Services

Dr. Robert W. Busby is a former biotech executive with more than 25 years industrial experience.  He is an accomplished scientific and organizational leader who provides independent consulting services for start-ups, biotech and pharmaceutical companies, leveraging his personal experience, industry knowledge, and professional network. An experienced preclinical R&D scientist, Dr. Busby specializes in strategic and operational IND consulting, where he helps small to mid-sized life science companies overcome the challenges of transitioning new therapeutics from discovery into first-in-human and proof-of-concept studies. 

• Strategic IND planning
• Objective analysis of candidate selection data
• Data-driven preclinical R&D representation
• Gap analysis on IND capability to build strong IND teams
• Writing/editing of reports for regulatory filings
• IND/NDA/MAA summary writing and editing
• Clinical pharmacology support throughout development
• ADME, PK/PD, and pharmacology data analysis
• Immunogenicity testing of peptides
• Due diligence on new projects or licensing opportunities
• Grant review, letters of support, letters of reference
• R&D operational efficiency consulting
• Organizational capabilities to execute business plan
• Assessing internal build out vs. outsourcing plans