2022 Fall Focused Symposium: Session 1

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2022 Fall Focused Symposium: Accelerating Translation of Tissue Engineering and Regenerative Medicine Technologies in the Dental, Oral, and Craniofacial Space
There have been significant strides in research in regenerative approaches to the repair and restoration of dental, oral, and craniofacial (DOC) tissues, ranging from bone graft materials to regenerative endodontics to temporomandibular joint repair. Yet few regenerative medicine therapies in the DOC space have been commercialized and widely adopted clinically. Difficulties in translation are related to scientific as well as non-scientific challenges. This symposium will highlight innovative tissue engineering/ regenerative medicine research in the DOC space, as well as layout the roadmap for overcoming challenges and translating technologies to the marketplace.

Learning Objectives

Attendees will increase their knowledge of cutting-edge regenerative medicine approaches to a variety of clinical challenges in the DOC space.
Attendees will increase their understanding of the technology commercialization pathway, from academic research to clinical trials to commercialization and beyond, including regulatory requirements and market development.
Attendees will be provided with an armamentarium of tools to approach translation of tissue engineering/ regenerative medicine research to the marketplace and beyond.

Time (EST)	Presentation
11:00 a.m.	Welcome + Introduction Jaques Nör, Donald A. Kerr Endowed Professor of Dentistry and Chair of the Department of Cariology, Restorative Sciences and Endodontics, University of Michigan School of Dentistry, Immediate Past President, AADOCR
11:10 a.m.	Intro to DOCTRC Initiative/ ITP Program/ Translation of Technologies to the Marketplace and Beyond Tanya Hoodbhoy, Director, Tissue Engineering and Regenerative Medicine Program Tissue Engineering & Regenerative Medicine Research Program NIH/NIDCR.
11:20 a.m.	Core 1. Market Assessment/ Development (Core) Francine Berkey, President, The Avenues Company
11:40 a.m.	Core 2. Regulatory (Core) Kay Fuller, RAC, President and Founder at Medical Device Regulatory Solutions, LLC
12:00 p.m.	Core 3. QAQC (Core) Shawn Bengston, Director, Quality Assurance, Quality Management Systems, McGowan Institute for Regenerative Medicine, University of Pittsburgh School of Dental Medicine Mike Jamieson, Director, Core Resources Center for Dental, Oral, & Craniofacial Tissue & Organ Regeneration (C DOCTOR) University of Southern California
12:20 p.m.	ITP 1. Regeneration of Bone (ITP) Yang Chai, University Professor George and MaryLou Boone Chair in Craniofacial Molecular Biology Director, Center for Craniofacial Molecular Biology Associate Dean of Research Ostrow School of Dentistry University of Southern California.
12:40 p.m.	ITP 2. Regeneration of Dentine-pulp (ITP) Luiz Bertassoni, Assistant Professor, School of Dentistry Knight Cancer Biology Program, Oregon Health & Sciences University Pamela Yelick, Professor, Orthodontics Director of the Division of Craniofacial and Molecular Genetics, Orthodontics Tufts University School of Dental Medicine
1:00 p.m.	Break
2:00 p.m.	Join Session 2 at https://www.pathlms.com/iadr/courses/45100/webinars/31013

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2022 Fall Focused Symposium: Session 1

Attendees will increase their knowledge of cutting-edge regenerative medicine approaches to a variety of clinical challenges in the DOC space.
Attendees will increase their understanding of the technology commercialization pathway, from academic research to clinical trials to commercialization and beyond, including regulatory requirements and market development.
Attendees will be provided with an armamentarium of tools to approach translation of tissue engineering/ regenerative medicine research to the marketplace and beyond.

Time (EST)	Presentation
11:00 a.m.	Welcome + Introduction Jaques Nör, Donald A. Kerr Endowed Professor of Dentistry and Chair of the Department of Cariology, Restorative Sciences and Endodontics, University of Michigan School of Dentistry, Immediate Past President, AADOCR
11:10 a.m.	Intro to DOCTRC Initiative/ ITP Program/ Translation of Technologies to the Marketplace and Beyond Lillian Shum, Director, Division of Extramural Research NIH/NIDCR
11:20 a.m.	Market Assessment/ Development (Core) Francine Berkey, President, The Avenues Company
11:40 a.m.	Regulatory (Core) Jeanne Wright, Pogram Director, University of Michigan IND/IDE Investigator Assistance Program (MIAP), Michigan Institute for Clinical and Health Research (MICHR).
12:00 p.m.	Quality Assurance (Core) Shawn Bengtson, Director, Quality Assurance, Quality Management Systems, McGowan Institute for Regenerative Medicine, University of Pittsburgh School of Dental Medicine Mike Jamieson, Director, Core Resources Center for Dental, Oral, & Craniofacial Tissue & Organ Regeneration (C DOCTOR) University of Southern California
12:20 p.m.	Regeneration of Soft Tissues (skin, muscles, salivary glands, mucosa, etc.) Sarah Knox, Professor Department of Cell & Tissue Biology, UCSF School of Dentistry Chelsea Bahney, Principal Investigator and Program Director/Bone Repair and Skeletal Engineering, The Steadman Clinic & Steadman Philippon Research Institute)
12:40 p.m.	Regeneration of Dentine-pulp (ITP) Pamela Yelick, Professor, Orthodontics Director of the Division of Craniofacial and Molecular Genetics, Orthodontics Tufts University School of Dental Medicine
1:00 p.m.	Break
2:00 p.m.	Join Session 2 at https://www.pathlms.com/iadr/courses/45100/webinars/31013

Contributors

Jacques Nör

Email
Jacques is the Donald Kerr Collegiate Professor of Dentistry and has served as Chair of the Department of Cariology, Restorative Sciences and Endodontics at the University of Michigan School of Dentistry since 2015. He has joint appointments as Professor of Otolaryngology (Medical School) and Professor of Biomedical Engineering (College of Engineering) at the University of Michigan. He is the current President of the American Association for Dental, Oral and Craniofacial Research (AADOCR). Jacques has served as Chair of the Oral Dental and Craniofacial Sciences (ODCS) NIH study section and is a member of the National Advisory Dental and Craniofacial Research Council (NADRC). He has published 215 peer-reviewed papers, 15 book chapters, and has been funded by the NIH since 2002. He has served as the Co-Director of the University of Michigan Head Neck SPORE. Jacques is a Fellow and past-Chair of the Section on Dentistry & Oral Health Sciences of the American Association for the Advancement of Sciences (AAAS), and recently became Fellow of the American Association for Dental Research (AADR). He received the Distinguished Scientist Award, the William J. Gies Award, and the Hatton Award from the International Association for Dental Research (IADR). Jacques is Associate Editor of the Journal of Dental Research and a member of several editorial boards. His research interests are in the study of the pathobiology of cancer stem cells in head neck squamous cell carcinoma and salivary gland cancer, as well the studies of mechanisms regulating dental pulp stem cell fate.
Francine Berkey

Director, Tissue Engineering and Regenerative Medicine Program, Tissue Engineering & Regenerative Medicine Research Program, NIH/NIDCR
Email

Francine is the President of The Avenues Company which provides a variety of professional services to clients primarily in dental, oral and craniofacial indications. Avenues has been working in the DOC space for almost 25 years and has engaged with companies developing and commercializing technologies and products in both diagnostics and therapeutics The Company has been intimately involved with the translation of many DOC products from early development through clinical studies and ultimately to clinical adoption. Avenues has also helped to develop and organize many scientific and clinical programs sponsored by major professional organizations representing dental and oral care specialists including the American Academy of Periodontology and the Academy of Osseointegration. Before co-founding Avenues, Francine worked with Interleukin Genetics on the first genetic susceptibility test for periodontal disease and was a part of the team at W.L. Gore and Associates Gore Regenerative Technologies that brought regenerative therapies to the periodontal and OMS specialties. She holds both a Master of Arts degree in Communication from the University of Wyoming and a PhD in Communication from the University of Utah.
Shawn Bengtson

Director, Quality Assurance, Quality Management Systems, McGowan Institute for Regenerative Medicine, University of Pittsburgh School of Dental Medicine
Email

Shawn Bengtson, RQAP-GLP joined the University of Pittsburgh's McGowan Institute in October 2001 following a 14-year career at the National Aeronautics and Space Administration (NASA).
In 2006, Shawn assumed the responsibilities as the Quality Systems Manager, leading to the implementation of a Quality Systems Program using the FDA GLPs as a reference standard for the MIRM Center Preclinical Studies.
In his current this role as Director of Quality Assurance and Quality Systems, Shawn Bengtson and his colleague Nika Hazen serve as the Quality Assurance Unit for Pitt Departments such as the Department of Virology- Infectious Disease Laboratories (GCLP), Center for Vaccine Research within Pitt’s Regional Biocontainment Laboratory (FDA Animal Efficacy Rule)
As the Quality Assurance Advisory Core for the Michigan-Pitt-Wyss RM Resource Center, Shawn and Nika provide a variety of support including regulated study planning and advisement, supplier assessment and qualification of CROs (FDA GLP) and ITP QA representation as study monitors.
Shawn Bengtson serves on the Pitt Clinical Trial Data Safety Monitoring Board (DSMB) is a voting member of the Pitt IACUC, Vice-Chair for GLP Exam Committee responsible for exam development for Quality Assurance Professional registration. Shawn has been an active member in a variety of leadership roles for the Society for Quality Assurance, a global organization for quality assurance professionals supporting the regulated industry.
Mike Jamieson

Director, Core Resources Center for Dental, Oral, & Craniofacial Tissue & Organ Regeneration (C DOCTOR) University of Southern California
Email

Dr. Michael Jamieson spent twelve years at the University of Southern California where he was the Associate Director of the International Center for Regulatory Sciences and an Assistant Professor in the Department of Regulatory and Quality Sciences. His research interests include the regulatory/translational/quality training and support of university-based researchers and the development of a new model for maximizing the efficiency of translating academic research and for conducting joint research projects between industry, not for profits and universities. He is currently the Core Resource Director and a member of the Internal Leadership Council for the NIDCR funded Center for Dental, Oral, & Craniofacial Tissue & Organ Regeneration (C-DOCTOR). C-DOCTOR represents a public-private partnership with the primary mission of providing comprehensive clinical, scientific, technical, regulatory, financial, and management resources to academic researchers to develop a model for the cost-effective transition and timely development of academic based research projects.
Yang Chai

University Professor, George and MaryLou Boone Chair in Craniofacial Molecular Biology; Director, Center for Craniofacial Molecular Biology; Associate Dean of Research, Ostrow School of Dentistry, University of Southern California
Email

Dr. Yang Chai is the University Professor and the George and MaryLou Boone Chair in Craniofacial Biology at the University of Southern California. He serves as the Director of the Center for Craniofacial Molecular Biology (CCMB) and Associate Dean of Research at the Herman Ostrow School of Dentistry of USC. Dr. Chai earned a DMD degree from Peking University School of Stomatology as well as DDS and PhD in Craniofacial Biology from the University of Southern California. He is most noted for his research on craniofacial development and birth defects, which has transformed the field and led to the successful rescue of cleft palate in mouse embryos. He also studies stem cells and is currently using innovative 3D-printed scaffolds seeded with stem cells to regenerate tissue for patients who have lost bone due to trauma, congenital defects, or disease.
Dr. Chai is a member of the National Academy of Medicine. He is an elected member of the American Academy of Arts and Sciences (AAAS). Dr. Chai has authored more than 160 scientific papers and numerous book chapters, and recently edited a book on craniofacial development. Dr. Chai has been continuously funded by the National Institute of Health for more than 25 years. His work has earned him multiple awards including the NIH MERIT award and the 2011 IADR (International Association of Dental Research) Distinguished Scientist Award.
Jeanne Wright

Email
Program Director, University of Michigan IND/IDE Investigator Assistance Program (MIAP), Michigan Institute for Clinical and Health Research (MICHR).

Jeanne Wright has been at the University of Michigan (UM) for over 15 years. Prior to this, she was working as a Research Nurse at Pfizer Global Research and Development in the Phase 1 Clinical Research Unit. After Pfizer, she came to UM as a Research Compliance Specialist at the Institutional Review Board (IRB), specializing in FDA regulated research. For the past 12 years, she has been working with the MICHR IND/IDE Investigator Assistance Team (MIAP) and has been the Program Director since 2018. MIAP provides regulatory consultations and assistance to all UM faculty with their research involving drugs, devices, and biologics, including preparation and submission of FDA meeting requests, and IND and IDE applications.
Lillian Shum

National Institutes of Health
Bethesda Maryland United States
Email

Dr. Shum is Director of the Division of Extramural Research at the National Institute of Dental and Craniofacial Research (NIDCR), National Institutes of Health (NIH). She provides leadership and guidance for the planning, development, implementation, and evaluation of NIDCR extramural research portfolio encompassing diverse areas in dental, oral, and craniofacial sciences. The goal is to support research to capture the most promising discoveries and emerging technologies for rapid translation to clinical applications for improving the health of all people.

Dr. Shum has been with NIH for 27 years and represents NIDCR on trans-NIH and interagency working groups, such as the NIH Common Fund’s High Risk-High Rewards Program, 21st Century Cures Regenerative Medicine Innovation Project, All of Us Research Program, and Coordinating Committee on Research on Women’s Health. Dr. Shum earned her PhD degree from the University of North Carolina Chapel Hill, completed postdoctoral training at the Center for Craniofacial Molecular Biology at the University of Southern California and at the University of California San Francisco School of Dentistry, and conducted research in the NIH intramural program on craniofacial skeletal development, before she joined that extramural program in 2003. She has led the Division of Extramural Research since 2014.
Pamela Yelick

Professor, Orthodontics, Director of the Division of Craniofacial and Molecular Genetics, Orthodontics, Tufts University School of Dental Medicine
Email

Dr. Pamela C. Yelick, PhD, is a tenured full professor in the Department of Orthodontics at the Tufts University School of Dental Medicine where she Directs the Division of Craniofacial and Molecular Genetics, and also is Director of the Genetics Program, Tufts University Graduate School of Biomedical Sciences. Pam is an internationally recognized leader in dental tissue engineering and craniofacial development, with ~100 peer-reviewed basic research publications, more than a dozen reviews, and over 300 abstracts since the year 2000. She has received national and international acclaim for her research on dental tissue and whole tooth tissue engineering and has participated in over 200 Invited Speaker Lectureships. Dr. Yelick is the Cofounder and Chief Scientific Officer of RegendoDent Inc., along with cofounder Luiz Bertassoni, Chief Medical Officer, Scott Olson, President and Chief Executive Officer, and Anissa Bartolome Project Manager. Their product, RegendoGel, revitalizes teeth by inducing the regeneration of natural dental pulp and dentin.
Sarah Knox

Professor, Department of Cell & Tissue Biology, UCSF School of Dentistry
Email
Chelsea Bahney

Principal Investigator and Program Director/Bone Repair and Skeletal Engineering, The Steadman Clinic & Steadman Philippon Research Institute)
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Description

Contributors

Jacques Nör

Francine Berkey

Shawn Bengtson

Mike Jamieson

Yang Chai

​Jeanne Wright

Lillian Shum

Pamela Yelick

Sarah Knox

Chelsea Bahney

Jeanne Wright