2012 07 18 Teleconference Minutes

Predictive Modeling for Human Health CoR Teleconference

Draft Minutes

July 18, 2012

Participants: Karin Aschberger (JRC), Yoram Cohen (CoR Co-chair, UCLA), Christian Del Mar (spelling? Affiliation?), Bengt Fadeel (Karolinska Institutet), Andrea Haase (Bundesinstitut für Risikobewertung), Patrick Hole (NanoSight), Robert Rallo (Universitat Rovira i Virgili), Stacey Standridge (NNCO), Vicki Stone (Heriot-Watt University), Brian Thrall (Pacific Northwest National Lab), Scott Thurmond (FDA), Amy Wang (EPA), and Bob Yokel (University of Kentucky)

Handouts:

• Draft scope statement
• Agenda

Minutes:

1.  I.            Introduction to the Predictive Modeling for Human Health CoR

The Communities of Research (CoRs, https://us-eu.org/communities-of-research/) were proposed at the U.S.-EU: Bridging NanoEHS Research Efforts workshop in March 2011. Three CoRs were announced at the Society of Toxicology Annual Meeting in March 2012, including this Community on Predictive Modeling for Human Health. The remaining 3 CoRs were announced at the NanoSafety Cluster Meeting in Grenoble, France in May 2012.

The Communities are intended to provide a platform for scientists in the U.S. and EU to develop a shared repertoire of protocols and methods to overcome research gaps and barriers. The CoRs are managed by the participants, with the U.S. National Nanotechnology Coordination Office and the Directorate-General for Research & Innovation in the EU providing administrative support.

1. II.            Discussion of CoR Scope & Subtopics

The CoR co-chairs presented the following draft scope statement and asked participants for feedback:

Estimates for the needs of animals for in vivo testing for nanomaterials exceed what is considered reasonable in any modern society.  Indeed in Europe particular emphasis is given towards the need to reduce reliance on animal models via the development of alternative (In vitro) test methods and development of quantitative structure-activity / structure-property relationships (QSARs / QPARs).

With thousands of new materials emerging, as well as thousands of variants of these materials, there is an urgent need for agreed concept of how to predict likely impacts on human health based on relationships between physico-chemical properties, properties of nanomaterials in situ under exposure conditions, and for identification of connections between those properties with impacts from studies done on previous materials.  Approaches such as intelligent recognition of patterns, neural networks, microscopic / semi-microscopic and mechanistic and phenomenological models need to be developed and compared to each other and to limited in vivo and extensive in vitro tests for validation purposes to establish their predictive power and their applicability to nanomaterials for which there are limited data available.

Several participants expressed the view that Community should have a focused, tangible scope with attainable short-term goals. Additionally, the following three themes were emphasized: correlation, modeling, and new approaches. Several comments stressed the need for the CoR to strengthen correlations between in vivo and in vitro studies, between high-throughput results on cell lines and organisms, between physico-chemical properties and human hazard, and between this CoR and other Communities, particularly the Ecotoxicity Testing CoR, the Exposure through the Life Cycle CoR, and the Databases and Ontologies CoR.

On the topic of modeling, suggestions were made to include physiologically-based pharmacokinetic (PBPK) in the scope and to use Quantitative Structure-Activity Relationships (QSARs) to group nanomaterials. There was a brief mention on the use of mechanistic studies vs. screening studies. Recommendations were also made to incorporate new approaches, such as bioinformatics or systems processing, and to consider the use of non-zebra-fish organisms.

1. III.            Discussion of CoR Goals

Several general suggestions were made to focus the CoR goals:

• Keep the goals focused, concrete, and tangible
• Focus on physico-chemical properties and characterization
• Make a list of properties of interest and include the degree of understanding and confidence
• Focus on areas that aren’t well-understood
• Set up a platform for data sharing
• Compile a list of key challenges

The proposal was made to create an “Inventory of Relevant Projects.” This inventory will be drafted before the next teleconference and discussed on the call to identify opportunities to connect projects and add value. Additions or corrections to the inventory can be emailed to Stacey (sstandridge@nnco.nano.gov).

1. IV.            Next Steps

CoR members are encouraged to advertise this Community to their networks and to invite colleagues to join. Membership suggestions can be emailed to Yoram and Bengt (yoram@ucla.edu and bengt.fadeel@ki.se), copying Stacey.

The second EU-U.S.: Bridging NanoEHS Research Efforts workshop (http://www.ttl.fi/partner/nanoehs_workshop/Sivut/default.aspx) will be held in Helsinki, Finland on October 25-26, 2012. The primary focus of the workshop will be building up the six Communities, with a breakout session on each CoR theme. Each CoR is responsible for selecting speakers and topics for their breakout session. Speaker suggestions can be sent to Yoram and Bengt, copying Stacey.

Stacey will send a doodle poll to the listserv in mid-September to schedule the next conference call. The primary purpose of the call will be to finalize the scope and goals for the CoR as well as to outline steps for achieving the goals.