• RFP Research Contract: Developing a vaccine against infectious diseases

    Specific Challenges: A group of researchers who formed a company after leaving academia decided to apply for an ambitious project involving a multi-institutional collaboration with an especially complex clinical component. They approached FreeMind less than 2 months before the deadline. With the assistance of several of our consultants and analysts, the proposal finally passed the first stage of review. FreeMind team then led the management of a lengthy negotiation process that involved submission of addition materials, eventually getting the contract fully approved.

  • Deployment-related medical research program clinical trial

    Specific Challenges: Initiating the work only two weeks before the deadline, this project posed great challenges. Some of these challenges included a team of researchers with no previous experience in writing and working with a government agency. The project was a large scale, multicenter Phase III clinical trial conducted at 15 sites in 4 countries, on 3 continents. As such, much coordination was needed to collect all the components necessary from all participating sites. The budget was the most complex aspect, requiring a subaward from each of the 15 sites (4 different currencies were used), with certifications of each of the costs. In addition to compiling the initial application, we also assisted the client with very lengthy and significant post-review demands of the DOD, including a complete overhaul of the budget.

  • RFP Contract: Establishing a multi-institution research center

    Specific Challenges: The client in this case was an independent and relatively small research institute who was applying for the first time for a contract of this magnitude. The project involved a partnership with 2 other large organizations with sometimes conflicting interests. In the 6 weeks that were available, we provided the client strategic guidance on the best presentation of the project and capabilities in light of the anticipated competition, and carefully managed the grant writing process, integrating the work of multiple writers from various backgrounds and scientific fields. The budget was especially complex, given the large number of subaward budgets.

  • Research Grant: ARRA Go-Grant

    Specific Challenges: Essentially, we started working with the client only 9 days before the deadline. Moreover, due to the publicity of the stimulus package (the award was part of the ARRA program), the competition was especially tough, with thousands of other applicants bidding for the same funds and ultimately less than 1% awarded.  The structure of the grant was also different than the ordinary format that is submitted to the NIH. We began working with the client, managing the writing of the various sections. Once the proposal passed the peer review with an excellent score, the institute requested budgetary adjustments, which we also helped coordinate.

  • Unsolicited R01: Understanding scientific mechanism of action

    Specific Challenges: Although the applicant was an experienced scientist, this was her first time applying for funding from the NIH, and hence was completely unfamiliar with the process. Being a foreign applicant was another hurdle that we needed to overcome, including significant inability to scientifically present the research project in English. Although the proposal scored very well, it was not selected for funding, and because of the highly favorable review, there was little input to guide the revision. Revision required strategically refocusing the application to advance it into the fundable range. This was completed successfully and the application was finally awarded.

  • Biodefense Challenge Grant: Developing therapeutics against Antrhax

    Specific Challenges: The writing of this proposal was managed on the client’s end by a person who was new to the company and was not involved in the particular research proposed. Senior management, or those directly involved in the research, were not readily available. The client provided us a large amount of relatively non-prioritized data, with little guidance available. It was necessary to apply a great deal of selectivity in order to decide what information to include and to a great degree the writing of the application was done by the FreeMind team alone. However, the project was eventually funded.
  • R01 grant in response to RFA: Developing technology for high-throughput genome sequencing

    Specific Challenges: This project was a particularly ambitious one, as it was focused on developing a technology with 10,000 times improved performance relative to current state of the art. By its nature, the subject material was more focused on technology and engineering aspects, rather than strict testing of a biological hypothesis. Moreover, we knew that the field was highly competitive, with many formidable competitors, whose capabilities were well known. In addition we had to take into account the delicate presentation of high profile collaborators so as to avoid overshadowing the lead PI and applicant organization.

  • RFP Research Project: Development of Therapeutic Medical Countermeasures for Biodefense and Emerging Infectious Diseases

    Specific Challenges: Large contracts such as this one include many inherent challenges regardless of prior experience, due to the many requirements and sheer scope of information and documentation required already at the submission stage. In this case, although the company had past grant experience, they were inexperienced with regard to the contract award process. This included not only the original submission but also how to best respond to and comply with the rigorous negotiation phase prior to award.  This is exactly where we stepped in to guide the entire process while performing many different roles – these included project manager, consultant, contacting subcontractors and providing both hands-on assistance as well as higher level strategy on issues spanning overall project structure, subcontractor issues, budgeting and indirect cost structure to name a few.

  • Unsolicited Fast Track SBIR – Clinical Testing of Medication Administration Safety Solution

    Specific Challenges: The complete lack of proposal writing experience of the PI and team meant that we had to introduce and instruct the company on all aspects of the proposal – both basic and complex. In addition, the clinical nature of the project required a multi-component collaboration structure including subaward budgets and other issues relating to collaborative project management. The clinical nature of this project necessitated strategic discussions and decisions regarding how to best break up the project into two coherent stand-alone SBIR Phases, as required from this specific grant mechanism. Also, the grant was awarded after a relatively quick resubmission process, which included many challenges of how to best answer, address and respond to reviewer comments while modifying the proposal and still remaining on track with the company’s corporate strategy.

  • Unsolicited Phase 1 STTR – Assess relevance and feasibility of a novel therapeutic for glaucoma

    Specific Challenges: This company had not previously submitted an STTR grant before. We submitted an original application, which received a good score, but was required a resubmission. The funded project was a resubmission of the previous application, meaning that we had to modify the previous grant to take into account t the reviewers critiques. The project underwent an overall change in structure, removing some studies and adding new studies, so all the grant documents had to be adapted to the new studies. Additional information had to be provided in many of the grant sections to address as many of the reviewers concerns as possible. Furthermore, coordinating the grant writing process with both the company and the university requires communication and organization.

  • BIOMEDICAL ADVANCED RESEARCH AND DEVELOPMENT AUTHORITY (BARDA): SCIENCE AND TECHNOLOGY PLATFORMS APPLIED TO MEDICAL COUNTERMEASURE (MCM) DEVELOPMENT

    Specific Challenges: The client approached FreeMind seeking assistance in preparing and submitting a full proposal to BARDA, after being invited by BARDA to do so in response to a white paper. At project initiation approximately six weeks were left for preparing the 280 pages long, full proposal. A team composed of an analyst and consultant with specific experience in BARDA applications was assigned, which provided a project plan for the writing process as well as a writing strategy, specific guidance, feedback, templates and drafts. The proposal was well received with reviewers and within four months the client was invited to negotiate the contract terms. During negotiations the FreeMind team continued to provide guidance, templates, drafts and feedback. The company was awarded in record time, 9 month after first approaching FreeMind.

  • NIH SBIR PHASE I CONTRACT

    Specific Challenges: The company experimented with an innovative approach, and sought non-dilutive funding to support further development of the technique to reach commercialization through integration into the company’s already marketed product. Two opportunities were identified at an early stage as particularly attractive, due to high compatibility between the expectations of the soliciting agency, and the client’s development strategy. A pressing schedule demanded simultaneous preparation to both applications. A committed and talented team on the clients’ end, working in full collaboration with an experienced grant consultant, allowed timely submissions with satisfactory results for both applications, one of which eventually resulting in an award.

  • UNSOLICITED STTR PHASE I GRANT – DEVELOPMENT OF INNOVATIVE DEVICE FOR PULMONARY DISEASE

    Specific Challenges: The small business assigned a new and young, but talented employee to manage the grant writing in response to the NSF grant mechanism. The employee used our templates and advice and after a number of back-and-forths, we succeeded to jointly write a robust project proposal. The PI was from a clinical setting and had limited time to review the application. Unfortunately, only a couple of days before the deadline, he got the chance to review the proposal and had last-minute doubts on the winning potential of the grant. The company and FreeMind were actually very optimistic about the content of the proposal and hence, our team advised both the company and PI to go along and submit the current version. The PI got motivated and provided a single but strong feedback round to the grant proposal and a few hours later we submitted the full grant package, still on time for the official deadline.

  • UNSOLICITED STTR PHASE I GRANT – DEVELOPMENT OF ANTIMICROBIAL THERAPEUTIC COMPOUND FOR URINARY TRACT INFECTIONS

    Specific Challenges: Last minute application with only 10 days to submission deadline. We managed to complete the registration process as well as conduct a thorough iterative review. All together, the grant was submitted on time and passed the peer review with an excellent score and enthusiasm.

  • BIOMEDICAL ADVANCED RESEARCH AND DEVELOPMENT AUTHORITY (BARDA): SCIENCE AND TECHNOLOGY PLATFORMS APPLIED TO MEDICAL COUNTERMEASURE (MCM) DEVELOPMENT

    Specific Challenges: After putting together a brief pre-application that summarized the proposed project and obtaining the Program Officer’s point of view, we submitted and received positive feedback from the review panel inviting the company to submit a full application. The full application comprised of a total of ~300 pages, including technical- and cost-related sections. The proposal was received extremely well and within a short period of time we entered into negotiations with BARDA. The applicant had very little experience with contract-term negotiations and our team composed of two senior grant writers, executive grant manager and analyst, was able to guide them successfully through each and every aspect of the process by not only providing continuous feedback, past contract experience and advice, but also iterative reviews and rectifications of the proposal sections. Moreover, we attended all communications between the company and agency. Altogether, our help was a major contribution to the eventual outcome: one year after submission of the full application, they received the official notice of award and signed a contract worth $24M.