Integrated Nonclinical Development Solutions, Inc.
James R. Herman, PhD, DABT
Partner and President
Jim has 20 years of nonclinical drug safety research and development experience that included serving as a study director, drug development team representative, safety assessment preparer and reviewer, and successive managerial appointments.
Prior to joining INDS, Jim was Drug Safety Research Site Lead at Pfizer Global Research and Development in Ann Arbor, MI. In that role, he was responsible for all personnel, resources, policies and procedures in the following drug safety department sections: General Toxicology, Pathology, and Investigative Toxicology (including Clinical Pathology labs).
Jim has significant experience in the regulatory toxicology field in all 3 regions (US, EU, and Japan), and has authored and/or critically reviewed over 100 nonclinical portions of IND and NDA submissions, including sections required for IBs and product labeling, and in addressing impurity issues.
Joyce Zandee, MS
Partner and Chief Operating Officer
Joyce holds an MS in Biostatistics from University of Michigan and a BS in Mathematics from Hope College. She has more than 20 years of experience in drug safety, focused on data analysis and visualization, data warehousing, report automation, resource analysis, and business modeling.
Prior to joining INDS, Joyce was Director of Business & Project Management, Site Operations Lead, and then Global Performance Excellence site lead in the Drug Safety department at Pfizer Global Research & Development in Ann Arbor, Michigan. In these roles, her passion was developing and implementing tools to facilitate business and scientific decision-making in the evaluation and characterization of drug safety.
While at Pfizer, Joyce was responsible for developing a web-based compound management portal, providing a dashboard of project status with the ability to drill-down to study details. She served as business project manager for a large-scale data warehousing project, providing subject-matter expertise for data reporting and web-based interpretations tools. She was the business project lead for a data warehouse which used Business Intelligence tools to visualize findings for a given study, to identify patterns across studies for a given compound, and to understand patterns in historical control data. She served as subject matter expert for multiple enterprise-wide application development and implementation projects.
Joyce received Masters' certificates in Project Management and IS/IT Project Management from Villanova University. She has participated in every phase of systems life cycle development - from requirements gathering, to application development, to validation, testing, and implementation.
Steven K. Duddy, PhD
Partner, Corporate Secretary, and Chief Scientific Officer
Steve has over 25 years of toxicology experience in academia and the pharmaceutical industry. Since 1996 he has focused on nonclinical drug safety research and compound development, emphasizing investigative research in to mechanisms of toxicity, clinical pathology, mechanisms of carcinogenesis, and toxicity issue resolution for nonclinical drug candidates. Steve has considerable experience as a drug development team representative and as a study director, developing and implementing experimental and regulatory strategies to support development of promising preclinical drug candidates. Additionally, Steve has experience managing laboratory researchers and resources, and he has published and presented extensively on his research, including contributions to ILSI/HESI working groups assessing chemically-induced hemangiosarcoma and PPAR mediated toxicity, and an ACS ProSpectives conference on Mechanisms of Chemically-Induced Toxicity for Medicinal Chemistry.
Prior to joining INDS, Steve was an Associate Research Fellow in Drug Safety R&D, Pfizer Global Research and Development in Ann Arbor, MI. He originally joined Parke-Davis Pharmaceutical Research in 1996, and had enjoyed academic research appointments at the W. Alton Jones Cell Science Center in Lake Placid, NY, and the Department of Pathology, University of North Carolina-Chapel Hill, before making the jump to pharmaceutical research.
Marc B. Bailie, DVM, PhD
Partner and Chief Development Officer
Marc spent eleven years at Parke-Davis Pharmaceutical Research and Pfizer Global Research & Development developing and leading the Safety Pharmacology Group within Drug Safety Research and Development. He has extensive experience in a broad array of models for the evaluation of pharmacologic and toxicological activity of compounds. He has contributed significantly to numerous task forces, issue resolution teams and special projects relating to drug development. Marc has also served on numerous Discovery and Development project teams and was one of the first to support the filing of a novel Exploratory IND paradigm with the FDA. He provided scientific direction for safety pharmacology both locally and on a global basis, and served as expert council for cardiovascular and general safety pharmacology, both within and outside of Pfizer.
Marc has published over 30 papers in peer-reviewed journals, has served periodically on the Safety Pharmacology Society Board of Directors since its inception and has lead and/or participated in several expert working groups sponsored by ILSI/HESI.
Herman M. Ulloa, DVM, MPH, DABT
Partner
Herm has over 22 years of nonclinical drug safety research and development experience at Parke-Davis Pharmaceutical Research and Pfizer Global Research & Development including roles as study director, clinical veterinarian, drug development team representative, and successive managerial appointments.
Prior to joining INDS, Herm was the head of General Toxicology at Pfizer Global Research and Development in Ann Arbor, MI. In this role he was responsible for all personnel, resources, policies and procedures in the following drug safety department sections Toxicology, In Vivo Toxicology, and Analytical and Formulations.
Herm has extensive experience with drug safety program study designs and protocols; laboratory animal medicine and surgery; test article formulations and vehicles; in vivo toxicology study conduct; and regulatory compliance and accreditation (GLP, USDA, AAALAC).
Joe Huetteman, BS
Partner and Chief Technical Officer
Joe is a highly skilled and knowledgeable information technology professional with expertise in data warehousing, visualization and analysis, business modeling and metrics development, and applying informatics technology for solving business challenges in the healthcare and pharmaceutical industries. Joe has extensive experience with multiple hardware and software platforms, and for designing and implementing information technology solutions to drive productivity, increase quality, reduce costs and meet unmet business and research needs. During his career, Joe was responsible for planning, developing and supporting large scale network and applications deployments, along with product/informatics software launches.
Prior to joining INDS, Joe was the Senior Principal Scientist, Site Lead/Data Systems at Pfizer Global Research & Development, Ann Arbor Laboratories. While at Pfizer, Joe was the architect for a large-scale data warehousing, analysis, and report automation project, and lead a team that designed and implemented a SAS-based safety pharmacology reporting system. Joe has also served as a Project Leader, Systems Engineering, Quality Institute at Saint Joseph Mercy Hospital, Ann Arbor and Manager, Corporate Network at STATPROBE Inc. Joe holds a bachelor of science degree in computer science from Eastern Michigan University.
Alan P. Brown, PhD, DABT
Senior Toxicology Consultant
Alan has 15+ years of experience with both the pharmaceutical and contract research (CRO) industries. Prior to joining INDS, Alan was the Senior Toxicologist and Manager of the Study Director Department at NAMSA, a CRO specializing in testing and advisory services for the medical device industry. Alan was previously a member of the management team in drug safety at Pfizer and served as a study director at the Toxicology Research Laboratory, University of Illinois at Chicago. Alan has significant experience in the safety evaluation of drugs for treating cancer and infectious diseases, and expertise in general toxicology, medical device biocompatibility testing, biomarkers, and GLP Regulations. Alan is the author/co-author of over 70 papers and abstracts.
Alan received a BS degree in microbiology from the University of Michigan, a PhD in pharmacology and toxicology from the University of Arizona, conducted postdoctoral research in toxicology at Michigan State University, and is a Diplomat, American Board of Toxicology. Currently, he is a member of the American College of Toxicology, Society of Toxicology, American Association for Cancer Research, past-president of the Michigan Regional Chapter of the Society of Toxicology, and on the board of directors for the Michigan Society for Medical Research.
Peggy Zorn, MS, MBA
Business Analyst
Peggy holds an MBA from Madonna University and an MS in Information Science from Wayne State University. She has more than 17 years of experience in the pharmaceutical industry, focused on nonclinical data management, data warehousing and data analysis as well as on regulatory submissions, document management and IT systems implementation and training.
Prior to joining INDS, Peggy was a Principal Consultant with Liquent for two years, where she served as project manager for several major electronic regulatory filings and an expert on electronic regulatory submissions. Before that, Peggy spent 15 years with Pfizer/Parke-Davis, working in the Drug Safety, Information Technology (IT), Document Management and Regulatory Affairs groups.
While at Pfizer/Park-Davis, Peggy was responsible for serving as the business liaison to many IT development projects, including the nonclinical data warehouse and automated reporting system, nonclinical document management environment, electronic regulatory submissions publishing system and the digital signature system for regulated documents.
Peggy received a Masters' certificate in Regulatory Affairs from the University of California-San Diego in 2009. She has been involved in several major regulatory filings, including investigational and new drug applications in both the United States and Europe. Peggy is a member of the SEND (Standard for Exchange of Nonclinical Data) industry-FDA working group where she leads the controlled terminology subteam. She also participates as part of the overall SEND leadership team. It is expected that the SEND standard will be final and implemented by the FDA for use in nonclinical submissions in 2011.