Expert Details

Expert in Pharmaceutical Product Development, Analytical Chemistry, Material Science, Process Development

Expert ID: 728891 California, USA

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Expert has extensive experience in pharmaceutical product development, particularly in developing drug/medical device combination products. He has over 15 years relevant experience in the pharmaceutical industry, highlighted by the launch of an anticipated $1B/year annual revenue drug/device product. Expert is well-versed in the FDA and rest of world drug and combination product regulations. His focus has been to develop the right product based on strong requirements to the patients to improve their lives.

As a pharmaceutical product developer, Expert has gained much experience in several areas. These include drug and excipient material science, specification setting, CRO and CMO management, active pharmaceutical product ingredient analytical sciences, drug delivery, formulation development and process development. As a six sigma black belt, Expert is always looking to improve the way business is performed, improving processes and eliminating waste.

In his product development role, Expert has written and reviewed CMC (chemical, materials and controls) sections of NDAs (new drug applications) for several drug delivery products, including oral, implantable, transdermal and electrolytic transdermal therapies. He has developed raw material portfolios for these type products, linking key materials to product requirements to insure their suitability for use. By setting relevant specifications and working with suppliers to maintain these specifications, Expert developed high reliability processes for the development projects.

He is also well versed in the regulations surrounding drug development, particularly on the materials, drug ingredients, drug products and quality areas. He recently took a class in "Interacting with the FDA". He keeps abreast of new requirements for the cGMP regulations, and is particularly adept at dealing with both the drug and medical device requirements for combination products.

Expert's original degree and work experience was in analytical chemistry, and he has expertise in analytical instrumentation and methodologies, particularly pertaining to drugs. He has a speciality in a subset of HPLC, ion chromatography. He has developed instrumentation and test methods for IC, while working for the market leader in the sector. He also has expertise in wet chemical analytical methods, polymer rheology and viscometry, physical test methods such as tensile testing and adhesive testing, and various forms of spectrophotometry.

Expert holds a six sigma black belt in process development and improvement. He has led several projects that have eliminated waste and improved the way processes are performed. These projects included drug excipient manufacturing development, electronic component manufacturing, and financial process business improvement. He has also mentored several six sigma green belts and taught six sigma tool methodologies to team members.

As a six sigma practicioner, Expert is not dogmatic about tool usage as many other practicioners are. Rather, he espouses a softer approach, where the tools are used as indicators and aids to really understand the root cause of problems and come up with achievable solutions. He is a big proponent of setting metrics to assess and measure the health of processes, and to take a big picture view of what's actually happening in the processes.

Expert has worked with a medical device company developing products for personalized medicine. He helped them assess skin adhesive chemistries, bioerodible films, and the chemical systems in their products.

Expert may consult nationally and internationally, and is also local to the following cities: San Jose, California - San Francisco, California - Sacramento, California - Oakland, California - Stockton, California - Fremont, California - Modesto, California - Salinas, California - Santa Rosa, California - Hayward, California

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Education

Year Degree Subject Institution
Year: 1987 Degree: Ph.D. Subject: Inorganic/Analytical Chemistry Institution: Rice University
Year: 1981 Degree: BSc Subject: Chemistry Institution: Hobart College

Work History

Years Employer Title Department Responsibilities
Years: 2010 to Present Employer: Undisclosed Title: Senior Scientist (contract) Department: Responsibilities: Expert is working with the development teams to a develop skin adhesive for a electronic patch. He is also working with them on developing erodible films and improving the chemical performance of their batery technology, all for the area of personalized medicine.
Years: 2005 to 2009 Employer: ALZA, a Johnson and Johnson Company Title: Principal Scientist Department: Responsibilities: Expert was the lead scientist in the development of a drug/device electrolytic transdermal patch delivery system. He helped overcome many major technical obstacles, including improving the shelf life from six to 18 months and reducing the failure rate from 6% to <50 ppm during this time frame. His responsibilities dealt with outside suppliers to improve their materials and processes, both in chemical and electronic component arenas.

He has filed six patents on the various improvements and technologies in this field.
Years: 2001 to 2005 Employer: ALZA Corporation Title: Manager, Specification Development Department: Responsibilities: He was responsible for the specifications and quality of all raw materials, including APIs and excipients, for all of ALZA's development projects. Expert worked closely with the development projects to determine key materials and the requirements for these materials. He was responsible for oversight of all of material specifications in the CMC sections of all of ALZA's drug filings, including authoring the requirements and reviewing dossiers.
Years: 1996 to 2001 Employer: ALZA Corporation Title: Principal Scientist Department: Analytical Sciences Responsibilities: Expert led the physical testing group within Analytical Sciences, which included rheological and viscometric testing, particle size determination, tensile testing test outsourcing, method validations, and method development. He acted as liaison between the group and several development projects.
Years: 1990 to 1996 Employer: Dionex Corporation Title: Manager, Suppressor Development Department: Responsibilities: Expert led the efforts in developing the core technology for ion chromatography. He developed technology that dramatically improved the reliability of the core technology, as well as developed IC test methods. He wrote several papers and presented numerous talks on the subject. He also holds six patents pertaining to ion chromatography.
Years: 1987 to 1990 Employer: Phillips Petroleum Company Title: Staff Scientist Department: Responsibilities: Expert was in charge of the wet chemical analytical chemistry group. This group performed testing in support of oil exploration, oil and chemical production, and product distribution. He developed numerous new test methods as well as lifted ion chromatography to the forefront of technology in the oil industry.

International Experience

Years Country / Region Summary
Years: 2006 to 2008 Country / Region: France Summary: Expert partnered with an electronic component manufacturer in France, who was a key supplier for his company. He helped them improve the reliability of the components used in his products, including electroplating, stamping, and injection molding improvements. He also developed test methods for them to insure the quality of their parts. He made several trips to their location to fully assess and implement the improvements.
Years: 2007 to 2008 Country / Region: China Summary: Expert worked with a printed circuit board manufacturer in Guangzhou who was a primary supplier to his company. He worked with them to improve their manufacturing processes to make the product more robust. He made one trip to Guangzhou.

Career Accomplishments

Associations / Societies
Society for Applied Spectroscopy
Professional Appointments
Northern California Section, Society for Applied Spectroscopy, former President, currently Treasurer
Awards / Recognition
Johnson and Johnson Global Standards of Leadership Award
Publications and Patents Summary
Expert holds six patents, one application filed, and an additional five to be filed.

He has written numerous articles and given several outside presentations in his various fields of expertise.

Additional Experience

Expert Witness Experience
He has given a deposition once dealing with intellectual property that he developed.
Vendor Selection
Expert has extensive experience in locating suppliers in the drug arena. These include excipient manufacturers, analytical test labs, and other CROs and CMOs. One of his specialities is in the interaction and management of these suppliers.

He has led several efforts in supplier selection by developing key requirements, translating those requirements to the potential candidates, and setting up metrics to make an unbiased assessment of their capabilities and ability to meet those requirements.
Marketing Experience
Expert often attends meetings to better understand the pharmaceutical marketplace. This is particularly important in product development as one must understand the current reimbursement potential, the competitive arena, and the regulatory direction to develop a product that meets those needs.

Language Skills

Language Proficiency
French Expert can read French, and has rudimentary speaking and writing skills.

Fields of Expertise

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