Dr. Mary Richardson
Mary, one of the co-founders of iuvo BioScience and its Chief Medical Officer, leads Lumino Advisors – leads Lumino Advisors, the company’s consulting division. 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 was Director of Nonclinical Safety.
Her extensive background includes in-depth research and development experience covering the full range of the preclinical product life cycle including discovery, product development, and post-market support in areas including life cycle management, geo-expansion and manufacturing. Her knowledge of global regulations and standards for registration of pharmaceutical and medical device products is exhaustive.
Mary’s 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
Dr. Kathleen Krenzer
Dr. Kathleen Krenzer is a Research Fellow in Toxicology at iuvo BioScience. She has been involved in the toxicology field for almost 20 years and has been a board-certified toxicologist (DABT) since 2007. She has worked on both the CRO -side and the Sponsor-side of medical product development, with a broad experience in medical devices. In her current role, she works with sponsors on a variety of issues such as biological evaluation strategy development, preparation of regulatory documents, including biological evaluation reports, and issues management. She received her Doctor of Optometry degree (OD) from the New England College of Optometry and her PhD in Pathology from Boston University. She is currently serving as the president of the Ocular Toxicology Specialty Section of the Society of Toxicology (SOT).
Nancy’s has more than 30 years experience and extensive expertise in compliance with applicable sterilization standards (EO and Steam), training and documentation, overseeing sterilization validation services, writing reports and protocols, and problem solving for clients and equipment. Nancy also has extensive experience serving as a QA expert conducting quality assurance activities related to GMP/GLP studies including monitoring of studies for compliance with the regulations, conducting phase audits/inspections, leading regulatory and notified body inspections, conducting supplier audits, and has a lead role in the Validation program. Her expertise has helped successfully address numerous Regulatory inquiries. Nancy holds a BS in Chemical Engineering from the University of Illinois.
Ray Proudlock is a member of our extended team overseeing iuvo BioScience’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 BioScience 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.
Donna Ventura - Director, Toxicology
Donna is responsible for overseeing microbiology, toxicology and chemistry laboratory operations. She is also responsible for the regulatory, accreditation and environmental requirements for the company and serves as a primary liaison for the veterinary care program, and participates in the institutional animal care and use committee. Donna provides consulting services including customer support and protocol development for biocompatibility and safety studies.
Before iuvo, Donna acquired over thirty years of medical device and pharmaceutical development and testing experience, in positions such as Manager of Toxicology for STS Duotek and Ethox International. She participates in the Sterilization Working Group for the Association of the Advancement of Medical Instrumentation (AAMI), and is the liaison for the Association for the Advancement and Accreditation of Laboratory Animal Care (AAALAC). Like Ben and Mary, Donna spent significant time at Bausch and Lomb, supporting the research and development program for lens materials and lens care formulations.
Donna graduated from Rochester Institute of Technology with a BS in Biology.
As a staff toxicologist, Jessica supports sponsors in their toxicology and biocompatibility programs including study design, data and literature review, gap assessments, safety assessments, and preparation of biological evaluation reports to support regulatory submissions. Prior to joining iuvo BioScience in 2018, Jessica earned her PhD in Toxicology from the University of Rochester School of Medicine and Dentistry, with a focus on developmental immunotoxicology.
Her interest in pursuing a career in toxicology stemmed from her previous experience as a Research Associate in the medical device space, where she was part of an R&D team that sought to develop medical devices for the delivery of novel moisture-curing, degradable tissue adhesives and sealants.
Jessica also holds a MS in Toxicology from the University of Rochester School of Medicine and Dentistry and a BS in Chemistry from the University of Pittsburgh. She has been a member of the Society of Toxicology (SOT) since 2014 and the American College of Toxicology (ACT) since 2019.