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
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.
* 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
Please contact us if interested in attending.