G. Alexander Fleming, MD

G. Alexander Fleming, MD

Executive Chairman and Founder

  • Medical training and laboratory research experience at Emory, Vanderbilt, and National Institutes of Health
  • Board certified in Internal Medicine and Endocrinology and Metabolism
  • Extensive clinical experience and FDA regulatory responsibilities for metabolic and endocrine disorders, growth and development, nutrition, lipid-lowering compounds, and reproductive disorders
  • Represented FDA in international arena with an extended assignment to World Health Organization, Geneva and three ICH working groups
  • Chaired professional education and training for FDA's Center for Drug Evaluation & Research (CDER)
  • Co-founded and served as editor in chief of the CDER's Virtual Journal of Drug Evaluation
  • Major contributor to FDA's Good Review Practice (GRP) initiative
  • Frequent invited lecturer at international symposia
  • Invited editorialist of the New England Journal of Medicine and commentator on National Public Radio
  • Member of numerous scientific advisory boards and expert committees

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

Leadership List

Officers

G. Alexander Fleming, MD
Executive Chairman

Thomas Seoh
President and Chief Executive Officer

Stephen Casey, MBA
Chief Operating Officer

 

Clinical Development

G. Alexander Fleming, MD

Brian E. Harvey, MD, Ph.D

Charles Alexander, MD

Giora Davidai, MD

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

Guenther Karmann, Ph.D

John K. Whisnant, Jr, MD

Michael Trautmann, MD

Peter Damsbo, MD

Richard Paul, MD

Rob Walsh, MD

Simon Bruce, MD

Theo Gana, MD, PhD

Todd J. Lorenz, MD

 

Regulatory Affairs

G. Alexander Fleming, MD

Brian E. Harvey, MD, Ph.D

Christopher Kotsopulos, MS

Doug Muchmore, MD

Frances Mielach, Ph.D, RPh.

Joshua Sharlin, Ph.D

 

EU Regulatory

Michael Trautmann, MD

 

Clinical Operations/Project Management

Chris Yun

Diane Paul, MS, RN

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

Lynn Schaich

Susan Manley

 

Pre-Clinical

Dave Edwards, Ph.D

Frances Mielach, Ph.D, RPh.

Joy Cavagnaro, Ph.D

Marijke Adams PharmD, Ph.D

Monalisa Chatterji,Ph.D

Virgil Whitehurst, Ph.D

 

CMC and Clinical Supplies Management

Knut Zellerhoff, Ph.D

Robert Kaster, Rph., ASQ-CQA

 

Medical Device

Christopher Kotsopulos, MS

Rob Walsh, MD

 

QA/QC

Christopher Kotsopulos, MS

Joshua Sharlin, Ph.D

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

Lynn Schaich

Robert Kaster, Rph., ASQ-CQA

 

Medical Writing/Regulatory Submissions

Marijke Adams PharmD, Ph.D

Peggy Hagerty

Russ Neubauer, Ph.D

Sandor Bernath, PhD, MBA

 

Process & Innovation management

Elizabeth Whalley Buono, BSN, RN, MBA, JD

 

Business Strategy & Management Support

Lisa Jansa, MBA

Stephen Casey, MBA

 

Founders

G. Alexander Fleming, MD

Lisa Jansa, MBA