2020 Conference Speakers
6th Perinatal Stem Cell Society Congress
March 4-6, 2020
Leonardo Museum, Salt Lake City, Utah, USA
March 4-6, 2020
Leonardo Museum, Salt Lake City, Utah, USA
Click on images to read bios
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Kyle Cetrulo President and Founder, Perinatal Stem Cell Society Co-Founder and CEO, Auxocell Laboratories, Inc. Kyle Cetrulo has been interested in Perinatal Stem Cells and non-profit organizations since 1998. As the former Director of the International Cord Blood Society (ICBS), Mr. Cetrulo organized the 5th and 6th International Congresses for the ICBS in 2002 and 2004, which had representatives from 23 countries participate in the meetings. In 2008, Mr. Cetrulo co-founded Auxocell Laboratories, Inc. (Auxocell). Auxocell achieved profitability in three years under his leadership and Mr. Cetrulo currently remains in the position of Chief Executive Officer at Auxocell. Editor of two editions of Perinatal Stem Cells (Wiley Press, 2010 and 2013) and 2006 guest editor of the Stem Cell Reviews journal special edition focused on Perinatal Stem Cells, Mr. Cetrulo developed relationships with the world’s preeminent stem cell researchers working in the perinatal stem cell field. In 2013, Mr. Cetrulo along with his co-founders, decided to form the non-profit International Perinatal Stem Cell Society, Inc., in order to provide a platform for collaboration and the dissemination of knowledge and information about perinatal stem cells. |
Kyle Cetrulo
Welcome |
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Renee Nordland Parent Advocate and the Founder of the Cord Tissue for Autism FaceBook Group Title: How Cord Tissue Change My Son’s Life Renee is a parent advocate and the founder of the Cord Tissue for Autism FaceBook Group. In 2016 her son Gage was diagnosed with Autism. Renee began to research every therapy and treatments that would help her child, stem cell and tissue treatment became top on her list. Ultimately, Renee decided to pursue a Cord Tissue therapy and has witnessed the incredible results in her child. Her goal is to help spread awareness of this treatment so that every autistic child has the opportunity to receive this treatment. |
Renee Nordland
How Cord Tissue Changed My Son’s Life |
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Frances Verter, PhD Founder and Director of the Parent’s Guide to Cord Blood Foundation Frances Verter holds a PhD in astrophysics and worked at NASA Goddard for decades. Conference Presentation Topic: Clinical Trials with Perinatal Tissues and Cells Parent's Guide to Cord Blood Foundation is a 501c3 charity that has been helping parents to learn about and navigate their cord blood options since 1998. We are the only organization in the world that actively maintains directories of family and public cord blood banks worldwide. Nowadays we also provide education on banking and therapy with cells from the umbilical cord and placenta. Our website www.parentsguidecordblood.org is available in multiple languages. CellTrials.org is a subsidiary of the Foundation that tracks clinical trials worldwide, and provides both free resources as well as databases for sale. Commercial databases from CellTrials.org typically list two dozen parameters per clinical trial, enabling clients to analyze the data however they want. Research by CellTrials.org has enabled the Foundation to offer the world’s only search portals of all clinical trials that are actively recruiting for studies with cord blood or umbilical cord tissue. Frances Verter holds a PhD in astrophysics and worked at NASA Goddard for decades. Her interest in stem cell medicine is inspired by her daughter Shai, who died of cancer in 1997. |
Frances Verter, PhD
Clinical Trials with Perinatal Tissues and Cells |
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Tomasz Baran MD, MBA Tomasz Baran is Board Member of PBKM (Polish Stem Cell Bank) operating in multiple European countries as FamiCord Group. Conference Presentation Topic: FamiCord’s Clinical Experience with WJ Derived Products in Multiple Clinical Applications At FamiCord Tomasz is responsible for Sales and Marketing activities towards healthcare professionals and expectant parents. Tomasz has both medical (MD since 1997) and business (MBA since 2007) background. He joined PBKM in 2010, prior entering cord blood banking sector he has been holding various position in pharmaceutical industry. |
Tomasz Baran MD, MBA
FamiCord’s Clinical Experience with WJ Derived Products in Multiple Clinical Applications |
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Neil Riordan, PA, PhD Founder and chief scientist at the Stem Cell Institute in Panama City, Panama, and co-founder of the Riordan-McKenna Institute in Southlake, Texas. Conference Presentation Topic: Results from Panama clinical trials using umbilical cord mesenchymal cells: Multiple Sclerosis and Autism Neil Riordan, PA, PhD is one of the early pioneers and experts in applied stem cell research. Dr. Riordan founded publicly traded company Medistem Laboratories (later Medistem Inc.), which was acquired by Intrexon in 2013. He is founder and chief scientist at the Stem Cell Institute in Panama City, Panama, and founder of the Riordan Medical Institute and Signature Biologics in the Dallas Fort Worth area. Dr. Riordan has published more than 70 scientific articles in international peer-reviewed journals. In the stem cell arena, his colleagues and he have published more than 20 articles on multiple sclerosis, spinal cord injury, heart failure, rheumatoid arthritis, Duchenne muscular dystrophy, autism, and Charcot-Marie-Tooth syndrome. In addition to his scientific journal publications, Dr. Riordan has authored two books about mesenchymal stem cell therapy: Stem Cell Therapy: A Rising Tide: How Stem Cells Are Disrupting Medicine and Transforming Lives and MSC (Mesenchymal Stem Cells): Clinical Evidence Leading Medicine’s Next Frontier. Dr. Riordan has also written two scientific book chapters on the use of non-controversial stem cells from placenta and umbilical cord. |
Neil Riordan, PA, PhD
Results From Panama Clinical Trials Using Umbilical Cord MSCs: Multiple Sclerosis and Autism |
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Joanne Kurtzberg, MD Director, Marcus Center for Cellular Cures (MC3) Director, Pediatric Blood and Marrow Transplant Program Director, Carolinas Cord Blood Bank Co-Director, Stem Cell Laboratory Conference Presentation Topic: Extending Perinatal Therapies for the Brain Dr. Joanne Kurtzberg is an internationally renowned expert in pediatric hematology/oncology, pediatric blood and marrow transplantation, umbilical cord blood banking and transplantation, and novel applications of cord blood in the emerging fields of cellular therapies and regenerative medicine. Dr. Kurtzberg pioneered the use of umbilical cord blood as an alternative stem cell source for unrelated hematopoietic stem cell transplantation (HSCT). Over the last two decades, Dr. Kurtzberg has established an internationally known pediatric transplant program at Duke, which treats children with cancer, blood disorders, immune deficiencies, hemoglobinopathies and inherited metabolic diseases. In 2010, Kurtzberg established the Julian Robertson Cell and Translational Therapy Program (CT2) at Duke. CT2 focuses on translational studies from bench to bedside with a focus on bringing cellular therapies in regenerative medicine to the clinic. Recent areas of investigation in CT2, which are funded by the Marcus Foundation, include the use of autologous cord blood in children with neonatal brain injury, cerebral palsy, and autism, as well as preclinical and clinical studies manufacturing microglial oligodendrocyte-like cells from cord blood to treat patients with acquired and genetic brain diseases. Studies of donor cord blood cells and donor cord tissue MSCs in adults with stroke and children with cerebral palsy and autism are also underway. In 2018, Dr. Kurtzberg established and became director of the Marcus Center for Cellular Cures (MC3) at Duke. Dr. Kurtzberg established one of the largest unrelated donor cord blood banks, the Carolinas Cord Blood Bank, in the world at Duke in 1998. The bank has a current inventory of >40,000 units and has provided cord blood units to over 2,500 patients undergoing unrelated donor HSCT over the past 20 years. Dr. Kurtzberg’s lab has developed novel assays enumerating ALDH bright cells to predict cord blood potency from segments attached to cryopreserved cord blood units, and is performing translational research testing cord blood expansion, cellular targeted therapies and tissue repair and regeneration. In 2012, under the direction of Dr. Kurtzberg, the Carolinas Cord Blood Bank received FDA approval for DuCord, a stem cell product derived from umbilical cord blood, for use in transplants between unrelated donors and recipients. Dr. Kurtzberg currently holds several INDs for investigational clinical trials. Additionally, she is the co-director of the Duke Hospital Stem Cell Transplant Laboratory. Dr. Kurtzberg has published over 300 peer-reviewed papers, multiple chapters and scientific reviews. She is a member of the American Society of Hematology, the American Association of Blood and Marrow Transplantation, the American Society of Pediatric Hematology/Oncology, the International Society of Cellular Therapies, the Pediatric Blood and Marrow Transplant Consortium (PBMTC), and multiple other organizations. She has served on the Board of the Foundation of Accreditation of Cellular Therapies, co-chaired the National Marrow Donor Program’s Cord Blood Advisory Group and has served on the Advisory Council of Blood Stem Cell Transplantation to Health and Human Services. Dr. Kurtzberg was awarded a Lifetime Achievement Award from the PBMTC in 2012. Most recently, she established and is the first president of the Cord Blood Association. *********************** Extending Cord Blood to Regenerative Therapies for the Brain Joanne Kurtzberg, MD; Director, Marcus Center for Cellular Cures; Director, Carolinas Cord Blood Bank; Director, Pediatric Blood and Marrow Transplant Program Cord blood cells can work through paracrine and trophic mechanisms to help endogenous cells heal brain tissue damaged by disease or injury. Learning from observations made using unrelated donor umbilical cord blood transplantation after myeloablative chemotherapy to treat children with certain inherited metabolic diseases, cord blood therapies have been developed to treat children with acquired brain injuries, like hypoxic ischemic encephalopathy, cerebral palsy, and autism. Results of preclinical and IND enabling studies will be presented to provide information about safety and potential mechanisms of action of cord blood cells in this setting. Data from early phase human clinical trials for safety and efficacy in these diseases will be presented by the speaker in this session. Learning Objectives: 1. Attendee will learn the history and evolution of cord blood banking and transplantation. 2. Attendee will learn about quality measures of cord blood units. 3. Attendee will learn about new clinical applications for cord blood therapies. |
Joanne Kurtzberg, MD
Extending Perinatal Therapies for the Brain |
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Rouzbeh R. Taghizadeh, PhD Director, Secretary, and Founder of the Perinatal Stem Cell Society Chief Scientific Officer, Auxocell Laboratories, Inc. Conference Presentation Topic: Umbilical Cord Tissue Processing Technologies for Perinatal MSC Banking Dr. Rouzbeh R. Taghizadeh has dedicated more than 15 years to bringing stem cell-based therapies to clinical practice. He earned his Ph.D. in Stem Cell Bioengineering in 2006 from the Massachusetts Institute of Technology (MIT) and cofounded AuxoCell Laboratories, Inc. as Chief Scientific Officer in 2008. At AuxoCell, Dr. Taghizadeh developed novel methods and technologies most notably, the patented AuxoCell Processing System (AC:Px™), in order to establish the collection, processing, and banking of stem cells from the human umbilical cord for eventual utilization in cell based therapies, regenerative medicine, and other clinical applications. Dr. Taghizadeh has contributed to numerous peer-reviewed publications, book chapters, and patents and is an editor of the 2nd edition of Perinatal Stem Cells. |
Rouzbeh R. Taghizadeh, PhD
Umbilical Cord Tissue Processing Technologies for Perinatal MSC Banking |
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Timothy Ganey, PhD Tim Ganey is Chief Scientific Officer for Vivex Biomedical, Marietta, GA; Director of the Atlanta Learning Center, and Director of Orthopedic Research at the Atlanta Medical Center; Chief Technical Officer, Spinplant GmbH, Leipzig, Germany; a Faculty Member of the TRM Facility in Leipzig Germany, and a faculty member at Nova Southeastern, Ft. Lauderdale, FL. Conference Presentation Topic: Quantification of Exosome Product As President of the US division of co.don Tissue Engineering, he guided a team that developed and commercialized a portfolio of cell-based therapeutics for cartilage, bone, and the first clinically available biologic for intervertebral disc in 1999. Dr. Ganey has been instrumental in several technology development initiatives, among them the use of cell-based therapeutics, electric field transduction, additive manufacturing (3D printing), and prescribed matrices for regenerative medicine. Patents issues include work stemming from pulsed-field delivery, artificial matrices for bone regeneration, electro-spinning methods and materials, mimetic material modification using photoactive lasers, and stem cell procurement and purification. His efforts have been aligned with the shifting paradigm supporting regenerative treatments for effective patient care – translation as the engine of implementation. |
Timothy Ganey, PhD
Quantification of Exosome Product |
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Ramon Coronado, MSc, PhD Executive Director Lester Smith Medical Research Institute Conference Presentation Topic: Exosomes to Treat Cancer Dr. Ramon Coronado, moved from Caracas, Venezuela to San Antonio, Texas in 2009 after completing his B.S. in Polymer Engineering. He studied biomedical engineering through the joint program at UTSA/UTHSCSA and a collaborative effort with the US Army Institute of Surgical Research, receiving his masters in 2012 and his Ph.D. in 2016. Passionate about translating care, he founded Mobile Stem Care in 2013, a company focused on delivering stem cell treatments to animals. Following his success in animal care, Dr. Coronado was named Executive Director for the Lester Smith Medical Research Institute in 2015 where he leads research on a variety of human based cellular therapeutics. He received the CellTex Young Investigator Award in 2016 for his work as Director and continues to explore the boundaries of human cellular therapies. In his free time, Dr. Coronado enjoys rock climbing and freediving. |
Ramon Coronado, MSc, PhD
Exosomes to Treat Cancer |
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Dr Rebecca Lim, PhD Dr Rebecca Lim is a stem cell biologist specializing in gestational tissue derived stem cells. She holds joint appointments with the Department of Obstetrics and Gynaecology, Monash University and The Ritchie Centre, Hudson Institute of Medical Research. Dr Lim holds adjunct appointments at the Australian Regenerative Medicine Institute and Chinese University Hong Kong. She serves on the scientific advisory board of the Centre for Commercialisation of Regenerative Medicine – Australia, and is a director of Meluha Capital, a Malaysian-owned biotech company. Conference Presentation Topic: Exosome Therapy for Bronchopulmonary Dysplasia - Are We Ready for Cell-free Regenerative Medicine? Dr Rebecca Lim leads the Amnion Cell Biology team at the Ritchie Centre where she is deputy Centre Head. Dr Lim’s team has been investigating the regenerative potential of human amnion epithelial cells (hAECs). Her research team has uncovered mechanisms through which the hAECs modulate inflammatory events and bolster endogenous repair processes. They have demonstrated that hAECs are able to directly influence the stem cell niche in order to bring about tissue regeneration. This work has now progressed to early phase clinical trials across multiple sites in Australia – in premature babies with bronchopulmonary dysplasia, adults with liver cirrhosis, and stroke. Most recently, Dr Lim has published two patents on hAEC-derived exosomes for regenerative medicine. |
Rebeca Lim, PhD
Exosome Therapy for Bronchopulmonary Dysplasia - Are We Ready for Cell-free Regenerative Medicine? |
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James L. Sherley, MD, PhD Founder and director of Massachusetts stem cell biotechnology company Asymmetrex, LLC Conference Presentation Topic: "A New Advance in Stem Cell Counting: Tissue Stem Cell-Specific Fraction from Simple Doubling Time Data” James L. Sherley, M.D., Ph.D. is the founder and director of Massachusetts stem cell biotechnology company Asymmetrex, LLC. Asymmetrex develops and markets technologies for advancing stem cell medicine, including the first-in-kind technology for specific counting of adult tissue stem cells. This technology is also applied to design optimized procedures for more effective manufacturing of therapeutic adult tissue stem cells at greatly reduced cost. Dr. Sherley is a graduate of Harvard College, with a B.A. degree in biology, and the Johns Hopkins University School of Medicine, earning joint M.D. and Ph.D. degrees. Prior to founding Asymmetrex, he held academic research appointments at the Fox Chase Cancer Center, Massachusetts Institute of Technology, and Boston Biomedical Research Institute. Dr. Sherley’s professional awards include Pew Biomedical Research Scholar, Ellison Medical Foundation Senior Scholar in Aging Research, and NIH Director’s Pioneer Award. |
James L. Sherley, MD, PhD
A New Advance in Stem Cell Counting: Tissue Stem Cell-Specific Fraction from Simple Doubling Time Data |
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Ben Noren Founder of VisibleFlow, Principal Investigator at CellDrop Conference Presentation Topic: Cell Microencapsulation for Enhanced Regeneration of Tissues Ben Noren received his PhD in Chemical Engineering from the University of Wyoming where his research focused on tissue engineering and biomaterial design applied to translational medicine. During his graduate degree he co-founded two companies—VisibleFlow, which implements ultraprecise laser etching to rapidly prototype microfluidic devices, and CellDrop, a tissue engineering startup using microfluidics and 3D bioprinting to create realistic tissue scaffolds for precise control over cellular fate and function. As Principal Investigator at CellDrop, Ben is commercializing his dissertation research microencapsulating living cells in inert hydrogel droplets to localize them within injured tissues and maintain their long term viability. This technology is being applied to develop a minimally invasive method to regenerate cartilage in osteoarthritic joints, repair severed nerves, and create realistic microenvironments for Islet cells in artificial pancreases. Ben has spent time as a graduate research fellow at the Woods Hole Marine Biological Laboratory where he advised the physiology course in microfluidics and collaborated with an international team of researchers to develop photosensitive biomaterial systems for tissue engineering. He was the recipient of the 2018 Fisher Innovation Launchpad award for his startup VisibleFlow, a National Science Foundation I-Corps grant for his startup CellDrop, and is the author multiple peer reviewed publications related to biomaterial technologies published in journals including Lab on a Chip, ACS Biomaterials Science & Engineering, and Current Opinion in Biotechnology. Additionally, Ben is a certified professional alpine ski instructor, kayak guide, and former All-American collegiate nordic ski racer. |
Ben Noren
Cell Microencapsulation for Enhanced Regeneration of Tissues |
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John Wetherell, PhD Pillsbury's San Diego Intellectual Property Leader, Board of Directors of the Cystic Fibrosis Foundation Conference Presentation Topic: Patent Protection for Stem Cell Innovations John Wetherell, Ph.D., Pillsbury's San Diego Intellectual Property leader, has 25+ years' experience closing IP deals and securing U.S. and international patents for biotechnology companies. John's counseling experience includes intellectual property acquisition, transactional due diligence, patent infringement and validity analyses, and freedom-to-operate opinions, as well as licensing and strategic counseling. His patent prosecution experience includes obtaining U.S. and foreign protection in biotechnology areas such as molecular biology, immunology, nanotechnology, medical diagnostics, microbiology and pharmacology. He also evaluates intellectual property portfolios for both companies and investors. At Pillsbury, John is the partner in charge of the Intellectual Property practice in the San Diego office, and co-leader of the National Life Sciences Group. He is also the leader of the Stem Cell Outlook and Planning Effort (SCOPE), a group established to provide multidisciplinary legal services to clients in this promising new area of technology. John received a B.S. in Chemistry, and a Ph.D. in Microbiology/ Immunology, both from the University of Florida, and a J.D. from Seton Hall University School of Law. He conducted postdoctoral research, including studies on the humoral and cellular immune responses in periodontal disease, at The Forsyth Institute in Boston, where he concurrently held an NIH post-doctoral fellowship and a Young Principal Investigator's award. Before becoming an attorney, he gained extensive experience as a research scientist and manager during his five-year tenure in the biotechnology industry. He also serves on the Board of Directors of the Cystic Fibrosis Foundation. John has written and lectured extensively for organizations and institutions around the world on patent law, biotechnology patent law, IP strategy, and related IP transactional issues. |
John Wetherell, PhD
Patent Protection for Stem Cell Innovations |
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Randy Yerden
Maximizing Phenotypic and Genotypic Integrity in Therapeutic Cells |
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Duncan Ross, Ph.D. Founder of Kimera Labs, Inc. Conference Presentation Topic: Exosome Characterization and Visualization Dr. Duncan Ross is an expert in stem cell culture and has developed and patented proprietary methods of stem cell manipulation and licensing using growth factors and nucleic acids. A native of Miami Beach, Florida, Dr. Ross earned a Bachelor of Science in Microbiology and Immunology and a Ph.D. in Immunology/Biochemistry from the University of Miami in Coral Gables, Florida, where his research focused on mechanisms of suppression of graft vs. host disease in minor antigen mismatched allogeneic hematopoietic stem cell transplantation. As founder of Kimera Labs, Inc., Dr. Ross’s work is focused on controlling disease with immunological molecular approaches, in particular, exosome isolation from perinatal cells and amniotic fluid. As a pioneer in the development of cell-free exosome products, Dr. Ross’s research has been and continues to be employed by many physicians and clinics in a variety of regenerative medicine protocols. Dr. Ross has been featured in various peer reviewed publications including “Blood” and “Biology of Blood and Marrow Transplantation”, in which he discussed the use of various cell types to suppress immunological diseases, and currently has a patent pending for wound healing exosomes. Dr. Ross is also the founding board member of the federal nonprofit research organization, The Kimera Society, which has developed a number of clinical partners in the US and abroad by serving as an educational conduit for clinics. |
Duncan Ross, PhD
Exosome Characterization and Visualization |
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Saadiq F. El-Amin III, MD, PhD Chief Science Officer for BioIntegrate™, Medical Expert on Fox 5 Atlanta “Play to Win” TV show, Owner of the El-Amin Orthopaedics & Sports Medicine Institute in Atlanta Conference Presentation Topic: Regenerative Medicine in Elite and Professional Athletes Saadiq El-Amin, MD, PhD is the Chief Science Officer for BioIntegrate™. Dr. El-Amin is a Board-Certified orthopaedic surgeon specializing in the shoulder, upper extremity and sports medicine. He received his orthopaedic surgery training at the University of Virginia Health Sciences Center in Charlottesville, VA and furthered his training and education by completing a fellowship in Shoulder and Sports Medicine Orthopaedic Surgery at Hospital for Special Surgery in New York, NY. While there he served as the Assistant Team Doctor for the New York Knicks and for the St. John’s University under the guidance of Dr. Answorth Allen and Dr. Lisa Callahan. He also has a PhD in Molecular and Cell Biology and a Master of Medical Science Research in Tissue Engineering from Drexel University College of Medicine in Philadelphia, PA. Dr. El-Amin completed his Postdoctoral fellowship in Chemical and Tissue Engineering also from Drexel University. Dr. El-Amin is the Medical Expert on Fox 5 Atlanta “Play to Win” TV show and Owner of the El-Amin Orthopaedics & Sports Medicine Institute in Atlanta. He is also the Team Physician for the North Gwinnett Bulldogs and Lanier Longhorns Football teams. Most recently, Dr. El-Amin served as the Team Physician for UIS-Springfield Athletics and was the Director of Shoulder and Sports medicine for the Southern Illinois University School of Medicine (SIU). He was also the Team Orthopedic Physician for the Springfield Foxes Semi-Pro Football Team, Quincy University and Robert Morris College. He has also served as an Adjunct Assistant Professor for the Department of Electrical and Computer/Biomedical Engineering and Medical Microbiology, Immunology and Cell Biology at SIU. Dr. El-Amin’s research interests include tissue engineering and regenerative medicine. He has published over 50 original research articles, book chapters and review articles, and have authored and co-authored several abstracts presented at national and international conferences. |
Saadiq F. El-Amin III, MD, PhD
Regenerative Medicine in Elite and Professional Athletes |
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Regan Archibald, LAc, FMP, CSSAc Create the award-winning clinic, East West Health, which is one of the few clinics in the nation to successfully integrate traditional eastern medicine, stem cell therapy, peptides and functional medicine. Conference Presentation Topic: Ending the Pain Crisis with TCM, Peptides and Perinatal Allographs Regan Archibald, LAc, FMP, CSSAc, graduated with his Masters of Science from the Traditional Chinese Medical College of Hawaii and went on to create the award-winning clinic, East West Health in 2004. East West Health has 4 locations throughout Utah, and one in Albuquerque, NM and Oahu, HI. It is one of the few clinics in the nation to successfully integrate traditional eastern medicine, stem cell therapy, peptides and functional medicine. Regan is also the founder of Go Wellness which is a training and educational program for some of the most transformative Doctors in the healthcare field. He loves mentoring, and coaching and working with individuals who are seeking natural solutions for pain. |
Regan Archibald, LAc, FMP, CSSAc
Ending the Pain Crisis with TCM, Peptides and Perinatal Allographs |
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Ian White, Ph.D. Founder of Self Care Regeneration, LLC, Chief Science Officer at REGENiSELF, LLC and lead Scientific Advisor for IMAC Regeneration Centers Conference Presentation Topic: Regeneration 101: Amniosomes in Regenerative Medicine Dr. Ian White is an expert in the field of regenerative medicine with 20 years’ experience working with cardiovascular biology, tissue regeneration and stem cell biology. Dr. White received his B.S. and M.S. degrees from Liverpool University, England prior to being hired at Dartmouth College to study the genetics of gamete biology. In 2000, Dr. White was recruited to Harvard University to work with hematopoietic stem cells and immune cell biology. Dr. White went on to receive his Ph.D. from the Ansary Stem Cell Institute of Cornell University. Following the completion of this Ph.D., Dr. White continued his work on stem cell biology at the Interdisciplinary Stem Cell Institute at the University of Miami’s Miller School of Medicine and Bascom Palmer Eye Institute. Dr. White published ground-breaking research in the field of regenerative medicine alongside Dr. Joshua Hare, including a book chapter on the use of Mesenchymal Stem Cells in Cardiology and a cover article on the role of peripheral nerves in cardiac regeneration. Dr. White is the Founder of Self Care Regeneration, LLC, Chief Science Officer at REGENiSELF, LLC and lead Scientific Advisor for IMAC Regeneration Centers. Dr. White has published extensively in the field of stem cell biology, clinical stem cell applications and regenerative medicine. |
Ian White, PhD
Regeneration 101: Amniosomes in Regenerative Medicine |
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Mike Druckman Chairs the Hogan Lovell’s Cell, Tissue, and Gene Therapies Working Group Conference Presentation Topic: Regulatory Questions All 361 Companies Should Understand Mike Druckman leverages his prior experience at the FDA in the Office of the Chief Counsel and what he has learned since then while extricating companies from regulatory problems to anticipate and prevent life science clients from getting into trouble in the first place. Mike chairs the Hogan Lovell’s Cell, Tissue, and Gene Therapies Working Group, a cross-disciplinary team that advises companies in this emerging space on the evolving regulatory and business challenges they face. Mike and the team work closely with companies developing stem cells, cord blood, placental tissues, gene therapies, proteins, and other cellular and tissue products to help people with serious health problems. Mike also advises companies with a full range of regulatory challenges involved in investigating new drugs, biologics, and combination products, obtaining FDA approval for those products, and in promoting, selling, and distributing them. |
Mike Druckman
Regulatory Questions All 361 Companies Should Understand |
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Jeremy J. Lim, PhD Senior Biomedical Engineer at MiMedx Group, Inc Conference Presentation Topic: Biological Properties of Dehydrated Human Amnion/Chorion Membrane and Umbilical Cord Allografts for Soft Tissue Healing Jeremy Lim, PhD is a Senior R&D Engineer at MiMedx Group, Inc., where he has been a member of the Research and Development team since 2013. Prior to MiMedx, Dr. Lim was an NSF Graduate Research Fellow at Georgia Tech and an ASEE/NSF Engineering Innovation Fellow at MedShape, Inc. He received his PhD in Biomedical Engineering from Georgia Tech and Emory University in Atlanta, GA and received his BS in Biomedical Engineering from Northwestern University in Evanston, IL. Dr. Lim’s research investigates the development and characterization of biomaterials to control cytokine delivery and regulate stem cell activity to promote healing and repair. Dr. Lim has published over 15 peer-reviewed scientific articles and book chapters to date. |
Jeremy J. Lim, PhD
Biological Properties of Dehydrated Human Amnion/Chorion Membrane and Umbilical Cord Allografts for Soft Tissue Healing |
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Sean Murphy, PhD Assistant Professor, Wake Forest Institute for Regenerative Medicine Director/Secretary and Co-founder of the Perinatal Stem Cell Society Conference Presentation Topic: Amnion Membrane-Derived Cells and Materials for Skin Wound Treatment Dr. Sean V. Murphy received his Bachelors degree from the University of Western Australia and his Ph.D. from Monash University, Melbourne, Australia. He is currently an Assistant Professor of Regenerative Medicine at the Wake Forest Institute for Regenerative Medicine in North Carolina, USA. His research focuses on developing regenerative medicine and tissue engineering strategies to establish and improve clinical treatments for lung disease. These strategies include cell therapies to restore normal function to lung tissue and minimize inflammation and scarring associated with disease, use of 3D bioprinting to fabricate new airway tissues for transplantation, and lung-on-a-chip technologies for disease modeling and drug discovery. Dr. Murphy is currently the Associate Editor of the journal Bioprinting, on the Editorial Board of multiple journals, including Stem Cells Translational Medicine and is Director, Secretary and Founder of the Perinatal Stem Cell Society. Dr. Murphy has published over 30 peer reviewed journal articles, multiple book chapters and reviews, and numerous awards and fellowships, most notably from the American Lung Association Senior Research Training and the American Australian Association. |
Sean Murphy, PhD
Amnion Membrane-Derived Cells and Materials for Skin Wound Treatment |
FDA Representative
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Mike Druckman Chairs the Hogan Lovell’s Cell, Tissue, and Gene Therapies Working Group Conference Presentation Topic: Regulatory Questions All 361 Companies Should Understand Mike Druckman leverages his prior experience at the FDA in the Office of the Chief Counsel and what he has learned since then while extricating companies from regulatory problems to anticipate and prevent life science clients from getting into trouble in the first place. Mike chairs the Hogan Lovell’s Cell, Tissue, and Gene Therapies Working Group, a cross-disciplinary team that advises companies in this emerging space on the evolving regulatory and business challenges they face. Mike and the team work closely with companies developing stem cells, cord blood, placental tissues, gene therapies, proteins, and other cellular and tissue products to help people with serious health problems. Mike also advises companies with a full range of regulatory challenges involved in investigating new drugs, biologics, and combination products, obtaining FDA approval for those products, and in promoting, selling, and distributing them. Mike Druckman
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Barbara Krutchkoff, PhD FAARM Executive Director, Institute of Regenerative and Cellular Medicine CEO of A3Cell/Consultancy Visiting Lecturer, Universite Paris Descartes Director of Cell and Gene Applications USAuthentic Trading Conference Presentation Topic: A RoadMap to Compliance Barbara Krutchkoff, PhD is a consultant for physicians and biomedical start-up companies in regenerative and cellular medicine. She is Executive Director of the Institute of Regenerative and Cellular Medicine, and Chair of the IRCM IRB, which provides support for translational research and validation of regenerative therapies. Her A3Cell/Exponential Resources consultancy helps venture funds, biotech entrepreneurs, and clinics vet the latest technology, strategize develop market strategies, navigate the regulatory pathway, as well as design and manage clinical studies. Barbara has worked tirelessly throughout her 25+ year career to engage with university and industry leaders and help to bring regenerative medicine safely to patients. As Chief of Scientific Affairs for Lipogems US, Barbara successfully gained FDA approvals, funding, and national distribution for an international start-up with a novel medical device wishing to enter the US market. She co- founded LSMRI, which facilitates translational research, and has developed a portfolio of innovative biologics and highly personalized therapeutic protocols. She currently serves on advisory boards of a variety of companies and organizations, including KLOTHO Therapeutics, RareCells, Personalized Stem Cells, and the Academy of Innovative Cancer Strategies. Her diverse educational background includes physics and computer science at the University of Florida, biomedical engineering graduate studies at Virginia Tech, Doctoral programs in behavioral phycology and integrative medicine, Stem Cell Fellowships at A4M and UCLA where she spent two years in the lab working with Bruno Peault focused on the basic science and mechanism of action of MSCs. Barbara is a board-certified Diplomat and Fellow of the AABRM (American Academy and Board of Regenerative Medicine). Barbara presents at various scientific conferences within the US and internationally and is currently involved in developing a platform for medical AR/VR training. She is an adjunct lecturer at the Universite Paris Descartes. Barbara, via IRCM, has helped to design and oversee over 400 clinical studies. She is on the IRCM/Regenerative Outcomes committee for the NIH outcomes registry and currently engaged in an initiative to employ blockchain to revolutionize clinic trial data collection and bioinformatics. Barbara Krutchkoff, PhD
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Doug Oliver Founder and President of Regenerative Outcomes, LLC Conference Presentation Topic: TBA Doug Oliver, MSW is a globally-recognized patient advocate and change maker. Based in Nashville, Tennessee, Mr. Oliver holds a Master of Social Work degree from the University of New England and has had an extensive career in medical social work, health care regulatory compliance. He is also Founder and President of Regenerative Outcomes, LLC, a patient-centric regenerative medicine regulatory consulting firm, assisting physicians and biotech with practice compliance and strategic IND development and submission assistance (www.regenerativeoutcomes.com). At age 32, Mr. Oliver was diagnosed with macular degeneration, and became legally blind at age 45. In 2015, after undergoing autologous bone-marrow stem cell therapy, he regained much of his lost vision. He helped craft key provisions in the 21st Century Cures Act, contributed to RMAT policy, and worked in stem cell policy development with the Foundation of State Medical Board. His eloquent use of storytelling to articulate social policy impacts on patients was recently celebrated at the 2019 World Stem Cell Summit in Miami, Florida, where he received the 2019 World Stem Cell Summit’s Stem Cell and Regenerative Medicine “Action” Award for Inspiration. Doug Oliver
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Timothy Ganey, PhD Tim Ganey is Chief Scientific Officer for Vivex Biomedical, Marietta, GA; Director of the Atlanta Learning Center, and Director of Orthopedic Research at the Atlanta Medical Center; Chief Technical Officer, Spinplant GmbH, Leipzig, Germany; a Faculty Member of the TRM Facility in Leipzig Germany, and a faculty member at Nova Southeastern, Ft. Lauderdale, FL. Conference Presentation Topic: Quantification of Exosome Product As President of the US division of co.don Tissue Engineering, he guided a team that developed and commercialized a portfolio of cell-based therapeutics for cartilage, bone, and the first clinically available biologic for intervertebral disc in 1999. Dr. Ganey has been instrumental in several technology development initiatives, among them the use of cell-based therapeutics, electric field transduction, additive manufacturing (3D printing), and prescribed matrices for regenerative medicine. Patents issues include work stemming from pulsed-field delivery, artificial matrices for bone regeneration, electro-spinning methods and materials, mimetic material modification using photoactive lasers, and stem cell procurement and purification. His efforts have been aligned with the shifting paradigm supporting regenerative treatments for effective patient care – translation as the engine of implementation. Timothy Ganey, PhD
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