HESI Insights - April 2019

HESI has a long history of conducting research on tumorigenesis pathways as well as safety and efficacy of cancer therapies.  Although much of HESI’s work is conducted via our multisector scientific committees, HESI has also adopted new approaches to supporting high-impact scientific innovation.  For example,  HESI THRIVE is a seed grant program that was recognized by the Biden Cancer Initiative for making cancer patient quality of life an active research priority. Rebecca Kirch of the National Patient Advocate Foundation comments on her experience working with THRIVE: “National Patient Advocate Foundation has been pleased to partner with HESI in developing, delivering and disseminating the THRIVE research initiative to help prioritize quality of life as a key part of extending life through cancer treatment. 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. Working with HESI and other partners looking ahead, we hope the early inertia from THRIVE drives momentum for robust stakeholder involvement and dedicated investment supporting high-quality survivorship that truly puts people at the heart of healthcare.”

At the recent Society of Toxicology (SOT) Annual Meeting, HESI helped organize and chair a session titled “Can We Panelize Seizure?” The session explored the current problem of seizure liability in drug discovery. Speakers covered solutions from best practices in using in vivo methods to novel in vitro solutions as well as some case examples and regulatory considerations. The session was well attended with good engagement from the audience. HESI is working with the speakers to discuss next steps and a potential review article. For more information, contact Jennifer Pierson (jpierson@hesiglobal.org).

This month, Dr. Lucilia Mouriès of HESI attended the OECD Food & Feed Safety meetings in Paris, France, to explore possible areas of synergy with HESI programs. The OECD Food & Feed Safety program aims to promote international harmonization in the risk/safety assessment of novel foods and feeds by encouraging information sharing, promoting harmonized practices and common frameworks in safety assessment and regulation, and preventing duplication of efforts among countries. To learn more about HESI’s efforts in this space, contact Lucilia Mouriès (lmouries@hesiglobal.org).

HESI recently attended a public workshop held at FDA on “Leveraging Human-Relevant Cardiomyocytes in Nonclinical Studies to Provide Mechanistic Insights into Cardiovascular Safety Liabilities.” The workshop featured experts from the public and private sectors with a variety of experience using human pluripotent stem cell-derived cardiomyocytes (hiPSC-CMs) in drug discovery. Participants engaged in discussion with panelists on what is needed to move this technology forward and gain broader acceptance including model characterization and validation. Slides from the meeting will be made available online in the next few weeks. HESI plans to work with FDA on formation of a manuscript detailing gaps and opportunities in this area. For more information, contact Jennifer Pierson (jpierson@hesiglobal.org).

There are a few still spots available for the 9–10 May 2019 workshop “Thyroid Hormone Assessment: Implications for Developmental and Reproductive Toxicology,” jointly planned by the DART Committee and the European Teratology Society Thyroid Task Force. We will be addressing the state of the science of thyroid hormone assessment testing in young rodents in regulatory settings and improving data interpretation of thyroid changes and their relationship to adverse outcomes. Visit the event webpage to view the draft meeting agenda, obtain lodging information, and register! Registration will close on 19 April 2019, or when we reach capacity. There is a nominal registration fee but if you have any questions or concerns or would like more information, please contact Connie Chen (cchen@hesiglobal.org).

Register now to celebrate 30 years of HESI science! The 2019 HESI Annual Meeting will be held 11–12 June 2019 in Alexandria, Virginia. This year’s program will bridge HESI’s past achievements and future plans to generate science for improved decision-making, enhanced human health and safety, and protected environments. The agenda features exciting speakers on topics including innovations in multidisciplinary science, the future of cancer risk assessment, and more, as well as great opportunities to network with leading scientists from around the globe. Click here to register.

• Emerging Systems Toxicology for the Assessment of Risk (eSTAR) Committee
  • Title: “Improving Formalin-Fixed Paraffin-Embedded (FFPE) Samples for DNA-Sequencing Events” (Abstract #1967)
• Translational Biomarkers of Neurotoxicity Committee
  • Title: “Circulating Biomarkers of Neurotoxicity: Identifying Fluidic Endpoints Correlating with Central Nervous System Toxicity in a Rodent Model of Neurotoxicity” (Abstract # 3575)

Charlene McQueen
HESI President