The Regenerative Medicine Resource Center: supporting preclinical interdisciplinary dental, oral and craniofacial projects
In this interview, Mutsumi Yoshida shares more about the Michigan-Pittsburgh-Wyss Regenerative Medicine Resource Center and its first round of funding.
What is the Michigan-Pittsburgh-Wyss Regenerative Medicine Resource Center?
We are one of the two national resource centers that’s supported by National Institute of Dental and Craniofacial Research (NIDCR), a branch of the National Institutes of Health (NIH; MD, USA), as a part of their Dental, Oral, and Craniofacial Tissue Regeneration Consortium (DOCTRC) initiative. We are a consortium comprised of three institutions — University of Michigan (MI, USA), University of Pittsburgh (PA, USA), and Wyss Institute at Harvard University (MA, USA). Our goal is to partner with scientists, engineers, clinicians, experts in the dental, oral and craniofacial field to help translate promising technologies that address unmet clinical needs to the clinic. We have a team of experts in science, clinical translation and commercialization, and also a funding mechanism called the Interdisciplinary Translational Project or the ITP Program.
Why was the resource center set up?
There has been a lot of great research in regenerative medicine and tissue engineering in the dental, oral, craniofacial field, but to date there are a few regenerative medicine/ tissue engineering-based therapies in the space. We are trying to fill the gap between the great discovery research and getting the technologies that arise from that research to the market and to the patients. There has been a lot of support from NIDCR and NIH in the regenerative medicine, including support that has led to the establishment of the resource centers.
The Resource Center takes a new approach to catalyze the clinical translation of tissue engineering/regenerative medicine therapies through its ITP program. By bringing together team of experts (ranging from commercialization/IP, market research and regulatory areas as well as in technical) at the beginning of the translational process, we endeavor to facilitate and accelerate the project’s clinical translation.
The funding provided through the resource center’s ITP program is open to any academic institutions as well as to for-profit entities. We have a ‘call for proposal’ approach where we solicit for proposals, followed by a two-round review process which not only looks at the science and the unmet clinical need but other factors that are critical in clinical translation such as regulatory, manufacturing, and commercialization considerations. The areas or tissue types that we look at in the dental, oral, craniofacial field are pretty diverse; we cover anything from bone, cartilage, composite tissues that might comprise of muscles, nerves, skin, oral mucosa, salivary gland or teeth, dental implants, and across therapeutic indications.
Can you tell me about any particularly exciting projects that you have funded so far?
We have funded 10 projects so far and have completed one full cycle of evaluations. The projects span from scaffolds to repair of temporomandibular joint disorders, technologies that help accelerate bone healing, a tissue-engineered functional lip, and antibody approaches to treat periodontal disease and bone regeneration to name a few.
At what stage is this research?
Getting the technology to the clinic is our objective and so most of the projects that we are supporting are in the preclinical stage, with the support from the ITP program geared towards achieving milestones that will get the projects ready for a clinical trial. Most of these studies have already completed their proof of concept in small animals; now, they are looking to do large animal studies or focusing on establishing scalable, reproducible and sourceable manufacturing approaches. With the support from the ITP program, we are also able to provide regulatory consulting and conduct an in-depth market research, to understand the commercial opportunities specifically in the DOC space.
Are there any trends that you see starting to become apparent in the techniques people are using or the processes they are going through?
We are still in the early stages of the program, and our first cycle of teams are a few months into their projects. The funding program is a year-long program, and right now we are in the second cycle where we will be making funding decisions later this summer. At this point in time it’s difficult to say with regards to the specific trends in the projects that we are receiving, but they are all very interesting projects that span a wide variety of tissues and technology types.
Some people feel that regenerative medicine hasn’t lived up to the hype, although we are still fairly early on in the field. What are your thoughts?
I think that’s right, in that the regenerative medicine is a younger field as compared to some of the other approaches. There is the gap to fill, to get regenerative medicine therapies on to the DOC market, and bridging that gap is what we are striving to do: taking the technologies that arose from the great research, and developing them into therapies from which the patients could benefit.
Do you think that these more structural or physical approaches are more difficult to commercialize than cell therapy?
I think there are a lot of considerations on both sides. Some of the considerations for cell therapy, for example, might be in terms of manufacturing and sourcing, as well as the outlook for the regulatory pathway. Products that are based on solely on polymeric scaffolds with a cell-free-type approach, may appear to be more straightforward from regulatory and manufacturing perspectives, but these technologies are often combined with cell therapy or other factors such as small molecules or biologics, which can increase the complexity. Those are all factors that we are considering when evaluating these projects in addition to the clinical needs and commercialization opportunities.
Is reproducibility something that researchers should be considering more? Do you think they are considering it early enough in that sort of process?
That is something that we are trying to accomplish through the resource center initiative. One of the things that is central to the resource center is the core services. We have experts that are focused on commercialization, IP, market research and regulatory areas as well as technology core services that we offer; for example, in the dental, oral and craniofacial field micro-CT or histology are commonly used techniques and we have core facilities that can perform these. With the objective achieving reproducibility and standardization to be able to reliably validate technologies, we are strongly emphasizing the utility of our core facilities with our ITP program.
How can scientists access these facilities?
Interdisciplinary Translational Projects Program (ITP) is one way. If researchers are interested, there is information on our website, which would be a great place to start. They can also reach out to us directly.
How did you get involved in the resource center?
Prior to coming to the resource center, I was with the Office of Technology Transfer at the University of Michigan where I collaborated with researchers to commercialize technologies developed at the University. My role with the resource center is to manage the ITP program, focusing on the translation of the regenerative medicine/ tissue engineering technologies, and running the day-to-day operations for the resource center, and these activities enable me to integrate my experience with technology commercialization and interest in the regenerative medicine/ tissue engineering.
What is it that interests you and helps you get up every day and come to work?
The projects are exciting and cutting-edge. It’s been great to be able to work with research teams across the country, and to see these technologies moving forward, and hopefully being made available to help the patients.
What are the plans for future? Are you hoping to expand the resource center and fund more people?
Yes — we have our second cycle of the ITP program that’s in progress right now, and will be making funding decisions later this summer. In addition, we have a new call for proposal that is open now with pre-proposals due on July 27, where we are soliciting new projects for the cycle 3 of the ITP program. Our goal is to build a strong portfolio of tissue engineering/ regenerative medicine technologies that address unmet clinical needs in the dental, oral, and craniofacial space, and support their translation towards clinical trials.