Formulation & Device Lifecycle Management for Biotherapeutics - The Value of Platform Technologies

3/22/2022 16:40 - 17:10

Formulation and device lifecycle management covers all improvements related to the drug delivery and administration profile of a medication. Associated activities most frequently commence either during late-stage development or once the product has already entered the market. This step-wise approach aims at initially bringing novel medicinal products to patients as timely as possible. Optimizations of the drug presentation, the administration route and the overall dosing procedure are of lower priority in case these would push out availability of the treatment. 

In this context, especially biopharmaceuticals that need to be administered parenterally are expected to benefit from an improved drug delivery profile. Reducing the dosing complexity can enable broader access to medications by facilitating a flexible care setting. This setting includes the option for home- and patient self-administration and contributes to a patient-centric disease management, leaving the choice of the treatment location to patients and their caregivers. 

To enable timely availability of product optimizations, technology platforms that are applied to multiple molecules across different disease areas and updated over time are expected to enhance early market entry of the most appropriate product presentation; ideally already at initial launch of a biological molecule. 

This presentation will discuss advantages and disadvantages inherent to using formulation and device platform technologies to improve the drug delivery profile of medicinal products, highlight development and commercialization aspects that can be leveraged across different molecules and indications, as well as aspects that need to be assessed for each molecule individually.

Beate Bittner, Senior Portfolio Strategy Director, Roche