Expert Details
Pharmaceutical Chemical Process R&D, Manufacturing, Disaster Recovery, Software Design
ID: 728464
New York, USA
design, computer hardware, client/server systems, web based systems, full implementation of systems from start to finish, management of scientists, and project management at the highest level in an organization.
As Manager, Chemical Process R & D, Expert designed, developed, and manufactured APIs at the multi-ton scale under total FDA requirements in the controlled substances area. Expert has been involved in at least 10 successful PAIs.
Expert was the Director of Chemical Process Development at Bristol Myers where he designed, developed and manufactured antibiotics, antiviral, and anticancer agents; some at the 600,000 kg level. Expertise in dynamic nmr utilized to follow chemical reactions.
Expert designed, developed and installed/implemented state-of-the-art computer software in the following areas: Order Entry & Point-of-sale inventory control, accounts payable, accounts receivable, CRM, pharmaceutical marketing and sales systems and specializes in designing, developing and deploying web database applications.
Expert has acted as expert witness in a treble damages patent lawsuit. His testimony was instrumental in settling the suit out of court for a large sum of money.
Expert is presently consulting for a major US pharmaceutical company since 2005 in the following areas: Chemical Process Research and Development, process discovery, process optimization, patent analysis, analyses of drug markets, competitive forces, intermediate sourcing, total market analyses, analyses of manufacturers and competitive capabilities, synthetic routes to target molecules, software design, development and implementation.
Education
| Year | Degree | Subject | Institution |
|---|---|---|---|
| Year: 1969 | Degree: Ph.D. | Subject: Organic Chemistry | Institution: Rensselaer Polytechnic Institute |
| Year: 1965 | Degree: B.S. | Subject: Chemistry | Institution: Rensselaer Polytechnic Institute |
Work History
| Years | Employer | Title | Department |
|---|---|---|---|
| Years: 2003 to Present | Employer: Undisclosed | Title: President & CEO | Department: |
Responsibilities:Consultant pharmaceutical industry in chemical process R & D, pharmaceutical marketing and sales. Expertise in the analyses of every aspect of a particular drug - api, competitive forces, opportunities, patent analyses, synthetic design, and process optimization. |
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| Years | Employer | Title | Department |
| Years: 2000 to 2003 | Employer: Johnson Matthey | Title: IT Manager | Department: Pharmaceutical Materials Division |
Responsibilities:21 CFR Part 11 implementation of major document management system both hardware, software, validation, and networking. Supervised 15 scientists on this project. |
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| Years | Employer | Title | Department |
| Years: 1994 to 2003 | Employer: Johnson Matthey | Title: Manager Chemical Process R & D | Department: Pharmaceutical Materials Division |
Responsibilities:Responsible for design, development of organic chemical processes and manufacture of APIs at the thousand kilo level. The emphasis was on controlled substances and organometallic compounds. Managed and supervised a 15-member department. |
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| Years | Employer | Title | Department |
| Years: 1991 to 1994 | Employer: Digital Microsystems | Title: President & CEO | Department: |
Responsibilities:President and founder of a full line IT company specializing in computer software, hardware, networking, and custom design of manufacturing software with an accounting base. |
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| Years | Employer | Title | Department |
| Years: 1969 to 1991 | Employer: Bristol Myers Pharmaceutical R & D | Title: Site Director | Department: Chemical Process R & D |
Responsibilities:Directed 22 scientists - BS/MS/Ph.D levels in the manufacture of all new products - antibiotics, antiviral agents, anticancer agents, tranquilizers, and many other products. Pre-IND, IND and NDA involvement at the highest levels.Manufactured antibiotics at the several hundred ton level. |
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Additional Experience
| Expert Witness Experience |
|---|
| Expert witness for a composition-of-matter patent issued to himself through a major US pharmaceutical company working closely with Skadden Arps in NYC. His testimony was instrumental in the settlement of this case out of court leading to a high cash settlement. His expertise in analytical chemistry and pharmaceutical organic synthesis and methodology contributed greatly to this success. |
| Training / Seminars |
|---|
| Expert has presented many seminars over the span of his industrial experience. Expert has also developed a course in general organic chemistry for an educational institution. |
| Vendor Selection |
|---|
| Expert's current consulting activities with a major US pharmaceutical company include this expertise of sourcing intermediates for API manufacture. |
| Marketing Experience |
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| Expert has written a state-of-the-art software package integrating in all aspects of the drug industry, organic synthesis, competitive forces, patents, DMFs, Orange Book, and other important databases. His expertise in this area is unrivaled. Expert provides a complete picture spanning all industries for a particular drug either generic or branded. |
| Other Relevant Experience |
|---|
| Expert possesses computer software development for many industries including retail, manufacturing, aqnd the pharmaceutical industry. Expert is an expert in Mobile App development for smart devices such as phones and tablets. Expert has marketed several commercial software packages such as an ERP package, CRM Package, automotive shop package, general accounting, and pharmaceutical marketing and sales. Expert pioneered in the use of robotics to chemical process optimization designing one of the first fully computer controlled robot systems on a large lab scale. He also designed and developed a semi-micro robotic system to run up to 18 chemical reactions simultaneously under computer control. This was presented at the 9th International Symposium on Laboratory Robotics in 1990. Expert has the ability to take any corporate database and design, develop and implement a web application of it using AJAX techniques causing it to operate in near windows desktop speed over the web. |
Fields of Expertise
21 CFR Part 11, active pharmaceutical ingredient, analysis technique, application software design, chromatography, chromatography applications, client/server database access software, computer validation, computer-system validation, Current Good Manufacturing Practice, database management system, Food and Drug Administration, Food and Drug Administration compliance, Food and Drug Administration validation, Good Manufacturing Practice, order entry software, pharmaceutical industry, pharmaceutical manufacturing, point-of-sale software, pre-approval inspection, process validation, software design, software validation, spreadsheet software, tracking software, World Wide Web application, chiral chromatography, pharmaceutical manufacturing facility auditing, chiral high-performance liquid chromatography, drug development, chemical separation, Good Laboratory Practice