As in previous workshops the emphasis is on problem solving, practical hands-on use of methods and software applied to drug design problems, and working together throughout the week.
This year we will offer a neglected disease case study focus expanding on the initial collaboration activities of the Scientists Against Malaria initiative. We plan to try to develop and test most promising designs and predictions as workshop followup.
It is an exciting time for me as I am finally now able to move into our third phase of innovation that you may recall my discussing in meetings past e.g., within InnovationWell. We have worked with you and many others to patiently develop the foundations of trust, community and collaboration, and now we enter heady and challenging days of developing the innovation ecosystem. I hope you will be able to participate in the partnerships and startups to be launched in coming months and years!
We are about making solutions really work through co-working. In this respect I must personally vouch that the folks at Leadscope have been an excellent partner that have helped advance the ToxBank data management and analysis infrastructure building upon OpenTox as a world leading innovative platform. They have not just talked, they have actually done things, and consistently!
In this context I am very happy to announce our full committment and collaboration to advancing the area of in silico and in vitro testing as supported by the new FDA regulations for non-active ingredients in drug formulations. This is truly a revolutionary step forward in our field of computational science in terms of regulatory acceptance.
We will hold a first event in Basel April 30 (see below), but can also arrange further face-to-face and virtual events to discuss developing this area further as an emerging best practice. I look forward to our further discussion!
Barry
Seminar on ICH M7 Guidance on Assessment of Impurities in Pharmaceutical Products April 30, Merian Hotel, Basel, Switzerland co-organised by Leadscope, USA and Douglas Connect, Switzerland
Our Topic Is your company planning on implementing the pending ICH M7 impurities guidelines? The guidelines which are expected to be approved in final form this summer permit the use of genotoxicity QSAR models to replace actual testing. The guidelines state that a QSAR statistical-based methodology and expert alerts system can be used to predict the outcome of a bacterial mutagenicity assay to support hazard assessment.
Learning objectives * Understand the scope, process and strategies necessary to support ICH M7-compliant QSAR computational toxicology regulatory submissions * Appreciate how expert rule-based and statistical-based in silico models operate * Learn how to generate and combine the results from different in silico systems * Identify what tools are available to support a chemical and biological interpretation of the results * Understand components of an expert opinion for conflicting in silico results
Agenda
9:00am - 9:15am Loftus Lucas - Introductions
9:15am - 9:45am Dr. Dan Benz - The ICH M7 Impurities guidelines for QSAR computational toxicology
9:45am - 10:15am Dr. Glenn Myatt - Two complementary in silico methodologies needed to support the ICH M7 Guideline
10:15am - 10:30am Coffee break
10:30am - 11:00am Dr. Dan Benz - Using, interpreting, generating consensus predictions and submitting in silico model results to US FDA
11:00am -11:30am Dr. Barry Hardy - Components of an expert opinion to support a regulatory submission
11:30am - 12:00 pm Roundtable discussion
12:00pm - 1:00pm Lunch
1:00pm - 2:00pm Informal discussions and networking
The OpenTox Euro 2014 meeting takes place 22 - 24 September in Athens, Greece. The meeting will be co-sponsored by ToxBank and eNanoMapper.
The theme of this year's meeting is industrial and regulatory application of predictive toxicology and includes sessions on read across, integrated testing strategies, systems biology, metabolism, nano safety, data resource management, visualisation and analysis.
The meeting program will include reviewed abstracts for talks and posters and interactive workshop activities and knowledge café discussions.
ToxBank uses ISA-Tab to describe a diverse range of biological datasets to ensure higher quality analysis #ToxBank #opentox #2014SOT #ToxExpo Visit Douglas Connect booth 1770
ToxBank supports a wide diversity of experimental and modelling activities carried out by 75 organisations within the SEURAT-1 research cluster, which is developing replacement alternatives for safety assessment.
SEURAT-1 is a public-private partnership funded by Cosmetics Europe and the EC.
ToxBank provides a unique combination of people and scalable infrastructure enabling Complex (Big Data) Omics Analysis. Come and discuss with us at #sot2014#opentox#toxbank#toxexpo Demos at Douglas Connect Stand 1770 #opentox
The background of developing Open Standards, Open Specifications and related Open Source Components with OpenTox provides a valuable foundation on which we are developing ToxBank as a reference extensible architecture for predictive toxicology.
I suggested OpenTox is developing itself as an Open Knowledge Community supporting accelerating innovation through knowledge sharing, application development, semantic interoperability and ontology for combining data and models, and learning from the application of developed tools to problem solving.
We are interacting with many partners on the SEURAT-1 program providing a rich context for requirements gathering, design and implementation, working closely with the evolving needs and development goals of the program.
We have been working on putting in place best practices on the description of data, and importantly the protocols used to generate and process that data.
I suggested it is also a priority that this practice includes the contributions of computational science and integrated analysis, and I encouraged both the OpenTox community and the ToxBank development to progress this important goal.
The above approaches provide a foundation on which we can integrate many advances in integrated analysis, systems biology, in vitro assay development, omics, and bioengineeering to support an event driven Weight of Evidence approach and semantic reasoning across ontology-linked heterogenous evidence.
You can download a copy of the slides here as a pdf:
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