Newel Health, Gerresheimer team up to help pharma embrace digital

Digital medicine specialist Newel Health has formed an alliance with packaging group Gerresheimer to help pharma companies roll out digital technologies for clinical testing and to develop new digital medical devices and hybrid therapies.

The aim is to help companies "deploy integrated drug and digital therapies that enable real-world data generation and personalised medicine at scale," said the two partners in a statement.

The collaboration brings together Switzerland-based Newel Health's Software as Medical Device (SaMD) and AI platforms with the German packaging giant's drug delivery and primary packaging expertise, including devices that can help patients adhere to treatment and provide data to healthcare professionals.

"By combining our SaMD expertise, real-world data, and AI capabilities with Gerresheimer’s global footprint, connected device, packaging, and digital health capabilities, we help pharma design and scale digital endpoints, regulated digital medical devices, and integrated drug+digital solutions across multiple indications," said Newel Health's chief executive, Ervin Ukaj.

Both companies have a proven track record in the digital health category. Newel Health has brought three SaMD products to market – to support patients living with hypertension, musculoskeletal pain, and Parkinson's disease – while life sciences companies are using Gerresheimer's digital technologies to manage supply chains and transform packaging into smart devices.

In addition, the German group has also launched a digital therapeutic (DTx) for Parkinson's and is developing another to support patients using GLP-1 agonist medicines for weight loss.

Now, the partners are drawing on this experience to help pharma companies embed digital endpoints, real-world data, and AI into clinical development and commercialisation, without needing to build a full digital and device stack internally.

Among the assistance being offered to pharma and biotech companies are the design and validation of digital endpoints for clinical trials, using connected devices and sensors, using Newel Health's H-Core platform to come up with SaMDs for monitoring, decision-making, adherence tools, and symptom tracking, and building the digital infrastructure to access real-world data and AI insights.

Another key proposition is to help build drug+device+digital combination – sometimes known as hybrid therapies – that can enhance the effects of drug therapy – an approach that has started to gather momentum following regulatory initiatives like the FDA's Prescription Drug Use-Related Software (PDURS) guidance in 2023, which laid out a regulatory framework for the category.

"Our collaboration with Newel Health underlines Gerresheimer's position as a system and solution provider at the interface of drug, device or packaging and digital solutions," said Mithun Ratnakumar, the company's head of digitalisation & new business models.