Who We Are



Dr. William Clementi

William A. Clementi Pharm.D., F.C.P.
Founder and Chief Regulatory Officer

Dr. Clementi held an academic appointment in pharmacology at the University of Texas Health Science Center in San Antonio, after completing a NIH Training Program in Clinical Pharmacology. He remained as a faculty member at UTHSCSA, holding positions of Instructor and then Assistant Professor.   In addition to teaching in the Colleges of Medicine, Dentistry and Pharmacy,  Dr. Clementi directed the Clinical Pharmacokinetic Consulting Service, providing pharmacokinetic and drug interaction expertise to the Intensive Care Units at the Audie Murphy VA Hospital and Bexar County Hospital.  His areas of interest remain cardiovascular pharmacology and applied principles of therapeutics to the clinical setting.  After completion of his tenure a the the University of Texas and receipt of a VA Merit Review Grant in Population Pharmacokinetics of Cardiovascular Drugs, he assumed the position of Associate Director of Clinical Research at Lorex Pharmaceuticals, where he directed and designed pivotal studies in hypertension and angina.  His responsibilities also included the oversight of a Phase II/III pain management program.  As a senior member of the development team, the efforts of the team lead to approvals for betaxolol in hypertension, the combination product of betaxolol with a diuretic, and zolpidem (Ambien).  Dr. Clementi was promoted to worldwide responsibilities in market development for Ambien and Kerlidex, the first low dose diuretic-beta blocker combination developed in the United States.  He has published over 60 papers on drug metabolism, baroreflex responses in blood pressure reduction, and predictive dosing models using Bayes Formulas and computer-assisted dosing.

Establishing a specialized consulting company proved an even more exciting challenge as new and novel therapies emerged during the last two decades.  Clementi Associates has successfully filed many INDs and a select number of NDAs for individual drugs and combination drug device products.  Clementi Associates expanded and held full electronic submission capabilities until a few years ago when these services matured and could successfully be outsourced.  Today Clementi Associates is focused on unique development problems and working with regulators to solve those problems.

Nancy Durst Clementi

Nancy Durst Clementi, M.D.
Chief Medical Officer

Dr. Nancy Durst Clementi brings more than 25 years of pharmaceutical industry experience, across a variety of disciplines, to Clementi Associates.

Dr. Clementi is Board Certified in Internal Medicine, and held an academic appointment in the School of Medicine and in the College of Pharmacy at the University of Texas Health Science Center at San Antonio. Working in the first NIH-funded General Clinical Research Center in a Veterans Administration hospital (Bartter GCRC at the Audie Murphy VA Hospital), Dr. Clementi carried out clinical pharmacology research and served as an investigator in industry-sponsored phase II, III and IV trials, in addition to her clinical and teaching responsibilities.

In 1983, Dr Clementi began her industry career, working at E.R. Squibb & Sons, G.D. Searle and Eastman Kodak/Sterling Drug/Sanofi Winthrop, in Clinical Research, Regulatory Affairs and Strategic Planning/Portfolio Management.

Dr. Clementi joined Wyeth in 1992 as Vice President, New Products Marketing, with responsibility for crafting products for launch. She was responsible for the medical marketing leadership on a number of significant product introductions, including Effexor®, Protonix®, and Rapamune®. In 2001, Dr. Clementi moved into Global Medical Affairs and in that role took responsibility for Global Medical Communications (global medical information and the US customer contact center), Medical Science Liaisons (MSLs), Publications and External Communications, Clinical Trial Registries, Promotional Review and Compliance, Regulatory Writing, Document Quality and Operations, and global protocol review. Dr. Clementi retired from Wyeth in 2008.

 

Submission Group

Our submissions group is seasoned and experienced in all aspects of document preparation and submissions.  Laurie Hariu B.A. and Kristen Zubriski B.A. apply their long and comprehensive experience with digital media, graphics, and text and layout editor software and tools to the e-submission process.  Their mastery of those tools allow them to seamlessly enter the e-submission space without skipping a beat. They have current tools and methods but more importantly the knowledge and discipline to resolve even complex document preparation issues typically found in critical submission.