Welcome to Bluestem Pharma Consulting
Access the Advantages of Early Access Programs
Early or expanded access allows patients with serious or life-threatening diseases to access medicines they cannot otherwise get through clinical trials or normal commercial channels.
Companies considering this specialty area often lack understanding and enlist an expert to develop a roadmap for their early access journey.
Bluestem Pharma Consulting is such an expert that can help minimize risk and accelerate future growth.
We founded Bluestem Pharma Consulting to help pharma or biotech companies better understand and implement best practices for:
- global early and expanded access programs
- the role of early access as part of a broader global market access strategy
- capturing and utilizing real-world data from access programs


Committed to Helping Enhance Access to Medicines Around the World
- Understand the global early access landscape and best practices around risk mitigation
- See how early access can enhance broader market access strategies associated with future commercial launches
- Develop and implement a tailored external expanded access policy
- Learn how expanded access in the US can evolve throughout the life cycle of the medicine in development
- Understand how and why early access mechanisms are being used for post-trial supply rather than an open-label extension trial
- Develop and implement a roadmap for implementation of a global early access program that complements future commercial launches
- Determine the best operational solution depending on the stage of development
- Select an external partner to operationalize a global early access program
- Develop and implement a plan to capture and use real-world data coming from an early access program
- Engage with relevant patient advocacy groups related to early access
Our Purpose
Improving Lives
Embark on a journey with BLUESTEM PHARMA CONSULTING, where our purpose is to help pharma and biotech companies find solutions that have significant implications for health and well-being of patients all over the world. Committed to creating a profound impact, we strive to enhance lives globally by pushing the boundaries of what’s possible in pharmaceutical excellence.