HESI Insights - February 2019
In honor of American Heart Month, this month’s 30th anniversary guest article will spotlight the achievements of the Cardiac Safety Technical Committee (CSTC). The CSTC was founded in 2008, although HESI cardiac initiatives began back in 2000. Dr. Norman Stockbridge (U.S. Food and Drug Administration) shares his experience: “You can count up publications, but I find a critically important characteristic is the collaborative interactions among industry and regulatory stakeholders, leading to identification of common areas of interest and identification of problems that can be addressed by shared resources. In my experience, no place were these principles so evident as they were in the Comprehensive In Vitro Proarrhythmia Assay (CiPA) project. This was not solely a HESI/CSTC project, but included elements executed by hundreds of academic, industry, and regulatory individuals working under various consortia. The HESI/CSTC did some of this work, but, more importantly, HESI/CSTC provided the coordination of all of the pieces—and without any contractual documentation of responsibilities. This project would not have succeeded without HESI/CSTC’s spontaneous leadership. Elements of CiPA are being implemented now, and ICH is convening discussion of guidance. HESI/CSTC is now turning its attention to other aspects of cardiotoxicity to see whether a set of assays can be developed using these principles to cover most or all of the cardiotoxicity seen with drugs. Such a development can be expected to lead to improved performance, higher specificity, and higher throughput—for cardiotoxicity assessment and maybe one day for toxicology generally.”
HESI science is advancing the use of alternative methods! The recent Joint Research Centre (JRC) Status Report on the “Development, Validation and Regulatory Acceptance of Alternative Methods and Approaches” includes mention of several HESI committee efforts:
- the HESI Animal Alternatives in Environmental Risk Assessment Committee’s EnviroTox Database,
- the HESI Bioaccumulation Committee’s multi-laboratory ring trial to assess the reliability of in vitro methods used to measure intrinsic hepatic clearance by rainbow trout,
- the HESI Genetic Toxicology Technical Committee’s work to advance the fields of genetic toxicology and human risk assessment, and
- the HESI PBPK Workgroup’s efforts to facilitate the uptake of PBPK modeling approaches in regulatory risk assessment.
The status report aims to provide evidence-based scientific support to the European policymaking process, and the inclusion of so many HESI programs further demonstrates the impact of HESI science on the global scientific community.
The third iteration of the COMPARE Allergen database, COMPARE 2019, was released on 18 January 2019. Fifty (50) new allergen sequences have been added this year, for a total of 2,081 sequences in the database. Check out the COMPARE website at www.comparedatabase.org for the detailed updates and a fresh “new look” thanks to programmatic support of the JIFSAN team! The COMPARE Database is a collaborative program under the umbrella of the HESI PATB committee. It is a transparent resource for the identification of protein sequences that are recognized allergens, developed to meet the needs of allergenicity safety assessments in foods. For more information, please visit the website or email email@example.com.
The Developmental and Reproductive Toxicology (DART) Committee is scoping a project aimed at providing additional confidence for using microCT for regulatory developmental toxicology studies. Readers, imaging technicians, and other interested parties are encouraged to share their in-house capabilities with HESI DART by contacting Shermaine Mitchell-Ryan (firstname.lastname@example.org).
Syril Pettit, HESI Executive Director, will be speaking at the National Toxicology Program (NTP) Board of Scientific Counselors Meeting this Friday, 15 February 2019. Syril will be discussing the changing toxicology landscape and challenges for the future of the field.
Click here to learn more about the meeting and to register.
The HESI Emerging Systems Toxicology for the Assessment of Risk (eSTAR) Committee and the Translational Biomarkers of Neurotoxicity Committee will present their work at SOT 2019 in Baltimore, Maryland, on 12–14 March 2019.
Tuesday, 12 March 2019
9:15 AM to 10:45 AM
Emerging Systems Toxicology for the Assessment of Risk (eSTAR) Committee Session: “Improving Formalin-Fixed Paraffin-Embedded (FFPE) Samples for DNA-Sequencing Events”
- Abstract Number/Poster Board Number: 1967/P354
- Presenting Author: Leah Wehmas
- Presentation Location: CC Exhibit Hall
Wednesday, 13 March 2019
8:00 AM to 10:45 AM
Translational Biomarkers of Neurotoxicity Committee Session: “Can We Panelize Seizure?”
- Presentation Location: Room CC Ballroom III
Thursday, 14 March 2019
8:30 AM to 11:30 AM
Translational Biomarkers of Neurotoxicity Committee Session: “Circulating Biomarkers of Neurotoxicity: Identifying Fluidic Endpoints Correlating with Central Nervous System Toxicity in a Rodent Model of Neurotoxicity”
- Abstract Number/Poster Board Number: 3575/P372
- Presenting Author: Syed Imam
- Presentation Location: Convention Center Hall A
More information about SOT 2019 is available here.
Registration is now open for the FDA workshop on “Leveraging Human-Relevant Cardiomyocytes in Nonclinical Studies to Provide Mechanistic Insights into Cardiovascular Safety Liabilities.” The agenda for this event is posted on the registration website and it will be held in the FDA Great Room at the White Oak campus in Silver Spring, Maryland, on 29 March 2019. Registration is free but required, so register today to reserve your spot! For more information, please contact Jennifer Pierson (email@example.com).
The Immuno-safety Technical Committee (ITC) will hold a training course in South San Francisco, California, on 9–10 April 2019 on the topic of cancer immunotherapies. This 2-day course will provide the foundation biology, describe therapeutic approaches across the various modalities, and discuss other safety-related issues. For more information and to register, please visit the website or contact Dr. Stan Parish (firstname.lastname@example.org).
Join us on 9–10 May 2019 for the “Thyroid Hormone Assessment Workshop: 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. Space is limited, so visit the event webpage to view the draft meeting agenda, obtain lodging information, and register! There is a nominal registration fee but if you have any questions or concerns or would like more information, please contact Connie Chen (email@example.com).
Enhancing the quality of human and ecological health protection efforts—while using fewer animal resources for testing—is a critical and growing priority. For decades, HESI has developed the science and collective insight to help realize these goals. In a recent European Commission JRC report, four different HESI scientific committees are cited as key technical contributors to this effort—across a broad range of endpoints and applications. At HESI, we are proud to be such an impactful part of international scientific progress to enhance the acceptance and utility of non-animal alternatives.