Newsletter Fall 2020



A Note from the CEO




Welcome to the Fall 2020 edition of Kinexions, Kinexum’s quarterly newsletter! In this issue is: an update on NASH development by Brian Harvey, MD, PhD, former Director of the FDA Division of Gastroenterology, and a note by a Kinexum panel urging developers to relook at Type 2 diabetes as a result of the FDA dropping the Cardiovascular Outcomes Trial requirement; a summary of Kinexum’s star-studded July webcast on the future of Type 1 diabetes; and some considerations for a COVID-19 plan for clinical trials affected by the pandemic. Also, please read a gripping piece by Larry Steinman, MD, PhD, co-discoverer of Tysabri, longtime former head of Stanford’s immunology and co-chair of the Metabesity conferences, as part of our personal biography series.  Finally, we've included the entire transcript and chat transcript of Kinexum’s historic September webinar on the role of biological clocks and other biomarkers of aging in regulatory development featuring leading aging biomarker researchers and Bob Temple, long-time thought leader from FDA...

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Newsletter Fall 2020 - A Note from the CEO, Thomas Seoh


NASH Development Update — Fall 2020





The Summer 2020 Update concluded with the following, May 22nd company announcement, as well as many unanswered questions:  "U.S. Food and Drug Administration (FDA) has notified Intercept that its tentatively scheduled June 9, 2020 advisory committee meeting (AdCom) relating to the company’s new drug application (NDA) for obeticholic acid (OCA) for the treatment of liver fibrosis due to nonalcoholic steatohepatitis (NASH) has been postponed..."

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Newsletter Fall 2020 - Brian Harvey, NASH Development Update—Summer 2020 




Webinar Recap: The Future of Type 1 Diabetes




At Kinexum’s July public webinar entitled, “The Future of Type 1 Diabetes: Where are we and where are we going?”, a panel of experts in pharmacologic advanced therapy and device innovation for type I diabetes (T1D) discussed the modalities currently used to treat individuals with T1D, as well as the elements of the disease on which preventative treatments should focus...

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Webinar Recap: The Future of Type 1 Diabetes by Brontë Jenkins, Associate, Kinexum


Lucky Larry, Immunologist in a Pandemic




I met the Kinexum team at Zan Fleming’s home in October 2019. Deborah and Zan welcomed us to their marvelous home after our second conference on Metabesity at the Carnegie Institution in Washington, DC last October.  The Fleming home is situated in Harper’s Ferry, high on a bluff overlooking the confluence of the Shenandoah and Potomac Rivers before they join forces and flow past our nation’s capital. In the fall of 2019, little did we know that in a few short months, a viral pandemic would change our lives drastically...

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Lucky Larry, Immunologist in a Pandemic by Larry Steinman, MD, Zimmerman Professor of Pediatrics, Stanford University 


A Note from the Chairman




As we approach the eve of Metabesity 2020 in the midst of the Pandemic, so much could be said.  Thomas has well summarized M20, other significant events, and the exceptional array of articles in this edition of Kinexions.  I will focus on a few people, starting with those who have managed to keep the firm stronger than ever in serving its clients while, at the same time, organizing a world-class conference.  Our COO Brian Oscherwitz, administrator Kristi Hultberg, and associates, Brontë Jenkins and Elijah Abass, have been doing the work of twice their number—all cheerful, unflappable, and relentless.  Fearless leader Thomas Seoh is a force of nature—with both a voracious love of science and innovation and practitioner of extreme ownership—working, learning, teaching all hours of the day and night.  His humility and compassion are not what you would expect in such a dynamo...

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A New Look for Multiple Therapeutic Shots on Goal for Treating Patients with Metabolic Diseases




The development of treatments for metabolic diseases—including diabetes, nonalcoholic steatohepatitis (NASH), obesity, and others—has seen a long, complex history. A golden era for diabetes therapeutic R&D was stimulated by results of the Diabetes Control and Complications Trial (DCCT) and the United Kingdom Prospective Diabetes Study (UKPDS) reported in the early 1990s...

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A New Look for Multiple Therapeutic Shots on Goal for Treating Patients with Metabolic Diseases



Preserving Clinical Trial Integrity in the Midst of a Pandemic — Hint: Don't Shoot the Albatross




In Samuel Taylor Coleridge’s Rime of the Ancient Mariner (1798), Coleridge explores the relationship between man and nature, and man’s struggle to control it.  One thing we ultimately learn is that humans cannot control all aspects of life, as much as it might be our inclination to do so. Rather, survival depends on coming to terms with nature...

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Preserving Clinical Trial Integrity in the Midst of a Pandemic — Hint: Don't Shoot the Albatross. by Brian Oscherwitz 


Webinar Recap: Biomarkers of Aging in Regulatory Development




On September 11, 2020, Kinexum and the Kitalys Institute held a seminal webinar entitled, "The Role of Biological Clocks and Other Biomarkers of Aging in Regulatory Development", which brought together a "dream team" panel of Steve Horvath of UCLA (discoverer of the DNA methylation epigenetic clock), Morgan Levine of Yale (developer of the INDEX biological clock offered by Elysium to support sales of its BASIS NAD+ supplements), and Polina Mamoshina of Deep Longevity (former head of biomarker development for AI leader Insilico Medicine) with Luigi Ferrucci (Scientific Director of the National Institute on Aging and preeminent FDA thought leader, Bob Temple in a public conversation...

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Webinar Recap: Biomarkers of Aging in Regulatory Development by EJ Abass, Associate, Kinexum 



Upcoming Conferences




Targeting Metabesity 2020


The third edition of the Targeting Metabesity conference will take place virtually on October 12-15, 2020. Last year's conference was described as "one of the most important longevity conferences of the year" and we look to provide an even more impressive program with this year’s edition. The full conference schedule can be found here, and we encourage all interested to register here. We look forward to "seeing" all of you there!

GSA 2020 Annual Scientific Meeting


The GSA 2020 Annual Scientific Meeting Online brings together researchers, educators, scientists, health care professionals, influential thought leaders, and industry experts to address today’s most pressing issues in the field of aging. The Kitalys Institute will be assembling a panel for the Pre-Conference Workshop, held from noon to 3 pm on October 27, 2020, titled "Translating Geroscience Healthspan Breakthroughs into Real-World Change: Science, Advocacy, and Policy". For more information, see here




Virtual Diabetes Technology Meeting


At this year's Diabetes Technology Meeting (held November 12-14, 2020), Kinexum Chairman and Founder, Zan Fleming, will be moderating a panel on the artificial pancreas and automated insulin delivery systems.




CVCT Forum 2020


Kinexum will be creating a panel at this year's CVCT Forum, to be held in Washington, DC this December. Conference organizer, Dr. Faiez Zannad, will also be a speaker at this year's virtual Targeting Metabesity meeting. 



New Kinexum Team Members