Kaizen Bioscience
Private biopharmaceutical investment and development organization focused on acquiring derisked, late-stage clinical assets and using computational modeling and data-driven approaches to design efficient clinical trials and accelerate regulatory submissions. Maintains academic partnerships and works in infectious disease and antimicrobial research.
Industries
Nr. of Employees
small (1-50)
Kaizen Bioscience
Philadelphia, Pennsylvania, United States
Services
Design and simulation of clinical trials using PK/PD models and virtual populations to optimize protocol parameters and reduce development timelines.
Application of ML/AI to analyze historical trial and real-world datasets to predict outcomes and inform trial design decisions.
Simulated bioequivalence studies to compare formulations using computational models.
Research programs focused on bacterial pathogens and antimicrobial resistance supported by laboratory and computational capabilities.
Regulatory planning services including pathway selection and preparation for regulatory filings.
Design and simulation of clinical trials using PK/PD models and virtual populations to optimize protocol parameters and reduce development timelines.
Application of ML/AI to analyze historical trial and real-world datasets to predict outcomes and inform trial design decisions.
Simulated bioequivalence studies to compare formulations using computational models.
Research programs focused on bacterial pathogens and antimicrobial resistance supported by laboratory and computational capabilities.
Regulatory planning services including pathway selection and preparation for regulatory filings.
Expertise Areas
- Model-informed drug development (MIDD)
- Clinical trial design and adaptive trials
- Pharmacokinetics and pharmacodynamics
- Infectious disease research and antimicrobial resistance
Key Technologies
- In silico clinical trials
- PK/PD modeling
- Machine learning / AI
- Virtual bioequivalence simulation
News & Updates
Press release announcing abstract acceptances, presentation of pediatric antibiotic pharmacokinetic data to ISOM, and intention to target FDA's CNPV pathway ahead of an NDA filing.
PDF version of the company's July 14 press release regarding abstract acceptances and pediatric PK data presentation.
Accepted abstracts and presentation of pediatric antibiotic pharmacokinetic data at a scientific meeting; company signaled regulatory targeting of FDA CNPV pathway ahead of an NDA filing.
Press release announcing abstract acceptances, presentation of pediatric antibiotic pharmacokinetic data to ISOM, and intention to target FDA's CNPV pathway ahead of an NDA filing.
PDF version of the company's July 14 press release regarding abstract acceptances and pediatric PK data presentation.
Accepted abstracts and presentation of pediatric antibiotic pharmacokinetic data at a scientific meeting; company signaled regulatory targeting of FDA CNPV pathway ahead of an NDA filing.