8:00 am Morning Coffee & Check-In
8:55 am Chair’s Opening Remarks
9:00 am Re-thinking Maximum Tolerated Dose (MTD) Using MIDD to Get the Dose Right First Time & Save Critical Development Time
Synopsis
- Learning how oncology modeling is evolving to prioritize optimal over maximum dosing
- Learn when is best to initiate dose optimization efforts
- Understand why MTD is being reconsidered
9:30 am Case Study: Dose Optimization for Bi-Specifics & Tri-Specifics
Synopsis
- How MIDD helps define rational starting doses for complex biologics
- Compare strategies for dose selection in multi-target modalities
- How modeling is supporting faster and safer advancement of novel immunotherapies
10:00 am Morning Break
Speeding Up Development Timelines by Leveraging MIDD Across the Pipeline to Accelerate Decisions
11:00 am Assessing How MIDD Can Support Early Clinical Decision Making & Accelerated Approval for Novel Modalities
Synopsis
- Learn how MIDD supported early clinical decision-making and accelerated development timelines for different modalities`
- Understand modeling strategies that helped define safe, effective doses earlier in the process
- How this ultimately combined with regulatory engagement and enabled faster progression to approval
11:30 am Mechanistic IS/ID Modeling to Enable Pediatric Vaccine Dose Selection: A Case Study in Predictive Immunogenicity Accelerating Innovation to Optimize Dosing & Speed Up Time-to-Market
Synopsis
- Learn how mechanistic IS/ID modeling can be applied to inform pediatric vaccine dose selection with predictive confidence
- Understand how model-informed development streamlines clinical trial design and supports regulatory interactions
- Gain actionable insights into implementing scalable modeling strategies to accelerate vaccine development across age groups
12:00 pm Lunch Break
1:00 pm Panel Discussion: Reflections From Drug Developers: What Worked When Applying MIDD, What Didn’t & Why?
Synopsis
- Hear firsthand experiences on how MIDD strategies have successfully expedited clinical and regulatory milestones
- Explore common challenges and resistance factors that limited MIDD adoption, with advice on overcoming these obstacles
- Analyze retrospective case studies to identify best practices and lessons learned from embedding MIDD more effectively across development teams
Enhancing MIDD Impact: Communicating Model Confidence, Navigating Uncertainty & Aligning Cross-Functional Teams
2:00 pm Overcoming Data Gaps in Early Discovery & Repurposing to Unlock Faster, Smarter Development Decisions
Synopsis
- Discuss why early-stage and repurposing projects often suffer from data sparsity and how this hinders MIDD decision making
- Explore strategies to navigate sparse or fragmented data environments
- Learn how organizations are overcoming data gaps to unlock earlier insights, reduce false starts and increase success rate of repurposing efforts
2:30 pm Turning Missing Data Into Actionable Insights: Practical Strategies to Strengthen MIDD Assumptions
Synopsis
- Discover proven methods to manage incomplete or inconsistent datasets while maintaining scientific rigor and model credibility
- Learn how to leverage literature, sensitivity analyses to validate modeling assumptions
- Understand how to transparently communicate assumptions and uncertainties to stakeholders, ensuring informed decision-making despite possible data gaps
3:00 pm Improving Communication Between Modelers & Clinical Teams – Reducing the Language Barrier & Building MIDD Capability In-House to Accelerate Development Timelines
Synopsis
- Lessons from ~7 years of building one of the largest translational modeling teams in the industry with an emphasis on an MID3-first strategy
- Cleverness and Curiosity: the innate characteristics that underpin how we identify, recruit, and train modelers from varied backgrounds
- The mechanics of coaching a high performing modeling team, at scale: building skillsets, collaboration, and model-informed impact