Newsletter Spring 2018 - note from the CEO Thomas Seoh

note from CEO for Spring 2018 Newsletter

Dear Friends of Kinexum,

Welcome to the Spring 2018 Kinexum Newsletter.  Guest author Professor Philip Home of Newcastle, an international authority in diabetes, writes provocatively that excess food is toxic, and no medication or other intervention which does not either reduce calorie intake or disposal will have a major effect on secondary conditions such as type 2 diabetes or NASH. Kinexum pre-clinical expert Dave Edwards writes on common pitfalls in pre-clinical drug development and what a developer can do about them.  Brandon Jones, a Kinexum medical writer and electronic submissions specialist, unpacks the electronic Common Technical Document (eCTD) structure, history, rationale and advantages. 

We also welcome new additions to the Kinexum team:  Grant Edwards, M.D., (former Deputy Director of the Division of Oncology Products at FDA), Michael Sharp, Ph.D. (medical devices), Joyce Reyes,   (biologics and cell therapy CMC), Lana Pauls, MPH (strategic regulatory and project management), Brandon Jones (medical writer and eCTD specialist) and Anand Khedker, Ph.D. (biosimilar expert), 

Zan and I moderated separate panels at the GTCbio 11th Diabetes Summit in Boston April 9-11, a number of us will attend the Americal Diabetes Association 78th Scientific Sessions in Orlando June 22-26, and Liz Whalley-Buono will present at the GTCbio Opioid Crisis and Alternatives conference in Los Angeles June 26-27.  We also will host public webcasts on April 27 (along with Hogan Lovells) on drug regulation outlook for 2018 and beyond and on May 11 on targeting metabolism to attack metabesic diseases by Michael Zemel, Ph.D., co-founder and CSO of Nusirt Biopharma, Inc.