Welcome to March  Insights. Inside this edition: HESI at SOT, Workshop on Effluent Testing, and more!
March Insights
HESI at SOT
HESI Luncheon CITE Lecture (Monday, 14 March 2016, 12:45–1:45 PM, Hilton New Orleans Riverside, Jefferson Ballroom). Only a few spots remain! Register now for the HESI CITE lecture “Zika Virus, Host-Pathogen Evolution, and Transdisciplinary Solutions to Rapidly Emerging Public Health Crises.” Dr. Dawn Wesson, Associate Professor of Tropical Medicine at Tulane University, will provide background on the evolution of Zika and other similar viruses, its transmission and mechanism of action, and her thoughts on what diverse scientific disciplines will be required to control this rapidly spreading threat. To register for this lunchtime lecture, please click here.

Poster Presentation (Wednesday, 16 March 2016, 9:30 AM–12:45 PM, CC Exhibit Hall). The following poster will be presented: “In Vitro Fish Hepatic Metabolism: A Ring Trial to Evaluate Transferability, Intra- and Interlaboratory Reproducibility” (H.M. Peterson, M. Embry, K. Fay, M.J. Bernhard, I. Bischof, J.W. Davis, J. Domoradzki, M. Halder, X. Han, J. Hu, K.M. Johanning, H. Laue, D. Nabb, J. Nichols, C. Schlechtriem, H. Segner, L. van der Wal, and J. Weeks).

HESI Members Contribute to New Toxicology Book

HESI is pleased to share a new book titled, Drug Discovery Toxicology: From Target Assessment to Translational Biomarkers, which was co-edited by Dr. J. Eric McDuffie at Janssen, a long-time HESI member, along with several other HESI members and partners. Congratulations to these collaborators! Check out the book here.

Open Surveys
  • Male Reproductive Toxicology. The DART Technical Committee has launched a survey toward understanding the predictivity of adverse findings in nonclinical male fertility studies to clinical outcomes in men. The survey is open to all who are willing to contribute data. To learn more about or to participate in the survey, please contact Connie Chen ([email protected]). Survey responses will be accepted on a rolling basis through 30 June 2016.

  • Nonclinical Neonatal Models.  The DART Technical Committee has formed a workgroup to understand the best use of nonclinical approaches for neonatal therapeutics.  In order to gain a better understanding of the scope and application of available approaches across industry, regulatory, and academic institutes, you are invited to submit your experience with current nonclinical models of drug development intended for neonatal pediatric diseases via an open survey. Contact Connie Chen ([email protected]) to learn more or to participate in the survey.
HESI Workshop on Effluent Testing
An international workshop on “Concepts, Tools, and Strategies for Effluent Testing” was held March 2 – 4, 2016.  The workshop was sponsored by the HESI Animal Alternatives in Environmental Risk Assessment Technical Committee, and was generously supported by and hosted at the L’Oréal Research and Innovation facilities in Aulnay-sous-Bois, France.  Additional support was provided by Sanofi. The workshop objectives were to review the current state of the science in effluent testing, identify novel approaches, and discuss strategies to reduce the environmental impacts of effluents, integrating alternative approaches for chemical risk assessment. 

The workshop was attended by 44 scientists from academic, government, and private sector institutions from 13 countries and 6 continents (nearly 7, since one participant recently completed a 2+ month research trip to Antarctica!).  The 1.5 day workshop consisted of plenary presentations on the state of the science, followed by breakout sessions focused on several “real world” case studies.

A short communication from the workshop is planned, along with a critical review of effluent testing approaches.  The committee will present initial results of a global effluent testing survey at the SETAC Europe Annual Meeting in May 2016, and plans to continue with follow-up work through the year.

For more information on this project, please contact Dr. Michelle Embry ([email protected]).  

  Effluent workshop attendees donning their “Save the Fatheads” t-shirts.
 
Congratulations to HESI Staff!
Dr. Jennifer Young Tanir recently received the Chemical Society of Washington (CSW) 2015 Charles L. Gordon Award. Jennifer is being recognized for exemplary service to the profession of chemistry, chemists, and the CSW. She has been a HESI Scientific Program Manager since 2011 and a board member of CSW since 2010 and has held several active roles including Secretary and Councilor. See more here.

Dr. Raegan O’Lone has been elected to the Society of Toxicology (SOT) Nominating Committee as Specialty Section representative from the Molecular Biology Specialty Section. Raegan has been with HESI since 2008, most recently as a Senior Scientific Program Manager, and an SOT member since 2012. See more here.

Congratulations to Jennifer and Raegan!  

                     Dr. Jennifer Young Tanir                                                      Dr. Raegan O'Lone             
UPCOMING EVENTS
HESI Translational Immunotoxicology Webinar 
on Pediatric Investigational Plans

The ITC Translational Immunotoxicology group will hold a webinar on pediatric investigational plans on Monday, 28 March 2016  at 11 AM EST.  A review of current preclinical challenges and strategies, regulatory policy perspective, and case studies will be presented.  For more information, please contact Stan Parish ([email protected]). 

Save the Date! HESI Annual Meeting
The HESI Annual Meeting will be held 7-9 June 2016 in Arlington, Virginia. This year will feature a case study from research to application, explore current environmental health challenges, and much more. A draft agenda and registration are coming soon.
RECENT PUBLICATIONS

Solomon HM, Markis SL, Alsaid H, Bermudez O, Beyer BK, Chen A, Chen CL, Chen Z, Chmielewski G, DeLise AM, de Schaepdrijver L, Dogdas B, French J, Harrouk W, Helfgott, Henkelman RM, Hesterman J, Hew KW, Hoberman A, Lo CW, McDougal A, Minck DR, Lelia S, Stewart J, Sutherland V, Tatiparthi AK, Winkelmann CT, Wise LD, Wood SL, Ying X. (2016).  Micro-CT imaging: Developing criteria for examining fetal skeletons in regulatory developmental toxicology studies – a workshop report. Regulatory Toxicology and Pharmacology (early online access).


Stewart J, Breslin WJ, Beyer BK, Chadwick J, De Schaepdrijver L, Desai M, Enright B, Foster W, Hui JY, Moffat GJ, Tornesi B, Van Malderen J, Wiesner L, Chen CL. (2016). Birth control in clinical trials: Industry survey of current use practices, governance, and monitoring. Therapeutic Innovation and Regulatory Science. 50(2):155–168 (open access).

Thybaud V, Kasper P, Sobol Z, Elhajouji A, Fellows M, Guerard M, Lynch AM, Sutter A, Tanir JY. (2016). Genotoxicity assessment of peptide/protein related biotherapeutics: Points to consider before testing. Mutagenesis. Accepted (29 Feb 2016).

FROM THE EXECUTIVE DIRECTOR

With a membership base of more than 600 scientists actively participating in HESI programs, we have a tremendous network of expertise and ideas.  Over the next 8 weeks, we will be sharing information on new opportunities for all of these partners – in the public and private sector – to be more directly engaged in the governance and strategy of HESI.  Stay tuned and get ready to engage!

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