7:30 am Check in & Coffee
7:45 am
Workshop A
8:30 am Navigating the Regulatory Landscape for Glioblastoma: Discussing Insights into Successful Strategies for Gaining Approval in Challenging & Complex Disease Spaces such as GBM
Synopsis
- Hurdles in gaining approval: Discuss difficulties in regulatory approval for GBM therapies due to the complexity of the disease
- Navigating the regulatory process: Highlighting effective approaches for navigating the regulatory process in GBM, including clinical trial design and data requirements
- Explore the role of collaboration: Highlighting the importance of relationships between biotech companies, regulatory agencies, and researchers in streamlining approval processes
- Successful FDA approval: Discussing appropriate processes for coming out of phase 3 clinical trials
Workshop B
8:30 am Enhancing Antibody Drug Conjugates Efficacy in Glioblastoma through Overcoming Blood-Brain Barrier Challenges
Synopsis
Due to the restrictive nature of the blood-brain barrier, there are many difficulties in drug delivery to the GBM. While ADCs offer targeted therapy by linking monoclonal antibodies with cytotoxic agents, their effectiveness in GBM is hindered by the BBB’s physical and biochemical barriers. This workshop will provide an in-depth examination of the strategies to improve ADC delivery and efficacy in GBM, focusing on overcoming BBB limitations and optimizing therapeutic outcomes.
Key Discussion Points:
- BBB Disruption and ADC Penetration: Analyze methods to enhance ADC delivery across the BBB, including chemical-induced disruption techniques and their potential for improving ADC efficacy in GBM treatment
- Current Success & Applicability in Pre-Clinical & Clinical Trials: Reviewing the current landscape for ADCs in treating glioblastoma alongside other CNS tumors
- Internalization and Cellular Mechanisms: Exploring challenges related to ADC internalization and lysosomal degradation, such as defects in cellular trafficking and lysosomal function, and reviewing approaches to enhance ADC cellular uptake and payload release
10:30 am Morning Break
Workshop C
11:00 am Optimizing and Evaluating Glioblastoma Models for Effective Drug Testing
Synopsis
This workshop will focus on refining and evaluating various models for simulating glioblastoma to enhance drug testing and treatment development. Explore different modelling techniques, assessing their effectiveness in mimicking the GBM microenvironment and translating findings to clinical applications. Cover patient-derived models, genetically engineered mice, and other relevant systems to identify the most suitable approaches for accurate drug screening and therapy optimization.
Key Discussion Points:
- Optimizing Patient-Derived Models: Strategies to refine patient-derived xenograft (PDX) and organoid models for personalized GBM therapies and improved drug screening
- Evaluating Model Utility: Comparing genetically engineered mouse models, xenograft cell lines, and syngeneic models for their relevance to GBM research
- Bridging the Translational Gap: Innovations in 3D and ex vivo culture systems, organ-on-a-chip, and microfluidic platforms to enhance translation from preclinical studies to clinical trials
Workshop D
11:00 am Harnessing Tumor-Treating Fields to Modulate the Tumor Microenvironment in Glioblastoma
Synopsis
This workshop will explore the transformative potential of TumorTreating Fields in manipulating the tumor microenvironment in glioblastoma. Experts will discuss the biophysical effects of TTFields, their impact on myeloid suppressor cells, and strategies for selecting effective payloads to enhance TME modulation.
Key Discussion Points:
- Mechanisms and Effects of Tumor-Treating Fields: Review the biological and biophysical impacts of TTFields, including their role in disrupting tumor cell proliferation, DNA repair, and cellular permeability, as well as their broader effects on the TME
- Impact on Myeloid Suppressor Cells: Explore how T TFields influence myeloid-derived suppressor cells within the TME, including their potential to alter the immune landscape and enhance therapeutic efficacy
- Optimizing Payload Delivery to Enhance TME Modulation: Discuss strategies for selecting and delivering effective payloads to complement TTFields, focusing on approaches to improve TME targeting and therapeutic outcomes
1:00 pm Lunch
Workshop E | 2.00 PM
Workshop E – Optimizing Clinical Trial Endpoints in Neuro-Oncology Trials, Glioblastoma Clinical Trials: Utilizing Biomarkers, Endpoints, & Models for Success
Synopsis
Many promising therapies for glioblastoma face challenges when moving from preclinical to clinical trials, particularly with the complexity of combination treatments. Designing effective trials is crucial, and this workshop will address strategies for overcoming these obstacles.
Key Discussion Points:
- Combining cell and gene therapies with standard-of-care treatment of primary disease
- Rethinking cell therapy approaches beyond simply response to providing a meaningful extension of length and quality of life
- Overcoming regulatory and funding barriers to early intervention