SETAC Global Advisory Group OMICS Cutting-edge science to solve real world problems

Ben Brown1,2 (steering committee) on behalf of our inaugural co-chairs:

Bruno Campos3 & Doris Vidal-Dorsch4

and our incoming co-chairs:

John Colbourne1 & Adam Biales5

1School of Biosciences, University of Birmingham, Birmingham, United Kingdom

2Lawrence Berkeley National Laboratory, USA 3Institute of Environmental Diagnosis and Water Research, CSIC, Barcelona, Spain

4Southern California Coastal Water Research Project, USA 5USEPA, USA

E-mail contact: jbbrown@lbl.gov

OMICS Global Advisory Group

Wu RD et al. JDR 2011; 90:561-572

OMICS Global Advisory Group

Formed in response to a changing landscape

• Recognition of scientific and logistical constraints in determining risks for an ever-increasing number and diversity of compounds and environmental admixtures

• EU: New legislation (REACH, Water Framework Directive) to regulate chemical substances based on their potential impacts on both human and environmental health – opening the door to new and emerging testing procedures

• USA: Toxic Substance Control Act (TSCA) updated for the first time since 1976 – emphasizing alternative testing modalities (including non-animal tests), and placing the EPA responsible for “affirmative findings” for new chemicals entering market

The premise

OMIC technologies have reached a required level of technical and analytical maturity to aid in the protection of environmental and human health

through knowledge-based risk assessment

OMICS AG Scope & Mission

• Provide a forum for discussion of the capabilities of omics technologies and a means of raising awareness among stakeholders

• Coordinate scientific efforts among diverse partners (Government, Academia, Industry) around the world

• Develop the utility of OMICs technologies in regulation by connecting molecular measurements to apical endpoints

• To improve the information used by decision makers and to facilitate the innovation of ethical and cost-effective testing procedures

Near-term objectives

• Analysis, identification and articulation of specific requirements

for the implementation of OMICs into environmental and health decision-making around the world

• A strategic road-map for coordinated activities that will help create fundamental knowledge and a path to transform the way we estimate risk and regulate chemicals and their mixtures

Upcoming meetings

Advancing the OMICS into regulatory frameworks: case studies and perspectives

Chairs: Doris Vidal, Bruno Campos, John Colbourne, Adam Biales, Chris Martyniuk

Upcoming meetings

Identification of Key challenges and/or limitations that must be

addressed in order to realize the potential of the AOP framework in research and regulatory decision making

Advancing the Adverse outcome pathway concept An international Horizon Scanning Approach”

spring 2017 SETAC Pellston Workshop ®

Upcoming meetings

Chairs: Dan Villeneuve; Natalia Reyero-Garcia

Objectives

• Introduce participants to sources of high throughput tox data

• Provide the background needed to use these data

• Provide examples of current and emerging applications of HTS data in different regulatory/risk assessment contexts

• Stimulate innovation that can further enhance the utility of HTS data for ecological risk assessment

SETAC FTM Spring 2017

High Throughput Screening in Ecological Risk Assessment State of the Science and Emerging Applications

North America

Developing the roadmap

Chairs: Bruno Campos; Doris Vidal-Dorsh

Objectives

• Identify of knowledge gaps

• Determine regulatory needs and legal requirements for omics applications

• Organize prior and coordinate ongoing case studies to maximize proof-of-concept

• Identify areas where omics could be applied to conduct risk assessment in the near-term (1-5 years)

• Propose standards for the validation of omics information in risk assessment and regulatory settings

• Generate information packets and modules to communicate findings effectively to all stake holders

• Annunciate our long-term (5+ years) vision of developments for these technologies, data analysis pipelines and their applications to risk assessment and regulation

Omics into Regulatory science: A roadmap Pre-proposal for a 2017/2018 SETAC Pellston Workshop ®

Long term objectives: make omics useful

• Impact for Policy Makers and Regulators: Radically reduce the cost and improve the accuracy of risk assessment for ecological and human health

• Impact for Industry and Academia: Provide enabling technologies for industry to obtain the best possible understanding of the bioactivities of compounds on humans and ecosystems

Expressiveness of testing

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Pharma

Ag

Chem

Our central hypothesis is that omics can be used to systematically discover the bioactivities of compounds – success will have dividends for many industrial sectors

Omics-enabled Screening

Case Study: Limonene • Limonene discovered in 1884 • Used at large scale in industry

since 1926 (scent, cleaner) • Insecticide in 1976 • Chemotherapeutic in clinical

trials since 1998 • Wound healing properties

studied since 2011

Who’s interested?:

• Biotech: single-compound-single-effect to multi-effect

• Ag: safety assessment that includes soil effects

• Pharma: new antibiotics and other therapeutics

Current practices

>100 yrs of productization: can we do better?

Steering Committee

Co-chairs

• Bruno Campos, Europe, Government

• Doris Vidal, NA, Government

Steering Committee

• John Colbourne, Europe, Academia (INCOMING Co-chairs)

• Adam Biales, NA, Government (INCOMING Co-chairs)

• Ben Brown, UK & USA, Academia

• Erica Brockmeier, Europe, Academia

• Geoff Hodges, Europe, Industry

• Natalia Garcia-Reyero, NA, Academia

• Craig Marvin, NA, Industry

• Anthony Chariton Australasia, Government

• Sharon Hook, Australasia, Government

• Jinhee Choi Australasia, Academia

• Pedro Carriquiborde, LA, Academia

• Omar Zapata, LA, Academia

• (David Drew, NA, student assistant to the SC and communication officer)