Dr. Zan Fleming

Dr. Fleming brings more than 25 years of industry and government experience in clinical research and medical and regulatory affairs to Boston Medical Technologies.Dr. Fleming will play a key role in helping Boston Medical Technologies advance heart rate variability testing as a global standard of care in diabetes practices.

Dr. Fleming was earlier a clinical reviewer at the Food and Drug Administration in Rockville, Maryland for 12 years.More recently he served as Supervisory Medical Officer, Division of Metabolism and Endocrine Drug Products, which included responsibility for all diabetes therapeutic products.Dr. Fleming represented the FDA in numerous national and international forums, including expert working committees on good clinical practice and general considerations for clinical trials.In addition, he served as a clinical scientist at the World Health Organization in Geneva, Switzerland and as a senior fellow and guest investigator at the National Cancer Institute, National Institute of Health in Bethesda, Maryland.

Since 1998, Dr. Fleming has served as Senior Vice President, Global Regulatory Affairs for Ingenix Pharmaceutical Services of Baskin Ridge, NJ, a global drug development and marketing service organization owned by UnitedHealth Group.He held the additional position of Chief Scientific Officer since 1999.During this time, he authored the book, Optimizing Therapeutic Development in Diabetes and other publications including an editorial in The New England Journal of Medicine.

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"In addition to his medical and regulatory affairs experience in both government and industry, Zan brings impressive leadership and consensus building skills that will be pivotal to developing standards and clinical practice guidelines that work for a broad range of constituents."

"According to data obtained from the more than 10,000 patient tests conducted with the Anscore System, a significant percentage of people with diabetes were found to have some form of early, intermediate or advanced autonomic dysfunction," said Zan Fleming."The clinical data suggests that Boston Medical Technologies has the opportunity to make an enormous contribution to improving outcomes and quality of life for people with diabetes.I am excited by the opportunity to help advance this highly promising new chapter in diabetes assessment into mainstream clinical practice."

About Boston Medical Technologies

Founded in 1994, Boston Medical Technologies is pioneering the development and worldwide deployment of office and hospital-based, non-invasive heart rate variability testing systems to improve the quality and cost-effectiveness of clinical care.

Dr. Fleming brings more than 25 years of industry and government experience in clinical research and medical and regulatory affairs to Boston Medical Technologies.Dr. Fleming will play a key role in helping Boston Medical Technologies advance heart rate variability testing as a global standard of care in diabetes practices.

Dr. Fleming was earlier a clinical reviewer at the Food and Drug Administration in Rockville, Maryland for 12 years.More recently he served as Supervisory Medical Officer, Division of Metabolism and Endocrine Drug Products, which included responsibility for all diabetes therapeutic products.Dr. Fleming represented the FDA in numerous national and international forums, including expert working committees on good clinical practice and general considerations for clinical trials.In addition, he served as a clinical scientist at the World Health Organization in Geneva, Switzerland and as a senior fellow and guest investigator at the National Cancer Institute, National Institute of Health in Bethesda, Maryland.

Since 1998, Dr. Fleming has served as Senior Vice President, Global Regulatory Affairs for Ingenix Pharmaceutical Services of Baskin Ridge, NJ, a global drug development and marketing service organization owned by UnitedHealth Group.He held the additional position of Chief Scientific Officer since 1999.During this time, he authored the book, Optimizing Therapeutic Development in Diabetes and other publications including an editorial in The New England Journal of Medicine.
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"In addition to his medical and regulatory affairs experience in both government and industry, Zan brings impressive leadership and consensus building skills that will be pivotal to developing standards and clinical practice guidelines that work for a broad range of constituents."

"According to data obtained from the more than 10,000 patient tests conducted with the Anscore System, a significant percentage of people with diabetes were found to have some form of early, intermediate or advanced autonomic dysfunction," said Zan Fleming.

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.
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Zan leaves a legacy of a vibrant successful CDER Seminar program that we will have to strive mightily to match.
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Zan is a communications wizard, a prolific writer and an accomplished speaker.He will be sorely missed.
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Zan showed mastery of diplomacy in putting together a teaching collaboration between MIT, Harvard and FDA.
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Zan has earned the admiration of industry counterparts by his creative ideas on improved drug development systems.