Recode Therapeutics Expands Leadership Team with Appointment of April Loui as Senior Vice President of Quality and CMC Regulatory Affairs
– Distinguished biotech industry veteran brings decades of experience to lead the scale-up of manufacturing capabilities for ReCode’s pipeline of first-in-class precision genetic medicines –
MENLO PARK, Calif.--(BUSINESS WIRE)--ReCode Therapeutics, a genetic medicines company using superior delivery to power the next wave of mRNA and gene correction therapeutics, announced today the appointment of April Loui, MBA, CSSBB, as senior vice president of quality and chemical, manufacturing and controls (CMC) regulatory affairs. Ms. Loui will oversee and manage ReCode’s quality and CMC regulatory strategies.
“April’s deep knowledge and wealth of experience will be instrumental in guiding the build of scalable, highly efficient, and consistent quality and manufacturing processes,” said Shehnaaz Suliman, M.D., MBA, M.Phil., chief executive officer of ReCode Therapeutics. “This is an important time for ReCode as we advance our lead programs for primary ciliary dyskinesia and cystic fibrosis into the clinic this year and we are delighted to welcome April to our leadership team."
Ms. Loui brings more than 25 years of pharmaceutical and biotech experience, with a proven track record of leading global organizations through regulatory inspections and product commercialization. Most recently, as founder and chief executive officer of Clarity Global, LLC Consulting, Ms. Loui advised emerging life sciences companies on best practices for development through commercial operations, ensuring compliance with health authority guidelines and alignment with enterprise objectives.
“I have great respect for ReCode’s innovation in precision genetic medicines and the science behind its differentiated delivery technology which holds immense promise for improving the way we treat a wide range of diseases,” said Ms. Loui. “The potential to make a lasting imprint on the future of genetic medicine is incredibly exciting, and I am thrilled to work alongside a passionate and talented leadership team united by this vision.”
Previously, Ms. Loui served as the vice president of quality at Alector, where she led the build and mobilization of GXP Quality systems in preparation for global clinical trials. Prior to Alector, she was the senior director of CMC clinical quality operations at Gilead Sciences, where she provided leadership for quality CMC strategies across clinical programs. She was also previously the head of quality at Avid Bioservices, leading the organization through multiple successful regulatory inspections and first product approvals.
Ms. Loui spent more than a decade at Genentech, a subsidiary of Roche, in leadership roles including management of Genentech’s external manufacturing quality operations. She has also held positions of increasing responsibility at Bayer Pharmaceuticals in process development, facility startups and regulatory affairs. Ms. Loui earned her MBA from Saint Mary’s College and her bachelor’s degree in Integrative Biology from the University of California, Berkeley.
About ReCode Therapeutics
ReCode Therapeutics is a genetic medicines company using superior delivery to power the next wave of messenger RNA (mRNA) and gene correction therapeutics. ReCode’s selective organ targeting (SORT) lipid nanoparticle (LNP) platform is a next-generation, genetic medicines technology that enables precise delivery to target organs and cells beyond the liver. The SORT LNP platform is the foundation for ReCode’s pipeline of disease-modifying mRNA and gene correction therapeutics. ReCode’s lead programs are focused on primary ciliary dyskinesia and cystic fibrosis. ReCode is leveraging its SORT LNP platform and nucleic acid technologies to expand its pipeline with therapeutics that use mRNA-mediated replacement and gene correction in target organs with precision targeting of disease-relevant cells. In 2022, ReCode was named among Fierce Biotech’s “Fierce 15” as one of the most promising early-stage biotechnology companies in the industry, and was described by Nature as one of the “Seven Technologies to Watch in 2022” for its SORT LNP platform. For more information, visit www.recodetx.com and follow us on Twitter @ReCodeTx and on LinkedIn.
The Grace Communication Group