NervGen Pharma Strengthens Leadership Team with Key Regulatory and Patient Advocacy Appointments
Key Insights
NervGen Pharma appointed Shamim Ruff as Chief Regulatory Affairs Officer and Christine McSherry as SVP of Patient Advocacy and Clinical Affairs to advance their spinal cord injury (search) treatment program.
Ruff brings over 30 years of regulatory expertise from companies including Stoke Therapeutics and Sarepta Therapeutics to guide NVG-291 toward potential approval as the first pharmacologic treatment for SCI.
McSherry, who founded the Jett Foundation (search) after her son's Duchenne muscular dystrophy (search) diagnosis, will ensure the SCI community's voice remains central to NervGen's clinical strategy.
NervGen Pharma Corp. has appointed two senior executives to strengthen its leadership team as the clinical-stage biopharmaceutical company advances its first-in-class neuroreparative therapeutic for spinal cord injury (search) (SCI). The company named Shamim Ruff as Chief Regulatory Affairs Officer and Christine McSherry as Senior Vice President of Patient Advocacy and Clinical Affairs.
Strategic Leadership Additions
"We are assembling a world-class leadership team as the company moves into a critical period of execution," said Adam Rogers, MD, President and Chief Executive Officer of NervGen. "Shamim's regulatory expertise and proven track record of success will be crucial as we advance NVG-291 toward potential approval as the first pharmacologic treatment for SCI, while Christine's unique combination of authentic patient advocacy and clinical development experience ensures the patient and family voice remains at the forefront of NVG-291's path forward."
Regulatory Affairs Leadership
Shamim Ruff brings more than 30 years of strategic leadership in regulatory affairs to NervGen, where she will oversee the company's regulatory strategy and work closely with the executive team. Most recently, Ruff served as Chief Regulatory Affairs Officer and SVP, Head of Quality Assurance at Stoke Therapeutics, leading regulatory strategy for the company's RNA medicine platform. Prior to Stoke, she served as Chief Regulatory Affairs Officer at Sarepta Therapeutics, where she built the company's regulatory affairs and quality organizations and led regulatory strategy for its rare and infectious disease pipelines.
Her career also included leadership roles at Sanofi-Genzyme, Amgen, Abbott, and AstraZeneca. Ruff holds a master's degree in analytical chemistry from the University of Loughborough, U.K., and a bachelor's degree in chemistry and biology from the University of Leicester, U.K.
"I've spent my career advancing novel therapeutics through regulatory pathways to approval, with the goal of delivering meaningful benefit to patients and their families," said Ruff. "NVG-291 represents a compelling opportunity in the treatment of SCI and is supported by promising clinical data from the Phase 1b/2a CONNECT SCI Study, indicating evidence of nervous system repair."
Patient Advocacy Focus
Christine McSherry brings more than 30 years of experience bridging patient advocacy and clinical development. She will play a pivotal role in ensuring the voice of the SCI community is central to NervGen's clinical strategy. Previously, McSherry co-founded Casimir (search), a clinical research organization that worked across more than 20 rare diseases, capturing and quantifying patient and caregiver perception of treatment benefit. Casimir's work pioneered the development of outcome measures to advance the FDA's patient-focused drug development initiative.
In 2001, she founded the Jett Foundation (search) after the diagnosis of her son, Jett, with Duchenne muscular dystrophy (search) (DMD). The Foundation became a leading voice for affected families and played a central role in the advocacy efforts that contributed to the FDA's approval of Exondys 51, the first approved therapy for DMD. McSherry continues to serve as a Director of the Jett Foundation and previously served on the Board of Directors of the Duchenne Alliance.
"I know what it means to be a family fighting for access to a treatment capable of changing lives, and that experience has shaped both my life and my career," said McSherry. "The most successful clinical programs are designed alongside the communities they are meant to serve, and NervGen's commitment to that approach is what drew me to the company. For too long, those living with SCI have been overlooked, defined by the belief that recovery was unattainable."
NVG-291 Development Program
NervGen's lead therapeutic candidate, NVG-291, is a subcutaneously administered, neuroreparative peptide. NVG-291 was evaluated in the Phase 1b/2a CONNECT SCI Study in individuals with chronic SCI between 1 to 10 years post-injury and is the first pharmacologic candidate to demonstrate durable improvement in function, independence, and quality of life. The Company's Phase 1b/2a CONNECT SCI Study in individuals with subacute SCI is ongoing, alongside preparation for a Phase 3 clinical trial in chronic SCI.
NVG-291 has received Fast Track designation from the FDA and Orphan Drug designation from the European Medicines Agency (search) (EMA) for the treatment of SCI. Through NVG-291 and the company's next-generation candidate, NVG-300, NervGen is pursuing a pharmacologic approach to transform the treatment paradigm for neurotraumatic and neurologic conditions with significant unmet medical need.