J. Kelly Ganjei
Chief Executive Officer
Mr. Ganjei joined Cognate in 2011 as the Chief Executive Officer. Mr. Ganjei has over 20 years of experience within the life science, venture capital and IT sectors and has lead companies through various stages of development, ranging from the virtual start-up, to the mid-cap restart, through the exponential growth phase, and into a public exit. Prior to joining Cognate, Mr. Ganjei was Principal at an SBA venture capital firm where he was brought on to support deal flow into and out of the fund, with a specific focus on regenerative medicine, immunotherapy and cell therapy investment opportunities. While in this role, he helped the venture capital firm exit the SBA program and was the key driver of several other strategic deals for various portfolio companies. Previously, Mr. Ganjei was the CEO and Co-founder of Remegenix, Inc. which transitioned to public exit with a $5 million funding commitment from Kodiak Capital. Prior to Remegenix, Inc., as the VP of Business Development at TissueGene, Inc., Mr. Ganjei helped close several tranches of TissueGene’s Series A and B funding and was responsible for developing the global informatics infrastructure for the company and its affiliates. Prior to TissueGene, Inc., he served as a Product Marketing Manager for LabVantage where he was the key technical sales and marketing lead for LabVantage’s life science software product offering globally and was responsible for the design of all life science product initiatives. Mr. Ganjei has published numerous scientific, peer-reviewed papers in a number of journals and has been an invited guest speaker and presenter at various business forums.
Mr. Ganjei received his B.S. in Microbiology from the University of Maryland College Park in 1995 and began his career at NIH in May of the same year.
Chief Financial Officer
Mr. Piré joined Cognate in 2015 as the Chief Financial Officer. Mr. Piré has more than 25 years of experience establishing and implementing strategic plans for growth and development in companies operating in a wide spectrum of industries. Previously, Mr. Piré was the Managing Partner at Cross-Border Consultants where he advised several clients. Indicative representations include a private equity fund on the acquisition of a $75 million, privately-held outerwear manufacturing business; a veterinary hospital group in connection with the financial restructuring and implementation of an external growth strategy; and a women’s ready-to-wear brand operating on four continents in the negotiation of multi-million dollar leases.
Before Cross-Border Consultants, Mr. Piré was Director of Business Development at Oberthur Fiduciare, a globally-recognized security printer focused on production of banknotes and other security documents. At Oberthur, Mr. Piré, was responsible for advising African ministries on strategies to prevent and eliminate counterfeiting of secure documents. From 1989 through 2007, Mr. Piré was based in New York as the Vice President, CFO of international, high-fashion brand Vertigo, a women’s ready-to-wear manufacturer, importer and distributer, where he managed 120 employees, Vertigo’s global network of franchises and in excess of $50 million in revenues. From 1996 through 2007, Mr. Piré was also the Founder and CEO of VPL, a manufacturer of private-label merchandise, whose products were featured at Express, Limited, Bebe, and Saks Fifth Avenue.
Mr. Piré received his MBA in Finance at Université Paris Dauphine in 1984 and his Masters in Economics and Finance at Université Paris II.
Chief Operating Officer
Mr. Stella joined Cognate in 2007. Mr. Stella has over 22 years of extensive manufacturing and operations experience in the biotech industry. Prior to attaining the role of COO, Mr. Stella served as Cognate’s Executive Vice President of Global Operations, responsible for overseeing the startup, on-going operations, and validation of the Memphis facility and overseas activities. Mr. Stella has been instrumental in the identification and continuing establishment of a number of commercial-ready systems to support the manufacture of cell therapies at commercial scales.
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 its Memphis facility. During his tenure at Cell Genesys he was directly responsible for the site operations and clinical manufacturing of the Autologous GVAX Lung Cancer Immunotherapy in NSCLC and BAC. 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.
Shari Lisa Piré
Chief Legal Officer
Ms. Piré joined Cognate in 2015. A seasoned attorney and member of the Cognate senior management team, Ms. Piré is fully engaged in a wide range of legal and general management matters. Leading all of the legal and corporate affairs of Cognate and its affiliates, Ms. Piré, develops, directs and advises the Board and the CEO, COO, CFO, and other executives on all legal and strategic matters, including the risks and benefits associated with transaction structuring and implementation. More specifically, Ms. Piré implements and manages all legal aspects of Cognate’s business including its growth strategy, acquisitions, manufacturing and development activities. She is further responsible for addressing certain regulatory matters (including securities law, FDA and cGMP matters) and for the strategy, maintenance and prosecution of the Company’s global patent portfolio and all litigation involving the Company. Ms. Piré also provides the same full range of legal services to Cognate’s partners and affiliates, including entities engaged in the development of immunotherapies and related products and services for the regenerative medicine industry.
Prior to joining Cognate, Ms. Piré gained extensive experience at Skadden, Arps, Slate, Meagher & Flom, LLP and Willkie Farr & Gallagher LLP, practicing for more than a decade in New York and five years in Paris, France, during which time Ms. Piré represented public and private companies operating in a variety of industries and geographies on every nature of corporate matter, including both foreign and domestic mergers, acquisitions, divestitures and private equity financings.
Ms. Piré holds a B.A. from the University of California at Irvine and a J.D., magna cum laude, from New York Law School.
VP of Corporate Development
Mr. Margolin has 10 years of biotechnology industry experience focused directly in the stem cell and regenerative medicine sectors. Prior to joining Cognate, Mr. Margolin served as a Senior Consultant and VP of Communications for the Alliance for Regenerative Medicine, a global advocacy organization that promotes legislative, regulatory, reimbursement, investment, technical and other initiatives to accelerate the development of safe and effective regenerative medicine technologies. Mr. Margolin was instrumental in the overall growth, impact and management of the organization. Simultaneously, Mr. Margolin served as the Vice President of Research for Adjuvant Partners, a life sciences business development and strategic consulting practice specializing in support for advanced therapies and regenerative medicine companies and organizations. Mr. Margolin also served as Director of Marketing at Cell Line Genetics, a New York-based biotechnology company specializing in stem cell characterization and quality assurance services and products and the Associate Director at the Genetics Policy Institute (GPI), a leading advocacy organization for the stem cell community. While at GPI, Mr. Margolin organized the World Stem Cell Summit, a flagship international event of the stem cell sector, from 2008 to 2010, founded and published three corresponding World Stem Cell Reports and managed GPI’s strategic initiatives. Prior to GPI, Mr. Margolin performed stem cell and personalized medicine market research, published various intelligence reports, and headed stem cell business development efforts for Burrill & Company and Burrill Life Sciences Media Group.
Mr. Margolin holds a Masters of Biomedical Science with a concentration in stem cell biology from the University of Medicine and Dentistry of New Jersey and an MBA from Rutgers University.
VP of Strategic Initiatives
Mr. Yoon joined Cognate in 2014 as Vice President of Strategic Initiatives, but has been an advisor to the Company since 2008 when he joined a venture capital firm that had invested in Cognate. In addition to being involved in the daily management of the Company as it pertains to the overall growth of our business, he also oversees intellectual property management and relationships with academic and industry R&D partners and affiliates. Mr. Yoon has over 10 years of biotechnology industry experience ranging from venture capital to bench research. Prior to joining Cognate, Mr. Yoon served as Senior Associate at a venture capital firm where he focused on seed to early stage regenerative medicine, immune technologies and cell therapies. At the venture capital firm, Mr. Yoon was involved with portfolio management, providing operational support to portfolio companies and to fund transactions. Until 2008, Mr. Yoon also served as a biomedical engineer at TissueGene, Inc., a clinical-stage biotech company developing cellular therapies, where he was involved in new product development. Mr. Yoon was also a lab member at the Johns Hopkins Neuroengineering & Biomedical Instrumentation Lab until 2005.
Mr. Yoon holds a B.S. in Biomedical Engineering, an M.S. in Bioinformatics from Johns Hopkins University and an M.B.A. from the McDonough School of Business at Georgetown University.
VP of Process Development
Ms. Noffsinger, the VP of Process Development, joined Cognate in 2002. Ms. Noffsinger manages the transition of technologies from research and development through scale up to manufacturing with a focus on clinical and commercial 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 certain of Cognate’s partners and affiliates.
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 also has 7 years of experience in bone marrow cell processing and graft engineering from Johns Hopkins Oncology Center. Ms. Noffsinger worked at Johns Hopkins University from 1996-2001 as 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 and Phase II trials for graft engineering, cellular immunotherapy and gene therapy. While 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, hematopoietic stem cell processing, graft engineering, cell cryopreservation, quality assurance, process validation, regulatory issues, molecular biology, GMP processing and translating research from “bench to clinic.” Her skills include cell selection, elutriation, flow cytometry, 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.
Ms. Noffsinger earned her B.S. in Medical Technology/Computer Science from Michigan Technological University in Houghton, MI.
VP of Information Systems
Mr. Khoury joined Cognate in 2014 as Vice President of Information Systems, but has been an advisor to the Company since 1994. He is responsible for the design, development and implementation of organizational information systems, software applications, infrastructure systems and Information Technology support. He also oversees the development of mission-critical applications and technology to support the Company’s long-term goals.
Mr. Khoury has over 10 years of experience in IT operations and strategy. Prior to joining Cognate, Mr. Khoury served as Director of Information Technology at a venture capital firm focused on seed and early-stage life sciences and advanced technology investments. While at this venture capital firm, he was responsible for designing and implementing a robust IT infrastructure capable of serving both the firm and its various portfolio companies.
Mr. Khoury received his B.S. in Electrical Engineering from the University of Balamand in Lebanon, and M.Eng. in Electrical & Computer Engineering from the University of Maryland. Mr. Khoury has also received an Executive Certificate in Delivering Information Systems from Harvard Business School.
VP of Quality & Regulatory Affairs
Mr. Mitchell, the VP of Quality & Regulatory Affairs, joined Cognate in 2016. Mr. Mitchell provides strategic leadership towards cGMP Quality Systems development and compliance, along with compliance towards various governmental regulations associated with cellular therapy product development, manufacture, and distribution. In addition, Mr. Mitchell oversees the establishment of qualification and validation standards for new products, procedures, and operational facilities. He also provides advice in various areas of compliance and new product commercialization to Cognate’s clients
Mr. Mitchell has worked in the biopharmaceutical industry for 37 years. During this time, he has acquired extensive experience within the pharmaceutical, biotechnology, and biologics industries focusing substantially in the areas of quality assurance & control, global compliance, validation, manufacturing operations, engineering, and regulatory affairs. The majority of his career has been in direct support of new biologic and drug product development and licensing, from IND submission and clinical production (GCP/GLP/GMP), through each phase of clinical study, and product BLA/NDA filing (plus 510(k) development and submission for medical devices), into commercialization. Mr. Mitchell came to Cognate with a balanced career spent within quality, operations, global compliance, and regulatory, with the majority of those years in management roles overseeing both project activities and operational departments in support of CMC development, clinical, and commercial GMP manufacturing operations.
Mr. Mitchell most recently served as Site Head of Biologics Quality Assurance for Commercial Operations with Shire Pharmaceuticals, located at their new manufacturing plant located outside of Atlanta, Georgia, designed for the large-scale processing of human plasma, purifying and producing commercial sterile Human Albumin for Injection and Human Immunoglobulin-G for Injection (IGIV). Before joining Shire, he was the Sr. Director of Quality Operations at Celgene, Inc., serving as the Site Head managing the site’s global licensure of commercial biological-based oncology therapeutic products. During the initial phase of Mr. Mitchell’s career, he spent working with Eli Lilly and Company within process engineering in the development, process scale-up, and commercialization of the first genetically engineered forms of human insulin.
Mr. Mitchell earned his B.S. in Molecular Genetics & Biochemistry from Purdue University in West Lafayette, Indiana
Sr. Director of Clinical Operations
Katherine Turner has been with Cognate since 2002 and has served as Director of Clinical Operations since 2008. Ms. Turner’s responsibilities include providing appropriate leadership, expertise and strategic input in managing clinical operations in support of investigational studies contracted at Cognate facilities. Her specific activities include, but are not limited to, coordination of clinical patient events within Cognate, patient/donor tissue receipt and process scheduling at Cognate, serving as central contact for designated clinical projects, addressing resolution of questions pertaining to information provided by clinical sites with respect to patient materials, patient batch record initiation and label issuance. Ms Turner also serves as liaison between Cognate, study sponsor, and study sponsor contractor(s) to expedite exchange of study-specific patient/product information.
From 2002 to 2008, Ms. Turner was Senior 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 renovation of support areas for the cGMP compliant environment for Cognate’s operations. 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 Cognate’s Sunnyvale, CA facility, overseeing maintenance and repairs of the physical building and grounds .