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Expertise Across a Spectrum of Opportunities
Early access programs offer a wide range of benefits to patients and the sponsor company but they remain relatively unfamiliar, are defined by regulatory requirements that vary by geography, and require specialized expertise to execute flawlessly.
With decades of experience in developing and implementing global early access programs on behalf of pharma and biotech companies and other stakeholders, BLUESTEM PHARMA CONSULTING can tailor solutions that minimize risk and accelerate future growth.
BLUESTEM PHARMA
CONSULTING provides counsel in the following areas helping companies:
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
