This strategic hire marks a transition for U-Ploid from discovery-stage research toward first-in-human clinical evaluation. In the Head of Regulatory Affairs role, Stonehouse will oversee the global regulatory roadmap for Lyvanta™, the company’s lead therapeutic designed to reverse age-related decline in oocyte (egg) quality.
Stonehouse joins U-Ploid with over 25 years of experience in international regulatory strategy. He most recently served as Vice President, International Regulatory Strategy at Vertex Pharmaceuticals, and his career includes senior leadership roles at Autolus (pioneering CAR-T therapies) and Celgene. Crucially for the UK ecosystem, Stonehouse served four years as Chair of the Bioindustry Association (BIA) Regulatory Affairs Advisory Committee, where he helped shape the UK’s post-Brexit life sciences regulatory landscape.
A pivotal moment for reproductive health therapeutics
The appointment coincides with U-Ploid’s move toward human clinical trials with its lead therapeutic candidate. The company recently attracted international attention following pre-clinical data demonstrating that Lyvanta™ achieved an 84% reduction in age-related mouse egg chromosomal errors (aneuploidy).
For IVF clinics and patients, this represents a potential paradigm shift. Lyvanta™ is a first-in-class therapeutic to focus on oocyte quality, addressing the primary cause of IVF failure and miscarriage in women aged 35 and over.
Tim Stonehouse, Head of Regulatory Affairs at U-Ploid, commented:
"I have spent my career navigating the complexities of bringing first-in-class modalities to market, from biologics to gene therapies. U-Ploid occupies a unique frontier in biotech, applying sophisticated molecular biology to the neglected space of reproductive longevity. The early data for Lyvanta™ is some of the most compelling I have seen in the sector, indicating that we can fundamentally change the success rate of assisted reproduction. My initial priority will be to further engage key regulators, such as FDA, EMA and MHRA, to build understanding and gain alignment on the most efficient development path for Lyvanta™. I am thrilled to join the team as we work to bring this much-needed treatment to patients.
Jordan Abdi MD, Co-founder and CEO of U-Ploid Biotechnologies, added:
"Attracting a regulatory heavyweight of Tim’s calibre is a testament to the strength of our science. As we move into the clinic, Tim’s deep expertise in global strategy and his experience of leadership within the BIA will be instrumental. Shaping the regulatory path for novel interventions is critical at this stage, and Tim is the ideal person to lead us through this next phase of growth."
ENDS
Notes to Editors
About U-Ploid Biotechnologies
U-Ploid Biotechnologies is an Oxford-based biotechnology company dedicated to solving one of the world’s most pressing challenges in fertility: declining egg quality. U-Ploid is developing Lyvanta™, a novel therapeutic that targets the molecular pathways of oocyte ageing. By reducing chromosomal errors by over 80% in pre-clinical mouse models, U-Ploid aims to significantly increase the probability of healthy pregnancies for women in their mid-30s and beyond.
For more information, visit: www.u-ploid.com
Media contact: jessica.farmery@lexcomm.co.uk