NEW YORK and BASEL, Switzerland, Nov. 15, 2021 /PRNewswire/ -- Aruvant Sciences ("Aruvant"), a private company focused on developing gene therapies for rare diseases, announced the appointment of Moya M. Daniels as senior vice president (SVP) of regulatory affairs and quality assurance (QA), effective immediately. Ms. Daniels brings over thirty years of regulatory, quality and clinical experience in the biopharmaceutical industry.
"Given her regulatory and QA expertise, particularly in the cell and gene therapy space, Moya will play a key role in helping to bring our investigational gene therapies through the FDA review process and ultimately to indviduals living with rare diseases," said Will Chou, MD, Aruvant chief executive officer. "Moya comes at an important time as we are preparing to start a pivotal study for our lead product candidate, ARU-1801, for individuals living with severe sickle cell disease."
Ms. Daniels has lead the regulatory and QA efforts at both private and public biopharmaceutical companies. She served as SVP of regulatory affairs and global quality assurance at Orchard Therapeutics, where she led the company's chemistry, manufacturing and controls (CMC) regulatory and generic good practice (GXP) quality strategy. She was part of the team that led the in-licensing of GSK's rare disease gene therapy portfolio. Subsequent to Orchard she was the executive vice president, head of regulatory affairs, quality and clinical operations at Histogen, Inc., a publicly traded clinical-stage therapeutics company, and SVP of good manufacturing practices (GMP) quality at SanBio, a regenerative medicine company. Prior to Orchard, Ms. Daniels served as vice president (VP) of regulatory affairs and QA at Fate Therapeutics, Inc. and before that led global regulatory strategy, quality and clinical operations at Osiris Therapeutics. There she played a critical role in obtaining regulatory approval of Prochymal®, the first approved allogeneic cell therapy indicated for the treatment of pediatric steroid refractory acute graft versus host disease.
"I am excited to join the executive team at Aruvant and help guide Aruvant's investigational gene therapies through the regulatory process," said Ms. Daniels. "To be able to apply my industry experience and work on bringing potentially curative treatments to the market is inspiring and fuels my passion to make a real difference in patients' lives."
About Aruvant Sciences
Aruvant Sciences, part of the Roivant family of companies, is a clinical-stage biopharmaceutical company focused on developing and commercializing gene therapies for the treatment of rare diseases. The company has a talented team with extensive experience in the development, manufacturing and commercialization of gene therapy products. Aruvant has an active research program with a lead product candidate, ARU-1801, in development for individuals suffering from SCD. ARU-1801, an investigational lentiviral gene therapy, is being studied in a Phase 1/2 clinical trial, the MOMENTUM study, as a one-time potentially curative treatment for SCD. Preliminary clinical data demonstrate that the unique potency of ARU-1801 allows engraftment and amelioration of SCD symptoms with only one dose of reduced intensity chemotherapy. The company's second product candidate, ARU-2801, is in development to cure hypophosphatasia, a devastating, ultra-orphan disorder that affects multiple organ systems and leads to high morbidity and mortality when not treated. Data from pre-clinical studies with ARU-2801 shows durable improvement in disease biomarkers and increased survival in disease models. For more information on the ongoing ARU-1801 clinical study, please visit www.momentumtrials.com, and for more on the company, please visit www.aruvant.com. Follow Aruvant on Facebook, Twitter @AruvantSciences and on Instagram @Aruvant_Sciences.
SOURCE Aruvant Sciences