Elizabeth Baker,
Pharmaceutical Policy Program Director,
Physicians Committee for Responsible Medicine
Elizabeth Baker, Esq., is the pharmaceutical policy program director for the Physicians Committee for Responsible Medicine, a U.S. based organization working for more effective, efficient and ethical research and testing. Ms. Baker focuses on modernizing drug development to save human and animal lives by integrating nonclinical methods that are more relevant to human biology. Ms. Baker leads the Nonclinical Innovation and Patient Safety Initiative (NIPSI), a broad group of drug development stakeholders working to advance human relevant technologies. Ms. Baker has authored numerous op eds, science blogs, regulatory petitions and manuscripts, including publication in Drug Discovery Today, ALTEX, The Hill, STAT News, the Food and Drug Law Institute Policy Forum, the North Carolina Central University School of Law Biotechnology and Pharmaceutical Law Review and the Physicians Committee’s Good Science Digest regarding FDA policy and innovative human biology-based science for drug development.
Advancing Nonclinical Regulation, Policy, Science, Education and Training
Tuesday, 15 October 2019 at 15:30
Add to Calendar ▼2019-10-15 15:30:002019-10-15 16:30:00Europe/LondonAdvancing Nonclinical Regulation, Policy, Science, Education and TrainingOrgan-on-a-Chip World Congress 2019 in Coronado Island, CaliforniaCoronado Island, CaliforniaSELECTBIOenquiries@selectbiosciences.com
Recent advances, 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 are expected to be more predictive for humans, and have mapped 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 regulations from requiring “animal” data to “nonclinical,” which encompasses animal in vivo and human and animal-based 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 NDAs that found no inclusion of organ chips in U.S. FDA submissions for approved drugs. Results will be updated for the meeting.
Add to Calendar ▼2019-10-14 00:00:002019-10-15 00:00:00Europe/LondonOrgan-on-a-Chip World Congress 2019Organ-on-a-Chip World Congress 2019 in Coronado Island, CaliforniaCoronado Island, CaliforniaSELECTBIOenquiries@selectbiosciences.com
Add to Calendar ▼2019-10-15 15:30:002019-10-15 16:30:00Europe/LondonAdvancing Nonclinical Regulation, Policy, Science, Education and TrainingOrgan-on-a-Chip World Congress 2019 in Coronado Island, CaliforniaCoronado Island, CaliforniaSELECTBIOenquiries@selectbiosciences.com
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