michael mendicino, ph.d.
KRISHNENDU ROY, Ph.d.
Dr. Michael Mendicino established Hybrid Concepts International (HCI) as a consultancy and advisory firm in the niche and emerging fields of cell therapy, gene and gene-modified cell therapies, other regenerative medicines, tissue engineering, and cell-based drug discovery. Michael also previously worked at four biotech companies, and/or consulted, all within the aforementioned fields, covering areas such as CMC and strategic regulatory affairs, R & D, commercial, and product & technology due diligence activities. During his FDA appointment, Michael worked primarily in what is now the Office of Tissues & Advanced Therapies (OTAT), where he performed regulatory submission review and provided guidance to sponsors for cell therapy products, devices and combination products. Michael is currently a representative on multiple Alliance for Regenerative Medicine (ARM) and International Society for Cellular Therapy (ISCT) committees (including Co-Chair of ARM’s Science & Technology Committee). Michael is an SCB Co-founder, past President and Board Chairman, and is currently a member of the Board of Directors for SCB.
Dr. Krishnendu Roy received his BS from the Indian Institute of Technology (India), his MS from Boston University, and his PhD in Biomedical Engineering from Johns Hopkins University. Following his PhD, he joined Zycos Inc., where he served first as a Scientist and then as a Senior Scientist in the Drug Delivery Research group. Dr. Roy left Zycos to join UT-Austin, where he was most recently Professor and Fellow of the Cockrell Chair in Engineering Excellence. He is currently the Robert A. Milton Chair at Georgia Tech. He also serves as the Director of the Marcus Center for Cell-Therapy Characterization and Manufacturing as well as the Director of the Center for ImmunoEngineering and the Technical Lead of the NIST/AMTech National Cell Manufacturing Consortium. He serves as a member of the Editorial Boards of the Journal of Controlled Release and the European Journal of Pharmaceutics and Biopharmaceutics. He also serves as a member of the Forum on Regenerative Medicine of the National Academies and has received numerous award and honors for his contributions to the field.
cell-based drug discovery
GARY GINTANT, Ph.d.
FRANCESCO PASQUALINI, PH.D.
Dr. Gary Gintant is a Senior Research Fellow in the Dept. of Integrative Pharmacology, Integrated Science and Technology, at AbbVie. He is involved in multiple drug discovery and safety activities and initiatives internally; external activities include various cardiac safety initiatives (such as ILSI/HESI Proarrhythmia Models Project, the Cardiac Safety Research Consortium, and the Comprehensive in Vitro Proarrhythmia Assay Initiative) while serving on various journal editorial boards, NIH study sections, and Safety Pharmacology Society committees. His research interests (reflected in numerous peer-reviewed publications and book chapters) include cardiovascular pharmacology, cellular electrophysiology/ion channels, arrhythmias, application of stem-cell derived cells and tissues to drug discovery efforts, and translational medicine. He gained his MA., M.Phil. and PhD. degrees from the College of Physicians and Surgeons of Columbia University, NY.
Dr. Francesco Pasqualini is a group leader at the Wyss Institute at Harvard University and at the Wyss Translational Center at the University and ETH Zurich. In these capacities, Francesco managed Ph.D. students and post-doctoral fellows on multi-million dollar research grants and industry collaborations. He has co-/authored international patents and research papers published in Science, Nature, and Cell journals. Francesco’s work focused on i) biophysically-descriptive computational models of human cardiac cells; ii) tissue-engineered cell culture platforms, organs-on-chips, for drug testing and disease modeling; and iii) quality assurance platforms for stem cell biology and regenerative medicine applications. Francesco serves as a reviewer for international journals and funding agencies, as an external expert for Life Sciences consulting firms, and as a board member for the Standards Coordinating Body for Gene, Cell and Regenerative Medicines and Cell-based Drug Discovery.
MARITZA MCINTYRE, PH.D.
Dr. McIntyre has almost 20 years’ experience in the development, evaluation and regulation of biological and small molecule products. She served as a 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 NIH, patient groups, ASCGT and the AAV2 Reference Standard Working Group. She has since served as Director and Vice President of Regulatory affairs for Bavarian Nordic, REGENXBIO, Inc., and NanoCor Therapeutics, and as Executive Vice President of Regulatory Affairs and Product Development at Bamboo Therapeutics. Currently she provides regulatory strategy and product development consulting to developers of advanced therapy products as an independent consultant at Advanced Therapies Partners, LLC. 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
MIKE KELLY, ph.d.
Dr. Mike Kelly has over 20 years of experience in the field of gene therapy. During this time, Mike has been responsible for various aspects of research, development and clinical manufacturing for a number of lentiviral, adenoviral and Adeno-associated virus (AAV) -based therapeutics. Currently, Mike works at Biogen, where he is a Director in the Asset Development and Portfolio Management group, leading the gene therapy portfolio. Prior to his current role, Mike was the Director of Gene Therapy Development at Genzyme Corporation, where he was responsible for process development and manufacturing for Genzyme's gene therapy programs. Prior to that, Mike was most recently the Site Director at Genzyme’s development and clinical manufacturing facility in San Diego. Before joining Genzyme, Mike worked at Cell Genesys and Somatix Therapy Corporation, where he held various roles in research and development and clinical manufacturing for gene therapy programs.
JASON WERTHEIM, m.d., ph.d.
Dr. Jason Wertheim serves as an Assistant Professor, a transplant surgeon and a biomedical engineer at Northwestern University. His research focuses on discovering new methods to develop liver and kidney tissue in the laboratory to alleviate the problem of organ shortage. His research involves a multidisciplinary, tissue engineering and regenerative medicine approach to develop organ scaffolds using pluripotent stem/progenitor cells that support the growth of new tissues that will eventually become whole organs. Dr. Wertheim's lab has partnered with the McCormick School of Engineering at Northwestern University and other leading academic and industrial centers to advance the field of tissue engineering and address the problem of organ shortage. Dr. Wertheim earned his BS in Chemical Engineering from MIT, and his MD in General Medicine and Ph.D. in Bioengineering from the University of Pennsylvania. Dr. Wertheim completed his residency in Surgery at Massachusetts General Hospital. Following his residency, he went on to complete a fellowship in Transplantation at the University of California, Los Angeles.
Elena Kfoury is General Manager for Axiogenesis (North America) while serving as President / CEO of the international Standards Coordinating Body, a consortium of non-government stakeholders that operates through public-private partnerships with government regulatory agencies and other government organizations involved in helping to establish consensus standards for regenerative medicine products. Previously, Elena was principal of Polymath Consulting where she advised manufacturers on combination medical device technology and regenerative medicine market and strategic planning. She also managed business development and strategic alliances / partnerships for the Harvard Stem Cell Institute (HSCI) and has held commercial roles at several benchmark cardiac medical device and specialty pharmaceutical companies, including Boston Scientific, Genzyme BioSurgery, and Elan Pharmaceuticals. Elena earned her SM from Harvard University in Health Policy and Management and her BA in Neuroscience from Amherst College. She also holds a Green Belt in Six Sigma (CSSGB) and Lean Six Sigma in Healthcare.