Nonclinical

• Review of draft regulatory documentation
• Briefing book support and authorship for pre-IND and INTERACT meeting interactions
• Study report and protocol content review and authorship
• Reagent QC and analytical methods documentation edits
• Authorship of full IND
• Authorship of Module 1, Module 2, Module 3, Module 4, Module 5
• Drafting or consolidation of TPP documents for regulatory filings

• Development of regulatory positioning and early interaction strategy
• General planning for IND readiness including gap analysis
• Animal model selection and study design
• Strategic interim leadership

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• IND roadmap delivery
• Gantt chart
• Timeline analysis
• Critical path identification
• Resource planning
• CRO/CDMO/vendor selection

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• Vendor/CRO selection
• Cross-functional vendor oversight with technical program management
• CRO audit planning and performance monitoring
• Project management, including maintaining up-to-date project timelines, organizing project team meetings, capturing meeting minutes, establishing RACI (responsible, accountable, consulted, informed) matrices, and following up on achievement of action items.

• Design of nonclinical proof-of-concept studies
• Feedback on critical quality attributes (CQA) and experimental ranges
• Compilation and review of nonclinical assay data
• Advisory on in vivo model selection and suitability, aka, a de novo nonclinical package or study design  
• Nonclinical study endpoint selection and study design
• Study report authorship
• De novo nonclinical package design
• Oversight of nonclinical study execution
• Nonclinical package/study gap analysis

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