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Biocompatibility Testing and Biomaterials for Medical Devices
Consulting experience in the set up and protocols for biological tests, pre-clinical evaluation submission summaries (regulatory), product (medical device) cleaning validation, GLP laboratory set up and management, biocompatibility/ toxicilty testing Strategy for the pre-clinical evaluation / toxicity testing of an…
Polymer Science, Adhesives, Adhesion, Biomaterials, Medical Device, Analytical Chemistry
Experienced Research And Development Scientist with an innovative collaboration mindset enabling over 85 patents/applications in the medical device industry. Strong research professional skilled in Medical Devices, Biocompatibility, Regulatory Support (EU-MDR), Surface Science, Nanotechnology, Coatings, Adhesion and Adhesives, Polymer Chemistry, Biomedical…
Chemistry and Biotechnology
Expert has over 15 years of research and management experience in analytical and protein chemistry with a focus on nanomaterials and biopolymeric materials. She has published over 10 peer-reviewed manuscripts related to nanomaterial synthesis and characterization. Expert has also contributed…
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…
Adhesives, Polymer Nanocomposites, Plastics, Biomaterials
Expert wrote his Ph.D. research in the area of thermosetting composite and rubbery materials. After graduation he began work with National Starch and Chemical Company in specialty pressure-sensitive adhesives and moved then to Integra Life Sciences in collagen-based regenerative biomaterials.…
Medical Devices, Biomaterials, Due Diligence, Business Development
Expert has extensive research and development expertise having spent over 20 years in the development of orthopaedic implants. This lead to over $1billion in sales. The technologies developed included calcium phosphate cement, 2 different calcium phosphate coatings, biodegradable implants and…
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…
Physical Characterization of Biopolymers, especially Shape Memory and Porosity
Expert's dissertation details his innovative work summarized below: • Created a method of solvent selection to make a porous xerogel (solution gelation chemistry). Demonstrated the method on two different sol-gel polymer formulations. • Created a shape-memory characterization method for porous…
Biomaterials, Drug Delivery, Tissue Engineering, and Regenerative Medicine
Expert is an internationally recognized expert in biomaterials development, drug delivery (e.g., protein, plasmid DNA, etc), tissue engineering, and regenerative medicine. Expert, PhD, received his B.S.E. in Mechanical Engineering and Material Science and Biomedical Engineering, cum laude, from Duke University…
Medical Device Technology, Molecular Biology, Virology, Infectious Diseases, Tissue Engineering
Expert is a Clinical Trials manager in the National Health Service, UK; where she is involved in Stroke trials. She has had significant experience in the area of Tissue engineering and Stem cell biology for the last 5 1/2 years…