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Expert has extensive experience in the preparation and submission of 510(k) documents to the FDA for approval of Class II medical devices. His first work in 510(k) preparation and submission was in 1987 for acceptance of a rapid immunoassay for Lyme Disease. Since then, he has worked with Regulatory Affairs personnel at several Biotechnology firms to prepare both hybrid 510(k) and standard 510(k) applications, to include medical instrument specifications, clinical testing in multiple, geographically distinct sites both in the US and in the EU, statistical analysis, etc. As always, the process requires adherence to requirements for document preparation, clear explanation of the technology and comparative patient data to an already accepted Class II medical device.

Expert has worked for many years in both the development of agglutinations assays for medical diagnosis of multiple human and animal diseases and use of commercial agglutination products, using standard latex microparticles, fluorescein dye-impregnated microparticles, polystyrene microparticles, ferro particles, gold sols and bentonite. These have included standard agglutination assays as well as reverse agglutination assays for detection of human pregnancy, for detection of antibodies to syphilis spirochetes, and detection of a wide variety of low-molecular weight hormones, and bacterial and parasitic infections. His first experience in the commercial development of microparticle agglutination assays in 1984 involved the development of submicron latex particles (0.9, 0.7, 0.5 and 0.3 micron diameter) coated with antibodies to low molecular weight hormones, bacterial toxins or bacterial cells, which then adhetred to dipsticks. Agglutination assays required optimized covalent coupling of antigen or antibody moieties to the surface of the microparfticles, the correct combination of reagents, including blocking agents and optimal buffering of the reagents. Finally packaging of reagents was performed to optimize product shelf-life.

Expert has worked in three areas of bioinstrumentation since 1984: 1) the development of bioassays (fluorescence microscopy, fluorometric, hapten detection, ELISA, Dot-ELISA, and related immunoassays, and DNA assays, etc.) for use in specific or generic instruments; 2) in the development of novel bioinstruments for use with unique bioassay applications, such as antibody-coated of DNA-coated microchips and nanochips, and; 3) development of instruments to rapidly detect genetic mutations in human DNA. He invented and received a US patent for a rapid DNA hybridization assay fopr the detection on single nucleotide polymorphisms (SNP) in human genes. He has product development, product optimization, and document preparation experience in such instruments and has managed the development of such devices.

Expert has been developing biomedical products for commercial use since 1984. He has worked at several large and small biotechnology firms on the east coast developing standard and rapid, self-contained immunoassays (rapid test devices (RTDs), DNA hybridization assays and supporting reagents for the assays, such as buffers, wash solutions, conjugates substrate solutions, and controls. In addition, he has extensive experience in all phase of biomedical product development, from inception, research phase, product development phase, quality control phase, manufacturing phase, packaging (inner and outer packaging and inserts) and government approval.

Expert has been developing biomedical products for commercial use since 1984. He has worked at several large and small biotechnology firms on the east coast developing standard and rapid, self-contained immunoassays, DNA hybridization assays and supporting reagents for the assays, such as buffers, wash solutions, conjugates substrate solutions, and controls. In addition, he has soup-to-nuts experience in all phase of biomedical product development, from research, product development, quality control, manufacturing, packaging and government approval phases, due to his experiences at several biotech firms developing self-contained "disposable" bioassays. These include simple agglutination assays, as well as self-contained immunoassay "Rapid Test Devices" (RTDs) for rapid detection of HIV-1 infection. Such devices are commercially important because they are designed to be compact and self-contained, minimizing disinfection and biohazard wastes disposal steps and costs. They also help reduce the chance for accidental infection of laboratory personnel during assay performance, minimizing insurance costs.

Expert has developed many enzyme-linked immunosorbent assays (ELISA) for a wide variety of bacterial, viral, fungal and parasitic diseases since the early 1980s. While at the Walter Reed Army Medical Center in Washington, DC, he developed numerous assays for human diseases of military significance, including assays for cutaneous and visceral leishmaniasis, toxoplasmosis, hydatid disease, coccidiodomycosis, and histoplasmosis. He then entered the private sector where he developed colorimetric immunoassays, including ELISA and Dot-ELISA assays for a large number of bacteria, viruses and toxins. He also developed tube fluorescence ELISA assays to detect pasteurization of products for the food and dairy industry. These assays were read using benchtop fluorometers desigend by his company. He also published the first book on the business of biotechnology which gave comprehensive descriptions of ELISA and Dot-ELISA formats for detection of both patient antibodies and actual pathogen material (microbes, parasites and their antigens).

Expert has experience in the area of humoral immunity. He has lectured nationally on the subject and taught Immunology to university studentse and has lectured nursing students and other allied health care students on antibody stimulation through the interaction of antigen with antigen specific immune cells (T Cells, antigen presenting macrophages and dendritic cells) and production by activated B cells (Plasma cells). He has experience in the production of epitope-specific antibodies for use in immunoassays and other bioassays. He has experience in the design of low molecular weight (hapten) antigens covalently linked to larger carrier proteins for intramuscular (IM) injection into animals, the collection, purification and most importantly the assay of purified immunoglobulins for strength (titer) and use in immunoassays.

Expert has worked in the field of Immunology as a Ph.D. since 1980. Prior to receiving his doctorate, he worked for 5 years performing original research in the immunology of parasitic diseases. Prior to that, he worked at several hospitals performing standard immunoassays for detection of infections or disease in patients. Since 1980 Expert has developed many enzyme-linked immunosorbent assays (ELISA) for a wide variety of bacterial, viral fungal and parasitic diseases. While at the Walter Reed Army Medical Center in Washington, DC, he developed many assays for diseases of military significance, including assays for cutaneous and visceral leishmaniasis, toxoplasmosis, hydatid disease, coccidiodomycosis, and histoplasmosis. When he left the military and entered the private sector in 1984, he developed colorimetric immunoassays, including ELISA and Dot-ELISA assays for a large number of bacteria, viruses and toxins at several biotech firms. He also developed tube fluorescence ELISA assays to detect proper pasteurization of products for the food and dairy industry, which were read using bench top fluorometers. Expert has worked for many years in both the development of agglutinations assays for medical diagnosis of multiple human and animal diseases and use of commercial agglutination products, using standard latex microparticles, fluorescein dye-impregnated microparticles, polystyrene microparticles, ferro particles, gold sols and bentonite. These have included standard agglutination assays, as well as reverse agglutination assays for detection of human pregnancy, for detection of antibodies to syphilis spirochetes, and detection of a wide variety of low-molecular weight human hormones, and human bacterial and parasitic infections. He published the first book on the business of biotechnology that gave comprehensive descriptions of ELISA and Dot-ELISA formats for rapid, sensitive and specific detection of both patient antibodies and actual pathogen material (antigens).

Expert has been performing research in immunoparasitology since 1974 and has over 50 publications in national and international journals in the field. He performed his Master's research on the parasitic worm schistosomiasis (Schistosoma mansoni) and his doctoral research was on malaria (Plasmodium bergheii) where he discovered a complement-mediated defect during fulminating malaria. He has extensive experience in the development of bioassays for parasite detection; he developed many immunoassays enzyme-linked immunosorbent assays (ELISA) for a wide variety of bacterial, viral fungal and parasitic diseases since 1981. While at the Walter Reed Army Medical Center in Washington, DC, he developed numerous assays, including ELISA and Dot-ELISA assays for diseases of military significance, including assays for cutaneous and visceral leishmaniasis, toxoplasmosis, hydatid disease, leptospirosis, coccidiodomycosis, and histoplasmosis. He then entered the private sector where he developed colorimetric immunoassays, for parasites, as well as bioassays for many bacteria, viruses and toxins. He also wrote and published the first book on the business of biotechnology which gave comprehensive descriptions of ELISA and Dot-ELISA formats for detection of both patient antibodies and actual pathogen material (antigens). He recently acted as an expert witness for a patient infected with a parasitic worm while vacationing in the Caribbean. His experience in parasitology resulted in a finding for the plaintiff of over $1 million in pain and suffering.

Expert has been managing the development of biomedical products for commercial use since 1984 and developed several commercial tests and standard reagents currently sold on the market. He has worked at several large and small biotechnology firms on the east coast as a senior manager developing standard and rapid, self-contained immunoassays, microwell Elisa assays for rotavirus and Lyme Disease, DNA hybridization assays and supporting reagents for the assays, such as buffers, wash solutions, conjugates substrate solutions, and controls. He has routinely managed complex product development contracts using Gantt charts. In addition to his extensive experience in all phase of biomedical product development, (from research, product development, quality control, manufacturing, packaging and government approval phases), he has worked at several biotech firms managing the development of self-contained "disposable" bioassays. These include self-contained simple agglutination assays, as well as self-contained immunoassay "Rapid Test Devices" (RTDs) for rapid detection of HIV-1 infection. Such devices are commercially important because they are designed to be compact and self-contained, minimizing disinfection and biohazard wastes disposal steps and costs. They also help reduce the chance for accidental infection of laboratory personnel during assay performance. Finally, he has worked closely with reagent manufacturinf companies to assure timely and correct preparation of reagents for a variety of immunoassays and has written quality control protocols for tersting of both reagents and cortrol.

Expert has worked for many years in detecting infections and pathogens using serology. Since 1984, he has developed agglutination assays for medical diagnosis of multiple human and animal diseases and has used commercial agglutination products. The serological tools included agglutination assays (standard latex microparticles, fluorescein dye-impregnated microparticles, polystyrene microparticles, Ferro particles, gold sols and bentonite particles). These were performed as standard agglutination assays as well as reverse agglutination assays for detection of human pregnancy, for detection of antibodies to syphilis spirochetes, and detection of a wide variety of low-molecular weight hormones, and bacterial and parasitic infections. His first experience in the commercial development of microparticle agglutination assays in 1984 involved the development of submicron latex particles (0.9, 0.7, 0.5 and 0.3 micron diameter) coated with antibodies to low molecular weight hormones, bacterial toxins or bacterial cells, which then adhered to dipsticks. While at the Walter Reed Army Medical Center in Washington, DC, he developed numerous assays for diseases of military significance, including assays for cutaneous and visceral leishmaniasis, toxoplasmosis, hydatid disease, coccidiodomycosis, and histoplasmosis. He then entered the private sector where he developed colorimetric immunoassays, including ELISA and Dot-ELISA assays for a large number of bacteria, viruses and toxins. He also developed tube fluorescence ELISA assays to detect proper pasteurization of products for the food and dairy industry, which were read using bench top fluorometers. He also published the first book on the business of biotechnology that gave comprehensive descriptions of ELISA and Dot-ELISA formats for detection of both patient antibodies and actual pathogen material (antigens).

Expert has performed basic research in the interactions of polyclonal and monoclonal antibodies, particularly regarding their interactions in biomedical assays. His work includes defining cross-reactions between closely related antigens from related pathogens.

Expert has developed multiple assays for detection of bioantigens from parasites, fungi, bacteria and viruses, analytes such as enzymes and drugs of abuse, and for microbial toxins (T2 Toxin). He has published extensively on such assays in the national and international medical literature.

Expert has extensive experience in the development, quality control and use of use biomedical applications in research areas, and in the commercialization and use of such applications in medicine, disease diagnostics, and the food and dairy industries.

Expert has performed original research worked in cellular immunology, particularly in the interactions of immune cells (macrophages, T Cells and B Cells) in the development, diagnosis and amelioration of human diseases.

Most of Expert' research work has been in the development of novel assays for use in the clinical immunology setting. This includes the development, quality control and manufacture of immunoassays for diagnosis of multiple human diseases and detection of pathogen antigens in human samples. Expert has been developing clinical assays since 1982. In addition, as a Army Medical Service Corps Officer, he worked at three of the four larget military medical centers in the United States and as part of his duties managed 19 clinical laboratory personnel at a 500 bed hospital. He oversaw the Clinical Immunology/Serology laboratory at this hospital and and four personnel working in this clinical laboratory. He also teaches Medical Technology courses to university students and has taken on the role of teaching most of the medical technology courses at this college until a Director is appointed. His courses include teaching propsective medical technology students immunoassays (ELISA, Dot-ELISA, Western Blot assay, syphilis testing, ABO compatibility and multiple, other aspects of clinical immunohematology).

Expert has specialized in grant writing for small to medium biotechnology and Pharma companies since 1988. He has helped scores of companies win Phase I and Phase II grants from the SBIR/STTR programs of the NIH, DoE, and DoD and has helped companies win both Phase I and II grants from the NSF. He has expertise in the developmet of complex grant applications for the Advanced Technology Program of the NIST. Altogether, he has won or helped win over $12 million dollars in grants from these organizations and and state grant agencies, as well as private investments from large multinationals seeking to acquire new, patentable technology.

Expert has extensive experience preparing scientific proposals for winning state and federal research and development grants for development and commercialization of biomedical products. He has both written and helped small to medium size biotechnology and pharma firms write complex grants to state government business development agencies (New Jersey and Michigan), several institues within the National Institutes of Health (NIH), the Department of Defense (DOD) and the National Science Foundation (NSF). He has helped firms also prepare and win grants from the NIST's Advanced Technology Program (ATP), resulting in millions of dollars of funding to small firms. In all, he has won or helped firms win about $15 million in Phase I and Phase II grants and state grants. His proposal preparation also led to financing by venture capital firms and a $3.5 million investment in a biotechnology firm he worked for by a very large, multinational Japanese firm.

Expert specializes in writing Phase I and Phase II grant proposals for small to medium size biotechnology and pharma firms based on their novel, proprietary technologies. He has assisted firms all over the country in winning grants. His expertise lies in the optimal research and development of scientific proposals to win Phase I and Phase II grants from the NIH, DoE, DoD and NSF, as well as the very difficult but highly lucrative Advanced Technology Program grants from the NIST. He has won or helped win about $15 million in grants from these federal institutions, as well as scientific research grants from state governments (New Jersey and Michigan). Recently, he developed a comprehensive report for a west coast pharmaceutical firm on its novel technology in radiation protection, which will be used to prepare many grant proposals and proposals to venture capital firms.

Expert has been developing clinical assays since 1982. Most of his research and development work in the private sector and as a military officer has been in the development of novel immunoassays and other medical diagnostic tests for use in the clinical diagnostics setting using antibodies produced under his guidance and management at severasl different biotechnology firms. These antibodies were used in antibody-based assays he developed for commercial or private (laboratory use). This assay development includes the research and product development, quality control, manufacture and packaging of immunoassays for diagnosis of multiple human diseases and detection of pathogen antigens in human samples. He has developed DNA probes for DNA assays at several biotech firms. He also invented and received a US patent for a novel and rapid DNA assay to detect single nucleotide polymorphisms (SNPs) in human DNA. In addition, as a US Army Medical Service Corps Officer, he worked at three of the four largest military medical centers in the United States. Part of his duties included managing 19 clinical laboratory personnel at a 500 bed hospital as an Army senior officer. He oversaw the Clinical Immunology/Serology laboratory at this hospital, which performed antibody-based and DNA probe assays to deterct disease, including cellular immunity and autoimmune disease of pateints at the 500 bed hospital and managed four personnel working in this clinical laboratory. Expert assessed new products for inclusion in the set of medical diagnostic tests available to physicians in the hospital clinical laboratory.

Regarding Bioterrorism, he has lectured on Bioterrorism and has sat on an NIH Grant Review Board on the development of vaccines against Bioterror agent, including pathogens (bacteria, viruses), and toxins listed as actual or potential bioterror agents, such as anthrax, Brucellosis, Cholera, Plague, toxigenic E coli, Salmonella, Shigella, Q fever, the hemorrhagic disease viruses, and toxins such as the Clostridium toxin and Staphylococcal toxin B. A parasitologist by training, Expert has developed many in vitro diagnostic assays using microtiter plate technology and nitrocellulose-based microtiter plates in parasitology. He has published his findings in parasitology in prestigious journals, including Science, The Journal of Clinical Investigation and Transactions of the Royal Sociery of Tropical Medicine. He also teaches Medical Technology courses to university students and has taken on the role of teaching most of the medical technology courses at this college until a Director is appointed. His courses include teaching propsective medical technology students the theory of the immune system and its application in the development and use in the development of immunoassays (ELISA, Dot-ELISA, Western Blot assay, syphilis testing, ABO compatibility and multiple, other aspects of clinical immunohematology).

He has performed grant writing services for over 25 small to medium size biotechnology and pharmaceutical firms throughout the USA. He has helped raise over $16 million in grant funds and contracts at client firms and at companies that he has worked as an employee. He has helped raise over $4.5 million in private funding from a US and Japanese multinational firm for a biotech firm. He sits with client scientists and business managers and assists them in formulating high quality grant proposals.Performed on-site consultation to biotech start-ups, such as DIGENE Diagnostics, CTC, Inc., Genome Data Systems, Inc., Advanced Instruments, Inc., and others on new product development, quality control and process troubleshooting. He resolved QC issues regarding passage of rapid dipsticks to detect drugs of abuse, and managed the final development steps of a cancer cell detection assay using DNA hybridization.He has acted as an expert witness in court cases where the plaintiff claimed that she was infected with a potentially deadly microbe by consuming infected food. He reviewed all court documents, depositions, performed research on the disease and prepared a comprehensive expert witness document regarding likelihood of true infection of the plaintiff. The expert document was instrumental in the plaintiff settling with the defendant law firm for over one million dollars in pain and suffering.He has consulted for large national biomedical firms developing rapid test kits for the detection of drugs of abuse. He has discovered errors in storage of raw materials and finished product, and has advised firms on improved ways to produce, package and store products, as well as quality control parameters for testing finished product to prevent recalls.He consulted as an expert witness for a defendant regarding a drug use/abuse case. He studied evidence, court records and prepared legal documents for the defendant's lawyer and rebuttal materials against State's evidence.