iuvo molecule

The iuvo Consulting Team

Shana Azri-Meehan

Shana Azri-Meehan

Director, Consulting Services

As Director, Consulting Services, Shana will be responsible for personnel management / development, providing consulting expertise,  leading sponsor interactions, troubleshooting projects and executing against the overall consulting business strategy.

Shana graduated from Memorial University of Newfoundland with a BS in Biology and has a PhD in Pharmacology from Dalhousie University in Halifax, Nova Scotia. Shana is a board-certified toxicologist with extensive experience in designing toxicology programs for US/EU regulatory submissions for Pharmaceuticals, and medical devices across a broad range of therapeutic areas.  Shana has held various roles at Clairol/Bristol-Myers Squibb, Johnson and Johnson, Colgate-Palmolive, Richardson-Vicks/Procter and Gamble and, most recently was the Managing Director, Regulatory and Product Development (Clinical, Medical Writing, Nonclinical) Specialty Solutions at Cardinal Health.

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, 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.

Jim Slota, MD, MSc

Jim Slota, MD, MSc

Toxicology Expert Consultant

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.

Omid Khodai, OD, MS, RAC

Omid Khodai, OD, MS, RAC

Regulatory Consultant

Omid has more than 20 years of experience in Clinical, Medical, and Regulatory Affairs in senior and executive management roles. He has coordinated all strategic and tactical aspects of regulatory submissions and clinical studies/trials according to standard operating procedures, study protocols, and domestic and international regulatory guidelines. Omid has skillfully led the development and delivery of products across diverse therapeutic and diagnostic areas.
 
Prior to consulting, Omid served as Director of Clinical Research at Boston Scientific.  In this role he led the clinical team to design and execute the company’s clinical trial strategy to produce a clinical evidence-base for regulatory, reimbursement, and commercial positions. Omid also served as Global Head of Clinical and Medical Affairs at STAAR Surgical, including successful approval of FDA Advisory Committee. Omid also served as Executive Director of Clinical and Medical Affairs and Scientific Communication at Bausch and Lomb where he successfully led the organization to approval of FDA Advisory Committee and commercialization of first of kind product as well as successful integration of a $5 Billion business through acquisition.
 
Omid earned a Doctor of Optometry degree in Ophthalmic Science from Salus University and a Master of Science in Regulatory Science from San Diego State University. He is also certified in a Regulatory Affairs as well as Biomedical Quality Auditing and Quality Management / Operational Excellence.