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Cayla Ruch, PhD, DABT

Toxicologist

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expertise areas:

Biocompatibility, Toxicology

Dr. Cayla Ruch is a Board-Certified Toxicologist with over 6 years of experience in the medical device industry. She was previously a Study Director responsible for conducting safety and efficacy preclinical studies and studies in compliance with the ISO 10993 standards. Before that, she worked as a Project Manager for the Biological Safety Team at NAMSA.

Dr. Ruch received her PhD in Nutritional Biochemistry from the University of Minnesota – Twin Cities, with a research focus on high fat diet induced neuroinflammation and cognitive decline. In 2023, she received her Diplomate of the American Board of Toxicology (DABT) certification. Dr. Ruch is an active member of the Society of Toxicology.

CORE COMPETENCIES

  • Preparing risk assessments and evaluation plans and reports in compliance with ISO 10993-1, ISO 10993-17, and ISO 14971 for submission to the FDA and other regulatory agencies
  • Evaluating and summarizing biocompatibility and general toxicology data ensuring compliance with the relevant regulatory requirements and standards
  • Working knowledge of the FDA, EU MDD, EU MDR, and other global medical device and/or biologics regulations, ISO 10993 series, ISO 18562 series, and 14971
  • Ensuring biocompatibility studies are in compliance with most recent regulatory requirements
  • Performing and summarizing Clinical Evaluations
  • Providing technical support to lab staff
  • Advising clients on technical issues related to biocompatibility and material characterization
    • Performing biocompatibility gap analysis and writing clear, concise reports
  • Performing and summarizing literature searches
  • Facilitating the collection of test data from other NAMSA entities as they relate to a specific project
  • Evaluating and determining biological relevance of unexpected results

 RECENT PROJECTS

  • Participated in EU-MDR remediation project ensuring legacy testing was compliant and relevant to current regulatory standards
  • Prepared testing strategies for a nebulizer to be in compliance with a first-in-human study

PUBLICATIONS

  1. So SW, Fleming KM, Duffy CM, Nixon JP, Bernlohr DA, Butterick TA. Microglial FABP4-UCP2 Axis Modulates Neuroinflammation and Cognitive Decline in Obese Mice. Int J Mol Sci. 2022 Apr 14;23(8):4354. doi: 10.3390/ijms23084354. PMID: 35457171; PMCID: PMC9032181.
  2. Duffy CM, Hofmeister JJ, Nixon JP, Butterick TA. High fat diet increases cognitive decline and neuroinflammation in a model of orexin loss. Neurobiol Learn Mem. 2019 Jan;157:41-47. doi: 10.1016/j.nlm.2018.11.008. Epub 2018 Nov 22. PMID: 30471346; PMCID: PMC6547825.
  3. Duffy CM, Swanson J, Northrop W, Nixon JP, Butterick TA. Microglial Immune Response to Low Concentrations of Combustion-Generated Nanoparticles: An In Vitro Model of Brain Health. Nanomaterials (Basel). 2018 Mar 9;8(3):155. doi: 10.3390/nano8030155. PMID: 29522448; PMCID: PMC5869646.
  4. Mavanji V, Butterick TA, Duffy CM, Nixon JP, Billington CJ, Kotz CM. Orexin/hypocretin treatment restores hippocampal-dependent memory in orexin-deficient mice. Neurobiol Learn Mem. 2017 Dec;146:21-30. doi: 10.1016/j.nlm.2017.10.014. Epub 2017 Oct 28. PMID: 29107703; PMCID: PMC5798856.
  5. Duffy CM, Xu H, Nixon JP, Bernlohr DA, Butterick TA. Identification of a fatty acid binding protein4-UCP2 axis regulating microglial mediated neuroinflammation. Mol Cell Neurosci. 2017 Apr;80:52-57. doi: 10.1016/j.mcn.2017.02.004. Epub 2017 Feb 16. PMID: 28214555; PMCID: PMC5399884.
  6. Duffy CM, Ahmed S, Yuan C, Mavanji V, Nixon JP, Butterick T. Microglia as a Surrogate Biosensor to Determine Nanoparticle Neurotoxicity. J Vis Exp. 2016 Oct 25;(116):54662. doi: 10.3791/54662. PMID: 27805611; PMCID: PMC5092232.
  7. Duffy CM, Nixon JP, Butterick TA. Orexin A attenuates palmitic acid-induced hypothalamic cell death. Mol Cell Neurosci. 2016 Sep;75:93-100. doi: 10.1016/j.mcn.2016.07.003. Epub 2016 Jul 21. PMID: 27449757; PMCID: PMC5399885.
  8. Duffy CM, Yuan C, Wisdorf LE, Billington CJ, Kotz CM, Nixon JP, Butterick TA. Role of orexin A signaling in dietary palmitic acid-activated microglial cells. Neurosci Lett. 2015 Oct 8;606:140-4. doi: 10.1016/j.neulet.2015.08.033. Epub 2015 Aug 22. PMID: 26306651; PMCID: PMC4811357.
  9. Hocum Stone L, Butterick TA, Duffy C, Swingen C, Ward HB, Kelly RF, McFalls EO. Cardiac Strain in a Swine Model of Regional Hibernating Myocardium: Effects of CoQ10 on Contractile Reserve Following Bypass Surgery. J Cardiovasc Transl Res. 2016 Aug;9(4):368-73. doi: 10.1007/s12265-016-9696-y. Epub 2016 May 16. PMID: 27184805.
  10. Butterick TA, Hocum Stone L, Duffy C, Holley C, Cabrera JA, Crampton M, Ward HB, Kelly RF, McFalls EO. Pioglitazone increases PGC1-α signaling within chronically ischemic myocardium. Basic Res Cardiol. 2016 May;111(3):37. doi: 10.1007/s00395-016-0555-4. Epub 2016 May 2. PMID: 27138931.
  11. Gac L, Butterick TA, Duffy CM, Teske JA, Perez-Leighton CE. Role of the non-opioid dynorphin peptide des-Tyr-dynorphin (DYN-A(2-17)) in food intake and physical activity, and its interaction with orexin-A. Peptides. 2016 Feb;76:14-8. doi: 10.1016/j.peptides.2015.12.001. Epub 2015 Dec 3. PMID: 26654796.
  12. Holley CT, Long EK, Butterick TA, Duffy CM, Lindsey ME, Stone LH, McFalls EO, Kelly RF. Mitochondrial fusion proteins in revascularized hibernating hearts. J Surg Res. 2015 May 1;195(1):29-36. doi: 10.1016/j.jss.2014.12.052. Epub 2015 Jan 7. PMID: 25655995.
  13. Holley CT, Duffy CM, Butterick TA, Long EK, Lindsey ME, Cabrera JA, Ward HB, McFalls EO, Kelly RF. Expression of uncoupling protein-2 remains increased within hibernating myocardium despite successful coronary artery bypass grafting at 4 wk post-revascularization. J Surg Res. 2015 Jan;193(1):15-21. doi: 10.1016/j.jss.2014.08.003. Epub 2014 Aug 8. PMID: 25199570; PMCID: PMC4268234.
  14. Butterick TA, Duffy CM, Lee RE, Billington CJ, Kotz CM, Nixon JP. Use of a caspase multiplexing assay to determine apoptosis in a hypothalamic cell model. J Vis Exp. 2014 Apr 16;(86):51305. doi: 10.3791/51305. PMID: 24797379; PMCID: PMC4172056.
  15. Cabrera JA, Butterick TA, Long EK, Ziemba EA, Anderson LB, Duffy CM, Sluiter W, Duncker DJ, Zhang J, Chen Y, Ward HB, Kelly RF, McFalls EO. Reduced expression of mitochondrial electron transport chain proteins from hibernating hearts relative to ischemic preconditioned hearts in the second window of protection. J Mol Cell Cardiol. 2013 Jul;60:90-6. doi: 10.1016/j.yjmcc.2013.03.018. Epub 2013 Apr 2. PMID: 23562790.