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7:30 am

Morning Coffee

8:15 am Chair’s Opening Remarks

Navigating Regulatory & Ethical Guidelines, Compliance & Patient Tissue Accessibility

8:30 am Roundtable discussion: Exploring Regulatory Guidelines & Best Practices for Model Developers

  • Joshua Breunig Associate Professor, Director, Brain Program, Cedars-Sinai Medical Center & UCLA

Synopsis

  • Exploring the current regulatory guidelines in incorporating regulatory body guidelines into models
  • Understanding how this applies in the context of genetic medicines
  • Sharing best practices of patient input at different stages of development
  • Which alternative model is likely to be the next approved regulatory method?
  • What techniques are regulators considering accepting (other than animal models) joas the next industry standard

9:00 am Access To Patient-Derived Cancer Models: Data, Services And Collaboration.

Synopsis

  • How to search for specific patient-derived cancer models (PDCMs): current PDCM data repositories
  • Outline of available PDCM-related services provided by European Research
  • Infrastructures for academic and industrial research
  • Discussing the potential benefits of collaboration with academics for advanced research on PDCMs

9:30 am Session reserved for

Synopsis

10:00 am Fireside Chat: Food for Thought: What Are the Implications Of Model Characteristics?

  • Marta Barisa Senior Fellow, Great Orman Street Institutue of Child Health (GOSH) UCL
  • Joshua Breunig Associate Professor, Director, Brain Program, Cedars-Sinai Medical Center & UCLA

Synopsis

Inflamaging: Potential Implications of Gender And Age Of Models Compared To Disease

  • How are people modelling the age/sex disparities of disease modalities?
  • The affect of immunological age on the immune response and thereby gaining an understanding of altered disease progression.
  • Why are age and sex underrepresented in the research/not empirically represented?
  • Sharing best practices of successful collaboration between patient groups and industry
  • To what extent does age/sex affect the results: the impacts of menopause on BRAF resistance mechanisms in melanoma following BRAF inhibition, compared to men on testosterone replacement therapy?
  • How do these factors affect clonal haematopoiesis? What implications does that have for translatability

10:30 am Session reserved for

Synopsis

11:00 am

Morning Networking Break

Bioinformatic Knowledge Is Power: Developments & Novel Techniques

11:40 am Deciphering Distinct Tumour Life Histories In Vivo with Somatic Transgenic Evolving Barcodes & Single-Cell Sequencing

  • Joshua Breunig Associate Professor, Director, Brain Program, Cedars-Sinai Medical Center & UCLA

Synopsis

  • How can genetic barcodes deconvolute the patterns of progression of different tumour types?
  • Detection of Clonal sweeps versus other patterns of evolution
  • Could this have the capacity to inform clinical standard-of-care or predict clinical success
  • Discussion of future applications of the method
  • Lessons learnt from technical challenges (germ line recombination, low barcode recovery issues, and the requirement of computational biology expertise)

12:10 pm Session reserved for

Synopsis

Immuno-Involvement? How Do We Turn The Tide On Tumours

12:25 pm Gamma Delta T-Cell Therapy: Development of ICT01, A First-In- Class, Anti-BTN3A Antibody For Activating Vγ9Vδ2 T Cell–Mediated Antitumor Immune Response

  • Aude de Gassart Head of Preclinical Model Development, ImCheck Therapeutics

Synopsis

  • Preclinical models for the development of monoclonal antibody targeting BTN3A, a membrane receptor with no ortholog in mice
  • Biomarker package to support Phase 1 clinical studies with a first-in-class therapeutic activating Vg9Vd2 T cell–mediated antitumor immune response
  •  How biomarkers allow to define the best combination strategies

12:55 pm T-Cell Therapy: How to Model a Trispecific T-cell Engager For MM: Lessons from ISB

  • Adam Drake Senior Director In Vivo Pharmacology, Ichnos Sciences

Synopsis

  • Discussing the efficacy, safety of T-cell engagers
  • Assessing the benefits and restrictions of collecting data in vivo vs in vitro for a T-cell engager
  • Overviewing the translational relevance of various datasets

1:25 pm Session reserved for

Synopsis

1:40 pm

Networking Lunch

2:25 pm Roundtable Discussion: Organ-on-a-Chip in IO – Where Are We in Today?

Synopsis

  • The potential of creating an autologous environment, conversely limitations of personalisation using organ-on-a-chip
  • Can we replicate/recapitulate the TME?
  • Understanding the complexity of layering of specific cell lines and components

3:25 pm Panel Discussion: How to Predict Your Immuno-Modulation & Immuno-Stimulatory Response?

  • Fernando Estrada Lecturer in Innate Immunology, University of Surrey
  • Aude de Gassart Head of Preclinical Model Development, ImCheck Therapeutics
  • Adam Drake Senior Director In Vivo Pharmacology, Ichnos Sciences
  • Juho Jalkanen Chief Operating Officer, Faron Pharmaceuticals

Synopsis

The potential of using IO, combinational or cell therapy to dial up another biologic to aid in the anti-tumour response. Could this be the next phase of development for immuno-oncology and what are the potential limitations of this approach? This panel will discuss:

  • Methods of stimulating/dialling up a biologic
  • Understanding of the differences between alternate types of biologics: Cytokine, Macrophage, NK cell
  • What are the benefits of utilising these biologics instead of an ADC/cell-therapy?
  • Sharing examples of effective and less effective biologic stimulation
  • Drawbacks of specific biologics
  • Understanding if this improve the clinical success?

4:05 pm Session reserved for

Synopsis

Next Gen Preclinical Models to Maximise Clinical Success

4:35 pm

Afternoon Refreshments & Networking

5:05 pm Optimising clinical therapeutic window using modelling and simulation, validating with nonclinical translational models and utility in an ongoing clinical study

Synopsis

  • An example of a cross-functional collaboration between clinical and non-clinical functions enabling dose and schedule optimisation for clinical testing
  • Illustrates the importance of translational understanding in light of increasing probability of successful drug development
  • Highly relevant considering recent regulatory moves towards optimisation of clinical dose and schedule.

5:35 pm Understanding Gene Signatures if Macrophage Activation to Access Immunological Memory

Synopsis

  • Bone marrow and spleen monocytes represent the main source of Tissue Macrophages in infection and malignancy
  • Monocyte derived macrophage activation programmes are plastic and single biomarkers are not adequate to characterise their activation
  • Gene signatures enable to understand the activation history of cells and point tophenotypic mosaicism in complex milieus such as tumours

6:05 pm Chair’s Closing Remarks & End of Summit