Preparing for commercialization?
Discuss commercial readiness, launch timing and organizational decisions with PharmaKonsult.
Executive Checklist
The Biotechnology Commercial Readiness Checklist
50 questions CEOs and boards should answer before a first commercial launch.
50 Questions CEOs and Boards Should Answer Before First Commercial Launch
A first product launch is a company transformation. This checklist helps biotechnology leadership examine commercial readiness across market, patient, physician, competition, evidence, access, organization, leadership, operations and launch governance.
It is designed to be used with the Commercial Readiness Framework and a formal launch readiness assessment. Timing guidance is illustrative; actual sequencing depends on the company, therapy, indication and market.
This HTML checklist is publicly crawlable. Use it as an executive discussion tool—not a substitute for independent commercial judgment.
Market
- 1. What is prevalence versus the diagnosed population?
- 2. How many patients are currently treated in the relevant pathway?
- 3. Where are patients geographically concentrated?
- 4. What is the realistic addressable opportunity at launch?
- 5. Which assumptions in the forecast have never been independently challenged?
Patient
- 6. How do symptoms first appear?
- 7. Where do diagnostic delays occur?
- 8. What triggers specialist referral?
- 9. How is diagnosis confirmed?
- 10. Where can patients be lost before treatment initiation?
Physician
- 11. Who diagnoses versus who treats?
- 12. How concentrated is the specialist universe?
- 13. What evidence will change physician behavior?
- 14. What institutional protocols influence adoption?
- 15. Which Centers of Excellence shape standards of care?
Competition
- 16. What therapies are used today?
- 17. What pipeline competitors may launch nearby?
- 18. What switching barriers exist?
- 19. How might guidelines evolve?
- 20. Is differentiation clinically and commercially credible?
Evidence
- 21. What clinical evidence will physicians require?
- 22. What health-economic evidence will payers require?
- 23. Are quality-of-life or resource-utilization data needed?
- 24. What real-world evidence plans exist?
- 25. Which evidence gaps remain actionable before launch?
Market Access
- 26. What reimbursement barriers are anticipated?
- 27. How will prior authorization work in practice?
- 28. What distribution and specialty pharmacy model is required?
- 29. Is patient support designed for the access journey?
- 30. Where could abandonment occur after prescription?
Organization
- 31. Which capabilities must be internal at launch?
- 32. What can be outsourced initially?
- 33. Is the organization designed around the market?
- 34. Are functional responsibilities clear?
- 35. What budget is required for a right-sized model?
Leadership
- 36. When must experienced commercial leadership be in place?
- 37. Does leadership have first-launch or rare-disease experience where relevant?
- 38. Can commercial leaders influence cross-functional decisions?
- 39. Is board communication on commercial risk adequate?
- 40. Are decision rights clear?
Operations
- 41. Are training, analytics and commercial operations sequenced?
- 42. Is supply chain ready for launch scenarios?
- 43. Are systems adequate for specialty execution?
- 44. Are patient services operationally defined?
- 45. Have dependencies across functions been mapped?
Launch Governance
- 46. Are milestones owned with deadlines?
- 47. Is there a clear escalation path?
- 48. Are the five greatest launch risks visible to leadership?
- 49. How will the organization know it is ready?
- 50. Is cross-functional governance operating before launch?
What Should Leadership Do Next?
Identify the questions the organization cannot answer clearly. Those gaps are often where commercial risk concentrates. Then prioritize actions while options remain open—before major hiring, board commitments or launch investment lock in.
