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).
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.
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!
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
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.