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Expert in Pharmaceutical Development & Validation
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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Expert has over 20 years of broad-based experience with pharmaceutical product development. His work in this area has ranged from early phase 1 drug characterization to phase 4 market product launch and validation. He has significant experience in bringing products to market on a worldwide basis.
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Expert has significant experience organizing, developing, and submitting process validation protocols and final reports. The reports were prepared to summarize and detail acceptance criteria and the complaince with FDA requirements. Based on his efforts, he has helped successfully launch four new products at two plant sites from 1993 through 1994. PRE-APPROVAL INSPECTION. Expert was involved in multiple FDA pre-approval inspections at three sites in the US and Puerto Rico. His team developed standard operating procedures, reports, spreadsheets, and all summary documents for successful pre-approval inspections.
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Expert has had significant experience in preparing technical dossiers and CMC implementation for registration and filing purposes for worldwide registration.
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Expert has developed protocols and methods of evaluating cleaning procedures for adequately assuring compliance with the most current FDA standards. He has prepared satisfactory cleaning procedures for removing drug residues in accordance with FDA and CGMP requirements.
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Expert has audited facilities and plants that manufacture the active pharmaceutical ingredient in bulk drug products. He ensures that the substances comply with FDA requirements.
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Experienced in designing and evaluating novel oral drug delivery systems, Expert and his staff have successfully developed and transferred from Europe a once-a-day antihypertensive drug into the US market. He has been also deeply involved in the formulation of other drug agents, including delivery of peptides via the oral route (as opposed to parenteral administration). He was involved with European companies in selecting and evaluating oral delivery of Calcitonin.
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Expert has been deeply involved with the design and scale-up of novel drug delivery systems for parenteral administration. One application involved the surfactant solubilization for lipid soluble agents and nanoparticle systems for intravenous use. The evaluation of manufacturing and sterilization processes were critical elements in this work.
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Knowledgeable of pharmaceutical development on a global scale, Expert is involved in the successful development of a worldwide registration plan for fast-track development and market launch.
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Expert has been heavily involved in the development and introduction into the European market of a nasal spray delivery system for Calcitonin. He was also very active with multi-dose and unit-dose nasal delivery formulations and packaging systems. Quality control procedures were developed for spray content and spray patterns in accordance with FDA expectations.
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A significant portion of Expert's career has been involved with international efforts to transfer dosage forms from research and development into plant sites. He has transferred analytical and pharmaceutical drugs from USA to Europe and vice versa. He has also worked in Puerto Rico and various European countries on projects related to scale-up and introduction of programs into production phases. The application of good manufacturing procedures and state-of-art technologies was utilized.
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Expert has evaluated polymorphs for effects on drug solubility, bioavailability, and product stability.
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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 Stamford, Connecticut.
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Degree |
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Subject |
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Institution |
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1973
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PhD
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Pharmaceutical Sciences
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Rutgers University
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1965
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MS
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Pharmaceutics
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Columbia University
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1961
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BS
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Pharmacy
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Brooklyn College of Pharmacy
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| Years |
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Employer |
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Title |
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Responsibilities |
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1995 to 2008
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Deatech Associates
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President
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Drug development strategies,
product development,
expert witness,
auditing for CGMP compliance,
validation and PAI support,
clinical manufacturing
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1990 to 1994
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Wallace Laboratories
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Director, Pharm. Development
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Formulation development,
Process Development,
Outsourcing management,
Clinical Manufacturing,
Validation and, PAI
Product Introductions
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1981 to 1990
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Rorer Group Inc.
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Department Director
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International Pharmaceutical Development and Coordination
Worldwide clinical study development
Process Engineering
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1987 to 1989
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Rorer Group
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Department Director
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Process and formulation scale-up,
Worldwide process introduction, and
Production introductions
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1984 to 1987
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Rorer Group Inc.
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Department Director
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Development of Pharmaceutical Analytical, microbiological, and quality services ,worldwide
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1981 to 1984
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Rorer Group Inc.
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Section Head
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Worldwide process and formulation scale-up and, plant troubleshooting
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1977 to 1981
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Purdue Frederick
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Director. Pharmaceutical Analysis
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Management of pharmaceutical analytical development, CMC preparation, and sterile validation efforts
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1977 to 1979
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Purdue Frederick
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Group Leader
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Pharmaceutical formulation development, and management of stability laboratory
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Associations/Societies
Expert is a member of the American Association of Pharmaceutical Scientists, the International Pharmaceutical Excipient Committee, the Regulatory Affairs Professional Society, and the Validation Advisory Committee of the PMA.
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Awards/Recognition
Expert received the Squibb Institute's President's Award for Technical Achievement in 1975.
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Selected Publications and Publishers
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- Pergamon Press
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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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Expert in homogeneous and hetrogeneous testing for patent case involving a taxane direvative.
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Drug formulation expert for consulting on Amifostine.
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Pharmaceutical drug development expert for consulting on testimony on behalf of DEA.
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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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Summary |
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Italy, Germany, Ireland, Spain, the UK
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He has significant experience in technology transfer with on-site visits to EEC countries, particularly Italy, Germany, Ireland, Spain, and the UK.
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| Language Skills: |
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| Foreign Language |
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Spanish
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French
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| Additional Skills and Services: |
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Other Skills and Services
Expert has significant experience in technology transfer with on-site visits to EEC countries, particularly Italy, Germany, Ireland, Spain, and the UK.
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Education
