Workshop Day

Workshop A - Tuesday, July 12

Software Solutions for the Animal Study Reproducibility Crisis & Enhanced Animal Welfare 09:00 - 12:00

According to a 2012 study published by Amgen researchers, 90% of the 50+ in vivo oncology studies were found to be irreproducible. Additionally, 95% of post-phase III clinical trial therapies in oncology have historically failed to receive regulatory approval due to a lack of demonstrated efficacy, not toxicity. This underscores the dire need to critically examine our current standard animal study conduct processes to both identify the causes contributing to the poor animal study irreproducibility and implement meaningful and effective solutions. Over the last several years, questions and debates concerning the validity of the preclinical science data have resulted in multiple published reviews on the problem. The reasons for this “Crisis of Animal Study Irreproducibility” are manifold but there are also several potential solutions available to mitigate these problems as well.

In this talk the following points will be discussed:

  • Factors contributing to the problem of animal study irreproducibility.
  • Publicly-available and online resources and practically-applicable concepts, such as the ARRIVE guidelines, PHISPS protocols, and the N3R Design Assistant.
  • First-hand experiences with a variety of in-house-built and commercially available animal study workflow software applications and databases and their direct and indirect impacts on the problems contributing to animal study irreproducibility.
  • Hands-on exploration and learning about Studylog Animal Study Workflow Software in the context of solving problems, improving animal study reproducibility and faithfully preserving detailed study results for future access.Researchers will walk away from the talk with an understanding of the factors which contribute to poor animal study reproducibility. They will also learn about the application of the latest public online tools to mitigate reproducibility problems. This will include learning about the benefits and challenges of home-built software and off-the-shelf animal study management technologies. Attendees will also get to experience and see for themselves how animal study workflow software, such as Studylog v4, can help solve many of the problems of study reproducibility, while easily standardizing the processes of detailed study design planning and study
    conduct, making adherence to and oversight of procedures easier, facilitating faster, easier and more detailed data collection and documentation, standardizing animal welfare parameter monitoring, data analyses, report creation, task and scheduling, as well as data preservation and access.

Eric Ibsen 
Chief Executive Officer
Studylog

Eric Ibsen, CEO Studylog

Kimberly Aardalen 
Scientific Technical Leader
Novartis Institutes for Biomedical Research

Kimberly Aaralen

Workshop places are limited!

Workshop B - Tuesday, July 12

Nilogen Oncosystems Workshop 12.50 - 15:30

 

Preclinical models have consistently failed to reliably predict clinical efficacy of oncology therapies in clinical trials. We still face a failure rate of over 90% in clinical trials with 50% or more of these failures due to lack of efficacy. The situation with Immuno-oncology therapies is even more challenging as having a fully human immune system with all its constituent components present is crucial to be able to correctly evaluate therapies.

Translational studies with cell lines, mouse models, patient-derived materials or organoids, all have the same challenge – a lack of an autologous, fully human tumor microenvironment.

This workshop will discuss the challenges faced using existing modelling systems and how Nilogen’s 3D-EXplore platform using fresh human tumor explants which retain an intact fully human immune compartment, overcomes the issue of heterogeneity enabling:

  • Sophisticated assays to consistently study multiple therapeutics in the same patient tissue including chemotherapeutics, antibodies, multi-specifics, ADCs, ADCCs, ACTs and Oncolytic virus, to effectively support Translational studies in a fully human platform across many indications.
  • The evaluate and quantification of therapeutic penetration, activation of the immune compartment, cellular proliferation, modulation of response, mechanism of action, tumor cell killing and phagocytosis.
  • Rapid functional assays using patient biopsies to significantly advance patient selection, trial enrichment, dosing and therapeutic comparisons in clinical trials to improve patient care and support improved go/no go decisions.

 

Chair's Opening Remarks 12.50 

 

John Waterman-Smith
Vice President Of Marketing & Business Development
Nilogen Oncosystems 

team-jon@2x

Using Human Tumor Explants to Advance Translational
Immuno- Oncology Therapies into the Clinic

Explore the Ultimate Holistic Human Explant Platform for Translational Immuno-Oncology with 3D 13:00 

 

Soner Altiok
CSO
Nilogen Oncosystems 

team-soner@2x-1

Panel Discussion: How to Overcome the Challenges of Effectively Translating Immuno-Oncology Therapies into the Clinic & Beyond 13:45

 

  • What are the key translational challenges faced by organisations across the spectrum of immune oncology therapies and combinations?
  • Why are traditional approaches failing to meet the criteria necessary for success in the clinic?
  • How can functional assays enhance our understanding of mechanism of action as well as efficacy?
  • Patient to patient variability – how should this be addressed preclinically as well as in clinical trials?
  • Clinical studies/trial enrichment – what are the big issues in successfully navigating immune oncology therapies through Phase I and II in the clinic? 

John Waterman-Smith
Vice President Of Marketing & Business Development
Nilogen Oncosystems 

team-jon@2x

Jun Zhang
MD, PHD, Associate Professor
University of Kansas Medical Centre, Medical Oncology

Picture3

Soner Altiok
CSO
Nilogen Oncosystems 

team-soner@2x-1

Refreshment & Networking Break 14:15

 

 

Developing Clinical Studies Using Nilogen’s Human Explant Technology 14:35

 

 

Jun Zhang
MD, PHD, Associate Professor
University of Kansas Medical Centre, Medical Oncology

Picture3

What’s next? Launch of a New Dimension in Translational Oncology R&D 15:00

 

 

John Waterman-Smith
Vice President Of Marketing & Business Development
Nilogen Oncosystems 

team-jon@2x

Closing Remarks & End of Workshop Day 15:30

 

 

Workshop places are limited!