• START HERE
  • START HERE
  • 1989
    HESI holds first workshop on Mouse
    Liver Tumors. This workshop was the
    first in a series jointly hosted by HESI,
    ILSI RSI, and the US EPA. The output
    of these workshops was foundational
    in informing the International
    Program on Chemical Safety (IPCS)
    conceptual framework for evaluating
    chemical mode of action.
    1989
    HESI was founded as a
    worldwide environmental
    sciences division within ILSI.
    (First meeting held
    April 5, 1989)
    1992
    HESI launches its
    first four technical
    committees.
    1992
    Dr. Denise Robinson
    appointed as HESI’s
    first Scientific Director.
    1993
    HESI’s Emerging Issues
    process
    – an initiative that
    stands today - is launched
    to promote the routine
    adoption of new science
    into HESI.
    1992
    HESI launches its first four technical committees:
    Carcinogenicity Technical Committee
    Immunotoxicology Technical Committee
    Water Quality Technical Committee
    Waste Management Technical Committee
    HESI ITC’s role is unique in that it facilitates
    tri-partite collaborations. It is very responsive to
    ‘grass-roots’ proposals and therefore has a unique
    ability to efficiently address questions raised by
    bench scientists with a good understanding of big
    picture questions, and it provides strong project
    management with managers that are also good
    scientists. For instance, the ITC played an important
    role conveying that one CRA assay does not fit all –
    that flexibility in assay design is good. The ITC
    impacts contributors’ careers by providing growth
    opportunities and increasing expertise.”
    Dr. Hervé Lebrec, Amgen
    Dr. Denise Robinson
    Dr. Robinson worked as the inaugural Executive Director of HESI from
    1992 – 2002, during which time she established much of HESI’s initial
    governance and programmatic infrastructure. During her tenure,
    Dr. Robinson greatly increased the number of active programs, HESI
    membership, and global reach. Dr. Denise Robinson earned her PhD in
    Pharmacology from Georgetown University School of Medicine. After
    leaving HESI, Dr. Robinson worked as the head of Science and
    Technology, Drug Safety R&D at Pfizer for over ten years. She is currently
    retired and resides in Connecticut, while continuing to devote time to
    professional organizations such as the Society of Toxicology.
  • 1993
    HESI takes an early lead in exploring non-animal
    methods for safety assessment with the launch
    of the Alternatives to Animal Testing (AAT)
    Technical Committee. The Committee’s research,
    with expert guidance from international safety
    assessors, ophthalmologists, and vision researchers,
    contributed to the abandonment of the in vivo
    Draize eye test in favor of in vitro approaches.
    1995
    The Water Quality Technical Committee
    holds a three-day workshop on
    Disinfection By-Products in Drinking
    Water with support from the US EPA, US
    NIEHS, UK Water Industry Research
    Council, Chlorine Institute, and the
    American Water Works Association.
    1996
    The Developmental and Reproductive
    Toxicology (DART) Committee launches
    with an initial project focused on
    conducting extensive literature reviews
    on non-traditional developmental toxicity
    endpoint measurement approaches.
    1997
    The HESI Peroxisome Proliferation
    Activated Receptor (PPAR) Committee
    rapidly launches a blinded pathology
    review study to address emerging
    concerns about potential carcinogenicity
    of drugs and chemicals with this
    mechanism of action.
    1999
    HESI celebrates its 10
    year anniversary with
    ~100 supporting
    organizations (about
    half private sector
    and half public
    sector). To see
    how we have
    grown to more
    than 300 members
    in 2019, click here.
    1995
    The Water Quality Technical Committee
    holds a three-day workshop on Disinfection
    By-Products in Drinking Water with support
    from the US EPA, US NIEHS, UK Water
    Industry Research Council, Chlorine
    Institute, and the American Water Works
    Association resulting in a comprehensive
    textbook on best practices for protecting
    human health.
    1996
    The Developmental and Reproductive Toxicology
    (DART) Committee launches with the goal of
    conducting extensive literature reviews on
    non-traditional developmental toxicity endpoint
    measurement approaches. Since its inception,
    DART has gone on to publish dozens of
    fundamental, peer-reviewed studies and original
    research that form the basis for best practices
    for DART assessment of chemicals and
    drugs worldwide.
    Several publications that came from the
    HESI-DART committee (2nd species papers;
    inhibin B paper; micro-CT evaluations of
    skeletons) were extremely useful to our
    organization and the regulatory
    environment surrounding our activities.
    The 2nd species paper and micro-CT papers
    were useful to demonstrate the importance
    of rabbits in developmental toxicity testing
    and the validity of using micro-CT
    evaluations in toxicity studies,
    respectively."
    Dr. Dinesh Stanislaus, GlaxoSmithKline
    1997
    The HESI Peroxisome Proliferation Activated
    Receptor (PPAR) Committee rapidly launches a
    blinded pathology review study to address
    emerging concerns about potential
    carcinogenicity of drugs and chemicals with this
    mechanism of action. The study results were
    published in a foundational paper that still informs
    human relevance evaluation for
    hemangiosarcomas observed in safety studies.
    This project pointed out to me how issues
    that had urgency could be addressed
    quickly through the HESI process, again
    bringing together international experts
    from government, academia, and industry.
    It also pointed out the success of HESI in
    being able to handle logistical and scientific
    issues in an expeditious manner,
    addressing the specific needs of the
    sponsors and committee members."
    Dr. Samuel Cohen,
    University of Nebraska Medical Center
  • 2000
    HESI reaches six active
    scientific committees.
    2001
    HESI is incorporated as an
    independent 501(c)(3)
    nonprofit charitable
    organization with its own
    governance, financing,
    and oversight.
    2001
    The Alternatives to
    Carcinogenicity Testing
    Committee publishes the
    results of a multi-year, 30
    million dollar study evaluating
    six distinct transgenic
    rodent assays.
    2002
    Dr. Michael Holsapple
    is hired as HESI’s second
    Executive Director.
    2003
    Agricultural Chemical Safety
    Committee project receives
    multiple international awards
    for reducing animal usage and
    enhanced testing efficiency.
    2000
    HESI's active scientific committees:
    Alternatives to Animal Testing
    Alternatives to Carcinogenicity Testing
    Developmental and Reproductive Toxicology*
    Immunotoxicology*
    The HESI role in the Alternatives to
    Carcinogenicity Testing project was a great
    example of the power of the model and the
    ability of this model to foster evolution of
    scientific thinking in an area critical to
    promoting human health. There were many
    individuals involved in making this project a
    success and it was the environment created by
    HESI that enabled this remarkable cross-
    functional effort to be so effective. It is clearly a
    model that has been perpetuated and enabled
    continuing contributions to the many
    challenges we face.”
    Dr. Jim MacDonald,
    Chrysalis Pharma Consulting
    Former Chair of the HESI ACT Program
    Nonclinical/Clinical Safety Correlations
    Risk Assessment Methodologies
    *These two committees are still active with
    evolving portfolios in 2019
    2001 HESI Staff
    Seated (from left): J. David Sandler, Scientific
    Project Manger; Amy M. Burk Fredericks, ILSI HESI
    Branch and Board Administrator; Karluss V. Thomas,
    Scientific Project Manager.
    Standing (from left): Denise Robinson, Ph.D.,
    Executive Director; Cynthia J. Nobles, Senior
    Secretary; Syril D. Pettit, Scientific Project Manager;
    Candice Y. Hamilton, Senior Secretary.
    Not pictured: Mary Anne Hazen, Senior Secretary;
    Eric L. Moore, Senior Secretary.
    2003
    The Technical Committee on Agricultural Chemical
    Safety
    , a multi-sector, international group of
    government, academic, and industry scientists,
    completes a multi-year project to develop an
    improved testing scheme for assessing the safety
    of crop protection chemicals. The program
    receives multiple international awards and
    citations for reducing animal usage and enhanced
    testing efficiency. Program outputs are
    incorporated into tiered testing guidelines across
    the globe and reduce overall animal testing.
    The Health and Environmental Sciences Institute
    (HESI) Agricultural Chemical Safety Assessment
    (ACSA) represented an early effort to reduce the
    number of animals and resources used in chemical
    safety evaluation by designing a tiered testing
    paradigm that incorporated existing knowledge of
    toxicity and exposure. This effort was an important
    springboard to the current efforts to increase the
    efficiency and effectiveness of toxicity testing
    through use of modern technologies to provide the
    most relevant information for decision-making.”
    Dr. Vicki Dellarco, U.S. EPA (retired)
    2001
    The Alternatives to Carcinogenicity Testing
    Committee publishes the results of a multi-year,
    30 million dollar study evaluating six distinct
    transgenic rodent assays. The results of this
    study inform International Conference on
    Harmonization guidelines for these assays and
    their acceptance by regulatory authorities
    including the FDA, EMA, Japan, Health Canada,
    and other drug safety agencies around the world.
    The success of this project is a strong
    recommendation for the tripartite approach
    that HESI is promoting. It was decided that
    ICH Guideline S1B would give companies
    the opportunity to use transgenic mice if
    further evaluated. This recommendation
    took place after evaluation of the HESI
    project and as a consequence, a lot of
    companies have replaced the two-year
    mouse study.”
    Dr. Jan Willem van der Laan,
    Medicines Evaluation Board
    Dr. Michael Holsapple
    Dr. Michael Holsapple holds a PhD in Pharmacology & Toxicology from
    Purdue University and was the Executive Director of HESI from 2002 –
    2011. Throughout all stages of his career, Dr. Holsapple has maintained
    an interest in immunotoxicology, including the importance of
    developmental immunotoxicity testing.
  • 2004
    HESI Genomics Committee publishes
    its seminal evaluation of the use of
    genomic microarrays for chemical and
    pharmaceutical risk assessment

    in EHP, and this article has since
    received ~500 citations and
    thousands of downloads.
    2006
    In response to global health concerns
    about unanticipated arrhythmias
    caused by marketed drugs, HESI
    undertakes a multi-site experimental
    program to inform novel safety
    testing that led to global
    safety practices.
    2006
    Seoul, Korea. The Protein Allergenicity
    Technical Committee
    convenes global
    experts at a workshop that informed the
    development of sera banks to support
    protein allergenicity safety assessment.
    2006
    Opportunities to enhance
    exposure-driven approaches to
    integrating biomonitoring data
    in human health risk assessment
    are highlighted in two pivotal
    publications by the HESI
    Biomonitoring Committee.
    2008
    The value and limitations of DNA
    adduct data for assigning mode
    of action for tumor development
    is the focus of discussions
    and publications from multi-
    disciplinary international
    team of safety scientists
    within the DNA Adducts
    Committee.
    2006
    In response to global health concerns about
    unanticipated and potentially lethal clinical
    arrhythmias associated with marketed drugs,
    HESI undertakes a multi-site experimental
    program to inform novel safety testing
    approaches. The results of this study published
    in 2006 - Hanson et al. – inform novel global
    cardiac safety standards and effectively eliminate
    the development of drugs with unanticipated
    arrhythmic effects.
    There is no other place, besides the HESI Cardiac
    Safety Committee, where there is this breadth of
    expertise and cross-sector partnership focused on an
    area of fundamental scientific need. And although we
    don’t often think about this because we’re focused on
    advancing our pharmaceutical and environmental
    safety assessment processes, but cardiovascular
    disease is the number one cause of mortality globally.
    There are significant public health impacts that can
    come from what we study and the capabilities we
    develop in this HESI program."
    Dr. Brian Berridge,
    National Toxicology Program NIH
    2004
    HESI Genomics Committee publishes its
    seminal evaluation of the use of genomic
    microarrays for chemical and pharmaceutical risk
    assessment
    in EHP. These articles have since
    received ~500 citations and thousands of
    downloads. The effort led to the launch of the first
    public microarray database that included
    experimental animal data (Tox-ArrayExpress) and
    spurred other efforts such as the MAQC
    (consortium on genomic data quality) and
    contributed to the identification of novel renal and
    genetic toxicity biomarkers.
    The project wouldn’t have
    happened [without HESI]. HESI
    brought people together to
    collaborate. HESI can bring people
    together to do a huge research
    project that no one else would do –
    this is very valuable."
    Dr. Jennifer Fostel, NIEHS / NIH
    2006
    Challenges and opportunities to enhance
    exposure-driven approaches to integrating
    biomonitoring data in human health risk
    assessment are highlighted in two pivotal
    publications in Environmental Health Perspectives
    and Toxicological Sciences by the HESI
    Biomonitoring Committee in 2006. These papers
    have been cited hundreds of times in the last ten
    years and continue to inform contemporary practice.
    2008
    The value and limitations of DNA adduct data for
    assigning mode of action for tumor development
    is the focus of discussions and publications from
    multi-disciplinary international team of safety
    scientists within the DNA Adducts Committee.
    This program led to the formation of the current
    Genetic Toxicology Technical Committee that has
    become a global leader in the design and
    evaluation of methods of genotoxicity testing.
    [Health Canada] fully appreciates the strength of the
    tri-partite approach used to advance applications and
    uptake of new tools and approaches. The HESI
    portfolio within GTTC is impactful, hitting all of the
    latest important topics and helping to advance and
    improve genetox methodologies. Working together
    alongside our industry and academic partners’ issues
    and challenges facilitates arriving at consensus. In
    addition, much of the work feeds directly into critical
    international exercises like revisions of OECD test
    guidelines, which are necessary to ensure the
    protection of human health.”
    Dr. Carole Yauk, Health Canada
  • 2010
    FDA and EMEA ‘qualify’ two novel
    urinary biomarkers of kidney toxicity
    (in rodents) for use in safety
    assessment based on results of a
    multi-year, multi-site experimental
    study
    conducted by the Biomarkers of
    Nephrotoxicity Committee.
    2012
    HESI’s 3rd Executive Director,
    Syril Pettit, launches her first full
    year in the leadership role and
    leads HESI’s first Annual Meeting
    in Europe (Prague) in June 2012.
    2014
    The first three RISK21 framework
    manuscripts are published and available
    for download online. These papers
    explain a transparent, scientifically
    accountable, and highly visual approach
    for performing accurate risk
    assessments in the 21st century.
    2014
    HESI celebrates its 25th
    anniversary
    and expansion of the
    scientific portfolio to includes 13
    scientific committees and more
    than 60 distinct projects. Over 260
    HESI publications are cited almost
    5,000 times in over 1,000 scientific
    peer reviewed journals.
    2014
    HESI signs MOU with
    FDA CDER stating a
    shared commitment
    to improving human
    health via enhanced
    regulatory science
    partnerships.
    Dr. Syril Pettit
    Syril Pettit became the HESI’s third Executive Director in November 2011
    after serving in other scientific staffing and leadership roles at HESI since
    joining the organization in 2000. During her tenure, she has expanded the
    organizational scope and membership and increased HESI’s focus on
    multidisciplinary solutions to public health problems. Dr. Pettit launched
    HESI’s highly recognized THRIVE initiative in 2015.

    Dr. Pettit holds a Doctorate in Public Health Leadership (DrPH) from the
    University of North Carolina’s Gillings School of Global Public Health,
    a Master’s Degree in Environmental Management (M.E.M.) from Duke
    University’s Nicholas School of the Environment, and a Bachelor’s Degree
    in Biology from Amherst College. She has authored dozens of scientific
    articles and lectured at international scientific meetings around the world
    on topics including public health, oncology, cardiac safety, genomics,
    collaborative approaches to science, and other drug and chemical
    safety issues.
    2013
    The HESI Protein Allergenicity Technical
    Committee (PATC) holds a Beijing workshop on
    food allergy and safety assessment on protein
    allergenicity and toxicity, clinical allergy, and the
    safety of genetically modified crops, fostering
    future collaborations with Chinese scientists
    and regulators.
    [The PATC] studies were related to
    evaluating the relevance of digestibility as
    a determinant of allergenicity and to
    assessing whether bioinformatic sequence
    comparisons should be based on identity or
    similarity. The outcome of these studies
    has provided new leads for studies on the
    process of sensitization and symptom
    elicitation in food allergy, and for studies
    on IgE cross-reactivity.”
    Dr. Ronald van Ree
    Academic Medical Center
    University of Amsterdam
    2010
    FDA and EMEA ‘qualify’ two novel urinary
    biomarkers of kidney toxicity (in rodents) for
    use in safety assessment based on results
    of a multi-year, multi-site experimental study
    conducted by the Biomarkers of Nephrotoxicity
    Committee. These markers are now routinely
    utilized non-clinically, have been incorporated
    into commercial testing platforms, and are
    under evaluation for clinical use.
    The multi-laboratory study data generated
    by the HESI Biomarkers Committee represent
    an important contribution to the biomarker
    qualification process. The FDA recognizes the
    significant effort that went into generating
    these data, and that they represent the
    outcomes of the first prospectively and
    collaboratively designed, executed, and
    analyzed qualification studies submitted
    as part of the BQDS process.”
    Dr. Janet Woodcock
    Director the FDA’s Center for
    Drug Evaluation and Research
  • 2015
    HESI Genetox Committee publication
    wins Society of Toxicology’s Risk
    Assessment Specialty Section Best
    Paper award and the Environmental
    and Molecular Mutagtenesis
    Editor’s Choice.
    2016
    COMPARE – HESI’s first public,
    curated, protein allergenicity
    database is released and is
    rapidly adopted as a global
    standard for safety evaluation.
    2017
    HESI reaches a new
    membership high with
    scientists participating
    from more than 300
    academic, government,
    NGO, research, and
    business organizations
    around the world
    2018
    HESI THRIVE program
    recognized by the U.S.
    White House Cancer
    Moonshot Program and
    the Biden Cancer Institute.
    2018
    HESI signs MOU with EPA to signal shared
    commitment to environmental science.
    2018
    Results of HESI’s multi-year
    ring trial on methods to
    assess aquatic
    bioaccumulation in fish
    are incorporated into new
    OECD test methods
    (319A and 319B) and
    guidance documents.
    2018
    HESI signs MOU with EPA to signal shared commitment to
    environmental science and launch a novel collaboration to improve the
    utility of modeling approaches for predicting absorption, distribution,
    metabolism and excretion (ADME) of synthetic or natural chemical
    substances in humans and other animal species.
    2018
    HESI THRIVE program recognized by the U.S.
    White House Cancer Moonshot Program for its
    innovative approaches to driving research that
    can improve cancer patient quality of life. This
    same program is named as one of only 30
    partners recognized by the Biden Cancer Institute.
    Findings of these innovative THRIVE studies will
    contribute essential evidence focused on minimizing
    treatment toxicities that impede quality of life - an
    outcome that is central to making good on the
    promise of providing patient-centered care that
    improves the lived experience for cancer patients and
    their families. HESI brilliantly dovetailed THRIVE's
    work with the Biden Cancer Moonshot activities to
    spotlight this broader constellation of cancer
    research priorities.”
    Rebecca Kirch,
    National Patient Advocate Foundation
    2016
    COMPARE – HESI’s first public, curated, protein
    allergenicity database is released and is rapidly
    adopted as a global standard for safety evaluation.
    CompareDatabase.org
    HESI has been a very effective coordinator for the
    different voices of the tripartite membership. This
    composition has made the outcome very useful and,
    being consensus-driven, reflective of the science
    behind the allergy hazard assessment. The usefulness
    derives from the efforts to make the COMPARE
    Database clearly derived from literature references
    with data that meets clear performance goals and are
    peer reviewed. I think COMPARE has had a big impact
    on how we move forward on the toxin database or
    sequence comparisons.”
    Dr. John Kough, U.S. EPA
    2018
    Results of HESI’s multi-year ring trial on methods
    to assess aquatic bioaccumulation in fish are
    incorporated into new OECD test methods
    (319A and 319B) and guidance documents.

    HESI becomes a fully independent organization
    by concluding its charter with ILSI.
    The field is moving away from live animal
    testing to alternative methods of risk
    assessment – this is very easy to say and
    really hard to do. HESI has helped
    advance methods for getting away from
    animal testing and has accelerated progress.
    When you get more people focusing on the
    same question, you bring more resources
    and more energy – you accelerate progress.
    HESI has done that.”
    Dr. John Nichols, U.S. EPA
  • Over the past 30 years, HESI science has been
    implemented around the world to improve
    decision-making, enhance human health
    and safety, and preserve the
    environment. Looking forward
    to the next 30 years, HESI is excited to
    continue creating a collaborative
    environment for scientists
    from academia, government,
    industry, and NGOs to come
    together to create science-based
    solutions for a healthier world.
HOME
1989 - 1993
1993 - 1999
2000 - 2003
2004 - 2008
2010 - 2014
2015 - 2018
2019
This site uses cookies to provide you with a personalized browsing experience. By clicking “Accept” or continuing to use the site you agree to allow cookies to be placed and accept the terms set out in our [Privacy Notice]. Please read the Privacy Notice for more information on how we handle information collected from users and how you can control the use of such information. Cookie settingsACCEPT
Privacy & Cookies Policy

Privacy Overview

This website uses cookies to improve your experience while you navigate through the website. Out of these cookies, the cookies that are categorized as necessary are stored on your browser as they are essential for the working of basic functionalities of the website. We also use third-party cookies that help us analyze and understand how you use this website. These cookies will be stored in your browser only with your consent. You also have the option to opt-out of these cookies. But opting out of some of these cookies may have an effect on your browsing experience.
Necessary
Always Enabled
Necessary cookies are absolutely essential for the website to function properly. This category only includes cookies that ensures basic functionalities and security features of the website. These cookies do not store any personal information.
Non-necessary
Any cookies that may not be particularly necessary for the website to function and is used specifically to collect user personal data via analytics, ads, other embedded contents are termed as non-necessary cookies. It is mandatory to procure user consent prior to running these cookies on your website.
SAVE & ACCEPT