 | Mike Stella
Vice President and General Manager, Cognate-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. |
| Aaron H. Heifetz, Ph.D.
Vice President of Business Development | | Aaron Heifetz joined Cognate in 2006. Aaron is responsible for general business development activities including sales of client services and customer support. Aaron has worked in increasingly responsible positions as an operating executive in biotechnology and health care companies. He has twenty years of industrial management experience in aggressive, creative environments within biomedical/biotechnology businesses with process and product development, manufacturing, and commercialization responsibilities. Before joining Cognate, Aaron was an associate at Toucan Capital serving in a variety of assignments. Previously, Aaron was Vice President, General Manager & Site Director of Cambrex Bio Science Baltimore, a contract developer and manufacturer of biologics and vaccines. At Cambrex, Dr. Heifetz was responsible for all technical and administrative functions, including Production, Quality, Business Development and Process Development. Under his guidance, several biological and vaccine products were developed, manufactured, and approved for clinical trials and commercial use. Aaron joined Cambrex in 1995 after ten years with W.R. Grace & Co.-Conn. At Grace, his product development and industrial research experience includes biotechnology and biomedical product development in the areas of gene transfer and expression, medical devices and specialty drug delivery. He was extensively involved in technology transfer to international cGMP manufacturing facilities, clinical study design and monitoring, and development of commercialization strategies. Aaron received a Ph.D. in Biomedical Sciences (Biochemistry) from The University of Texas Graduate School of Biomedical Sciences, The University of Texas Health Science Center at San Antonio. He was a postdoctoral fellow at the Johns Hopkins School of Medicine in Baltimore, Maryland. Aaron received his BA at Tulane University in New Orleans, Louisiana. |
| 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
Manufacturing Supervisor | | 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). |
| David Betts
Director, Quality Control | | David Betts is the Director, Quality Control, at the Memphis Cognate BioServices facility, serving in that capacity since 2007. Mr. Betts is responsible for the cGMP quality control testing of raw materials, intermediates, and final product. He coordinates testing at Cognate and contract laboratories. Mr. Betts is involved in method development and validation of QC assays and equipment. He has oversight of the cGMP cleanroom environment and contamination control. He has over 16 years of QC experience in the pharmaceutical, medical device, and cell therapy industries. He has designed, staffed, and managed quality laboratories through successful establishment inspections, clinical trials, and commercial launches. He previously headed the microbiology lab at KV Pharmaceutical in St Louis. Prior to that, he managed the QC lab for Cell Genesys, beginning in San Diego and later moving to Memphis , implementing cross-site environmental monitoring programs. He headed the microbiology lab of therapeutic ophthalmics company InSite Vision, in the San Francisco Bay area. He was also a bench analyst in the microbiology lab of a contact lens solution manufacturer, Paragon Vision Sciences, later acquired by Allergan. Mr. Betts graduated from the University of Arizona with a BS in microbiology and a minor in chemistry. |
| Lori Noffsinger
Manager, Process Development | | 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. |
| Kevin McIntosh, Ph.D.
Sr. Director, Research | | Kevin McIntosh is currently Senior Director of Research for Cognate BioServices, Inc. Having served in this role since 2002, Dr. McIntosh manages the Immunology, Molecular Biology and Preclinical divisions within the Company. The research group has multiple responsibilities that involve assay development, intellectual property development, research projects for clients and production of specialized cell types for the Company, collaborators and vendors. Dr. McIntosh frequently collaborates with outside investigators from academia as well as industry on research projects that require grant support, lab support and cells derived for use in preclinical animal models. An area of expertise includes mesenchymal stem cells (MSCs) derived from bone marrow, adipose tissue and the umbilical cord matrix. The Immunology group has developed innovative strategies for characterizing immune responses to allogeneic stem cells, including lymphoproliferation assays, T cell subset analysis of cytokine production, cytometric analysis of T cell activation markers and antibody production. The Molecular Biology and Immunology groups work closely together to devise strategies for stem cell tracking in vivo and immune evasion technologies to facilitate engraftment of allogeneic stem cells. Similarly, the Immunology and Preclinical groups collaborate to assure production of sufficient numbers of MSCs for immunology, efficacy, and safety studies in various animal models. Prior to joining Cognate, Dr. McIntosh was employed by Osiris Therapeutics, Inc. as Associate Director of Immunology. During his tenure with Osiris (1996 to 2002), Dr. McIntosh’s group discovered and analyzed the suppressive properties of bone marrow-derived MSCs that are currently in late phase clinical trials for treatment of graft versus host disease. As an Assistant Professor at Johns Hopkins School of Medicine (1981 to 1996), Dr. McIntosh developed immunosuppressive strategies for the treatment of the autoimmune disease, Myasthenia Gravis. During his postdoctoral fellowship at Georgetown University (1979-1981), Dr. McIntosh studied the immunosuppressive properties of T cells derived from umbilical cord blood. Dr. McIntosh earned his B.S. (1974), M.S. (1976) and Ph.D. (1979) degrees from the University of Illinois in Champaign-Urbana. |
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