Based in the US, I leverage more than 30 years of experience in the pharmaceutical industry to guide biopharmaceutical companies as they explore the benefits of early access programs and integrate these programs and related initiatives into their global market access strategies.While these programs can offer a wide range of benefits to both the sponsor company and patients, they remain relatively unfamiliar, are defined by regulatory requirements that vary by geography, and require specialized expertise to execute flawlessly. I am passionate about helping patients around the world with unmet medical needs get access to lifesaving or life-changing medicines, and supporting companies as they implement these important programs.I began my career in pharma in 1991 as a statistician at 3M Pharmaceuticals and then joined Orphan Medical in 1994 to oversee the development and FDA approval of ANTIZOL. In 2006 I joined UK-based Idis, the pioneer in developing the concept of named patient programs. During my 12 years at Idis (and later Clinigen), I held various operational, commercial and management roles. I joined Tanner Pharma Group in 2019, a US-based company focused on design and implementation of global early access programs. During my combined time at Idis, Clinigen, and Tanner, I was involved with the implementation of more than 200 global access programs including expanded access programs in the US. If you have a need to speak with an expert in this area, please do not hesitate to reach out to me at john@bluestempc.com or call me at +1 651 503-7327.Some may ask what "Bluestem" means. I am an avid gardener, and the Little Bluestem prairie grass is prized for its blue-green leaf color and upright form. Densely mounded, it reaches a height of 3 feet by autumn, when it turns a striking reddish bronze, bearing illuminated tufted seeds. The rigid clumps can withstand snow and rain, allowing the reddish grass stems to remain upright for most of the winter.
