Shawn Sheeron
Vice President,
Clinical Operations
Mr. Sheeron is Vice President, Clinical Operations. He has more than 25 years of experience in the management of clinical trials. He has conducted Phase I – IV trials in drugs, biologics, medical devices and combination products. Mr. Sheeron has extensive experience conducting trials throughout North and South America, Europe and Asia-Pacific. He has executed studies in multiple therapeutic areas, including Oncology, Hepatology, Pulmonology, and Infectious Diseases. Mr. Sheeron has worked in several mid-sized, global CROs and small biotech companies in Southern California and Massachusetts, most notably, Intercept Pharmaceutical where he led the POISE trial which led to the approval of Ocaliva™, the first new treatment for PBC in 20 years. Mr. Sheeron received an MBA from Aspen University and a BS in Nursing from Graceland University.
Lee Landeen, Ph.D.
Executive Director,
Pre-clinical Development
Dr. Landeen is Executive Director Preclinical Development and responsible for overseeing preclinical/nonclinical studies in support of filing Investigational New Drug (IND) applications for the company as well as new extramural grant applications. Previously, he held the title of Executive Director Cell Biology at Vital Therapies where his responsibilities included Phase 3/pre-commercialization CMC support, analytical development, and mechanistic understanding of the company’s extracorporeal cell-based liver treatment. He has held other management positions at cell-based/regenerative medicine companies including Organogenesis, Shire/Shire Regenerative Medicine, Advanced BioHealing, and Advanced Tissue Sciences and has been involved with wound healing and cardiovascular repair products from development through commercialization. In addition, he has consulted for various early-stage biologics companies. He received his B.S. and M.S. degrees in microbiology from University of Arizona and his Ph.D. in bioengineering from University California, San Diego.
Michael Ginsberg, Ph.D.
Senior Director,
Product Development
Dr. Ginsberg is Director of Product Development at Angiocrine Bioscience. Following his post-doctoral fellowship at Rockefeller University, Michael undertook a post-doctoral position at Weill Cornel Medical college, where he was introduced into the world of vascular biology and hematopoiesis by Dr. Shahin Rafii. While under Dr. Rafii’s guidance, he gained tremendous knowledge and expertise in the study of endothelial cells, the predominant cell-type that is necessary for the formation of the human vasculature. This work culminated in a seminal paper describing the manner in which amniotic cells could be reprogrammed into a functional, viable source of endothelial cells for potential therapeutic use. Through this work, Michael learned the intricacies involved in culturing and cultivating large quantities of endothelial cells in general, a process that would be necessary for their use in clinical applications. These experiences provided the foundation of his work that are now being done at Angiocrine Bioscience, as he is currently heading the manufacturing of GMP-grade E-CEL™ cells for their use in the clinic. Additionally, Michael is directing research aimed at identifying multiple indications for which these cells may have a beneficial therapeutic outcome. Dr. Ginsberg earned his Ph.D. from Columbia University, New York and completed post-doctoral fellowships in the lab of Dr. James Darnell Jr at Rockefeller University, New York and Shahin Rafii, MD at Weill Cornell Medicine.
Margie Breneman, PMP
Senior Director,
Project Management
Ms. Breneman is Senior Director, Project Management at Angiocrine Bioscience. Margie has over 20 years of experience leading teams in medical device, pharmaceutical and biotech companies. As QA Associate Director of Strategic Initiatives at Illumina, Margie led the Quality Systems Improvement Program to ensure compliance to ISO and FDA requirements for DNA sequencing products, including the MiSeqDx System, the first FDA approved device for in vitro diagnostic (IVD) testing. Margie also headed teams at Guidant and Abbott in areas of process improvement (Lean, Kaizen, 5S), facility design, cost reduction, software development, and technology transfer. In 2007, she received the Abbott Vascular President’s Award for the implementation of the CAMSTAR MES system to capture cGMP data for XIENCE, the market-leading drug eluting stent. Margie has a degree in Industrial Engineering from California Polytechnic State University, San Luis Obispo, a professional certificate in Regulatory Affairs from San Diego State University, and is a certified Project Management Professional (PMP).
Daniel J. Nolan, Ph.D.
Director,
External Research
Dr. Nolan is Director of External Research at Angiocrine Bioscience. An alumni of Stony Brook University, Daniel remained there for his graduate studies ultimately performing his research in the laboratory of Dr. Vivek Mittal. Dr. Mittal fostered Daniel’s interest in vascular biology with work centered on the temporal contribution of endothelial progenitor cells to tumor vasculature. His exposure to a wide range of technology led to his recruitment by Dr. Shahin Rafii at Weill Cornell Medical College. This became fertile grounds for advances as Dr. Rafii’s team was rapidly accelerating their understanding of the capacities of the E-CEL™ platform and Daniel was transforming the technological landscape of protocols within the laboratory to achieve these advances. His own work focused on the distinctions between the endothelial cells of the various tissues. The protocols he developed were the foundations to establish a series of tissue specific microvascular endothelial cells. An accomplished flow cytometrist and microscopist, Daniel continues his characterizations of distinct populations of endothelial cells at Angiocrine Bioscience.
Gayle Bresnahan
Director,
Clinical Operations
Ms. Bresnahan is the Director, Clinical Operations at Angiocrine Bioscience. She has more than 20 years of experience in the conduct and management of clinical research trials. She has led trials in Phase I – III in multiple therapeutic areas, including Oncology, Diabetes, Nephrology, Neurology and Infectious Disease. Ms. Bresnahan has worked in several small biotech companies in Southern California. Prior to joining Angiocrine, she most recently served at Retrophin as Associate Director, Clinical Operations, where she led the Sparsentan clinical program. Ms. Bresnahan received her BS in Business Administration from Bristol University.