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Dr. Zan Fleming

Dr. Alexander “Zan” Fleming is co-founder, president and CEO of Kinexium, LLC, a cardiometabolic strategic consulting organization. He also sits on over a dozen clinical advisory boards for major pharma and biotech companies.

Previously, he served as chief medical officer of Boston Medical Technologies and chief scientific officer of Ingenix Pharmaceutical Services – A UnitedHealth Group Company.

For 12 years, he served as reviewer and supervisory medical officer at the FDA, as head of the metabolic group. He has extensive clinical experience and regulatory responsibility in 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 those of the first statin, insulin analogs, metformin, PPAR-agonist, and growth hormone for non-GH deficiency indications. He was responsible for the regulation of the earliest biotech products including human insulin and growth hormone. He also helped to shape a number of FDA policies and practices related to therapeutic review and regulatory communication.

His regulatory and technical expertise has been requested in numerous international settings including the World Health Organization, where he was assigned during 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) and participated on other ICH committees.

Dr. Fleming is the cofounder and editor in chief of the Virtual Journal of Drug Evaluation, of FDA’s Center for Drug Evaluation and Research (CDER), a major contributor to FDA’s Good Review Practice (GRP) initiative, and chair of the committee responsible for education and training at CDER. He is lead author of the book, “Optimizing Development of Therapies for Diabetes.” He serves on numerous scientific advisory boards and expert committees and has served as invited editorialist to The New England Journal of Medicine and as a commentator on National Public Radio.

We chose Melior Discovery because they were responsive and cost effective. We are staying with them as a chosen scientific partner because of their thoughtful scientific input to experimental design and attention to detail. Their expertise and flexibility allowed us to quickly adapt the study design and evaluate additional outcome measures to pursue unexpected activity.
Sridharan Rajamani, Ph.D., Senior Research Scientist
Gilead Sciences
I have been working with Melior on a number of projects over the course of a few years now. They have been a great partner throughout this time. The scientists whom I have worked with have been great problem-solvers and were customer focused.
Jay Lichter
Avalon Ventures
Melior provided State-of-the-art Preclinical Pharmacology Support for a period of nearly a year where a series of in vivo studies were completed on a weekly basis. The staff was extremely user-friendly and the operational processes were excellent. I can recommend Melior without reservation.
Richard DiMarchi, PhD
Cox Professor of Chemistry & Gill Chair in Biomolecular Sciences Indiana University, Department of Chemistry
Because Melior could do the orthotopic intracranial implants, we were able to do survival studies with brain tumor-bearing animals that were treated with our therapy, showing a beautiful survival with our agent versus control. Talk about something that gets your investors going! These beautiful survival curves with our agent versus control and visual photos are in all of our investor decks because… it's powerful.
Bruce Ruggeri, Ph.D.
Modifi Bio
Melior works in many therapeutic areas, like CNS, inflammatory disease, GI, cardiovascular, and oncology. I was very pleased that when it came to doing tumor studies, both subcutaneous and intracranial, they did them well. They reported on the studies on time and did the data analysis really well.
Bruce Ruggeri, Ph.D.
Modifi Bio
Their areas of expertise are extensive, and they are very experienced, responsive, and flexible in terms of how the study is run. Their pricing is reasonable, making them the best option for a young, not well-funded company like ours.
Maxine Gowen
Tamuro Bio
Melior’s team was very experienced and knowledgeable. They were always very open to suggestions and questions, spending a lot of time helping us feel comfortable with the study design. I would give them very high marks.
Maxine Gowen
Tamuro Bio
The most important factors in choosing to work with Melior were the fit between the tests they could run and our needs, as well as their tight budget and proximity. Melior was the best fit for our research goals.
Ira Spector
SFA Therapeutics