HESI Insights - January 2022

HESI’s 2021 Annual Report is now available!

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HESI’s 2021 Annual Report is now online! See what our Scientific Committees and Special Programs have accomplished this past year! Click here to read the full report now!

National Birth Defects Awareness Month


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January is National Birth Defects Awareness Month! The Developmental and Reproductive Toxicology (DART) Technical Committee has brought together experts from across sectors for more than 25 years and initiated activities to advance the science related to the use of DART studies for use in human health risk assessment. The DART committee has members active in many professional societies, including its longstanding partner the Society for Birth Defects Research and Prevention. More information on the committee’s current projects and a full list of the committee’s publications is available online here. If you are interested in participating or partnering with the committee, please reach out to either Connie Chen or Shermaine Mitchell-Ryan.

Cervical Cancer Awareness Month

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From targeted antibodies that inhibit critical tumor survival pathways to the use of immunomodulatory check point inhibitors, Immunotherapy is transforming the way we treat cervical cancer. As we continue to expand our treatment armamentarium with novel immunotherapeutic agents, we must continue to identify and address challenges associated with immune related adverse events.  HESI’s Immuno Safety Technical Committee (ITC) has explored toxicities associated with blockade of immunosuppressive and check point mechanisms in our 2019 Cancer Immunotherapies training course. To learn more about cancer immunotherapies we invite you to register for our virtual/on demand 2022 Immuno Safety training course. In addition to various topics in cancer immunotherapies, the course will offer discourse on a variety of Immune Safety related subjects.  Watch our Events page for more information about the launch of the virtual course (coming soon).

For more information about the Immuno Safety Technical Committee please contact Shermaine Mitchell-Ryan

Environmental Epidemiology Committee – Webinar Series

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Last year, HESI’s Environmental Epidemiology Committee launched a webinar series to illustrate the critical role epidemiology can play in the field of quantitative risk assessment. Details and presentation recordings are available on the Committee webpage.

The Committee will continue this series in 2022.

This month, the Committee would like to highlight a webinar hosted by the International Society of Exposure Science. This presentation will feature Dr. Rachael Jones (Utah Center for Promotion of Work Equity Research), and will be held on January 25th (from 11 am to 12 pm ET). Dr. Jones will use COVID-19 to illustrate the relative strengths and limitations, and linkages between risk assessment and epidemiology.

More information and a link to the registration page are available HERE.

To learn more about the Environmental Epidemiology Committee or the webinar series, or to suggest speakers, please contact Dr. Sandrine Deglin (sdeglin@hesiglobal.org).

HESI Board of Trustees Meeting

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The HESI Board of Trustees will meet on January 18th and 19th to review 2021 achievements and challenges, approve a 2022 organizational budget, progress the strategic plan, and refine Board priorities for 2022.

HESI’s Board of Trustees is comprised of 14 public sector representatives and 13 private sector representatives. We are proud to work with this group of amazing scientists and thank them for their commitment to HESI and HESI’s mission of developing science-based solutions for a safer, more sustainable world.

For more information on these efforts, please contact HESI (hesi@hesiglobal.org).

New Propagate Publication in PLOS ONE

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An international, interlaboratory ring trial confirms the feasibility of an extraction-less “direct” RT-qPCR method for reliable detection of SARS-CoV-2 RNA in clinical samples

RT-qPCR is used world-wide to test and trace the spread of SARS-CoV-2. Extraction-less or direct RT-PCR is an open-access qualitative method for SARS-CoV-2 detection from nasopharyngeal (NP) or oral pharyngeal (OP) samples with the potential to generate actionable data more quickly, at a lower cost, and with fewer experimental resources than full RT-qPCR. This study engaged ten global testing sites, including laboratories currently experiencing testing limitations due to reagent or equipment shortages, in an international inter-laboratory ring trial. Participating labs were provided a common protocol, common reagents, aliquots of identical pooled clinical samples and purified nucleic acids, and used their existing in-house equipment. We observed 100% concordance across labs in the correct identification of all positive and negative samples, with highly similar Ct values observed. The test also performed well when applied to locally collected patient NP samples, provided the viral transport media did not contain charcoal or guanidine, both of which appeared to potently inhibit the RT-PCR reaction. Our results suggest that direct RT-PCR assays are a feasible option for more efficient COVID-19 testing as demanded by the continuing pandemic.

Read the full article in PLOS ONE published here:

Mills et. al. January 13, 2022. PLOS ONE. An international, interlaboratory ring trial confirms the feasibility of an extraction-less “direct” RT-qPCR method for reliable detection of SARS-CoV-2 RNA in clinical samples

HESI presentations at upcoming SOT 2022 Annual Meeting

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The following HESI Scientific Committees will be presenting at the upcoming Society of Toxicology meeting, which will be held virtually and in person in San Diego, CA March 27-31, 2022:

Accepted Talks

PBPK Models

  • Optimizing the Design of Repeated-Dose Animal Studies to Inform Human Health Risk Assessment by Integrating Exposure, In vitro, and In Silico Data; Platform session; Speaker Dr. Michelle Embry  3/31/2022 8:30 – 11:15


  • HESI Scientific Program Manager, E’Lissa Flores, was invited by the Education Committee of the Immunotoxicology Specialty Section (ITSS) of the Society of Toxicology (SOT) to speak at their 8th Networking/Mentoring event for student and postdoctoral trainees. This event allows trainees to meet experts from the ITSS working in academia, government, industry, nonprofits, and contract research organizations.

Accepted Posters

Botanical Society Consortium (BSC):

  • Application of In Silico and In Vitro Approaches for Evaluating Developmental and Reproductive Toxicity in Botanical Products, 3/28/2022 2:30:00 PM to 3/28/2022 4:15:00 PM
  • A Strategy for Developing a Framework of Genotoxicity Assays for Safety Assessment of Botanicals 3/30/2022 2:30:00 PM to 3/30/2022 4:15:00 PM
  • In Silico Prediction of Botanical Constituents’ Metabolites 3/30/2022 2:30:00 PM to 3/30/2022 4:15:00 PM
  • Physiologically based pharmacokinetic (PBPK) simulations and modeling of botanical constituents – TBD

Emerging Systems Toxicology for the Assessment of Risk (eSTAR):

  • A Collaborative Initiative to Establish Molecular Biomarkers for Assessing Risk of Chemical Carcinogenesis to Reduce Reliance on Conventional Rodent Carcinogenicity Studies, 3/30/2022 10:45:00 AM to 3/30/2022 12:30:00 PM


HESI participation in MPS World Summit

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HESI is among 30+ international organizations and companies supporting a series of annual Microphysiological systems (MPS) World Summits to present the latest scientific achievements, discuss the advances and challenges, and enable communication between young and newly interested scientists and pioneers of the MPS field.

HESI’s mission aligns with the proposed goal of the MPS World Summit of planning a series of global conferences on microphysiological systems towards bringing all stakeholders together from across sectors and career stages to promote the development and application of this technology, to facilitate its expanded scientific and regulatory use.

Please see the 2022 Summit event page (https://mpsworldsummit.com/session/hybrid-conference/) and submit your abstracts (due January 31st, 2022, 11:59pm PST). The Summit will be a hybrid event, held May 30th-June 3rd, 2022. For questions about the initiative, feel free to reach out to HESI’s contact point: Lucilia Mouriès (lmouries@hesiglobal.org).

From the Leadership

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Happy New Year to the HESI Family!  COVID-19 continues to serve us curve balls, so thanks to Omicron the January Board meeting was moved to a virtual meeting.  Hopefully, this will be our last virtual meeting and the June 8-9 meeting will be face-to-face in Washington!

For the January 2022 edition of Insights, I want to highlight a few items from the upcoming January 18-19 Board meeting.  Syril will begin the Board meeting with a 2021 Look Back and 2022 Look Ahead that is summarized in the 2021 HESI Annual Report.  The future is bright despite the challenges of COVID-19 with 17 publications, 19 new committee initiatives and increasing cross-committee collaboration highlighting a culture of innovation that is thriving!  We also saw a strengthening of compliance policies, formalizing committee chair training, and growth in cross-sector membership and financial reserves, all of which provide a strong organizational foundation.  The Board will discuss a proposal to create a Special Project Reserve to seed strategic initiatives identified from the Science Foresight document.  The EIC deserves a hearty thanks for creating a roadmap for the next ten years!  A major portion of the meeting will focus on the three Board Strategic Initiatives:  Science Foresight (e.g., Public Health Education), Academic Outreach (e.g., Innovation Prize), and Global Outreach (e.g., Global Risk Assessment Training Center – GRATC).  Our new Board/EIC members will be voting for the first time on these key initiatives:  Roger Chammas (University Sao Paolo), Rose Omari (CSIR-STEPRI, Ghana), Sarah Hughes (Shell), Tracey Papenfuss (Charles River Labs), Patricia Escobar (Merck), and Stefan Pfuhler (P&G).

We are planning for the first true face-to-face meeting in June after a 27-month hiatus!  If all goes well, our keynote speaker will be Dr. Kenneth Olden who was awarded the first HESI Innovation Prize.

Again, thank you for your contributions to advancing HESI’s Mission in 2021 – we have thrived during this difficult time due to your dedication, sweat equity, and ingenuity!  We look forward to the return to normalcy in 2022.

Best regards,





Jon C. Cook, PhD, ABT, DABT

HESI President

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