ADELAIDE, Australia, Oct. 28, 2025 (GLOBE NEWSWIRE) — Avance Clinical, the award-winning Australian led, global CRO built exclusively to service the clinical research needs of biotech companies, today announced the launch of its Center of Excellence dedicated to central nervous system (CNS) disorders. This strategic initiative addresses the unique clinical trial execution challenges facing biotech companies developing neurological therapies, offering integrated solutions from first-in-human studies through Phase III trials.
Building on more than 50 completed CNS trials over the last five years, the center aims to help biotech developers tackle critical operational bottlenecks including complex protocol requirements, challenging patient recruitment, and elevated screen failure rates that average 57% in CNS trials compared to 36.3% across other therapeutic areas.
Comprehensive CNS-Focused Services
The center provides end-to-end support including CNS-specific protocol design, regulatory strategy across multiple jurisdictions, specialized site networks, targeted patient recruitment strategies, and advanced data management and analysis for complex CNS endpoints.
Distinguished Leadership
Leading the center is Dr. Francesco Bibbiani, whose appointment as Vice President & Therapeutic Area Head, CNS Center of Excellence represents a significant strategic acquisition. Bibbiani brings over 25 years of CNS clinical development experience from senior leadership roles at Neurogene, Dyne Therapeutics, Ultragenyx, PTC Therapeutics, and Eisai Inc. His expertise spans Phase I through pivotal trials across multiple CNS conditions including Parkinson’s disease, Huntington’s disease, neuromuscular disorders, and epilepsy, complemented by board certification in neurology and 25+ peer-reviewed publications.
“CNS drug development presents complex clinical trial challenges, particularly for biotech companies with innovative mechanisms and constrained resources,” said Bibbiani. “Our center integrates specialized CNS clinical expertise with proven operational excellence, enabling sponsors to execute high-quality trials efficiently from first-in-human studies through pivotal Phase III programs.”
Strategic Partnership Model
Designed exclusively for biotech companies, the center operates as a true partnership that strategically incorporates Australia’s unparalleled regulatory advantages across all trial designs. Whether conducting early phase studies exclusively in Australia or managing global multi-regional trials, the center maximizes the Australian advantage through accelerated startup timelines, streamlined regulatory pathways, and strategic program structuring that optimizes the 43.5% R&D tax incentive. This approach transforms Australia’s unique benefits into competitive advantages for both Australia-only early phase trials and international late phase programs spanning multiple geographies.
Key Differentiators
Avance Clinical’s key differentiators include exclusive biotech focus across all trial phases, involving thorough program analyses and strategic advice by subject matter experts through specialized centers of excellence, in-house regulatory affairs teams, access to over 2,000 specialized clinical sites globally, and proprietary GlobalReady process enabling seamless transition from early phase Australian studies to multi-regional late phase programs.
About Avance Clinical
Avance Clinical is the largest premium full-service Australian headquartered CRO delivering high-quality clinical trials in Australia, New Zealand, Asia, North America and Europe for international biotechs. The company has won multiple Frost & Sulivan CRO Market Leadership and Customer Value Leadership Awards. With over 30 years of experience and deep expertise across more than 250 indications, Avance Clinical provides services from pre-clinical to late phase trials, supported by best-in-class regulatory, clinical and operational expertise.
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CONTACT
Gabe Martinez
Director Content, Media & PR
308-237-5567
[email protected]
A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/54b00624-bed6-4c08-869b-15aaa69c303b
