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Licensing, Biopharma, Pharma, Medical Devices, Chemistry, Agreements, Business Development
Expert has more than 25 years of expertise in transactional and regulatory counseling, acquisition, licensing, due diligence, dispute resolution, opinions, and appeals for the development and commercialization of health care, pharmaceutical, biotechnology, chemical, computer and electronics technologies. With more than…
Food Safety
Expert has developed a predictive model to estimate the growth of salmonellae during the cooling of beef carcasses. This model was used during an evaluation of proposed USDA regulations, to determine the relative probability of salmonellae growth under a variety…
Bionanosciences, Nanomaterial interfacing & targeting, Cell biology & biophysics, Molecular imaging, Microscopy
The expert has been actively designing and developing surface chemistries and coatings that allow a controlled organic/inorganic interfacing of colloidal nanomaterials with biomolecules. Over the past 14 years, projects carried out by the expert have focused on engineering the surface…
Molecular Pathology and Novel Solutions to Thrombosis, Cancer, Sepsis, Immunopathology.
Expert has pioneered the identification of the proteins of the Coagulation cascade responsible for Thrombosis, Hemostasis, Disseminated Intravascular Coagulation, Sepsis, Inflammation and the roles in neoplastic cell invasion and metastasis. He was the first to successfully identify and isolate Factor…
Neuroscience, Genetics, Gene Therapy, Biochemistry and Lab Equipment
Expert has expertise using and developing animal models for specific neurological conditions, from his work in gene therapy. In particular, Expert published the first gene therapy treatment that corrected a rodent model of Parkinson's disease, and has collaborated with two…
Drug Delivery, Formulation Development of NCE\’s, Pre-formulation, Stability, and Clinical Manufacturing
She has been involved in contract manufacturing of pharmaceuticals for the drugs and devices. Contract manufacturing for drugs have included identification, evaluation, screening and selection of CRO's and CMO's in the area of sterile solution and oral solids. For the…
Immunology, Vaccinology, Infectious Diseases, Recombinant Proteins
Expert has been involved in numerous animal studies examining various aspects of infectious disease agents. Expert has worked with animal models of infection with the following diverse pathogens: Schistosoma mansoni, Candida albicans, Borrelia burgdorferi, and S. aureus. In addition, he…
Orphan Drugs: FDA/EU/Canada; FDA Approval; Drug Development: CMC, QA, QC, Manufacturing
12 product approvals from FDA including 6 new chemical entities, a 510k device, and three major pharmaceutical efficacy indication supplemental approvals. All received 5-10 years of regulatory exclusivity (Hatch-Waxman, Orphan Drug). These products are generating over $100 million dollars in…
Toxicology, Environmental Medicine, Biochemistry, Cancer Causation, DNA Damage & Repair, Genetics, Arsenic, Metals
Expert has published about 120 articles, mostly on metal carcinogenesis and environmental toxicology, with an emphasis on arsenic. She was first to report on the comutagenicity of arsenic and later developed the only animal model of arsenic-induced skin cancer. She…
Due Diligence, Competitive Differentiation, Science Scouting, Innovation Assessment, Research Tools, Expert Witness, Cancer Biomarkers, Cancer Immunology, Assay Development, Research Devices
Developed multiple novel immunoassays and immunology products for start-up biotechnology company. Founding Director, Research and Development for privately held company in San Diego. Oversaw innovation and entrepreneurship at Mitchell Cancer Institute resulting in 5 spin-out biotechnology companies in the area…