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Molecular Psychiatry and Neuroscience, Neuropharmacology, Cancer Immunotherapy
Expert has combined his extensive expertise in molecular biology, immunology, molecular neuroscience and psychiatry, and cancer biology to develop a new avenue in the discovery of suitable molecular targets for complex treatment of neurodevelopmental disorders (e.g. ADHD). The new treatment…
Disaster Related Environmental Regulation and Permitting for Recovery and Mitigation Projects
Expert has worked for multiple years in marine ecology and regulatory compliance.Expert specializes in understanding effective watershed processes and restoration techniques. He has built that understanding on his knowledge of aquatic organism life history diversity, fluvial geomorphologic concepts, riparian-aquatic interactions,…
Transdermal Development Including INDs, ANDAs, NDAs, MAAs, CMC, Preclinical, Clinical, Bioequivalence
I have been involved in transdermal product development for 15 years and have spearheaded the development of quality control, quality assurance, regulatory affairs and clinical research departments. Among my activities are: 1. Designing preclinical, clinical and bioequivalence studies. 2. Filing…
Chemical Processing, Powder Processing, Energetic Materials, Automotive Safety, Aerospace/Defense
Expert has over 30 years experience in process development, pilot scale operation, scale-ups, process equipment selection, chemical processing and formulations development, designs and trouble shooting of chemical and solids processing plants. Has experience in energetic, propellants and hazardous material formulations…
Hospital Tests and Kits, Clinical Chemistry, Coagulation, Serum Controls, Manufacturing Processes
Expert received his PhD in Biochemistry (Enzyme kinetics on NAD kinase in 1981), where he proposed a mechanism, Rapid Equilibrium Random with two dead end complexes for the enzyme, using enzyme inhibition studies. He was able to apply this knowledge…
wound healing, burns, clinical research, FDA regulations, drugs, devices, medical writing
Expert provides scientific knowledge and regulatory background to assist companies in the research and development of clinical, animal and laboratory studies designed to promote pharmaceutical drugs and medical device products specializing in wound healing and burn care. Additional Services: •Development…
Parenteral/Sterile Product Formulation Development; Protein Peptide Formulation; Drug Delivery
Former Director, Formulation Research, Hoffmann-La Roche Inc.- primarily parenteral formulation and drug delivery systems – Extensive experience in the areas of formulation, drug delivery and clinical manufacturing - Member of Global Formulation Research Leadership Team – Four successfully launched peptide/protein…
Biomaterials, Intraocular Lens Implants, DNA Analysis
Expert has completed doctoral studies in developing a novel polymer for intraocular lens implants. During this study she has designed several new experimental methods to detect polymer biocompatibility and toxicity to ocular and other cell types. Expert also has extensive…
Technical Writing of Test Procedures and Test Reports. EMC Testing Oversight & General Mitigation
Expert writes EMC test procedures and reports, provides training and consultation for EMC laboratory management, EMC measurements, mitigation, and testing oversight. He also performs internal audits for EMC laboratories accredited to ISO/IEC 17025. He worked in a NVLAP accredited facility…
Pharmaceutical Manufacture and Supply in Startup New Product Companies & Acquisition Integration
Expert has successfully developed and led a diversity of complex operations and projects in a variety of cultures and environments. These range from turnarounds and startups of flagship greenfield operations to cross functional teams in world-wide new product launches, and…