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Edward Kavalerchik, M.D.

Executive Medical Director,
Clinical Development

Dr. Kavalerchik is Executive Medical Director, Clinical Development. Edward is a board-certified oncologist trained at University of California San Diego with extensive exposure in general and hematologic oncology and blood and marrow transplantation. He practiced as a staff physician and associate director of Stem Cell Lab at Blood and Marrow Transplantation Division at Scripps Clinic and Scripps Green Hospital while advanced fellowship in Clinical and Translational Medicine from the Scripps Translational Science Institute under the leadership of Eric Topol, MD. He completed a 4 years post-graduate fellowship at California Institute of Regenerative Medicine investigating basic and translational aspects of human embryonic, hematopoietic, and cancer stem cell biology in the laboratory of Catriona Jamieson MD, PhD at UCSD. He received undergraduate degree from MIT and MD from Renaissance School of Medicine at Stony Brook University, SUNY. Since 2011, Dr. Kavalerchik has held a number of clinical drug development positions of increasing responsibility in oncology, hematology and autoimmune disorders covering all stages of development from pre-IND through BLA at Onyx Pharmaceuticals (acquired by Amgen), Medivation (acquired by Pfizer), Stemcentrx (Acquired by Abbvie).

Kenneth N. Wills, Ph.D.

Kenneth N. Wills, Ph.D.

Executive Director,
Research

Dr. Wills is the Executive Director of Research at Angiocrine Bioscience. He has more than 25 years’ experience in biotherapeutic drug development at both small biotechs and large pharmaceutical companies.  Dr. Wills has led and managed multiple R&D teams to successfully transition quality drug candidate compounds from the discovery phase through final preclinical translational development. In his first scientific position at a small biotech start-up called Canji, he successfully launched a recombinant adenovirus (rAd) delivery system program, transforming the initial tumor suppressor gene therapy program into an efficacious treatment in multiple tumor models that was deemed successful enough for Schering-Plough to purchase the initial rAd-p53 program in 1995 before buying the whole company a year later. While at Schering-Plough, two cancer projects initiated in his lab; rAd-p53 and rAd-IFN-alpha2b, progressed into clinical trials. The latter is currently enrolling for a Ph III trial in bladder cancer (Instiladrin).  At Pfizer, Dr. Wills led a multi-site team of scientists in the discovery and translational development of an active vaccination approach for treating tauopathy related neurodegenerative diseases such as Alzheimer’s (AD) and FTD.  Dr. Wills graduated Phi Beta Kappa, Summa Cum Laude from UCSB before earning his Ph.D. in Pharmacology from Stanford University.

Lee Landeen

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.

Ronda Schreiber, Ph.D.

Ronda Schreiber, Ph.D.

Senior Director,
Technical Operations

Dr. Schreiber is Senior Director of Technical Operations at Angiocrine Bioscience. Ronda led multiple programs within Research & Development, Translational Research, and Manufacturing Sciences, during her near 30 years tenure within the biotechnology field. Pre-clinical and development studies led by Ronda supported successful FDA submissions that spanned approval of clinical protocols and improvements to commercial products. Ronda has broad expertise in biomaterial development. She has led projects to identify optimal features of scaffolds for cell delivery and tissue repair and managing biocompatibility testing per ISO10993-1 guidelines. In addition to her leadership roles in R&D, Ronda has led multiple investigations of manufacturing failures, identifying root causes and implementing corrective and preventative actions. Utilizing her skills across technical operations, Ronda currently leads initiatives to broaden and optimize Angiocrine’s manufacturing capabilities for current clinical and future, commercial cell therapy production. Ronda earned her Ph.D. at Mount Sinai’s Biomedical Graduate Program in New York and completed her post-doctoral work at the Scripps Research Institute’s Department of Immunology.

Michael Ginsberg

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

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.

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

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.