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Today's Featured Biography

Monte Scheinbaum

I took early retirement from FDA four years ago and became a consultant for
clinical, scientific and regulatory matters with regard to analgesics,
addictive drug products and a variety of other drug types. My experiences as a chemist, a physician in the pharmaceutical industry, a clinical investigator and an FDA reviewer have covered a broad range of subspecialty areas.

As a chemist, I studied under one of the greatest chemists of the 20th
century, R.B. Woodward, at Harvard. I was two years in Switzerland and a
chemistry professor before going to medical school.

My early work in the pharmaceutical industry spanned many target illnesses,
including among others, analgesia, depression, hypertension, congestive
heart failure, asthma, allergic rhinitis, gynecological disorders, breast
cancer and peptic ulcer disease. Accomplishments at Boots Pharmaceuticals included filing the original prescription NDA for pediatric ibuprofen and being the father of Meridia. I wrote the US patent for sibutramine, fought with the mother company to let
me test it in obesity, wrote the plans and protocols for the clinical
development and carried out the initial trials. There would have been no
Meridia without me. Boots would have dropped it as a poorly effective
antidepressant with side effects like weight loss.

Experience as an investigator at the Clinical Research Center in New Orleans
included carrying out clinical trials for many companies, mostly in
preventative medicine (such as hypertension, diabetes, and lipid lowering).
I had the unique experience of becoming an investigator on what had been my
baby at the previous job, performing a study of 150 obese patients with
sibutramine. While I was at FDA, sibutramine was approved, but I was
recused from participating in that approval process.

Experience as an FDA reviewer involved analgesics (particularly opioids and
treatments for chronic pain), products for treating addictions (including
matters related to scheduling and abuse liability) and a variety of other
drug types. I reviewed and recommended approval for such drugs as Flonase,
Rhinocort, Duraclon and the OTC switch for Nicoderm CQ. I was the secondary
reviewer involved in the approvals of Revia and Zyban. I reviewed several
transdermal analgesic products.

I am board-certified in ClinicalPharmacology, but have experience in all phases of clinical research and development. Now I have been helping pharmaceutical companies and CRO's, both American and European, with their submissions, trial designs, clinical planning, clinical pharmacology, licensing, lawsuits and other matters. Much of this
has been concerned with, but certainly not limited to analgesic, addictive drug products and endocrine drugs. My consulting includes both prescription and OTC drug
matters. I helped with the successful NDA for the controlled-release
morphine formulation known as Avinza.

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