G. Alexander Fleming, MD

G. Alexander Fleming, MD

Executive Chairman and Founder

Dr. Alexander Fleming is Founder and Executive Chairman of Kinexum. He is also President and Chief Executive Officer of Tolerion, a biotechnology company developing disease-modifying treatments for type 1 diabetes and other autoimmune diseases. Dr. Fleming received his M.D. and internal medicine training from Emory. He completed fellowship training in endocrinology at Vanderbilt and metabolism at National Institutes of Health, where he was a senior fellow.

At the US Food and Drug Administration from 1986-98, Dr. Fleming was responsible for the therapeutic areas of diabetes, other metabolic and endocrine disorders, growth and development, nutrition, lipid-lowering compounds, and reproductive indications. He led reviews of landmark approvals, including metformin and the first statin, insulin analog, PPAR-agonist, and growth hormone for non-GH deficiency indications. Dr. Fleming oversaw clinical review of the earliest biotech products, including human insulin and growth hormone. He also helped to shape FDA policies and practices related to therapeutic review and regulatory communication. He was a major contributor to FDA's Good Review Practice (GRP) initiative and led the committee responsible for education and training at CDER. He conceived and directed the first FDA pilot project to utilize the internet for regulatory communication. 

Dr. Fleming’s regulatory and technical expertise has been requested in numerous international settings. He was assigned from FDA to the World Health Organization from 1991-92. Dr. Fleming was a member of the expert working groups on Good Clinical Practices and General Considerations for Clinical Trials of the International Conference on Harmonization (ICH). He also participated on other ICH committees, including the Common Technical Document working group. 

Dr. Fleming has frequently published scientific articles and book chapters. The most recent chapter, Regulatory Considerations for Early Clinical Development, is in Translational Research Methods for Diabetes, Obesity and Cardiometabolic Drug Development, published by Springer in October 2018. Dr. Fleming is also lead author of the book, Optimizing Development of Therapies for Diabetes. He has been a member of many corporate and advisory boards to academic and commercial institutions and professional societies. He serves on the joint technology working groups of the European Association for the Study of Diabetes and American Diabetes Association.

Dr. Fleming coined the term "Metabesity," which refers to the constellation of cancer, heart and neurologic diseases, diabetes, and the aging process itself, all of which share common metabolic root causes and potential preventive therapies. He organized the first Congress on Metabesity in London in October 2017, which will be followed by the second Congress in Washington, D.C., in 2019.

Additional resources, publications, and other information from Dr. Fleming are available in the Kinexum Information Center.

Leadership List

Officers

G. Alexander Fleming, MD
Founder and Executive Chairman

Thomas Seoh, J.D.
President and Chief Executive Officer

Brian Oscherwitz, MBA, PMP
Chief Operating Officer

 

Clinical Development

G. Alexander Fleming, MD

Arthur Santora, MD, Ph.D

Brian E. Harvey, MD, Ph.D

Charles Alexander, MD

Doug Muchmore, MD

Giora Davidai, MD

Gordon B. Cutler, Jr., M.D.

Grant Williams, MD

Guenther Karmann, Ph.D

John K. Whisnant, Jr, MD

Michael Trautmann, MD

Mustafa A. Noor, MD, FACP

Peter Damsbo, MD

Ramachandra (Ram) G. Naik, M.D.

Simon Bruce, MD

Theo Gana, MD, Ph.D

Todd J. Lorenz, MD

 

Regulatory Strategy and Operations

G. Alexander Fleming, MD

Arthur Santora, MD, Ph.D

Asoke Mukherjee, Ph.D

Brian E. Harvey, MD, Ph.D

Catherine Bernard, Ph.D

David Reinhold Brill, Ph.D

Dia Hill, B.S.

Frances Mielach, Ph.D, RP.h

Gabrielle Wiederkehr, MSc

Grant Williams, MD

Joshua Sharlin, Ph.D

Michael Sharp, Ph.D 

Susan Manley, MS

 

Biostatistics

Alan Fisher, DrPH

 

EU Regulatory

Catherine Bernard, Ph.D

Gabrielle Wiederkehr, MSc

Michael Trautmann, MD

 

Clinical Operations/Project Management

Brian Oscherwitz, MBA, PMP

Chris Yun, B.S.

Gabrielle Wiederkehr, MSc

Julie Waltz Gerlach, B.S.N., M.P.H., R.A.C.

Susan Manley, MS

 

Pre-Clinical

Asoke Mukherjee, Ph.D

Dave Edwards, Ph.D

Frances Mielach, Ph.D, RP.h

Joy Cavagnaro, Ph.D

Michael B. Zemel, Ph.D.

Virgil Whitehurst, Ph.D

 

CMC, Formulation/Process Development & Sourcing

Anand Khedkar, Ph.D

David Bergstrom, Ph.D

Jo Van Betsbrugge, PhD

Knut Zellerhoff, Ph.D

Robert Kaster, RPh., ASQ-CQA

 

Medical Device

Michael Sharp, Ph.D

 

QA/QC

Brian Oscherwitz, MBA, PMP

Jennifer Zhao, B.S.

 

Medical Writing/Electronic Submissions

Jennifer Zhao, B.S.

Kristi Hultberg, B.S.

Sandor Bernath, Ph.D, MBA

 

Botanicals

Jinhui Dou, Ph.D.

 

Government Relations and Public Affairs

Scot Faulkner, MPA

 

Defense & National Security Practice

Dean E.Calcagni, MD

 

Commercialization and Business & Corporate Strategy

Brian Oscherwitz, MBA, PMP

Lisa Jansa, MBA

Martin Lafontaine

Thomas Seoh, J.D.