iuvo molecule

Lumino Advisors Consulting Team

Kathleen Krenzer, OD, PhD, DABT

Kathleen Krenzer, OD, PhD, DABT

Research Fellow - Toxicology

Dr. Kathleen Krenzer is a board-certified toxicologist (DABT) serving as a Research Fellow in toxicology, with a focus on ophthalmic product development.  Prior to joining iuvo, Kathleen was a Senior Principal Scientist at Bausch + Lomb in the non-clinical safety group.

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.

Kirk Van Ness, PHD, DABT

Kirk Van Ness, PHD, DABT

Toxicology Expert Consultant

Kirk P. Van Ness, PhD, DABT, has more than 20 years of drug development experience with both small molecules and biotherapeutics. He brings a strong preclinical development regulatory background in toxicology coupled with expertise in mechanistic toxicology focused on renal-, hepatic- and immunotoxicology. Dr. Van Ness is capable of designing, implementing and finalizing a broad range of nonclinical safety assessment studies for biopharmaceuticals (recombinant cytokines, mAbs, Fc-fusion proteins), small molecules, anti-sense RNA therapeutics and nanoparticle drug delivery systems.

Kirk has comprehensive knowledge of the nonclinical development regulatory requirements necessary to advance successful drug candidates through the pipeline. He has worked with small and large drug development companies to guide nonclinical study designs in support of all phases of clinical development and has assisted with FDA interactions and adherence to FDA-ICH guidelines.  As an integral member of drug development teams at Amgen (and previously at Immunex), ZymoGenetics and Sarepta (formerly AVI BioPharma) he has experience working with pharmacokinetic, regulatory, clinical, research and manufacturing colleagues to ensure on time quality deliverables. Kirk is a board-certified toxicologist (Diplomate of the American Board of Toxicology) since 2009.

Kirk received a BA in Biology from Indiana University. He earned a Masters Degree in Fisheries investigating PCB contamination in Puget Sound fish and a PhD in toxicology researching aflatoxin metabolism from the University of Washington.

Cheryl Marker, PHD

Cheryl Marker, PHD

Toxicology Expert Consultant

Cheryl Marker, PhD, 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.

Anthony Di Pasqua, PHD

Anthony Di Pasqua, PHD

Formulation Expert Consultant

At iuvo BioScience, we can assist customers in developing an appropriate pharmaceutical formulation for dosing of active pharmaceutical ingredients for use in pre-clinical and clinical testing. Our formulation expert, Anthony Di Pasqua, PhD, has over a decade of experience designing drug formulations to enhance efficacy and/or minimize their side-effects of therapeutically active compounds. He has been involved in the design and characterization of solid, semisolid, and liquid dosage forms.

From capsules, gels and patches to solutions, suspensions and emulsions, Dr. Di Pasqua has the technical know-how to translate basic scientific concepts into therapeutic applications. His expertise also extends to dosing these formulations in animal models via appropriate routes of administration.

To date, Anthony has 39 published peer-reviewed papers and three patents. From optimizing lipid nanoparticles to deliver mRNA more effectively to preparing gels that improve transdermal delivery of lidocaine, Anthony has a wide range of experiences that can be used to help you develop a drug delivery strategy that works best for your product.

Ray Proudlock

Ray Proudlock

Genetic Toxicology Expert Consultant

Ray Proudlock is a member of our extended team overseeing iuvo’s Genetic Toxicology laboratory. He is a world-renowned scientist and brings a deep scientific expertise in genetic toxicology and a wealth of experience from leadership roles in multiple organizations.

Prior to his role with iuvo and as a consultant, Ray was Scientific Director at Moltox (Molecular Toxicology, Inc.), overseeing the development of new genetic toxicology testing products and providing technical assistance to clients world-wide.  Before his tenure at Moltox, Ray was the Head/Scientific Director of Genetic Toxicology at Charles River Laboratory, Montreal.  In this role, he established and supervised an FDA/OECD GLP compliant genetic toxicology laboratory capable of performing over 200 genetic toxicity studies per year.

Additionally, Ray has held leadership roles at Bausch + Lomb, USA and Huntingdon Life Sciences, UK.  He is the author of the current definitive practical guide to Genetic Toxicology (Genetic Toxicology Testing: A Laboratory Manual, published by Elsevier) as well as numerous publications and has been a frequent invited speaker on issue related to Genetic Toxicology across the globe.

Ray is available for advice on all aspects of genetic toxicology testing including test strategy, issue management, assay performance, and reporting.  We can offer experienced technical and strategic assistance in your product development program including test management and advice on specific issues including impurity qualification and technical problems with specific tests.

Mary Richardson, PhD, DABT

Mary Richardson, PhD, DABT

Consultant

As Chief Scientific Officer at iuvo and one of the company’s co-founders, Mary heads up the Research and Development team. Most recently Mary served as Executive Director of Preclinical Development at Bausch + Lomb, continuing in that role when Valeant Pharmaceuticals purchased the company. Previously, she had been Director of Nonclinical Safety.

Her extensive background includes in-depth research and development experience covering the full range of the preclinical product life cycle. This includes discovery, product development, and post-market support in areas including life cycle management, geo-expansion, and manufacturing. She brings exhaustive knowledge of global regulations and standards for registration of pharmaceutical and medical device products.

Her technical leadership and expertise in drug development of small molecules, peptides, and medical devices has resulted in regulatory approval and success of numerous NDAs, INDs, IMPDs, and 510(k) submissions. She’s an in-demand speaker with many published articles in scientific journals.

Mary earned her PhD from the University of Rochester School of Medicine and Dentistry and is a highly experienced board-certified toxicologist (Diplomate of American Board of Toxicology – DABT) with broad-based technical skills in pharmaceuticals, OTC, medical devices, drug metabolism, toxicology, pharmacokinetics, and pharmacology.