Creating Value through Innovation in the Biomanufacturing Industry

August 23-24, 2018
Rubin Campus Center, Worcester Polytechnic Institute

Agenda

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Wednesday, August 22, 2018

7:00 pm - 9:00 pm    ABioM SIG Executive Council Meeting

Thursday, August 23, 2018

7:30 am - 5:00 pm    Registration
8:00 am - 5:00 pm    Exhibition Tables
8:00 am - 8:30 am    Networking/Light Breakfast Fare
8:30 am - 8:40 am    Opening Remarks/BMES President        

Need for Advanced Biomanufacturing

8:40 am - 9:30 am    Keynote: Terry Flotte, University of Massachusetts Medical Center
9:30 am - 10:05 am    Mike Laflamme, University of Toronto
10:05 am - 10:40 am    Kenny Choi, Mustang Bio
10:40 am - 11:10 am    Coffee Break and Networking
11:10 am - 11:45 am    Taby Ahsan, Rooster Bio
11:45 am - 12:00 pm    Tracy Hookway, Binghamton University
12:00 pm - 12:15 pm    Xiaojun (Lance) Lian, Penn State University
12:15 pm - 1:15 pm      Networking and Lunch

Tools to support Advanced Biomanufacturing

1:15 pm - 1:50 pm    Peshwa Madhusudan, GE Cell Therapy
1:50 pm - 2:05 pm    Yi Hong, University of Texas at Arlington
2:05 pm - 2:40 pm    Anjelica Gonzalez, Yale University
2:40 pm - 3:15 pm    Todd McDevitt, Gladstone Institute
3:15 pm - 3:45 pm    Coffee Break and Networking
3:45 pm - 4:20 pm    Jianping Fu, University of Michigan
4:20 pm - 4:55 pm    Rapid poster talks (5 student winners)
4:55 pm - 5:30 pm    Julie Murrell, Millipore Sigma
5:30 pm -6:30 pm    Posters/Cocktail Hour
6:30 pm - 9:00 pm    Dinner

Friday, August 24, 2018

The Future

7:30 am - 8:30 am    Breakfast
8:30 am - 9:05 am    Lloyd Rose, Army Medical Research

9:05 am -9:40 am    Glenn Gaudette, Worcester Polytechnic Institute
9:40 am -9:55 am    Benjamin Cosgrove, Cornell University
9:55 am -10:25 am    Coffee Break and Networking
10:25 am -11:00 am    Doris Taylor, Texas Heart Institute
11:00 am - 11:15 am    Jeannine Coburn, Worcester Polytechnic Institute
11:15 am - 12:00 pm    State funded panel discussion on academic and industry partnerships
12:00 pm    Conclusions, Glenn Gaudette, Kaiming Ye


Speakers

Terence R. Flotte, MD

Dean of the School of Medicine, Provost and Executive Deputy Chancellor, The Celia and Isaac Haidak Professor of Medical Education 

Since joining UMass Medical School in 2007, Dean Flotte has led numerous successful initiatives elevating the academic stature of the institution, including establishing the Department of Quantitative Health Sciences; establishment of neurosurgery; urology and ophthalmology as academic departments; recruitment of numerous department chairs; and development of the Advanced Therapeutics Cluster.

During Flotte’s time as dean of the School of Medicine, class size has increased from 103 to 162; a revised curriculum has been developed and implemented including “Learning Communities” guided by faculty mentors. In 2016, the medical school opened its first regional campus in Springfield, Mass. The research enterprise of the institution has grown to more than $280 million and a new 512,000-square-foot multiuse facility was built to accommodate the growing clinical and translational research laboratories as well as provide a new educational home for faculty and students.

An internationally known pioneer in human gene therapy, Flotte is currently investigating the use of gene therapy for genetic diseases, including alpha-1 antitrypsin deficiency and Tay-Sachs disease. In 1995, he led the team at Johns Hopkins that became the first to use the apparently harmless adeno-associated virus, or AAV, as a vehicle to deliver corrective genes to targeted sites in the body, including the damaged airways of adults with cystic fibrosis. He is the author of more than 250 scholarly papers and his research has been funded by the National Institutes of Health and the Alpha One Foundation. Since 2015, Flotte has also been editor-in-chief of gene therapy’s oldest journal family, Human Gene Therapy.

Flotte joined the medical school from the University of Florida, where he was the Nemours Eminent Scholar and chair of the Department of Pediatrics for the College of Medicine. Flotte received his undergraduate degree in the biological sciences from the University of New Orleans in 1982, and his medical degree from the Louisiana State University School of Medicine in 1986. After serving his residency in pediatrics at Johns Hopkins University, he completed a pediatric pulmonary fellowship and postdoctoral training in molecular virology there in 1992, before joining the Hopkins faculty for four years.

In 1996, Flotte joined the faculty of the University of Florida and was appointed associate director of University of Florida’s Powell Gene Therapy Center. In 2000, he was named director of the Powell Center and founding director of the newly established University of Florida Genetics Institute, a cross-campus multidisciplinary unit encompassing gene therapy, human genetics, agricultural genetics and comparative genomics. In 2002, he stepped down from these roles to accept the position of chair of the Department of Pediatrics.

 

Michael Laflamme, MD, PhD

Ischemic heart disease remains the leading cause of death in Canada and worldwide. Modern medical management has improved the prognosis of patients after myocardial infarction (MI), but existing therapies are largely aimed at slowing disease progression rather than restoring lost contractile function. My laboratory is focused on developing novel therapies for post-MI heart failure based on human pluripotent stem cells (hPSCs) because hPSCs are the only stem cell type capable of differentiating into large quantities of phenotypically unambiguous cardiomyocytes. Our goal is to restore the electrical and contractile function of injured hearts by “remuscularizing” the infarct scar with hPSC-derived cardiomyocytes.  

Our laboratory has already made a number of important advances in this area, including the development of efficient protocols to guide hPSCs into cardiomyocytes and specialized cardiac subtypes, proof-of-concept transplantation studies with hPSC-derived cardiomyocytes in rodent MI models, and the first direct demonstration that hPSC-derived cardiomyocytes can become electrically integrated and activate synchronously with host myocardium in injured hearts. Our ongoing work builds on these successes and is bringing us closer to a viable cell therapy. Current projects in the lab include 1) developing  scalable approaches to promote the maturation of hPSC-derived cardiomyocytes in vitro, 2) creating and validating new tools to characterize the electrical behavior of hPSC-derived cardiac grafts in vivo, 3) exploring novel pharmacological and gene-engineering approaches to improve host-graft electromechanical integration and graft electrophysiological function, and 4) testing the efficacy and safety of hPSC-derived cardiomyocyte transplantation in highly relevant preclinical MI models. 

 

Kenny Choi, Director of Process Development, Mustang Bio, Inc.

Presentation Title: Development and Commercialization of CAR T cell Therapies

Mustang Bio, Inc. (“Mustang”), a Fortress Biotech Company, is a clinical‐stage biopharmaceutical company focused on the development and commercialization of a broad range of proprietary chimeric antigen receptor engineered T cell (CAR T) immunotherapies and gene therapies in areas of unmet need. Mustang aims to acquire rights to these technologies by licensing or otherwise acquiring an ownership interest, to fund research and development, and to outlicense or bring the technologies to market. Mustang has partnered with top medical institutions to advance the development of CAR T and CRISPR/Cas9-enhanced CAR T therapies across multiple cancers, as well as lentiviral gene therapy for XSCID.

 

Taby Ahsan, Phd, Rooster Bio

Director, Analytical Development

Dr. Ahsan has extensive experience in both basic and translation studies in the fields of tissue engineering and stem cells. For her training, she received her BSE at the University of Pennsylvania, her PhD at UCSD, and was a Postdoctoral Fellow at GA Tech. Shortly after her PhD, she worked at the tissue engineering company Advanced Tissue Sciences in La Jolla, CA. Starting in 2009, she was a faculty member in the Biomedical Engineering Department at Tulane University, leading an independent research laboratory focused on biomechanical regulation of both pluripotent and adult stem cells. Taby was also a Member and Chair of the Cell, Tissue, and Gene Therapy Advisory Council (CTGTAC) at the FDA. In 2017 Taby joined RoosterBio Inc. in her continued efforts to have a positive impact on public health.

 

Anjelica Gonzalez

Donna L. Dubinsky Associate Professor of Biomedical Engineering

Anjelica L. Gonzalez is the Donna L. Dubinsky Associate Professor of Biomedical Engineering. Her appointment in Biomedical Engineering in association with the Vascular Biology and Therapeutics Program has provided a supportive and convenient platform for her research, focused on the development of biomaterials for use as investigational tools, particularly for the investigation of immunological responses to inflammatory signals from endogenous and exogenous sources.

Gonzalez has a dedicated interest in training the next generation of scientists to think interdisciplinary and approach problems form a scientifically global perspective. With a mutli-disciplinary approach, the Gonzalez lab combines organic chemistry, molecular biology, mathematics, computational modeling and image analysis to develop biomimetic scaffolds to dissect the human immunological process. 

Research projects in the Gonzalez lab include the development of biomaterials for investigating the influence of outside-in mediated signaling through adhesion molecules on cellular architecture and subsequent signaling pathways. These activities are investigated in leukocytes, neural stem cells, pericytes and endothelial cells. Research areas include microvascular and tissue homeostasis of lung, skin, and brain. This work extends to many different diseases and disorders including wound repair, scar formation, fibrosis, ischemic stroke, and Sweet’s syndrome.

 

Todd McDevitt, PhD

Senior Investigator, Gladstone Institute of Cardiovascular Disease, Professor, University of California, San Francisco, Department of Bioengineering and Therapeutic Sciences

Presentation: Manufacturing of interneurons from human pluripotent stem cells

Dr. Todd McDevitt’s research focuses on engineering technologies that direct the differentiation and morphogenesis of stem cells into functional tissue constructs. He is working to create human tissue models that can be used to study development and new approaches to treat multiple diseases that afflict the cardiovascular, neurological, immunological, and musculoskeletal systems.

Dr. McDevitt has received several awards, including a New Investigator Award from the American Heart Association (2004) and the Society for Biomaterials Young Investigator Award (2010). He was also recognized as one of the “40 Under 40” by Georgia Trend magazine (2013) and was inducted in the American Institute of Medical and Biological Engineering (AIMBE) College of Fellows (2014).

Dr. McDevitt graduated with a bachelor’s degree in Biomedical and Electrical Engineering from Duke University. He earned a doctorate in Bioengineering from the University of Washington, where he worked on methods to engineer cardiac and skeletal muscle tissue. He then completed a postdoctoral fellowship in the Department of Pathology at the University of Washington, in which he studied signaling pathways that affect the proliferation of cardiomyocytes derived from pluripotent stem cells.

 

Jianping Fu

Associate Professor, Mechanical Engineering, Associate Professor, Biomedical Engineering, Associate Professor, Cell and Developmental Biology, Associate Director, Michigan Center for Integrative Research in Critical Care

Jianping Fu is currently an Associate Professor at the University of Michigan, Ann Arbor, with a primary appointment in the Mechanical Engineering Department and courtesy appointments in the Biomedical Engineering Department and the Cell and Developmental Biology Department.  He is a Core Faculty Member for the UM Center for Organogenesis, the UM Comprehensive Cancer Center, and the UM Center for Systems Biology. 

Dr. Fu received a B.E. degree (2000) from the University of Science and Technology of China (USTC) and a M.S. degree (2002) from the University of California at Los Angeles (UCLA), both in Mechanical Engineering. He earned his Ph.D. degree in Mechanical Engineering from the Massachusetts Institute of Technology (MIT) in 2007 for thesis completed with Dr. Jongyoon Han.  Dr. Fu was an American Heart Association Postdoctoral Fellow in Dr. Christopher S. Chen's group at the University of Pennsylvania from 2007 to 2009.

Dr. Fu’s current research focuses on Mechanobiology, Stem Cell Biology, Developmental Biology, and Bioengineering.  Dr. Fu is the recipient of the American Heart Association Scientist Development Award (2012), the National Science Foundation CAREER Award (2012), the Mechanical Engineering Outstanding Faculty Achievement Award (2014), the Robert M. Caddell Memorial Award for Research (2014), the Ted Kennedy Family Team Excellence Award (2015), the Rising Star Award from the Biomedical Engineering Society - Cellular and Molecular Bioengineering (2016), and the George J. Huebner, Jr. Research Excellence Award (2018). Dr. Fu's research on modeling human development using human pluripotent stem cells has contributed significantly to the emerging field of "Artificial Embryos", which was selected by the MIT Technology Review as “10 Breakthrough Technologies of 2018”. 

Dr. Fu's research group is currently supported by the National Science Foundation (NSF), the National Institutes of Health (NIH), the American Heart Association (AHA), and some other foundations and agencies. 

 

Dr. Julie Murrell

Dr. Julie Murrell is the Head of Cell Therapy Bioprocessing and leads a team of scientists and engineers at MilliporeSigma, the Life Science business of Merck KGaA, Darmstadt, Germany. Dr. Murrell first led technology scouting activities related to monoclonal antibody manufacturing at the company and more recently has driven the efforts to establish robust analytics and develop manufacturing strategies for stem cell industrialization, with a focus on hMSCs, T cells and iPSCs. The group also supports collaborators with process development services. Dr Murrell earned her Ph.D. at Tufts University School of Medicine in the field of Developmental Neuroscience, completed a Post-Doctoral Fellowship in Translational Medicine at Harvard Medical School and a Fellowship in Stem Cell Biology at the University of Massachusetts before joining MilliporeSigma. She also worked in early phase drug development for small molecules at Burroughs Wellcome.

 

Lloyd F. Rose, PhD

Portfolio Manager, Clinical and Rehabilitative Medicine Research Program, U.S. Army Medical Research and Materiel Command

Dr. Lloyd Rose graduated in 1994 from the University of Texas at Austin with a Bachelor of Arts degree in History. Following a stint with the Department of the Treasury, Dr. Rose returned to the University of Texas at Austin, receiving his Bachelor of Science degree in Microbiology in 2006. From 2006 to 2012, Dr. Rose studied poxvirus immune evasion mechanisms, earning a Ph.D. in Microbiology and Immunology from the University of Texas Health Science Center at San Antonio. After completing his degree he began a postdoctoral fellowship at the U.S Army Institute of Surgical Research working on burns, scarring and skin regeneration. In 2015, he moved to the U.S. Army Medical Research and Material Command, Fort Detrick, Maryland to manage research projects in Regenerative Medicine. Currently, Dr. Rose serves as the Regenerative Medicine portfolio manager in the Clinical and Rehabilitative Medicine Research Program, responsible for planning, budgeting and execution of Army, Defense Health Program and Congressional Special Interest funds directed toward dynamic and innovative regenerative medicine research.

 

Doris A. Taylor, PhD, Hon DSc, FAHA, FACC

Dr. Taylor is leading international regenerative medicine research efforts, creating cutting edge therapies for chronic disease and “building the future treatments of tomorrow." An educator with over 25 years of teaching experience, she is truly committed to moving innovative therapies from bench to bedside, while preparing students/fellows to compete at an international level in the field of cardiac and vascular repair and regeneration.

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