Zan Fleming Leaves Improved CDER Seminars as Legacy

Zan Fleming Leaves Improved CDER Seminars as Legacy

By John Senior, MD

G. Alexander "Zan" Fleming, MD, familiar to many as host of the weekly CDER Seminars for the past two academic years, has announced his plans to leave federal service at the end of August and to seek opportunities in private sector pharmaceutical research and development. He intends to remain based in the Washington area.

Zan is a native of Nashville, Tenn., but grew up in Pensacola, Fla., the son of a busy practicing cardiologist who nevertheless found time to write and publish several books. He majored in biochemistry and molecular biology in college at Vanderbilt and the University of West Florida, followed by graduate work at Emory University before attending medical school there. He then trained in internal medicine and endocrinology, and subsequently was board-certified in both. It may be noted that he was elected president of both his college alumni and medical school classes.

Zan was bitten by the research bug early in life and continued asking questions and seeking answers. As a medical staff fellow and senior staff fellow at the National Cancer Institute, he extended his early interests in the study of growth hormone effects on children to the investigation of amino acid derivatives as plasma signals for metabolic regulation.

Zan joined CDER as a medical officer in the Division of Metabolic and Endocrine Drug Products in 1986 and three years later became a medical team leader in the division while continuing to see patients on a part-time basis. He was a primary medical reviewer for three important new molecular entities: lovastatin to treat high cholesterol and metformin and troglitazone to treat diabetes.

For 18 months beginning in 1991, he was assigned to the World Health Organization in Geneva where he participated in writing the WHO good clinical practice document. Since its beginning in 1991, Zan has represented the FDA at International Conference on Harmonization meetings and is a member of the expert working groups on Good Clinical Practice (E-6) and on General Considerations for Clinical Trials (E-8).

He has worked in China on drug development projects and in Russia, Ukraine and Belarus on accrediting FDA approvals in those countries. Zan is frequently asked to meet with foreign officials and scientists visiting the FDA. Most recently, he organized and participated in symposia on drug development and evaluation in Boston, Vienna, Moscow, Kuoshiung in Taiwan, Beijing, Seoul and London.

In addition to becoming an excellent medical reviewer, Zan has continued to manifest outstanding vision, creativity and leadership. He has been an active contributor to the design and development of the CDER initiative on good review practices. Zan founded the Center's new virtual Journal and has served as its editor-in-chief. He wrote about initiating a career development path for medical reviewers, which came to fruition as the CDER Reviewer Career Path. As 1996-98 chair of the Committee for Advanced Scientific Education, he has fostered significant programmatic improvements in scientific excellence and a new atmosphere of collegiality at CDER Seminars.

Zan has a special interest in the concept of task and problem focus in facilitating the drug development process. TPF is an issues-oriented means of communicating among drug developers and evaluators using an electronic, Web-like environment to capture organize, and store decisions and the data and other information on which they are based. TPF is being developed as a proof-of-concept project for the good review practices initiative.

Some comments from his friends about this quintessential Renaissance man:

  • Zan is the ultimate team builder . . . and can be your most trusted friend. Yuan-Yuan Chiu
  • Zan leaves a legacy of a vibrant successful CDER Seminar program that we will have to strive mightily to match. Ken Kobayashi
  • Zan is a communications wizard, a prolific writer and an accomplished speaker. He will be sorely missed. Lori Frederick
  • Zan showed mastery of diplomacy in putting together a teaching collaboration between MIT, Harvard and FDA. Alan Moses of Harvard
  • Zan has earned the admiration of industry counterparts by his creative ideas on improved drug development systems. Tim Franson of Eli Lilly

 

Reprinted from News Along the Pike, August 1998, FDA Center for Drug Evaluation and Research.

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