Quality Assurance for Biomanufactured Regenerative Medicine Products (Qual-Regen)

The Medical Technology Enterprise Consortium (MTEC) is excited to post this summary announcement for a 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 RPP focuses on quality management of biomanufacturing processes and/or development of a prototype for a universal biomanufactured product or process. Technology Focus Areas: The major objective of this 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. To meet the intent of this RPP, proposed prototype solutions must address at least one of the three Focus Areas described below. An ideal Solution Brief is one that integrates manufacturing process or quality management development with scientific testing and characterization throughout the project. Solution Briefs may address one or more focus areas. Projects not aligned to at least one of these Focus Areas will not be considered for funding. These focus areas of interest are listed in order of importance. More detail for each focus area is included within the full RPP document available on the MTEC members only site. 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 Potential Follow-on Task: There is potential for award of one or more follow-on tasks based on the success of this project (subject to change depending upon Government review of work completed). Note that any potential follow on work is expected to be awarded non-competitively to resultant project awardees: Designing and implementing pilot or full-scale Good Manufacturing Practice (GMP) production of successful products for use in advanced preclinical and initial clinical trials; Development of prototype device to Investigational Device Exemption (IDE) stage for initiation of clinical trials; Pre-clinical testing in validated animal model to test safety and efficacy of manufactured product or cell based therapy for the advancement of prototype development toward regulatory filing for initiation of clinical trials; Conduct of clinical trials. Potential Funding Availability: The U.S. Government (USG) Department of Defense (DoD) currently has available approximately $16.9 Million (M) of Fiscal Year (FY) 2019 and 2020 to fund approximately 6 projects (up to $2.82M/project). The anticipated Period of Performance (PoP) for each focus area is 3 years. Dependent on the results and deliverables, additional time may be added to the period of performance for follow-on tasks. 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 Solution Brief. The Solution Brief shall contain the MTEC Offeror's technical concept and approach supported by scientific rationale to support the feasibility of the proposed work. To meet the statutory requirement of the Other Transaction Authority, Solutions Briefs shall also address the significant participation of a Nontraditional Defense Contractor, Small Business or Nonprofit Research Institution on the team or the willingness to provide 1/3 cost share to the project. The Offeror shall also include a budget, statement of work, and regulatory and commercialization plan. Upon evaluation of the Solution Briefs, Offerors who received favorable overall ratings will be invited into Step 2 of the Solution Brief process. Offerors who are not invited to proceed into Step 2 will be provided feedback. Step 2: Select Offeror(s) shall provide a virtual or in-person - pitch of the proposed project during a meeting with the Government sponsors. The pitch shall provide more details about the technical and business viability of the proposed work along with a detailed Cost Proposal in accordance with the MTEC Proposal Preparation Guide (PPG) and updated statement of work/milestone payment schedule. At the conclusion of the Step 2 evaluation, Offerors who are favorably evaluated will be invited to submit a final solution brief and a cost proposal (which may be amended from the initial brief to incorporate discussion points from the government interaction). Because of the nature of the requirements set forth in the 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 is included in the full RPP document available on the MTEC members only site. 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 (see below for a link). 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: Solution Briefs are due no later than April 14, 2020 at 12:00pm Eastern Time. The full version of the RPP is posted to the MTEC website (http://mtec-sc.org) and a notice is posted on www.beta.SAM.gov. MTEC membership is required for the submission of a Solution Brief in response to this MTEC RPP. To join MTEC, please visit http://mtec-sc.org/how-to-join/. For inquiries regarding this RPP, please direct your correspondence to the following contacts: Technical and membership questions - Dr. Lauren Palestrini, MTEC Director of Research, contact@example.gov Programmatic questions - Ms. Kathy Zolman, MTEC Director of Program Operations, contact@example.gov MTEC Member Collaboration Database Tool - Ms. Melissa Sanchez, MTEC Program Administrator, contact@example.gov