8:00 am Morning Coffee & Check-in
8:55 am Chair’s Opening Remarks
Optimize Clinical Trials With Modeling: Use MIDD to Advance Protocols, Reduce Patient Burden & Cut Costs
9:00 am Optimizing Strategic Dose Selection in First-in-Human Trials Using MIDD: Enhancing Patient Safety & Accelerating Drug Development
Synopsis
- How model-based predictions can guide safer, more effective dose selection
- Understand the key challenges that arise in FIH trials and how modelling can mitigate them
- Hear examples of FIH oncology trials accelerated through smarter starting dose strategies and how these have saved costs
9:30 am Driving Early Success in Diabetes & Obesity Drug Development: Choosing the Optimal Drug Candidate with Model-Based Strategy to Reduce Risk & Accelerate Go/No-Go Decisions
Synopsis
- How model-based approaches were used to enable a Multiple Ascending Dose (MAD) study to serve as an early proof of concept in diabetes/obesity drug development
- Using pharmacometrics modeling to evaluate drug behavior and guide go/no-go decisions before progressing to costly Phase 2 trials
- Real-world application: A case study illustrating how modeling accelerated candidate selection and reduced development risk
10:00 am Morning Break & Speed Networking
Synopsis
The ideal opportunity to get face-to-face with many of the leading experts in MIDD who are working in DMPK, PK/PD, pharmacometrics and clinical pharmacology and engage with attendees for important in-depth conversations.
11:00 am Designing Better Clinical Trials Using MIDD – Advantages for Safety, Ethics & Efficiency
Synopsis
- Discover how to integrate MIDD into your strategic planning from the offset, transforming it from a supplementary tool to a core driver of clinical development
- Explore how MIDD enables precise determination of safe and effective drug doses, minimizing patient exposure to unnecessary procedures
- Learn how MIDD’s predictive power minimizes number of healthy volunteers and patients required in early-phase trials
11:30 am Optimal Dose: Technique or Mindset, Getting the Most Out of Your Service Provider: Overcoming Barriers to MIDD Execution
Synopsis
- Introduce a systems thinking framework to identify what aspects of MIDD are required: identifying questions of interest in an integrated manner
- Contrast challenges for big pharma vs (virtual) biotech
- Illustrated with case studies
12:00 pm Accelerating Clinical Trial Entry: Tailoring Modality-Specific- MIDD Strategies for Maximum Efficiency in ADC & TCE trials
Synopsis
- Hear advice on designing modality-specific approaches where strategic plans were uniquely differed for contrasting modalities
- Learn the type of in vitro and in vivo data required for translational modeling for FIH dose selection for ADCs and TCEs
- Gain insights from case studies where this tailoring approach has enabled acceleration of clinical trials
12:30 pm Lunch Break
Decode Global Regulatory Expectations: Apply MIDD Strategically to Strengthen Submissions & Gain Faster Approvals
1:30 pm Understanding ICH M15: What Does This Mean for You? Ensuring Compliance to Accelerate Approvals & Optimize MIDD Impact
Synopsis
- Outlining the key principles of the draft ICH M-15 guidelines and what they signal for industry adoption
- Understanding the M15 Harmonized Assessment Framework: Its key elements and how they provide a structured approach to support your modeling and simulation evidence
- Practical steps for aligning modeling practices with global regulatory expectations
2:00 pm Optimizing Pediatric Formulation Development Strategy Using MIDD: ~ A Case Study in Aligning the Regulatory Approval Path Without a Pediatric Trial
Synopsis
- Hear real-world insights from the strategy lead behind successful regulatory interactions using MIDD to reduce or eliminate clinical studies, particularly in pediatric programs
- Discover how purpose-fit modeling tools were applied to align both FDA and EMA expectations
- Understand the challenges and successes in navigating complex regulatory landscapes, and how persistence helped secure regulatory alignment
2:30 pm Afternoon Break and Poster Session
Synopsis
This is an informal session to help you connect with your peers in a relaxed atmosphere and forge new and beneficial relationships. With an audience of senior leaders working in MIDD,DMPK, PK/PD, pharmacometrics and clinical pharmacology, you will have the opportunity to display a poster presenting your own work. Additionally, you will have the chance to review others’ posters displaying cutting-edge work from drug discovery right through to exciting clinical trial updates.
Dose Optimization: Apply MIDD to Inform FIH Dosing, Avoid MTD & Support Project Optimus Goals
3:30 pm What You Can Learn From Project Optimus: Driving More Informed Dose Optimization & Improved Patient Outcomes Across Therapeutic Areas
Synopsis
- Explore key takeaways from Project Optimus
- How to use models to address FDA expectations
- Understand what regulatory shifts mean for your dose strategy
4:00 pm Roundtable Discussions: Improving the Usage of MIDD for Better Dose Optimization In Different Therapeutic Areas to Balance Treatment Safety & Efficacy Whilst Accelerating Development Timeline
Synopsis
In this interactive session, join focused roundtables discussions tailored to key therapeutic areas including Oncology, CNS and Immunology & Inflammation.
Each table will provide an opportunity for in-depth conversation around the unique challenges within these areas. Share experiences, explore innovative approaches and gain practical insights to help improve and streamline development timelines in your specific field.
Oncology
- Moving beyond Maximum Tolerated dose (MTD) for long-term efficacy and safety
- Managing high inter-patient variability in tumour response
CNS
- Overcoming challenges in modeling blood-brain barrier penetration
- Managing delayed therapeutic effects that complicate early PK/PD assessment in CNS disorders
I&I
- Modeling pathogen dynamics and host immune response
- Navigating dose optimization in chronic conditions where long-term safety and adherence are critical