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Expert in Hydrogel Science and Technology for Drug Delivery, Medical Devices and Consumer Products
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's major contributions are in microbial control of wide range of medical devices and pharmaceuticals. He has a background in chemical engineering and polymer science. He has decades of experience from numerous companies- large device and pharmaceutical companies to startups developing medical devices and drug delivery systems. He has taken products from the laboratory to full commercial release. In developing these products there are regulatory needs, depending on the product, for low bioburden to full sterilization, 10^-6 sterility assurance levels (SAL). He has worked with a diverse range of materials from liquids, hydrogels, and plastics to structural metals and combinations thereof. He is an expert in the use of antimicrobials, determination of bioburden and all means of sterilization, including electron beam, gamma ray, ethylene oxide and thermal. With products developed, he has worked on long term stability at a range of temperatures. This includes selection of packaging materials and testing of the package with the product. Expert's [particular] expertise comes from background in materials science and extensive experience in all major sterilization processes. He therefore knows the changes in properties of a device, including package, due to sterilization and shelf life. A good example of this is Expert's extensive experience in developing hydrogels from formulation to process and product. As use of hydrogel in a sterile product, it must overcome the issues of being a growth medium by choice of using antimicrobials. As hydrogels have high water content, the choice of the package is crucial. The interaction the sterilization process has upon the hydrogel has to be considered and operating conditions have to be established. The sterilization dose may not be high enough to achieve the required SAL but if too high may over cure or degrade the product. Another product area where he has made significant contributions is dialyzers. These devices are made of many different polymeric materials, therefore choosing effective materials including the membrane, that will be functional and not be damaged by sterilization is crucial.
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Show Only Primary Areas of Expert Consulting
Secondary Expertise
510(k) document, accelerated aging, autoclave, bandage, cannula, catheter, color additive, Current Good Manufacturing Practice, disposable medical device, Food and Drug Administration, Food and Drug Administration chemical registration, Food and Drug Administration compliance, Good Laboratory Practice, Good Manufacturing Practice, implantable device, mechanical integrity, medical adhesive tape, medical device coating material, medical device evaluation, medical device manufacture clean room, medical device manufacturing, medical device package testing, medical device premarket approval, medical device safety, medical device testing, medical filter, medical instrument cleaning, medical package, medical package strength, medical package testing, medical packaging, medical polymer extrusion, medical polymer molding, medical pressure-sensitive adhesive, medical product, medical product manufacturing, medical protocol, medical seal, microwave sterilization, new drug application, polyvinyl chloride quality control, surgical instrument, therapeutic device, transcutaneous electrical nerve stimulator
Basic Expertise
biologic sterilization, biomedical device design review, biomedical engineering, cleaning validation, clinical protocol, clinical trial, clinical trial design, cost, cost reduction, decontamination equipment, disposable device high-speed automated assembly, durable medical equipment, electronic bone growth stimulator, electronic medical device, FDA medical device regulation, governmental registration process, heparin coating material, implant coating material, medical device clinical research, medical device corrosion, medical device design, medical device endotoxin detection, medical device endurance testing, medical device hazard analysis, medical device inspection, medical device liability, medical device manufacturing automation, medical device manufacturing quality control, medical device marketing, medical device mechanical stress analysis, medical device packaging design, medical device packaging material, medical device packaging process, medical device packaging standard, medical device product development, medical device reliability testing, nosocomial infection, oxidized cellulose, package design, pathology | 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;
Bridgeport, Connecticut;
New Haven, Connecticut;
Hartford, Connecticut;
and Philadelphia, Pennsylvania.
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Degree |
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Subject |
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Institution |
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Honors |
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1973
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PhD
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Chemical Engineering, Polymer Science
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City University of New york
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NSF Fellowship
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1967
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ME
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Chemical Engineering
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City College of New York
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1964
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BE
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Chemical Engineering
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City College of New York
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Vice President American Rocket Society, CCNY Chapter
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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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2006 to
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(Undisclosed)
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Consultant
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He is an established expert technical consultant in product and process development for medical device companies. He specializes in drug delivery, OTC topicals, wound dressings, medical electrodes, and medical devices. He is expert in advanced development of materials: membranes, hydrogels, super-absorbents and other materials for medical or cosmetic use. He has developed hydrogels businesses(s) from formulation to manufacturing. He has experience and expertise in packaging, sterilization, toxicology, and stability studies. He invented products. He has assisted attorneys in filings and office actions and advised on patentability to avoid litigation.
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1993 to 2006
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Vyteris Inc.
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Manager Materials Development
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He was lead inventor responsible for directing research and development of novel hydrogel reservoirs as major component of iontophoretic drug-delivery system. He oversaw all phases of product scale-up from bench to commercial manufacturing. He administered budgets and managed technologists and laboratory staff. He developed and executed all specifications for component reservoirs. He interacted effectively with other disciplines including medical professionals, attorneys, QA, QC, manufacturing, contractors, consultants, and vendors. He coordinated Intellectual Property issues with company executives and attorneys. He write and submitted patent applications and position papers. He served as technical lead in opposition suits against competitors.
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1992 to 2000
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Becton Dickinson & Co.
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Becton Dickinson Transdermal Systems
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Manager
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He began work as a consultant. He was offered a position in BDTS. He trasferred to Vyteris when division was bought by investors in 2000. His work responsibilities were the same as those stated for Vyteris Inc.
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Associations/Societies
AIChE, ACS, AIC, AAMI
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Licenses/Certifications
FAIC
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| Publications: |
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Publications and Patents Summary
He has 20 US patents and at least 10 publications.
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| Government Experience: |
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Agency |
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Role |
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1965 to
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NASA
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Project Director
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1967 to
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NIH
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Project Director
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Recent Client Requests:
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Expert for consulting on Market research and applications.
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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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Expert Witness Experience Summary:
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He supports clients and law firms by formulating technical arguments in patent litigations and serving as expert witness in federal court. He had taken the lead in eight EP patent oppositions by formulating theories, supplied evidence and chose witnesses. All opositions were won in EU court.
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Recent Litigation Client Requests:
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Steam turbine expert for consulting on cause of oil leak.
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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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1991 to 1992
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Ireland
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2006 to
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Netherlands
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He has developed materials used in medical devices and drug delivery systems that led to multiple commercial products. He has set standards that have been approved by FDA. Many materials developed by him have been used in medical and consumer products for decades.
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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Supplier and Vendor Location and Selection He sources, locates and sets specifications with suppliers and vendors in his areas of expertise. He has with extensive experience has inside information on many vendors and their products or services.
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Other Skills and Services
He is creative and effective problem solver. He has based upon his experience and expertise in many fields been able to determine outcome of issue quickly and ultimately correctly saving clients both time and resources.
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Education
