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Darin Kent is a Board-Certified Senior Principal Toxicologist at NAMSA who has been in the biomedical industry for 29 years, with over 20 years at NAMSA. He has focused on medical devices for a wide variety of therapeutic areas, including ocular, cardiovascular, tissue-derived, wound closure/treatment, and many others. Darin’s expertise includes analytical chemistry, chemical characterization, biocompatibility, risk assessment, and toxicology.
Prior to joining NAMSA in 2004, Darin held positions at Commonwealth Biotechnologies and Parke-Davis Pharmaceutical Research. Darin has been a toxicologist and consultant at NAMSA since 2009, as well as a Scientist and GLP Study Director, and has authored hundreds of assessments for many clients large and small. He has produced deliverables used in many successful medical device regulatory submissions throughout the world.
Darin holds a Bachelor’s degree in biochemistry from California State University – San Francisco, Master’s and PhD degrees in organic chemistry from the University of California, San Diego, and is a Diplomate of the American Board of Toxicology.
CORE COMPETENCIES
- Preparing risk assessments, evaluation plans, and reports in compliance with ISO 10993-1, ISO 10993-17, and ISO 14971 for submission to the US FDA, Notified Bodies, and other regulatory agencies
- Working knowledge of FDA, EU MDR, and other global medical device regulations, as well as biologic regulations, the ISO 10993 series and 14971
- Developing biological evaluation plans and biological risk assessments for the evaluation of the biological safety of medical devices
- Plans and assessments consider the safety of the materials of construction, clinical use, type and duration of patient contact, biocompatibility/chemical testing performed, clinical history, patient population, regulatory guidance, and safety thresholds of extractable chemicals
- Planning toxicological risk assessments of extractable chemicals observed during analytical analysis through toxicological literature searches, calculated tolerable intake/exposure of chemicals and subsequent margin of safety determinations as they relate to patient exposure
- Preparing gap analysis documents to ensure previously performed biocompatibility studies comply with most the recent regulatory requirements and provides biological significance of differences that may be observed
- Advising clients on technical issues related to biocompatibility and material characterization, in addition to determining biological relevance of unexpected results
- Routinely drafts and defends responses to regulatory deficiencies associated with medical device biocompatibility evaluations
- As a study director, was responsible for all aspects of GLP compliance of preclinical biocompatibility studies (ISO-10993 series, MHLW, USP, EP) and providing interpretation of results, observations, and impact of unexpected circumstances
- Developed and coordinated special toxicology/efficacy studies, as well as routine biocompatibility studies according to GLP and Non-GLP regulations for various models.
- Studies included: cytotoxicity, local tissue implantation, irritation, hemocompatibility, sensitization, systemic toxicity, pyrogenicity, ocular toxicity, genotoxicity, bone regeneration, dura repair, hemostasis, and wound healing
PUBLICATIONS
- Yamazaki T, Benedetti E, Kent D, Goodman, M. (2010). ChemInform Abstract: Conformational Requirements for Sweet-Tasting Peptides and Peptidomimetics. Cheminform. 25.
- Carraway J, Kent D, Young K, Cole A, Friedman R, Ward K. (2008). Comparison of a new mineral based hemostatic agent to a commercially available granular zeolite agent for hemostasis in a swine model of lethal extremity arterial hemorrhage. Resuscitation. 78. 230-5.
- Kent D, Cody W, Doherty A. (2002). Synthesis of 3-(3-pyrrolidinyl)alanine and its derivatives as arginine peptidomimetics for incorporation into serine protease inhibitors. 10.1007/0-306-46862-X_302.
- Goodman M, Zhu Q, Kent D, Amino Y, Iacovino R, Benedetti E, Santini A. (1997). Conformational analysis of the dipeptide taste ligand L-aspartyl-D-2-aminobutyric acid-(S)-α-ethylbenzylamide and its analogues by NMR spectroscopy, computer simulations and X-ray diffraction studies. Journal of peptide science : an official publication of the European Peptide Society. 3. 231-41.
- Goodman M, Kent D, Zanetti M, Gerloni M, Kohmura M, Ashi Y. (1997). An immunological approach to the structural basis of the sweet taste. Pure and Applied Chemistry – PURE APPL CHEM. 69. 715-720.
- Goodman M, Zhu Q, Kent D, Amino Y, Iacovino R, Benedetti E, Santini A. (1997). Conformational analysis of the dipeptide taste ligand L-aspartyl-D-2-aminobutyric acid-(S)-α-ethylbenzylamide and its analogues by NMR spectroscopy, computer simulations and X-ray diffraction studies. Journal of Peptide Science – J PEPT SCI. 3. 231-241.
- Kent D, Cody W, Doherty A. (1996). ChemInform Abstract: Two New Reagents for the Guanylation of Primary, Secondary, and Aryl Amines.. Tetrahedron Letters – TETRAHEDRON LETT. 37. 8711-8714.
- Benedetti E, Gavuzzo E, Santini A, Kent D, Zhu Y-F, Zhu Q, Mahr C, Goodman M. (1995). Sweet and bitter taste: Structure and conformations of two aspartame dipeptide analogues. Journal of Peptide Science. 1. 349 – 359.
- Yamazaki T, Benedetti E, Kent D, Goodman M. (1994). Conformational Requirements for Sweet-Tasting Peptides and Peptidomimetics. Angewandte Chemie-international Edition – ANGEW CHEM INT ED. 33. 1437-1451.