Day One | Wednesday, September 24, 2025
8:00 am Morning Coffee & Registration
9:00 am Chair’s Opening Remarks
Overcoming Drug Delivery Challenges Through Emerging Device Solutions & Formulation Alignment
9:10 am Innovative Device Strategies for Brain-Targeted Drug Delivery to Overcome Barriers and Enable Collaborative Development
Synopsis
- Overcoming challenges in brain drug delivery: Develop approaches to bypass the blood-brain barrier and reduce risks from invasive methods for safer, more effective treatments
- Innovating delivery methods: Explore novel devices and alternative delivery routes to enhance how drugs are delivered to the brain
- Collaborating for better solutions Integrate advancements in device design, modelling, drug formulation and related innovations to develop more effective therapies for brain disorders
9:40 am Engineering Precision: Overcoming Barriers in Ocular Drug Delivery
Synopsis
- Discussing how human factor analysis and ocular injector design and collaboration must start in the beginning
- Outline how to develop a stable formulation that can be loaded to an injector
- Review when to marry and when to communicate with the regulator: final formulation with the final injector
- Integrating formulation science, device development, and regulatory strategy to enable robust validation and maintain design history integrity across diverse delivery platforms
10:10 am Speed Networking & Morning Break
Synopsis
Join this exclusive networking session tailored for device development experts like yourself. Designed for generating impactful connections within the space, meet with fellow industry peers to share insights and expertise to elevate your work.
Enhancing Device Selection for Improved Device & Drug Compatibility
11:10 am Developing a Broad Platform Strategy to Gain Flexibility in Device Selection
Synopsis
- Creating flexible platform strategies to accommodate a wide range of dose volumes and viscosities, ensuring adaptability in device selection
- Building a broad device portfolio to support various formulations, from low viscosity to high viscosity drugs, and different dose volumes
- Using a bracketed approach to characterize formulation behavior under various conditions, providing actionable insights for device compatibility and future scalability
11:40 am The Importance of Supply-Chain Integration in Enabling User-Friendly On-Body Injectors
Synopsis
- Exploring how Vertiva enhances the user’s experience of on-body injectors thanks to an advanced platform technology that offers a ready-to-use device with a pre-filled and pre-loaded cartridge
- Discussing how at the outset of the device design process, the specialist skills and capabilities required to perform pre-loading of a drug-filled cartridge were identified as a key enabler, and in turn, led to the partnership with Thermofisher, which has since become an integral part of development to clinical readiness
- Outlining how supply-chain integration favors de-risking, contributes to a faster time-to-market, and enables technological solutions that improve patients’ experiences
12:10 pm Roundtable Discussion: Collaborative Approaches to Solving Large-Volume Injectable Delivery Challenges
Synopsis
- Engaging industry stakeholders to identify real-world strategies for overcoming largevolume delivery challenges
- Leveraging vendor insights and collaborative dialogue to de-risk development and enable patient-centric solutions
- Comparing device case studies to define best practices in large-volume injectable development
12:40 pm Lunch Break & Networking
Cross-Functional Development Strategies to Align Formulation, Device & Commercial Goals
1:40 pm Aligning Drug Formulation Needs With Device Capabilities to Prevent Redesign Delays
Synopsis
- Selecting drug delivery devices early for real-world demands
- Evaluating the effect of device on formulation efficiency
- Assessing device compatibility to ensure product reliability in the field
2:10 pm Session Reserved for Zacros America
2:20 pm Enabling Commercial Success Through Informed Device Strategy
Synopsis
- Balancing technical feasibility and user needs to support optimal delivery system selection
- Leveraging human factors data and complaint trends to proactively mitigate risk and enhance patient experience
- Overcoming integration challenges across formulation, device, and manufacturing to ensure robust, scalable development
2:50 pm Afternoon Break & Networking
3:50 pm Preparing for the Future of Drug Delivery Testing
Synopsis
- Explore evolving challenges and practical solutions in drug delivery device testing
- Closely examine current testing standards and regulatory expectations
- See how modern testing systems eliminate operator influences during the testing process
- Discuss emerging trends in pharmaceutical devices and drug development (highviscosity drugs)
Assessing Risk Management Strategy to Prepare for Commercial Launch & Scale-Up
4:20 pm Proactive Risk Management Strategies for Safe & User-Centric Combination Products
Synopsis
- Collaborating across companies, vendors, and cross-functional teams to develop a combination product risk management strategy
- Sharing best practices for risk management to enable patient-centric design
- Identifying potential design hazards early to minimize safety risks and improve product usability