William Le
Senior Director of Clinical Operations Clarity Pharmaceuticals
Drug development leader with 20+ years of experience in Clinical Operations and Program Management, successfully advancing innovative therapies from preclinical development through IND-enabling activities and multiple stages of clinical development. Proven track record of guiding complex programs from early clinical development through Phase III and regulatory submission, including two NDA/BLA filings, with one therapy achieving approval for a rare cancer indication.
A 20-minute case study presentation exploring real-world site coordination challenges, followed by a 20 minute facilitated roundtable discussion where attendees share experiences and strategies to improve site readiness and treatment delivery.
- Defining what clinical sites require from manufacturers, including format, delivery method, documentation, and support
- Coordinating chain of custody and ensuring product integrity from production through to administration
- Identifying bottlenecks at the clinical site level, including patient throughput and handling constraints
- Improving collaboration between CMC teams and clinical stakeholders to enable smoother delivery
- Across the two days, which single supply chain or manufacturing bottleneck has emerged as most urgent, and what does a credible industry-level response to it look like?
- Where does the field realistically stand on isotope supply security in five years, and which production pathways, technologies, and investment models will determine whether commercial-scale alpha therapy becomes a reality?
- How must the relationship between biopharma, CDMOs, isotope providers, logistics specialists, and clinical sites evolve structurally to one that can reliably deliver therapies to patients at scale?
