Program Leadership and Portfolio Strategy
- Seasoned Global Program Leader (GPL) support for programs through IND, proof-of-concept, and approval.
- End-to-end development (IDP, CDP), risk mitigation and scenario planning
- Portfolio prioritization and governance support
Preclinical Development Strategy
- IND-enabling planning and oversight
- Pharmacology, PK/PD, translational and toxicology planning
- Dose projection and first-in-human (FIH) readiness
Clinical Development Strategy
- Study designs, combinations and indication strategy
- Clinical development plan (CDP)/Integrated development plan (IDP)
- Proof-of-concept and registrational pathways
- Global regulatory alignment and positioning
Quantitative and Translational Strategy
- Model-informed drug development (MIDD) strategy
- Dose selection and optimization
- Clinical pharmacology and pharmacometrics guidance
- Biomarker and translational integration
RWD/RWE and AI-Driven Insights
- Real-world evidence strategy and integration
- External control arm and value-based design support
- AI/ML data analytics and interpretation
Business Development & Due Diligence
- Asset evaluations and opportunity assessments
- Competitive landscape and differentiation analysis
- BD support for licensing, M&A, and co-development