Pre-Conference Workshop Day

Tuesday, December 7

8:00 am Registration Opens & Coffee Welcome

9:00 am Workshop A – CMC, Quality Control & Manufacturing Policy

  • Kaja Jeyanthan Analytical Development Scientist in Viral Development & Manufacturing Science, Turnstone Biologics
  • Sheryl Tran Senior Director Quality & Compliance, Vyriad

Synopsis

As this industry continues to push through clinical trials and making great strides towards another OV approved therapeutic, there remains critical questions surrounding the CMC, QC and manufacturing challenges of an oncolytic immunotherapy. This session will be led by industry experts, walking us through a series of presentations and interactive discussions to together debate, discuss and learn how to optimize OV therapeutics to reach the patient, safely, effectively, and rapidly.

Topics to Cover:

  • Deconvoluting the CMC supply chain for oncolytic virus success
  • Explore how pharma and biotech are adapting and modifying novel processes to ensure an optimized CMC supply chain
  • What are the biggest analytical challenges we face when it comes to oncolytic viruses?
  • How are we streamlining different product verticals into one business unit when the field has long been fragmented using multiple externals service providers?
  • Assessing assay selection strategies for optimized analytic methods for oncolytic viruses
    Achieving scale-up faster through adopting new manufacturing methods from the ground up

12:00 pm Speed Networking & Refreshments

1:00 pm Workshop B – Regulatory Guidance for Clinical Stage Oncolytic Virotherapy

Synopsis

As T-Vec exists as the only approved oncolytic virotherapy for patients, the regulatory environment and the clinical production of OV’s remain complex as ever. Led by biopharma leaders, this session will set out to deconvolute the regulatory landscape of OV clinical development, taking vital learnings from the Cell and Gene Therapy environment.

Topics to Cover:

  • Reviewing where the OV community fits in with existing regulatory guidelines
  • Considering the existing guidance for cell and gene therapy regulations and how can this be a valuable tool as OV’s navigate regulations
  • Patient population considerations for OV clinical stage trials

4:00 pm End of Pre-Conference Workshop Day