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Expert in Controlled-Release Drugs
Available for your Consulting and Expert Witness Needs
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Summary of Expertise:
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Listed with other top experts in: |
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SOLID PHARMACEUTICAL PRODUCT; TABLET COATING; DRUG DOSAGE FORM DEVELOPMENT. Expert has served as Director of Product Development at the leading firm involved in the discovery and application of pharmaceutical coating products and technology. In that capacity Expert directed all activities focused on developing coating systems for use on solid cores, including tablets and multiparticulates, as part of the drug dosage form development process. He developed and implemented a broadly applied framework (model) for new product development to guide research efforts, plan projects, ensure regulatory/GMP compliance, develop budgets, monitor progress, and secure a proprietary position. A number of new product types have resulted from this effort. In addition to product discovery, Expert also evaluated external technologies and companies in the context of acquisitions and joint ventures. PHARMACEUTICAL COATING MATERIAL; POLYMER DRUG-DELIVERY METHOD; DRUG RELEASE POLYMER. Expert's prime focus for the past several years has been the discovery and development of new pharmaceutical coating formulations. As a key part of that effort he developed and implemented a detailed protocol designed to thoroughly characterize coating raw materials and to determine their influence on the performance of the ultimate coating formulation. An emphasis was placed on defining the relevant properties of the polymeric components and on interactions with other critical ingredients, e.g. plasticizers. Compatibility with drug substances and stability were also evaluated as important parameters in the total product development process. Expert can answer in-depth questions on cellulose coating materials, coating material salts, and medical polymers. CONTROLLED-RELEASE DRUG DELIVERY; DELAYED-ACTION DRUG; TIMED-RELEASE DRUG. Expert has over 20 years experience in modified-release formulation technologies applied to the pharmaceutical, agrochemical, and specialty chemical sectors. Techniques emphasized include film coating and various microencapsulation methods. He has published and delivered invited presentations in the area of modified release technology and was a well-critiqued lecturer on controlled release in a short course devoted to film coating. COATING INSPECTION; COATING MEASUREMENT; COATING PROPERTY; COATING MATERIAL CHARACTERIZATION. In a very recent assignment Expert has established and directed an analytical chemistry department whose main focus was the analysis and characterization of pharmaceutical film coatings. His activities included direct measurements of color, weight gain, thickness, and other attributes as well as indirect assessment of coating integrity via the determination of drug release profiles or tablet disintegration rates. Other key functions in which he was active include formulation stability, validations, and technical problem resolution. COATING PROCESS; CONTROL SYSTEM. As a necessary complement to his main focal point of developing pharmaceutical coating materials, Expert has gained an understanding of the coating process from the standpoint of processing parameters, equipment, troubleshooting, and optimization.
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Show Secondary and Basic Areas of Expertise | Localities:
Expert may consult nationally and internationally, and is also local to the following cities: New York, New York;
Yonkers, New York;
Newark, New Jersey;
Jersey City, New Jersey;
Paterson, New Jersey;
Elizabeth, New Jersey;
Trenton, New Jersey;
Philadelphia, Pennsylvania;
Allentown, Pennsylvania;
and Baltimore, Maryland.
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Degree |
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Subject |
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Institution |
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Honors |
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1970
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PhD
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Organic Chemistry
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Ohio State University
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National Institutes of Health Predoctoral Fellow
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1965
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BS
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Chemistry
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College of the Holy Cross
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| Years |
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Employer |
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Department |
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Title |
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Responsibilities |
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1996 to
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(Undisclosed)
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President
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Consultant
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1990 to 1996
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Colorcon
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Product Development
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Director
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Directed all pharmaceutical product development and regulatory support activities.
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1976 to 1988
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Pennwalt Corporation
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Research and Development
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Manager
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Managed all novel formulation and biotechnology product development adtivities within the Technical Division
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1970 to 1976
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Rohm and Haas Company
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Senior Research Chemist
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Organic Chemical Synthesis
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Associations/Societies
Expert is a member of the American Association of Pharmaceutical Scientists, the American Chemical Society, the Chemical Consultants Network, the Licensing Executives Society and Phi Lambda Upsilon.
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Professional Appointments
Expert was a National Institutes of Health Predoctoral Fellow (1966-70) and founding member of the Polymer Focus Group of the American Association of Pharmaceutical Scientists.
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Awards/Recognition
Expert received the Award of Special Recognition from the Controlled Release Society (1985).
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| Publications: |
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Publications and Patents Summary
Expert is the author of a number of publications in the areas of organic chemistry, pharmaceutical delivery systems, agricultural formulations and market anaylsis. In addition, he has delivered a number of invited presentations in those areas.
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Selected Publications and Publishers
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- Seed Trade News
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- Proceedings of the International Symposium on Control. Rel. Bioact. Mater
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- AAPS Symposium
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- Engineering Foundation Conference
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- Proceedings of the International Symposium on Control. Rel. Bioact. Mater
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| Selected Consulting Examples: |
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Expert has provided numerous on-site consultations to firms in the pharmaceutical, excipient, agricultural chemical markets as well as to intellectual property law and investment banking firms.
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Recent Client Requests:
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Expert in Microencapsulation and materials selection for consulting on definition of materials and encapsulation process.
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Oral dosage form expert for consulting on formulation development.
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Click the green button above to contact
Expert for a free initial screening call regarding your expert consulting needs.
Expert is available for consulting to corporate, legal and government clients.
Remember, your initial screening call to speak with
Expert is free.
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Recent Litigation Client Requests:
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Pharmaceutical manufacturing expert for trade secret litigation case.
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Expert in controlled release drugs for consulting on Doryx tablets for patent litigation.
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Expert in controlled release pharmaceutical for consulting on patent infringement.
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Expert in sustained release technology for consulting on alleged fraud in the procurement of the patent on K-Dur, as sustained-release potassium drug.
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Expert in use of a pan coater for powder drug layering of inert cores to form pellets.
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Expert in pharmaceutical manufacturing for consulting on processes and requirements for filing a change of site in an NDA.
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Click the green button above to contact
Expert for a free initial screening call regarding expert testimony,
litigation consulting and support, forensic services, or any related expert witness services.
A few litigation needs include product liability, personal injury, economic loss, intellectual property
(patent, trademark, trade secret, copyright), and insurance matters. Remember, your initial screening
call to speak with
Expert is free.
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| International Experience: |
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| Years |
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Country / Region |
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Summary |
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to
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England/France
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Expert visited and regularly interacted with colleagues at former employer's facilities in England and France.
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1985 to 1985
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Switzerland
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He organized and chaired the Controlled Release Society Symposium on the Controlled Release of Bioactive Materials in Geneva, Switzerland (1985).
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| Language Skills: |
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| Foreign Language |
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German
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French
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Expert is President/Owner of an independent consulting firm providing product and business development services to the pharmaceutical and specialty chemical industries and to the intellectual property and invertment banking communities.
Click the green button above to contact
Expert for a free initial screening call regarding your marketing research, industry research, and company
research needs. For research needs involving multiple experts or secondary research,
a Research Director can be assigned to coordinate the work into a custom report for you as a potentially quicker
and more cost effective alternative to doing this work yourself or hiring a boutique consultancy.
Remember, your initial screening call to speak with
Expert is free.
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| Additional Skills and Services: |
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Training/Seminars
Expert has delivered a number of invited presentations and training sessions, e.g., modified-release pharmaceutical film coating.
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Supplier and Vendor Location and Selection Expert has experience locating vendors of
pharmaceutical excipients,
formulation development services,
analytical chemistry services, and processing/manufacturing services.
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Education
