Resource Guide

Training Opportunities

• FFMI fastPACE (a 4-week biomedical innovation and commercialization course designed for the busy medical academician with an early stage project)
• Education and Training programs available from MICHR
• SBIR/STTR Training from BBC Entrepreneurial Training & Consulting
• Tissue Engineering and Regeneration Grant (training grant) Tissue Engineering and Regeneration (TEAM) is an interdisciplinary research-intensive training program for individuals who wish to pursue careers in the oral sciences with a focus in the area of restoration of oral-craniofacial tissues.

Regenerative Medicine

• Michigan-Pittsburgh-Wyss Regenerative Medicine Resource Center
• C-DOCTOR
• California Institute of Regenerative Medicine
• McGowan Institute for Regenerative Medicine
• Wake Forest Institute for Regenerative Medicine
• Regenerative Medicine Foundation
• Tissue Engineering and Regenerative Medicine International Society
• American Academy and Board of Regenerative Medicine
• The Transplantation Society
• International Society for Stem Cell Research
• Biomedical Engineering Society
• Society for Biomaterials
• Materials Research Society
• Osteology Foundation

Manufacturing

• Advanced Regenerative Manufacturing Institute
• Navigating the Manufacturing Process and Ensuring the Quality of Regenerative Medicine Therapies – Proceedings of a Workshop

Standards

• The Regenerative Medicine Standards Landscape: This report provides a snapshot of the current landscape for regenerative medicine standards. It outlines existing and in-development standards, providing a reference that individual organizations can use to identify available standards to improve their operations.
• Needed Standards in Regenerative Medicine: Community Perspectives: Needed Standards in Regenerative Medicine report. The objective of the report is to outline standards needs identified by the community that could have the greatest benefit to the field and improve the safety and quality of regenerative medicine products.

FDA Regulations

Good Laboratory Practice (GLP)

• 21 CFR Part 58: Good Laboratory Practice for Nonclinical Laboratory Studies
• FDA Guidance: Questions and Answers on Good Laboratory Practice (March 1998)
• FDA Compliance Program Guidance Manual 7348.808 Good Laboratory Practice (May 2018)

Medical Devices

• 21 CFR Part 812: Investigational Device Exemptions
• 21 CFR Part 814: Premarket Approval of Medical Device
• 21 CFR Part 820: Quality System Regulation
  • Subpart C: Design Controls
  • Subpart D: Document Controls
  • FDA Guidance: Design Control Guidance for Medical Device Manufacturers (March 1997)
• FDA Guidance: Use of International Standard ISO 10993-1, “Biological Evaluation of Medical Devices – Part: Evaluation and Testing within a Risk Management Process” (June 2016)
• FDA Guidance: General Considerations for Animal Studies for Medical Devices (Oct 2015)
• FDA Guidance: The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510 (k)] (Jul 2014)
• FDA Guidance: Evaluation of Devices Used with Regenerative Medicine Advanced Therapies (Feb 2019)

Meeting with the FDA

• FDA Compliance Program Guidance Manual 7348.808 Good Laboratory Practice
• FDA Guidance: Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program (May 2019)

Drugs

• 21 CFR Part 312: Investigational New Drug Application

Cellular and Gene Therapy products

• FDA Guidance: Preclinical Assessment of Investigational Cellular and Gene Therapy Products (Nov 2013)
• FDA Guidance: Current Good Tissue Practice (CGTP) and Additional Requirements for Manufacturers of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) (Dec 2011)
• FDA Guidance: Regulatory Considerations for Human Cells, Tissues, and Cellular and Tissue-Based Products: Minimal Manipulation and Homologous Use (Dec 20, 2017)

Other FDA Guidance

• Expedited Programs for Regenerative Medicine Therapies for Serious Conditions (Feb 2019)
• Same Surgical Procedure Exception under 21 CFR 1271.15(b): Questions and Answers Regarding the Scope of the Exception (Nov 2017)

Enabling Activities

The scientific goals of this SRI are to catalyze regenerative medicine (RM) at UM through a materials-centric approach by: identifying patterns and signatures in tissues in spatially and temporally; incorporating this information into materials design; and engineering tissues based on materials with sensing, diagnostic and therapeutic abilities.  Equally important is the creation of an enabling environment for the RM community at UM.  We’d like to take this opportunity to communicate some of the enabling activities we have implemented and benefits of being involved in our BSI program.  These activities sync with our philosophy that teams out-compete individuals and are geared toward integrating RM expertise across campus to better engage people and create an environment to foster new ideas and make “big” things happen.

We had a successful initial Grand Challenge earlier this year with the theme of how to regenerate tissues/organs to optimally integrate with the host. We brought together clinicians, scientists, and engineers to explore new ideas and catalyze new collaborations to address key barriers to the translation of RM technologies.  Following talks defining clinical problems and emerging technologies as potential solutions, breakouts led to the definition of key barriers, which informed RFA centered around incorporating programmable materials to control the key biological elements inhibiting clinical success of tissue engineered medical products (TEMPs). We funded 3 proposals/new partnerships in the areas of programmable materials for monitoring inflammation and regeneration (Aaron Morris, BME, Katherine Gallagher, Surgery & Peter Tessier, Pharmacy); host integration of cell-dense, microvascularized grafts using in situ programmable hydrogel composites (Brendon Baker, BME & Mario Fabiilli, Radiology); and engineered IL-2 muteins for immunotherapy against inflammation and autoimmune diseases (James Moon, Pharmacy & Isabelle Lombaert, Dentistry). Plans are underway in Spring 2023, tentatively centered around aspects of translation unique to regenerative medicine.

Drs. Brendon Baker and Ariella Shikanov launched two groups that meet monthly to brainstorm: a PI group and a student group, Biomaterials in Regenerative Medicine (BIRM). Both groups bring researchers with shared interests together on a regular basis. PI meetings facilitate collaborations and focus on formulating and critiquing specific aims to improve grant success.  The student-focused meetings offer opportunities for trainees to present their research and stay current with the literature 2^nd Wednesday of the month.  Both meetings are open to all – please contact Brendon, Ariella or Cait for more information.

Our SRI helped support UM’s membership in the Advanced Regenerative Manufacturing Institute (ARMI), which enables anyone at UM to access ARMI’s services, including funding opportunities exclusive to members; access to shared facilities, equipment and discounts on materials; BioFab and regulatory consulting and access to a regulatory library.  Several PIs at UM, including Lisa Larkin, Ariella Shikanov and Steve Feinberg, have taken advantage of ARMI’s services as their technologies get closer to FDA submissions.

In addition to these ongoing activities, we surveyed the RM community at UM for additional activities of interest.  Responses were bracketed into 5 areas: 1) funding opportunities, 2) translational guidance, 3) team building; 4) networking; 5) specific scientific expertise needed.  We are prioritizing activities to be responsive to these needs of the community, but here are a few ideas. The monthly meetings have created an ecosystem for collaboration.  To date we have focused on informal guidance in specific aims, but are happy to expand to more formal grant reviews.  The interactions also position us to form research interest groups and position UM to be proactively responsive to RFAs.

Leveraging the structure and expertise developed as part of the Michigan-Pittsburgh-Wyss Regenerative Medicine Resource Center, we are in position to offer translational RM guidance to UM investigators as related to the development of a technology via the Translational Research Consult Program.  Example topics include: how might the envisioned product be classified by the FDA, what elements affect this classification, and what are the pathways associated with that classification? What are some Good Laboratory Practice (GLP) protocol requirements that might be relevant to the envisioned product? What factors should be considered as first target indication is defined?

We will re-launch a RM translational fellowship in 2023. This fellowship will provide a structured program to prepare trainees for a career as an entrepreneurial investigator or for a translationally oriented career in non-academic sectors. Trainees will split effort pursuing independent laboratory research and engaging in translational research/commercialization training.
Please also visit our website, which we hope to evolve into a one-stop gateway to promote and enhance research and educational activities in RM at UM and serve as a resource for UM researchers.  The website is updated weekly with events and funding opportunities.