PHARMACEUTICAL CEO CRISIS RESPONSE PLAN

FIRST 24 HOURS

Hour 1-2: Immediate Data Review

• Request all raw data and case studies from the research team that identified the issue
• Call legal team lead to understand formal reporting requirements and potential liabilities
• Consult with an independent hepatologist to verify the findings and understand the medical significance

Hour 3-6: Core Team Assembly

• Gather key executives (R&D, Legal, Regulatory Affairs, Communications, Manufacturing)
• Present findings and draft immediate action plan
• Assign clear responsibilities and establish 24/7 crisis management protocol

Hour 7-12: Board Preparation

• Brief board chairs individually before the full board meeting
• Prepare detailed briefing document including:
  • Medical evidence and risk assessment (1 in 8,000 over 5 years)
  • Financial exposure analysis
  • Potential regulatory pathways
  • Communication strategies

Hour 13-24: Initial Analysis & Strategy Formation

• Meet with executive team to validate findings
• Develop preliminary strategy for board consideration:
  • Accelerated reporting timeline
  • Patient notification protocol
  • Potential risk mitigation measures

SECOND 24 HOURS

Hour 25-36: Strategy Development

• Prepare comprehensive strategy for board meeting:
  • Patient safety intervention plan
  • Financial impact mitigation
  • Regulatory approach framework
  • Communications strategy

Hour 37-42: Stakeholder Preparation

• Individual briefings for board members ahead of the board meeting
• Focus on:
  • Patient safety imperatives
  • Legal risks of nondisclosure
  • Financial modeling of different scenarios
  • Potential reputational damage

Hour 43-46: Final Preparation

• Prepare board meeting presentation:
  • Clear data presentation
  • Decision framework with multiple options
  • Recommended path forward
• Briefing for communications team on potential media scenarios

Hour 47-48: BOARD MEETING

• Present facts and strategic framework to board
• Facilitate discussion addressing:
  • Patient safety vs. financial impact
  • Legal risks of different timelines
  • Board fiduciary duties
  • Long-term company reputation

POST-BOARD MEETING (FIRST 72 HOURS)

Immediate Aftermath

• Brief communications team to prepare for market reaction
• Initiate patient notification plan through medical affairs
• Begin drafting public statement for earnings call

EARNINGS CALL PREPARATION

• Prepare for earnings call (72-hour mark)
• Develop consistent messaging that balances transparency with appropriate disclosure
• Anticipate analyst questions and prepare responses
• Conduct mock Q&A session with tough questioning

PUBLIC STATEMENT

• Deliver transparent but responsible statement that:
  • Acknowledges the issue without causing panic
  • Outlines steps being taken to address it
  • Demonstrates commitment to patient safety
  • Provides clear timeline for resolution

REGULATORY PREPARATION

• Initiate formal adverse event reporting process
• Schedule pre-emptive meeting with key regulators
• Prepare comprehensive data package for regulatory submission

EMPLOYEE COMMUNICATION

• Internal announcement to employees:
  • Frame this as commitment to company values
  • Outline internal next steps
  • Reinforce ethical commitment to patients

LONGER-TERM STRATEGIC ACTIONS

Week 2:

• Implement enhanced pharmacovigilance program for ongoing safety monitoring
• Launch additional epidemiological study to confirm findings
• Meet with patient advocacy groups to establish open dialogue

Week 3-4:

• Prepare for potential congressional testimony if needed
• Develop patient compensation framework
• Begin strategic portfolio review to reduce dependence on single drug

Ongoing:

• Institute monthly safety review board
• Establish patient support program for affected individuals
• Implement culture transformation to prioritize safety signaling

KEY DECISION FRAMEWORK

Throughout this process, I would apply the following decision filter:

1. What is the right thing for patients?
2. What does the science dictate we should do?
3. What are our ethical obligations?
4. How would we want our company to act if we were patients?
5. What sets the standard for ethical behavior in our industry?

This approach balances multiple stakeholders while maintaining integrity to our core mission of patient service. It acknowledges financial realities while refusing to prioritize them over patient safety. It also positions the company as a leader in transparency and ethical conduct, which serves long-term interests better than attempting to manage the news.

The strategy embraces the reality that in today's information ecosystem, bad news always emerges eventually. The choice is between controlling the narrative through responsible disclosure or having it forced through less desirable means later. By choosing the path of transparency, we potentially reduce long-term financial and reputational damage while staying true to our core mission.