Stage 1 · Toolkit 1.1
Target Product Profile & Development Strategy
Define what the product is intended to become and how development decisions support that goal.
What it helps control
Operational support
Helps teams establish the procedures, working records, trackers, and evidence needed for Target Product Profile & Development Strategy.
How it helps your team
Make early development choices clearer, traceable, and easier to defend.
Designed for
Discovery leaders, translational scientists, nonclinical teams, programme leaders, and development governance groups.
Included files
Know exactly what the toolkit contains
The file names below show what is included. File contents become available only after purchase.
Word documents
- Target Product Profile Template
- Product Development Strategy Template
- Therapeutic Area Landscape Template
- Unmet Need Assessment Template
- Differentiation Strategy Template
- Development Assumption Guidance
- TPP Decision Memo
Excel workbooks
- TPP Tracker
- Competitive Landscape Matrix
- Product Assumption Log
- Development Gap Tracker
- Evidence Support Matrix
Related toolkits
Continue within stage 1
Candidate Selection & Development Readiness
Decide whether a candidate is ready to enter formal development.
1.3Translational Pharmacology & Biomarker Strategy
Link mechanism, biology, pharmacology, biomarkers, and clinical rationale.
1.4ADME / DMPK Program Management
Plan and govern absorption, distribution, metabolism, excretion, PK, and exposure evidence.