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 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.
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 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.
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.
Mike has over 30 years of programming experience using a wide range of technologies.
Mike is the lead web developer at INDS and Technical Project Lead for the SEND Explorer application.
Prior to working for INDS, Mike was a Software Engineer for Siemans Medical Systems for 12 years, responsible for web application development for enterprise level medical imaging and archive systems. He also designed and developed most of the reporting technologies used in their medical imaging and archive package, making extensive use of XML, C# and related technologies.
Mike holds a bachelor of science degree from the University of Michigan.
Krista has a PhD in Biochemistry & Molecular Biology and Toxicology from Michigan State University where she characterized the role of Hypoxia Inducible Factor (HIF) 1/2α in the inflammatory response to inhaled allergens in a transgenic mouse model. She received her BS in Biology from the University of Wisconsin-Madison. Before joining INDS, she was a Postdoctoral Fellow with The Dow Chemical Company in Midland, MI where she led a research program on the development of an in vivo rat model for the identification of low molecular weight respiratory sensitizers.
Krista has previous experience doing clinical research at the University of Wisconsin-Madison in the Department of Surgery where she was involved in the Islet Cell Transplant Research Program. She has recently been nominated as a Councilor for the Michigan Regional Chapter of the Society of Toxicology and also serves on the Communications Committee for the American College of Toxicology.
Ashley obtained a Ph.D. in Pharmacology and Toxicology from Michigan State University where she conducted research investigating mechanisms of idiosyncratic drug-induced liver injury. She has a B.S. in Ecology and Evolutionary Biology from the University of Michigan and spent two years working in an environmental toxicology laboratory in the School of Public health examining mercury exposure and neurochemical alterations in wildlife specimens.
More recently, Ashley was a Postdoctoral Researcher at Indiana University and performed research to elucidate the mechanism by which oxidative DNA damage triggers epigenetic alterations using a mouse model of inflammation-driven colon tumorigenesis. She is excited about returning to the field of toxicology, specifically drug safety, and eager to apply the knowledge and skills she has gained during her Ph.D. and post-doctoral position at IU to solving toxicology-related issues faced during the drug development process.
Sylvia has over 20 years of toxicology, metabolism and immunology experience having served as study director, study monitor, laboratory supervisor, head of general toxicology, project team representative, and therapeutic area leader. She has expertise across multiple therapeutic areas including immuno-inflammation, CNS and dermatology, supporting all stages of development from early discovery to post-approval.
Prior to joining INDS, Sylvia supported drug development for leading pharmaceutical organizations including GlaxoSmithKline, Pfizer, Pharmacia and Boehringer-Ingelheim. In her role as Senior Scientific Director of Nonclinical Safety at GSK, she had oversight for all nonclinical safety assessment activities for the dermatological area with a portfolio of over 40 Rx/Cx products developed globally. She provided ongoing leadership and direction to a global team of project representatives and partnered closely with key internal stakeholders, including skin biology scientists, clinical pharmacologists, global chemists and regulatory teams. She also served as Head of General Toxicology for several years leading global toxicology operations overseeing a team of study directors, study monitors, technicians and support staff to ensure all active in house and contracted studies were conducted and completed on a timely basis and in full compliance with GLPs.
She is a respected leader, manager, and mentor having built and developed high-performing, diverse teams including toxicologists, pathologists, animal technicians, and students.
Her specialties include immunotoxicology, drug safety evaluation, pharmacokinetics/toxicokinetics, dermatology, animal model development, and integrated nonclinical regulatory submissions.