Shaemus Gleason

Company: Clarity Pharmaceuticals

Job title: Executive Vice President

Seminars:

Panel Discussion: Designing for Demand – Process Strategies to Support Scale-Up of Radiotherapeutic Manufacturing 1:30 pm

Evaluating scale-up vs. scale-out approaches in radiopharmaceutical manufacturing. Efficiencies for making the transition from Phase 3 to commercial. Future-proofing production by aligning process design with commercial demand forecast. Planning processes that accommodate isotope variability, decay kinetics, and short half-lives.Read more

day: Conference Day Two

Panel Discussion: Addressing Barriers in Supply Chains to Ensure Reliable Isotope Access & Consistent Patient Delivery 9:30 am

Identify sourcing and logistics bottlenecks including cold chain constraints, regulatory delays, and cross-border customs challenges that impact isotope availability and the timely delivery of radiopharmaceuticals. Compare centralized and local production models for short- and long-lived isotopes to minimize supply chain risks, costs, and lead times while ensuring the delivery of therapies to clinical sites on…Read more

day: Conference Day One

Panel Discussion: Discussing Perspectives on Regulatory Expectations to Improve Submission Clarity & Accelerate Development Timelines 3:30 pm

Explore key differences in manufacturing practices for pharmaceutical vs industrial isotope use, including how processes, quality standards, and documentation are adapted for GMP compliance. Review common regulatory questions and challenges faced when submitting Drug Manufacturing Files (DMFs), and how these vary across agencies like the FDA and EMA. Discuss how to balance confidentiality with regulatory…Read more

day: Conference Day One