National Academies Press: OpenBook

Applying Systems Thinking to Regenerative Medicine: Proceedings of a Workshop (2021)

Chapter: Appendix B: Speaker Biographical Sketches

« Previous: Appendix A: Workshop Agenda
Suggested Citation:"Appendix B: Speaker Biographical Sketches." National Academies of Sciences, Engineering, and Medicine. 2021. Applying Systems Thinking to Regenerative Medicine: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26025.
×

Appendix B

Speaker Biographical Sketches

Amy Abernethy, M.D., is the principal deputy commissioner of food and drugs at the Food and Drug Administration (FDA) and helps oversee the agency’s day-to-day functioning and directs special and high-priority initiatives that cut across offices overseeing FDA’s regulation of drugs, medical devices, tobacco, and food. As the acting chief information officer, she oversees FDA’s data and technical vision and its execution. Dr. Abernethy, a hematologist/oncologist and palliative medicine physician, is an internationally recognized clinical data expert and clinical researcher. Her areas of expertise include cancer data, real-world evidence, clinical trials, health services research, patient-reported outcomes, clinical informatics, and patient-centered care. Before coming to FDA, Dr. Abernethy served as the chief medical officer, the chief scientific officer, and the senior vice president for oncology at Flatiron Health (a member of the Roche Group), where she led the research oncology, clinical operations, and data science teams and contributed to the overall strategic vision of the company, including directing its research vision on real-world evidence. Prior to that, Dr. Abernethy was a professor of medicine at the Duke University School of Medicine, where she ran the Center for Learning Health Care in the Duke Clinical Research Institute and the Duke Cancer Care Research Program in the Duke Cancer Institute. At Duke, she pioneered the development of technology platforms to spur novel advances in the care of people with cancer and other serious life-limiting illnesses. Dr. Abernethy was formerly an appointed member of the National Academies of Sciences, Engineering, and Medicine’s National Cancer Policy Forum, an elected member of the American Society for Clinical Investigation, and the past president of the American Academy of

Suggested Citation:"Appendix B: Speaker Biographical Sketches." National Academies of Sciences, Engineering, and Medicine. 2021. Applying Systems Thinking to Regenerative Medicine: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26025.
×

Hospice and Palliative Medicine. Dr. Abernethy received her M.D. at Duke University, where she also did her internal medicine residency, served as the chief resident, and completed her hematology/oncology fellowship. She received her Ph.D. from Flinders University in Australia, with a focus on evidence-based medicine and clinical informatics, and her bachelor’s degree from the University of Pennsylvania.

John Balchunas, M.S., is the workforce director for The National Institute for Innovation in Manufacturing Biopharmaceuticals. In addition, Mr. Balchunas is responsible for business development and industry partnership for the professional development program at North Carolina State University’s (NCSU’s) Biomanufacturing Training and Education Center. Prior to joining NCSU in 2014, Mr. Balchunas served as the director of workforce development for the North Carolina Biotechnology Center (NCBiotech). As part of NCBiotech’s education and training program for nearly 10 years, Mr. Balchunas forged an array of partnerships with industry to understand and communicate biopharmaceutical manufacturing workforce needs. Mr. Balchunas started his career as a technical writer in the biomanufacturing and medical diagnostic industries. He holds an M.S. in technical communication and a B.S. in microbiology from NCSU and was selected as a Marano Fellow in The Aspen Institute’s 2012–2013 Sector Skills Academy.

William Bialek, Ph.D., received his A.B. and Ph.D. (1983) from the University of California, Berkeley. After postdoctoral stays in the Netherlands and the Institute for Theoretical Physics at the University of California, Santa Barbara, he returned to Berkeley to join the faculty in physics and biophysics (1986). At the end of 1990 he moved to the newly formed NEC Research Institute and then, in 2001, to Princeton University. Since 2009 he has also been a visiting faculty member at the Graduate Center of the City University of New York. Dr. Bialek is interested very broadly in whether it is possible to find theoretical principles that have the power and generality that people have come to expect in physics yet encompass the complexity and diversity of life’s most beautiful phenomena. This search has led him to think about biological systems on many scales, including the dynamics of single-protein molecules, genetic networks in a developing embryo, neural coding and computation in the brain, and the collective behavior of animal groups. He is as passionate about teaching as about research, and he has had the pleasure of working with a stream of extraordinary young colleagues.

Adrian Bot, M.D., Ph.D., is the vice president and the global head of translational medicine at Kite, a Gilead Company, developing genetically engineered cell products for oncology indications. Dr. Bot has more than 20

Suggested Citation:"Appendix B: Speaker Biographical Sketches." National Academies of Sciences, Engineering, and Medicine. 2021. Applying Systems Thinking to Regenerative Medicine: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26025.
×

years of experience in the biopharmaceutical industry with a focus on the discovery and development of immunotherapies. He obtained his M.D. in Romania in 1993 and his Ph.D. in biomedical sciences at the Mount Sinai School of Medicine in New York in 1998. Subsequently, he was a guest scientist at the Scripps Research Institute in La Jolla, California. Prior to his appointment as the chief scientific officer at Kite Pharma in 2011 and then the vice president of translational medicine, where he contributed to the development of first-in-class and breakthrough cell therapy products for cancer, Dr. Bot served in various senior research and development leadership positions at MannKind Corp and Alliance Pharmaceutical Corp in La Jolla, California. His prior and current activities and appointments include editorial boards (Journal of Immunology, International Reviews of Immunology), leadership appointments in global professional societies (Society for Immunotherapy of Cancer), and advisory boards (Elicio Therapeutics).

Atul Butte, M.D., Ph.D., is the Priscilla Chan and Mark Zuckerberg Distinguished Professor and the inaugural director of the Bakar Computational Health Sciences Institute at the University of California, San Francisco. Dr. Butte is also the chief data scientist for the entire University of California Health system, with 20 health professional schools, 6 medical schools, 5 academic medical centers, 10 hospitals, and more than 1,000 care delivery sites. Dr. Butte has been continually funded by the National Institutes of Health for 20 years, is an inventor on 24 patents, and has authored more than 200 publications, with research repeatedly featured in The New York Times, The Wall Street Journal, and Wired magazine. Dr. Butte was elected into the National Academy of Medicine in 2015, and in 2013 he was recognized by the Obama administration as a White House Champion of Change in Open Science for promoting science through publicly available data. Dr. Butte is also a founder of three investor-backed, data-driven companies: Personalis (initial public offering, 2019), which provides medical genome sequencing services; Carmenta (acquired by Progenity, 2015), which discovers diagnostics for pregnancy complications; and NuMedii, which finds new uses for drugs through open molecular data. Dr. Butte trained in computer science at Brown University, worked as a software engineer at Apple and Microsoft, received his M.D. at Brown University, trained in pediatrics and pediatric endocrinology at Children’s Hospital Boston, then received his Ph.D. from the Harvard Medical School and the Massachusetts Institute of Technology.

Elana Fertig, Ph.D., runs a National Cancer Institute (NCI)-funded hybrid computational and experimental laboratory in the systems biology of cancer and therapeutic response. Her wet laboratory develops time-course models of therapeutic resistance and develops single-cell technologies. Her

Suggested Citation:"Appendix B: Speaker Biographical Sketches." National Academies of Sciences, Engineering, and Medicine. 2021. Applying Systems Thinking to Regenerative Medicine: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26025.
×

computational methods blend mathematical modeling and artificial intelligence to determine the biomarkers and molecular mechanisms of therapeutic resistance from multi-platform genomics data. These techniques have broad applicability beyond her resistance models, including notably to the analysis of clinical biospecimens, developmental biology, and neuroscience. Dr. Fertig is an associate professor of oncology and the assistant director of the Research Program in Quantitative Sciences and the associate director of the Convergence Institute at the Johns Hopkins University Sidney Kimmel Comprehensive Cancer Center, with secondary appointments in biomedical engineering and applied mathematics and statistics, affiliations in the Institute of Computational Medicine, the Center for Computational Genomics, machine learning, the Mathematical Institute for Data Science, and the Center for Computational Biology. Prior to entering the field of computational cancer biology, Dr. Fertig was a NASA research fellow in numerical weather prediction. Dr. Fertig’s research is featured in more than 80 peer-reviewed publications, R/Bioconductor packages, and competitive funding portfolio as the principal investigator and the co-investigator. She serves on the editorial boards of the pre-eminent computational biology journals PLOS Computational Biology and Cell Systems and as a study section member for the NCI systems biology and informatics technology for cancer research study sections. Notably, she led the team that won the HPN-DREAM8 algorithm to predict phospho-proteomic trajectories from therapeutic response in cancer cells.

Paul Francois, Ph.D., is an associate professor in the Department of Physics at McGill University. His research focuses on the development of approaches inspired by statistical and computational physics for the theoretical understanding of the dynamics of biological systems and of their evolution. He works in close collaboration with experimentalists of a variety of systems, from embryonic development to early immune recognition.

Alison Gammie, Ph.D., is the director of the Division of Training, Workforce Development, and Diversity, which supports research training, career development, and diversity-building activities at the National Institute of General Medical Sciences (NIGMS). Prior to coming to NIGMS, she was a senior lecturer at Princeton University, where, in addition to teaching, mentoring, and running a research laboratory, she served as an academic advisor, an associate member at the Cancer Institute of New Jersey, and the director of diversity programs and graduate recruiting. Honors include Princeton’s President’s Award for Distinguished Teaching, the Graduate Mentoring Award, and the American Society for Microbiology Hinton Award for advancing the research careers of underrepresented minorities.

Suggested Citation:"Appendix B: Speaker Biographical Sketches." National Academies of Sciences, Engineering, and Medicine. 2021. Applying Systems Thinking to Regenerative Medicine: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26025.
×

Sui Huang, M.D., Ph.D., is a molecular and cell biologist with a strong background in theoretical biology. He has devoted his research to understanding the very phenomenon of cancer from a complex systems perspective. Life scientists now readily acknowledge that the “whole is more than the sum of its parts,” but the question is: What exactly is the “more” that we need in order to understand the “whole”? Can this abstract philosophical notion be reduced to a rigorous formal concept and concrete molecular entities? Pursuing this question has guided Dr. Huang’s research in cancer and cell biology over the past decade. Before joining the Institute for Systems Biology (ISB) in fall 2011, Dr. Huang held faculty positions at the University of Calgary (Institute of Biocomplexity and Informatics), where he helped establish biocomplexity as a discipline in research and teaching, and at the Harvard Medical School (Children’s Hospital), where he obtained the first experimental evidence for the existence of high-dimensional attractors in mammalian gene regulatory networks. Dr. Huang grew up in Geneva and Zurich. He received his M.D. from the University of Zurich and obtained thereafter, as the first recipient of the Ph.D.-Program-for-Physicians Award of the Swiss National Science Foundation, his Ph.D. in molecular biology and physical chemistry for work on interferons. As a postdoctoral fellow at Children’s Hospital Boston, he investigated tumor angiogenesis and cell growth control. In that period, he also studied dynamical systems through his affiliation with the New England Complex Systems Institute. Seeing how both interferons and anti-angiogenic agents have failed to live up to their celebrated promise of curing cancer has had a lasting impact on Dr. Huang’s views. The humbling recognition of the profound complexity of the living state fostered the desire to overcome the orthodoxy of reductionist, monocausal and deterministic thinking that prevailed in biomedicine and to put to use his knowledge of complex systems theory in his experimental research. Time was ripe in the late 1990s because the arrival of the “omics” technologies, and systems biology paved the way toward this interdisciplinary approach. With his move to ISB, Dr. Huang continues to unite experiment and theory to gain insights into the essence of multicellularity and cancer.

Iya Khalil, Ph.D., is the global head of the AI Innovation Center at Novartis. She is a technology entrepreneur and a physicist with a vision of transforming medicine and health care into a discipline that is quantitative, predictive, and patient-centric via artificial intelligence (AI) and big data. Prior to coming to Novartis, Dr. Khalil co-founded two AI and machine learning companies, Gene Network Sciences Inc. and GNS Healthcare, and was the co-inventor of the proprietary AI and machine learning software platform that underpins both entities. Dr. Khalil’s machine learning and AI expertise spans 18 years with applications in drug discovery, drug

Suggested Citation:"Appendix B: Speaker Biographical Sketches." National Academies of Sciences, Engineering, and Medicine. 2021. Applying Systems Thinking to Regenerative Medicine: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26025.
×

development, clinical trial optimization, real-world evidence and pharmaceutical commercial applications, and all the way to treatment algorithms that can be applied at the point of care. She is a frequent speaker at industry conferences including Exponential Medicine, Milken Global Conference, Health 2.0, SXSW, Bio, and TEDx and was recently profiled in Forbes magazine as one of the women making AI more accessible and less scary. Dr. Khalil has published extensively in AI and machine learning for health care, including peer-reviewed journal articles and poster presentations at scientific conferences. She was recognized by President Obama in 2014 as a leading entrepreneur in genomic medicine and more recently named to Inc. magazine’s list of top female founders of 2018. Dr. Khalil received her Ph.D. and M.S. in physics from Cornell University. Dr. Khalil is also fluent in Arabic. She is also a passionate member of Springboard enterprises, the largest network of innovators, investors, and influencers who are dedicated to building high-growth women-led technology companies.

Theresa Kotanchek, Ph.D., is the chief executive officer of Evolved Analytics LLC, a data science and analytics system and software provider (www.evolved-analytics.com). Using proprietary algorithms, evolved analytics discovers elusive relationships in complex data systems, extracting new insights and knowledge. Evolved Analytics’s suite of global solutions is broad, reaching across multiple industry sectors, enabling new catalyst, drug, and materials discoveries; enhanced business forecasting; supply chain planning and logistics; and automated process and quality control. Prior to assuming her current role, Dr. Kotanchek spent 23 years in executive and leadership positions at Dow Chemical, including the vice president for sustainable technologies, innovation sourcing, and information research; the chief technology officer of Dow Chemical China Company Limited; the global business director of Dow Ventures; the global research and development director of Dow Plastics; and the corporate director of materials science and engineering. Dr. Kotanchek holds a doctorate in materials science and engineering, a master of science in ceramic science, and a bachelor of science in ceramic science and engineering from The Pennsylvania State University. She is currently the vice chair of the National Academies of Sciences, Engineering, and Medicine’s National Materials and Manufacturing Board and has served as a member of the Committee on Foundational Best Practices for Making Value in America. Internationally recognized, she has given more than 200 invited lectures, published more than 100 technical articles, and holds 6 U.S. patents.

Jane Lebkowski, Ph.D., has been actively involved in the development of cell and gene therapies since 1986 and is the president of research and development (R&D) at Regenerative Patch Technologies (RPT), a biotechnology

Suggested Citation:"Appendix B: Speaker Biographical Sketches." National Academies of Sciences, Engineering, and Medicine. 2021. Applying Systems Thinking to Regenerative Medicine: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26025.
×

firm developing composite stem cell–based implants to restore retinal architecture and function in patients with macular degeneration. In this role Dr. Lebkowski oversees all of RPT’s operations. From 2013 to 2017, Dr. Lebkowski also served as the chief scientific officer and the president of R&D at Asterias Biotherapeutics Inc., where she headed all preclinical, product, regulatory, and clinical development of Asterias’s regenerative medicine and dendritic cell based–cancer immunotherapy products. Prior to joining Asterias, Dr. Lebkowski was the senior vice president of regenerative medicine and the chief scientific officer at Geron Corporation. Dr. Lebkowski led Geron’s human embryonic stem cell program from 1998–2012 and was responsible for all research, preclinical development, product development, manufacturing, and clinical development activities supporting cell-based therapies for several regenerative medicine indications including spinal cord injury and cardiovascular disease. From 1986–1998, Dr. Lebkowski was the vice president of R&D at Applied Immune Sciences, where she directed activities to develop T cell–based cancer immunotherapies for solid tumors, hematologic malignancies, and AIDS. Following the acquisition of Applied Immune Sciences by Rhone Poulenc Rorer (RPR, currently Sanofi), Dr. Lebkowski remained at RPR as the vice president of discovery research. During Dr. Lebkowski’s tenure at RPR, she coordinated preclinical investigations of gene therapy approaches for the treatment of cancer, cardiovascular disease, and nervous system disorders and directed vector formulations and delivery development. Dr. Lebkowski received her Ph.D. in biochemistry from Princeton University in 1982 and completed a postdoctoral fellowship at the Department of Genetics at Stanford University in 1986. Dr. Lebkowski has published more than 80 peer-reviewed publications and has 13 issued U.S. patents. Dr. Lebkowski has served on the board of directors of the American Society of Gene & Cell Therapy (ASGCT) and on numerous scientific advisory boards and professional committees including those supported by ASGCT and International Society for Stem Cell Research.

Bala Manian, Ph.D., has been a part of the Silicon Valley entrepreneurial community over the past four decades as an entrepreneur, an investor, and an innovator. Dr. Manian has been a founder or a co-founder of a large number of successful life sciences and medical technology companies in Silicon Valley over that 40 years. Before the Silicon Valley experience, he was an academic, as a member of the teaching faculty at the University of Rochester. An expert in the design of electro-optical systems, Dr. Manian is a prime driver behind many successful commercial products. While his educational training is in physics and engineering, his contributions have centered predominantly in life sciences and medical technology. As example of cross-disciplinary convergence, in February 1999 the Academy of Motion Picture Arts and Sciences awarded Dr. Manian a technical Academy Award

Suggested Citation:"Appendix B: Speaker Biographical Sketches." National Academies of Sciences, Engineering, and Medicine. 2021. Applying Systems Thinking to Regenerative Medicine: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26025.
×

for advances in digital cinematography. He has been recognized through several awards for his contributions as an educator, an inventor, and an entrepreneur. Dr. Manian holds more than 50 patents, many of which have resulted in successful commercial products. Dr. Manian received a B.S. in physics from Loyola College in Chennai, a postgraduate level diploma in instrumentation from the Madras Institute of Technology in Chennai, an M.S. in applied optics from the University of Rochester, and a Ph.D. in mechanical engineering from Purdue University.

Douglas Olson, Ph.D., received his bachelor’s degree in chemistry from Maryville College and his Ph.D. in medicinal chemistry from Purdue University. Most of Dr. Olson’s career has been spent in the medical device and in vitro diagnostics industry. He served as the president of Diagnostic Products Corporation’s instrument systems division and as the corporate chief scientific officer prior to its sale to Siemens Health Care. Dr. Olson is the holder of eight U.S. patents and the author of a number of publications. He is a cancer survivor and patient number two in the initial University of Pennsylvania chimeric antigen receptor T cell clinical trial. He is a former member of the board of directors of the Eastern Pennsylvania chapter of the Leukemia & Lymphoma Society and is on the board of directors of Bühlmann Laboratories and Bühlmann Diagnostics Corp and currently serves as the president and the chief executive officer of Bühlmann Diagnostics Corp.

Larsson Omberg, Ph.D., M.Sc., is the vice president of systems biology at Sage Bionetworks and oversees a research agenda that focuses on both genomics and participant-centered research where data are being collected using remote sensors and mobile phones. The group focuses heavily on using open and team-based science to get a large number of external partners to collaborate on data-intensive problems. Dr. Omberg has a background in computational biology and has been developing computational methods for genomics analysis and disease modeling. Dr. Omberg obtained an M.Sc. in engineering physics from the Royal Institute of Technology in Stockholm, Sweden, and a Ph.D. from The University of Texas at Austin in physics before performing a postdoctoral fellowship in computational biology and biostatistics at Cornell University.

Anne Richelle, Ph.D., completed her Ph.D. in the Engineering Department of Université Libre de Bruxelles on the modeling, optimization, and control of yeast fermentation processes. After a first postdoc at the same university focused on the metabolic modeling of mammalian cells, she joined the lab of N. E. Lewis at the University of California, San Diego, to work on the integrated modeling of genotype–phenotype relationship in Chinese hamster ovary (CHO) cells, research for which she received the Eli Lilly Innovation

Suggested Citation:"Appendix B: Speaker Biographical Sketches." National Academies of Sciences, Engineering, and Medicine. 2021. Applying Systems Thinking to Regenerative Medicine: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26025.
×

Fellowship Award. She is currently working at GlaxoSmithKline on the integration of systems biology tools from a process engineering perspective.

Sally Temple, Ph.D., is the scientific director of the Neural Stem Cell Institute (NSCI) and oversees scientific programs with the goal of understanding the role of neural stem cells in central nervous system development, maintenance, and repair. A native of York, England, Dr. Temple leads a team of 30 researchers focused on using neural stem cells to develop therapies for eye, brain, and spinal cord disorders. In 2008 she was awarded the MacArthur Fellowship Award for her contribution and future potential in the neural stem cell field. Dr. Temple received her undergraduate degree from Cambridge University, Cambridge, United Kingdom, specializing in developmental biology and neuroscience. She performed her Ph.D. work in optic nerve development at University College London, United Kingdom. She received a Royal Society fellowship to support her postdoctoral work at Columbia University in New York where she focused on spinal cord development. In 1989 Dr. Temple discovered that the embryonic mammalian brain contained a rare stem cell that could be activated to proliferate in vitro and produce both neurons and glia. Since then, her laboratory has continued to make pioneering contributions to the field of stem cell research by characterizing neural stem cells and the intrinsic and environmental factors that regulate their behavior. Her laboratory’s research on the characterization of neural stem and progenitors brings us closer to developing effective clinical treatments for central nervous system damage in which tissue is lost, for example, due to neurodegenerative diseases or trauma. As the scientific director of NSCI, Dr. Temple oversees the research mission from basic to translational projects. Dr. Temple is a member of the board of directors and is a past president of the International Society for Stem Cell Research.

Dawn Tilbury, Ph.D., leads the Directorate for Engineering at the National Science Foundation (NSF) in its mission to support engineering research and education critical to the nation’s future and to foster innovations to benefit society. Engineering breakthroughs address national challenges, such as smart manufacturing, resilient infrastructure, and sustainable energy systems. Engineering also brings about new opportunities in areas ranging from advanced photonics to prosthetic devices. The Engineering Directorate helps to advance NSF’s Ten Big Ideas, including the Future of Work at the Human-Technology Frontier, the Quantum Leap, Understanding the Rules of Life, and NSF INCLUDES. The Engineering Directorate provides about 40 percent of the federal funding for fundamental research in engineering at academic institutions and distributes about 1,600 research awards each year. Partnerships with industry are a key component of the

Suggested Citation:"Appendix B: Speaker Biographical Sketches." National Academies of Sciences, Engineering, and Medicine. 2021. Applying Systems Thinking to Regenerative Medicine: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26025.
×

Engineering Directorate’s programs, including GOALI (Grant Opportunity for Academic Liaison with Industry) where industry researchers collaborate directly on academic research projects, and INTERN, which allows graduate students funded on NSF projects to spend up to 6 months in a non-academic internship (such as a company, government laboratory, or nonprofit organization). The Industry-University Cooperative Research Center program brings together NSF researchers with funding provided by industry and other government agencies to do pre-competitive research, and the ERC (Engineering Research Center) program supports large-scale convergence research projects together with workforce development, diversity and inclusion, and an innovation ecosystem. The Engineering Directorate coordinates NSF’s I-Corps program, providing entrepreneurial training to faculty, graduate students, and postdocs. NSF’s Small Business Innovation Research and Small Business Technology Transfer programs, housed in the Engineering Directorate, support fundamental research being done in high-tech small businesses helping them transition new technologies into the commercial marketplace. A professor at the University of Michigan since 1995, in both mechanical and electrical engineering, Dr. Tilbury has a background in systems and control engineering. She received a B.S. in electrical engineering, summa cum laude, from the University of Minnesota in 1989, and an M.S. and a Ph.D. in electrical engineering and computer sciences from the University of California, Berkeley, in 1992 and 1994, respectively. She is the inaugural chair of the Robotics Steering Committee and served as an associate dean for research in the College of Engineering. She was elected a fellow of the Institute of Electrical and Electronics Engineers in 2008 and a fellow of the American Society of Mechanical Engineers in 2012, and she is a life member of the Society of Women Engineers. Dr. Tilbury retains her position with the University of Michigan and shall return after her term with NSF expires.

Seshu Tyagarajan, Ph.D., is the global head of late-stage chemistry, manufacturing, and control (CMC) strategy for Novartis cell and gene therapy (CGT) and technical operations (NTO). She has 20 years of experience in the biopharmaceutical industry at companies such as Merck, Roche, Phyton, Biogen, and Eli Lilly. She holds an M.S. in bioengineering from Purdue University and a Ph.D. in chemical engineering from Rutgers University. Dr. Tyagarajan’s career has spanned biologics and the cell and gene therapy space in the areas of CMC team leadership, current good manufacturing processes manufacturing, manufacturing sciences, and research and development. Her current responsibilities include successful transition of CGT pivotal trials into the manufacturing organization (NTO) and overseeing artificial intelligence collaborations for the cell and gene space.

Suggested Citation:"Appendix B: Speaker Biographical Sketches." National Academies of Sciences, Engineering, and Medicine. 2021. Applying Systems Thinking to Regenerative Medicine: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26025.
×

Ben Wang, Ph.D., holds the Gwaltney Chair in Manufacturing Systems and is a professor in the Stewart School of Industrial and Systems Engineering, and a professor in the School of Materials Science and Engineering at the Georgia Institute of Technology. In addition, he serves as the executive director of the Georgia Tech Manufacturing Institute. Dr. Wang is a fellow of the Institute of Industrial Engineers, the Society of Manufacturing Engineers, and the Society for the Advancement of Material and Process Engineering. From 2017 to 2019 he served as the chair of the National Materials and Manufacturing Board at the National Academies of Sciences, Engineering, and Medicine. In those 3 years the board oversaw several landmark studies, including A Vision for Center-Based Engineering Research, A Quadrennial Review of the National Nanotechnology Initiative, Frontiers of Materials Research: A Decadal Survey, and Strategic Long-Term Participation by DOD in Its Manufacturing USA Institutes. Dr. Wang’s professional focus is on strengthening manufacturing competitiveness through technology, infrastructure, workforce, and policy. In addition to authoring or co-authoring more than 260 refereed journal papers, he is a co-author of 3 books and has a portfolio of issued and applied-for patents that now exceeds 35, 15 of which have been licensed or are in discussion for commercialization. Dr. Wang earned his bachelor’s degree in industrial engineering from Tunghai University (Taiwan) and his master’s degree and Ph.D. in industrial engineering from The Pennsylvania State University.

Robert Zambon, Ph.D., is the Real-World Innovation Leader in Janssen Scientific Affairs at Janssen Pharmaceuticals. In his role, Dr. Zambon leads and supports strategic innovation initiatives for Janssen Scientific Affairs focused on the usage of innovative technologies, analytics, data, and partnerships to accelerate and advance real-world research and initiatives across all of Janssen’s therapeutic areas. Dr. Zambon has close to 20 years of experience in the life sciences industry with experience in strategy development, program management, clinical research, product development, sales force training, client management, regulatory affairs, analytics, and market research. He has led and supported research programs in the areas of cardiology, orthopedics, immunology, infectious disease, and medical countermeasures. Dr. Zambon received his Ph.D. in molecular and cell biology at the University of Maryland and his B.S. in biotechnology at Rutgers University.

Peter Zandstra, Ph.D., graduated with a bachelor of engineering degree from McGill University in the Department of Chemical Engineering, obtained his Ph.D. from The University of British Columbia (UBC) in the Department of Chemical Engineering and Biotechnology, and continued his

Suggested Citation:"Appendix B: Speaker Biographical Sketches." National Academies of Sciences, Engineering, and Medicine. 2021. Applying Systems Thinking to Regenerative Medicine: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26025.
×

research training as a postdoctoral fellow in the field of bioengineering at the Massachusetts Institute of Technology. Dr. Zandstra is the chief scientific officer for CCRM, the founding director of the School of Biomedical Engineering at UBC, and the director of the Michael Smith Laboratories at UBC. He holds an academic appointment as a professor at the University of Toronto’s Institute of Biomaterials and Biomedical Engineering. He is the Canada Research Chair in Stem Cell Bioengineering and is a recipient of a number of awards and fellowships including the Premiers Research Excellence Award (2002), the E.W.R. Steacie Memorial Fellowship (2006), the John Simon Guggenheim Memorial Foundation Fellowship (2007), Canada’s Top 40 Under 40 (2008), the University of Toronto’s McLean Award (2009), and the Till and McCulloch Award (2013). Dr. Zandstra is also a fellow of the American Institute for Medical and Biological Engineering, the American Association for the Advancement of Science, and the Royal Society of Canada. His research focuses on understanding how complex communication networks between stem cells and their progeny influence self-renewal and differentiation and how this information can be applied to the design of novel culture technologies capable of controlling cell fate.

Suggested Citation:"Appendix B: Speaker Biographical Sketches." National Academies of Sciences, Engineering, and Medicine. 2021. Applying Systems Thinking to Regenerative Medicine: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26025.
×
Page 137
Suggested Citation:"Appendix B: Speaker Biographical Sketches." National Academies of Sciences, Engineering, and Medicine. 2021. Applying Systems Thinking to Regenerative Medicine: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26025.
×
Page 138
Suggested Citation:"Appendix B: Speaker Biographical Sketches." National Academies of Sciences, Engineering, and Medicine. 2021. Applying Systems Thinking to Regenerative Medicine: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26025.
×
Page 139
Suggested Citation:"Appendix B: Speaker Biographical Sketches." National Academies of Sciences, Engineering, and Medicine. 2021. Applying Systems Thinking to Regenerative Medicine: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26025.
×
Page 140
Suggested Citation:"Appendix B: Speaker Biographical Sketches." National Academies of Sciences, Engineering, and Medicine. 2021. Applying Systems Thinking to Regenerative Medicine: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26025.
×
Page 141
Suggested Citation:"Appendix B: Speaker Biographical Sketches." National Academies of Sciences, Engineering, and Medicine. 2021. Applying Systems Thinking to Regenerative Medicine: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26025.
×
Page 142
Suggested Citation:"Appendix B: Speaker Biographical Sketches." National Academies of Sciences, Engineering, and Medicine. 2021. Applying Systems Thinking to Regenerative Medicine: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26025.
×
Page 143
Suggested Citation:"Appendix B: Speaker Biographical Sketches." National Academies of Sciences, Engineering, and Medicine. 2021. Applying Systems Thinking to Regenerative Medicine: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26025.
×
Page 144
Suggested Citation:"Appendix B: Speaker Biographical Sketches." National Academies of Sciences, Engineering, and Medicine. 2021. Applying Systems Thinking to Regenerative Medicine: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26025.
×
Page 145
Suggested Citation:"Appendix B: Speaker Biographical Sketches." National Academies of Sciences, Engineering, and Medicine. 2021. Applying Systems Thinking to Regenerative Medicine: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26025.
×
Page 146
Suggested Citation:"Appendix B: Speaker Biographical Sketches." National Academies of Sciences, Engineering, and Medicine. 2021. Applying Systems Thinking to Regenerative Medicine: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26025.
×
Page 147
Suggested Citation:"Appendix B: Speaker Biographical Sketches." National Academies of Sciences, Engineering, and Medicine. 2021. Applying Systems Thinking to Regenerative Medicine: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26025.
×
Page 148
Next: Appendix C: Statement of Task »
Applying Systems Thinking to Regenerative Medicine: Proceedings of a Workshop Get This Book
×
 Applying Systems Thinking to Regenerative Medicine: Proceedings of a Workshop
Buy Paperback | $40.00 Buy Ebook | $32.99
MyNAP members save 10% online.
Login or Register to save!
Download Free PDF

Regenerative medicine products, which are intended to repair or replace damaged cells or tissues in the body, include a range of therapeutic approaches such as cell- and gene-based therapies, engineered tissues, and non-biologic constructs. The current approach to characterizing the quality of a regenerative medicine product and the manufacturing process often involves measuring as many endpoints as possible, but this approach has proved to be inadequate and unsustainable.

The Forum on Regenerative Medicine of the National Academies of Sciences, Engineering, and Medicine convened experts across disciplines for a 2-day virtual public workshop to explore systems thinking approaches and how they may be applied to support the identification of relevant quality attributes that can help in the optimization of manufacturing and streamline regulatory processes for regenerative medicine. A broad array of stakeholders, including data scientists, physical scientists, industry researchers, regulatory officials, clinicians, and patient representatives, discussed new advances in data acquisition, data analysis and theoretical frameworks, and how systems approaches can be applied to the development of regenerative medicine products that can address the unmet needs of patients. This publication summarizes the presentation and discussion of the workshop.

READ FREE ONLINE

  1. ×

    Welcome to OpenBook!

    You're looking at OpenBook, NAP.edu's online reading room since 1999. Based on feedback from you, our users, we've made some improvements that make it easier than ever to read thousands of publications on our website.

    Do you want to take a quick tour of the OpenBook's features?

    No Thanks Take a Tour »
  2. ×

    Show this book's table of contents, where you can jump to any chapter by name.

    « Back Next »
  3. ×

    ...or use these buttons to go back to the previous chapter or skip to the next one.

    « Back Next »
  4. ×

    Jump up to the previous page or down to the next one. Also, you can type in a page number and press Enter to go directly to that page in the book.

    « Back Next »
  5. ×

    Switch between the Original Pages, where you can read the report as it appeared in print, and Text Pages for the web version, where you can highlight and search the text.

    « Back Next »
  6. ×

    To search the entire text of this book, type in your search term here and press Enter.

    « Back Next »
  7. ×

    Share a link to this book page on your preferred social network or via email.

    « Back Next »
  8. ×

    View our suggested citation for this chapter.

    « Back Next »
  9. ×

    Ready to take your reading offline? Click here to buy this book in print or download it as a free PDF, if available.

    « Back Next »
Stay Connected!