RME Course Instructors
North Florida Integrative Medicine
Dr. Angeli Maun Akey, MD, FACP, ABIHM/ABOIM, IFMCP is board-certified in Internal Medicine and Integrative and Holistic Medicine, and trained in Functional and Regenerative Medicine. She has been in clinical practice for thirty years. Dr. Akey is the founding medical director of North Florida Integrative Medicine, Ageless Medical Solutions, the former Palm Beach Institute of Preventive Medicine, and co-founder of FIRRIMup™ Doctors. Her interests in other healing traditions have led her to previously teach at the Florida School of Acupuncture and Oriental Medicine. She now specializes in both the detection of chronic disease at its earliest stage, and in the slowing or reversal of its progression.
Her undergraduate experience was at the University of Florida, where she was accepted on a music and five academic scholarships. She was subsequently the youngest person ever
admitted to the University of Florida College of Medicine in the Junior Honors Medical Program. She taught as Assistant Clinical Professor at Yale University where she did her internal medicine residency and served as a Chief Resident. She precepts medical students and teaches them the FIRRIMup™ approach to navigating and solving complex medical problems. She is the author of the book, Fine-Tune Your Hormone Symphony (2011) which describes the FIRRIMup™ model in detail and teaches online at FIRRIMupDoctors.com. She has co-authored the books, Kick Covid-19 to the Curb (2020) and Fine-Tune Your Immune System (2021). She is the co-editor of the highly acclaimed Fascia, Function, and Medical Applications, the first textbook on fascia geared toward medical doctors.
Dr. Akey is a sought-after national and international speaker at medical conferences where she has taught and presented using this model in conferences across the US, and internationally in the Caribbean, Brazil, Poland, Spain, France, and Italy. Currently, Dr. Akey serves as an Editor-in-Chief of the Integrative Medicine section of PubMed’s StatPearls. She is the co-founder of the American Academy of Regenology. She and Dr. O'Neil-Smith have a passion to educate in the FIRRIMup™ Model and have partnered with their company FIRRIMupDoctors.com for telemedicine consults, publishing, and web-based teaching directed to both consumers and physicians. She resides with her husband and sons in her hometown of Gainesville, Florida, USA.
Dr. Angeli Maun Akey, MD, FACP, ABIHM/ABOIM, IFMCP is board-certified in Internal Medicine and Integrative and Holistic Medicine, and trained in Functional and Regenerative Medicine. She has been in clinical practice for thirty years. Dr. Akey is the founding medical director of North Florida Integrative Medicine, Ageless Medical Solutions, the former Palm Beach Institute of Preventive Medicine, and co-founder of FIRRIMup™ Doctors. Her interests in other healing traditions have led her to previously teach at the Florida School of Acupuncture and Oriental Medicine. She now specializes in both the detection of chronic disease at its earliest stage, and in the slowing or reversal of its progression.
Her undergraduate experience was at the University of Florida, where she was accepted on a music and five academic scholarships. She was subsequently the youngest person ever
admitted to the University of Florida College of Medicine in the Junior Honors Medical Program. She taught as Assistant Clinical Professor at Yale University where she did her internal medicine residency and served as a Chief Resident. She precepts medical students and teaches them the FIRRIMup™ approach to navigating and solving complex medical problems. She is the author of the book, Fine-Tune Your Hormone Symphony (2011) which describes the FIRRIMup™ model in detail and teaches online at FIRRIMupDoctors.com. She has co-authored the books, Kick Covid-19 to the Curb (2020) and Fine-Tune Your Immune System (2021). She is the co-editor of the highly acclaimed Fascia, Function, and Medical Applications, the first textbook on fascia geared toward medical doctors.
Dr. Akey is a sought-after national and international speaker at medical conferences where she has taught and presented using this model in conferences across the US, and internationally in the Caribbean, Brazil, Poland, Spain, France, and Italy. Currently, Dr. Akey serves as an Editor-in-Chief of the Integrative Medicine section of PubMed’s StatPearls. She is the co-founder of the American Academy of Regenology. She and Dr. O'Neil-Smith have a passion to educate in the FIRRIMup™ Model and have partnered with their company FIRRIMupDoctors.com for telemedicine consults, publishing, and web-based teaching directed to both consumers and physicians. She resides with her husband and sons in her hometown of Gainesville, Florida, USA.
CSO, Phase Holographic Imaging (PHI), Lund, Sweden
Digital holographic imaging has existed as a brainchild since the '70s. Now, it is a reality since computers became powerful enough to handle the algorithms required to reconstruct the hologram of an imaged object – or even living cell cultures. PHI has proudly been part of this development and today advances cutting-edge research by applying digital holography to cell-based science.
Dr. Alm has cooperated with PHI since 2005 and is a vital part of the PHI team since 2009. All insights gained through her PhD studies at Lund University, Sweden, her postdoc time at Roswell Park, Buffalo, NY, and the years after that working as a researcher and lecturer at Lund University, have been applied in the development of a genuinely novel cell analysis system. Her focus has been to develop a method that will neither cause cell stress nor harm while also providing accurate kinetic data. This goal has been reached both through in-house studies and collaborations as well as joint publications with researchers around the world, e.g., at Malmö and Lund universities, Northeastern University in Boston, UCSF in California, and many more. In cooperation with other members of the Regenerative Manufacturing Consortium and the Testbed Accelerator in Winston Salem, Digital holography is currently being developed for a future in smart manufacturing of stem cells. Dr Alm aims to introduce digital holographic microscopy measurements as a standard for non-invasive cell quality control.
Director, Wake Forest Institute for Regenerative Medicine
Anthony Atala, MD, is the G. Link Professor and Director of the Wake Forest Institute for Regenerative Medicine, and the W. Boyce Professor and Chair of the Department of Urology at Wake Forest University. His work focuses on growing human cells, tissues and organs. Fifteen applications of technologies developed in Dr. Atala's laboratory have been used clinically in human patients.
Dr. Atala was elected to the Institute of Medicine of the National Academies of Sciences (now the National Academy of Medicine), to the National Academy of Inventors as a Charter Fellow, and to the American Institute for Medical and Biological Engineering. Dr. Atala is a recipient of the US Congress funded Christopher Columbus Foundation Award, bestowed on a living American who is currently working on a discovery that will significantly affect society; the World Technology Award in Health and Medicine, for achieving significant and lasting progress; the Edison Science/Medical Award; the Fast Company World Changing Ideas Award; the R&D Innovator of the Year Award; and the Smithsonian Ingenuity Award.
Dr. Atala’s work was listed twice as Time Magazine’s top 10 medical breakthroughs of the year, and as one of 5 discoveries that will change the future of organ transplants. Dr. Atala’s work was ranked in 2019 by the Project Management Institute as one of the top 10 most impactful biotech projects from the past 50 years. Dr. Atala was named by Scientific American as one of the world’s most influential people in biotechnology, by U.S. News & World Report as one of 14 Pioneers of Medical Progress in the 21st Century, by Life Sciences Intellectual Property Review as one of 50 key influencers in the life sciences intellectual property arena, and by Nature Biotechnology as one of the top 10 translational researchers in the world.
Dr. Atala has led or served several national professional and government committees, including the National Institutes of Health working group on Cells and Developmental Biology, the National Institutes of Health Bioengineering Consortium, and the National Cancer Institute’s Advisory Board. He was a Founder of the Tissue Engineering Society, the Regenerative Medicine Society, the Regenerative Medicine Foundation, the Alliance for Regenerative Medicine, the Regenerative Medicine Development Organization, the Regenerative Medicine Manufacturing Society, and the Regenerative Medicine Manufacturing Consortium.
Dr. Atala works with several journals and serves in various roles, including Editor-in-Chief of: Stem Cells Translational Medicine; Therapeutic Advances in Urology; and BioPrinting. He is the editor of 25 books, has published more than 800 journal articles and has applied for or received over 250 national and international patents.
Associate Professor, Wake Forest Institute for Regenerative Medicine
Graca Almeida-Porada, MD, PhD, is a Professor of Regenerative Medicine and the Director of the Fetal Research and Therapy Program at Wake Forest Institute for Regenerative Medicine. Dr. Almeida-Porada’s research focuses on the development of cellular and gene delivery platforms to treat genetic and immune-mediated diseases. She is particularly interested in improving the outcome of stem cell transplantation and gene therapy in fetal and neonatal patients with genetic disorders, and in developing therapies for children with immune-mediated diseases.
She has been a member of several NIH study sections, she serves as an Editor, or on the Editorial Boards, of several scientific journals, she is the co-editor-in-chief of Current Stem Cell Reports. She was inducted into Phi Beta Delta in 2006. She is the co-founder of the International Fetal Transplantation and Immunology Society. Dr. Almeida-Porada holds several patents and has authored more than 200 scientific works including papers, abstracts, and book chapters.
Chief Regulatory Science Affairs Program Officer, WFIRM
Before joining WFIRM, Dr. Bauer was Chief of the Cellular and Tissue Therapies Branch in the Division of Cellular and Gene Therapies, in the Office of Tissues and Advanced Therapies (OTAT) at the Center for Biologics Evaluation and Research (CBER), U.S. Food and Drug Administration (FDA). Dr. Bauer has three decades of experience in regulatory science research, regulatory oversight, and policy development for regenerative medicine product development. Dr. Bauer was a member of FDA’s Senior Biomedical Research and Biomedical Product Assessment Service (SBRBPAS). As the Chief of CTTB, Dr. Bauer supervised CBER scientific staff engaged in review of cell- and gene-based biological therapies, policy development in emerging areas of cellular therapies, and research relevant to their use in clinical trials. Dr. Bauer has extensive regulatory experience with review of hundreds of regulatory submissions from all phases of product development from IND to BLAs including many novel cell, gene and tissue engineering applications. Dr. Bauer also headed FDA’s multipotent stromal cell (MSC) research consortium that published over twenty papers illustrating challenges and improvement strategies for characterization of complex MSC-based cellular and tissue engineering products. Dr. Bauer received his Ph.D. in Biochemistry from the University of Maryland in 1986. From 1986 through 1991, Dr. Bauer was a scientific member of the Basel Institute for Immunology in Basel, Switzerland. His research interests include development of strategies to improve characterization of stem-cell based therapies and to enhance our understanding of how manufacturing of regenerative medicine products influences the biological properties of these complex and heterogenous products.
Program Director, Division of Undergraduate Education (DUE), National Science Foundation (NSF)
V. Celeste Carter received her Ph.D. in Microbiology from the Pennsylvania State University School of Medicine. She completed postdoctoral studies at the University of California at Berkeley. She joined the Division of Biological and Health Sciences at Foothill College to develop and head both Biotechnology and Bioinformatics Programs.
She served as a Program Director twice in the Division of Undergraduate Education (DUE) at the National Science Foundation (NSF) as a rotator. Dr. Carter accepted a permanent program director position in DUE in 2009; she is the Lead Program Director for the Advanced Technological Education (ATE) Program in DUE. Dr. Carter also works on other programs in DUE and NSF, and she serves on federal interagency working groups.
V. Celeste Carter received her Ph.D. in Microbiology from the Pennsylvania State University School of Medicine. She completed postdoctoral studies at the University of California at Berkeley. She joined the Division of Biological and Health Sciences at Foothill College to develop and head both Biotechnology and Bioinformatics Programs.
She served as a Program Director twice in the Division of Undergraduate Education (DUE) at the National Science Foundation (NSF) as a rotator. Dr. Carter accepted a permanent program director position in DUE in 2009; she is the Lead Program Director for the Advanced Technological Education (ATE) Program in DUE. Dr. Carter also works on other programs in DUE and NSF, and she serves on federal interagency working groups.
Senior Director of Research
Mallinckrodt Pharmaceuticals
Dr. Allen Comer is a Senior Director of Research at Mallinckrodt Pharmaceuticals. In this role, he leads the company’s research and development efforts for its pipeline products, including StrataGraft®. Dr. Comer also serves as Principal Investigator of the company’s Biomedical Advanced Research and Development Authority (BARDA) contract, which supports the late-stage development of StrataGraft.
Dr. Comer has been involved in the development of StrataGraft since 2000, holding positions of increasing responsibility in the areas of research and development, quality control, and clinical development. Prior to joining Stratatech Corporation, Dr. Comer led a series of research and development and drug discovery programs in both academia and industry.
Dr. Comer received his B.S. in Biological Sciences (Biochemistry) at North Carolina State University in Raleigh, N.C. He received his Ph.D. in Genetics at the University of North Carolina at Chapel Hill in Chapel Hill, N.C. and his fellowship in molecular genetics at the University of Wisconsin in Madison, Wis. Dr. Comer’s research has been featured in 14 publications.
Vice President, Therapeutics Development
Abla Creasey is the CIRM Vice President of Therapeutics Development. In this capacity, she leads all programs in Translational and Clinical development, with a focus on advancing these therapies to marketing approval. Abla has been instrumental in building and managing CIRM'S clinical portfolio of diverse therapeutic areas including oncology, neurology, ophthalmology, and others. She has led the CIRM Therapeutics Team since 2018 and delivered on a key strategic goal to identify, recruit, and develop fifty innovative clinical stage projects and manage them to success. Ten of the current 70 FDA approved and in the public domain projects with Regenerative Medicine Advanced Therapies Designation are among the Therapeutics grants portfolio. Abla also oversees Translation, Clinical and Marketing Approval Advisory Panels that work with grantees on all aspects of product development including preclinical, clinical, regulatory, manufacturing, project management, and strategic topics.
Abla has extensive experience in research and development, including clinical trial strategy and operations, as well as biologics process development & manufacturing, regulatory, and overall strategic product development. Prior to joining CIRM in 2016, she was at Johnson & Johnson for 12 years. While there, Abla held multiple senior level positions, including Senior Scientific Director in Pharmaceutical Development & Manufacturing Sciences (PDMS) at Janssen Therapeutics. Prior to that, she was an Executive Director, heading drug delivery, pharmacology, analytical characterization, clinical & quality at Advanced Technologies & Regenerative Medicine (ATRM), another J&J company. Prior to ATRM, Abla was Vice President of Biological Sciences at ALZA Corporation, where she headed discovery efforts in formulation, preclinical and oral drug delivery. Before joining ALZA in 2004, Abla held senior level positions in R&D, clinical development, and regulatory affairs within the biotechnology industry, including Chiron Corporation and Cetus Corporation. Abla received in 2008 the Ellis Island Medal of Honor for her biotechnology contributions. She served on the Mills College Board, Oakland, Ca, and the Dean of UC Berkeley School of Public Health Advisory Board. She has 23 patents and authored over 50 publications.
Abla received a B.S. in biology from the College of Notre Dame in Belmont, California, and earned her Ph.D. in medical microbiology from the University of California, Berkeley. She completed a post-doctoral fellowship at the Stanford University School of Medicine in infectious disease, biochemistry, and immunology.
Associate Professor, Wake Forest Institute for Regenerative Medicine
Dr. Tracy Criswell is currently an Associate Professor at the Wake Forest Institute for Regenerative Medicine. She received her Bachelor’s of Science degree in Biology from the University of Cincinnati in 1998 (Magna Cum Laude) and her PhD in Cellular and Molecular Biology from Case Western Reserve University in 2004. Her thesis work focused on identifying the cellular effects of low dose ionizing radiation exposure on breast cancer. After the completion of her PhD, Dr. Criswell joined the laboratory of Dr. Carlos Arteaga at Vanderbilt University where her research focused on the role of TGFβ signaling in breast cancer metastases. In 2009, she joined the Wake Forest Institute for Regenerative Medicine as a senior research fellow and was subsequently promoted to a faculty position in 2012. In addition to WFIRM, Dr. Criswell has cross appointments in Integrative Physiology and Pharmacology, Molecular Medicine and Translational Science and the Virginia Tech-Wake Forest University School of Biomedical Engineering and Science. She currently serves as a liaison for Women in Medicine and Science (WIMS), serves on the Wake Forest Graduate School Council and is Co-Chair of the WFGS Committee on Race and Equity. She is actively involved in curriculum development at WFIRM, and is a mentor for high school, undergraduate and graduate student trainees.
John W. Strohbehn Distinguished Professor
Departments of Biomedical Engineering & Surgery
Director, Center for Advanced Genomic Technologies
Director, Center for Biomolecular and Tissue Engineering
Duke University
Dr. Charles A. Gersbach is the John W. Strohbehn Distinguished Professor of Biomedical Engineering at Duke University, the Director of the Duke Center for Biomolecular and Tissue Engineering, and the Director of the Duke Center for Advanced Genomic Technologies. His research interests are in genome and epigenome editing, gene therapy, regenerative medicine, biomolecular and cellular engineering, synthetic biology, and genomics. His work has led to new approaches to study genome structure and function, program cell biology, and treat genetic disease. Dr. Gersbach's work has been recognized through awards including the NIH Director's New Innovator Award, the NSF CAREER Award, the Outstanding New Investigator Award from the American Society of Gene and Cell Therapy, and induction as a Fellow of the American Institute for Medical and Biological Engineering and member of the National Academy of Inventors. He is also the co-founder of three biotechnology companies and an advisor to several others.
Assistant Professor and Chief Workforce Development Officer, Wake Forest Institute for Regenerative Medicine
Dr. Gary Green is assistant professor and chief workforce development officer for the Wake Forest Institute for Regenerative Medicine and chief workforce development officer for the RegenMed Development Organization. His academic interests include education and workforce development for regenerative medicine and related convergent technologies. Prior to joining WFIRM, Green was president of Forsyth Technical Community College in Winston-Salem, NC, a regional and national leader in biotechnology education. The National Center for the Biotechnology Workforce was established there under his leadership and he hosted visits to the College's biotechnology program by Presidents George W. Bush and Barack Obama. He has presented on bioscience workforce development regionally, nationally, and internationally, including White House, Department of Labor, US-EU, APEC, and US-Canada workforce conferences. Green has appeared on CNN, C-SPAN, and NPR addressing education and workforce development issues. He is an affiliate graduate faculty member at the Belk Center for Community College Leadership and Research at North Carolina State University and is co-chair of the National Industry Advisory and Leadership Council of InnovATEBio: The National Biotechnology Education Center. He also serves on the advisory board of the National Center for the Biotechnology Workforce and the board of directors of Higher Ed Works, a North Carolina educational advocacy organization. Green received his BA, MA and EdD degrees from the University of Kentucky.
Patsy and Alan Dorris Chair in Pediatric Technology, Associate Chair for Translational Research & Professor, Wallace A. Coulter Department of Biomedical Engineering; Director, Center for 3D Medical Fabrication; Director, Tissue Engineering & Mechanics Laboratory, Georgia Institute of Technology and Emory University
Dr. Hollister is the Patsy and Alan Dorris Chair in Pediatric Technology and Professor of Biomedical Engineering at the Georgia Institute of Technology. He directs the Center for 3D Medical Fabrication as well as the Tissue Engineering and Mechanics Laboratory at Georgia Tech. Dr. Hollister’s research focuses on the computational design, 3D printing fabrication and characterization of biomaterial devices and scaffolds for tissue reconstruction. He was co-inventor of an airway splint in both resorbable and permanent versions that to date has been implanted and saved the lives of 25 children with Tracheobronchomalacia. This work has been featured in a number of mainstream media outlets including The Today Show, NPR, CNN, the New Yorker, the Doctors Show, CBS Morning News and USA Today. He was awarded the 2013 Popular Mechanics Breakthrough Innovation award for the airway splint together with Dr. Glenn Green.
Chief Technology Officer, RegenMed Development Organization (ReMDO); Executive Director, Regenerative Medicine Manufacturing Society (RMMS)
Dr. Hunsberger obtained his B.A. in neuroscience from Wesleyan University and his Ph.D. in neuroscience from Yale University where his work focused on the beneficial effects of exercise in treating depression. He then did his postdoctoral work at the National Institutes of Health where he was the Julius Axelrod Post Doctoral Fellow and worked in areas of mood disorders and stroke. He then was a research fellow at the National Institutes of Health Center for Regenerative Medicine where he coordinated efforts for advancing clinical translation of stem-cell technologies. He then came to Wake Forest Institute for Regenerative Medicine where he worked on various director initiatives seeking to translate regenerative medicine technologies into the clinic to treat patients. He is currently chief technology officer of a non-profit organization, RegenMed Development Organization (ReMDO) that is advancing regenerative medicine manufacturing platform technologies in pre-competitive space. One of the programs focuses on development of a universal media to support clinical cell manufacturing. The other program focuses on development of a tunable bioink system for 3D bioprinting. He is also executive director of the Regenerative Medicine Manufacturing Society (RMMS) which is a professional society that has a vision of enabling the adoption of manufacturing platform technologies into standards, regulatory pathways, and commercial products by assembling a diverse network of stakeholders.
Assistant Professor, Wake Forest Institute for Regenerative Medicine
Dr. Ju received his Ph.D. degree in Biomedical Engineering from the University of South Florida, FL. After completing his Ph.D. degree and post-doctorate training at the Wake Forest Institute for Regenerative Medicine (WFIRM), he became a faculty at WFIRM. Dr. Ju’s research focuses on various aspects of developing various biomaterials for > 25 years, including 3D scaffold design, surface modification of scaffold, cell-biomaterials interaction, control release drug delivery system, 3D bioprinting, and implantable medical device (e.g. implantable biosensors). Dr. Ju has been involved in multiple research projects concerning the development of engineering complex functional bioengineered tissue including in situ musculoskeletal tissue regeneration using a multi-growth factor delivery system, the development of cardiovascular tissue regeneration using the electrospun scaffold with dual micro-nanofiber architecture, and other functional tissue regenerations (e.g. bone, heart valve, trachea, corporal tissue). More recently, Dr. Ju has applied his expertise to the development of a novel biomaterial system including decellularized tissue scaffold for 3D bio-printed muscle tissue engineering applications and wound care skin graft that delivers regenerative bioactive factors (e.g. conditioned media factors) as well as the development of the universal bioreactor platform for the clinical manufacturing of a wide range of regenerative medicine products.
Dr. Ju received his Ph.D. degree in Biomedical Engineering from the University of South Florida, FL. After completing his Ph.D. degree and post-doctorate training at the Wake Forest Institute for Regenerative Medicine (WFIRM), he became a faculty at WFIRM. Dr. Ju’s research focuses on various aspects of developing various biomaterials for > 25 years, including 3D scaffold design, surface modification of scaffold, cell-biomaterials interaction, control release drug delivery system, 3D bioprinting, and implantable medical device (e.g. implantable biosensors). Dr. Ju has been involved in multiple research projects concerning the development of engineering complex functional bioengineered tissue including in situ musculoskeletal tissue regeneration using a multi-growth factor delivery system, the development of cardiovascular tissue regeneration using the electrospun scaffold with dual micro-nanofiber architecture, and other functional tissue regenerations (e.g. bone, heart valve, trachea, corporal tissue). More recently, Dr. Ju has applied his expertise to the development of a novel biomaterial system including decellularized tissue scaffold for 3D bio-printed muscle tissue engineering applications and wound care skin graft that delivers regenerative bioactive factors (e.g. conditioned media factors) as well as the development of the universal bioreactor platform for the clinical manufacturing of a wide range of regenerative medicine products.
Professor, Wake Forest Institute for Regenerative Medicine
Sang Jin Lee, Ph.D, is currently a tenured Associate Professor at Wake Forest Institute for Regenerative Medicine (WFIRM), Wake Forest School of Medicine. Dr. Lee received his Ph.D. in Chemical Engineering at Hanyang University, Seoul, Korea in 2003 and took a postdoctoral fellowship in the Laboratories for Tissue Engineering and Cellular Therapeutics at Harvard Medical School and Children’s Hospital Boston and the WFIRM where he is currently a faculty member. He is also cross-appointed to the Virginia Tech-WFU Biomedical Engineering and Science. Dr. Lee has authored more than 140 scientific publications and reviews, has edited 2 textbooks, and has written 34 chapters in several books. Dr. Lee has extensive knowledge and experience in biomaterials science, especially, biodegradable polymers and tunable hydrogels, with specific training and expertise in key research areas for tissue engineering and regenerative medicine. His research team has developed various biomaterial systems that improve cellular interactions by providing appropriate environmental cues. These biomaterial systems consist of drug/protein delivery systems, nano/micro-scaled topographical features, and hybrid materials that can actively participate in functional tissue regeneration. Recently, his team is utilizing automated 3D bioprinting technology to manufacture complex, multi-cellular living tissue constructs that mimic the structure of native tissues. This can be accomplished by optimizing the formulation of biomaterials to serve as bioinks for 3D bioprinting, and by providing the biological microenvironment needed for the successful delivery of cells and biomaterials to discrete locations within the 3D structure.
Sang Jin Lee, Ph.D, is currently a tenured Associate Professor at Wake Forest Institute for Regenerative Medicine (WFIRM), Wake Forest School of Medicine. Dr. Lee received his Ph.D. in Chemical Engineering at Hanyang University, Seoul, Korea in 2003 and took a postdoctoral fellowship in the Laboratories for Tissue Engineering and Cellular Therapeutics at Harvard Medical School and Children’s Hospital Boston and the WFIRM where he is currently a faculty member. He is also cross-appointed to the Virginia Tech-WFU Biomedical Engineering and Science. Dr. Lee has authored more than 140 scientific publications and reviews, has edited 2 textbooks, and has written 34 chapters in several books. Dr. Lee has extensive knowledge and experience in biomaterials science, especially, biodegradable polymers and tunable hydrogels, with specific training and expertise in key research areas for tissue engineering and regenerative medicine. His research team has developed various biomaterial systems that improve cellular interactions by providing appropriate environmental cues. These biomaterial systems consist of drug/protein delivery systems, nano/micro-scaled topographical features, and hybrid materials that can actively participate in functional tissue regeneration. Recently, his team is utilizing automated 3D bioprinting technology to manufacture complex, multi-cellular living tissue constructs that mimic the structure of native tissues. This can be accomplished by optimizing the formulation of biomaterials to serve as bioinks for 3D bioprinting, and by providing the biological microenvironment needed for the successful delivery of cells and biomaterials to discrete locations within the 3D structure.
Director, Center for Regenerative Medicine, Dept. of Molecular Medicine
Scripps Research
Dr. Loring is an internationally recognized pioneer in human pluripotent stem cell research, having begun her work on these cells more than 20 years ago. She has extensive experience in both academia and industry, and is currently Professor emeritus at Scripps Research in La Jolla, CA, and advisor to Aspen Neuroscience, the company she founded to develop a cell replacement therapy for Parkinson’s disease, using dopamine neurons derived from autologous induced pluripotent stem cells. Her publications include landmark studies of the genomics and epigenetics of pluripotent stem cells, with a focus on safety and efficacy of cell therapies. Dr. Loring serves on scientific journal editorial boards, grant review committees, scientific advisory and ethics boards, and the BOD for a patient advocacy foundation. She is the recent recipient of a Stem Cell Pioneer award and a Rosalind Franklin Award. She is a American Institute for Medical and Biological Engineering (AIMBE) Fellow and was named as one of the 11 Most Influential Women in Advanced Therapies. She is interested in development of broad applications of pluripotent stem cells, including for rescue of endangered species and for investigating the effects of space flight on the nervous system. In the press, she has been called a “stem cell evangelist” and the “godmother of stem cells”.
Assistant Professor
Wake Forest Institute for Regenerative Medicine (WFIRM)
Josh Maxwell is an Assistant Professor at WFIRM. He graduated from Allegheny College in 2004 with a bachelor’s degree in Biology. Josh then received his Ph.D. in Cell and Molecular Physiology in 2010 from Loyola University Medical Center in the Department of Cell and Molecular Physiology studying the IP3 receptor in cardiac tissues. Dr. Maxwell then went on to post-doc with Dr. Lothar Blatter at Rush University Medical Center studying intracellular calcium handling, heart failure, and arrhythmogenesis. He then moved to Emory University in 2014 where he began studying cardiac regenerative medicine. Josh recently moved to WFIRM in August 2021 where he continues his pioneering work developing stem cell-based approaches for heart failure.
Professor, Wake Forest Institute for Regenerative Medicine
Frank Marini is a professor at the Wake Forest Institute for Regenerative Medicine, with affiliation in the Department of Cancer Biology and the Center on Diabetes, Obesity and Metabolism at the Wake Forest School of Medicine. Marini earned his PhD at the University of Texas MD Anderson Hospital in 1998. His expertise includes molecular biology and microscopic imaging.
Frank Marini is a professor at the Wake Forest Institute for Regenerative Medicine, with affiliation in the Department of Cancer Biology and the Center on Diabetes, Obesity and Metabolism at the Wake Forest School of Medicine. Marini earned his PhD at the University of Texas MD Anderson Hospital in 1998. His expertise includes molecular biology and microscopic imaging.
Director
Center for Biologics Evaluation and Research, FDA
Peter Marks received his graduate degree in cell and molecular biology and his medical degree at New York University and completed Internal Medicine residency and Hematology/Medical Oncology training at Brigham and Women’s Hospital in Boston. He has worked in academic settings teaching and caring for patients and in industry on drug development. He joined the FDA in 2012 as Deputy Center Director for CBER and became Center Director in 2016.
Louis Calder Professor, Department of Bioengineering, BioScience Research Collaborative, Rice University
Antonios G. Mikos is the Louis Calder Professor of Bioengineering and Chemical and Biomolecular Engineering at Rice University. His research focuses on the synthesis, processing, and evaluation of new biomaterials for use as scaffolds for tissue engineering, as carriers for controlled drug delivery, as non-viral vectors for gene therapy, and as platforms for disease modeling. His work has led to the development of novel orthopaedic, dental, cardiovascular, neurologic, and ophthalmologic biomaterials. He is the author of over 690 publications and the inventor of 32 patents.
Mikos is a Member of the National Academy of Engineering, the National Academy of Medicine, the National Academy of Inventors, the Chinese Academy of Engineering, the Academia Europaea, and the Academy of Athens. He has been recognized by various awards including the Jensen Tissue Engineering Award of the Tissue Engineering and Regenerative Medicine International Society-Global, the Lifetime Achievement Award of the Tissue Engineering and Regenerative Medicine International Society-Americas, the Founders Award of the Society For Biomaterials, the Founders Award of the Controlled Release Society, the Acta Biomaterialia Gold Medal, the Robert A. Pritzker Distinguished Lecturer Award of the Biomedical Engineering Society, and the Marshall R. Urist Award for Excellence in Tissue Regeneration Research of the Orthopaedic Research Society. He is a Founding Editor and Editor-in-Chief of the journal Tissue Engineering.
Antonios G. Mikos is the Louis Calder Professor of Bioengineering and Chemical and Biomolecular Engineering at Rice University. His research focuses on the synthesis, processing, and evaluation of new biomaterials for use as scaffolds for tissue engineering, as carriers for controlled drug delivery, as non-viral vectors for gene therapy, and as platforms for disease modeling. His work has led to the development of novel orthopaedic, dental, cardiovascular, neurologic, and ophthalmologic biomaterials. He is the author of over 690 publications and the inventor of 32 patents.
Mikos is a Member of the National Academy of Engineering, the National Academy of Medicine, the National Academy of Inventors, the Chinese Academy of Engineering, the Academia Europaea, and the Academy of Athens. He has been recognized by various awards including the Jensen Tissue Engineering Award of the Tissue Engineering and Regenerative Medicine International Society-Global, the Lifetime Achievement Award of the Tissue Engineering and Regenerative Medicine International Society-Americas, the Founders Award of the Society For Biomaterials, the Founders Award of the Controlled Release Society, the Acta Biomaterialia Gold Medal, the Robert A. Pritzker Distinguished Lecturer Award of the Biomedical Engineering Society, and the Marshall R. Urist Award for Excellence in Tissue Regeneration Research of the Orthopaedic Research Society. He is a Founding Editor and Editor-in-Chief of the journal Tissue Engineering.
Associate Professor, Wake Forest Institute for Regenerative Medicine
Dr. Sean Murphy received his Bachelors degree in Molecular Biology (Honors) from the University of Western Australia in 2006 and his Ph.D. in Stem Cell Therapy in 2012. Dr. Murphy joined Wake Forest Institute for Regenerative Medicine in 2012 and is currently an Associate Professor. His research focuses on developing cell and biomaterial therapies and applying tissue engineering and regenerative medicine strategies to treat disease.
Assistant Professor of Physical Medicine and Rehabilitation
Mayo Clinic
Dr. Nagelli received his doctorate from The Ohio State University in Biomedical Engineering with a focus on Biomechanics. His PhD research involved understanding the effects of injury prevention training on high-risk biomechanics among anterior cruciate ligament reconstructed athletes. After his PhD, Dr. Nagelli joined the Musculoskeletal Gene Therapy Laboratory at Mayo Clinic as a Postdoctoral Research Fellow to work with Dr. Chris Evans on a project focused on Gene Therapy for Articular Cartilage Repair. Since completing his Postdoctoral Training, Dr. Nagelli is an Assistant Professor at Mayo Clinic, and his current research focuses on understanding the mechanobiological basis of articular cartilage injury and regeneration. He has received funding from the NIH T32 Musculoskeletal Training grant, the American Academy of Orthopedic Sports Medicine, the Rochester Epidemiology Project, the Reinig Immunotherapy of Arthritis Treatment Award, and the Alliance of Regenerative Rehabilitation Research and Training.
Mayo Clinic
Dr. Nagelli received his doctorate from The Ohio State University in Biomedical Engineering with a focus on Biomechanics. His PhD research involved understanding the effects of injury prevention training on high-risk biomechanics among anterior cruciate ligament reconstructed athletes. After his PhD, Dr. Nagelli joined the Musculoskeletal Gene Therapy Laboratory at Mayo Clinic as a Postdoctoral Research Fellow to work with Dr. Chris Evans on a project focused on Gene Therapy for Articular Cartilage Repair. Since completing his Postdoctoral Training, Dr. Nagelli is an Assistant Professor at Mayo Clinic, and his current research focuses on understanding the mechanobiological basis of articular cartilage injury and regeneration. He has received funding from the NIH T32 Musculoskeletal Training grant, the American Academy of Orthopedic Sports Medicine, the Rochester Epidemiology Project, the Reinig Immunotherapy of Arthritis Treatment Award, and the Alliance of Regenerative Rehabilitation Research and Training.
Nathan F. Simms Distinguished Professor
Department of Biology
North Carolina A&T State University
Robert H. Newman is the Nathan F. Simms Distinguished Professor in the Department of Biology at North Carolina A&T State University. He received a B.A. in Biology and Biochemistry from McDaniel College in 1999 before earning his Ph.D. in Biochemistry and Molecular Biology from the Johns Hopkins University Bloomberg School of Public Health in 2006. He then conducted postdoctoral research in the Department of Pharmacology and Molecular Sciences in the Johns Hopkins University School of Medicine, where he examined the organization and regulation of cellular phosphorylation networks using a combination of live cell imaging and functional protein microarrays. Upon completion of his postdoctoral training, he joined the Department of Biology at North Carolina A&T State University where his lab uses a combination of biochemical, computational, systems, and synthetic biology strategies to better understand crosstalk between cellular signaling pathways involved in the etiology of a variety of disorders, including diabetes, cardiovascular disease, and cancer. Since joining NC A&T in 2012, he has been awarded over $19M in extramural research funding from the National Institutes of Health (NIH), the National Science Foundation (NSF), and the Department of Defense (DoD), published over 30 peer-reviewed articles, and mentored 70 undergraduate students, 25 graduate students, and 5 postdoctoral fellows. Importantly, many of his undergraduate and graduate students have gone on to pursue Ph.D. degrees and postdoctoral training at some of the nation's leading institutions, including Johns Hopkins University, the University of Virginia, Washington University in St. Louis, Wake Forest University, and the University of North Carolina at Chapel Hill. Dr. Newman is also committed to excellence in the classroom, where he has developed both graduate and undergraduate courses to help students better understand and apply biological concepts. During his classes, one of his overarching goals is to help students successfully transition from passive to active modes of learning. To accomplish this, he strives to create learning environments where students not only receive information, but where they also develop the skills necessary to actively pursue knowledge. Over the years, he has received several awards for teaching and research, including both the NC A&T Outstanding Young Investigator Award and the NC A&T Junior Faculty Teaching Excellence Award in 2016, the NC A&T Interdisciplinary Research Award in 2018 and 2020, and the UNC Board of Governors' Award for Excellence in Teaching in 2022.
Professor, Wake Forest Institute for Regenerative Medicine
Dr. Christopher Porada received his Bachelor’s degree in Molecular Biology from Colgate University in 1991 (magna cum laude, Phi Beta Kappa) and his PhD in Cellular and Molecular Pharmacology and Physiology from the University of Nevada in 1998 (summa cum laude), focusing on fetal gene therapy for the treatment of hematologic diseases. After completing his PhD, he conducted a post-doctoral fellowship in the Department of Medicine at the VA Medical Center in Reno, focusing on stem cell biology and the immune aspects of gene delivery. In 2001, he joined the Department of Animal Biotechnology at the University of Nevada, Reno as an Assistant Professor, and was subsequently promoted to an Associate Professor at the same Institution. He has authored over 125 scientific abstracts, over 60 full-length manuscripts, and has written chapters in nearly a dozen books. He serves on the Editorial Board for several international journals, and is a member of several international societies. Dr. Porada regularly serves as a reviewer for NIH, NYSTEM, several other international grant agencies, and over 40 international journals focused on gene therapy, gene and drug delivery, stem cell biology, cancer, and stem cell transplantation. Dr. Porada joined the faculty at WFIRM in 2011.
CEO, Implants Therapeutics
Mahendra Rao received his MD from Bombay University in India and his PhD in Developmental Neurobiology from the California Institute of Technology. Mahendra Rao
is internationally known for his research involving human embryonic stem cells (hESCs) and other somatic stem cells and has worked in the stem cell field for more than thirty
years with stints in academia, government and regulatory affairs and industry. Dr. Rao has an extensive background teaching medical and graduate students, as well as
postdoctoral fellows at different academic institutions. Dr. Rao lead the Stem cell and Regenerative Medicine division at LiFE Technologies and then served the Director of the
NIH Center of Regenerative Medicine and lead a group at the Laboratory of Stem cell Biology at the NIH focused on translational work related to Parkinsons disease and
Schwann cell pathology. Dr. Rao has served on the Board of panCELLa, Thermogenesis, Aastrom, Q therapeutics and other companies involved in stem cell processing and therapy. Dr Rao also served as the Chair of the CBER (FDA) advisory committee (CTGTAC) and has served on advisory panels the governments of the U.S., Singapore and India on stem cell policy. Dr. Rao currently serves on several editorial boards, review panels and scientific advisory boards and is currently the CEO of panCELLa Inc and Implant Therapeutics
and continues his consulting work in the field of Regenerative Medicine.
Mahendra Rao received his MD from Bombay University in India and his PhD in Developmental Neurobiology from the California Institute of Technology. Mahendra Rao
is internationally known for his research involving human embryonic stem cells (hESCs) and other somatic stem cells and has worked in the stem cell field for more than thirty
years with stints in academia, government and regulatory affairs and industry. Dr. Rao has an extensive background teaching medical and graduate students, as well as
postdoctoral fellows at different academic institutions. Dr. Rao lead the Stem cell and Regenerative Medicine division at LiFE Technologies and then served the Director of the
NIH Center of Regenerative Medicine and lead a group at the Laboratory of Stem cell Biology at the NIH focused on translational work related to Parkinsons disease and
Schwann cell pathology. Dr. Rao has served on the Board of panCELLa, Thermogenesis, Aastrom, Q therapeutics and other companies involved in stem cell processing and therapy. Dr Rao also served as the Chair of the CBER (FDA) advisory committee (CTGTAC) and has served on advisory panels the governments of the U.S., Singapore and India on stem cell policy. Dr. Rao currently serves on several editorial boards, review panels and scientific advisory boards and is currently the CEO of panCELLa Inc and Implant Therapeutics
and continues his consulting work in the field of Regenerative Medicine.
Chief Education Program Officer, Wake Forest Institute for Regenerative Medicine
Joan’s work is focused on providing high quality educational programming within the field of tissue engineering and regenerative medicine. In her role, she also works to increase awareness of the Institute’s leadership role within the field of biomedicine. Joan's professional background includes more than 20 years of specialized experience in administration, education, research, fund raising, collaborative team building, program development and direct care/services delivery within the university, community and non-profit, public health, and education setting. Throughout her career, she has recognized the importance of education and the need to develop collaborative, multidisciplinary education and research training across formal and informal educational environments.
Research Chemist, Institute for Bioscience and Biotechnology Research, National Institute of Standards and Technology; NIIMBL Federal Technical Program Manager, Office of Advanced Manufacturing, National Institute of Standards and Technology
Dr. Schiel received his BS (2004) and Ph.D. (2009) in chemistry from the University of Nebraska-Lincoln, and is currently serving as the Federal Technical Program Manager for NIIMBL, a Manufacturing USA institute accelerating adoption of advanced biomanufacturing technologies. Dr. Schiel also maintains a research lab in the NIST Biomolecular Measurement Division. Dr. Schiel coordinates the development of Reference Materials that support the biomanufacturing industry, including the recombinant IgG1κ NIST monoclonal antibody Reference Material 8671 (NISTmAb). He also leads an analytical research team developing innovative approaches toward production/characterization of next generation biotherapeutics (e.g. viral vectors, cell therapy products, and vaccines) and de-risking of innovative technologies for lifecycle appropriate implementation and regulatory assimilation. Dr. Schiel joined the Office of Advanced Manufacturing as a Federal Technical Program Manager for NIIMBL in 2021. In this role he inspires an innovative and interconnected advanced biopharmaceutical manufacturing ecosystem by working across academic, industry, and federal stakeholders. Dr. Schiel is very passionate about mobilizing community knowledge to inform and enhance federal strategy and initiatives to advance the competitiveness of the US Bioeconomy across all sectors. He is an author of over 45 peer-reviewed publications, an editor of the ACS book series "State-of-the-Art and Emerging Technologies for Therapeutic Monoclonal Antibody Characterization", and contributing author of 5 national strategy reports on advanced manufacturing and the bioeconomy. Dr. Schiel was the recipient of numerous awards including the Arthur S. Flemming Award, Department of Commerce Gold Medal, ACS Division of Analytical Chemistry Fellowship, Bioanalysis Young Investigator Award, and UNL Early Achiever Award.
Treat Wellness, LLC
Dr. Kathleen O’Neil-Smith, MD FAARM is a magna cum laude graduate of Boston University School of Medicine. She completed postgraduate training in pathology at Harvard’s Massachusetts General Hospital and internal medicine at the Brigham and Women’s Hospital in Boston. She is an elite athlete, mom, interenal medicine trained, now a functional and regenerative medicine thought leader.
She has a degree in exercise physiology and has been an athlete on the national rowing team for 40 years and a coach for six years. She has worked as an office and hospital-based internist. In 2008, she shifted to Functional and Regenerative Medicine after completing a two-year fellowship. She completed a stem cell certification through A4M and a TBI certification through AMMG (Age Management Medicine Group). She teaches on the clinical use of peptide therapy at American Academy of Anti-Aging Medicine (A4M).
She has had a direct access practice for over a decade in Functional, Integrative, and Regenerative Internal Medicine in Boston called “Treat Wellness” which reflects her core belief in good medicine. Dr. O’Neil-Smith is an international thought leader in the clinical use of peptide therapy. She has extensive knowledge of regenerative medicine with personal use of peptides and stem cells in her private medical practice. She treated her only son with such therapies when told he had a severe traumatic brain injury that caused five intracranial bleeds and the prognosis was slim that he would return to normal function. He has since graduated with a math degree and works in corporate America using his math skills. He was hired only two years after that TBI. She is an innovative, creative and compassionate doctor. Her teaching style is approachable, friendly, and creative. She makes complex ideas simple, which is a testimony to her early career as a high school and college science teacher prior to going to medical school. She is the co-author of Kick Covid-19 to the Curb (2020) and Fine-Tune Your Immune System (2021). Sheand Dr. Akey have a passion to educate in their FIRRIMup™ Model and have partnered to form their web-based company, FIRRIMup Doctors. At FIRRIMupDoctors.com, they teach and are available for telemedicine consults and web-based teaching directed to both physicians and consumers alike.
She currently resides with her family in her hometown of Boston, Massachusetts, USA.
Dr. Kathleen O’Neil-Smith, MD FAARM is a magna cum laude graduate of Boston University School of Medicine. She completed postgraduate training in pathology at Harvard’s Massachusetts General Hospital and internal medicine at the Brigham and Women’s Hospital in Boston. She is an elite athlete, mom, interenal medicine trained, now a functional and regenerative medicine thought leader.
She has a degree in exercise physiology and has been an athlete on the national rowing team for 40 years and a coach for six years. She has worked as an office and hospital-based internist. In 2008, she shifted to Functional and Regenerative Medicine after completing a two-year fellowship. She completed a stem cell certification through A4M and a TBI certification through AMMG (Age Management Medicine Group). She teaches on the clinical use of peptide therapy at American Academy of Anti-Aging Medicine (A4M).
She has had a direct access practice for over a decade in Functional, Integrative, and Regenerative Internal Medicine in Boston called “Treat Wellness” which reflects her core belief in good medicine. Dr. O’Neil-Smith is an international thought leader in the clinical use of peptide therapy. She has extensive knowledge of regenerative medicine with personal use of peptides and stem cells in her private medical practice. She treated her only son with such therapies when told he had a severe traumatic brain injury that caused five intracranial bleeds and the prognosis was slim that he would return to normal function. He has since graduated with a math degree and works in corporate America using his math skills. He was hired only two years after that TBI. She is an innovative, creative and compassionate doctor. Her teaching style is approachable, friendly, and creative. She makes complex ideas simple, which is a testimony to her early career as a high school and college science teacher prior to going to medical school. She is the co-author of Kick Covid-19 to the Curb (2020) and Fine-Tune Your Immune System (2021). Sheand Dr. Akey have a passion to educate in their FIRRIMup™ Model and have partnered to form their web-based company, FIRRIMup Doctors. At FIRRIMupDoctors.com, they teach and are available for telemedicine consults and web-based teaching directed to both physicians and consumers alike.
She currently resides with her family in her hometown of Boston, Massachusetts, USA.
Professor, Wake Forest Institute for Regenerative Medicine
Dr. Soker, is a Professor of Regenerative Medicine, Biomedical Engineering and Cancer Biology and the Chief Science Program Officer at the Wake Forest Institute for Regenerative Medicine (WFIRM). Dr. Soker received his PhD from the Technion-Israel Institute for Technology, followed by a postdoctoral fellowship at the Children’s Hospital Boston and Harvard Medical School. He was then recruited to the Laboratory for Tissue Engineering and Cellular Therapies as Assistant Professor of Surgery at the Harvard Medical School.
Research Interests: Dr. Soker’s research focuses on multiple aspects of regenerative medicine including identification of new sources of cells and scaffolds for tissue engineering, tissue neovascularization and real-time imaging technologies. Some of his research projects have been translated into clinical applications in patients including the use of cells, biomaterials and bioengineered tissues to repair muscles, skin wounds and damages urological tissues. In parallel, Dr. Soker has been making bioengineered tissue models of human development and disease. This technology enables screening of existing drugs on a personalized basis and development of new drugs and test them on cells derived from individual patients. Based his work, a new Wake Forest Organoid Research Center (WFORCE) was recently established, on which he serves as the scientific director.
Other Scientific Activities: During his scientific career, Dr. Soker won numerous prizes for his research projects and publications and had obtained funding for his research from different sources including NIH (NCI, NIBIB, etc.), DoD, the state of North Carolina, private foundations and industry. Dr. Soker is an inventor of patents in the area of regenerative medicine and regenerative medicine. Some served as the foundation for biotech companies he founded along with others at WFIRM and others have been licensed to companies.
Assistant Professor of Biomedical Engineering
University of Arizona
Dr. Shang Song is an Assistant Professor of Biomedical Engineering at the University of Arizona. Her laboratory uses engineering approaches and biomaterials to manipulate cellular microenvironment for developing new regenerative therapies. Dr. Song completed postdoctoral fellowship training in the Department of Neurology and Neurological Sciences at Stanford University. She graduated with a PhD in Bioengineering from the Joint Program at University of California, Berkeley and San Francisco (UC Berkeley & UCSF). She received her Bachelor’s degree in Biomedical Engineering with Honors from Brown University. Dr. Song was awarded scholarships and fellowships from organizations such as National Institute of Health Ruth L. Kirschstein Research Service Awards (NRSA) (NIH F32), Stanford University Dean’s Postdoctoral Fellowship, National Science Foundation Graduate Research Fellowship (NSF-GRFP), 30 under 30 by Forbes Magazine, Gates Millennium Scholar amongst others.
University of Arizona
Dr. Shang Song is an Assistant Professor of Biomedical Engineering at the University of Arizona. Her laboratory uses engineering approaches and biomaterials to manipulate cellular microenvironment for developing new regenerative therapies. Dr. Song completed postdoctoral fellowship training in the Department of Neurology and Neurological Sciences at Stanford University. She graduated with a PhD in Bioengineering from the Joint Program at University of California, Berkeley and San Francisco (UC Berkeley & UCSF). She received her Bachelor’s degree in Biomedical Engineering with Honors from Brown University. Dr. Song was awarded scholarships and fellowships from organizations such as National Institute of Health Ruth L. Kirschstein Research Service Awards (NRSA) (NIH F32), Stanford University Dean’s Postdoctoral Fellowship, National Science Foundation Graduate Research Fellowship (NSF-GRFP), 30 under 30 by Forbes Magazine, Gates Millennium Scholar amongst others.
Manager, Product Research Engineering, Cook Biotech Inc.
Loran Solorio is the Manager of Product Research Engineering at Cook Biotech, Inc. She leads a team of talented engineers in the development of new platform technologies based on advanced biomaterials. Prior to moving to her management position in late 2021, Loran was a Development Engineer focused on the design and development of several innovative products including new medical devices and combination drug/device products in various stages of regulatory approval and commercialization. Before joining Cook Biotech, Loran spent two years as a Postdoctoral Researcher in Biomedical Engineering at the University of Michigan, during which time she interfaced with groups in
Interventional Cardiology and Cardiac Surgery as well as individuals at Cook Medical. Previously, Loran completed her Ph.D. and postdoctoral work in the Department of Biomedical Engineering at Case Western Reserve University in Cleveland, OH. Her doctoral thesis, completed in 2012, was focused on spatiotemporal delivery of growth factors from polymer microspheres to guide chondrogenic differentiation of mesenchymal stem cells. Loran’s undergraduate work was performed at Saint Louis
University, where she received a B.S. degree majoring in Biomedical Engineering with a minor in Engineering Mathematics.
Loran Solorio is the Manager of Product Research Engineering at Cook Biotech, Inc. She leads a team of talented engineers in the development of new platform technologies based on advanced biomaterials. Prior to moving to her management position in late 2021, Loran was a Development Engineer focused on the design and development of several innovative products including new medical devices and combination drug/device products in various stages of regulatory approval and commercialization. Before joining Cook Biotech, Loran spent two years as a Postdoctoral Researcher in Biomedical Engineering at the University of Michigan, during which time she interfaced with groups in
Interventional Cardiology and Cardiac Surgery as well as individuals at Cook Medical. Previously, Loran completed her Ph.D. and postdoctoral work in the Department of Biomedical Engineering at Case Western Reserve University in Cleveland, OH. Her doctoral thesis, completed in 2012, was focused on spatiotemporal delivery of growth factors from polymer microspheres to guide chondrogenic differentiation of mesenchymal stem cells. Loran’s undergraduate work was performed at Saint Louis
University, where she received a B.S. degree majoring in Biomedical Engineering with a minor in Engineering Mathematics.
CEO, Organamet Bio, Inc.
Dr. Doris Taylor is a revolutionary innovator, scientist, entrepreneur, and global thought leader in regenerative medicine and biomanufacturing. Passionate to create cures for heart disease, which kills more people than any other disease and has an economic impact of 219 billion dollars annually, Doris lives her motto: “Build the future today – and do it with Heart”. Founder of Organamet Bio Inc., with a mission to cure heart disease and reduce healthcare costs, Taylor’s goal is to bioengineer safe, effective personalized replacement hearts that are available fairly and equitably (www.organametbio.com [organametbio.com]).
In 1998 Taylor pioneered the first functional repair of an injured heart with stem cells. In 2008 she developed perfusion decellularization, recognized as one of the “Top 10 Research Advances” by the American Heart Association, which transforms un-transplantable organs into a scaffold for building new organs using stem cells. After being nominated as one of the “100 most influential people in the world” by Time magazine Taylor turned to disease prevention and is developing “cellular signatures” of heart disease and aging.
Dr. Taylor proudly grew up in Mississippi, deeply impacted by ordinary people doing extraordinary things to change the world. She earned a B.S. from Mississippi University for Women (MUW) and a Ph.D. from UT Southwestern Medical Center (Dallas). Taylor is a Fellow of the American Heart Association, American College of Cardiology, and European Society for Cardiology, was awarded an honorary Doctor of Science degree by MUW, and the national Distinguished Alumnus Award by the American Association of State Colleges and Universities. In 2019 she was elected as a Senior member of the National Academy of Inventors and, in 2020, as a fellow to the American Institute for Medical and Biological Engineering.
Taylor has sat on numerous think tanks and international scientific committees including at the NIH the FDA, AABB, the Alliance for Regenerative Medicine and the Advanced Regenerative Manufacturing Institute (ARMI). She sat for almost 2 decades on the jury for the Institut de France LeFoulon-Delalande Foundation Grand Prix, awarded annually to individuals making worldwide contributions to cardiovascular medicine. Dr. Taylor appears as an expert on cell therapy, women’s health, cardiac repair and organ transplantation in the public media and her work is recognized and featured in most worldwide media outlets.
Fellow, University of Pittsburgh
Wang joined Dr. Ambrosio’s Lab as a Postdoctoral Research Associate in June 2019 where he received his Ph.D. degree in Materials Science and Engineering with Biomedical Engineering concentration. His current projects focus on 1) developing skeletal muscle-on-a-chip systems to understand age-related changes in muscle regeneration, and 2) engineering extracellular vesicles to promote skeletal muscle regeneration/repair after injury.
Chairman and Director, Strait Access Technologies, South Africa
Emeritus Professor, Wake Forest Institute for Regenerative Medicine
Professor Williams, who studied metallurgy at the University of Birmingham (UK) in the 1960s, has had 55 years-experience in biomaterials, medical device technology and tissue engineering, mostly at the University of Liverpool, where he was Professor of Clinical Engineering, Director of the UK Centre for Tissue Engineering and Pro-Vice Chancellor. He was Professor of Biomaterials and Director of International Affairs at Wake Forest Institute of Regenerative Medicine, North Carolina, USA until 2022; he has the title of Emeritus Professor from both Liverpool and Wake Forest. He has published over 35 books and 440 papers: his textbook, Essential Biomaterials Science, was published by Cambridge University Press in 2014. He was Editor-in-Chief of Biomaterials, the world’s leading journal in this field between 2000 and 2014. He was elected as Fellow of the Royal Academy of Engineering in 1999 and as Fellow of the Learned Society of Wales in 2021; he has received major awards from the US and European societies of biomaterials. He was scientific advisor to the European Commission and wrote several opinions on risk management in health technologies and nanotechnologies, upon which several regulations were based. In South Africa, he is the Founding Director and Chairman of a company, Strait Access Technologies, that has developed low cost, high technology medical devices that can be used with minimally invasive procedures to treat young adults in sub-Sarah Africa who are suffering from rheumatic heart disease but currently have no therapies available to them.
Assistant Professor, Wake Forest Institute for Regenerative Medicine
Dr. Victoria Weis is currently an Assistant Professor at the Wake Forest Institute for Regenerative Medicine (WFIRM). Dr. Weis is formally trained in gastrointestinal cell biology and pathophysiology and has expertise in disease modeling in gastrointestinal tissues. Following her Bachelor’s Degree in Biology from Washington University in St. Louis, she began her research career as a research technician studying the homeostasis of the stomach epithelium. In 2013, she earned her PhD in Cell and Developmental Biology from Vanderbilt University. Her thesis work focused on disease progression in gastric metaplasia to understand the pathophysiology and identify potential biomarkers. She continued her early postdoctoral studies at Vanderbilt University supported by a competitive T32 training grant. In this work, she investigated the molecular mechanisms of diarrheal disease in the rare pediatric congenital disorder Microvillus Inclusion Disease (MVID). In 2017, Dr. Weis joined WFIRM as a senior research fellow and promoted to a faculty position in 2021. At WFIRM, she is currently investigating a stem cell-based therapy for Necrotizing Enterocolitis, a life-threatening intestinal disease in premature infants. She has recently earned a NIDDK K01 and American Gastroenterological Association Research Scholar Award for this work.
Advisory Industry Consultant for SAS Institute's Global IoT Division
Dr. Wolff is an Advisory Industry Consultant for SAS Institute's Global IoT Division. He has 30 years of experience in the health and life science industries as a scientist and analyst working in the U.S. and Europe.
Prior to joining SAS, Mark held various research and leadership positions in academia, government and industry. He holds a Bachelor of Science degree from Loyola University in Maryland, a Master of Science and a Doctorate in Toxicology from North Carolina State University and has an academic appointment as a Visiting Fellow at the University of Miami Institute for Data Science and Computing.
Chief of Site Operations, Javara Research
Amanda Wright began her career in clinical research in 1998, working as a Clinical Research Coordinator at PMG Research. She has served in various roles across the site enterprise, including leadership roles in operations, patient engagement, business development and marketing. A great deal of her career has been centered on forging shared value strategic partnerships and collaborations that serve to innovate business process, patient engagement and predictive modeling. In addition to her professional work, Amanda has served as a community leader, holding multiple roles with Greater Gift, a non-profit 501(c)(3) organization founded in 2010 to celebrate clinical trial participation. Serving as Executive Director from 2013 to 2019, she remains on the Board of Directors as a strong voice for strategic program development and expansion.
Amanda serves on numerous additional boards and committees throughout the industry, many of which are centered on patient engagement and enhancement of the clinical trial process to address current industry trends. Amanda is a graduate of UNC-Chapel Hill as well as various leadership programs.
Associate Professor, Dept. of Microbiology, Immunology & Molecular Genetics, University of California, Los Angeles (UCLA)
Dr. Lili Yang received her Ph.D. degree in Biology from the California Institute of Technology (Caltech) in 2004, studying with Dr. David Baltimore. She then stayed at Caltech and led a multi-institutional Engineering Immunity Program from 2004 to 2012, developing gene- and cell-based immunotherapies for cancer and HIV/AIDS. She joined the University of California, Los Angeles (UCLA) as an Assistant Professor in 2013. Her laboratory at UCLA studies tumor immunology and cancer immunotherapy, with a special focus on stem cell-engineered immunotherapy for cancer. So far her work has resulted in over 60 publications, 20 patents, 2 clinical trials, and 2 biotech startups.
In recognition of her scientific achievements, Dr. Lili Yang has received multiple prestigious awards, including a TR35 (Innovators Under 35) Award from the MIT Technology Review Magazine , a Forbeck Scholar Award, a Director’s New Innovator Award from the National Institute of Health (NIH), a Translational Research Award from the California Institute for Regenerative Medicine (CIRM), a Young Investigator Award from the American Association of Immunologists (AAI), and an Outstanding New Investigator Award from the American Society of Gene & Cell Therapy (ASGCT). In year 2022, Dr. Lili Yang was recognized as Women in Biopharma (20 of the Top women leaders in Biopharma R&D) by the Endpoints News.
Professor, Department of Orthodontics; Director, Division of craniofacial and Molecular Genetics; Director, Genetics Program, Tufts Graduate School of Biomedical Sciences
Dr. Pamela C. Yelick, PhD, is a tenured full professor in the Department of Orthodontics at the Tufts University School of Dental Medicine, Boston MA, where she Directs the Division of Craniofacial and Molecular Genetics. Dr. Yelick also Directors the Genetics Program at the Tufts University Graduate School of Biomedical Sciences and holds adjunct appointments in the Tufts Biomedical Engineering and Developmental, Molecular and Cellular Biology Departments. Dr. Yelick is an internationally recognized leader in dental tissue engineering and craniofacial development and disease, with ~125 peer-reviewed basic research publications, more than two dozen reviews, and over 400 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 300 Invited Speaker Lectureships. Dr. Yelick is the Cofounder and Chief Scientific Officer of RegendoDent Inc., along with cofounder and Chief Medical Officer Luiz Bertassoni, President and Chief Executive Officer Scott Olson, and Project Manager Anissa Bartolome. Their product, RegendoGel, is a first-generation regenerative endodontic product that revitalizes teeth by inducing natural dental pulp and dentin regeneration. Dr. Yelick was recently elected Vice President of the International Association for Dental Research, a four-year term of VP, President Elect, President, and Immediate Past President. Dr. Yelick has received many awards including the IADCR Distinguished Scientist Award in 2017 and 2019, was elected as a 2022 AAAS Fellow in recognition of her sustained contributions to the field of Craniomaxillofacial development, disease and regeneration.
CEO, BioSpherix Medical, div. of BioSpherix, Ltd.
Educated as cell biologist/biochemist at Syracuse Univ and Univ Rochester, he was
cloning stem cells in 1976 when he developed an incubator enhancement that radically improved the growth and robustness of the cells. He went on to develop dozens of other tools and instruments for leading cell biologists over the following 40 years, all to better meet the needs of their cells, and now cited in thousands of publications. From this vantage point he saw a common theme, and defined a set of Cytocentric Principles which are getting recognized as fundamental quality concepts for live cells. His company BioSpherix is the exclusive source for a unique modular equipment platform, which enables anyone anywhere in the new live cell industry to now practice these principles. The universal cellular need for full-time protection from microbes, chemical biocides, antibiotics, and exposures to suboptimal temperature, pH, CO2 , O2 , and redox can now be satisfied and results in better cells and better data from cells.
Educated as cell biologist/biochemist at Syracuse Univ and Univ Rochester, he was
cloning stem cells in 1976 when he developed an incubator enhancement that radically improved the growth and robustness of the cells. He went on to develop dozens of other tools and instruments for leading cell biologists over the following 40 years, all to better meet the needs of their cells, and now cited in thousands of publications. From this vantage point he saw a common theme, and defined a set of Cytocentric Principles which are getting recognized as fundamental quality concepts for live cells. His company BioSpherix is the exclusive source for a unique modular equipment platform, which enables anyone anywhere in the new live cell industry to now practice these principles. The universal cellular need for full-time protection from microbes, chemical biocides, antibiotics, and exposures to suboptimal temperature, pH, CO2 , O2 , and redox can now be satisfied and results in better cells and better data from cells.