Pre-Conference Focus Day | Tuesday December 12
Clinical Design & Manufacturing Strategies Focus Day
This Focus Day unites the oncolytic virotherapy community to discuss and share their current progress and understanding of optimizing their clinical studies and manufacturing strategies. Topics of discussion will include CMC, clinical trial design, regulatory considerations, viral vector design, viral vector stability and raw material management. Take part in this deep-dive focus day and hear from the leading minds as they take us through valuable clinical design data, manufacturing considerations and best practices, for you to take back to your team.
9:00 am Morning Welcome Coffee
9:50 am Chair’s Opening Remarks
Tackling Toxicity & Immunogenicity Challenges to Streamline Your OV Candidate from Pre-Clinical Phases into the Clinic
10:00 am Understanding the Importance of Predictive Toxicology & Biomarkers to Enhance Safety & Efficacy in Cancer Treatment
Synopsis
- Utilizing predictive toxicology assays for early toxicity assessment
- Identification and validation of biomarkers for monitoring treatment response
- Correlating pre-clinical toxicity findings with clinical outcomes
10:30 am Pre-Clinical PK, BD, & Immunogenicity Studies to Support FIM Studies with Vesicular Stomatitis Virus – Glycoprotein (VSV-GP)
Synopsis
- Strategies and approaches employed to bring Vesicular Stomatitis Virus pseudotyped with LCMV glycoprotein (VSV-GP) through IND-enabling tox/biodistribution studies to enable first-in-man trials
- More specifically, novel molecular toolset to capture time course of viral replication, understand the unique PK, analyze shedding, vector persistence, assess the time course kinetics of immune responses after both intravenous and intratumoral administration in mice
11:00 am Neural Stem Cells as an Allogeneic Stem Cell-Based Platform for Oncolytic Virotherapy
Synopsis
- NSC-based virotherapy has shown promising results in preclinical studies, demonstrating improved tumor targeting, enhanced virus replication, and increased antitumor efficacy compared to traditional oncolytic viral therapy alone
- NSCs can potentially be combined with other therapeutic modalities, such as chemotherapy or immunotherapy, to create synergistic effects and improve overall treatment outcomes
11:30 am Morning Break & Networking
Advance the Design of Clinical Trials to Develop Robust CMC Processes & Ensure You Meet the Regulatory Standards
12:30 pm Fireside Chat: Navigating the Regulatory Landscape: Considerations for Oncolytic Viruses
Synopsis
- Development of guidelines and requirements for pre-clinical safety and toxicity studies specific to oncolytic viruses in the CMC field
- Addressing translational challenges when transitioning from animal models to human patients
- Establishing effective collaboration with regulatory authorities to ensure successful initiation of clinical trials
- Guidance for determining the distribution of each transgene in toxicity studies for more complex oncolytic viruses entering the clinic
- Understanding and navigating the differences in regulatory requirements across various regions and jurisdictions for oncolytic viruses
- Overcoming challenges associated with the regulatory pathway for approval and market authorization of oncolytic viruses in the CMC domain
1:30 pm Roundtable Discussion: Explore the Key Features of Designing Your Clinical Trials: Navigating the Pathway to Successful Clinical Translation & Market Approval
Synopsis
- Evaluating the role of CMC in clinical trial design and execution
- Developing robust processes for CMC to ensure consistent quality control throughout the trial
- Analyzing the impact of different trial designs, such as phase I, II, and III studies, on CMC considerations
- Overcoming challenges in selecting appropriate control arms and randomization strategies while considering CMC requirements
- Highlighting the significance of patient stratification, inclusion/exclusion criteria, and sample size estimation in CMC planning
- Ensuring timely identification and reporting of adverse events to maintain product quality and patient safety
2:30 pm Networking Lunch
Improving Quality, Traceability & Stability Through Supply Chain Management & Manufacturing Considerations
3:30 pm Understanding the Raw Materials & Supply Chain Management of Oncolytic Viruses to Ensure Quality, Traceability & Reliability
Synopsis
- Ensuring the quality and traceability of raw materials used in oncolytic virus manufacturing
- Managing the supply chain and mitigating risks associated with critical raw materials
- Considerations for sourcing, qualification, and validation of raw materials
4:00 pm Exploring the Significance of Optimized Cell Substrates & Viral Vectors in Improving Therapeutic Efficacy
Synopsis
- Selection of appropriate cell substrates for oncolytic virus production
- Engineering viral vectors for enhanced replication, targeting, and safety
- Considerations for stability and genetic stability of viral vectors during manufacturing
4:30 pm Harnessing the Power of Viral Payloads for Optimal Delivery & Expression of Your OV Candidate
Synopsis
- Reviewing the types of payloads for oncolytic virotherapy
- Highlighting the advantages of using gene-based payloads: immunomodulatory genes, therapeutic transgenes
- Engineering viruses for optimal payload delivery and expression