Leigh Ann Soltysiak, MS, Senior Advisor Sales and Marketing
Leigh Ann is is a global commercialization strategist within the digital health, diagnostic, med-tech and biopharmaceutical sectors.. She is the Founder of Silverleaf Consulting, LLC® where she advises companies to achieve greater success in the marketplace through product planning, launch strategy and marketing/sales execution. Prior, she worked at Johnson & Johnson in Institutional Sales, District Management and Brand Management for the flagship hematology/oncology product PROCRIT®. Serving in Global Launch Leader and Global Strategic Marketing roles, she led the launch of multiple products, most notably STRATAFIX®. She was recognized with the J&J Standard of Leadership, Strategy & Pipeline Innovation and President’s Cup Awards. She is Adjunct Professor at the Steven’s Institute of Technology and Entrepreneur-in-Residence for technology start-ups, Stevens Venture Center. She leads the HHS 2020 Tick Borne Disease Working Group as Co- Chair, appointed by the Secretary of Health. She served on the board for the Enright Melanoma Foundation and the Healthcare Businesswomen’s Association. Ms. Soltysiak received a M.S. in Integrated Marketing from Northwestern University and a B.S., in Advertising from Syracuse University.
Spencer R Keilich PhD, Lead Scientist
Spencer Keilich is a biomedical engineer with prior experience in devices for experimental biology, cell culture, immunohistochemistry, flow cytometry, fluorescent and confocal microscopy, molecular biology techniques and biomedical and engineering software. In his graduate work he focused on the study of influenza infection and aging-induced disability. His role at QCDx is to participate in the design of rare cell detection methods that utilize the RareScope instrument to detect and characterize CTC and other blood cell subpopulations such as lymphocytes that play critical roles in cancer or infectious diseases. His graduate research in immunology gives him a strong background in cancer biology, identifying immunological targets, and therapeutic intervention. Dr. Keilich received a B.S. in Biomedical Engineering from Worcester Polytechnic Institute and a PhD in Biomedical Science with a concentration in Immunology from University of Connecticut School of Medicine.
Kenneth I Kaitin PhD, Director
Kenneth Kaitin is the Director of the Tufts Center for the Study of Drug Development and a Professor of Medicine and of Public Health at Tufts University School of Medicine. He is also an Advisory Professor at Shanghai Medical College at Fudan University, and he serves on the faculty of the European Center for Pharmaceutical Medicine at the University of Basel. Dr. Kaitin is an internationally recognized expert in drug development science and policy. He writes, speaks, and teaches on global trends in pharmaceutical development and regulation, and he has provided public testimony before the U.S. Congress. A former President of the Drug Information Association, Dr. Kaitin is currently Editor-in-Chief of Expert Review of Clinical Pharmacology, and he is a consultant to the U.S. Department of Defense on bioterror countermeasures. In 2011, he received the Dr. Louis M. Sherwood Award, granted by the Academy of Pharmaceutical Physicians and Investigators, and in 2020 he was named a Global Fellow in Medicines Development by the International Federation of Pharmaceutical Physicians. Dr. Kaitin serves on several public and private life science company boards of directors. He received his BS from Cornell University and MS and PhD in pharmacology from the University of Rochester.
Harry H Penner JD LLM, Co-Founder & Chairman
Harry has 30+ years of executive experience in the pharmaceutical and biotechnology sectors. He is currently on the Board of Directors of Prevention Pharmaceuticals, Affinimark Technologies, Neurovail, Aria Neurosciences and Carogen. He has been a director of Celldex since the merger between Celldex and AVANT Immunotherapeutics in March 2008 and had been a director of AVANT since 1997. In 2001, he founded Nascent BioScience, a firm engaged in the creation and development of new biotechnology companies, where he is currently Chairman and Chief Executive Officer. From 1993 to 2001, he was President, Chief Executive Officer and Vice Chairman of Neurogen Corporation. From 1985 to 1993, he was an Executive Vice President of Novo Nordisk A/S, serving from 1988 to 1993 as Executive Vice President for North America and President, Novo Nordisk of North America. From 1985 to 1988 he was the company's Executive Vice President and General Counsel in Denmark. He has served as BioScience Advisor to the Governor and the State of Connecticut, Co-Chair of Connecticut United for Research Excellence, Chair of the Connecticut Board of Governors of Higher Education and Chair of the Connecticut Technology Council. Mr. Penner received a B.A. from the University of Virginia, a J.D. from Fordham University and an L.L.M. in International Law from New York University.
S. Michael Sharp, PhD, Senior Advisor Quality & Regulatory
Michael is a Senior Regulatory Affairs and Clinical Research Executive, with more than 40 years of experience to the development and approval of medical devices. He is a Fellow of the Regulatory Affairs Professional Society and the American Society of Laser Medicine and Surgery. He has been responsible for the development and prosecution of 510(k)s, PMAs and NDAs as well as numerous IND, IDE and CE Mark Technical Dossier submissions for multiple Medical Devices. Also for the conception, planning and conduct of clinical trials of both medical devices and drugs, including multi-national, multi-center trials, Phase 1 first in man oncology studies, and pivotal PMA trials.He has held Senior Executive Regulatory positions among others at Kinexum, MOJ Clinical and Medical Case Reports, Eqalix, Inc., Becker & Associates/NSF, AngioDynamics, Inc., ConforMIS, Inc., Ikonisys, Inc., Winship Cancer Institute, Emory University School of Medicine, AAI International, Div. of AAI Pharma, Synthes, USA, Intelligent Surgical Lasers, VISX, Inc, How-medica, Div. of Pfizer. Dr. Sharp received a BA from Chapman University and a PhD from California Coast University.
Liming Shao PhD, Advisor to the Board
Liming is a Professor of Medicinal Chemistry at School of Pharmacy, Fudan University, Shanghai and Director of the Shanghai Center for Drug Discovery & Development.
Prior to joining Fudan University, Liming was a senior director at Sepracor Inc./Sunovion Pharmaceuticals Inc. in drug discovery research. For over 30 years, as a medicinal chemist, Liming participated in or led programs that cover a broad range of drug discovery research and development and which have resulted in 20 advanced leads for preclinical development for the treatment of pain, depression, ADHA, schizophrenia, Parkinson’s disease and the acceptance by the FDA of 4 IND applications and 1 NDA.
Liming’s academic training was at the Tokyo University where he received his Ph.D. in Organic Chemistry followed by a postdoctoral fellowship at Harvard University.
Triantafyllos (Fyl) Tafas PhD, Founder, CEO & Director
Fyl is a Life Sciences entrepreneur and developer of precision diagnostics aiming to transform human health. He founded QCDx in 2017 to develop and commercialize a next-generation rare cell detection technology, by leading a multi-disciplinary team, working at the intersection of genomics, optics, microfluidics and big data. He co-founded Ikonisys Inc. in 2000 and served as the CSO, CTO and then President a robotic microscopy platform and diagnostic products used by major clinical customers in the US and Europe to deliver more than 300,000 cancer diagnostic tests. Prior to that, he developed a new prenatal Down screening biomarker which was licensed to Chromavision (Clarient Inc./Neogenomics) and introduced the first Prenatal Chromosomal Abnormalities Screening Program for Greece. He co-authored more than seventy publications and is the co-inventor to 38 US patents and multiple patents pending. He was awarded the prestigious Jefferson Medal Award by the New Jersey Intellectual Property Law Association and the Distinguished Services Award from the University of Athens, Greece. He is holding a B.S. in biology and Ph.D. in ecology and populations biology from the University of Athens, .
Andreas Typaldos, Director
Mr. Typaldos is a veteran and pioneer software and technology entrepreneur, as well as founder and/or owner of businesses in the hospitality and other commercial areas. He has been founder and founding or early investor of a number of software and technology companies in the US and Europe, through a Typaldos Family Office. He has deep and broad management and enterprise development experience, with expertise and international and financial contacts, over a wide range of industries. He is CEO of Xandros Inc. He co-founded Cogia GMBH (Frankfurt, DE). He is major shareholder of CoinAnalyst. He is Executive Chairman of Bridgeways Inc,, and Chairman of Arkados Group Inc. He is founder, CEO, and venture partner of the Kerna Group, and Chairman or CEO of a number of Group companies. He is Chairman and CEO of Scalix Coproration. He is holding a BS in Mathematical Methods for Engineering and Operations from Columbia University and a Masters in Computer Science from Pratt Institute.