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Phone: (510) 643-0598
Jane M. Alexander, B.S.N., M.P.H.
Ms. Alexander began her career in biotech-pharmaceutical research as a CRA at Applied Immune Sciences (AIS), a start-up company in the San Francisco Bay Area. Since 1993, she has held a series of clinical operation positions at start-up biotech companies. Her principal work has been monitoring and operational support of clinical studies in phases 1-3, testing small molecules, biologics, and devices. She was instrumental in developing clinical operations departments at Sugen Inc. (Pfizer) and Ilypsa (Amgen), where currently she is the associate director of clinical operations. She also has recent experience as an independent clinical consultant to several small biotechs and large pharmaceutical companies. Prior to her biotech career, for 17 years she practiced nursing in hospital, clinic, public school, public health surveillance, and clinical research settings. She
holds an M.P.H. in epidemiology from UCLA and a B.S.N. from the University
of Washington, in Seattle.
Lincoln Bynum, M.D.
Dr. Bynum received his undergraduate degree from Harvard University and his
medical degree from the University of Oklahoma School of Medicine. His postgraduate
training was in internal medicine and pulmonary disease. His experience in
the pharmaceutical industry includes 12 years at Syntex, where he participated
in clinical research as a medical monitor and program director for all phases
of drug development. Since 1995, he has worked as a consultant to pharmaceutical,
biotechnology, and medical device companies as part of a contract research
organization (CRO). Currently, he is the vice president for medical consulting
and product development services for ICON Clinical Research, an international
CRO with U.S. west coast offices in Mountain View, San Bruno, and Irvine,
CA.
Karen A. Henry, M.P.H.
Ms. Henry held the roles of manager of data management, statistician, trial monitor, trial manager, manager of SOP development and clinical trials training, and instructor. Her participation has been in all phases of drug, biologics, and diagnostic trials in various therapeutic areas, and on the side of the sponsor and investigator. Her past employment has been with New York State Psychiatric Institute/Columbia Presbyterian Medical Center, UC San Francisco Medical Center, Berlex Laboratories, and Chiron Corporation. She currently works for a start-up company as manager of clinical operations. She holds an M.P.H. in biostatistics from Columbia University.
Michael Huston, M.B.A., RAC
Mr. Huston is a principal in Huston Associates, LLC, a consulting company
with more than 20 years of drug development experience, from basic research
through commercial product launches. Mr. Huston has managed interdisciplinary
project teams for the last 10 years, beginning as a bench research scientist
and subsequently working in each discipline of drug development. Mr. Huston
has directed clinical programs in such areas as infectious disease, oncology
and neurological indications. His teams have successfully filed several IND's,
eight New Drug Applications, two Abbreviated New Drug Applications and two
Biological License Applications, leading to seven currently marketed products.
Mr. Huston consults in strategic planning and interdisciplinary drug development
projects for biotechnology and pharmaceutical companies and has taught courses
in clinical trials design at UC Santa Cruz and Berkeley Extensions.
Madeline Miller, D.V.M.
At Gilead Sciences, Dr. Miller works in project management on project and portfolio planning and analysis operations. Previously, she worked on post-marketing research programs in support of Gilead's anti-viral and anti-infective products and supervised the Clinical Finance and Contracts group, supporting all phases of clinical research. Prior to this, she was director, Clinical Research Operations, in support of phase 1-3 clinical studies. Dr. Miller began her 13-year career in pharmaceutical research at Biometric Research Institute (BRI), a contract research organization. At BRI, she was a research associate and project director supporting clinical studies for a variety of therapeutic areas, including head injury, stroke, analgesia, cardiovascular surgery, radio-imaging, and auto-immune diseases. Dr. Miller earned her doctorate in veterinary medicine and has a masters degree in biological sciences. She was in clinical veterinary practice for 9 years prior to beginning her career in pharmaceutical development.
Kay Ranganathan, M.D., M.P.A.
Dr. Ranganathan has more than 10 years of experience monitoring and managing
clinical trials in both biopharmaceutical companies and contract research
organizations. Her experience also includes hiring, training, and mentoring
clinical research professionals. She is president of ClinfoSource, Inc., which
provides innovative online training, documentation products, and support services
to clinical research professionals in the biopharmaceutical industry and at
investigational sites.
Beverly D. Smolich, Ph.D.
Dr. Smolich has more than fifteen years of academic and industrial biomedical
research experience. Following postdoctoral research in cell signaling at
Syntex, Inc., Dr. Smolich joined SUGEN (Pfizer, Inc.) where she led biomarkers
and proof of concept clinical trial programs, including clinical trial protocol
and informed consent development. Her research expertise includes translational
medicine, pre-clinical research, and pharmacology. Recently, Dr. Smolich has
successfully developed a pre-clinical and clinical research consulting business.
Helen Street, M.S., RN
Ms. Street has over 18 years of experience with broad-based project management and clinical expertise in the biotech, pharmaceutical, and clinical research organization industries. Currently she is a clinical consultant for the biotech industry. As Executive Director, Clinical Research for Kosan Biosciences Oncology, she was responsible for coordinating global clinical trials in collaboration with Medical Affairs and Roche. She was also responsible for the management and alignment of staff members, two clinical compounds, and their back-up running 15 to 19 clinical trials. She joined Kosan in February 2002 from SUGEN, where she was the senior director of clinical operations. She has worked at a number of contract research organizations (RTI, ClinTrials, BRI and PRA) over the course of her industry career in various capacities, from regional CRA, senior CRA manager, project director to director of project management. She has also had prior industry experience as a clinical scientist at Athena Neurosciences and as a coordinator at an HIV unit and clinical research site. Her primary focus is in the therapeutic area of oncology. Before joining the industry in 1988, she worked in the field of mental health in various capacities. For over 14 years, she has served as an officer and flight nurse in the USAF Reserves, and was deployed to Desert Storm. She holds a degree in nursing and two independent master of science degrees in educational psychology and public administration.
Mariana Tran, M.B.A., Ph.D.
Dr. Tran is currently the vice president of business development and operations for Cardinal Clinical Research, Inc., a global CRO with offices in the United States, Russia, and India. Dr. Tran has over seven years of leadership experience in academic institutions and the biotechnology industry. She built and led cross-functional teams to develop programs in clinical research, project management, and basic sciences for leading universities. She has also consulted extensively in the biotechnology industry on marketing and financial strategies. Dr. Tran holds a Ph.D. in neurobiology and an M.B.A., with an emphasis on finance. She has conducted research on metabolic diseases and epilepsy for over 12 years, and has received awards and recognition from the American Epilepsy Society and the Society for Neuroscience for her scientific contributions.
Liz Wool, BSN, CCRA, CMT
Ms. Wool is president and CEO at QD-Quality and Training Solutions, Inc., a consulting firm providing clinical quality systems (business processes, SOPs, standards, policies) and training services to sponsor companies, CROs, and investigational sites involved in clinical research. She possesses 30 years of experience in the healthcare arena including 18 years in the product development industry inclusive of positions in biotech and pharmaceutical companies, investigational sites, CROs, and academia. Her areas of expertise include quality and compliance, quality systems development and process improvement, clinical trial management, managing studies at investigational sites, as well as establishing and managing clinical development training departments in local biotechnology and pharmaceutical companies. She supports the Association of Clinical Research Professionals (ACRP) by serving as vice president of the Northern California Chapter.