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

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

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.