Adam Gridley, President and Chief Executive Officer
Mr. Gridley joined Histogenics in 2014, and has more than 20 years of experience in the medical device, biotechnology and pharmaceutical industries. Before joining the Histogenics team, Mr. Gridley served in several senior roles of increasing responsibility at Merz, a privately-held specialty healthcare company focused on the development and commercialization of products for aesthetics, dermatology and neurosciences, where he was most recently Senior Vice President of Technical Operations. During his time at Merz, he served as the global site head responsible for a variety of functions, including R&D, Manufacturing, Quality Operations, Finance and IT. Previously, Mr. Gridley was Senior Vice President of Corporate Development for BioForm Medical, Inc. a publicly-traded company that was acquired by Merz in 2010. His responsibilities included all business development, investor relations, strategic planning, and R&D functions, and he was part of the leadership team who led the Company’s IPO and subsequent acquisition by Merz. Mr. Gridley has held several key strategic leadership roles in the orthopedics space during his career including Director of Business Development and Investor Relations at Gliatech Inc. Mr. Gridley holds a B.S. and a M.B.A. from the University of Denver.
Don Haut, Chief Business Officer
Dr. Haut joined Histogenics in 2017, and has more than 20 years of executive management experience in business development, licensing, mergers and acquisitions, strategic planning and commercial management, with over $4 billion in transactions completed across the biotechnology, pharmaceutical and medical device industries. Prior to Histogenics, Dr. Haut was Managing Director of Haut Capital, providing executive-level business development and strategic planning services for a variety of public biotechnology and medical device companies, and currently serves on the Board of Directors for two health care companies: Arthrosurface, Inc. and Xiros, Ltd. He was previously Vice President for New Business Ventures at The Medicines Company, where he was responsible for leading Sales Operations, as well as a number of transactions, including that company’s deal to license Alnylam’s PCSK9 inhibitor. Previously, he was the Senior Vice President for Strategy and Business Development at Smith and Nephew’s Advanced Surgical Devices Division, where he was responsible for all strategy development, mergers and acquisitions and licensing activities, and also built and ran Smith & Nephew’s Women’s Health business. Dr. Haut also previously held similar roles at 3M, JSB Partners and McKinsey and Company. Don obtained his M.B.A. at the Olin Business School of Washington University in St. Louis, his Ph.D. in molecular biology at the University of Missouri-Columbia, and his undergraduate degree at the College of Wooster.
E. Lynne Kelley, Chief Medical Officer
Dr. Kelley joined Histogenics in 2018 and brings more than 20 years of executive management and surgical experience in medical affairs, clinical operations, regulatory affairs and product development to Histogenics. Before joining Histogenics, Dr. Kelley held various medical affairs roles within the industry including: Chief Medical Officer at Senseonics, World Wide Vice President of Medical Affairs at Becton Dickinson & Company Medical Surgical Systems Division, Vice President and Medical Director at Kimberly Clark, and Medical Director at Boston Scientific Peripheral Interventions and Vascular Surgery division. Prior to her work at Boston Scientific, Dr. Kelley was an assistant professor of vascular surgery and radiology at Yale University. Dr. Kelley is a board certified general and vascular surgeon having received her medical degree from Dartmouth Medical School and completed her Residency in General Surgery at Dartmouth Hitchcock Medical Center. During her training she was awarded an NIH-sponsored basic science research grant at Harvard Medical School. She completed a Fellowship in Vascular Surgery at Harvard Medical School, Massachusetts General Hospital and was awarded the Marco Polo Fellowship providing advance training in Endovascular Surgery at the University Paris Hospital, Henri Mondor. Dr. Kelley also received a B.A. in biology from Boston University.
Stephen Kennedy, Executive Vice President & Chief Operating Officer
Mr. Kennedy joined Histogenics in 2013, and has more than 30 years of experience in biological manufacturing and process development, including 18 years at Genzyme Corporation, where he had a strong history of company development and delivering process and organizational performance improvements resulting in increased profit. As Genzyme’s Senior Vice President of Biologics Technical Operations, he developed cGMP biologics manufacturing operations at facilities in Belgium and France, oversaw Genzyme’s gene therapy operation in San Diego, and formed the global Biologics Operations organization. Before this, Mr. Kennedy developed the manufacturing process optimization organization that supported Genzyme’s full range of products, including all biologics, Carticel® and hyaluronic acid products, such as Seprafilm®. Early in his career at Genzyme, Mr. Kennedy focused on implementation and optimization of cell culture manufacturing technologies used in the production of flagship products at Genzyme, including Ceredase® and Cerezyme®. He has also served as Executive Director of the Novartis/MIT Center for Continuous Manufacturing at the Massachusetts Institute of Technology. Mr. Kennedy has a B.S. from the University of Michigan, an M.S. from the University of Rochester and an M.B.A. from Boston University.
Jon Lieber, Chief Financial Officer
Mr. Lieber joined Histogenics in 2015, and has more than 20 years of experience in financial and executive management at emerging growth, life sciences companies and in investment banking. Prior to Histogenics, Mr. Lieber most recently served as the CFO of Metamark Genetics, Inc., a privately held, urology-focused, molecular diagnostics company, as the CFO and Treasurer of Repligen Corporation, a publicly held manufacturer and supplier of high-value consumables to the life sciences industry, and the CFO of Xcellerex Inc. (acquired by GE Healthcare), a company engaged in the manufacture and sale of capital equipment and related consumables to the life sciences industry. Previously, Mr. Lieber served as the CFO of Altus Pharmaceuticals where he led all public and private capital raising activities at the company, including its $110 million initial public offering and a subsequent $90 million follow-on offering. Prior to joining Altus, Mr. Lieber was an investment banker for 10 years where he originated and executed on numerous corporate financings and merger and acquisition transactions at SG Cowen and Salomon Brothers Inc. He received a B.S. in business administration and finance from Boston University and an M.B.A. in finance from New York University Stern School of Business.
Caroline Dugopolski, VP of Technical Operations
Mrs. Dugopolski joined Histogenics in 2014, and has more than 15 years of experience supporting cGMP biopharmaceutical manufacturing operations in both technical and quality roles. She leads the Histogenics program team responsible for manufacturing, testing, and disposition of the NeoCart® product to support the success of our Phase 3 clinical trial. Prior to joining Histogenics, Caroline spent thirteen years at Genzyme Corporation where she initially held roles focused on process engineering and team leadership in providing technical support for large-scale commercial biologics manufacturing. Her work primarily focused on manufacturing and technology for Genzyme’s core enzyme replacement therapy products (Cerezyme®, Fabrazyme®, and Myozyme®). Caroline was responsible for addressing production issues, analyzing process performance, and implementing process improvements. Caroline transitioned into a Quality Program Management role in which she made critical contributions to close quality system gaps. She led cross-functional teams through the design, implementation, and operation of remediated quality systems to enable successful completion of Genzyme’s work plan to improve quality systems at its Allston Landing Facility. Caroline has a B.S.E. in chemical engineering and a M.S. in biomedical engineering from the University of Michigan.
Peter Hamilton, VP of Operations & Engineering
Mr. Hamilton joined Histogenics in 2011 as Vice President, Manufacturing and Production, and has over 25 years of experience in manufacturing, engineering and technical roles. Prior to joining Histogenics, Mr. Hamilton served as Vice President Operations for Choice Therapeutics, Inc., a startup wound care company specializing in antimicrobial dressings using silver nylon. Mr. Hamilton served as the Operations Manager at BioSphere Medical from February 2000 until June 2007. Mr. Hamilton was a Senior Development Engineer at Boston Scientific, from 1991 through 2000. Mr. Hamilton served as a Design Engineer at Deknatel from 1988 until 1991. Mr. Hamilton is the holder of sixteen U.S. patents. He holds a B.S. from Wentworth Institute of Technology and an M.B.A. from Anna Maria College.
Harris Shuman, VP of Finance
Mr. Shuman joined Histogenics in 2015, and has more than 25 years of experience in technical accounting, controlling, and financial management roles. Prior to Histogenics, he most recently served as Director of Finance and Accounting at Epizyme, Inc., which he joined in 2010. There, he was instrumental in getting the company IPO-ready leading to the company’s successful IPO in 2013. He also led all finance activities as it related to its multiple collaborations. Prior to working at Epizyme, Mr. Shuman served in strategic and financial management roles at Virgin HealthMiles, a Virgin Group company and Oxigene, Inc. Before, Mr. Shuman worked in a number of startup companies in a financial capacity after he started his career in Public Accounting at Laventhol & Horwath. Mr. Shuman is a CPA licensed in Massachusetts. He received his B.S. in accounting from University of Massachusetts and his M.S.F from Bentley University.
Sumitra Ghate, Senior Director, Regulatory Affairs
Ms. Ghate joined Histogenics in 2017 as Senior Director, Regulatory Affairs, having over 22 years of pharmaceutical and biotech drug/device development experience. Prior to joining Histogenics, Ms. Ghate worked for Eli Lilly and Company for 19 years and CyDex, Inc. for 3 years. Her last role was with Lilly as Director, Medical Device Regulatory Affairs, leading a team with a focus on combination products, drug delivery systems and digital health initiatives. Past roles were in analytical development, quality, clinical trial manufacturing, and Regulatory Affairs for therapeutic proteins (CMC and clinical). Ms. Ghate holds a B.S. in biology and a B.A. in chemistry from the University of Kansas. She also has US and EU Regulatory Affairs Certification (RAC).
Nance Moran, Senior Director, Program Management
Mrs. Moran formally joined Histogenics in 2016, and has over 18 years of experience in Research and Development and Veterinary Technology. Prior to joining Histogenics, Mrs. Moran was a Scientist for Genzyme Corporation for over 15 years working in Orthopaedic regenerative and pain therapies. Mrs. Moran holds a M.S. from the University of Nebraska Kearney. She was also an active Board member and President of the Academy of Surgical Research.
Eric Blahut, Senior Director, Manufacturing
Mr. Blahut began his career by working for the technical co-founder of Histogenics, Dr. Shuichi Mizuno, at the Brigham and Women’s Hospital in Boston. He joined Histogenics as a research associate when the company was founded in the year 2000. In the years since, he has been instrumental in the development of the NeoCart product and testing methods. Mr. Blahut’s contributions to Histogenics have ranged from product development to surgeon trainings and regulatory filings. He manufactured the first NeoCart implant for the Phase 1 clinical trial and then went on to oversee Phase 2 and Phase 3 clinical manufacturing. As the longest tenured employee at Histogenics, Mr. Blahut holds the honor of being the un-official historian of the company. He received a B.S. in animal science from the University of Massachusetts Amherst.
Sheila Boyce, Senior Director Facilities and Engineering
Prior to joining Histogenics in 2014, Mrs. Boyce was the lead engineer on multiple successful projects at Genzyme Corporation, most notably the scale-up and commercialization of hyaluronic acid based Seprafilm® and development and implementation of the terminal viral inactivation process for ATryn®, the first therapeutic agent produced using transgenic animals to gain FDA approval. During her fifteen years at Genzyme Corporation, Mrs. Boyce was the recipient of two Genzyme Corporation Vice President’s Awards recognizing outstanding dedication and contribution to the success of a program. She currently serves on the Northeastern University Bioengineering Industrial Advisory Board. She has a B.S. in Chemical Engineering from Northeastern University.
Michael Healy, Sr. Director, Quality
Mr. Healy joined Histogenics in 2015 and has more than 25 years of experience in quality, operations, and technical roles. Prior to joining Histogenics, Mr. Healy served as Quality Manager for Citra Labs, a Zimmer-Biomet company, which specializes in anti-coagulant and blood rejuvenation products. Mr. Healy served as a Sr. Quality Consultant from 2011 until 2013. Mr. Healy was the Director of QA for Formatech, a contract manufacturing Organization from 2002 until 2011. Prior to joining Formatech, Mr. Healy spent seven years in production management at Organogenesis, a tissue engineering company specializing in epidermal and dermal skin grafts. Mr. Healy began his career at Enzytech (later acquired by Alkermes), holding roles in research and development, culminating in the role of Engineering Manager. Mr. Healy is a co-inventor on 7 U.S. and several worldwide patents. He holds a dual B.S. in computer sciences and biology from Bridgewater State College and a M.S. in biology from Northeastern University.
Photo credit: Tatiana Blanco Photography