Senior Vice President and Chief Commercial Officer
Prior to joining Abeona, Mr. Amoroso held various senior level commercial positions at leading biopharmaceutical companies, including Kite, Eisai Inc., Celgene Corporation (now a subsidiary of Bristol-Myers Squibb Company), and Sanofi. At Kite, he was responsible for the company’s worldwide commercial organization leading the commercialization efforts for the autologous CAR T-cell therapy, YESCARTA®, and the future cell therapy pipeline. Before Kite, Mr. Amoroso was Senior Vice President, Americas for Eisai’s Commercial Oncology Business Group, where he was accountable for teams charged with creating and driving commercial strategy and implementation for the company’s approved products and earlier-stage assets. Previously, Mr. Amoroso worked at Celgene for six years in several commercial roles before serving as the organization’s Commercial Lead for CAR T-cell therapy programs. In this capacity, he helped Celgene develop an organizational model to commercialize cell therapies including specialized manufacturing and customer services for patients with lymphoma and myeloma. Before joining Celgene, Mr. Amoroso held various marketing and sales leadership positions over his 10-plus year tenure at Sanofi. Mr. Amoroso earned his M.B.A. in Management from the Stern School of Business, New York University, and his B.A. in Biological Sciences, summa cum laude, from Rider University.
Chief Technical Officer
Jay Bircher, Chief Technical Officer, brings more than 28 years of pharmaceutical, biotechnology and medical device experience, knowledge and leadership in the areas of microbiology, quality assurance, quality control, regulatory compliance, validation, sterile manufacturing and operational excellence. Mr. Bircher has lead FDA (CBER and CDER), EMEA and other regulatory body inspections with successful outcomes.
Prior to Abeona, he held quality positions of increasing responsibility with GlaxoSmithKline, Amgen, Tyco Healthcare and most recently Becton, Dickinson and Company (BD), where he was Head of Quality from groundbreaking of a 120,000 ft2-sterile manufacturing facility through an FDA pre-approval inspection (PAI) and eventual launch of several ready-to-administer, prefilled syringe products. Later in his tenure at BD, Mr. Bircher served as Head of Manufacturing where he was responsible for all formulation, fill and packaging operations. He holds a B.S. from Marshall University and is Six Sigma certified.
Chief Accounting Officer, Principal Financial Officer
Ed Carr, Chief Accounting Officer, joined Abeona in 2018, bringing more than 25 years of corporate public accounting experience to the Company. Most recently, he served as Vice President and Assistant Controller at Coty Inc., a publicly listed multinational company. Mr. Carr has significant experience managing various accounting, financial reporting, internal controls, tax and treasury matters. Prior to Coty, he served for more than 10 years as Chief Accounting Officer at Foster Wheeler AG. Mr. Carr, who is a Certified Public Accountant, began his career at Ernst & Young LLP. He holds a B.S. and Master of Professional Accountancy from West Virginia University.
Victor Paulus, Ph.D.
Senior Vice President, Head of Regulatory Affairs
Victor Paulus, Ph.D. joined Abeona in 2019, bringing 30 years of experience in the pharmaceutical industry, including over 20 years specializing in Regulatory Affairs. Prior to joining Abeona, he served as Vice President and Global Head of Regulatory Affairs at the clinical-stage immunotherapy company Hookipa Pharma. Previously, Dr. Paulus was Global Head of Regulatory Affairs for Advanced Accelerator Applications, a Novartis Company, where he secured orphan designations and product approvals for Gallium Ga68 dotatate and Lutetium Lu177 dotatate. Earlier in his career, Dr. Paulus served as Director of Regulatory Affairs for Pediatric Vaccines at GlaxoSmithKline and Senior Director of Regulatory Affairs for Biosimilar drug development at Dr. Reddy’s. He also held roles of increasing responsibility at Organon, Elusys Therapeutics, and the Population Council. Dr. Paulus began his career as a laboratory technician at the Salk Institute manufacturing vaccines for the US Army and then managed a cell culture laboratory at Centocor and viral vaccine production at what is now Sanofi Pasteur. He was also Manager of Regulatory Affairs for MCM (Merck-Connaught-Merieux), developing novel combination pediatric vaccines. Dr. Paulus has BSc degrees in Biology and Biochemistry, an MSc in biology (parasitology) and a Ph.D. in public health.
Juan Ruiz, M.D., Ph.D.
Head of European Medical Affairs
Juan Ruiz, Ph.D., joined Abeona as Chief Medical Officer in 2017 and transitioned to Head of European Medical Affairs in October 2018, bringing years of experience in clinical drug development including C-level positions at Lykera Biomed and Digna Biotech, where he spent more than 10 years leading teams dedicated to developing gene therapy translational medicine programs. His proven track record demonstrates a start-to-finish scope, from early preclinical and proof of concept studies to manufacturing, regulatory IND and IMPD submissions, clinical trial design and execution, as well as manufacturing and quality control of the adenoviral vectors. Dr. Ruiz has been instrumental in achieving multiple Orphan Product Designations, has led teams for successful Scientific Advice and Protocol Assistance meetings with the FDA and EMA, and has helped design Patient Reported Outcomes (PRO) in the U.S. to assess skin outcome measures in patients with systemic sclerosis for use as primary endpoints in late-stage clinical trials.
He is the author of more than 40 peer-reviewed journal articles and book chapters and is an inventor on multiple issued patents. Dr. Ruiz earned his Ph.D. in molecular biology from the University of Navarra. He was a post-doctoral fellow at the University of Connecticut and earned his MBA from the IESE Business School at the University of Navarra.
Jodie Gillon, M.P.H.
Vice President, Patient Advocacy & Clinical Affairs
Jodie Gillon, M.P.H. joined Abeona in 2019, bringing more than 20 years of industry experience in various roles across Development, Medical and Corporate Affairs. Prior to joining Abeona, she cumulatively spent over a decade with Pfizer as the Global Medical Lead for Patient Engagement within the Rare Diseases Business Unit and the Director of Medical Communications within the Chief Medical Office. In these roles, Ms. Gillon facilitated collaborations with patient groups across many therapeutic areas and served as a core member of several cross-functional teams. Prior to Pfizer, she was the Head of Patient Advocacy and Professional Affairs with Achillion Pharmaceuticals. Ms. Gillon also previously served as the Head of the Chief Medical Office of AstraZeneca, which was preceded by additional roles at Novartis and Oridion. She holds a M.P.H. with a dual degree in Health Economics and Epidemiology from Hebrew University in Jerusalem and a BSFS from Georgetown’s School of Foreign Service.
Brendan O’Malley, J.D., Ph.D.
Vice President, Head of Legal and IP
Brendan O’Malley, J.D., Ph.D., joined Abeona in 2019 as Chief IP Counsel, bringing significant technical and legal expertise to the Abeona team. Prior to joining Abeona, he was a partner at the prominent New York patent litigation firm Fitzpatrick Cella Harper & Scinto, where he started his career as a summer associate in 2006, and then at Venable LLP, which merged with Fitzpatrick in 2018. While at Fitzpatrick and Venable, Dr. O’Malley litigated a wide variety of biopharmaceutical patent cases in the United States District Courts, at the Federal Circuit, and before the U.S. Patent and Trademark Office, negotiated numerous settlement and license agreements, and provided many patent opinions in connection with M&A due diligence in the biotech space.
While attending law school at Benjamin N. Cardozo School of Law, Dr. O’Malley served as a judicial intern to Judge William H. Pauley in the U.S. District Court for the Southern District of New York.
Before law school, he earned a Ph.D. in Molecular Biology & Microbiology from Tufts University School of Medicine, where he studied the role of protein-protein interactions in hepatitis virus assembly, and a B.S. degree magna cum laude from the University of Massachusetts Dartmouth.
Vice President, Human Resources
Kristina Maximenko joined Abeona as Vice President of Human Resources in 2018, bringing significant experience in multiple functional areas such as recruitment, employee relations, organizational development and employment law with a focus on rapidly growing small- to medium-size companies. Most recently, Ms. Maximenko was Global Director of Human Resources at Advanced Accelerator Applications (AAA), an innovative nuclear medicine company that was acquired by Novartis in January 2018. In this role, she led the human resources (HR) function across 11 international AAA locations and served as the human resources head in the U.S. Ms. Maximenko was instrumental in growing the company from about 400 people to more than 650 people globally in two years, setting up company-wide HR programs and building cohesive company culture. She also played a key role during the integration process of AAA into Novartis and was a member of AAA’s Executive Committee.
Prior to that, Ms. Maximenko was a Global Human Resource Manager at FastGroup, a European technology company. She established their presence in the U.S. and built the HR function from the ground up. From 2010 to 2012, Ms. Maximenko worked in Employee Relations Operations at Macquarie, an Australian investment bank, where she supported three business groups in all phases of employee lifecycle, international assignments and compliance. She earned her Master’s in international law from Far Eastern National University in Russia.
Vice President, Business Operations
Scott Nogi joined Abeona as Vice President of Business Operations in 2018. Prior to Abeona, he served as Executive Director of Kolot Chayeinu / Voices of Our Lives, where he led the business strategy and operations, finances and staff and board relations for the non-profit organization. Before that, Mr. Nogi was Vice President of Business Development at Access Pharmaceuticals, Inc. where he worked on out-licensing. He was also Vice President of Operation at SCO Capital Management, where he managed all back-office staff and systems. Mr. Nogi earned his MBA in management and strategy from the Stern School of Business at New York University and his BFA also from New York University.