Synopsis
Organoids, Tissue Bioengineering and AI/ML Tools:
New Approach Methodologies (NAMs) Minimizing Animal Studies for Pharmacology / ADME / Tox in the Context of the FDA Roadmap
With the recent FDA memo on phasing out preclinical animal testing requirements for certain drugs and promoting the use of New Approach Methodologies (NAMs), the shift in broader strategy has brought new technologies to the forefront. This symposium covers a broad spectrum of NAMs, including organ-on-a-chip and AI/ML computation modeling, to reduce traditional animal studies in pharmacological safety and efficacy assessments. These future technologies and discoveries are essential to faster drug development and deeper understanding of human disease, ultimately resulting in better and safer novel treatments.
Topics covered:
- FDA stance on future preclinical data packages required for biologics investigational new drug (IND) applications
- Innovative approaches to Tissue Bioengineering in invitro organ systems
- Immune incorporation in modelling human tissues
- Tissue-on-a-chip advances in preclinical pharmacological and efficacy studies
- AI/ML computation modeling of real-world human data
Learn more and register here.
