other for mutually beneficial and especially productive research.

In order to cultivate their centers, academic institutions must confirm that centers and their researchers are adopting a strategic approach towards non dilutive funding. That approach must take into account the center mission, resources, challenges and the changing funding atmosphere in order to be able to identify all of the relevant funding opportunities, both solicited and unsolicited and make the most of these opportunities to maximize the level of funding brought to the center and the institute at large.

FreeMind, through its experience working with academic and other large research institutes is particularly poised to work with academic centers as a whole or with any of their constituent laboratories, in order to secure funding for the specialized research that is conducted. We work with the administration to devise a strategic plan that incorporates a global view of the center and its special needs. We then assist with the compilation of all grants and contracts, including center grants, construction contracts and other applications to secure funding for establishing the center’s infrastructure and research capabilities. And as with any other researcher, we work with the center’s scientists on an individual basis to obtain funding for their laboratories