The services offered by M³ are aligned with our organizing principles, the "three Ms": Mode, Margin and Management.
- Mode (of Action): A mechanism-based approach to the risk assessment of all chemicals is already happening. In the age of "Big Data," the shift from low-throughput data collection based on observation of phenotypic outcomes to high-throughput methods data collection relying more on in vitro, in silico, and in chemico measurements managed through expert systems and using integrated testing approaches was inevitable.
M³ can advise on and help implement approaches to establishing toxicological mode of action for chemicals of concern.
M³ can research and prepare rationales for data bridging, read-across and test waivers in compliance with the relevant legislative mandate and appropriate regulatory agencies.
M³ can help establish compliant dossiers and cost-effective testing programs that observe the "three Rs" of humane research (replacement, reduction, refinement) and support Integrated Approaches to Testing and Assessment (IATA).
- Margin (of Exposure): Both the ability for regulatory programs to prioritize limited resources and the capacity for the public to understand and appreciate rests on accurate measurement and communication of the frequency and duration and exposure to environmental chemicals. Advancement of research supporting the development of high-throughput "exposure-to-activity" and Margin of Exposure estimates (for example) is critical to ensuring testing using animals is reserved for only high-risk chemicals.
M³ can advise on and help implement approaches to collecting and interpreting exposure data for chemicals in products and the environment, including the development of population-based measures (e.g. biomonitoring, molecular epidemiology) to verify mode of action conclusions.
M³ can research and prepare exposure-based waivers for chemicals (i.e. Threshold of Toxicological Concern) in compliance with the relevant legislative mandate and appropriate regulatory agencies.
M³ can research and prepare estimates of exposure to support food additive submissions to FDA, exposure evaluations needed for human health and ecological risk assessments at EPA, and to inform Integrated Approaches to Testing and Assessment (IATA) and exposure-led modern approaches to risk assessment.
- Management: Professional and competent management of risk, using modern probabilistic approaches supported by high-throughput approaches to toxicity and exposure evaluation, will require internationally-coordinated and -supported effort, not to mention database(s) of empirical and predictive "mode-of-action" data on chemicals. Professional management of information will be needed to develop more automated approaches to using and interpreting high-throughput data via expert systems, machine learning, data mining, and structure-based modeling. Professional management of policy and regulatory issues will be needed to organize existing information, establish evidence-based "best practices" and focus resources on information needs, not information gaps. The Adverse Outcome Pathway concept holds tremendous promise as this new informational framework.
M³ can help manage risk by providing expert advice on and helping implement modern approaches to risk assessment (i.e. exposure-led and supported by high-throughput methods for evaluating toxicity and exposure) for chemicals in products or the environment.
M³ can help manage information through establishment of organizational frameworks (i.e. Adverse Outcome Pathway research and preparation) and identifying the best non-testing approaches - such as computational modeling, toxicogenomic studies, etc. - to establish Integrated Approaches to Testing and Assessment (IATA) that exhaust the utility of existing data and easy-to-collect data to achieve cost savings and reduce animal use.
M³ can help manage policy and regulatory issues by locating and interpreting applicable regulations and data requirements, performing advocacy and outreach to the appropriate regulatory authorities and agencies on your behalf to establish "fit for purpose" Integrated Approaches to Testing and Assessment (IATA) that are accepted and supported by regulatory agencies.
M³ can help manage your communication and advocacy needs through drafting position papers, comments for public dockets, commentary and other pieces for publication.
M³ can provide professional and competent management of coalitions and testing consortia that arise for specific chemical and chemical category data needs - such as those needed for cost-effective compliance with US regulations (FIFRA, US EPA Endocrine Disruptor Screening Program, Endangered Species Act, etc.) and international regulations (REACH, etc.)
Below are some testimonials from colleagues familiar with the caliber of work that M³ delivers: