Friday, September 27, 2019 New questions and answers added September 27, 2019! The Wadsworth Center and Health Research Inc. are requesting applications from up to three investigators/inventors/companies to work closely with the Wadsworth Center to develop and optimize a point-of-care device that can detect the presence of Candida auris from a skin or nasal swab. It is envisioned that the selected partner(s) will work with the Wadsworth Center to design and supply a functional prototype device(s) that meets the technical criteria that will be defined in the Request for Proposal (RFP). The Wadsworth Center will evaluate the device for sensitivity, specificity, reproducibility and ruggedness in comparison to the current gold standard laboratory methods. The partners will work together in a design/build/test cycle over the 18 months period to evaluate the device(s) and determine whether any have reached the “readiness to engage a manufacturer” stage. The total amount available for this funding opportunity is $750,000 and each of the selected applicants will receive $250,000 over an 18 months period. Background Infectious disease testing is being revolutionized by point-of-care diagnostic devices. These devices are being developed for use in healthcare facilities as well as for over-the-counter sale in pharmacies. The revolution is driven in part by advances in micro- and nanoscale technology enabling the development of microfluidic and microelectronic devices. By and large, these devices are good but do not yet achieve the sensitivity and accuracy obtained with larger and more complex instruments or traditional ‘gold standard’ tests. C. auris is an emerging fungal pathogen that presents a serious global health threat. The pathogen is often multidrug-resistant, meaning that it is resistant to multiple drugs commonly used to treat fungal infections. C. auris is difficult to identify with standard laboratory methods, and it can be misidentified in laboratories without special technology. C. auris misidentification may lead to inappropriate patient management, which can result in the spread of the disease. C. auris was first identified in New York State in 2016. As of June 25, 2019 there were 339 clinical cases and 494 screening cases reported to the NYSDOH. As of July 12, 2019, the national clinical case count is 716 across 12 states with nearly 90% of cases in NY, NJ, and IL. CDC reports include an additional 1,342 patients found colonized with C. auris by targeted screening in ten states. C. auris cases have also been reported from several countries on different continents including 620 cases from six European Union countries for the period 2013–2017. Clinical cases are people who are ill from the fungal pathogen. Screening cases are people who are not ill but who carry the pathogen on their skin and are identified as part of our surveillance efforts. These cases can lead to spread of the fungal pathogen throughout a hospital or healthcare unit. Most outbreaks of C. auris occur in healthcare settings, and infection is almost exclusively seen in people with complex healthcare needs, such as residents of nursing homes who require long term ventilator support and people with multiple ICU admissions. For this reason, it is important to quickly identify C. auris so that healthcare facilities can take special precautions to prevent its spread. Questions and Answers Q1 | We do not offer a point of care option that would meeting the requirements listed in the RFP. However, we do have the ability to automate the current method in place (real-time PCR LDT) into a sample-to-answer format. The simplified workflow would allow increased adoption of the C. auris LDT in other laboratories, as it would be much easier to run. Is this at all desirable? Answer The described system does not appear to meet the intent of the RFP. Q2 | While our platform does seem well aligned to address this clinical problem, we do not have an assay for this organism. Please advise if there is still interest. Answer If the system is portable and easy to use and has likely potential to be adapted to Candida auris, then there is interest. Note that this RFP is collaborative and there is ample molecular mycology expertise at the Wadsworth Center. Q3 | Am I allowed to submit two proposals using two different technologies (I have two collaborators with different technologies)? Answer The RFP does not limit the number of proposals any applicant organization may submit in response to the announcement. Q4 | How much preliminary or proof-of-concept data are required for this submission? Answer The amount of preliminary or proof-of-concept data included is at the discretion of the applicant. There is no minimum required level. Q5 | Are we allowed to have co-investigators from CDC? Answer Yes, this decision is up to the applicant. Q6 | Is it possible to have a Wadsworth Center PI listed as collaborator on the application? Answer No, as that would constitute a conflict of interest. However, if your proposal is selected for an award, we will work with you collaboratively. Q7 | Will Wadsworth Center provide access to relevant isolates and DNA samples? Answer The Wadsworth Center PI has access to relevant panels of fungal isolates and DNA samples for the validation studies. These materials will be made available to the successful applicants as part of the project. Q8 | Are we able to submit a similar proposal to Wadsworth Center and NIH? Answer There is no restriction on submitting a proposal used for other funding agencies. Please note there will be due diligence at the time of the award to avoid duplication of funding. Q9 | Is there a plan to provide a critique of applications after the awards decisions are announced? Answer A written critique will not be provided to applicants. Q10 | Are there any font, line or space limits in the preparation of the application? Answer In addition to the 6-page limit described in the RFP, it is recommended that applicants use a minimum font size Arial 11 or Times New Roman 12. Q11 | Are we able to modify or correct an application after submission? Answer No change is possible to the application after the submission deadline. Q12 | Would you publicly disclose any submitted grant materials? Answer All application materials will be kept strictly confidential to the extent allowed by applicable state and federal law. Q13 | What is the recommended length for the LOI? Answer A brief LOI will suffice as a response to this RFP. Q14 | Do you anticipate providing feedback on submitted LOIs? Answer The submission of an LOI will be acknowledged, but no additional feedback will be provided by NYSDOH/HRI. Q15 | Is a budget breakdown required in the LOI? Answer There is no requirement for a budget breakdown in the LOI. Q16 | We see that one of the points for project scope discusses working closely to evaluate and optimize the prototype. Is this more of a research grant where the business is leading the development or is it more similar to a contract where the Wadsworth Center is leading development and the business is executing? Answer The selected applicants will lead the development with Wadsworth Center collaboration. Q17 | Do you have any further details about how shared IP ownership has historically occurred with Wadsworth Center? Answer A mutually agreeable arrangement for shared IP will be negotiated with the successful applicants as part of the contract negotiations. Q18 | Should a contract be awarded, is there potential for continued partnerships to further develop the device? Answer Yes, there definitely would be the potential for a continued partnership to further develop the device. Q19 | Can we talk on the phone more about what you are looking for, and how our platform could meet those goals? Answer Unfortunately, we cannot talk to any potential applicants about their idea or device during the application period. However, answers to any questions we receive will be posted on the website. If you have specific questions, we’d be happy to include them in our answers. Q20 | Can we obtain examples of a successful RFP and report following the project completion? Answer We don’t have any examples of successful applications or final reports, but we would expect that you follow the general NIH SBIR/STTR format, https://sbir.nih.gov/. Also, with the exception of the abstract, applications are strictly confidential. Q21 | Can we have a follow-up conversation with a person in charge, to clear up any remaining questions? Answer Unfortunately, we cannot talk to any potential applicants about their idea or device during the application period. However, answers to any questions we receive will be posted on the website. If you have specific questions, we’d be happy to include them in our answers. Additional Questions Received as of August 19, 2019 Q22 | Are you looking for a “high-risk, high-payoff” technology, e.g., similar to the Small Business Innovation Research (SBIR) program, or do you have an interest in implementing the technology at the Wadsworth Center / Health Research Inc. soon after the 18 months period? What is your envisioned timeframe for a proposed technology to have a “major public health impact” – Would you prefer a highly innovative or a relatively mature technology closer to “manufacture ready”? Answer The intent of the RFP is to develop a working prototype that is portable, rapid, cost-effective, and can be independently evaluated for analytical performance. It is, however, not expected that this device will be “manufacture ready.” Both “high-risk, high-payoff” and relatively mature technology deployed for other infectious diseases would be suitable. It is, of course, also of interest to implement the technology for public health surveillance in NY as soon as possible. Q23 | What is the longer term goal/interest of the Wadsworth Center / Health Research Inc., in the post RFP project period: e.g., generate a joint/shared intellectual property, being involved in a potential further commercialization, a full implementation of the developed platform and assays at the Wadsworth Center / Health Research Inc. and/or broader; future expansion of the platform and assay panels to other infectious/cancer diseases of interest to Wadsworth Center / Health Research Inc.? Do you have any preferred business models in the collaboration / commercialization steps (e.g., venture capital, merger/collaboration with a larger, dominant diagnostics company)? Answer The long-term goal is to develop a sensitive and specific, low-cost, easy to use, point-of-care device to screen for C. auris in the first stage, and for additional pathogens in a later stage. The strategy for the business model and intellectual property sharing will be determined by the characteristics of the partner and the device, and will be finalized at the time of the award. Q24 | Should a commercialization plan/status, and/or a present financing plan be included as a part of the proposal? Would the reviewers examine the commercial potential and aspects of the proposed technology, and should the sections addressing current competitive technology on the market, a value proposition, market size, etc., be included in the proposal? Answer The review criteria do not include the commercial potential of the proposed technology. Similarly, any details regarding the need for a C. auris point-of-care device will not be necessary. Other details such as a commercialization plan, financing plan, competitive technologies, etc. could be covered in the review criteria outlined in RFP. Q25 | Could you comment on some aspects or models how you envision the intellectual property to be shared, e.g., company “background intellectual property” (already in place) vs. intellectual property developed during the project in the collaboration with Wadsworth Center / Health Research Inc.? Answer Intellectual property developed collaboratively during the project will be negotiable on mutually agreeable terms with Wadsworth Center / Health Research Inc. Additional Question Received as of August 22, 2019 Q26 | Our company has already developed a working prototype of a portable and rapid molecular diagnostic device (it has not been approved by FDA yet) and it has been tested with another fungal diagnostic panel, but not C. auris. Question is: are we still eligible to apply for this funding as this funding is for developing a device? Answer Applications proposing a brand-new platform or re-purposing of an existing platform from another diagnostic test, are eligible for this RFP. Additional Questions Received as of September 27, 2019 Q27 | Is there any limit on the number of references? Answer There is no limit on the number of references cited in the application. Q28 | Does the six-page limit apply to references cited in the application. Answer The reference list does not count towards the six-page limit. More News
