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Newsletter Summer 2018 - note from the CEO

Dear Friends of Kinexum,

Welcome to the Summer 2018 Kinexum Newsletter!  

We have three expert guest authors:  (i) Professor Lutz Heinemann discusses the status of biosimilar insulins; (ii) Rob Claar describes fast-track opportunities for development of stem cells and other advanced therapies in Japan; and (iii) Dr. Bart van der Schueren, Belgian representative to the EMA, reflects on key differentiators between the EMA and the FDA.  In addition, our Lana Pauls contrasts her experiences at the FDA, at IQVIA, the world’s largest CRO, and at Kinexum. 

 

We welcome David Brill, a US/European regulatory affairs expert who spent some decades at Boehringer Ingelheim, and Kinexum Associate Jennifer Zhao, a magna cum laude graduate of the Dartmouth College Class of 2018, who begins an initial one year stint with us in July.

 

Rob Claar presented on his topic in a Kinexum webcast earlier this month, and Bart van der Schueren will present on July 13, and we will have a future webcast on US and EU regulation of advanced therapies.  Recordings and slides of our webcasts are available on our website.  Also, our Fall Newsletter will contain a follow up piece on CMC aspects of advanced therapies.  Please - we would love any feedback on your interest level and value to you of these articles and webcasts.