OCULOSCR.COM - Key Persons
Job Titles:
- 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.
Job Titles:
- CEO
- Member of the Board of Directors
- Member of the Leadership Team
- President
- President and CEO, Iuvo BioScience
Prior to co-founding iuvo BioScience and taking on the roles of President and CEO, Ben was Vice President of Quality for the Pharmaceutical, Solutions and External Manufacturing organizations of Valeant Pharmaceuticals. Prior to the acquisition of Bausch + Lomb by Valeant, Ben served as Global VP of Quality for the Pharmaceutical Business Unit, and was a member of the B+L Global Leadership Team.
Earlier in his career, he held the position of Director, Quality and Technical Services for Norwich Pharmaceuticals (a contract manufacturing and development organization), responsible for driving new business development and revenue and leading the technical services organization (project managers, engineers, formulators, method developers, etc.) in delivering customer projects, as well as heading up the site quality organization. Ben began his career with Procter & Gamble Pharmaceuticals as a Process Engineer, moving up to roles of increasing responsibility in Product Development, OTC Engineering (Cayey, PR) and Global Clinical Supplies.
Ben holds a BS from Carnegie Mellon University with a double major in Chemical Engineering and Biomedical Engineering, and a dual MS/MAT in Chemistry and Education from Binghamton University.
Job Titles:
- Director of Finance
- Member of the Leadership Team
Bobby is a well-established Finance executive who brings years of experience in all aspects of finance and accounting, specifically in the healthcare industry. Bobby received his Bachelor of Business Administration and MBA from St Bonaventure University. As a CPA he began his career in public accounting at KPMG and then joined Carestream Health where his career progressed through a series of positions including Corporate Accounting and Financial Reporting Manager, Assistant Controller and, ultimately, Corporate Strategy & Finance Manager. Bobby brings a wealth of financial expertise to iuvo as well as experience leading and supporting mergers, acquisitions, and complex debt transactions.
Job Titles:
- 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.
Job Titles:
- Member of the Board of Directors
- Ampersand As an Executive Advisor
- Executive Advisor, Ampersand Capital
Daniel joined Ampersand as an Executive Advisor in 2023 and has more than 25 years in senior life science executive roles. He joined the clinical drug development team at Pharmacia & Upjohn in 1996. He later founded TFS (TFS Health Sciences), a global midsized clinical Contract Research Organization serving 250 biopharma customers worldwide. Daniel is the recipient of numerous entrepreneurial achievement awards.
In 2010, Daniel received the Swedish National Award as "Man of The Year" by Ernst & Young and in the same year was awarded the title "Entrepreneur of The Year" by Founders Alliance and Grant Thornton. His expertise covers biopharma outsourced services (drug discovery, pre- clinical and clinical) and research technology-enabled services. He is currently serving on the following Board of Directors: Ampersand portfolio company iuvo Bioscience (US), Avance Clinical (Australia), Trialbee (US), PathoQuest (France/US), Scantox (Denmark) and Inhalation Sciences (Sweden). Daniel holds a technical degree in Chemical Engineering and an OPM from Harvard Business School.
Job Titles:
- Member of the Leadership Team
- 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.
Job Titles:
- Chief Medical Officer
- Professor of Ophthalmology
Dr. Charles B. Slonim most recently served as an Professor of Ophthalmology and Affiliate Professor of Plastic Surgery at the University of South Florida College of Medicine in Tampa and Associate Clinical Professor of Ophthalmology at the University of Florida College of Medicine in Gainesville, Florida.
Dr. Slonim teaches physicians about ophthalmic and oculoplastic diseases, diagnoses, and surgeries, as well as contact lens technology. He has lectured extensively to ophthalmologists, optometrists, and other physicians throughout the United States, and in more than 55 international cities in more than 34 countries around the world. He served as a Consultant at the Olympic Vision Center in the Olympic Village during the 1992 Summer Olympics in Barcelona. He has been a world-renowned Consultant for a number of major contact lens and ophthalmic pharmaceutical companies. He served as the Medical Director for Bausch and Lomb Pharmaceutical, Inc. from 1990-2009 and as a Member for Scientific Advisory Board of Sirion Therapeutics, Inc. and Sirion Holdings Inc. He is the team Ophthalmologist for many Tampa Bay area professional and intercollegiate sports teams, including the Tampa Bay Lightning of the National Hockey League and the University of South Florida intercollegiate sports programs. He has published one book, Eye Was There: A Patient Guide to Coping with the Loss of an Eye, more than 50 scientific journal articles, 26 ophthalmic book chapters, and 11 clinical symposia.
Dr. Slonim has served as the Medical Monitor for more than 32 clinical trials from which NDA approvals for 10 drugs have been successfully rewarded.
Dr. Slonim is a graduate of Johns Hopkins University and New York Medical College and completed his Ophthalmology Residency from Mt. Sinai Medical Center in Cleveland, Ohio.
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.
Job Titles:
- Director, Human Resources
- Member of the Leadership Team
Elizabeth has over 20 years of experience in several facets of Human Resources. In her role at iuvo BioScience, Elizabeth is responsible for providing overall leadership to the company's human resources programs, including strategic human resource planning, recruiting/staffing, onboarding, training, benefits, payroll, performance management, engagement, compensation, employee relations, compliance, and safety. Elizabeth serves on the Executive Committee, Leadership Council and Safety Committee.
Prior to joining iuvo, Elizabeth held various leadership roles including Manager of Talent Acquisition for Home Properties, a publicly traded real estate investment trust and Manager of Operations for EFPR Solutions, a division of EFPR Group, LLP.
Elizabeth attended the College of Wooster and holds a B.A. in Communications as well as several educational certificates from DDI International and the Society for Human Resource Management
Job Titles:
- Member of the Board of Directors
- General Partner, Ampersand Capital
Eric, who joined Ampersand in 2013, has 18 years of middle market healthcare investment experience. Eric's current and past board seats include Alliance Pharma, Leinco Technologies, ALPCO, vivitide, CutisPharma, Genoptix, Interpace Diagnostics, LakePharma, Nexelis and Nexcelom Biosciences. Prior to Ampersand, he spent seven years as a member of the investment team at Water Street Healthcare Partners. Prior to Water Street, Eric worked at Beckman Coulter and at One Equity Partners. Eric holds a B.A. in Economics from Northwestern University and a M.B.A. from the University of Chicago.
Job Titles:
- Associate Director, Clinical Technology
Ms. Cardosa has 13 years of clinical research experience and joined Oculos in January 2013. She has worked on pediatric and adult studies with indications of Dry Eye, Glaucoma, Post-Op Inflammation, Uveitis, ARMD, Amblyopia, Nasolacrimal Duct Obstruction, Esotropia, Leukemia and Lymphoma. Esmeralda has experience with case report form creation, remote electronic data monitoring, on-site monitoring, data verification and coding, site selection, maintenance regulatory files, study start up, investigator meeting preparations and managing central monitoring. She has earned her CCRP certification through SOCRA and is currently in the process of obtaining her Bachelor of Science Degree from the University of Central Florida.
Job Titles:
- Toxicology Expert Consultant
Jim Slota, MD, MSc serves as a toxicology consultant for Lumino Advisors. 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.
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.
Job Titles:
- Member of the Board of Directors
- Vice President, Ampersand Capital Partners
Mario joined Ampersand in 2018. Most recently, he was an Associate at PNC Riverarch Capital, a middle market private equity firm. Prior to PNC Riverarch, Mario was at TM Capital, a middle market investment bank, where he focused on healthcare M&A transactions. Mario's current and past board seats include AcuraBio and Precision Coating. Mario holds a B.S. in finance with a concentration in economics from Rochester Institute of Technology.
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.
Job Titles:
- 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.
Job Titles:
- Genetic Toxicology Expert Consultant
- Member of Our Extended Team
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.
Job Titles:
- Director of Clinical Operations
Roselyn Judd has over 30 years of experience in ophthalmology and 25 years of experience in clinical research. She has been responsible for managing clinical trials for CROs, Pharmaceutical companies and academic institutions. Prior to joining Oculos, Roz was a Global Clinical Site Developer for Alcon, Clinical Trials Manager at Vanderbilt University and the Director of Clinical Operations at Sirion Therapeutics. In her current position, Roz is responsible for the overall study and resource management for Oculos.
Job Titles:
- Chief Commercial Officer
- Member of the Leadership Team
As the Chief Commercial Officer at iuvo, Sanjeev is responsible for corporate and commercial growth across all business units (Toxicology, Analytical, Microbiology, Sterilization Validation, Consulting, Ophthalmic R&D, Clinical Research).
Sanjeev is a well-established operational and business executive who brings years of experience in sales, marketing, business and corporate development both in pharma service companies as well as commercial organizations. Sanjeev spent his early years in pharmaceutical and medical device development organizations before moving into the pharma services business. He spent three years with a global ophthalmic CRO, and most recently was the SVP of Sales and Marketing and Global Head of Ophthalmology at CBCC Global Research.
Sanjeev holds a BS in Molecular Biology from UC San Diego, has completed graduate work in Finance from the Drucker School of Management and an MBA in Marketing and Entrepreneurship from the University of Southern California - Marshall School of Business.
Job Titles:
- Member of the Leadership Team
- 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.
Job Titles:
- Member of the Board of Directors
- Member of the Leadership Team
- Clinical Research Executive
- President, Clinical Services
- President, Clinical Services, Iuvo BioScience
Shannon leads the Clinical Research team and is responsible for the overall operation and performance of the clinical research business, which includes: clinical operations, biostatistics, data management, medical/safety, project management, medical writing, and regulatory compliance.
Shannon is an experienced clinical research executive who brings more than 27 years of diverse experience to this role across various stages of device and drug development. During Shannon's time at Promedica International (PMI), a California Corporation, she held the roles of clinical research coordinator, clinical research specialist, project manager, clinical trial manager, clinical service director, and VP clinical services and data management.
Shannon holds a BS in Civil Engineering from University of California, Irvine and a Master of Business from University of Phoenix.