Graca Almeida-Porada, MD, PhD
Wake Forest Institute for Regenerative Medicine
Graça Almeida-Porada, M.D., Ph.D. is a Professor of Regenerative Medicine at the Wake Forest Institute for Regenerative Medicine, and a Professor in the Department of Cancer Medicine, Section of Hematology and Oncology, and in the School of Biomedical Engineering and Sciences at the Wake Forest School of Medicine.
She founded and leads the Fetal Research and Therapy Program at WFIRM, which is aimed at pursuing basic and translational research to develop prenatal treatments for genetic disorders and other life-threatening conditions. Dr. Almeida-Porada is an internationally recognized physician-scientist, whose pioneering research could completely transform the entire paradigm for how genetic diseases are clinically managed. Her 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 prenatal recipients and children with genetic disorders, to cure diseases before they start.
Throughout her entire career Dr. Almeida-Porada has been supported by the National Heart, Lung, and Blood Institute to investigate, develop and manufacture novel prenatal and post-natal therapies for hematological genetic disorders. She is the co-founder of the International Fetal Transplantation and Immunology Society whose mission is to accelerate clinical applications of stem cell transplantation and gene therapy approaches, to treat fetuses with congenital disorders. She has twice served as the President of this Society and is a permanent member of its Advisory Board. She also founded and served as the first Chair of the American Society of Gene and Cell Therapy’s Prenatal Cell and Gene Therapy Committee.
Dr. Almeida-Porada is also an educator and has been fully committed to promoting knowledge and training of the next generation of scientists. She holds multiple patents and has authored more than 400 scientific works including peer-reviewed papers, abstracts, and book chapters. Dr. Almeida-Porada is the editor-in-chief of Current Stem Cell Reports and serves in multiple other editorial and clinical trial advisory boards.
Anthony Atala, MD
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.
Tracy Criswell, PhD
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 on the Wake Forest Graduate School Council. She is actively involved in curriculum development at WFIRM, and is a mentor for high school, undergraduate and graduate student trainees.
Bruce Culleton, MD
ProKidney
Dr. Culleton is Chief Executive Officer at ProKidney, an autologous cell therapy company focused on preserving kidney function in patients with advanced chronic kidney disease. Previously, he served as Chief Medical Officer and later as General Manager at CVS Kidney Care. Before joining CVS Health, he worked in senior global clinical leadership roles at Becton Dickinson and at Baxter Healthcare. Before his industry career, Dr. Culleton was a Clinical Associate Professor, Department of Medicine at the University of Calgary.
Dr. Culleton holds a Doctor of Medicine degree from Memorial University of Newfoundland and a Master's degree in Business Administration from Northwestern University, Kellogg School of Management. He completed a specialization in Internal Medicine and Nephrology through the Royal College of Physicians and Surgeons of Canada, as well as a fellowship in Clinical Epidemiology at Boston University, Framingham Heart Study.
Vijay Gorantla, MD, PhD
Wake Forest Institute for Regenerative Medicine
Dr. Gorantla is a tenured professor of surgery and director of the Vascularized Composite Allotransplantation (VCA) Program at Wake Forest University School of Medicine and the Wake Forest Institute for Regenerative Medicine. His clinical expertise is in hand transplantation and reconstructive transplantation with academic interests in ex vivo organ preservation, nerve regeneration, non-invasive imaging, and targeted immunomodulation. The Gorantla lab focuses on a wide range of research including organ transplantation, reconstructive microsurgery, nanomedicine, regenerative pharmacology, biosensors and point of care devices, cellular therapies, regenerative medicine applications in transplantation and the relationship between the immune system and regenerative, oncogenic and autoimmune processes.
Joshua Hunsberger, PhD
ReMDO; 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.
Tim Kelly, PhD
RoosterBio
Tim Kelly, Ph.D., has served as Chief Executive Officer of RoosterBio, Inc. since October 2021, helping to grow the company’s revenue 31% on average year-over-year since his appointment. He previously served as President of Manufacturing at Asklepios Biopharmaceutical, Inc. (AskBio) where he was responsible for the manufacturing strategy and delivery of AAV-based gene therapy products. For 15 years prior, he was with KBI Biopharma, Inc., an industry-leading contract development and manufacturing organization, where he ultimately served as President and Chief Executive Officer. He began his corporate experience at Diosynth Biotechnology.
Tim has overseen development and manufacturing programs for over 350 biologics at all stages of development and commercialization and has supported numerous successful FDA and international regulatory inspections throughout his career. Tim earned his Ph.D. in molecular genetics and biochemistry from Georgia State University and his BA in biology from College of the Holy Cross.
Jacob Koffler, PhD
UC San Diego School of Medicine; Auxilium Biotechnologies
Dr. Koffler is an Assistant Professor of Neurosciences at the UC San Diego School of Medicine and Co-founder and CEO of Auxilium Biotechnologies. His work in neural engineering focuses on advancing strategies to promote and guide axonal regeneration following traumatic injuries, including spinal cord and peripheral nerve damage. His research integrates tissue engineering, 3D bioprinting, neuroscience, stem cell technologies, conductive biomaterials, and targeted drug delivery to develop next generation regenerative therapies.
As CEO, Dr. Koffler leads the company’s strategy and vision and drives the translation of these technologies into clinical and commercial reality. Auxilium is currently conducting an active clinical trial that is recruiting patients while simultaneously expanding into in-space biomanufacturing. The company’s space program leverages microgravity-enabled 3D bioprinting to fabricate complex biological structures and regenerative implants that cannot be produced under terrestrial conditions, positioning Auxilium at the forefront of next-generation manufacturing for medicine on Earth and beyond.
Frank Marini, PhD
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.
Joshua Maxwell, PhD
Wake Forest Institute for Regenerative Medicine
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.
Antonios G. Mikos, PhD
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.
Mikos is a Member of the National Academy of Engineering, the National Academy of Medicine, the American Academy of Arts and Sciences, the National Academy of Inventors, the Chinese Academy of Engineering, the Academia Europaea, the European Academy of Sciences, the Royal Academy of Pharmacy of Galicia, 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 Robert A. Pritzker Distinguished Lectureship Award of the Biomedical Engineering Society, the Biomaterials Global Impact Award, and the Acta Biomaterialia Gold Medal. He is a Founding Editor and Editor-in-Chief of the journal Tissue Engineering.
Patricia Nano, PhD
Post-doc Fellow, Bhaduri Lab, University of California
Dr. Patricia Nano is a quantitative developmental biologist focused on the molecular programs that shape the human brain and how their disruption contributes to neurodevelopmental disorders. She is currently a postdoctoral fellow at the University of California, Los Angeles in the laboratory of Dr. Aparna Bhaduri, where she develops computational and experimental platforms to probe cell type diversity in the human cerebral cortex. Complementing her work in functional genomics are Dr. Nano’s roots in chemical biology: as a Ph.D. student in the lab of Dr. James Chen (Stanford University), Dr. Nano developed deep mutational scanning pipelines to map the structure-activity landscape of developmental signaling regulators.
Dr. Nano’s most recent work integrates single-cell transcriptomic atlasing, quantitative gene network analysis, and pooled CRISPR screening in human cortical organoids and primary neural cultures. Her tools have identified novel transcriptional and epigenetic regulators of human cortical cell fate and regional identity and have been applied to collaborations exploring brain tumor progression, 16p11.2del-linked disorders, and, with the NIH BRAIN Initiative, more expansive single-cell atlases of the human and non-human primate brain.
Robert Newman, PhD
North Carolina Agricultural and Technical State University
Dr. Newman is a biochemist and molecular biologist whose research focuses on the intricate architecture of cellular signaling. With a career spanning over two decades of specialized study in kinase activity and synthetic biology, Dr. Newman serves as a leader in both high-level molecular research and the mentorship of the next generation of scientific innovators at North Carolina A&T.
Newman’s rigorous academic foundation began at McDaniel College, earning a BA in Biology and Biochemistry in 1999. They went on to complete a Ph.D. in Biochemistry and Molecular Biology at Johns Hopkins University in 2006. Following their doctoral work, Dr. Newman spent six years as a Postdoctoral Fellow in the Jin Zhang Lab within the Department of Pharmacology and Molecular Sciences at the Johns Hopkins University School of Medicine, specializing in the spatiotemporal regulation of cellular signaling. Currently leading the Newman Lab, Dr. Newman investigates the organization and regulation of cellular signaling networks.
Dr. Laura Niklason MD, PhD
Humacyte Inc. ; Yale University
Dr. Niklason is the founder, President and CEO of Humacyte. Dr. Niklason founded Humacyte in 2005, while a professor at Duke University. Humacyte is a regenerative medicine company, advancing a category-defining platform technology for manufacturing off-the-shelf human tissues at commercial scale. Humacyte received FDA approval for its engineered blood vessel, Symvess™, in December 2024 for the treatment of traumatic injuries in adults and is currently commercializing the engineered blood vessel in the United States.
Niklason received her PhD degree in Biophysics from the University of Chicago and her MD from the University of Michigan. She completed her medical training in anesthesiology and critical care medicine at the Massachusetts General Hospital in 1996. She was a professor at Duke University from 1998 – 2005, before moving to Yale University in 2005. Niklason’s scientific and business career has focused primarily on regenerative strategies for cardiovascular and lung tissues. She was inducted into the National Academy of Inventors in 2014, into the National Academy of Medicine in 2015, and the National Academy of Engineering in 2020. She was also named (along with Bill Gates and Joe Biden) as one of 34 leaders who are changing healthcare by Fortune Magazine in 2017. In November 2020, Niklason assumed the role of President and CEO at Humacyte and continues as an adjunct professor at Yale University.
Christopher Porada, PhD
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.
Ritu Raman, PhD
MIT
Ritu Raman, PhD is the Eugene Bell Career Development Associate Professor of Mechanical Engineering at MIT. Her lab is centered on tissue engineering biological actuators for applications in regenerative medicine and biohybrid robotics. Ritu’s research has received several recognitions including the Presidential Early Career Award for Scientists and Engineers (PECASE), the National Science Foundation CAREER Award, the Army Research Office Early Career Award, and the Office of Naval Research Young Investigator Award, as well as Rising Star Junior Faculty Awards from the Biomedical Engineering Society and the American Society of Mechanical Engineers.
She has been named a National Academy of Engineering (NAE) Grainger Frontiers of Engineering Fellow and National Academy of Sciences (NAS) Kavli Frontiers of Science Fellow, and included on both the Forbes 30 Under 30 and MIT Technology Review 35 Under 35 lists. Ritu’s efforts to add hands-on experiences to classes at the intersection of mechanical engineering and biology were recently recognized by an MIT Spira Award for Excellence in Teaching. Beyond the classroom, Ritu is passionate about broadening access to scientific literacy in tissue engineering, and is the author of the MIT Press book Biofabrication.
Joan Schanck, MPA
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.
Jana Stoudemire
Axiom Space
As part of the In-Space Solutions team for Axiom Space, Jana is helping to create new market sectors in the commercial space economy for in-space manufacturing of biomedical and advanced material applications on the world's first commercial space station. She transitioned from pharma to lead life science research in microgravity as part of the team managing the International Space Station U.S. National Laboratory (ISS-NL), then joined Space Tango where she successfully established the initial foundational partnerships that are helping to define an emerging biomedical market on orbit.
Jana is a member of the National Academies of Sciences, Engineering, and Medicine Committee on Biological and Physical Sciences in Space, Regenerative Medicine Manufacturing Society member, a WOMEN In Advanced Therapies leadership mentor, National Stem Cell Foundation International Space Station Program Advisor, United Mitochondrial Disease Foundation Board of Trustees Member, and past New Organ Alliance Oversight Committee Member and co-chair of the Microgravity Enabling Technology Committee. Jana also served as co-editor of the book entitled, In-Space Manufacturing and Resources: Earth and Planetary Exploration Applications published in 2022 (Wiley, ISBN: 978-3-527-34853-4).
Xiuzhi Susan Sun, PhD
Wake Forest Institute for Regenerative Medicine
Dr. Xiuzhi Susan Sun is a Professor at the Wake Forest Institute for Regenerative Medicine at the Wake Forest University School of Medicine. She has more than 30 years of experience in the design and fabrication of biomaterials derived from natural biopolymers and biomolecules. Her research encompasses environmental, food, and biomedical applications, with a current focus on synthetic peptide hydrogels that mimic the human extracellular matrix. These hydrogels enable advanced 3D cell and organoid culture systems, 3D disease and developmental models, and stem cell–based research.
Dr. Sun is a pioneer in 3D hiPSC culture and biomanufacturing, a disruptive technology that supports the self‑organization of physiologically relevant organoids, including hepatic, cerebral, cardiac, and retinal systems. She has authored more than 240 peer‑reviewed journal articles and holds 17 patents. Her work has significantly advanced technology transfer and commercialization, bridging fundamental research and real‑world applications. She is also the founder of PepGel, LLC. Dr. Sun’s achievements have been recognized through her election as a Fellow of the National Academy of Inventors (NAI) in 2018 and a Fellow of the American Society of Agricultural and Biological Engineers (ASABE) in 2016. She has served as a University Distinguished Professor at Kansas State University since 2011. She earned her Ph.D. from the University of Illinois at Urbana–Champaign.
Kyung Sung, PhD
Cellular and Tissue Therapies Branch, FDA
As Chief of the Cellular and Tissue Therapies Branch at the FDA, Dr. Kyung Sung oversees the regulatory review process for a diverse portfolio of cell therapies, tissue products, and medical devices, while also serving as a hands-on reviewer. She directs regulatory science programs that develop novel engineering tools and assays to improve the characterization and manufacturing of these products, directly supporting the FDA's public health mission. Before joining the FDA in 2015, Dr. Sung was a Biotechnology Patent Examiner at the USPTO. She holds a Ph.D. in Chemical Engineering from the University of Michigan and conducted postdoctoral research at the University of Wisconsin, Madison.
John Tisdale, MD
Cellular and Molecular Therapies Branch of the National Heart, Lung and Blood Institute (NHLB), NIH
John Tisdale, MD, is a senior investigator and chief of the Cellular and Molecular Therapeutics Branch of the National Heart, Lung, and Blood Institute (NHLBI) at NIH. Dr. Tisdale’s research focuses on developing curative strategies for sickle cell disease through transplantation of allogeneic or genetically modified autologous hematopoietic stem cells. An elected member to the American Society for Clinical Investigation and recipient of American Society of Hematology's Ernest Beutler Prize, Dr. Tisdale has over 250 publications. He was the Principal Investigator on the gene therapy trial of lovo-cel for SCD that was FDA approved in 2023.
Victoria Weis, PhD
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.
Yu Shrike Zhang, PhD
Harvard Medical School; Brigham and Women’s Hospital
Dr. Zhang is Associate Professor in the Department of Medicine at Harvard Medical School and Associate Bioengineer in the Division of Engineering in Medicine at the Brigham and Women’s Hospital. Dr. Zhang is directing the Laboratory of Engineered Living Systems, where the research is focused on innovating medical engineering technologies, including 3D bioprinting, organs-on-chips, microfluidics, and bioanalysis, to recreate functional tissues and their biomimetic models, for applications in regenerative medicine and personalized medicine. He has ~50,000 citations and an h-index of >110. His scientific contributions have been recognized by >50 international, national, and regional awards.