Tuesday 18th October 2022
Making a Dent in Solid Tumours with Next Generation Targets
8:30 - 10:30
Innate immune therapies have shown potent anti-tumour activity in some solid cancers, but the complex nature of the tumour microenvironment remains a large hurdle preventing further progress. Learning from antibody-based and cell therapy success alike, this deep-dive workshop will delve into the ins and outs of the solid tumour microenvironment, and map out the targets and strategies which are changing the game to fuel effective targeting on the tumour microenvironment with innate immune therapies.
- Elucidating the biology of the TME and mechanisms of actions targets to inform target validation for maximal localisation and penetration in solid tumours
- Harnessing prognostic biomarkers to indicate responses to innate immune treatment and supercharge clinical development
- Reflections and learnings from CAR-T to optimise targeting with innate cells and overcome all-target off-tumour toxicity
Associate Professor, MD PhD
Optimising Donor Sourcing to Develop Consistent & Scalable Cell Therapies & Minimise the Cost of Goods
11:30 - 1:30
As the industry scales up for allogeneic production, a stable source of healthy screening donors is essential to minimise the risk of faulty batches. Navigating donor characterisation, logistical hurdles in Europe, and regulatory issues associated with donor selection, is key to advancing effective and commercially viable therapies to patients.
- Mapping out cell source types, methods and yields to define future cell sourcing strategies
- Using screening technologies to demonstrate equivalence from one donor to another with equivalence studies, to shift away from dependence on individual donors
- Characterising the regulatory differences by region and iPSC-derived cells compared to non-iPSC derived cells to accelerate reliable cell sourcing practices
COO & Founder
Spotlighting Regulatory Differences Between the EMA & the FDA to Supercharge Clinical Development in Europe
2:30 - 4:30
With NK cell therapies catching up with the scale of CAR-T constructs, and macrophage and gamma delta therapies moving toward the clinic, clarification of the regulatory requirements is needed to accelerate development in Europe. This deep-dive session will make sense of the complex regulatory map in Europe and the US to understand the differences in requirements to advance clinical development both sides of the pond.
- Discussing which regulatory requirements surrounding manufacturing changes, starting material selection and donor testing should be considered to ease release into the EU market
- Creating an interface between CMC and regulatory quality to create shortcuts into Europe with reliable clinical data from the US
- Clarifying the European regulatory stance on genomic sequencing, centralised systems and combination therapy development to inform future pipeline development