Opus Genetics, a patient-first gene therapy company developing treatments for inherited retinal diseases, today announced the appointments of Vikram Arora, Ph.D., DABT, as Vice President of Non-Clinical Development; Erin O’Neil, M.D., as Vice President of Clinical Development; and Sarah Tuller, J.D., RAC, as Vice President of Regulatory Affairs and Medical Writing.
Vikram Arora, Ph.D., DABT, appointed Vice President of Non-Clinical Development
Erin O’Neil, M.D., appointed Vice President of Clinical Development
Sarah Tuller, J.D., RAC, appointed Vice President of Regulatory and Medical Writing
RESEARCH TRIANGLE PARK, N.C., July 21, 2022 (GLOBE NEWSWIRE) -- Opus Genetics, a patient-first gene therapy company developing treatments for inherited retinal diseases, today announced the appointments of Vikram Arora, Ph.D., DABT, as Vice President of Non-Clinical Development; Erin O’Neil, M.D., as Vice President of Clinical Development; and Sarah Tuller, J.D., RAC, as Vice President of Regulatory Affairs and Medical Writing. Dr. Arora will report to Opus Chief Scientific Officer Ash Jayagopal, Ph.D., and Drs. O’Neil and Tuller will report to Opus Chief Development Officer Jennifer Hunt.
“Vik, Erin and Sarah are all seasoned, accomplished leaders in their respective areas of expertise and we welcome them to our growing Opus Genetics team at this exciting time for the company,” said Ben Yerxa, Ph.D., CEO of Opus Genetics. “We envision a new, efficient model to transform the treatment of rare inherited retinal diseases, and these leaders are the tip of the spear for the important work to come as we prepare for our first program to enter the clinic and to continue to develop our pipeline.”
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 Ph.D. 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.
“Vik’s deep pharmacology and toxicology experience will be invaluable in advancing Opus assets from inception to IND, and in spearheading the regulatory management of our preclinical programs,” said Dr. Jayagopal. “We’ve assembled an impressive cadre of talent on our scientific team, including recent additions of Director of Gene Therapy Scott Greenwald, Gene Therapy Senior Scientist Mayur Choudhary and Senior Scientific Fellow Krishna Fisher. With the appointment of Vik, we’ve rounded out the scientific foundation to bring forward first-in-class retinal gene therapies.”
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 M.D. from the University of Pennsylvania, a Postbaccalaureate Premedical Certificate from Bryn Mawr College and a B.A. 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.
“I’m thrilled to welcome Erin and Sarah to the Opus development team,” said Ms. Hunt. “Opus’ goal is to maintain a steady clinical pace and file one IND per year. With her inherited retinal disease gene therapy clinical development and patient care experience, Erin is well suited to lead Opus’ clinical program development. Combined with Sarah’s background in clinical regulatory affairs and impressive track record of shepherding successful IND fillings, we have the development team leadership in place to expeditiously bring our programs through the clinic and to patients in need.”
About Opus Genetics
Opus Genetics is a groundbreaking gene therapy company for inherited retinal diseases with a unique model and purpose. Backed by Foundation Fighting Blindness’s venture arm, the RD Fund, Opus combines unparalleled insight and commitment to patient need with wholly owned programs in numerous orphan retinal diseases. Its AAV-based gene therapy portfolio tackles some of the most neglected forms of inherited blindness while creating novel orphan manufacturing scale and efficiencies. Based in Research Triangle Park, N.C., the company leverages knowledge of the best science and the expertise of pioneers in ocular gene therapy to transparently drive transformative treatments to patients. For more information, visit www.opusgenetics.com.
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