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
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pharma consulting
Our Services

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
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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.

Our Testimonials

Expanded Access Coordinator, GSK

I’ve had the pleasure of working with John at both Clinigen and Tanner Pharma. John has been working within the managed access space for a long time at some key companies in the market. John has always continued to impress me with his knowledge and passion and goes the extra mile to understand his client’s needs. He has strong regulatory knowledge and understands what is means to run a successful managed access program. He is approachable, patient and I would happily recommend John to anybody who is looking for an expert to guide them through the process.

Bluestem Pharma Testimonial

Senior Executive, Former Service Partner Company

I had the pleasure of working for and with John in 2017/18 and later in 2021 as John was my client. John has the unique skill of bringing IQ and EQ to any situation. He is my go-to person if I have a question on how to distribute unlicensed medicines around the world. I have seen John display high level of integrity and work ethics. He treats everyone with respect, intelligence and kindness. I would work for him any day and would work with him again. Just waiting for the next opportunity to do so.

Senior Executive and Former Colleague

I had a chance to work with John over a period of several years while we were both at Idis and then Clinigen. We worked closely on a number of projects related to managed access programs. He is an expert in this field and is absolutely passionate about supporting patients. Through targeted and thoughtful questions, John was able to quickly identify the needs of our clients, and then lead the team to implement pragmatic solutions that met the needs of all stakeholders. I would not hesitate to recommend John as a consultant who can help companies of all sizes define and develop their strategy to provide early access to medicines around the world.

Senior European Biotech Leader, Ultragenyx

John is the most knowledgeable expert on international early access to innovative drugs that I ever met. He has 20 years of experience with the ever-changing regulations governing early access in multiple countries and helped us set up a reliable and compliant distribution network in record time which changed the lives of patients affected by inherited errors of metabolism in 12 European countries. I am impressed by John’s sense of urgency, his customer orientation and flexibility and would recommend him to anyone seeking advice on this challenging area of business.

 

Partnership

Strategic Alliances: Collaborating to Give Patients Hope for the Future

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BLUESTEM PHARMA CONSULTING is committed to advancing global well-being through access to medicines. Guided by principles of excellence, integrity, and sustainability, we help companies to understand the early access landscape and develop best practices for implementation of these programs. Our collaborative approach, strategic partnerships, and unwavering commitment to ethical practices defines us. Join us on a transformative journey as we shape the future of access to medicines, enriching lives and fostering a healthier world.