The RegenMed Development Organization (ReMDO) is excited to announce a grant opportunity intended to create a continued impact on the rate of clinical translation for regenerative medicine therapies and the commercialization of regenerative medicine products within the global market. ReMDO, a 501(c)3 non-profit organization with the mission to accelerate discovery and translation of regenerative medicine therapies, is part of a thriving and growing regenerative medicine landscape called the Regenerative Medicine Hub (RegenMed Hub). While the RegenMed Hub is a physical place, it is also a part of an innovation corridor of ideas, energy, resources, and people dedicated to expanding biotechnology research and business in the areas of 3D printing, biomaterials, cell and tissue therapies, and biomanufacturing. Additional information regarding ReMDO and the RegenMed Hub is available at remdo.org.
ReMDO’s 2022 Regenerative Medicine Manufacturing grant call encourages small, medium, and large companies to submit letters of interest with an accompanying white paper that addresses a gap in technical capabilities for one or more of the following topic areas (see Attachment A for a more detailed description of topics):
- Cell and Biomaterial Manufacturing
- Standards and Quality Control
- Additive Manufacturing
- AI and Automation
ReMDO intends to support clearly defined projects that meet the requirements set forth in this announcement and continue to drive the need to successfully translate regenerative medicine to clinical practice and to the global market quickly. It is expected that awarded amounts will range from $50,000 to $200,000. Supported work will utilize our state-of-the-art facilities and Test Bed, and project resources will provide technical and management assistance. Other identified and agreed upon costs necessary for successful completion the project within the Test Bed may be considered. Supported projects may start November 15, 2022, and are expected not to exceed a two-year period of performance. For more information on ReMDO and how you can help us grow our vision of the RegenMed Hub, please visit our website at remdo.org.
The timeline for ReMDO’s 2022 regenerative medicine manufacturing grant call is as follows:
- 04/27/2022 | Formal Request for Proposals Released
- 07/01/2022 | Letter of Interest (LOI)/White Paper Submission Date
- 07/15/2022 | White Papers Selected for Full Proposals
- 10/14/2022 | Full Proposals Due
- 11/01/2022 | Selected Grantees Announced
- 11/15/2022 | 2022 Selected Grantee Expected Grant Start Date
- Letter of Interest (LOI)/White Paper
Letter of Interest (LOI)/White Paper must be no longer than 2-3 page and provide the following information:
- Organization name
- Organization primary contact and contact information
- Letter of interest
- Identification of topic area for white paper
- Project title, scope, estimated timeline, estimated cost, potential teaming/collaboration, and impact statement
- Identification of teaming and/or teaming needs
LOI/White Papers must be on organization letterhead and signed by a company official. Companies may submit more than one LOI/White Paper to address different topics or different projects within a topic area. Companies must be sure that each white paper has an unique title and is submitted separately. Multiple scopes in one submission will not be accepted. LOI/White Paper submissions should be emailed to: email@example.com, no later than July 1, 2022, at 3 pm EDT. Submissions will be acknowledged within 24 hours of receipt. Do not include any confidential or personal information in the letter of intent.
- Open/Individual Call Requirement
ReMDO will acknowledge all LOI/white paper submissions that meet the requirements set forth in #1 within 24 hours of receipt. ReMDO will schedule applicants into open and/or individuals calls to review the submitted LOI/White Papers and ask any outstanding questions. Calls will only take place during business hours between July 1, 2022, and July 7, 2022.
- Full Proposal Requirement
Companies that are notified of the white paper selection on July 15, 2022, will receive a full proposal template packet that must be completed no later than October 14, 2022. The full proposal template packet will require the selected white paper topics to further refine and define the project scope, timeline, cost, teaming agreements, and other ancillary information. Companies with full proposals selected for award will be notified and the awards will be announced no later than November 1, 2022. Awards are expected to be initiated on November 15, 2022, after final negotiation and execution.
All requirements submitted by applicants will be reviewed by at least 3 reviewers. White papers and full proposals will be evaluated on: 1) Adherence to defined requirements; 2) Expected Impact; 3) Feasibility; and 4) Innovation. Cost share and innovative partnerships are not required, but highly recommended. All submitted material will remain confidential.
All questions should be sent to firstname.lastname@example.org. Please allow 24 hours for response. To learn more about ReMDO and to see how you can participate in our initiatives, please visit our website at www.remdo.org.
Attachment A: Regenerative Medicine Manufacturing Topics Defined
|Topic Area||Topic Description|
|Cell and Biomaterial Manufacturing||Cell and biomaterial manufacturing is a foundational process needed to scale up and commercialize any regenerative medicine-based product. Below we have outlined strategic areas that ReMDO would like to advance in our ecosystem. The first strategic area is smart manufacturing. The field of regenerative medicine could be greatly improved by applying the core principals of Smart Manufacturing. Expected benefits in terms of time and cost savings would drive additional commercial investments in the field. Put simply, Smart Manufacturing represents highly adaptive, computer-based monitoring of manufacturing processes that allow for in-process optimization of production. The application of Smart Manufacturing principals would yield safer and more effective clinical products for patients. It would also pave the way for the automation of manufacturing processes, as well as facilitate production scale-up. Project support will be considered for new technologies applicable to Smart Manufacturing in the ReMDO Regenerative Medicine Hub ecosystem. These technologies might include “Smart” biological sensors, quality control, robotics, software, data management and other tools for addressing current manufacturing challenges within the regenerative medicine manufacturing space. The second strategic area is shipping and logistics. Capabilities for the worldwide shipment of biological samples and clinical products to and from centralized manufacturing sites represents another challenge in accelerating the commercial growth of regenerative medicine. Project support will be considered for the development of new technologies that address the logistics of shipping required for centralized manufacturing within the regenerative medicine space. Such technologies should be appropriate for prototyping/testing within the Regenerative Medicine Hub ecosystem. The third strategic area is in space manufacturing. Regenerative medicine manufacturing in a microgravity environment offers many commercial opportunities. The microgravity environment offers optimal conditions for precision in manufacturing across scales ranging from the atomic to the microanatomical. Programs will be considered for support that leverage the microgravity environment for commercial opportunities. Manufacturing areas that may benefit from a microgravity environment include tissue engineering, therapies to combat the effects of aging and infectious disease.|
|Standards and Quality Control||The standardization of quality assurance assays and other protocols relevant to regenerative medicine clinical manufacturing is needed. Technologies will be considered for support that provide standardized solutions such as molecular fingerprinting, functional analyses, and prediction of therapeutic potential for regenerative medicine clinical products. These standardized assays will be tested within the ReMDO Regenerative Medicine Hub ecosystem with the long-term goal of adoption by the commercial regenerative medicine clinical manufacturing field. New technologies are also needed for quality control of manufacturing across the entire manufacturing spectrum, from raw materials to clinical products ready for delivery to the patient. Innovative solutions that support the quality assurance needs for industrialized regenerative medicine clinical manufacturing will be considered. These technologies should provide a clear benefit for a variety of manufacturing processes.|
|Additive Manufacturing||ReMDO is currently seeking to develop new programs in additive manufacturing that can be applied to various areas of regenerative medicine. One strategic area is in building natural scaffolds for tissue engineering. Another strategic area is in in-vivo bioprinting for tissue engineering. A third area is in scaling up and automating the bioprinting of personalized medicine diagnostics.|
|AI and Automation||Artificial intelligence has demonstrated the potential to revolutionize manufacturing. Applying artificial intelligence to regenerative medicine clinical manufacturing would yield untold benefits across numerous areas. Examples would include, but not be limited to: (a) process optimization, (b) predictive algorithms for safety, (c) predictive algorithms for efficacy, (d) predictive algorithms for personalized products or therapies, (e) predictive algorithms for customizing cells or scaffolds. Automation of clinical manufacturing processes would facilitate the scalability of production of regenerative medicine products; making these therapies widely available and assessable to patients. New technologies will be considered from the fields of robotics, data analytics and integration, and advanced biosensors using label free techniques for in-process monitoring of regenerative medicine products.|