1 Computational Toxicology Promotes Regulatory Science
11
30. Amberg A, Beilke L, Bercu J et al (2016) Principles and procedures for implementation of ICH
M7 recommended (Q)SAR analyses. Regul Toxicol Pharmacol 77:13–24
31. Barber C, Amberg A, Custer L et al (2015) Establishing best practice in the application of
expert review of mutagenicity under ICH M7. Regul Toxicol Pharmacol 73:367–377
32. FDA. Qualification of medical device development tools- guidance for industry, tool developers, and food and drug administration staff. Retrieved from https://www.fda.gov/downloads/
MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM374432.pdf.
Accessed on 26 Nov 2018
33. FDA. FDA’ predictive toxicology roadmap. Retrieved from https://www.fda.gov/downloads/
scienceresearch/specialtopics/regulatoryscience/ucm587831.pdf. Accessed on 26 Nov 2018
34. EPA. Endocrine disruptor screening program (EDSP) in the 21st century. Retrieved from
https://www.epa.gov/endocrine-disruption/endocrine-disruptor-screening-program-edsp21st-century. Accessed on 26 Nov 2018
35. European Chemical Agency. Read-across assessment framework (RAAF). Retrieved from
https://echa.europa.eu/documents/10162/13628/raaf_en.pdf. Accessed on 26 Nov 2018
36. Solid Waste and Chemicals Management Center, MET, China. Latest progress of chemicals
management in China. Retrieved from http://chemical-net.env.go.jp/pdf/20180123_Seminar1.
pdf. Accessed on 26 Nov 2018
37. Huang R, Xia M, Sakamuru S, Zhao J, Shahane SA, Attene-Ramos M, Zhao T, Austin CP,
Simeonov A (2016) Modelling the Tox21 10K chemical profiles for in vivo toxicity prediction
and mechanism characterization. Nat Commun 7:10425
38. Chesnut M, Yamada T, Adams T, Knight D, Kleinstreuer N, Kass G, Luechtefeld T, Hartung
T (2018) Regulatory acceptance of read-across. Altex 35(3):413–419
Rebecca Kusko is the SVP and Head of R&D at Immuneering Corporation. She completed
her undergraduate degree at MIT in Biological Engineering and earned a Ph.D. in Genetics and
Genomics from BU before joining Immuneering in 2014. At Immuneering, she has been accelerating pharma R&D using advanced algorithms. Additionally, she is a board member of the MAQC
Society, an initiative around best practices for big data analysis.
Huixiao Hong is Chief of Bioinformatics Branch, Division of Bioinformatics and Biostatistics,
National Center for Toxicological Research (NCTR), US Food and Drug Administration (FDA),
working on the scientific bases for regulatory applications of bioinformatics. Before joining the
FDA, he was Manager of Bioinformatics Division of Z-Tech, an ICFI company. He was a research
scientist position at Sumitomo Chemical Company in Japan and a visiting scientist at National
Cancer Institute at National Institutes of Health. He was also Associate Professor and the Director of Laboratory of Computational Chemistry at Nanjing University in China. Dr. Hong is the
member of steering committee of OpenTox, the member of board directors of US MidSouth Computational Biology and Bioinformatics Society, and in the leadership circle of US FDA modeling
and simulation working group. He published more than 180 scientific papers and served as Editorin-Chief and Editorial Board member for multiple peer-reviewed journals. He received his Ph.D.
from Nanjing University in China in 1990 and conducted research in Leeds University in England
in 1990–1992.
11
30. Amberg A, Beilke L, Bercu J et al (2016) Principles and procedures for implementation of ICH
M7 recommended (Q)SAR analyses. Regul Toxicol Pharmacol 77:13–24
31. Barber C, Amberg A, Custer L et al (2015) Establishing best practice in the application of
expert review of mutagenicity under ICH M7. Regul Toxicol Pharmacol 73:367–377
32. FDA. Qualification of medical device development tools- guidance for industry, tool developers, and food and drug administration staff. Retrieved from https://www.fda.gov/downloads/
MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM374432.pdf.
Accessed on 26 Nov 2018
33. FDA. FDA’ predictive toxicology roadmap. Retrieved from https://www.fda.gov/downloads/
scienceresearch/specialtopics/regulatoryscience/ucm587831.pdf. Accessed on 26 Nov 2018
34. EPA. Endocrine disruptor screening program (EDSP) in the 21st century. Retrieved from
https://www.epa.gov/endocrine-disruption/endocrine-disruptor-screening-program-edsp21st-century. Accessed on 26 Nov 2018
35. European Chemical Agency. Read-across assessment framework (RAAF). Retrieved from
https://echa.europa.eu/documents/10162/13628/raaf_en.pdf. Accessed on 26 Nov 2018
36. Solid Waste and Chemicals Management Center, MET, China. Latest progress of chemicals
management in China. Retrieved from http://chemical-net.env.go.jp/pdf/20180123_Seminar1.
pdf. Accessed on 26 Nov 2018
37. Huang R, Xia M, Sakamuru S, Zhao J, Shahane SA, Attene-Ramos M, Zhao T, Austin CP,
Simeonov A (2016) Modelling the Tox21 10K chemical profiles for in vivo toxicity prediction
and mechanism characterization. Nat Commun 7:10425
38. Chesnut M, Yamada T, Adams T, Knight D, Kleinstreuer N, Kass G, Luechtefeld T, Hartung
T (2018) Regulatory acceptance of read-across. Altex 35(3):413–419
Rebecca Kusko is the SVP and Head of R&D at Immuneering Corporation. She completed
her undergraduate degree at MIT in Biological Engineering and earned a Ph.D. in Genetics and
Genomics from BU before joining Immuneering in 2014. At Immuneering, she has been accelerating pharma R&D using advanced algorithms. Additionally, she is a board member of the MAQC
Society, an initiative around best practices for big data analysis.
Huixiao Hong is Chief of Bioinformatics Branch, Division of Bioinformatics and Biostatistics,
National Center for Toxicological Research (NCTR), US Food and Drug Administration (FDA),
working on the scientific bases for regulatory applications of bioinformatics. Before joining the
FDA, he was Manager of Bioinformatics Division of Z-Tech, an ICFI company. He was a research
scientist position at Sumitomo Chemical Company in Japan and a visiting scientist at National
Cancer Institute at National Institutes of Health. He was also Associate Professor and the Director of Laboratory of Computational Chemistry at Nanjing University in China. Dr. Hong is the
member of steering committee of OpenTox, the member of board directors of US MidSouth Computational Biology and Bioinformatics Society, and in the leadership circle of US FDA modeling
and simulation working group. He published more than 180 scientific papers and served as Editorin-Chief and Editorial Board member for multiple peer-reviewed journals. He received his Ph.D.
from Nanjing University in China in 1990 and conducted research in Leeds University in England
in 1990–1992.