Day Two | Thursday, September 25, 2025
8:00 am Morning Coffee & Registration
8:50 am Chair’s Opening Remarks
Navigating Current Regulatory Challenges to Unlock Global Market Growth
9:00 am Using Platform Strategy Approach to Accelerate Device Submission
Synopsis
- Sharing acceleration levers utilized to accelerate device submission
- Outlining details related to leveraging an existing device platform strategy while balancing other portfolio priorities
- Explaining key learnings toward resources required to implement platform approach replication of this strategy across other device programs
9:30 am Decoding EDDO Guidance: Accelerating Market Readiness for Injectable Devices
Synopsis
- Facilitating cross-industry dialogue to accelerate interpretation and adoption
- Linking device functionality to regulatory expectations to avoid submission delays
- Contextual assessment of EDDO applicability to prevent over-interpreting guidance
10:00 am Roundtable Discussion: Navigating the Effects of U.S. Policy Shifts in Pharma Supply Chains
Synopsis
- Understanding tariff impacts to inform resilient sourcing and budgeting strategies
- Discussing long-term strategic options for pharma companies and CMOs to adapt procurement and manufacturing models in response to the evolving U.S. trade policy
- Identifying supply chain vulnerabilities, including regulatory and quality risks tied to international component and service providers
10:30 am Morning Break & Networking
Overcoming Usability & Alignment Gaps to Optimize Patient-Centric Device Design
11:30 am Usability Considerations for Large Volume Subcutaneous (LVSC) Oncology Medication
Synopsis
- Outlining ergonomic challenges and the impact of LVSC on nurses’ workload in oncology clinics
- Discussing key insights from usability studies on nurses’ capability and acceptability for administering LVSC medication
- Translating usability study results into actionable recommendations for device development
12:00 pm Embedding Patient Centric Design Considerations Into Risk Management & Device Selection to Improve Product Safety
Synopsis
- Reviewing aspects of the patient population that should be considered when identifying product risks and designing products to control those risks
- Selecting and tailoring delivery devices based on patient characteristics and patient experience
- Exploring the challenges of device selection in a world of platforms
12:30 pm Lunch Break & Networking
Aligning Strategy, Functions, & Partners to Accelerate Injectable Device Development
1:30 pm Accelerating Timelines from Device Selection to IND Submission
Synopsis
- Driving early device planning with clinical and commercial expectations
- Effective cross-functional alignment on device development strategies (DV, shipping studies, E&L, HF)
- Onboarding manufacturing CMOs for combination product design transfer (Supplier audits, design transfer planning, assembly line qualification, and risk based control strategy)
2:00 pm 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
2:30 pm Afternoon Break & Networking
Developing Strategic Partnerships, Cost Efficiency & Digital Acceleration for Scalable Success
3:30 pm Strategies for Selecting Fully Integrated Partners to Streamline Injectable Device Supply Chains
Synopsis
- Discussing how to evaluate true end-to-end CDMO capabilities to reduce handoffs and misaligned timelines
- Proactively identifying geographic and single-source material risks early in project planning
- Partnering for scalability to mitigate disruption as project volumes increase or shift
- Assessing real-world pitfalls of fragmented outsourcing and practical solutions to avoid them
4:00 pm Roundtable Discussion: Managing Costs & Reimbursement in the Development of High-Value Injectable Devices
Synopsis
- Navigating milestone payments and risk management for investment success
- Evaluating the supply chain to reduce unnecessary expenses including overspill
- Exploring pricing and reimbursement strategies early in development to ensure market access and commercial viability
4:30 pm Leveraging AI & Digital Strategies to Drive Efficiency in Device Development
Synopsis
- Exploring how AI and digital tools can streamline and enhance the device development process
- Discussing the role of advanced technologies in improving efficiency and decision-making across development stages