 | Mike Stella
General Manager & VP, Operations - Memphis | | Mike Stella joined Cognate in 2007. He also currently serves as General Manager for TC CEF the Joint Venture between TiGenix and Cognate in Memphis, TN. Mr. Stella has Over 16 years of Manufacturing and Operations experience in the biotech industry. Prior to joining Cognate, Mr. Stella served as Director of Operations at Cell Genesys, Inc where he held responsibilities for Manufacturing, Facilities, Environmental Health and Safety and Clinical Distribution for their Memphis, TN facility. Before joining Cell Genesys, Mr. Stella served as regional Manager for the Interstate Companies which was focused on the procurement and utilization of blood and blood components in therapeutic and diagnostic products. |
| Michael Scott
Sr. Director, QA/Regulatory | Michael Scott joined the Cognate team in 2011 as the Senior Director of Quality and Regulatory Affairs. Previously, Mr. Scott was the Director of Quality and Regulatory Affairs for Tissue Genesis, Inc., a high-growth, clinical-stage Biotechnology Company based in Honolulu, Hawaii.
Mr. Scott has served in the Biotech, Pharmaceutical and Medical Device industries for over 20 years with such companies as Abbott Laboratories, Hospira, Psi Health Solutions and LabNow. He has also provided consulting services to the medical industries specializing in quality systems, regulatory compliance, validation, process engineering, and as a liaison to the Food and Drug Administration.
Mr. Scott holds a Bachelor’s Degree in Biology from the University of Texas at Austin and a Master’s Degree in Quality Systems Management from the National Graduate School of Business at Falmouth. He is a member of the College of Natural Sciences Foundation Advisory Council for the University of Texas at Austin, the American Society for Quality (ASQ), the International Society for Pharmaceutical Engineering (ISPE) and a volunteer pilot for Angel Flight South Central. |
| Katherine Turner
Director, Clinical Operations | | Katherine Turner is currently Director, Clinical Operations for Cognate BioServices, Inc., having served in this role since 2008. Ms. Turner’s activities include providing appropriate leadership, expertise and strategic input in managing clinical operations in support of investigational studies contracted at Cognate facilities. Specific duties include, but are not limited to, coordination of clinical patient events within Cognate, coordinate patient/donor tissue receipt and process scheduling at Cognate, serve as central contact for designated clinical projects, coordinate resolution of questions pertaining to information provided by clinical sites related to patient materials, patient batch record initiation and label issuance, and serve as liaison between Cognate, study sponsor, and study sponsor contractor(s) to expedite exchange of study specific patient/product information. During the period of 2002 to 2008, Ms. Turner was Director, Manufacturing for Cognate. Ms. Turner’s activities included managing cGMP operations associated with the production of clinical, cellular based products. Ms. Turner successfully coordinated the design and renovations of support areas for the cGMP compliant environment for Cognate operations. Ms. Turner coordinated production schedules, projects, material acquisition and associated activities with the various departments at Cognate. Ms. Turner has been involved in various aspects of the generation of operational documents and regulatory filings. In addition, Ms. Turner served as Facility Manager for the Sunnyvale, CA facility, overseeing maintenance and repairs of the physical building and grounds. Prior to joining Cognate, Ms. Turner was employed by Osiris Therapeutics as Senior Manager, Manufacturing. During her tenure with Osiris (2000 to 2002), Ms. Turner was responsible for managing the operation of the cGMP Cell Manufacturing Facility and the production of MSC-based cellular products in support of multiple clinical trials. While at Karmanos Cancer Institute (1990 to 2000), Ms. Turner managed daily operations of the Hematopoietic Stem Cell Laboratory of the Bone Marrow Transplant Program as a Bone Marrow Lab Technologist. Additionally, during the period of 1988 to 1990 at Harper Hospital / Wayne State University, Ms. Turner assisted in the conduct of bone marrow clinical research performing laboratory tests and statistical tabulations. This included preparation of bone marrow specimens for transplantation, cryopreservation, progenitor assays, data analysis, development of documents and procedures and monitoring pharmaceutical studies as they applied to the laboratory. Ms. Turner earned a BS in Biology / Business minor from Saginaw Valley State College (1985). |
| Lisa McClain-Moss
Director, Manufacturing | | Lisa McClain-Moss is currently the manufacturing supervisor, having joined the company in 2007. Ms. McClain-Moss’ activities include the management of cGMP production of cellular therapies and project lead for the transfer of new technologies into GMP production. Prior to joining Cognate, she was the Therapeutics Production Section Head at St. Jude Children’s Research Hospital. Ms. McClain-Moss has over 15 years experience in cell culture and the production of biologics including process development and scale up. She also has 5+ years in diagnostic testing. Ms. McClain-Moss earned a B.S. in Microbiology from Tennessee Technological University (1992). |
| Lori Noffsinger
VP, Operations - Baltimore | | Lori Eby Noffsinger is currently the Manager of Process Development for Cognate Bioservices, Inc., joining Cognate in 2002. Ms Noffsinger manages the transition of technologies from research and development through scale up to manufacturing with a focus toward clinical application. Ms Noffsinger assists in designing and conducting validation and optimization experiments. She also assists in writing and reviewing controlled documents and in technology transfer as well as technical consulting for other groups in Cognate and collaborating companies. Prior to joining Cognate, Ms Noffsinger served most recently as an implementation and product specialist for Stemsoft Software Inc., Vancouver, BC. Ms Noffsinger spent a year traveling to Cell Processing Laboratories, implementing, validating, training and installing laboratory oriented database software. Ms Noffsinger is an accomplished Medical Technologist with 14 years of experience in transfusion medicine, beginning with blood bank positions. She has 7 years experience in bone marrow cell processing and graft engineering at Johns Hopkins Oncology Center. Ms Noffsinger worked at Johns Hopkins University from 1996-2001as a Research and Development Specialist for Oncology/Hematalogic Malignancies. In the Development Immunotherapy Lab, Ms Noffsinger assisted in effective management of projects and resources to achieve phase I-II trials for Graft Engineering, Cellular Immunotherapy and Gene Therapy. During her years at Johns Hopkins (University and Hospital), Ms Noffsinger collaborated with Companies on development of prototypes, verification and validation of several devices, processes, and reagents/drugs. She gained general experience in the areas of Immunology, Hematapoetic Stem cell Processing, Graft Engineering, Cell Cryopreservation, Quality Assurance, Process Validation, Regulatory issues, Molecular Biology, GMP Processing and translating research from “bench to clinic”. She developed skills involving cell selection, elutriation, flow cytometery, designing, performing and validating immunologic assays, writing controlled documents and the training of clinical personnel. She also has experience with ex vivo expansion of bone marrow, cytotoxic T-cells, dendritic cells and other cell types for therapeutic use as well as for clinical research activities for the university and hospital. Lori earned her Bachelor of Science in Medical Technology / Computer Science from Michigan Technological University in Houghton, MI, USA. |
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