The Ferryman

OpenTox Association activities

Following up on the initial OpenTox project which was funded by the EU under FP7, OpenTox has developed as an open standards platform supporting application and infrastructure development in predictive toxicology and safety assessment. The OpenTox Association was founded 27 March this year as an international member-based non-profit association.

The purpose of the Association is to promote the community-based exchange and use of open knowledge, software, methods, tools, data, reference resources, and standards in the scientific activities of predictive toxicology, safety assessment and risk management, including the 3Rs goal of the Reduction, Refinement and Replacement of Animal Testing. Working groups have been formed which working virtually on an ongoing basis to elaborate further the open standards and integrating resources approach developed by the OpenTox community.

The OpenTox Euro 2015 meeting takes place 30 Sept - 2 Oct in Dublin, Ireland. The conference theme is Reproducible High Quality Safety Science on Complex Systems and will include conference sessions on Information Requirements & Standards, Characterisation of Systems, High Content Screening, Metabolism, Modelling Cellular Perturbations & Responses, Linking Parameters & Evidence across Scales, Simulation, Systems Biology and Knowledge Integration Supporting Decision Making.

OpenTox Association Working group meetings will be held on the topics of Application Programming Interfaces, Adverse Outcome Pathways, Data and Metadata Standards and Resource Deployment. The meeting will also include a General Assembly of the Association in addition to hands-on modelling and analysis sessions, poster session and knowledge cafes.

To submit an abstract for the meeting:
(Deadlines: 31 July for speaker program, 31 August for posters)
http://www.opentox.net/submit-abstract-poster-or-chair

Information and updates on the program will be posted at:
http://www.opentox.net/events/opentox-euro-2015

Barry Hardy
President, OpenTox Association
On behalf of the Organising Committee

More information on the OpenTox Association:
http://www.opentox.net/the-opentox-association

Roland Grafstrom and Pekka Kohonen win Scientific Lush Prize

Our close scientific co-workers Roland Grafstrom and Pekka Kohonen, have been awarded the scientific Lush Prize recognising their recent research achievements in advancing alternative testing methods, including with the bioinformatics data analysis work done with us on ToxBank.

Well done Roland and Pekka, and a well deserved honouring too!

More information on the Lush 2014 Prize is located at:

http://www.lushprize.org/2014-prize/2014-prize-winners/

 

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http://barryhardy.blogs.com/cheminfostream/2014/10/echeminfo-drug-design-meeting-johns-hopkins-9-11-feb-2015.html

Innovation in Development and Translational Medicine

On the 13 February 2015 we will hold an InnovationWell workshop at Johns Hopkins, Baltimore.

The goal of the workshop is to discuss experiences, practices and solutions in drug development and translational medicine.

We will discuss case study experiences involving collaboration in drug and biotech discovery and development, obstacles experienced in practice and methods used to overcome barriers, approaches used to data sharing including IP and contractual issues, practices in knowledge management and innovation success.

We will subsequently flush out the real problems and issues involved in current practices in translational medicine, identify the strengths and weaknesses in current approaches being used and explore new strategies that might be of use to address and achieve improved translational success.

The workshop will be facilitated by Frank Hollinger (Sphaera Pharma), Michael Liebman (Strategic Medicine) and Barry Hardy (Douglas Connect).

Further information on the program can be found at
http://www.innovationwell.net/events/innovationwell-2015

OpenTox USA 2015

I am pleased to announce the program for the OpenTox USA 2015 meeting which will take place 10-12 Feburary at Johns Hopkins, Baltimore.

The goal of the meeting is to discuss and develop important components for driving 21st century approaches to safety assessment forward. We assume that collaboration driven by an open global platform and open standards will be a key success factor. Integrating heterogenous evidence supported by a common knowledge framework and ecosystem of tools and partners will enable practical application, judgements and decisions including industrial application and regulatory acceptance.

The program will involve conference sessions and associated hands-on workshops, poster session and knowledge cafes.

The main themes of the meeting are:

Data Science, facilitated by Barry Hardy (Douglas Connect)
Adverse Outcome Pathways, facilitated by Stephen Edwards (US EPA)
Exposure Modelling, facilitated by Tim Pastoor (Syngenta)
Integrating Evidence and Analysis, Thomas Hartung (Johns Hopkins)
Risk Assessment & Management Applications, Grace Patlewicz (Du Pont)

We are open for submission of abstracts for consideration for the program.

Further information on the program can be found at
http://www.opentox.com/events/opentox-usa-2015

On behalf of the OpenTox Community and the Organising Committee.

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ToxBank Public Access

I am pleased to inform that we are commencing providing public acccess to the ToxBank Data Warehouse. 

Public access to the data warehouse may be requested using the form available at: http://www.toxbank.net/enquiries/request-data-warehouse-access

Users may access protocols or data that have been made available within the ToxBank Data Warehouse. 

We also provide a request option to support the incorporation of data.

Tutorials on the use of the ToxBank resources are made available in the ToxBank Library at http://www.toxbank.net/tutorials

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ICH M7 Guidance on Assessment of Impurities in Pharmaceutical Products

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



Please contact us if interested in attending.

http://www.douglasconnect.com/submit-enquiry

OpenTox supports event-driven ontology-based Weight of Evidence

OpenTox supports event-driven ontology-based Weight of Evidence.

#opentox #2014SOT #ToxExpo  #ToxBank Visit Douglas Connect booth 1770

 

 

ToxBank uses ISA-Tab to describe a diverse range of biological datasets

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 75 organisations within SEURAT-1 cluster

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 Launch at SOT 2014 #opentox #2014SOT #ToxExpo