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Translational Research Opportunities in Healing and Regeneration of Oral and Craniofacial Tissues”

​Meeting Summary
Programmatic Consultation
July 21-22, 2013

Co-chaired by Dr. David Mooney, Harvard University and Dr. Nadya Lumelsky, NIDCR

Introduction

NIDCR convened a Programmatic Consultation to obtain expert input from an interdisciplinary group of scientists on directions and approaches for overcoming key obstacles and identifying optimal strategies for translating tissue engineering and regenerative medicine (TE/RM) research opportunities for clinical applications in repair and regeneration of oral and craniofacial tissues. NIDCR and other NIH Institutes have been investing in the TE/RM field for many years, and many examples of proof-of principle successes have been reported. However, only a few technologies have reached the clinic to date. The goal of this workshop was to examine the TE/RM research landscape, including state-of-the-science knowledge base, emerging and innovative technologies, investigator networks and workforce pipeline, as well as regulatory and commercialization pathways. The expected outcome was to identify those areas where a focused defined effort could significantly accelerate translational research realizing the initiation of clinical trials within the next 5 to 10 years.

Given that oral and craniofacial diseases, disorders and injuries typically involve multiple rather than individual tissues, and that the survival and function of many of these tissues are intimately linked to their proper vascularization, the participants were asked to concentrate on the most clinically-relevant scenarios of composite tissue regeneration.
Dr. Somerman opened the meeting with a description of NIDCR’s investment in TE/RM research and the contributions of TE/RM investment to the overall NIDCR portfolio. She encouraged the panelists to focus the discussion on a broad spectrum of issues preventing TE/RM translation. Lastly, Dr. Somerman emphasized the importance of defining specific outputs and milestones for translation of TE/RM to the clinic.

Dr. David Mooney, co-chair of the meeting, charged the panel to focus the discussion on TE/RM technologies where NIDCR investment has a strong potential to result in measurable translational outcomes. Additionally, he stressed the importance of centering the discussion on technologies that are sufficiently mature to transition into phase I/II clinical trials within the next 5-10 years. In his words: “If the technology requires derivation of a new mouse model, it should not be discussed here today”.

Discussion Topic 1: Tooth and Periodontium
This discussion was led by Dr. Paul Krebsbach (University of Michigan) with contribution from Dr. William Giannobile (University of Michigan; on the phone).

The long term goal is to produce predictable, reproducible periodontal regeneration therapies. Dental practitioners should be able to carry out these procedures in their dental offices. The treatments and outcomes will be influenced by multiple factors (in addition to the regeneration technology itself), including underlying periodontal infection, chronic inflammation, genetic background, and presence of other diseases, such as diabetes. It will be important to arrest the disease, when possible, and normalize the tissue microenvironment for the success of periodontal regeneration. Thus therapies combining anti-microbial and inflammation resolving mediators with anabolic and anti-resorptive agents hold significant promise.

Improvement of currently existing therapies might be the most productive direction to pursue in advancing the field in the short term. Given the structural and functional complexity of the tooth and periodontium, pragmatic approaches to clinical regeneration should be limited only to a few tissues and interfaces, such as between alveolar bone and periodontal ligament, or periodontal ligament and cementum.

A clinical need exists for the development of patient-specific therapies to repair bone and supporting structures around the teeth and for long-lasting bone support of tooth replacement dental implants. Clinical translation might be feasible in several areas in the near future where considerable preclinical work has already been performed within the context of a defined regulatory pathway for clinical penetrance in the next 5 years:

  • Development of 3-D printed scaffolds to facilitate repair of tooth-supporting alveolar bone defects. Platform technologies of 3-D printing for dental implants are already in the clinic on a commercial scale. Oral, dental and craniofacial imaging technologies are also well-developed and are used by clinicians for three-dimensional imaging. These imaging technologies will permit fabrication of 3-D printed scaffolds that can be engineered to contain bone stimulatory or biomimetic molecule for local bone regeneration around teeth and implants. First- in-human proof-of-principle studies are ongoing.
  • The use of host-modulatory and bone anabolic agents for patients with periodontal disease to regenerate alveolar bone and periodontium. A number of potential approaches using cell, gene and protein delivery for periodontal regeneration have been proposed and tested. Unfortunately, these approaches failed during clinical evaluation, because of an exuberant host inflammatory response, the risk of re-infection and poor wound healing following these regenerative procedures. Targeted anti-inflammatory and bone anabolic therapies coupled with regenerative therapies could significantly improve the outcomes of periodontal regeneration.
Components needed for success in periodontal regeneration may include:

  •  Large animal models reflecting the complexities of human disease
  •  Rigorous non-destructive functional assays and endpoints for longitudinal studies of regenerative response in large animal models
  •  Biocompatible and biodegradable biomaterials
  •  Effective and safe stem and progenitor cell sources
  •  Effective and safe anti-resorptive, anti-inflammatory and anti-microbial agents
  •  Efficient cell delivery technologies
  •  Efficient biomolecule delivery technologies for in vivo delivery of anabolic and other bioactive agents
  •  Technical standard protocols
  •  Scalable fabrication technologies for transitions from small to large animal models and to human clinical trials
  •  Optimized technical, regulatory and commercialization infrastructure
  •  Comparative effectiveness research to define clinical design criteria
  •  Effective interdisciplinary collaborations and partnerships where members of teams “speak the same language”
Many examples of animal models, cells, biomaterials, and biomolecule delivery technologies, etc. for periodontal regeneration have been published; however, the results are often contradictory, lack standardization, and are not evidence-based, thus are difficult to translate. This motivates the need for greater standardization of these studies in the future. Safety and efficacy studies in large animal models are not always predictive of human response. Human studies provide the most accurate information when they are matched with a technology for a specific clinical indication and are informative for defining pre-clinical models in which the technology must be tested.

The clinical design criteria for periodontal regeneration were not clearly defined during the meeting, and it remained unclear which specific endpoints or products would constitute success, i.e. “how good is good enough?” as compared to the current state-of-the art approaches in periodontal regeneration.

The commercial path forward for periodontal regeneration technologies is additionally complicated due to the lack of a patient reimbursement base for these procedures. Thus expensive procedures will be difficult to take to clinical application. Development of less risky, simple and inexpensive procedures is needed. In addition there is a need to develop effective strategies for transition from proof of principle studies to pre-clinical large animal studies, and to phase I and II clinical trials. Academic researchers often lack expertise to make these transitions, and often lack the expertise in regulatory science that is required for commercialization of the technologies. Academic researchers need additional training and mentoring in regulatory science and need to form appropriate partnerships early during their research projects.

Discussion Topic 2: Craniofacial bone and osteochondral composites
This topic was led by Dr. Gordana Vunjak-Novakovic (Columbia University) with contribution from Dr. Michael Longaker (Stanford University; on the phone).

There are two areas of key clinical needs in craniofacial bone regeneration: (1) production of high-quality vascularized, innervated and mechanically-competent bone in sizes and shapes compatible with the human anatomy; and (2) formation of functional interfaces between bone and vasculature, bone and cartilage, as well as between bone, skeletal muscle and tendons.

We are confronted with a three main types of clinical scenarios:
  • Congenital abnormalities (such as hemifacial microsomia, Treacher Collins Syndrome, cleft palate, Crouzon Syndrome, McCune-Albright Syndrome, Stickler Syndrome – all of which involve bone loss and/or deformity)
  • Cancer patients with large sections of bone being removed surgically, followed by radiation (these patients are known to heal poorly and to show inability for regeneration of vasculature and bone)
  • Trauma with loss of bone and surrounding soft tissues
The craniofacial region presents special challenges to tissue regeneration, because the face is a unique and expressive part of the body and issues of esthetics are as important as function. These needs necessitate a faithful restoration of lost or deformed tissue with minimal tissue fibrosis and scarring. The specific challenges for the regeneration of craniofacial bone include:

  • Enormous diversity of tissue shapes
  • Anatomical differences between the individuals
  • Complex tissue interfaces (bone/cartilage/vasculature/muscle/ligaments)
  • Anisotropy of tissue architectures and mechanical properties
  • Need for seamless functional integration with the host bone and vasculature with the establishment of blood flow
  • Meeting these needs and challenges require development of personalized treatment modalities that take into account the specifics of the defect and of the patient being treated, including the nature of defect, the need to restore soft tissue interfaces, as well as age and systemic conditions that affect healing, such as diabetes, osteoporosis and history of radiation.
Regeneration of vascularized bone could be augmented by a design of biomaterial scaffolds that can promote angiogenesis, and facilitate development of functional anastomoses and patent vasculature while supporting bone regeneration and morphogenesis. Our understanding of the principles for the design of such biomaterials is already significant and is constantly growing. We should be able to translate this knowledge into effective practical modalities for vascularization of the craniofacial complex within the next 5 years.

A related topic of key interest and high potential for application is that of harnessing the tissue inflammatory response to direct and enhance endogenous healing of bone and surrounding soft tissues. This effort can significantly benefit the whole field of craniofacial regeneration through the design of “smart biomaterials” with immunomodulatory properties that can tightly control the levels and timing of application of immunomodulatory factors possibly in a combinatorial fashion. This is another area where a substantial knowledge is already available to enable translational outcomes within a short timeframe.

Controlled delivery and presentation of BMPs and other anabolic biomolecules to cells on bioactive and biodegradable scaffolds may help to optimize bone regeneration outcomes and minimize side effects. A number of promising biomolecule delivery technologies are already available, but they need to be tested in large animal models and undergo regulatory approval. In addition, targeted delivery of morphogens and growth factors to induce endogenous progenitor cell mobilization and homing could be a viable approach to bone regeneration. Unfortunately, clinical experience with BMP-2 has not been particularly favorable. While BMP-2 induces bone formation, it also has been linked to an excessive inflammatory response and to heterotopic ossification. BMP-2 is particularly risky when it is used for bone regeneration in cancer patients following tumor resection; there is a possibility of BMP-2 promoting dormant tumor relapse. Thus BMP-2 might be more suitable for bone regeneration following trauma or for congenital craniofacial bone defects. Wnt family ligands represent another promising class of biomolecules for these applications. Overall, this is an area that would require more research to become ready for translation.

There also exists a need for optimization and standardization of cell sources and derivation/differentiation protocols. Currently, the following cell sources are being considered as strong candidates for bone regeneration applications: mesenchymal stem cells derived from adipose tissue, bone marrow and dental tissues, and induced pluripotent stem cells.

To realize the promise of these cells for bone regeneration, it will be important:

  • To develop robust functional assays to address the quality and quantity of new bone; particularly important are assays in large animal models
  • To standardize cell expansion and differentiation protocols, and reliably assess safety and toxicity of these cells. Currently, the field suffers from a lack of consensus regarding comparative usefulness of different cell sources for producing high-quality bone.
Certain in vitro bone-generation technologies hold great promise, such as in vitro bioreactors where conditions promoting bone formation can be tightly controlled and imaged in real-time. Such bioreactors also allow application of biophysical forces to facilitate bone maturation.

Additionally, 3-D printing technologies hold promise, particularly for the development of composite multi-tissue constructs. 3-D printing can be executed either with combinations of cells and biomaterials or with biomaterials alone. The drawback of 3-D printing involving cells is its high cost. 3-D printing without cells, however, can be accomplished relatively inexpensively.

Another practical bone regeneration approach that may have a shortened path to the clinic is augmentation of the effects of autologous bone flaps that are widely utilized in surgical practice for bone reconstruction. Advanced biomaterials, scaffolds, and targeted biomolecule delivery could significantly improve the viability and functionality of these bone flaps as well as promote functional integration between flaps and host tissues.

A number of congenital craniofacial abnormalities involving bone deformities are rare diseases, but collectively they represent a significant medical problem. A potential strategy that can facilitate translating advances in bone regeneration to help these patients is orphan products regulatory pathway. This pathway may help to accelerate the process of FDA approval and commercialization of bone regeneration technologies as a whole for these and a wide range of other applications.

Overall, an ideal bone regeneration strategy should produce high quality bone using approaches that are simple enough to be practical for regulatory approval, clinical translation, and commercialization. From this perspective, in vivo bone regeneration avoiding the use of in vitro-expanded exogenous cells, represents an attractive possibility. Many technological building blocks for clinically-relevant bone regeneration are already in place; however, to bring them to the clinic, there is a need to improve human disease-relevant animal models, advance standardization and scale up technologies, build functional multidisciplinary teams of scientists, engineers and clinicians, and put in place financial resources for facilitating regulatory approval and commercialization.

We have a lot of technology already available that needs to be matched with the clinical needs. To this end, it is necessary for the clinicians to be more specific about their requirements by identifying problems and solutions that can make a difference in the clinic, and for the researchers to know how their systems can function and what they can provide within the context of real clinical situations. For both the long-term and short-term translational goals, it only makes sense to start from the clinical problems and search for the available technologies to solve the problem. This is a reverse paradigm to much of the current academic research that tends to move freely between ideas and findings and only later looks for applications.

Discussion Topic 3: Musculoskeletal tissues of the face
This topic was led by Dr. David Mooney (Harvard University)

The key clinical needs in facial skeletal muscle regeneration include (1) reconstruction of human size vascularized and innervated muscle, and (2) integration with host muscle, bone vasculature and the nervous system. These needs arise as a result of a broad range of traumatic injuries, craniofacial congenital abnormalities and post-tumor resection surgeries.
It is important to define success by establishing tight metrics of desired muscle function resulting from reconstructive therapies. Overall, new therapies should demonstrate better outcomes than those already available today. They should provide long-term and durable restoration of the structure and function of the face, including facial animation, mastication, and swallowing as well as pain reduction. Additional metrics may need to be defined. Patient-reported outcomes assessments will be useful in identifying additional metrics of muscle regeneration success.

Current TE/RM research strategies being pursued for skeletal muscle regeneration include:

  • Classic in vitro tissue engineering approaches, such as combining cells with bioactive scaffolds and biomolecules to generate muscle tissue
  •  In vivo muscle regeneration is being explored via stem/progenitor cell injection with or without co-delivery of morphogens and growth factors to mobilize endogenous muscle regenerative capacity
Although a certain level of success has already been achieved, many issues remain. These include:

  • Stem/progenitor cell injection in vivo typically results in low cell survival and retention in tissues; thus improved cell delivery protocols should be developed
  • The majority of in vitro and in vivo muscle regeneration strategies have only been tested in small animal models; transition into large animal models will be necessary to advance the translational pipeline
  • While investment in improved cell delivery options is needed, adult skeletal muscle stem/progenitor cells - satellite cells- have already been identified and relatively well- characterized, therefore this area currently does not need a major investment.
Important questions to address: Are TE/RM strategies for skeletal muscle regeneration ready for translation? What should be the first clinical application(s)? Should TE/RM approaches displace or supplement currently used therapies? What would define success? What should be the design of clinical trials; who should conduct them – academic or commercial entities?

There was uniform agreement on the panel that building skeletal muscle “from scratch” with TE/RM technologies should be a long-term goal; however, it would be unrealistic to move this technology into clinical trials within the next 5-10 years. A more realistic short-term goal is functional augmentation of autologous skeletal muscle flaps, which are already being widely used in the clinic for treatment of traumatic muscle injury. Current TE/RM technologies may significantly improve the function of muscle flaps using a number of approaches. One example is the controlled release of a combination of inductive growth factors and/or morphogens to enhance re-vascularization, re-innervation, and integration of flaps with the host’s blood supply and nervous system. Such an advance would significantly improve the state-of the-art for muscle flap grafting, because long-term viability and function of muscle flaps are crucially dependent upon their robust integration into the host muscle. If integration does not occur within first 18-24 months following surgery, the grafted tissue deteriorates and loses its function. The panelists agreed that TE/RM technologies can provide a major contribution to muscle flap-based reconstructions.

Augmentation of the existing flap technology may have a relatively straightforward regulatory path through FDA, particularly if the technology does not involve testing and approval of new pharmacological compounds and new manufacturing protocols.

Successful reconstruction of the musculoskeletal tissues of the face will be determined by our ability to build facial muscle and the craniofacial bone composite tissues. In this regard, regeneration of functionally-competent bone remains a very strong need.

Discussion Topic 4: Functional tissue interfaces and attachments
This topic was led by Dr. Sunita Ho (University of California, San Francisco)
The discussion primarily focused on the interfaces and attachments of the periodontal complex and the tooth. The clinical needs and functional endpoints were not fully addressed during the course of the discussion. The answer to “how good is good enough” question, compared to the current state of the art was not completely defined.

A number of interfaces exist in the tooth and periodontium, including periodontal ligament (PDL)-bone, PDL-cementum, enamel-dentin, and enamel-cementum. The PDL is an atypical ligament tissue, because unlike other ligaments, it is vascularized and innervated. The interface between the PDL and the other tissues is a dynamic and graded biological and biomechanical continuum. The sophisticated properties of these interfaces create significant challenges for their reconstruction. Also, additional challenges are related to their small sizes (100-150 microns), and to the requirement for this small space to withstand large loads from mastication.

Due to the complexity of the PDL, it is currently not known if and to what extent the PDL can regenerate on its own. Human disease-relevant large animal models are needed to address this question. Since PDL is a vascularized organ, it is possible that resolution of disease-related inflammation could induce endogenous regeneration. Important structural parameters of the PDL, which must be taken into consideration for regeneration include:

  • Highly organized and textured surface
  • Specific collagen fiber orientation
  • Gradient of elastic modulus provided by the variation in the extent of collagen crosslinking
  • Specific ratio of organic to inorganic components
  • Need for vascularization to provide access to nutrients and possibly regeneration
  • A minimal set of functional requirements for PDL regeneration may include:
  • Vasculature
  • Correct fiber orientation
  • Surface texture
  • Durable and flexible attachment to bone and cementum
General technologies for engineering PDL-like organ are available, but they need to be tuned for this specific application, such as downsizing for the small dimensions of the PDL. Natural biological materials could be useful for PDL engineering.

An additional question to consider is whether it would be useful to focus on creating PDL-like structures (pseudo-ligament) for dental implants to promote functional integration between implants and host tissues and to improve implant stability. Pseudo-ligament engineering has been attempted, and it might be a promising direction for moving forward.

Discussion Topic 5: Overview of translational opportunities and regulatory pathways
This topic was led by Drs. Jeffrey Karp (Harvard University) and Malcolm Moos (US Food and Drug Administration)
An important unmet clinical need in the dental and craniofacial field is the regeneration of high-quality vascularized bone for implant placement, alveolar ridge regeneration, and craniofacial bone regeneration. In many cases, it is not solely the amount of regenerated bone per se that matters; if the surrounding soft tissue cannot support bone maturation, survival and integration of the bone would be compromised. Thus bone regeneration should be treated as a composite system regeneration problem. Engineering of bone constructs in vitro followed by transplantation in vivo may not be a feasible goal within the next 5-10 years; however, in vivo bone regeneration approach (in vivo bioreactors) augmented by functionalized biomaterials, scaffolds, bioactive molecules and cells might be a more achievable goal in the short term. Improvement of bone/muscle flaps (discussed earlier in the workshop) might be a productive way to move forward.
Problems with translation of TE/RM technologies are not limited to the dental/craniofacial field. In fact, beyond the hematopoietic stem cell transplantation area, the promise of TE/RM technologies so far has not fully met expectations despite the fact that a number of clinical trials are now underway. 

The main obstacles for translation include:

  • Lack of control over cells and processes, particularly those in vivo. For example, delivery of cells to targeted sites in the body is inefficient, and cell survival post-delivery is generally poor. Thus better cell delivery protocols and cell tracking/imaging technologies should be developed. This issue is especially relevant to large animal and human applications. Many of the imaging technologies that work well in small-size animals are not ideal for large animals and humans because of the insufficient sensitivity and resolution of these technologies, probes and sensors.
  • Insufficient understanding and control over the cells’ secretome, i.e. over soluble biological mediators secreted by the cells in vivo. For example, it is thought that one of the therapeutic actions of MSCs is accomplished by their immunomodulatory effects on tissues, and that these effects are mediated by soluble molecules produced by these cells. However, because the composition and the biological action of the immunomodulatory MSC secretome is not fully understood, it is currently difficult to measure and exert tight control over the pleiotropic effects of MSCs in vivo.
  • Also with respect to cellular secretome, many cell potency and characterization assays are performed in vitro, yet the composition of the secretome and its downstream signaling are likely to undergo significant changes following transplantation of the cells in vivo, because these are highly influenced by the local tissue microenvironment. This situation motivates development of pre-clinical animal models to study longitudinal in vivo cell phenotypes and responses and well as improvement in cell tracking and imaging modalities. This effort will drive translational advances both in a short- and in a long- term.
  • Many of the imaging modalities suitable for animal studies are inappropriate for human applications, because of the safety and toxicity considerations; safe alternatives will be needed.
  • Development of consistent and standardized scaling up and manufacturing protocols for TE/RM products and biologics for large animal and human applications is needed. The issues of high costs of these technologies should be addressed. In this regard, simple technological solutions are preferred. Simple technologies would be also easier to regulate. In some cases, identifying the mechanisms of the regeneration process in the system to be translated could simplify the regulatory approval.
Often the margins of clinical benefit for TE/RM applications are not substantial or are not sufficiently understood to drive robust translation process; thus the investors are not willing to take risks of committing resources to therapies that have an uncertain future. As companies become more risk adverse, academics need to facilitate phase I/II trials, and form stronger links with orphan products regulatory markets and companies. Academics need to think more like a company: de-risk at every stage, think about a resulting “product”.

We need to create a list of the highest priority clinical problems that bioengineers and clinicians believe could be solved in a short-term, and prioritize these problems on the basis of the lowest hanging fruit where investment by NIH can be rapidly translated into clinical success. The considerations to be used in prioritizing this list include availability of relevant predictive animal models, an option of conducting of short definitive clinical trials with clear and recognized primary endpoints, and lack of current approaches to address the medical problem vis-à-vis an opportunity for TE/RM approach to offer a substantial benefit to justify additional investment.

Additional questions to consider: Are there new biology and technologies that are enablers, what are the most promising technologies available? What evidence should be considered as adequate proof of concept from pre-clinical models? How do we prioritize clinical needs? How do we rapidly advance clinical studies in academia?
FDA perspective. 

To enter into early phase clinical trials the following should be considered (not a complete list):

1. Evidence of proof of concept; data need to be very strong
2. The dose of cells to be tested in humans should be below the number of cells that form tumors in animal models
3. First in man clinical trials are inherently risky; the populations should be chosen carefully to balance risk with the prospect of benefit. Clinical design may need to allow for the detection of clinical benefit
4. Concept of “working backwards”: begin with thinking how to demonstrate therapeutic benefit of your technology, and then design the translational path from the pre-clinical research to the initiation and completion of the clinical trials to achieve your primary goal.

Summary of the Workshop
The discussions of the day were summarized by Dr. David Mooney
The panel reached a consensus that regeneration of functional vascularized bone and skeletal muscle would address clinical needs for many oral and craniofacial diseases and injuries. It was also concluded that in the short-term the emphasis should be placed on simpler goals. Specifically, TE/RM-based augmentation of viability, integration and durable function of bone and soft tissue flaps that are already being used in surgical practice today would be a realistic objective. Such technologies could reach clinical trials within the next 5-10 years. Cell-based TE/RM therapies should be viewed as a longer-term goal.

To realize translation it will be necessary to address a number important issues, depending on the specific strategy, including:

  •  Establishing clear metrics of success
  •  Developing human disease-relevant animal models
  • Scaling up and GMP-grade manufacturing of human-size volumes of tissue
  •  Standardizing protocols and quality management
  •  Conducting safety and toxicity studies
  •  Training of the interdisciplinary workforce
  •  Intellectual property issues
  •  Licensing, commercialization and reimbursement issues
  •  Building large collaborative teams that include clinicians and other professionals with expertise in conducting clinical trials
  •  Seeking clinical trials expertise early on in the research and development process
Some European models, such as AO Foundation might be a good example to follow: https://www.aofoundation.org/Structure/pages/newsdetail.aspx?newslist=h. For realizing TE/RM therapies for rare craniofacial diseases, orphan products regulatory pathway might be a viable path forward. Such small scale cases can later be expanded into a broader range of TE/RM-based applications.

In addition, it would be useful to create a database of high priority oral and craniofacial clinical problems. For each problem, this database should describe specific clinical needs, design criteria for clinical trials, available standardized animal models, etc. The database should also contain such information as the magnitude of the clinical problem, the number of people affected and the therapeutic market size. Professional and clinical societies should be able to help to define parameters of such database. Given that industry is risk averse, finding financial means to support the high costs of moving TE/RM therapies through clinical trials and commercialization pipeline is crucial for success. It might be necessary for the academics to conduct phase I/II clinical trials and to engage industry early in the process.

The panel agreed that a success in translating TE/RM technologies to clinic could be enhanced by strengthening a partnership between NIH and different TE/RM community stakeholders. Although NIH is already actively pursuing this goal, additional effort could accelerate translational pipeline. For example, NIH might consider expanding its support of phase I clinical trials, and it would be useful if NIH could help in engaging industry to work with the academics during pre-clinical and clinical stages of translation. Moreover, NIH mediation in building large translational teams by bringing together people who usually do not work together and directing them to solve specific clinically-focused problems would also benefit the overall effort.

Agenda of the meeting and slides attachments

July 21
7:30 pm-9:00 pm. Dinner and warm-up conversations

Bethesda Marriott Suites Restaurant
6711 Democracy Blvd., Bethesda, MD 20817
Participants will assemble and discuss preliminary ideas posted on Basecamp prior to the meeting.

July 22
Democracy I, Room 602
6701 Democracy Blvd., Bethesda, MD 20817

8:30 am. Welcome and introductions
Dr. Nadya Lumelsky, Program Director, NIDCR

8:45 am. Goals of the meeting
Dr. Martha Somerman, Director, NIDCR

9:00 am. Charge to the participants and discussion format
Dr. David Mooney, Harvard University

9:15 am. Discussion Topic 1: Tooth and Periodontium
Discussion leader: Dr. Paul Krebsbach, University of Michigan

10:00 am. Summary of Discussion Topic 1
Dr. Paul Krebsbach

10:10 am. Break

10:25 am. Discussion Topic 2: Craniofacial bone and osteochondral composites

Discussion leader: Dr. Gordana Vunjak-Novakovic, Columbia University

11:10 am. Summary of Discussion Topic 2
Dr. Gordana Vunjak-Novakovic

11:20 am. Discussion Topic 3: Musculoskeletal tissues of the face
Discussion leader: Dr. David Mooney

12:05 pm. Summary of Discussion Topic 3

Dr. David Mooney
Introduction MS.pdfTooth and Periodontium Slides.pdCraniofacial bone osteochondral compos Craniofacial Skeletal Muscle Slides.pdf

12:15 pm. Break

12:30 pm. Working lunch

Discussion Topic 4: Functional tissue interfaces and attachments

Discussion leader: Dr. Sunita Ho, University of California San Francisco

1:15 pm. Summary of Discussion Topic 4

Dr. Sunita Ho

1:25 pm. Discussion Topic 5: Overview of translational opportunities and regulatory pathways
Discussion leaders: Dr. Jeffrey Karp, Harvard University, and Dr. Malcolm Moos, US Food and Drug Administration

2:10 pm. Summary of Discussion Topic 5
Dr. Jeffrey Karp

2:20 pm. Break

2:30 pm. Meeting summary: discussion and ranking of short- and long- term translational research opportunities and priorities
Moderators: Co-chairs

3:30 pm. Concluding remarks
Dr. Martha Somerman

3:45 pm. Meeting Adjourn

Functional interfaces and attachment sitesTranslational opportunities and reg TE-RM Workshop Summary.pptx

Programmatic Consultation
“Translational Opportunities in Healing and Regeneration of
Oral and Craniofacial Tissues”

July 21-22, 2013

PARTICIPANT LIST

Jennifer Elisseeff, PhD
Johns Hopkins University
Department of Biomedical Engineering
5031 Smith Building, 400 N. Broadway
Baltimore, MD 21231
Phone: (410) 614-6837
Email: jhe@bme.jhu.edu

William Giannobile, DDS, DMSc*
University of Michigan
Department of Periodontic & Oral Medicine
1011 N. University Ave, Rm #3397
Ann Arbor, MI 48109
Phone: (734) 763-2105
Email: wgiannob@umich.edu

Linda Griffith, PhD
Massachusetts Institute of Technology
Department of Biological Engineering
MIT 16-429, 77 Massachusetts Ave.
Cambridge, MA 2139
Phone: (617) 253-0013
Email: griff@mit.edu

Farshid Guilak, PhD
Duke University Medical Center
Biomedical Engineering Department
375 MSRB, Box 3093
Durham, NC 27708
Phone: (919) 684-2521
Email: guilak@duke.edu

Sunita Ho, PhD
University of California, San Francisco
Department of Preventive & Restorative Dental Sciences
707 Parnassus Ave
San Francisco, CA 94143
Phone: (415) 514-2818
Email: Sunita.Ho@ucsf.edu

David Kaplan, PhD
Tufts University
Department of Biomedical Engineering
Science & Technology Center, Room 251
Medford, MA 2155
Phone: (617) 627-3251
Email: david.kaplan@tufts.edu

Jeffrey Karp, PhD
Brigham & Women's Hospital
Department of Medicine
75 Francis Street
Boston, MA 2115
Phone: (617) 817-9174
Email: jeffkarp@mit.edu

Paul Krebsbach, DDS, PhD
University of Michigan
School of Dentistry
1011 N. University
Ann Arbor, MI 48109
Phone: (734) 936-2600
Email: paulk@umich.edu

Wendy Liu, PhD
University of California, Irvine
Department of Biomedical Engineering
The Henry Samueli School of Engineering
Irvine, CA 92697
Phone: (949) 824-1682
Email: wendy.liu@uci.edu

Michael Longaker, MD*
Stanford University
Institute for Stem Cell Biology and Regenerative Medicine
257 Campus Drive, Room GK106
Stanford, CA 94305
Phone: (650) 736-1707
Email: longaker@stanford.edu

Phil Messersmith, PhD
Northwestern University
Department of Materials Science and Engineering
2170 Campus Drive, Silverman Hall 4627
Evanston, IL 60208
Phone: (847) 467-5273
Email: philm@northwestern.edu

David Mooney, PhD
Harvard University
School of Engineering and Applied Sciences
40 Oxford Street; Pierce Hall 319
Cambridge, MA 2138
Phone: (617) 384-9624
Email: mooneyd@seas.harvard.edu

Malcolm Moos, MD, PhD
US Food and Drug Administration
Center for Biologics Evaluation and Research
1401 Rockville Pike, HFM-730
Rockville, MD 20852
Phone: (301) 827-0683
Email: malcolm.moos@fda.hhs.gov

Gordana Vunjak-Novakovic, PhD
Columbia University
Department of Biomedical Engineering
622 West 168th Street
New York, NY 10032
Phone: (212) 305-4692
Email: gv2131@columbia.edu
* Phone participants


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This page last updated: March 18, 2016