Mary Richardson, PhD, DABT
Chief Scientific Officer, Executive Vice President
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.
David Kudla, MBA
Vice President, Laboratory Operations
David is a well-established senior operational and business leader who brings decades of experience in operational, quality and general management assignments. David spent nearly twenty years at Celltech Pharmaceuticals in various quality roles prior to moving to Advancis Pharmaceutical Corporation where he served as the VP of Quality Assurance. David then moved to Shire in a senior quality assurance and quality control role prior to joining Unither in 2011 where he ultimately served as the General Manager of their North American operation. Just prior to joining iuvo, David was with ECRI serving as Director in their Strategy and Enterprise Project Management Office delivering enterprise strategy deployment and operational excellence.
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.
Nancy Rakiewicz
Manager, Quality and Regulatory
Nancy 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 acquired twenty-five years of medical device and pharmaceutical sterilization and validation experience as Manager of Sterilization and Manger of Sterilization Validations for STS Duotek and Ethox International. She participates in the Sterilization Standards Committee and several sterilization working groups for the Association of the Advancement of Medical Instrumentation (AAMI).
Nancy graduated from the University of Illinois at Urbana-Champaign with a BS in Chemical Engineering.
