Clinical Development & Regulatory Strategy

Problem Statement

Since founding of the SC Consortium significant progress was made across industry in establishing a pharmacokinetic-based clinical bridging approach from intravenous to subcutaneous administration. With the availability of enabling technologies, today, even high-dose biotherapeutics can be developed with a SC regimen from the start. There is still a lack of a cross-industry position on the most appropriate development pathway that will be addressed by the CDRS subteam to form a basis for a health authority interaction on the topic.

Desired Future State

SC drug developers across the industry understand and adopt consistent practices around implementation of SC clinical strategy, and are inspired to engage SC clinical trials earlier and more often in drug development

Biggest Accomplishments in 2023

The greatest subteam achievement was the conduct of an 2023 AAPS workshop (led by consortium member Ryan Nolan) on technologies that facilitate subcutaneous administration of high-dose mAbs as well as on clinical development consideration. The AAPS is the leading society in the field of pharmaceutical sciences and as such, this created significant visibility of the consortium
The workshop included an overview on the current status of the clinical development pathway for biotherapeutics (presentation by consortium representation Beate Bittner) that was highly valued by the audience and demonstrated the aim of the Consortium to share available knowledge in the field

Most notably, during the AAPS panel discussion, the sub team had a first engagement with a representative from the FDA, which is considered as a significant milestone for the consortium.
Subteam members were also part of the organizing team and presenters at the Controlled Release Society 2023 Annual Meeting on SC delivery and clinical development considerations, where the consortium activities were highlighted; attendees: Beate Bittner (Roche), Ryan Nolan (Halozyme), Manuel Felix-Sanchez (Novartis)

Impact of 2023 Tactics: Clinical Design & Regulatory Strategy Sub-Team

In 2023, the Clinical Development and Regulatory Strategy Subteam (CDRS) led a collaborative workshop with the American Association of Pharmaceutical Scientists covering topics such as technologies for subcutaneous administration and the current clinical development pathway for biotherapeutics. CDRS co-leads Beate Bittner (Roche) and Ryan Nolan (Halozyme) together with Manuel Felix-Sanchez (Novartis) also presented at the Controlled Release Society 2023 Annual Meeting on subcutaneous delivery and clinical development considerations.