Expert Details

Expert in Pharmaceutical Development, cGMP, Formulation, Analytical Development, Poorly Soluble compounds

Expert ID: 725062 Oregon, USA

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Expert is an expert in pharmaceutical development. He has 20+ years experience solving commercially relevant problems in the pharmaceutical industry. He has extensive experience managing multi-disciplinary drug delivery projects from inception to completion, and has over 20 patents in the area of drug delivery and drug delivery materials development. His drug delivery expertise includes oral, parenteral, discovery support, formulation, dosage form development (IR and CR), process design, and in vivo study design. He designed and built a cGMP facility for drug formulation and dosage form manufacturing and has extensive experience with cGMP management and documentation. He has extensive project management experience in all phases of drug development. Expert also has extensive project management experience, having led a group of 20 scientists in the development of these drug delivery technologies. He also has extensive experience in market/competitive analysis and prior-Art assessment for new products/technologies in the drug delivery area.

Expert is an expert in delivery of poorly soluble drugs. He has 15+ years experience solving commercially relevant problems in the pharmaceutical industry. He has extensive experience managing multi-disciplinary drug delivery projects from inception to completion, and has over 20 patents in the area of drug delivery and drug delivery materials development. His drug delivery expertise includes oral, parenteral, discovery support, formulation, dosage form development (IR and CR), process design, and in vivo study design. In support of these areas, he has extensive solid and liquid analytical method design and characterization experience (e.g., thermal, X-ray, SAXS, NMR, optical spectroscopy, fluorescence, particle sizing, surface characterization, ultracentrifugation, confocal microscopy, optical and electron microscopy, and GPC). Much of his work included analyzing crystallization, including X-ray analysis, morphology control (size, shape, habit, and polymorph), thermodynamics/kinetics of crystallization, and salt-form selection. In addition, he has a strong background in a variety of nanotechnologies for drug delivery, including liposomes, micelles, nanocrystals and polymeric nanoparticles. He has extensive experience in the delivery of poorly soluble drugs, including development of new technology, stability assessment, performance prediction, and process development (e.g., SEDDS, polymer dispersions, nanocrystals, and cyclodextrin complexes). Expert also has extensive project management experience, having led a group of 20 scientists in the development of these drug delivery technologies. He also has extensive experience in market/competitive analysis and prior-Art assessment for new products/technologies in the drug delivery area.

Expert has extensive experience developing a variety of nanotechnologies for delivery of poorly soluble drugs. These technologies include liposomes, micelles, nanocrystals and polymeric nanoparticles. Specifically, these technologies have been designed to deliver compounds for a wide variety of compound properties and therapeutic applications, and have been demonstrated in the clinic. The nanotechnologies he developed were demonstrated in vivo for oral, topical, IV, and ocular administration. Much of the efforts on oral drug delivery were directed at the delivery of poorly soluble drugs. In addition, these nanotechnologies were formulated into solid dosage forms and subsequently successfully dosed in the clinic. Expert also has extensive experience in stability assessment, performance prediction, and process development for these nanotechnologies.

He guided selection of dosage forms for a large pharma clientHe helped guide selection of lead compounds for a Discovery start-up companyHe selected appropriate technologies for delivery of insoluble compounds for a large pharma clientHe developed a summary of available oral and topical drug delivery technologies for a large pharma clientHe developed a detailed survey of nanotechnology companies for targeting of drugs for a large pharma client

Expert may consult nationally and internationally, and is also local to the following cities: Portland, Oregon - Eugene, Oregon - Salem, Oregon - Springfield, Oregon - Bend, Oregon

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Education

Year Degree Subject Institution
Year: 1993 Degree: PhD Subject: Material Science, Optical and Chemical Physics Institution: U. of Oregon
Year: 1988 Degree: MS Subject: Physics Institution: U. of Oregon
Year: 1987 Degree: BS Subject: Physics Institution: Boise State University

Work History

Years Employer Title Department Responsibilities
Years: 2013 to Present Employer: Undisclosed Title: President and Founder Department: Responsibilities: Topo provides broad consulting and project management services for drug development. Expert leads and runs day-day operations and is the primary consultant.
Years: 2008 to 2012 Employer: Agere Pharmaceuticals, Inc Title: Founder and CSO Department: Responsibilities: Founded company focused on providing solubilization services to the pharmaceutical industry. Designed, built, and managed a cGMP spray drying manufacturing facility with a cGMP analytical lab. Managed day-day operations, raised capital, organized and lead business development team, and developed proprietary technologies.
Years: 1993 to 2008 Employer: Bend Research, Inc. Title: Executive management team for pharmaceutical drug delivery research Department: Responsibilities: 1) Nanotechnology, Targeting and Drug Discovery technologies
2) Drug Delivery Technologies, including Oral Solubilization, Parenteral, Topical Technologies
3) Optical materials/systems group, responsible for obtaining funding (over $3MM) through SBIR grant writing
Years: 2016 to Present Employer: Undisclosed Title: CEO and Founder Department: Responsibilities: Seraán provides broad consulting and project management services for drug development. Expert leads and runs day-day operations. Serán provides laboratory services, including formulation, discovery, analytical development for the biotechnology and pharmaceutical industry, as well as consulting and project management services.

Career Accomplishments

Associations / Societies
AAPS, APS, AAAS, ACS
Publications and Patents Summary
He has 30 patent and patent applications and 24 publications

Additional Experience

Vendor Selection
Selected key pharmaceutical excipients for various drug delivery systems, including dispersions, nanoparticle formulations, oral dosage forms, and injectibles. Evaluated suppliers of critical pharmaceutical excipients from several vendors. Managed multiple in vivo outsources
Marketing Experience
Key understanding of drug discovery and drug delivery trends in the pharmaceutical industry.
Extensive understanding of how active pharmaceutical ingredients interact with dosage forms
Leader in utilizing mathematical modeling to guide drug delivery
Other Relevant Experience
He provides a unique combination of consulting, mathematical modeling, and laboratory analysis in the pharmaceutical and materials industries. He has extensive experience in intellectual property strategy, assessment, and development.

Fields of Expertise

analytical laboratory, biodegradable system, capsule packaging process, cellulose coating material, chewable tablet, clinical trial documents generation, combination drug therapy, computer-assisted drug therapy, controlled-release drug delivery, controlled-release oral drug delivery, cross-platform development, development process, dosage form, drug degradation, drug development, drug dosage form development, drug targeting, drug therapy, enteric-coated tablet, excipient, gelatin capsule, intellectual property strategy, liposome, micelle, nanocapsule, pharmaceutical analytical chemistry, pharmaceutical capsule, pharmaceutical drug, pharmaceutical industry, pharmaceutical manufacturing, pharmaceutical solution, pharmaceutics, softgel capsule, solid pharmaceutical product, tablet, technology development, X-ray diffraction analysis, drug delivery, oral drug delivery, nano drug delivery, polymer drug-delivery method, dosage, pharmaceutical product development, pharmaceutical product formulation, nanobiotechnology, laboratory quality assurance, confocal microscopy, analytical science, analytical research, analytical instrumentation, analytical method optimization, 21 CFR Part 11, active pharmaceutical ingredient, investigational drug procedures, bulk drug, Karl Fischer reagent, Karl Fischer technique, analytical monitoring, diffractometer, polymer processing analytical instrumentation, colonic drug delivery, Current Good Manufacturing Practice, laboratory procedure, analytical test, analytical testing, analytical chemistry instrument, mathematical analysis, pharmaceutical manufacturing facility auditing, analytical transmission electron microscopy, analytical electron microscopy, technical training, analytical standard, analytical method validation, pharmaceutical quality assurance, parenteral drug delivery, instrumentation (equipment), pharmaceutical inventory management, pharmaceutical quality control, computer-aided drug design, laboratory, analysis technique, microscopy, water analysis instrument, analytical data quality assurance, transdermal drug delivery, programmable drug delivery, process chemistry, polymer selection, optics, ocular drug delivery, nasal drug delivery, material analysis, Good Manufacturing Practice, Good Laboratory Practice, fluorescence, finite element analysis, chromatography, chemometrics, calorimetry, buccal drug delivery, analytical chemistry

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