Getting better medicines to patients faster remains the holy grail of pharmaceutical R&D. In 2020, Boehringer Ingelheim identified through benchmarking data that there was opportunity to accelerate clinical development timelines from Phase 1 clinical trials through to regulatory approval.
“We had a choice to make, there and then,” recounts Uli Broedl, then Head of CD&O, “we could choose to do nothing or we could take the organization on a transformation journey.” With backing from the Board, a new, high performing Clinical Development and Operations (CD&O) group, via a four ‘pillar’ transformation, was created:
1. Changes in which roles are represented on the key development teams – streamlining and clarifying the decision making and governance for each medicine asset
2. Mindset and culture change – individuals and teams being empowered and taking accountability
3. Changes in how clinical operations will be conducted – moving from the transactional to being relationship driven with patients and sites
4. Changes in IT systems and data – capturing the benefits of new technology by replacing stand-alone legacy systems with one integrated system.
Changes in how clinical operations will be conducted
“Patient and site engagement is at the very center of our way of working” says Candice Fitzgerald, Head of CD&O Regions. “We knew in order to drive speed in delivery, we must make the most compelling case for patients and investigator sites to work with us.”
The first step therefore, was to incorporate patient and site needs into Boehringer Ingelheim throughout clinical development. However, in order to really benefit from this new approach, time consuming and administrative tasks impacting Boehringer Ingelheim clinical trial teams needed to be minimized. The second step was to implement a new Regions Target Operating Model across all of Boehringer Ingelheim’s regions and country operating units. “This enabled more than 600 FTEs to focus on key value-generating activities, such as:
- Earlier and more effective engagement with patients and sites (customers)
- Proactive frontloading activities to help accelerate clinical trial execution
- Capturing strategic insights and turning them into actions
- More proactive risk mitigation and robust oversight of clinical trial performance and delivery” says Fitzgerald.
Changes in IT systems and data
The aim here is to replace 5 legacy R&D systems with 1 integrated system and capture the benefits of using new technology. “This new system will:
- Accelerate clinical development cycle times
- Enhance end-user enablement and improve the site experience via real-time data
- Reduce manual effort and bring cost efficiency” says Carina Reinicke, Head of CD&O Capabilities.
Boehringer Ingelheim and Syneos Health collaboration
A transformation effort of this scale, needs to involve external partners to help deliver. Syneos Health is one of those partners, supporting Boehringer across several of the transformation pillars. James Man, Syneos Health Programme Director says, “It has been our pleasure to provide our management consulting, medical communications and clinical expertise in a fully integrated interdisciplinary Syneos Health Team to Boehringer Ingelheim. We have enjoyed where needed, providing respectful challenge to co-create the best outputs with our Boehringer Ingelheim colleagues.“
A success story
As of March 2024, Boehringer Ingelheim CD&O has:
- Become ~400 days faster in its clinical development programs since the start of 2022 – indexed by internal benchmarking
- Moved to 6th position in patient engagement in R&D – indexed by the 2023 PatientView Report
- Moved to 5th position in clinical trial site engagement – indexed by the 2023 CenterWatch Report
Fitzgerald says: “Syneos Health offered (and continues to offer) fantastic project management, change management, communications and technical support to help us drive our very ambitious goals. It is a pleasure working with this team.”
