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Winter 2018 Newsletter - 12/2017



Newsletter – Winter 2018

 

NOTE FROM KINEXUM CEO

By Thomas Seoh

President and Chief Executive officer

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Dear Friends of Kinexum,

Welcome to our Winter 2018 Kinexum Newsletter. Gordon Cutler, M.D., an expert endocrinologist on the Kinexum Clinical Development team who has had a distinguished career at NIH and Eli Lilly, writes incisively on a hierarchy of drug development principles. 

Gaby Wiederkehr, MSc, a Lausanne-based member of the Kinexum Regulatory team, who has led global regulatory groups at Novartis, Ciba-Vision, Acino Pharma and Bayer Consumer Care, reports on the FIP (International Pharmaceutical Federation) meeting earlier this fall in Seoul and shares an ironic story about a Big Pharma’s attempt to increase drug access.

Two articles relate to the World Congress on Targeting Metabesity that Kinexum helped organize in London at the end of October. Guest author Payal Marathe, a senior associate at Close Concerns, summarizes her address at the conference, entitled “The Most Important Stakeholder: People,” which highlights five societal things that need to happen if we are to effectively prevent diabetes, obesity and other chronic diseases.  Monalisa Chatterji, a Bangalore-based expert on the Kinexum Non-Clinical team, previously with organizations such as AstraZeneca, Biocon and Reametrix, summarizes her take-homes from the congress.(read more)     

PHARMACEUTICAL INNOVATIONS: PAST, PRESENT AND FUTURE

By Gordon B. Cutler, Jr., M.D. This email address is being protected from spambots. You need JavaScript enabled to view it.

Drug discovery has never been easy.  Nearly 2000 years ago, Galen described more than 150 drug products—single and compound products from natural sources, discovered empirically over millenia—that were used by physicians in the Greco-Roman period. (read more) 

5 THINGS PATIENTS NEED FOR DIABETES PREVENTION

By Payal Marathe

Senior Associate, Close Concerns This email address is being protected from spambots. You need JavaScript enabled to view it.

I was delighted to speak at the first World Congress on Targeting Metabesity, to represent the perspective of patients and the public. (read more)

Responses to Payal from Prof. Philip Home Click here

An Epiphany - NOTE FROM KINEXUM FOUNDER

By Alexander Fleming, M.D.

Executive Chairman This email address is being protected from spambots. You need JavaScript enabled to view it.

We are entering the season of lights, celebrations, and imagining peace on earth.  The Christian celebration of Christmas ends on January 6 with the observance of Epiphany, marking the visit of the Magi—wise men—to the stable.  I love the word and concept of epiphany, which is much broader and older than its liturgical use.  To the ancient Greeks, ἐπιφάνεια, epiphaneia, meant a striking manifestation, an experience of sudden and striking realization.  Its meaning evolved to include the unexpected grasp of reality precipitated by a simple event or other trigger.  

I experienced an epiphany at the first Metabesity Congress in London though this event did not qualify as simple.  It was one of the most enlightening, engrossing, and consequential conferences of any that I have ever experienced.  As Thomas has described, it was a meeting of preeminent experts from multiple, diverse disciplines who deeply connected with one another around a very broad theme. My epiphany is that after a career centered on developing therapies to manage or palliate disease, I should devote my remaining days to things that prevent disease or restore health. (read more) 

REporT FROM FIP CONGRESS, SEOUL, 9/2017

By Gabrielle Wiederkehr, MSC This email address is being protected from spambots. You need JavaScript enabled to view it.

First some background on “FIP”: FIP, the International Pharmaceutical Federation, is the global body representing pharmacy and pharmaceutical sciences. Through 140 national organizations, academic institutional members and individual members, FIP represents over three million pharmacist and pharmaceutical scientists around the world. (read more)

pERSONAL REFLECTIONS ON METABESITY 2017

By Monalisa Chatterji, Ph.D. This email address is being protected from spambots. You need JavaScript enabled to view it.

The 2017 Metabesity Congress was a unique forum which brought together thought leaders from different domains, resulting in the exploration of areas much beyond the defined agenda.  Discussions over the two days touched aspects of society, policy-making, reimbursement, ethics, science, human behavior, and technology! (read more) 

 

Recent Publications

Improving the Clinical Value and Utility of CGM Systems: Issues and Recommendations

http://care.diabetesjournals.org/content/early/2017/10/20/dci17-0043?papetoc=

                      We introduce you to the newest member of the Kinexum team:

Dahlia Sperling

Medical Writing

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To learn more about Dahlia

 

Kinexum provides strategic regulatory, clinical and non-clinical, manufacturing and other translational advisory services for life science product development.

Our experts typically have decades of experience in government, industry and/or academia, and have broad experience with a range of modalities (including small and large molecules, devices and digital health) and therapeutic areas (including diabetes, cardiovascular, GI, oncology, neurology, wound healing and infectious diseases).We manage and salvage complex assignments, and file regulatory submissions and negotiate with the FDA and agencies in other major markets.

If you would like to learn more about how Kinexum can help you, please contact us at: This email address is being protected from spambots. You need JavaScript enabled to view it. , Kinexum Services LLCPO Box 1260, 550 East Ridge Street, Harpers Ferry, WV 25425, (p) +1 (304) 535-3037, (f) +1 (304) 535-3166,  www.Kinexum,com.Follow us on