Trial Design Built for Neurodegenerative Complexity
Avance Clinical designs neurodegenerative disease trials, or co-designs them with your team, from day one around the complexities of the disease: heterogeneous patient populations, challenging endpoints, and biomarkers that must work for both patient selection and efficacy. That includes practical attention to inclusion criteria, enrichment strategy, endpoint selection, visit schedules, and the operational burden that shapes both screen failure and attrition, with the goal of de-risking later development earlier.
One Specialist Team for Design and Delivery
The same team that designs the trial is there to deliver it, an approach designed to give sponsors greater confidence before the first patient is dosed. The CNS Center of Excellence brings medical, scientific, and operational leadership together under Dr. Francesco Bibbiani, MD, CPI, Vice President & Therapeutic Area Head, Neuroscience, whose work spans Alzheimer’s and Parkinson’s disease with senior roles at Eisai and other biopharma companies, and Marty Kraut, PhD, PMP, Director of Operations, CNS Center of Excellence, with more than two decades of CNS-focused project management and clinical operations experience. Sponsors work with dedicated, hands-on experts rather than a rotating account team.
Built to Clear the Hurdles Unique to Neurodegeneration Trials
Neurodegeneration trials rarely stall for one reason. They stall where scientific and operational risk meet: biomarkers that must work for both patient selection and efficacy, high screen failure, rater-dependent endpoints that drift, and, in Alzheimer’s, caregivers who act as gatekeepers to enrollment. Avance Clinical’s patient selection, site, recruitment, and rater-training approach is designed to address exactly those risks.
Australia lets biotechs start most early-phase trials without an IND, with study start-up in 5–6 weeks from final protocol to approval and R&D rebates of up to 43.5% on eligible spend. Through GlobalReady, neurodegenerative disease programs can move from early-phase trials in Australia into later-phase studies across Australia, Asia Pacific, North America, and Europe with continuity in data standards, operational quality, and scientific oversight. Our agile, high-touch model is backed by Avance Clinical’s established global infrastructure.
