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Aduhelm Development Problems

Aduhelm, developed by Biogen, is a drug intended to treat Alzheimer's disease by targeting amyloid plaques in the brain. The development and approval process for Aduhelm were fraught with challenges, including clinical trial setbacks, regulatory controversies, and management issues.

Key Problems

Clinical Trial Issues

Regulatory Challenges

Cost and Pricing Issues

Management and Coordination Failures

Document Version Mismatches

Impact on Stakeholders

Conclusion

The Aduhelm Development highlights the critical importance of effective project management, including robust document version control, in large-scale pharmaceutical projects. The clinical trial issues, regulatory challenges, and management failures underscore the need for meticulous planning, coordination, and transparency to avoid similar problems in future projects.

The estimated financial losses associated with the Aduhelm development and approval process, combining immediate costs and market impact, could be around $20 billion. This includes: