Curran M. Simpson is the President and Chief Executive Officer and member of the Board of Directors at REGENXBIO. Mr. Simpson previously served as the Company’s Chief Operating Officer. In that role, he led key business functions including Research & Clinical Development, Corporate Strategy, Manufacturing & Quality, Regulatory, and Commercial Operations. Mr. Simpson joined REGENXBIO in 2015 with extensive leadership experience across biopharmaceutical operations and served as the Company’s Chief Technology and Operations Officer before becoming COO. Prior to joining REGENXBIO, he was the Regional Supply Chain Head for North America and Interim Chief Operating Officer at GlaxoSmithKline (GSK). Mr. Simpson earlier served as interim CEO of Human Genome Sciences (HGS), where he led the integration of HGS into GSK, and as Senior Vice President of Operations and Vice President of Manufacturing Operations at HGS. Prior to HGS, Mr. Simpson was Director of Manufacturing Sciences at Biogen. Earlier in his career, Mr. Simpson served in an overseas assignment at Novo-Nordisk Biochem in Denmark and in various senior development and engineer roles at Genentech, working on Herceptin and Avastin, among other roles. Mr. Simpson has an M.S. in surface and colloid science from Clarkson University and a B.S. in chemistry from the Clarkson College of Technology.
Steve Pakola, M.D. is the Chief Medical Officer for REGENXBIO. Prior to joining REGENXBIO, Dr. Pakola was Chief Medical Officer at Aerpio Pharmaceuticals. Dr. Pakola brings more than 20 years of biopharmaceutical experience, including holding key leadership roles in preclinical and clinical development, regulatory affairs and medical affairs. Dr. Pakola's therapeutic area experience encompasses retinal disorders, including diabetic retinopathy, diabetic macular edema and age-related macular degeneration, as well as other non-ophthalmic disease areas. He was the lead inventor and program lead for the Jetrea® (ocriplasmin) program, from inception in 2002 through the therapy’s United States and European regulatory submissions in 2012. Prior to Aerpio, Dr. Pakola served as Chief Medical Officer at Amakem NV and ThromboGenics Inc. Earlier in his career, Dr. Pakola served as Associate Director of Cardiovascular Clinical Research at Boehringer Ingelheim, where he was Global Medical Lead on the Lipid-Lowering Development Program and the USA Medical Lead for the Direct Thrombin Inhibitor Dabigatran Program. Prior to that, Dr. Pakola served in senior-level clinical development positions at Quintiles Cardiovascular Therapeutics and at Organon. Dr. Pakola earned a B.A., summa cum laude, and an M.D. from the University of Pennsylvania, where he was elected to the Alpha Omega Alpha Honor Medical Society.
Dr. Olivier Danos is the Chief Scientific Officer for REGENXBIO. Prior to joining REGENXBIO, Dr. Danos was Senior Vice President, Cell and Gene Therapy at Biogen Inc. At Biogen, Dr. Danos led company efforts dedicated to identifying and developing new technologies for gene transfer and genome engineering. Dr. Danos also co-founded Lysogene, a NAV Technology Licensee focused on the development of gene therapy product candidates for the treatment of Mucopolysaccharidosis Type IIIA. Prior to Biogen, Dr. Danos served as Senior Vice President, Molecular Medicine, Synthetic Biology and Gene Regulation at Kadmon Pharmaceuticals. Earlier in his career, Dr. Danos was Director of the Gene Therapy Consortium of the University College of London, Scientific Director at Genethon and Senior Director of Research at Somatix Therapy Corporation. Dr. Danos has directed research focused on gene therapy at the Necker - Enfants Malades Hospital in Paris, the French National Centre for Scientific Research and the Pasteur Institute in Paris.
Mitchell Chan is the Chief Financial Officer at REGENXBIO. Mr. Chan has more than 20 years of finance experience in the life sciences industry. Previously, Mr. Chan served as an Operating Partner at Catalio Capital Management, LP, a venture capital firm focused on investments in biomedical technology companies. From 2018 to 2021, Mr. Chan was the Chief Financial Officer of Viela Bio, Inc., a clinical-stage biotechnology company, where he oversaw the acquisition of Viela by Horizon Therapeutics plc for $3.1 billion. Prior to Viela, Mr. Chan served as the Director of Investor Relations for AstraZeneca, North America. Mr. Chan also held several roles of increasing responsibility within the Roche Group, at Genentech, and F. Hoffmann-La Roche AG, including in bio-oncology commercial finance, research and development finance, and mergers and acquisitions. In addition, Mr. Chan is a board member of Avalo Therapeutics, a clinical-stage biotechnology company focused on the treatment of immune dysregulation. Mr. Chan holds Executive Certifications from Stanford University, University of California (Haas), and University of Pennsylvania (Wharton) and earned his B.S. in Biochemistry, M.S. in Medical Biophysics, and an MBA from the University of Toronto (Rotman School of Management).
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Shiva G. Fritsch serves as Chief Communications and People Officer at REGENXBIO, where she leads the company’s people, communications, and patient advocacy strategy, overseeing talent management, total rewards, internal and corporate communications, public relations, and patient advocacy efforts. She drives work that strengthens organizational effectiveness, culture, and employee engagement, and ensures clear, strategic communications. Ms. Fritsch leads patient advocacy efforts that build and deepen connections with patient communities and inform the heart of REGENXBIO’s work to improve lives through the curative potential of gene therapy. With more than two decades of experience spanning research, development, and organizational leadership, Ms. Fritsch brings a multidisciplinary perspective to building high-performing, mission-driven organizations. She partners with executive teams to strengthen leadership capability, guide organizational transformation, and scale talent strategies to support the company’s growth and evolution. She shapes communications that drive employee and stakeholder engagement. Prior to joining REGENXBIO, she held various leadership roles at Novavax, Inc., Howard Hughes Medical Institute and Human Genome Sciences, Inc. She earned her MBA from the University of Maryland’s Robert H. Smith School of Business and holds a BA in Biology and Neurobiology from Bryn Mawr College.
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Patrick J. Christmas II is the Chief Legal Officer at REGENXBIO. He has over 15 years of life sciences leadership and public market experience. Mr. Christmas has managed the legal, compliance, government affairs and business development functions at several biotech and pharmaceutical companies during times of significant growth and business success. Before joining REGENXBIO, he was Vice President, General Counsel and Secretary at Lumara Health (formerly KV Pharmaceutical Company - NYSE: KV.A) through its acquisition by AMAG Pharmaceuticals and Perrigo. Prior to Lumara Health, he was General Counsel and Secretary at the Wellstat Group of Companies and General Counsel at BioVeris Corporation (formerly NASDAQ: BIOV) until its acquisition by Roche. Prior to his extensive life sciences experience, Mr. Christmas was an Associate at Akin, Gump, a leading international law firm. Mr. Christmas received his J.D. degree with honors from the University of Notre Dame and a B.A. in Economics from Boston College.
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Dr. Ram Palanki is the Executive Vice President & Chief Commercial Officer at REGENXBIO.
Dr. Palanki has nearly 20 years of experience in the development and commercialization of biopharmaceuticals and medical devices. Before joining REGENXBIO, Dr. Palanki was Senior Vice President of Commercial for the Americas at Santen Inc. Previously, he served as the executive team member leading the strategy and operations for pre-launch and global commercialization of a first-in-class biologic at ThromboGenics. Over the span of his career, Dr. Palanki has held roles of increasing responsibility at several small, mid-sized and large companies, including the launch of LUCENTIS® at Genentech. He is an active board member and strategic advisor to publicly traded and private biotech companies, technology start-ups and global non-profits.
Ram holds a PharmD from Albany College of Pharmacy, Union University, NY, and his post doctorate from Rutgers University, NJ.
Dr. Palanki has nearly 20 years of experience in the development and commercialization of biopharmaceuticals and medical devices. Before joining REGENXBIO, Dr. Palanki was Senior Vice President of Commercial for the Americas at Santen Inc. Previously, he served as the executive team member leading the strategy and operations for pre-launch and global commercialization of a first-in-class biologic at ThromboGenics. Over the span of his career, Dr. Palanki has held roles of increasing responsibility at several small, mid-sized and large companies, including the launch of LUCENTIS® at Genentech. He is an active board member and strategic advisor to publicly traded and private biotech companies, technology start-ups and global non-profits.
Ram holds a PharmD from Albany College of Pharmacy, Union University, NY, and his post doctorate from Rutgers University, NJ.
Craig Malzahn is the Executive Vice President, Product Development and Chief Technology Officer at REGENXBIO. Mr. Malzahn previously served as the Company’s Senior Vice President of Technical Operations, and has more than 30 years of experience in the biopharmaceutical industry. Prior to joining REGENXBIO in 2019, Mr. Malzahn served as Vice President and Site Head at GlaxoSmithKline (GSK). In that role, he led GSK’s commercial large-scale, drug substance biopharmaceutical site in Rockville, MD. At GSK, Mr. Malzahn also served as Senior Director of Supply Chain across the Rockville and Upper Merion, PA manufacturing sites. Prior to GSK, Mr. Malzahn was Director of Supply Chain for Human Genome Sciences (HGS), where he oversaw their transition from a clinical-stage supply chain to a commercial-stage supply chain with the commercial launch of Benlysta®. Previous to HGS, Mr. Malzahn held several roles of increasing responsibility in vaccine manufacturing at Baxter and North American Vaccines. Mr. Malzahn earned his M.S. in Biotechnology from the Johns Hopkins University and B.S. in Biology from Virginia Tech.
Nina Hunter is the SVP, Global Regulatory Strategy and Quality at REGENXBIO. She leads regulatory policy and strategy, overseeing regulatory affairs from research and development through approval. Dr. Hunter drives this strategy with a focus on worldwide regulatory requirements to accelerate product development, global registration, and effective regulatory agency interactions. She is also responsible for the Quality Assurance and Quality Control functions. She previously led Corporate Strategy activities for REGENXBIO, including the global partnership with Nippon Shinyaku for the development and commercialization of REGENXBIO’s MPS programs, as well as research and academic collaborations to advance the discovery and design of potential new AAV gene therapies.
Prior to joining the company in 2020, Dr. Hunter spent 12 years at the FDA as Director of Office of Clinical Policy and Programs, leading cross-agency functions for various FDA Commissioners and Principal Deputy Commissioners. She received her AB from Bowdoin College and Ph.D. from Harvard Medical School.
Prior to joining the company in 2020, Dr. Hunter spent 12 years at the FDA as Director of Office of Clinical Policy and Programs, leading cross-agency functions for various FDA Commissioners and Principal Deputy Commissioners. She received her AB from Bowdoin College and Ph.D. from Harvard Medical School.