Newsletter Winter 2019 - Note from the CEO

Note from the CEO 

Dear Friends of Kinexum, 

Welcome to the Winter 2019 edition of Kinexions, the Kinexum newsletter! 

Featured here are five Kinexum and guest authors on a plethora of topics:  

(i) Sue Manley, Kinexum Project Manager and former Global Head of Regulatory Operations for Novartis, discusses considerations for small to mid-sized companies in planning to file an NDA;

(ii) Dave Bergstrom, PhD, Kinexum strategic formulations and sourcing expert, outlines strategies for approaching CMC, new product development, and sourcing;

(iii) Tom Hedberg, PhD, a Kinexum senior medical writer and Executive Director of the International Medical Crisis Response Alliance (IMCRA), details the emerging silent epidemic of diabetes in China;

(vi) Jennifer Zhao, Kinexum Associate and recent graduate of Dartmouth, recaps Kinexum’s October webinar on the Targeting Aging with MEtformin (TAME) clinical trial that is pioneering a regulatory pathway with FDA for multiple diseases of aging; and

(v) Michael Cobb, software engineer of analytics software startup Navya Network, describes an application of machine learning in healthcare in the form of scalable treatment solutions for cancer diagnoses. 

Please join us for the next Kinexum public webcast on Friday, December 14, 2018, from 11 a.m. to noon, EST, by Tom Hedberg, PhD, on the causes, effects, and global aspects of post-traumatic stress disorder (PTSD) and responses to current treatment failure; you may register here.  

If you missed our previous webinar on the TAME clinical trial, you can find a recording here.

Kinexum will be in San Francisco during the upcoming JP Morgan Healthcare Conference, January 6-10, 2019, including at the RESI conference. If you would like to meet to discuss matters such as regulatory or clinical development strategy or negotiations with or a submission to FDA or another regulatory authority, please email  This email address is being protected from spambots. You need JavaScript enabled to view it.  to make an appointment.  

We are also very excited to announce our Metabesity 2019 congress on October 15-16, 2019 at the Carnegie Institution for Science in Washington, DC. Building on the great success of Metabesity 2017 in London, we are assembling another stellar set of speakers, including Victor Dzau, President of the National Academy of Medicine, Richard Hodes, Director of the National Institute of Aging, and Janet Woodcock, Director of the FDA Center for Drug Evaluation and Research. Updates will appear in future Kinexions issues.

Wishing you a happy, healthy and fulfilling holiday season and 2019! 


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