Safety Scientific Working Group

2026

• Kordzakhia, G., Levin, G., Torres, C., Nyström, P., Li, H., & Hedman, K. (2026). Estimation of exponential rates in non-homogeneous populations using the EAIR estimator. Journal of Biopharmaceutical Statistics, 1–19. https://doi.org/10.1080/10543406.2026.2664116

2025

• Lin LA, Hammad TA, Liu W, Ma Y, Whalen E, Sinvhal R, Munsaka M, Wang W. Leveraging Multi-National Observational Study in Post-Marketing Safety Assessment: Challenges and Strategies. Ther Innov Regul Sci. 2025 Nov;59(6):1526-1536. doi: 10.1007/s43441-025-00836-5. Epub 2025 Aug 5. Erratum in: Ther Innov Regul Sci. 2025 Nov;59(6):1537. doi: 10.1007/s43441-025-00858-z. PMID: 40762766.
• Hendrickson, B.A., Drogaris, L., and Munsaka, M. Data Monitoring Committees. In Pharmacovigilance: A Practical Approach. Elsevier, St. Louis, MO, Second Edition, 2025.
• Hendrickson, B.A., Rosenberg, T., and Setze, C. Product Aggregate Safety Assessment. In Pharmacovigilance: A Practical Approach. Elsevier, St. Louis, MO, Second Edition, 2025.
• Munsaka, M.S., Introduction to Quantitative Methods and Visual Analytics in Drug Safety Data in Clinical Trials. In Pharmacovigilance: A Practical Approach. Elsevier, St. Louis, MO, Second Edition, 2025.
• Verdugo, Maria., Wick-Urban, Bettina., Da Silva-Tillmann, Barbara. Benefit-Risk Management. In Pharmacovigilance: A Practical Approach. Chapter 15. Elsevier, St. Louis, MO, Second Edition, 2025.
• Ma, Y., Haddad, J., Liu, W. et al. Review of Recent Pharmacoepidemiologic Post-Market Safety Studies Through the Lens of the Estimand Framework. Ther Innov Regul Sci 59, 971–980 (2025). https://doi.org/10.1007/s43441-025-00780-4

2024

• Hendrickson BA, McShea C, Ball G, Talbot S. How Aggregate Safety Assessment Planning Supports Investigational New Drug Safety Reporting Decisions. Ther Innov Regul Sci. 2024 Jul;58(4):579-590. doi: 10.1007/s43441-024-00634-5. Epub 2024 Mar 30. PMID: 38555342.
• Gebel M, Renz C, Rodriguez L, Simonetti A, Yang H, Edwards B, Higginson JM, Charpentier N, Colopy M. A Survey to Assess the Current Status of Structured Benefit-Risk Assessment in the Global Drug and Medical Device Industry. Ther Innov Regul Sci. 2024 Jul;58(4):756-765.
• Hedman K, Lisovskaja V, Nyström P. A safety estimand for late phase clinical trials where the analysis period varies over the subjects. Clin Trials. 2024 Aug;21(4):483-490.
• Simonetti A, Colilla S, Edwards B, Kübler J, Lackey L, Rodriguez L, Talbot S, Yang H, Wang W, Williams D, Higginson JM. Key Opinion Leaders' Interviews to Inform the Future of Benefit-Risk Planning in the Medical Total Product Life Cycle of Global Pharmaceutical and Medical Device Organizations. Drug Saf. 2024 Sep;47(9):853-868.
• Hedman K, Kordzakhia G, Li H, Nyström P. Estimand Framework and Statistical Considerations for Integrated Analysis of Clinical Trial Safety Data. Ther Innov Regul Sci. 2024 Nov;58(6):1120-1128.

2023

• Hendrickson, B.A., Agarwal, A., Bennett, D., Kübler, K., McShea, C. and Tremmel, (2023). L. Value and Implementation of the Aggregate Safety Assessment Plan. Pharm Med 37(3):171-181

2022

• Munsaka, M., Liu, M., Xing, y., Yang, H. (2022). Leveraging Machine Learning, Natural Language Processing, and Deep Learning in Drug Safety and Pharmacovigilance. In Data Science, AI, and Machine Learning in Drug Development. Yang, H. (Ed.). doi.org/10.1201/9781003150886
• Hendrickson, Barbara A. The Aggregate Safety Assessment Plan – a valuable tool for clinical trial safety planning. Pharma Focus Asia. Issue 46: 24-27, 2022.
• Waschbusch M, Rodriguez L, Brueckner A, Lee KJ, Li X, Mokliatchouk O, Tremmel L, Yuan SS. Global Landscape of Benefit-Risk Considerations for Medicinal Products: Current State and Future Directions. Pharmaceut Med. 2022 Aug;36(4):201-213. doi: 10.1007/s40290-022-00435-x. Epub 2022 Jul 3. PMID: 35780471.

2021

• Buchanan J, Li M, Ni X, Wildfire J. A New Paradigm for Safety Data Signal Detection and Evaluation Using Open-Source Software Created by an Interdisciplinary Working Group. Ther Innov Drug Dev. (2021). doi.org/10.1007/s43441-021-00319-3
• Hendrickson BA, Wang W, Ball G, Bennett D, Bhattacharyya A, Fries M, Kuebler J, Kurek R, McShea C, Tremmel L. Aggregate Safety Assessment Planning for the Drug Development Life-Cycle. Ther Innov Regul Sci. 2021 Jul;55(4):717-732. doi: 10.1007/s43441-021-00271-2. Epub 2021 Mar 23. PMID: 33755928.
• Wang, W., Munsaka, M., Buchanan, J., & Li, J. (Eds.). (2021). Quantitative Drug Safety and Benefit Risk Evaluation: Practical and Cross-Disciplinary Approaches (1st ed.). Chapman and Hall/CRC. https://doi.org/10.1201/9780429488801

2020

• Ball G, Kurek R, Hendrickson BA, Buchanan J, Wang WW, Duke SP, Bhattacharyya A, Li M, O'Brien D, Weigel J, Wang W, Jiang Q, Ahmad F, Seltzer JH, Herrero-Martinez E, Tremmel L. Global Regulatory Landscape for Aggregate Safety Assessments: Recent Developments and Future Directions. Ther Innov Regul Sci. 2020 Mar;54(2):447-461. doi: 10.1007/s43441-019-00076-4. Epub 2020 Jan 6. PMID: 32072595; PMCID: PMC7222952
• Wang W, Nilsson M, Revis R, Crowe B. Interactive visualization for clinical safety data review. Biopharmaceutical Report 2020;27:2-8

2018

• Zink RC. (2018). Introduction to the Special Section for Sources of Safety Data and Statistical Strategies for Design and Analysis. Therapeutic Innovation & Regulatory Science 52: 140.
• Zink RC, Marchenko O, Sanchez-Kam M, Ma H & Jiang Q. (2018). Sources of safety data and statistical strategies for design and analysis: Clinical trials. Therapeutic Innovation & Regulatory Science 52: 141-158.
• Izem R, Sanchez-Kam M, Ma H, Zink RC & Zhao Y. (2018). Sources of safety data and statistical strategies for design and analysis: Post-market surveillance. Therapeutic Innovation & Regulatory Science 52: 159-169.
• Marchenko O, Russek-Cohen E, Levenson M, Zink RC, Krukas-Hampel M & Jiang Q. (2018). Sources of safety data and statistical strategies for design and analysis: Real world insights. Therapeutic Innovation & Regulatory Science 52: 170-186.
• Ma H, Russek-Cohen E, Izem R, Marchenko O & Jiang Q. (2018). Sources of safety data and statistical strategies for design and analysis: Transforming data into evidence. Submitted to Therapeutic Innovation & Regulatory Science 52: 187-198.
• Wang, W., Whalen, E., Munsaka, M., Li, J., Fries, M., Kracht, K., Sanchez-Kam, M., Singh, K. Zhou, K. (2018). On Quantitative Methods for Clinical Safety Monitoring in Drug Development. Statistics in Biopharmaceutical Research, 10(2), 85–97. https://doi.org/10.1080/19466315.2017.1409134

2017

• Marchenko O, Jiang Q, Chuang-Stein C, Mehta C, Levenson M, Russek-Cohen E, Liu L, Sanchez-Kam M, Zink RC, Ke C, Ma H, Maca J & Park S. (2017). Statistical considerations for cardiovascular outcome trials in patients with type 2 diabetes mellitus. Statistics in Biopharmaceutical Research 9: 347-360.

.

• Colopy M, Duke S, Ball G, Gordon R, Ahmad F, Jiang Q, Wang Wenquan & Wang William. (2016). ASA Biopharm’s Safety Monitoring Working Group: Survey of statisticians, thought leaders and regulatory guidance. JSM Proceedings 3030-3042.
• Fries M, Kracht K, Li J, Munsaka M, Sanchez-Kam M, Singh K, Wang W, Whalen E, Zhou K. (2016). Safety monitoring methodology in the premarketing setting. JSM Proceedings 2247-2269.

.

• Marchenko O, Jiang Q, Chakravarty A, Ke C, Ma H, Maca J, Russek-Cohen E, Sanchez-Kam M, Zink RC & Chuang-Stein C. (2015). Evaluation and review of strategies to assess cardiovascular risk in clinical trials in patients with type 2 diabetes mellitus. Statistics in Biopharmaceutical Research 7: 253-266.