Pre-Conference Focus Day | Tuesday December 12, 2023

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 Fireside Chat: Showcasing Beacon’s Platform

10:30 am Neural Stem Cells as an Allogeneic Stem Cell-Based Platform for Oncolytic Virotherapy


  • 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

11:00 am Morning Break & Networking

Advance the Design of Clinical Trials to Develop Robust CMC Processes & Ensure You Meet the Regulatory Standards

12:00 pm Fireside Chat: Navigating the Regulatory Landscape: Considerations for Oncolytic Viruses

  • Boris Minev President, Medical & Scientific Affairs, Calidi Biotherapeutics Inc.
  • King Lee VP Regulatory Affairs & Quality Assurance, CaroGen Corporation


  • 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

1:00 pm Networking Lunch

Improving Quality, Traceability & Stability Through Supply Chain Management & Manufacturing Considerations

2:00 pm Understanding the Raw Materials & Supply Chain Management of Oncolytic Viruses to Ensure Quality, Traceability & Reliability

  • Sheryl Tran Sr. Director of Quality and Compliance, VYRIAD


  • 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

2:30 pm Navigating the Potential of Combination Studies & Oncolytic Viruses for Improved Therapeutic Outcomes


  • Innovative combinations of oncolytic viruses with other therapeutic modalities 
  • Leveraging the immune system with immune checkpoint inhibitors, vaccines, and immune stimulators 
  • Targeting tumor microenvironment and immune evasion mechanisms for enhanced efficacy 
  • Examples of preclinical and clinical studies demonstrating enhanced antitumor efficacy

3:00 pm Harnessing the Power of Viral Payloads for Optimal Delivery & Expression of Your OV Candidate


  • 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 

3:30 pm End of the Pre-Conference Focus Day