Inactive

The Medical Technology Enterprise Consortium (MTEC) is excited to post this pre-announcement for an upcoming Request for Project Proposals (RPP) focused on quality management of biomanufacturing proce... The Medical Technology Enterprise Consortium (MTEC) is excited to post this pre-announcement for an upcoming Request for Project Proposals (RPP) focused on quality management of biomanufacturing processes and/or development of a prototype for a universal biomanufactured product or process. Program Background: The Government has identified a need for regenerative medicine prototype development efforts and manufacturing technologies. Current Good Manufacturing Practice (cGMP) quality is a requirement by the Food and Drug Administration (FDA) and European Medicines Agency to provide patients with clinical-grade products that are safe and have defined quality characteristics. However, process standardization and robust manufacturing techniques are lacking in regenerative medicine, which will continue to impede progress in advancing regenerative medicine based technologies and treatments toward the clinic. This is likely due to the immaturity of the regenerative medicine field, which could benefit from the development and advancement of many manufacturing capabilities. This upcoming RPP will focus on quality management of biomanufacturing processes and/or development of a prototype for a universal biomanufactured product or process. Applications will need to clearly state innovative solutions for the biomanufacturing of regenerative medicine products and regulatory strategies to obtain FDA clearances or approvals, if appropriate. The major objective of this upcoming RPP is to overcome current challenges in biomanufacturing of regenerative medicine products and enable successful cGMP manufacturing and clinical translation of regenerative medicine based therapies. To accomplish this, the Government is seeking solutions for quality management of manufacturing processes or prototypes for cell, tissue, or organ bioengineering technologies. This upcoming RPP specifically targets solutions to the following Focus Areas (not listed in order of importance): Technology Focus Areas: FOCUS AREA #1: Processing technologies for Quality Management of Acellular Matrices or SC-Derived Cell Based Therapies (Assurance or Quality Testing) FOCUS AREA #2: Manufactured Universal Acellular Matrix FOCUS AREA #3: Innovative Manufacturing Process for Stem Cell (SC)-Derived Cell Based Therapies NOTE: There will be a face-to-face opportunity to discuss these technology focus areas of this upcoming RPP with Dr. Tony Gover, Director of Clinical and Rehabilitative Medicine Research Program (CRMRP), U.S. Army Medical Research and Development Command (USAMRDC) at the MTEC annual membership meeting on March 4-5 in Houston, TX. The meeting is free for MTEC member organizations to attend. For more information regarding the MTEC annual membership meeting: https://www.mtec-sc.org/event/mtecs-5th-annual-membership-meeting/ Registration for the meeting is active: https://events.bizzabo.com/219932/home Potential Funding Availability The U.S. Government (USG) Department of Defense (DoD) currently has available approximately $16.9 Million (M) . Awards resulting from this RPP are expected to be made in FY20, subject to available federal funds for this program. The USG may apply additional dollars for follow-on efforts via post award modification to any resultant awards after the evaluation and acceptance of work and cost plan. Dependent on the results and deliverables, additional time may be added to the period of performance for follow-on tasks. MTEC expects to make a total of six (6) awards to qualified teams to accomplish the statement of work. If a single proposal is unable to sufficiently address the entire scope of a specific focus area, several Offerors may be asked to work together in a collaborative manner. See the “MTEC Member Teaming” section below for more details. However, if an optimal team is not identified, then MTEC may make multiple, individual awards to Offeror(s) to accomplish subset(s) of the key tasks. The anticipated Period of Performance (PoP) for each focus area is three (3) years. Acquisition Strategy: The MTEC will use a streamlined, accelerated approach for this acquisition. This approach will consist of the following steps: Step 1: MTEC members who wish to offer a solution to the RPP must submit a Solutions Brief. The Solutions Brief shall contain the MTEC Offeror’s technical concept and approach supported by scientific rationale to support the feasibility of the proposed work. The Offeror will also be expected to present a detailed budget, statement of work, and regulatory and commercialization plan. Step 2: As part of the Government review of the Solutions Brief, MTEC members who have submitted a favorable Solutions Brief based on the RPP criteria may be invited to present and discuss their solution with the Government sponsors for the research via a virtual or in-person “pitch” of the proposed project along with a Milestone Payment Schedule, Project Management and description of innovative approach. Step 3: MTEC Offeror(s) will be notified of the down select recommendation(s), and if selected, will be invited to submit a detailed Cost Proposal in accordance with the MTEC Proposal Preparation Guide (PPG). Because of the nature of the requirements set forth in the forthcoming RPP, this streamlined, interactive approach is anticipated to be a better means to highlight company methodologies and skills and allow the government to gain a fuller appreciation of the work required to be completed. It provides more freedom and initiative to the Offeror to describe how they would approach and solve such an action. The full description of this contracting approach will be included in the RPP. MTEC Member Teaming: While teaming is not required for this effort, Offerors are encouraged to consider teaming during the proposal preparation period (prior to proposal submission) if they cannot address the full scope of technical requirements of the RPP or otherwise believe a team may be beneficial to the Government. MTEC members are encouraged to use the MTEC Database Collaboration Tool to help identify potential teaming partners among other MTEC members. The Database Collaboration Tool provides a quick and easy way to search the membership for specific technology capabilities, collaboration interest, core business areas/focus, R&D highlights/projects, and technical expertise. Contact information for each organization is provided as part of the member profile in the collaboration database tool to foster follow-up conversations between members as needed. The Collaboration Database Tool can be accessed via the “MTEC Profiles Site” tab on the MTEC members-only website. MTEC: The MTEC mission is to assist the U.S. Army Medical Research and Development Command (USAMRDC) by providing cutting-edge technologies and supporting effective materiel life cycle management to transition medical solutions to industry that protect, treat, and optimize Warfighters’ health and performance across the full spectrum of military operations. MTEC is a biomedical technology consortium collaborating with multiple government agencies under a 10-year renewable Other Transaction Agreement (OTA), Agreement No. W81XWH-15-9-0001, with the U.S. Army Medical Research Acquisition Activity (USAMRAA). MTEC is currently recruiting a broad and diverse membership that includes representatives from large businesses, small businesses, “nontraditional” defense contractors, academic research institutions and not-for-profit organizations. Administrative Information: The RPP will be posted to the MTEC website (mtec-sc.org) and a notice will be posted on www.beta.SAM.gov to notify interested parties. MTEC membership is required for the submission of a full proposal in response to this upcoming MTEC RPP. To join MTEC, please visit http://mtec-sc.org/how-to-join/. For inquiries regarding this pre-announcement, please direct your correspondence to the following contacts: Technical and membership questions – Dr. Lauren Palestrini, MTEC Director of Research, lauren.palestrini@officer.mtec-sc.org Programmatic questions – Ms. Kathy Zolman, MTEC Director of Program Operations, kathy.zolman@ati.org MTEC Member Collaboration Database Tool – Ms. Melissa Sanchez, MTEC Program Administrator, melissa.sanchez@ati.org