RME Course Instructors
Professor, Department of Neurosurgery and Brain Repair, USF Morsani College of Medicine
Cesar V. Borlongan holds the position of Distinguished Professor at USF Morsani College of Medicine’s Department of Neurosurgery and Brain Repair. His highly innovative translational “bench to clinic” research has led to 6 FDA-approved clinical trials of cell transplantation in stroke, traumatic brain injury, and cerebral palsy. He is an author of more than 550 peer-reviewed publications, lead editor of 2 books, and editor and editorial board member of many scientific journals, including Stem Cells, Stroke, Journal of Cerebral Blood Flow and Metabolism, PLoS One, and Brain Research. He is funded by NIH, DOD, VA, and several stem cell-based biotech companies. He has been a regular study section reviewer for NIH, DOD and VA, and has served over the last decade as the Scientific Chair of Maryland Stem Cell Research Foundation. He was the 2015 President-Elect of American Society for Neural Therapy and Repair, and currently the President of Italy based International Placenta Stem Cell Society. He was featured in The Lancet for Lifeline Perspectives in 2008.
His research interests include pathological examination of the role of impaired mitochondria, splenic response, and gut dysbiosis in the inflammation-plagued secondary cell death that accompanies stroke and traumatic brain injury. In addition, he probes the potential of stem cells in rescuing the mitochondria, silencing the splenic reaction, and normalizing the gut microbiome towards sequestration of both central and peripheral inflammation. Altogether, his strategy is to understand the pathological condition of CNS disorders with a focus on inflammation and its treatment with stem cell-based regenerative medicine.
Founder and CEO, Javara
Jennifer Byrne’s career has been devoted to leading teams and building relationships to transform the clinical research landscape into an integrated component of clinical care. In 2018, she founded Javara with a vision to revolutionize the industry by accelerating access to clinical trials – for patients, sponsors, and healthcare systems alike. Prior to Javara, Jennifer served as CEO for PMG Research; she is also the founder of Greater Gift (501(c)3). Jennifer has earned many industry honors during her tenure, recognized most recently as a PM360 ELITE, CenterWatch Top 20 Innovator and PharmaVOICE Woman of Influence. Jennifer is a graduate of Texas A&M University.
Associate Professor, Department of Bioengineering
Bradshaw and Holzapfel Research Professor in Transformational Science and Mathematics
Paul Dalton is a futurist, inventor, and educator specializing in 3D printing, tissue engineering, and biofabrication. He pioneered and developed melt electrowriting, establishing it as a distinct class within 3D printing. Today, this groundbreaking technology is utilized by over 60 laboratories worldwide. Dr. Dalton brings an interdisciplinary and global perspective to the tissue engineering community, having lived and conducted research in Australia, Canada, China, the UK, and Germany before joining the University of Oregon. His work focuses on reimagining the future of advanced manufacturing and its translation into biomedical applications.
Associate Professor, Pharmaceutics; Founder/Co-Director, Chronic Pain Research Consortium, Duquesne University
Dr. Janjic is tenured Associate Professor of Pharmaceutics and Founder/Co-Director of the Chronic Pain Research Consortium (CPRC) at Duquesne University in Pittsburgh, USA. She has received her pharmacy degree at Belgrade University and her PhD at University of Pittsburgh School of Pharmacy. She completed her post-doctoral training at Scripps Florida and Carnegie Mellon University. The primary focus of her research is the implementation of Quality by Design to manufacturing of nanomedicines for imaging supported drug delivery. In her 18-year-long career in nanotechnology, she has developed multiple imaging and drug delivery platforms and biomaterials, which resulted to date in 4 patents, more than 80 publications, and numerous invited presentations at national and international meetings. Her research interests lie at the intersection of immunology, inflammation, transplantation, and pain. Her work has been awarded innovator awards and supported by NIH, USAF, CDMRP and ARPA-H grants. Her research interests lie at the intersection of immune and peripheral nervous system and its implications in neuromuscular, inflammatory and trauma pain. Dr. Janjic is the Pittsburgh Business Times Innovator Award recipient for her pain nanomedicine work. Her work on pain nanomedicine has been featured by NPR news and received multiple recognitions. Her designs have been successfully validated in experimental small and large animal models of transplant rejection, neuroinflammation, neuroregeneration and pain, and she has been the key formulation scientist behind clinically tested MRI reagents. Her pragmatic approach to manufacturing in nanomedicine she shares with her students, both in her own research laboratory and by teaching manufacturing in the graduate program at Duquesne University for over a decade. She is passionate about solving manufacturing problems to expedite bringing high quality nanomedicines to patients.
Professor, Wake Forest Institute for Regenerative Medicine
Dr. Lim’s research interests encompass biomaterials, tissue engineering, biofabrication, regenerative engineering, and controlled drug delivery systems. Her work has been widely recognized, with over 150 peer-reviewed publications and numerous patents, some of which have been licensed to companies for clinical trials and commercialization. Dr. Lim has been honored with prestigious awards such as the TERMIS International Fellow Award and KTERMS Award, highlighting her contributions to the field. Dr. Lim has delivered over 160 invited presentations worldwide and has contributed to academic and professional organizations, including serving as President of the Korea Tissue Engineering and Regenerative Medicine Society and as Program Chair of TERMIS AP 2014. Her editorial roles span several leading journals, including Tissue Engineering and Regenerative Medicine, Biomaterials Research and Bioprinting. Dr. Lim has held academic appointments at Wake Forest University School of Medicine, where she is currently a Professor in the Wake Forest Institute for Regenerative Medicine and Affiliate Faculty of Biomedical Engineering and Mechanics at Virginia Tech. She has also served as a Visiting Scholar at Cornell University in 2019, and as a Scientist and Visiting Scholar at the Massachusetts Institute of Technology (MIT) and Harvard Medical School in the Division of Health Sciences and Technology in 2001, contributing to advanced research on drug delivery systems and biomaterials for regenerative applications. Her research has focused on developing bioactive scaffolds, novel bioinks, hydrogels, and advanced 3D printing technologies to address challenges in tissue regeneration. Dr. Lim has supervised numerous graduate students and postdoctoral fellows who have gone on to impactful careers in academia, industry, and research. Dr. Lim’s innovative work bridges fundamental science and translational applications, advancing the field of regenerative medicine and contributing to the development of cutting-edge biomaterials for clinical use.
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 and is an author or co-author of over 125 publications. He joined the FDA in 2012 as Deputy Center Director for CBER and became Center Director in 2016, and is a Fellow of the American College of Physicians and a member of the National Academy of Medicine.
Associate Professor, Department of Social Science and Health Policy, Wake Forest University School of Medicine
Dr. Zubin Master is an Associate Professor in the Department of Social Science and Health Policy at Wake Forest University School of Medicine and Associate Director of Wake Forest University’s Center for Bioethics, Health & Society. He is affiliated with Wake Forest Institute of Regenerative Medicine and the Maya Angelou Center for Health Equity. He joined the Wake Forest community from Mayo Clinic’s Biomedical Ethics Research Program a year ago and previously held an appointment at Albany Medical College. Dr. Master also worked for the federal public service as a Senior Policy Advisor for Health Canada. Dr. Master is member of the International Society for Stem Cell Research’s Public Policy Committee and Education Committee, and was one of the society’s first Goldstein Science Policy Fellows. He is Associate Editor for the journal Accountability in Research which publishes research on research integrity and regularly serves for the NIH Societal and Ethical Issues in Research special emphasis panel that reviews bioethics grants.
Dr. Master’s research interests broadly cover ethical and policy issues related to stem cells and regenerative medicine, genetics, research ethics, and the responsible conduct of research. His current NIH-funded studies aim to understand how beliefs and perceptions of patients seeking experimental care are influenced by mis(dis)information and to devise potential strategies to correct misinformation and elicit behavioral change, including the use of AI technology. Dr. Master is also interested in understanding the factors that contribute to health disparities surrounding novel areas of regenerative care and to develop strategies to ensure equitable access. Dr. Master’s has published over a hundred articles and his work has been presented nationally and internationally. At WFUSM, Dr. Master teaches research ethics courses for the Translational and Health System Science program, and a course on the ethical and policy issues of regenerative medicine for the Translational Biotechnology program.
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 moved to WFIRM in August 2021 where he continues his pioneering work developing stem cell-based approaches for heart failure. His laboratory’s work has been supported by the NIH, NSF, FDA, and institutional awards.
Professor, Biomedical Engineering, Tulane University
Prof. Moore was born and raised in Nebraska and received his BS in Biological Systems Engineering from the University of Nebraska. He received his PhD in Biomedical Engineering from the Mayo Clinic College of Medicine and Science where he pursued research in the development of a biodegradable spinal cord implant. He then went on to do postdoctoral research in bioengineering retinal regeneration at MIT and the Schepens Eye Research Institute at Harvard Medical School. Dr. Moore joined the Tulane Biomedical Engineering faculty as an Assistant Professor in 2007 and was promoted to Associate Professor and later Professor, and has now been serving as Department Chair since 2022. He co-founded AxoSim, Inc. in 2014 and has served as Chief Science Officer and then VP of Research since 2024. Dr. Moore has received a CAREER Award from the NSF and numerous awards for teaching, technology innovation, and contributions to diversity. He lives in the heart of New Orleans with his wife Lisa and their three children, all of whom he loves even more than research and academics.
Professor, Department of Dermatology, Stanford University
Dr. Oro is the Eugene and Gloria Bauer Professor of Dermatology at Stanford University, Program in Epithelial Biology, co-Director of the Center for Definitive and Curative Medicine, and co-director of the Child Health Research Institute. Dr. Oro uses the skin to address mechanistic question in regenerative medicine, cancer, and autoimmunity. He has a longstanding interest in skin tissue development, regeneration, and carcinogenesis that has led to the investigation of the mechanistic basis of human ectodermal and hair disorders and common skin cancers. More recently, he has pioneered AI-enabled clinical manufacturing of tissue replacement therapy using genetically-corrected pluripotent cell-derive multi-lineage differentiation.
Sr. Director, Engineering, ProKidney
Mr. Papali holds a BS in chemical engineering from Yale University and received a Six Sigma Black Belt from Xavier University. He has spent over 35 total years in manufacturing, R&D, engineering, maintenance, and facilities roles with 25+ years of experience in Pharmaceutical manufacturing including design, construction, startup, validation, operation, maintenance, and shutdown of facilities. Mr. Papali has led $350+MM in total capital investment projects with subject matter expertise in Maintenance and Calibration operations, Pharmaceutical clean room design and operation, Pharmaceutical contamination control, Structured Problem-Solving Methodologies, and Regulatory Audit Interaction/Management.
Consultant-Regenerative Medicine
Mahendra Rao received his MD (MBBS) 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 iPSC as well as other somatic stem cells and has worked in the stem cell field for more than twenty five years with stints in academia, government and regulatory affairs and industry.
Dr. Rao’s contributions have been recognized my multiple groups. He was named one of the top ten influential people in the stem cell field and was honored by the Federation of Biologists (FABA) India for his achievements in the stem cell field . He was awarded the NBRI (National Brain Research Institute) medal (India) for his contributions to neuroscience research. More recently his achievements were recognized by the Pathfinder award that is awarded annually by the Regenerative Medicine Foundation.
Until 2010 Dr. Rao led the Stem Cell and Regnerative Medicine division at LiFE Technologies and also served as the Chair of the CBER (FDA) advisory committee (CTGTAC). Dr. Rao subsequently joined the NIH under the leadership of Dr. Francis Collins to serve as the founding Director of the NIH Center of Regenerative Medicine and as the Chief of the Laboratory of Stem cell Biology at the NIH. Throughout his career Dr. Rao has provided advisory and consultancy services to Pharma, oversight committees, advisory panels on large scale projects related to stem cell biology. Advisory activities have included serving on advisory panels to the governments of the U.S., Singapore and India on hESC and iPSC policy and with the FDA and other regulatory authorities on PSC related issues most recently as the CIRM and ISSCR liaison to the ISCT.
Dr. Rao ongoing efforts are focused on translational work and he currently serves as the CSO for Vita Therapeutics and is on the Board of Directors at NKURE and Eyestem. He also is a SAB member Stellular Bio and Reprocell. Dr. Rao will continue his focus on developing low-cost technologies for use in developing countries such as India and to provide consultant and advisory services to biotechnology companies in the regenerative medicine field.
Russ has worked in the bioscience industry for over thirty - five years. Formerly he was an executive with the Burroughs Wellcome and Glaxo Wellcome companies. He was heavily involved with the commercial development of antivirals like AZT and 3TC which are mainstay treatments for HIV illness. He was CEO of the Kucera Pharmaceutical Company- a start- up bio-pharmaceutical company based in Winston-Salem. He has led a national biotechnology workforce effort for twenty years called the National Center for the Biotechnology Workforce (NCBW). The NCBW is based in Winston-Salem, a part of North Carolina’s Community College System, Forsyth Technical Community College and is a part of the college’s division of Education to Business. The NCBW focuses on achieving best practices and skill standards for the skilled technical worker. Russ leads or co- leads several NSF ATE grant initiatives including BETA Skills, Workforce Hub of InnovATEBIO, and the NSF Workforce effort for the Piedmont Triad Regenerative Medicine Engine. Russ is a Board Director for the North Carolina Life Sciences Organization.
Director, Process Development of Cell and Gene Therapy, Charles River Laboratories
Alex Sargent – better known as “Sarge” – is currently the Director of Process Development of Cell and Gene Therapy at Charles River Laboratories. He obtained his PhD from Case Western Reserve University in Cleveland Ohio, where he studied the challenges and promises of stem cell biology, neuroimmunology, and Cleveland sports teams. He then went on to the Lerner Research Institute at the Cleveland Clinic Foundation to continue his research in stem cell biology and neural regeneration. Since joining the biotech industry, he has worked at several large companies on drug discovery and the research and development of groundbreaking cell and gene therapies. These include Lonza Inc., where he patented new technologies for cell therapy manufacturing and CRISPR gene editing, and AstraZeneca, where he worked to bring new chimeric antigen receptor (CAR) T-cell therapies into clinical trials. He is passionate about the challenge of curing cancer, working on cell and gene therapy process and analytical development from discovery, through regulatory submission, manufacturing, and clinical trials. He wakes up each day excited to help advance cell and gene therapy to treat and cure disease, with the steadfast goal of improving human lives.
Industry leader for vascular and regenerative medicine
Mr. William (B.J.) Scheessele is a commercial leader with over 25 years of experience creating and growing businesses in the vascular and regenerative medicine markets. He is responsible for providing leadership, direction, and strategic vision to drive the commercial launch of the Acellular Tissue Engineered Vessel (ATEV™) in its initial vascular indications and follow-on market expansion.
Mr. Scheessele has served as Chief Commercial Officer, at Humacyte since August 2021. He served as Executive Vice President, of Global Marketing for Quest Medical Imaging Inc. from 2018 to 2021. Previously, Mr. Scheessele served as Vice President, Marketing at Sientra, Inc., a medical device company, from 2017 to 2018. Prior to that, he served as Vice President of North America Marketing and Canada Country Manager, among other roles in sales and marketing, at LifeCell Corporation, a regenerative medicine company, from 2007 to 2016, and as Vice President, North American Marketing and Reimbursement at Allergan plc, a global biopharmaceutical company. From 2016 to 2017, after its acquisition of LifeCell Corporation. Earlier in his career, Mr. Scheessele worked in business development and product management with Cordis Corporation, a medical device company and subsidiary of Johnson & Johnson, from 1998 to 2007. Mr. Scheessele earned a BSE in biomedical engineering and economics and an M.B.A. from Duke University.