Providing expertise in three key areas, all of which complement each other.
Preclinical Development
- CMC and “Quality-by-Design” scientific and development strategy of biotherapeutics
- Program focused evaluation of drug development technologies, best fit-for-purpose target drug candidate platforms and scaffolds, devices and external partners to define start-to-finish integrated solutions tailored to target drug candidate to maximize outcomes and probability of success
- In vitro, ex vivo and in vivo pharmacology testing planning in support of Clinical Pharmacology and Modeling & Simulation strategies
- Assay development and bioanalytical strategies for preclinical and clinical studies (PK, immunogenicity, biomarkers, etc.)
Translational Research
- Evaluation of discovery platforms and outcomes validation
- Understanding disease etiologies and patient subtypes from patient derived biological and clinical data
- Pharmacology and pharmacodynamic assessment of drug candidates and their best fit in support of clinical development strategies
Strategy & Innovation
- Program management
- Horizon scanning to identify key innovations in science, drug scaffolds, new technologies and platforms that are likely to impact drug development strategies as part of portfolio evaluations
- Market and competitive intelligence analysis of a rapidly evolving landscape and proactively evaluate and define the “right spot” opportunities to portfolio management to maximize successful approval and post launch value
