Mr. Leising has over 20 years of gene therapy, vaccine and biopharmaceutical experience in manufacturing, quality, facility startup and process development roles across a variety of products in both the clinical and commercial stages. Mr. Leising previously served as Director of Manufacturing Quality at Novartis Gene Therapies (formerly AveXis). In this role, he was responsible for implementation and oversight of the site quality systems for AAV gene therapy for the Durham facility startup, validation and licensure for Zolgensma, as well as for multiple clinical molecules. Prior to Novartis Gene Therapies, Mr. Leising was Director of Clinical Gene Therapy Manufacturing at Pfizer’s former Bamboo facility overseeing Phase 1 manufacturing of their AAV-based gene therapies and future clinical manufacturing infrastructure. Mr. Leising holds an M.S. in biotechnology from the University of Maryland and a B.S. in biology from the Florida Institute of Technology.
Dr. Arora brings over 20 years of research and development experience in pharmacology and toxicology spanning early drug discovery to IND-enabling non-clinical programs to support global regulatory submissions for commercial therapeutics including Xembify®, Prolastin-C® and HyperRAB®. Dr. Arora joins Opus following 11 years of leadership at Grifols where he led late-stage discovery research and subsequent development aspects of R&D projects, including pharmacology/toxicology, pharmacokinetics and viral safety for candidates in the pipeline. He also acted as the lead non-clinical R&D representative to regulatory agencies. Prior to Grifols, Dr. Arora served as Director of Pharmacology & Toxicology at Talecris Biotherapeutics, Principal Research Scientist at Bayer HealthCare, and Team Leader and Post-Doctoral Fellow at AVI BioPharma (now Sarepta Therapeutics) where he conducted preclinical studies leading to some of the earliest first-in-human trials of antisense-based gene therapies. Dr. Arora is a published investigator and patent holder in the areas of pharmacology, toxicology, genetics, drug metabolism and pharmacokinetics. He earned his PhD in Pharmacology and Toxicology from the University of Nebraska Medical Center and a B.S. in Human Biology from the All India Institute of Medical Sciences.
Dr. O’Neil also currently serves as Attending Ophthalmologist at the Center for Inherited Retinal Degenerations and Ophthalmic Genetics at the Children’s Hospital of Philadelphia (CHOP), where she maintains a clinical affiliation. In this role, she oversees the treatment of pediatric patients with retinal degenerations and ocular manifestations of genetic disease. Dr. O’Neil also served as a principal investigator on a Foundation Fighting Blindness trial optimizing gene therapy for Choroideremia, for which she was awarded the Diana Davis Spencer Clinical Fellowship Award. Prior to her medical career, Dr. O’Neil served in business operations and marketing roles, including a role as Associate Product Marketing Manager at Google. Dr. O’Neil earned her MD from the University of Pennsylvania, a Postbaccalaureate Premedical Certificate from Bryn Mawr College and a BA with a Minor in Economics in International Relations from Pomona College.
Ms. Tuller has over 20 years of experience in regulatory strategy and operations, spanning numerous clinical and commercial-stage products across a wide range of therapeutic indications, including multiple orphan disease programs. She has led or been a part of numerous successful IND, NDA, MAA and BLA applications, including those of Portrazza® in metastatic, squamous NSCLC, Phoslyra® in ESRD, and Avonex Pen® in relapsing MS. Prior to joining Opus, she was Vice President RA at Disc Medicine, and held regulatory leadership positions at Astellas Pharma, where she supported the ophthalmology gene therapy, mitochondrial diseases, and regenerative (cell) medicinal product franchises, as well as prior appointments of increasing regulatory responsibility at companies including Biogen, ImClone, Fresenius, and Baxter. She earned her J.D. in IP law from the University of Dayton School of Law, holds a B.S. in Chemistry, and is RAC certified.
Dr. Yerxa is President and CEO of Opus Genetics. Dr. Yerxa has more than 25 years’ experience in biotechnology, drug development and in translating promising research discoveries into clinical milestones and treatments in the pulmonary, oral health, cardiovascular, HIV and ophthalmology fields. Dr. Yerxa served as CEO of the Foundation Fighting Blindness where he established the RD Fund, a venture philanthropy investment fund. Prior to joining the Foundation, Dr. Yerxa served as president and co-founder of Envisia Therapeutics, a company focused on developing novel ocular sustained delivery therapies for the front and back of the eye. He also has previously held founding and executive positions in several ophthalmology-based R&D organizations, including Liquidia Technologies, Clearside Biomedical, Parion Sciences and Inspire Pharmaceuticals. Dr. Yerxa serves on the board of directors at Clearside Biomedical and Nacuity Pharmaceuticals. Dr. Yerxa holds 60 U.S. patents. An inventor of DIQUAS™, an innovative treatment for dry eye approved in Japan, he has been involved in the discovery and development of investigational new drugs, Phase 3 clinical programs, new drug applications, and drug approvals. Dr. Yerxa earned his Ph.D. in organic chemistry from University of California, Irvine, and BA in chemistry from the University of California, San Diego.
Dr. Kelley serves as vice president, investments & alliances, for the Foundation Fighting Blindness. In this role, he is responsible for identifying, coordinating, and managing all external investment opportunities that strategically align with FFB’s mission, and leading and managing the Foundation’s partnerships and collaborations. Prior to joining the Foundation, Dr. Kelley was a senior program officer with the Burroughs Wellcome Fund, where he developed and led multiple advisory boards for identifying and funding gaps in interdisciplinary science and translational medicine, and was director and head of discovery, preclinical and translational medicine, at Tengion, where he helped develop a cell and tissue-based engineering platform for the regenerative medicine company. Dr. Kelley earned a Bachelor of Arts in chemistry at University of North Carolina at Chapel Hill and a doctorate in pharmacology and experimental therapeutics from Louisiana State University Health Sciences Center. He was an American Heart Association postdoctoral fellow at UNC Chapel Hill in Dr. Cam Patterson’s cardiovascular biology and translational genomics lab, and recently earned an MBA from the Fuqua School of Business at Duke University.
Dr. Bennett is the F.M. Kirby Emeritus Professor of Ophthalmology at the Perelman School of Medicine and previously served as director of the Center for Advanced Retinal and Ocular Therapeutics (CAROT) at the University of Pennsylvania. In addition to Dr. Bennett’s positions at the University of Pennsylvania, she has been an Investigator at the Center for Cellular and Molecular Therapeutics at The Children’s Hospital of Philadelphia (CHOP) for more than a decade. She also co-founded life science companies Spark Therapeutics (acquired by Roche), GenSight Biologics and Limelight Bio. Dr. Bennett received her Ph.D. in Zoology and Cell Biology from the University of California, Berkley, and obtained an M.D. from Harvard University. She also completed postdoctoral fellowships in Radiobiology and Environmental Health at the University of California, San Francisco, Human Genetics at Yale School of Medicine and Development Genetics at the Johns Hopkins University School of Medicine. She received her B.S. in Biology from Yale University.
Dr. Pierce is the Chatlos Professor of Ophthalmology and Director of the Ocular Genomics Institute in the Department of Ophthalmology, Massachusetts Eye and Ear and Harvard Medical School. Dr. Pierce received his Ph.D. in Biochemistry from the University of Wisconsin-Madison and his M.D. from Harvard Medical School. He completed his residency in Ophthalmology at Harvard and fellowship in Pediatric Ophthalmology at Children’s Hospital, Boston, where he also assumed his first faculty position. He was then recruited to the Department of Ophthalmology at the University of Pennsylvania School of Medicine, where he was promoted to Associate Professor with tenure. He returned to Harvard in 2011 to establish the Ocular Genomics Institute (OGI), which aims to translate the promise of precision medicine into clinical care for patients with inherited eye diseases.
Mr. Boye is co-founder and Chief Technology Officer of Atsena Therapeutics. He is also an Associate Scientist of Pediatrics and Associate Director of the Powell Gene Therapy Center at the University of Florida. His research on AAV and ocular gene therapy spans 20 years and over 110 publications. He has focused primarily on the utilization of recombinant AAV as a gene therapy vector for the treatment of retinal disease and has designed AAV vectors used to establish proof of concept in animal models of autosomal recessive retinitis pigmentosa, X-linked retinitis pigmentosa, Achromatopsia, Bardet-Biedl syndrome, Usher syndrome and multiple forms of Leber congenital amaurosis (LCA). Many of these gene therapies have since been applied in the clinic. A secondary focus of his research is synthetic virology. Using a combination of directed evolution and rational design, he aims optimize the AAV capsid and genome to improve its performance and safety. He is a prolific inventor of AAV-related technologies, holding 10 awarded and eight pending patents.
Dr. Ayyagari is a Professor of Ophthalmology, Pathology and Biomedical Sciences Graduate program, Viterbi Family Endowed Chair and Director of the Shiley Eye Institute Biobank, at the Shiley Eye Institute and University of California, San Diego, California. She is an internationally renowned leader in the field of genetics and disease mechanisms of inherited retinal degenerations. Dr. Ayyagari obtained her PhD in Biochemistry and trained in ophthalmic genetics during her post-doctoral fellowship. She has published more than 130 peer-reviewed articles, mentors high school, graduate and medical school students, and post-doctoral scholars, and serves on several national and international scientific advisory boards/committees.