Andrew Moreo serves as Operations Manager for the GMP and Viral Vector Core Facilities at Nationwide Children’s Hospital (NCH) in Columbus, Ohio.

Mr. Moreo has a B.S. in Biology from Purdue University and nearly two decades of experience in genetic and molecular research, with the last 11 years focused on AAV production. During his time at NCH, Andrew has led the development of an adherent AAV production platform that is robust, adaptable and high-yielding across a wide array of serotypes.

This platform has delivered over 1.5×10¹⁷ viral particles in support of 40+ Phase 1 INDs. He also led in the expansion of the GMP facility from a single product legacy space to a new multi-product facility capable of handling up to four independent products simultaneously.

In his role, Moreo continues to lend his expertise in the development of new vector production platforms as well as the transfer of existing technologies to clients wishing to pursue advanced phase production.

Anne Kantardjieff serves as Director of Plasmids and Small Molecules Manufacturing at bluebird bio. Prior to that, she was the Director of Early Stage Process Development at Alexion Pharmaceuticals, where her team was responsible for cell line development as well as upstream and downstream process development for Alexion’s early clinical biologics portfolio.

Kantardjieff is the recipient of the 2018 ACS BIOT Van Lanen award, recognizing her service to the Biotechnology Division of the American Chemical Society division, where she also serves as secretary.  She obtained her Ph.D. in Chemical Engineering from the University of Minnesota, and her B.Eng. in Chemical Engineering from McGill University in Montreal, Quebec, Canada.

Krishanu Saha is an Assistant Professor in the Department of Biomedical Engineering at the University of Wisconsin-Madison. He is also a member of the Wisconsin Institute for Discovery, Carbone Cancer Center, and Stem Cell and Regenerative Medicine Center as well as the National Academies’ Forum on Regenerative Medicine.  

Prior to his arrival in Madison, Dr. Saha studied Chemical Engineering at Cornell University and the University of California in Berkeley. He was a Society in Science: Branco-Weiss fellow at the Whitehead Institute for Biomedical Research at MIT, and in the Science and Technology Studies program at Harvard University. Major thrusts of his lab involve gene editing and cell engineering of human cells found in the retina, central nervous system and blood.

Dr. McIntyre has 20 years of experience in the development, evaluation and regulation of biological and small molecule products within startup biotech firms, the Food and Drug Administration (FDA), and as a consultant. Dr. McIntyre was a product reviewer and ultimately Branch Chief in the Division of Cellular and Gene Therapies at FDA/CBER, where she was actively involved policy development and liaison activities to stakeholder groups. She has since worked in regulatory affairs and product development at Bavarian Nordic, REGENXBIO, Inc. and NanoCor Therapeutics. She served as Executive Vice President of Regulatory Affairs and Product Development at Bamboo Therapeutics where, as part of the senior management team, she participated in portfolio selection, product development and fundraising that resulted in an initial $50 million finance round and ultimate the sale of the company to Pfizer.

As president of Advanced Therapies Partners LLC, Dr. McIntyre provides strategic regulatory and product development advice to biotech companies, academics, and venture capital firms. She has proven success in defining development strategies for products with complex regulatory challenges including special designations (orphan, RMAT, pediatric orphan drug designation), endpoint selection, accelerated approval, complete response letters and dispute resolution. She has also been involved in the preparation of some of the first BLA and MAA submissions for gene therapy products to FDA and EMA. She has multidisciplinary experience, including chemistry manufacturing and control (CMC), preclinical, and clinical with a wide range of product types, including novel gene and cell therapy products, vaccines, biological products and small molecules at varied stages of product development.

Through her participation in industry associations, including ASGCT and the Standards Coordinating Body she has continued to contribute to gene therapy regulatory policy development.

Dr. McIntyre received a Ph.D. in virology from the University of Chicago and graduated magna cum laude with an Honors B.S. in biology from Wayne State University.

Dr. Hari Pujar is Vice President of Technical Development and Manufacturing at Moderna Therapeutics, a privately-held RNA therapeutics company. He was previously Global Product Leader for pediatric and adult vaccine franchises in the commercial division of Merck & Co., Inc., with responsibility covering R&D, manufacturing, and commercial strategy, representing over $2B+ in annual revenue. Earlier at Merck, Dr. Pujar managed bioprocess development, external bioprocess R&D, and external cGMP manufacturing of vaccines, novel biologics, and biosimilars, where he contributed to product development from late discovery through commercialization, including global regulatory filings for several vaccine and biologics candidates.

He has been active in leadership roles with the American Chemical Society, including serving as the Chair of the Biotechnology Division. He served as an adjunct faculty at University College London, and as a steering committee member of the EPSRC Innovative Manufacturing Research Center for Bioprocessing, and the Center for Innovative Manufacturing in Emergent Macromolecular Therapies, both at University College London.

He has authored numerous peer-reviewed publications and is a co-editor of the book, “Vaccine Development and Manufacturing.” He has won the James van Lanen Award of the American Chemical Society and is a Fellow of the American Institute of Medical and Biological Engineering.

Dr. Pujar holds a bachelor’s degree in chemical engineering from Institute of Chemical Technology, Mumbai, a Ph.D. in chemical engineering from the University of Delaware and an MBA in finance from the Wharton School at the University of Pennsylvania.

Prior to becoming the Chief Executive Officer of ZIOPHARM in May 2015, Dr. Laurence Cooper was a tenured Professor (early/exceptional promotion) at The University of Texas MD Anderson Cancer Center (MDACC), with joint appointments in the Division of Pediatrics and Department of Immunology. He also served as Section Chief of Cell Therapy at the Children’s Cancer Hospital at MDACC where, as a Visiting Scientist at MDACC, he will continue to lead scientific efforts to develop new treatment approaches which pair genetic engineering with immunotherapies.

287Dr. Cooper has coauthored dozens of peer-reviewed journal articles, abstracts, and book chapters. He has initiated multiple trials under INDs infusing T cells and NK cells. He is undertaking the first protocols using a new approach to gene therapy based upon the Sleeping Beauty transposon/transpoase system and has helped develop clinical-grade artificial antigen presenting cells for numerically expanding and activating lymphocytes. Dr. Cooper obtained his M.D. and Ph.D. degrees at Case Western Reserve University in Cleveland and then training in Pediatric Oncology and Bone Marrow Transplantation at the Fred Hutchinson Cancer Research Center in Seattle. 

Dr. Mark Osborn is an Assistant Professor at the University of Minnesota in the Department of Pediatrics and the Division of Blood and Marrow Transplantation. He is a member of the Masonic Cancer Center, the Stem Cell Institute, The Institute for Engineering in Medicine, and the Center for Genome Engineering.  His laboratory focuses on gene and cell therapy for inherited and acquired lethal pediatric disorders and applies the latest methodologies in gene therapy and genome engineering. 

Luk H. Vandenberghe, Ph.D., is an Assistant Professor at Harvard Medical School and and Associate Member of the Broad Institute of Harvard and MIT in Boston, MA. He directs the Grousbeck Gene Therapy Center at Massachusetts Eye and Ear Infirmary in Boston, USA, a part of the Ocular Genomics Institute, a bench to bedside research program to study, diagnose, and develop treatments for diseases of the eye. He received a degree in cellular and genetic engineering from the University of Leuven, Belgium. His previous work led to the discovery of novel AAV serotypes such as AAV9, novel insights into AAV structure-function, and vector immunobiology.

His laboratory at Harvard addresses mechanistic questions on AAV virology, develops technologies aiming to overcome hurdles to gene therapy clinical applications, and actively translates gene therapy programs in hearing and vision. His research focuses on delivery questions, specifically on the adeno-associated virus (AAV) for therapeutic gene delivery. Recent studies leverage structural and evolutionary information on AAV as a starting point for the design of synthetic viral vector systems, a first generation of which is referred to as AncAAVs which are now progressing to the clinic for a number of indications.

Dr. Vandenberghe previously co-founded GenSight Biologics and Akouos. He also is a founder, board member, and advisor to Odylia Therapeutics, a non-profit catalyzing translation for gene therapies within the challenging field of ultra-rare disorders. Dr. Vandenberghe has over 50 peer reviewed publications and more than a dozen licensed patents, mostly related to gene therapy methods, technologies, and applications.

Theresa M. Reineke is a Distinguished McKnight University Professor in the Department of Chemistry at the University of Minnesota. She also holds graduate faculty appointments in the Departments of Chemical Engineering/Materials Science and Pharmaceutics. Her educational background includes receiving a Bachelor of Science from the University of Wisconsin-Eau Claire, a Master of Science from Arizona State University, and a Ph.D. from The University of Michigan. She then received a National Institutes of Health Postdoctoral Fellowship to further her research background at the California Institute of Technology prior to beginning her independent faculty career.

Her research group is currently focused on enabling fundamental and applied technology advancements of polymers in the fields of gene and cell therapy, oral drug delivery, and sustainability for which she has published more than 110 peer-reviewed manuscripts and received several awards such as the American Society of Gene and Cell Therapy Outstanding Investigator Award, the National Institutes of Health Director’s New Innovator Award, and the American Chemical Society Division of Polymer Chemistry Carl S. Marvel Creative Polymer Chemistry Award.

Reineke is also a founding Associate Editor of ACS MacroLetters and currently on the Editorial Advisory Boards of the ACS journals Biomacromolecules and Bioconjugate Chemistry.

Dr. Courtman is trained in cellular and molecular pathology and biophysics with, extensive expertise in the development of novel therapies for cardiovascular disease. He has a long standing interest in the development of novel cardiovascular biomaterials and the regulation of biological responses within the unique spatially-oriented matricellular environment of blood vessels.

Dr.Courtman has participated in the development of a number of cellular-based gene therapies for the treatment of cardiopulmonary disorders taking them from initial concept, through appropriate animal disease models, and into first-in-human clinical trials. He is currently directing the manufacturing of these cell products for trials treating patients suffering from pulmonary arterial hypertension, myocardial infarction, and sepsis.

He is a Scientist and Director of Biotherapeutics at the Ottawa Hospital Research Institute, Assistant Professor at the University of Ottawa, and Chief Scientific Officer of Northern Therapeutics.

Matthew Porteus M.D., Ph.D. is an Associate Professor in the Department of Pediatrics, the Institute of Stem Cell Biology and Regenerative Medicine, and the Child Health Research Institute at Stanford. He received his B.A. from Harvard University in “History and Science” and his M.D. and Ph.D. degrees at Stanford University. He completed his post-doctoral medical training in Pediatrics and Pediatric Hematology/Oncology at Boston Children’s Hospital and the Dana Farber Cancer Institute, and his post-doctoral research training under the mentorship of Dr. David Baltimore.  

His primary research focus is on developing genome editing as an approach to cure disease, particularly those of the blood but also of other organ systems as well. His research program has made important discoveries in advancing the field of genome editing including the first use of genome editing using engineered nucleases in human cells and optimizing the use of the CRISPR/Cas9 system in primary human stem cells.  

He also works as an attending physician on the Pediatric Hematopoietic Stem Cell Transplant service at Lucile Packard Children’s Hospital where he cares for children under going bone marrow transplantation for both malignant and non-malignant diseases. His goal is to combine his research and clinical interests to bring innovative curative therapies to patients. He served on the National Academy Study Committee of Human Genome Editing and as a History and Science major at Harvard he wrote his undergraduate thesis on the social interpretation of the recombinant DNA controversy in the early 1970s. 

Michelle Berg joined Abeona in June of 2015, serving initially as Vice President, Patient Advocacy and transitioning in late 2017 to Vice President, Patient Affairs & Community Engagement to better reflect departmental focus. As lead for the Patient Affairs department, Michelle’s role encompasses development and provision of education and information on rare disease, drug development, gene therapy, and advocating for change and awareness for the impact on communities served specifically through Abeona’s pipeline programs. Berg is a contributing author and speaker on patient focused programming and rare disease advocacy.

Previously, she was the first hire with Aldevron, LLC, now a leading global contract manufacturing organization specializing in biological reagents for R&D through clinical trial use. During her time there, she held multiple positions with increasing responsibility, contributing to the growth and reach of the organization, focused on developing strong relationships, collaborations, and services. Additionally, she performed research on behalf of the Department of Plant Sciences, North Dakota State University. Her B.S. in Biotechnology was attained from North Dakota State University in 1997. She brings over 17 years of experience in the gene and cell therapy, vaccine, gene editing and molecular diagnostic fields.