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Title: “Facing Challenges – a successful Team Lilly story behind Baqsimi’s commercial dose, product specifications and regulatory approval”
Speakers: Thomas Hardy, M.D., P.h.D., Brian Pack, Ph.D., and Douglas James, B.S.
BAQSIMI is the first and only nasally administered glucagon for the treatment of severe hypoglycemia in patients with diabetes ages 4 years and above. It is a life-saving medication using a novel user-friendly ready-to-use device. In this presentation, the Baqsimi team will share with the audience the unique challenges and how the cross-functional team members applied PK/PD model-informed drug development approach to justify the dose in adult and pediatric patients and support the commercial drug product development.