Harvard Case - Who Lives & Who Dies: Expanded Access for Experimental Drugs at Chimerix (A)
"Who Lives & Who Dies: Expanded Access for Experimental Drugs at Chimerix (A)" Harvard business case study is written by Amitabh Chandra, Spencer Lee-Rey. It deals with the challenges in the field of Operations Management. The case study is 18 page(s) long and it was first published on : Jun 8, 2021
The main protagonists in this case are:
- Dr. Michael Sherman: CEO of Chimerix, facing the difficult decision of balancing patient needs with responsible drug development.
- Patients and their families: Desperate for access to brincidofovir as a potential life-saving treatment.
- Healthcare providers: Facing ethical dilemmas in treating patients with limited treatment options.
- Regulatory bodies: Responsible for ensuring safety and efficacy of experimental drugs.
3. Analysis of the Case Study
This case study presents a complex ethical and strategic challenge for Chimerix. The company must balance the following:- Ethical considerations: Providing access to potentially life-saving drugs while ensuring patient safety and responsible drug development.
- Logistical challenges: Managing the complexities of expanded access programs, including patient selection, drug distribution, and data collection.
- Financial considerations: Balancing the costs of expanded access programs with the company's financial resources and long-term sustainability.
- Competitive landscape: Maintaining a competitive advantage in the pharmaceutical industry while navigating ethical and regulatory pressures.
Framework: This case study can be analyzed using the Framework for Ethical Decision Making which includes:
- Gather the Facts: Understand the situation, the stakeholders involved, and the potential consequences of different decisions.
- Identify the Ethical Issues: Determine the ethical principles at play, such as beneficence, non-maleficence, justice, and autonomy.
- Consider the Alternatives: Explore different options for expanding access to brincidofovir, weighing the potential benefits and risks of each.
- Evaluate the Alternatives: Assess the ethical implications of each option, considering the principles identified in step 2.
- Make a Decision: Choose the option that best aligns with the company's ethical values and strategic goals.
- Reflect on the Decision: Evaluate the outcome of the decision and consider how to improve future decision-making.
4. Recommendations
Chimerix should implement the following recommendations to address the challenges of expanded access to brincidofovir:
- Expand Compassionate Use Programs: Establish a well-defined and transparent compassionate use program for patients with life-threatening conditions who have exhausted all other treatment options. This program should include strict eligibility criteria, robust data collection, and ongoing monitoring of patient outcomes.
- Targeted Clinical Trials: Conduct targeted clinical trials to investigate the efficacy and safety of brincidofovir in specific patient populations. This will provide valuable data for regulatory approval and ensure the drug is used appropriately.
- Strategic Partnerships: Collaborate with key healthcare providers and advocacy groups to develop a comprehensive strategy for expanding access to brincidofovir. This includes establishing communication channels, providing training on the drug, and supporting patient education efforts.
- Invest in Technology and Analytics: Leverage technology and analytics to streamline the process of patient selection, drug distribution, and data collection. This will improve efficiency and ensure the program is scalable.
- Develop a Strong Communication Strategy: Communicate transparently with patients, healthcare providers, and the public about the availability of brincidofovir, the criteria for access, and the ongoing research efforts.
5. Basis of Recommendations
These recommendations are based on the following considerations:
- Core Competencies and Consistency with Mission: Chimerix's core competency is drug development, and its mission is to improve patient outcomes. Expanding access to brincidofovir aligns with these core values.
- External Customers and Internal Clients: The recommendations address the needs of patients, healthcare providers, and regulatory bodies.
- Competitors: By expanding access to brincidofovir, Chimerix can establish a leadership position in the treatment of viral infections and gain a competitive advantage.
- Attractiveness: Expanding access to brincidofovir has the potential to generate significant revenue for Chimerix, improve patient outcomes, and enhance the company's reputation.
These recommendations are based on the following assumptions:
- Patient Safety: Brincidofovir is safe and effective for treating specific viral infections.
- Regulatory Approval: Brincidofovir will eventually receive regulatory approval for use in specific patient populations.
- Financial Resources: Chimerix has the financial resources to support the expanded access program.
- Collaboration: Key stakeholders, including healthcare providers, advocacy groups, and regulatory bodies, will collaborate with Chimerix to ensure the program's success.
6. Conclusion
Chimerix faces a complex ethical and strategic challenge in expanding access to brincidofovir. By implementing a multi-pronged approach that prioritizes patient access while ensuring responsible drug development and resource allocation, Chimerix can navigate this challenge effectively. This approach will allow the company to fulfill its ethical obligations, improve patient outcomes, and maintain a competitive advantage in the pharmaceutical industry.
7. Discussion
Alternatives not selected:
- Restricting access to brincidofovir: This option would prioritize responsible drug development but would deny access to potentially life-saving treatment for patients in need.
- Uncontrolled distribution: This option would provide immediate access to the drug but would raise concerns about patient safety and data collection.
Risks and Key Assumptions:
- Safety concerns: There is a risk that brincidofovir may have unforeseen side effects in expanded access programs.
- Data collection challenges: Collecting accurate and reliable data from expanded access programs can be challenging.
- Financial constraints: Chimerix may face financial constraints in supporting the expanded access program.
Options Grid:
| Option | Benefits | Risks | Assumptions |
|---|---|---|---|
| Expand Compassionate Use Programs | Increased patient access, valuable data collection | Safety concerns, data collection challenges | Patient safety, regulatory approval |
| Targeted Clinical Trials | Robust data collection, regulatory approval pathway | Limited patient access, financial constraints | Patient enrollment, regulatory approval |
| Strategic Partnerships | Improved communication, resource sharing | Potential conflicts of interest, logistical challenges | Collaboration, shared goals |
| Invest in Technology and Analytics | Improved efficiency, scalability | High initial investment, data security risks | Technological advancements, data security |
| Develop a Strong Communication Strategy | Transparency, public trust | Potential for misinformation, negative media coverage | Effective communication channels, public engagement |
8. Next Steps
To implement these recommendations, Chimerix should take the following steps:
- Establish a dedicated team: Create a cross-functional team responsible for overseeing the expanded access program.
- Develop a detailed plan: Develop a comprehensive plan outlining the program's goals, objectives, and implementation strategy.
- Secure necessary resources: Allocate sufficient financial and human resources to support the program.
- Engage key stakeholders: Establish communication channels and build relationships with healthcare providers, advocacy groups, and regulatory bodies.
- Monitor and evaluate: Continuously monitor the program's progress and make adjustments as needed.
By taking these steps, Chimerix can ensure a successful and ethical expansion of access to brincidofovir, ultimately improving patient outcomes and strengthening the company's position in the pharmaceutical industry.
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