High Dose / High Volume

Problem Statement

Gaps exist in the industry regarding understanding and implementation of best practices for CMC, clinical, and regulatory development of HDHV products

<span data-metadata=""><span data-buffer="">Desired Future State

An improved understanding of patients’ perceptions of SC drug-delivery tradeoffs, including formulation physical properties and device attributes, focused on the optimal tradeoff point between pain and high-dose/volume delivery, so that high-dose/volume SC products can be designed to minimize discomfort and ultimately increase patient acceptance of SC products, enable self-administration and improve adherence

<span data-metadata=""><span data-buffer="">Biggest Accomplishments in 2023

Completion of literature search and landscape of HDHV pain knowledge

Drafted a manuscript reviewing SC pain on injection for high dose and high volume drugs.

Identified gaps and made recommendations for future SC product design.

Impact of 2023 Tactics: High Dose / High Volume Sub-Team

In 2023, the high dose high volume (HDHV) team completed a comprehensive literature search and landscape assessment of pain associated with HDHV products. The team utilized this knowledge to draft a manuscript that provides an overview of the interdependency of meta-variables (e.g., formulation, device, administration parameters, and patient) on pain associated with HDHV products, identifies gaps within the existing knowledge, and makes recommendations for future HDHV SC product design.