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HESI: Advancing Science for a Healthier World

HESI is a research institute focused on creating science-based solutions for a sustainable, healthier world. They conduct accurate and efficient chemical risk assessments, promote safe and effective medicines, ensure environmental quality and sustainability, and protect sensitive populations. With partnerships across academia, industry, government, and patient advocacy organizations, HESI's research and programs have had a significant impact on global safety research.

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HESI: Advancing Science for a Healthier World

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  1. HESI: Health and Environmental Sciences Institute Updated April 2015 HESI Washington, DC USA www.hesiglobal.org

  2. HESI Mission Create science-based solutions for a sustainable, healthier world. Accurate and Efficient Chemical Risk Assessment Safe and Effective Medicines Environmental Quality and Sustainability Food Safety

  3. Protecting sensitive populations Sustaining critical environments Supporting ecological and human safety of essential food resources Predicting and Protecting Against Adverse Effects from Chronic Exposures Promoting Discovery

  4. The HESI Model: Bridging Research to Application Academic & basic research sector Industry R&D Government Research & Regulation Patient Advocates, Foundations & NGOs • SAFETY & INNOVATION FOR HUMAN & ENVIRONMENTAL HEALTH

  5. 90 University & Research Centers >70 Distinct Projects 14 Scientific Committees 66 Corporate Sponsors 47 Government Agencies Impact via Quality Science Across multiple sectors From 14 Countries From 12 Countries

  6. HESI achieves its mission via… Scientific Research Publication Communication & Translation Millions in in-kind research annually Novel programs with interdisciplinary and cross-sector focus Tools Training Platforms for Interaction

  7. Active public-private partnership

  8. In 2014/2015…. Two OECD supportive research projects • Pig-A genotoxicity mutation assay • Fish hepatic biotransformation assay – bioaccumulation HESI research part of active guideline discussions with ICH • Cardiac paradigms (CIPA project) • Developmental toxicity (2nd Species Project) HESI: A Key Contributor to Global Safety Research

  9. HESI’s scientific programs and publications have.. Influenced their approach to safety or risk assessment decision-making; 70% Influenced their level of confidence in the use of particular technologies, markers, endpoints, or analysis approaches; 80% Directly and positively impacted safety of patients and the environment We know the model works…

  10. Increasing public and private sector involvement Organization Strong & Growing 65

  11. History of Success

  12. Creating frameworks to integrate data and decision-making Prioritize risks, Protect ecosystems and their inhabitants

  13. Integrating Alternatives to Animal Testing for Ecotox Globally recognized HESI roadmaps to guide integration of data and decisions. Innovating Chemical Risk Assessment Assessing Adverse vs Adaptive Transitions in Toxicity Pathways Enhancing AgChem Safety

  14. A spotlight on one of many… US EPA Scientific and Technological Achievement Award (Honorable Mention) UK National Center for the Replacement, Refinement, and Reduction of Animals in Research “Highly Commended Prize” Impact cited in 2 National Academy reports • Basis for OECD Guideline for Testing of Chemicals (443): Extended One-Generation Reproductive Toxicity Study • Canine study requirement dropped in EPA Pesticide guidelines; • Increased use of ADME to enhance dose selection Enhancing AgChem Safety

  15. Informing discovery & decision-making with new technologies • First large scaleTGx experimental program, first public array/tox dbase • Led to adoption of data standards, genomic biomarkers • Resource for strengths & limitations of TgX use for safety Toxicogenomics for Risk Assessment Transgenic Models for Cancer Risk Assessment • $33M collaborative effort • Critical data on predictivity of available transgenic models • Data underpins current guidelines on alternatives to 2 year mouse bioassay • Improved prediction of safety

  16. Translating from animal to human, and back to improve predictive safety • HESI Approach to Biomarkers • Consensus on Safety or Translational Need • Experimental Data • Analysis & Publication • Integration of Data & Context of Use Nonclinical cTn serum assays Urinary Renal Protein Biomarkers Non-clinical Inhibin Assays MicroRNAs as translation tox markers

  17. 2015: PROGRAMS TO IMPACT SCIENCE AND HEALTH

  18. Chemical Safety Evaluation

  19. Predictive models Risk assessment methodologiesSustainabilityCapacity Building & Education

  20. Predictive Models Utility of 2nd Species for assessing developmental toxicity Zebrafish & multi-generational epigenetics Pig-A assay for genotoxicity Bioaccumulation: In vitro method, hepatic clearance in trout

  21. Risk Assessment Methodologies RISK21 AOP and Ecotox

  22. Sustainability

  23. Capacity Building & Education

  24. Scientist from the following organization’s collaborate with HESI on Chemical Risk Assessment research….and many more!

  25. SAFE AND EFFECTIVE MEDICINES

  26. ‘Crossing over the valley of death’ FasterCures. 2010. http://www.fastercures.org/reports/view/3

  27. Underfunded? Or inefficient?FasterCures. 2010. http://www.fastercures.org/reports/view/3 Region of Opportunity Patient Experience

  28. Contemporary Drivers

  29. Prevent Another TGN 1412 Enhance drug discovery, don’t compromise safety Support Cancer Patient Survival & Quality of Life Ensure new therapeutic modes are safe for sensitive populations

  30. Enhance drug discovery, don’t compromise safety

  31. What It Will Do: • Prevent early attrition due to hERG liabilities • Provide a more complete assessment of proarrhythmic risk • Obviate need for a TQT study and improve efficiency • Potential to re-label drugs with risk warnings • Standardize in vitro & in silicoassays; establish best practices for stem-cell derived cardiomyocytes • Likely lead to revision of S7B, E14 guidelines Nature Review: Drug Discovery. Aug 2013

  32. Prevent Another TGN 1412

  33. HESI STUDY RESULTS: • Significant variability revealed (controls, assay selection, design, situational use, interpretation) • Identified opportunities to improve forward prediction with collaborative approach • HESI MOVING FORWARD • Centralized repository for positive/ negative controls for CRA • Prospective study across labs w consistent protocols, controls: outcome to help ID sources of variability, build best practices, guide interpretation.

  34. Ensure new therapeutic modes are safe for sensitive populations

  35. FC-Fusion Proteins (Biopharmaceuticals) a significant new area of therapeutic development FC domain enhances half-life Biopharmaceuticals with Fc region from IgG are known to cross placenta How to assess safety for women of childbearing age?

  36. Support Cancer Patient Survival & Quality of Life

  37. Simple numbers…terrible cost • 7 fold higher risk of cardiac mortality www.fredhutch.org

  38. HESI’s is innovating the field with support for:- modeling-translational safety signals or monitoring-interdisciplinary platforms

  39. Scientist from the following organizations collaborate with HESI on Drug Safety research….and many more!

  40. The HESI Model: Bridging Research to Application Academic & basic research sector Industry R&D Government Research & Regulation Patient Advocates, Foundations & NGOs • SAFETY & INNOVATION FOR HUMAN & ENVIRONMENTAL HEALTH

  41. CREATING NEW COMMUNITIES OF PRACTICE TO ENHANCE RELEVANCE & EFFICIENCY IMPLEMENTING FIT FOR PURPOSE SCIENCE TO MEET PATIENT & ENVIRONMENTAL NEEDS Bridging Innovative Research and Application to Enhance Safety POOLING RESOURCES TO EXPEDITE EFFORTS, DIVERSIFY EXPERTISE-BASE MOVING OUTCOMES INTO PUBLIC DOMAIN TO BENEFIT PUBLIC HEALTH AND ENVIRONMENT COMMUNITY AT LARGE

  42. HESI: Health and Environmental Sciences Institute Syril D Pettit, MEM Executive Director spettit@hesiglobal.org

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