Controlled Drug and Sustained Drug Release Formulations and Dosage Forms Expert

Expertise

• Oral solid dosage form formulation and process development.
• Drug delivery technology for controlled release dosage forms (osmotic, matrix and multiparticulates) and enhancing the oral bioavailability of poorly soluble compounds.
• Controlled release and sustained release drug dosage forms.
• Spray dried and hot melt extruded dispersions.
• Development and application of drug delivery technology.
• Extensive experience in formulation and process development for controlled and sustained release formulations and poorly soluble compounds for oral delivery.
• Osmotic systems, multiparticulates, and amorphous solid dispersions proficiency.

Experience

Undisclosed Company, Managing Partner, 2007 - Present

• Drug formulation, process development and CRO and CMO management for over 60 pharmaceutical companies and expert witness work.
• Project areas encompass NCE development, product enhancement, fixed dose combinations.
• Experienced in formulation development and scale-up, transfer and troubleshooting. Specific technology expertise in oral controlled release technologies (osmotic, matrix, multiparticulates) and amorphous solid dispersions.

Bend Research, Bend, OR, Director, Controlled Release, 1996 - 2006

• Responsible for formulation, process development and technology transfer for a wide range of drug delivery technologies including oral osmotics and multiparticulates.
• Led team to commercialize Zmax® sustained release microsphere product with Pfizer.
• Extensive experience in formulation and process development of hot melt and spray dried dispersion-based and immediate release (IR) and controlled release (CR) dosage forms.

Sarcos Research Corporation, Salt Lake City, UT, Project Leader, 1995 - 1996

• Responsible for project planning management and development of electro-mechanical topical drug-delivery system.

INTERx Research Corporation/Merck & Co., Lawrence, KS, 1988 - 1995

Research Fellow and Sr. Research Chemist

• Developed aqueous-based coatings for oral osmotics.
• Responsible for design and evaluation of erodible injectable systems for bone-growth promotion.
• Led electromechanical drug-delivery effort.

Honors & Publications

Credentials

• Dissertation: Characterization of a Self-Regulating Insulin Delivery System

Academic and Professional Affiliations

• American Association of Pharmaceutical Scientists (AAPS)
• Advisor for the Journal of Pharmaceutical Sciences

Publications and Patents

• Author - Co-Author of publications in peer reviewed medical and pharmaceuticals journals (including presentations).
• Over 40 patents (including patent applications)

Education

• Ph.D. Pharmaceutics, University of Utah, Salt Lake City, UT
• B.S. Chemical Engineering, University of California,Los Angeles, CA