Your Consulting Resource from Development to Launch

Dr. Kathleen Krenzer is a board-certified toxicologist (DABT) serving as a Research Fellow in toxicology, with a focus on ophthalmic product development. 

Kathleen’s expertise in nonclinical product development stems from her previous experiences as a Study Director at a contract research laboratory, overseeing both pharmaceutical and medical device testing, and as a principal/senior principal scientist at Bausch + Lomb where she covered both pharmaceutical and medical device development programs, including 510(k), PMA, IND, and NDA submissions, geo-expansion activities, as well as nonclinical support for marketed products.

As a clinician-scientist, Kathleen brings a wealth of expertise in the area of ophthalmic product development, always maintaining focus on the ultimate beneficiary, the patient.  Her background in ophthalmic development includes early discovery with testing in efficacy models through clinical evaluations, having served as part of clinical investigative teams for numerous ophthalmic products.

Kathleen received her BS in Biology from the University of Notre Dame.  She earned her Doctor of Optometry degree (OD) from the New England College of Optometry, where she continues to serve as an adjunct professor, teaching in the College’s international programs.  She earned her PhD from Boston University School of Medicine in Pathology, focusing on ocular pathology and dry eye disease, and continued her post-doctoral training at the Schepens Eye Research Institute of Harvard University. Kathleen also served in the presidential chain for the Ocular Specialty Section of the Society of Toxicology (2018-2020).

Cheryl Marker, PhD, and a board-certified toxicologist (DABT), currently serves as a toxicology consultant at iuvo. Dr. Marker has more than 15 years of experience in the medical device and pharmaceutical industry as well as several years of clinical trial experience. Prior to joining iuvo, Cheryl was a Study Director at Contract Research Organizations (CROs) where she gained extensive experience overseeing a wide variety of study types including toxicology, pharmacology, biocompatibility, medical device, and interventional/surgical studies.

Cheryl also has expertise dealing with Good Laboratory Practices (GLP) requirements and ISO 10993 standards. Cheryl’s clinical trial experience includes contributing to investigational new drug (IND) applications, interacting with internal review boards (IRBs) and data safety monitoring boards (DSMBs), and managing/coordinating sites. Most recently, she managed a multi-site Phase I clinical trial. Cheryl earned her BS in Chemical Engineering with an emphasis in Biochemical Engineering from the University of Minnesota. She earned her PhD in Pharmacology with an emphasis in Neuroscience from the University of Minnesota Medical School. During Cheryl’s graduate studies, she focused on opioids, pain, and analgesia.

Jim Slota, MD, MSc serves as a toxicology consultant at iuvo. Dr. Slota has over a decade of experience in the clinical medicine and medical device space. After graduating from medical school, Dr. Slota pursued clinical research opportunities at George Washington University where he served as Co-Investigator for several clinical trials.

Jim earned his MSc in Material Science and Engineering from North Carolina State University with a focus on bio- and nanomaterials. Prior to joining iuvo, Jim was a Biocompatibility Specialist at Applied Medical where he worked closely with Applied’s internal engineering team to develop biological evaluation plans and biocompatibility risk assessments for various medical device categories.

Jim brings expertise in development stage biomaterial selection, pre-clinical stage toxicological risk assessment, and biological testing analysis with an emphasis on material-based cytotoxicity challenges.