Cognate is the premier commercial-ready CDMO for your cell and gene therapy needs. We are a dynamic, results-driven organization focused on providing the broadest range of expertise across the various cell types and technologies used in the commercialization of cell and gene therapy for regenerative medicine, cellular immunotherapy, and advanced cell therapy companies, organizations, and institutions.
We offer a unique combination of standard and custom services to companies across all points of clinical and commercial development. Our development and manufacturing services are focused on clients seeking rapid development of products from clinical studies into commercial manufacturing, with a unique capacity to handle all aspects of scale-up and commercial readiness
Cognate leverages the combined know-how and expertise of its business, scientific and technical teams to successfully develop autologous and allogeneic products across multiple cell-based technology platforms from start to finish for you and your patients.
In our operating history we've successfully manufactured and delivered products to and from the US, EU and Asia, and we've handled all aspects of the supply chain, manufacturing, storage, shipping and clinical trial logistics, and regulatory support for protocol and IND development for complex products involving multiple drug substance Intermediates all the way to minimally manipulated primary cells.
"Learn from yesterday, live for today, hope for tomorrow. The important thing is not to stop asking questions." - Albert Einstein
I am particularly motivated to go the extra mile for our clients and their patients. Our dedication and commitment are rewarded with every success story of a patient that has received a product made by Cognate. I take great personal satisfaction in seeing my team repeatedly step up to the plate, solve a problem, or overcome a hurdle and deliver the highest quality products for our clients.
When not working, I occasionally try to get the highest score possible in 18 holes of golf, thereby achieving the lowest cost per swing.
Kelly joined Cognate in 2011 as the Chief Executive Officer and has over 25 years of experience within the life science, venture capital, and IT sectors. He has guided 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, Kelly was a Principal at an SBA venture capital firm where he was recruited to create deal flow and provide leadership to several of their investments. The fund was highly focused on cell therapy investments and was an investor in Cognate. While in this role, he helped the venture capital firm exit the SBA program and was the key driver of several strategic deals for their portfolio companies.
Previously, Kelly was the CEO and Co-founder of RemeGenix, a company working on treatments for Alzheimer’s disease and traumatic brain injury. Prior to RemeGenix, he was the VP of Business Development at TissueGene. He and the executive team closed both Series A and B funding prior to the company being taken public. While there he was also responsible for developing the global informatics infrastructure for the company and its affiliates. Prior to TissueGene, as the key technical sales and marketing lead for LabVantage, he helped shape, develop and market their life science software product offering globally.
Shortly after graduating with a BS in Microbiology from University of Maryland, Kelly started his career in the T-Cell Molecular Biology Unit of the Laboratory of Cellular and Molecular Immunology at the National Institute of Allergy and Infectious Disease at the NIH. He had the distinct pleasure of working with and being mentored by Drs. Luciano D’Adamio, Ron Schwartz, BJ Fowlkes, Polly Matzinger, and others intensely engaged in a deeper understanding of the molecular mechanisms of the immune system.
Mike joined Cognate in 2007 and has over 22 years of extensive manufacturing and operations experience in the biotech industry. Prior to attaining the role of CBO, Mike served as Cognate’s Chief Operating Officer, responsible for overseeing the startup, on-going operations, and validation of the Memphis facility and overseas activities. He’s 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, Mike 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, Mike 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.aa
Shari joined Cognate in 2015. A seasoned attorney and member of the Cognate senior management team, she 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, Shari 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, she implements and manages all legal aspects of Cognate’s business including its growth strategy, acquisitions, manufacturing, and development activities. Shari 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 intellectual property portfolio and all litigation involving the Company. She 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, Shari 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.
“Individual commitment to a group effort – that is what makes a team work, a company work, a society work, a civilization work.” – Vince Lombardi
Will joined Cognate in 2018 as Chief Financial Officer with over 25 years in finance and accounting roles. Will has experience in Big 4 public accounting, investment banking, treasury management, financial planning & analysis, corporate development, and investor relations. As CFO at Cognate, he is responsible for all financial, accounting, treasury, corporate compliance and FP&A functions and plays a key role in working with the executive leadership team to facilitate growth and enhance profitability by adding a financial viewpoint to strategic and operational decisions.
Prior to joining Cognate, Will served as CFO of Veraction, a leading provider of transportation spend management solutions. He previously served as VP of Corporate Development at MRC Global (NYSE:MRC), where he was a key member of the team responsible for the strategic positioning and execution of MRC’s $477 million IPO. In addition, Will spent 11 years with investment banking firm Morgan Keegan. Will also served in a treasury and FP&A role with Mueller Industries and he began his career at Ernst & Young. Will is a Certified Public Accountant.
Tom joined Cognate Bioservices in 2020 as the Vice President Global Head of Quality. He is actively leading a coordinated approach to establishing and maintaining a best practice based, harmonized global corporate quality system for Cognate and Cobra.
Tom has over 30 years of experience in the GMP regulated industry where he has cultivated a deep understanding of international regulatory requirements and expectations. He has a specific background in manufacturing biologics, small molecule sterile products and medical devices. Tom has held Manufacturing, Quality and Compliance roles throughout his career, most recently serving as the Global Head of Quality for Lonza’s bioscience business. Previously, Tom held senior corporate level Quality roles in AstraZeneca, MedImmune and Abbott Laboratories. He has been active in the Parenteral Drug Association for many years participating in both Interest Groups and Task Forces and was the founding President of the Missouri Valley local chapter of PDA.
Tom has earned a B.S. degree with a combined major in Biology and Chemistry from SUNY Albany University and an M.B.A. in Management from Canisius College.
Scott joined Cognate in August of 2017 as VP of Manufacturing. He has 20+ years of extensive experience in commercial manufacturing, including hands-on development and management of the Quality, Manufacturing and Operations branches of the organization, spanning the Pharma and Biotech industries. He most recently worked at Pfizer in St. Louis, MO and prior to that Baxter in Bloomington, IN. Leveraging his experience as an engineering project manager for CRB Consulting Engineers supporting design projects for the Pharma and Biotech industries and as a Quality Assurance/Systems consultant supporting quality improvement initiatives for several clients, with his operations background, Scott was an instrumental hire for Cognate’s recent commercial expansion and roll out.
Scott received his B.S. in Chemical Engineering from Wayne State University and Lean Six Sigma Black Belt certification from Villanova.
Scott joined Cognate in 2017. Prior to Cognate, Scott served in Business Development positions at Cook Regentec and also served as Director of NorthAmerican sales at CellGenix GmbH, a leading cell therapy tools and reagents manufacturer. At CellGenix, Mr. Broughton successfully grew sales, building the North American office, logistics and sales team. Prior to working in the cell therapy field, Mr. Broughton worked at Baxter’s Fenwal and Biosciences Divisions. During his ten years with Baxter, Mr. Broughton was responsible for products in the blood collection, processing and plasma derivatives divisions. Prior to his medical device and cell therapy experience, Scott worked with companies in the manufacturing and computer software industries.
Roy joined Cognate in October, 2019, and is a seasoned HR professional with corporate experience creating and leading human resources at organizations with well-known brands. His expertise includes identifying and developing company cultures, change leadership, building employee engagement, executive coaching, training, compliance, benefits, compensation, talent acquisition, retention strategies, mergers, and acquisitions, restructuring, organizational development, and performance management.
Most recently, Roy was a Talent Strategist with FH Solutions Group, a national HR consulting organization. Roy also served as the chief human resources officer for more than 14,000 employees at TruGreen headquartered in Memphis, TN.. Roy led the human resources function during the company’s divestiture from ServiceMaster and its merger with the number one competitor in that industry, Scotts Lawn Service. During this time Roy helped identify and communicate the company’s culture, which boosted employee engagement from 45% to 68%, increased revenues to exceed $1.4B and led to the corporate Memphis office’s recognition as “Best Places to Work” for four consecutive years. In addition, Roy built the first human resources team at Bath & Body Works retail stores, a $1.8B division of Limited Brands. During his tenure, the company grew to more than 1,700 stores and 32,000 employees in nine years within the US and UK.
Karim joined Cognate in 2014 as Vice President of Information Systems, and has served as an advisor to the Company since 2006. He is responsible for the strategic direction and execution of Cognate’s information systems, including mission-critical applications and technology to support the Company’s long-term goals.
Karim brings more than 15 years of hands-on experience in information systems and operations management to Cognate. He provides oversight for the architectural design and implementation of all operational and business support systems. Karim also streamlines optimization and efficiency across the enterprise through digital transformation and business intelligence.
Karim holds a Bachelor of Science in Electrical Engineering from the University of Balamand in Lebanon, and a Master of Science in Electrical and Computer Engineering from the University of Maryland. He also received a certificate of Executive Education in Delivering Information Systems from the Harvard Business School.
Jae joined Cognate in 2014 as Vice President of Strategic Initiatives, and has been an advisor to the Company since 2008. 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 innovation management, and relationships with academic and industry partners. Jae has over 15 years of biotechnology industry experience ranging from bench research, venture capital investing, and corporate management.
Prior to joining Cognate, he served as a senior associate at the venture capital firm Toucan Capital, where he focused on seed to early-stage regenerative medicine, and immune technologies. At the venture capital firm, Jae was involved with portfolio management, providing operational support to portfolio companies, and fund transactions. Until 2008, he also served as a biomedical engineer at TissueGene, Inc., a biotech company developing cellular therapies, where he was involved in new product development. Jae was also a lab member at the Johns Hopkins Neuro-engineering & Biomedical Instrumentation Lab until 2005.
Jae holds a B.S. in Biomedical Engineering, M.S. in Bioinformatics from the Johns Hopkins University, and an M.B.A. from McDonough School of Business at Georgetown University.
Lori has been with Cognate since 2002 and has 30+ years of experience in transfusion medicine, apheresis, and bone marrow cell processing (for clinical transplant use) as well as extensive capabilities with process development and optimization in the Biotech Cellular Therapies Industry. She currently leads the Cognate-Baltimore team which focusses on process/analytical development, optimization and characterization as well as product testing. Prior to joining Cognate, Lori served as a product specialist for Stemsoft Software Inc., Vancouver, BC where she managed the installation, customization, and implementation of laboratory-oriented database software. Lori started her career at Johns Hopkins Hospital and University Laboratories where she ultimately leveraged experience in blood banking and graft engineering to manage projects in cellular and gene immunotherapy therapies that supported Phase I and Phase II trials in the Hopkins Hematological Malignancies group. While at Johns Hopkins, She also collaborated with primary investigators and biotech companies on device development of prototypes and optimization/characterization of unique equipment, processes, and products. Lori has a BS from Michigan Technological University with a concentration in computer science and is a certified Medical Technologist (ASCP).
Executive Director, Manufacturing & Operations
Sr. Director, Quality Assurance
Sr. Director, Quality Control
Director, Product Development
Director, Clinical Operations
Director, Innovative Solutions
Director, Quality Control-Analytical
Director, Supply Chain
Director, Regulated IT
Director, IT Operations
Sr Manager, Business Development & Client Integration
Client Account Manager
Client Account Manager
Sr. Project Manager
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