Kristie Sullivan,
Vice President for Research Policy,
Physicians Committee for Responsible Medicine
Kristie Sullivan, M.P.H., is the Vice President of Research Policy with the Physicians Committee for Responsible Medicine, where she directs efforts to implement human-relevant alternatives to the use of animals in medical research, education, and the testing of drugs, chemicals, and other regulated products.
Ms. Sullivan has given more than 40 presentations to a variety of audiences and has co-authored publications with industry and government colleagues. She has organized several expert workshops, meetings, and trainings on a variety of topics related the modernization of regulatory toxicology. She is a founding member and Secretary of the American Society for Cellular and Computational Toxicology and has served on a number of government advisory committees.
Ms. Sullivan received her Master of Public Health in Toxicology from the University of Michigan. Before joining the Physicians Committee, Ms. Sullivan worked at the University of Michigan Occupational Safety and Environmental Health En¬vironmental Laboratory and the New York City Department of Health and Mental Hygiene.
Luncheon Presentation on Policy: Advancing Nonclinical Regulation, Policy, Science, Education and Training in the United States
Tuesday, 18 June 2019 at 14:00
Add to Calendar ▼2019-06-18 14:00:002019-06-18 15:00:00Europe/LondonLuncheon Presentation on Policy: Advancing Nonclinical Regulation, Policy, Science, Education and Training in the United StatesOrgan-on-a-Chip and Tissue-on-a-Chip Europe 2019 in Rotterdam, The NetherlandsRotterdam, The NetherlandsSELECTBIOenquiries@selectbiosciences.com
Recent developments, such as the U.S. Food and Drug Administration’s Predictive Toxicology Roadmap, represent a fundamental shift in how drugs will be developed and regulated. U.S. regulators now state the need to move away from animal testing towards new approach methodologies that can be expected to be more predictive for humans, and have begun mapping their plans for doing so. The Nonclinical Innovation and Patient Safety Initiative (NIPSI) collaboration is addressing the factors that impede the uptake of modern, predictive approaches, such as organ chips. Projects include changing U.S. FDA and International Council on the Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) regulations from requiring “animal” data to “nonclinical,” which encompasses in vivo, in vitro and in silico approaches; lobbying the U.S. Congress to increase funding allocated for human-based approaches; and working to establish a qualification pathway that covers in vitro platforms and computer models. The presentation will include results from a recent review of new drug applications (NDA) that found no inclusion of organ chips in U.S. FDA submissions for approved drugs.
Add to Calendar ▼2019-06-18 00:00:002019-06-19 00:00:00Europe/LondonOrgan-on-a-Chip and Tissue-on-a-Chip Europe 2019Organ-on-a-Chip and Tissue-on-a-Chip Europe 2019 in Rotterdam, The NetherlandsRotterdam, The NetherlandsSELECTBIOenquiries@selectbiosciences.com
Add to Calendar ▼2019-06-18 14:00:002019-06-18 15:00:00Europe/LondonLuncheon Presentation on Policy: Advancing Nonclinical Regulation, Policy, Science, Education and Training in the United StatesOrgan-on-a-Chip and Tissue-on-a-Chip Europe 2019 in Rotterdam, The NetherlandsRotterdam, The NetherlandsSELECTBIOenquiries@selectbiosciences.com
