Dennis M. Hoover, DVM, PhD-
Dr. Dennis M. Hoover is Board Certified in Veterinary Pathology with broad experience in non-clinical safety assessment for the selection and registration of new chemical entities. He received his DVM from the University of Guelph in Ontario, Canada, in 1975 and his PhD in Veterinary Pathology from Purdue University in 1980. Dr. Hoover then spent more than two decades at Eli Lilly and Company in various bench and management roles, where his focus was centered on Toxicology. As a Toxicological Pathologist, Dr. Hoover performed both compound selection studies, and standard and long term registration studies including rodent carcinogenicity bioassays. Areas of in-depth study included neuropathology, male reproductive pathology, and ultrastructural pathology of various target organ toxicities.
As a Toxicology project leader, Dr. Hoover was involved with all phases of drug development from early discovery to Phase III clinical trials, including associated regulatory presentations and interactions. As Director of Pathology and Preclinical Safety, Dr. Hoover’s duties included the review and approval of all reports for multi-dose safety studies, laboratory management, process improvement, and the development of staff recruiting programs. Dr. Hoover also served on corporate governance committees, particularly for the review and guidance of research discovery teams transitioning from target identification to first human dose.
Business development responsibilities at Lilly included development of an Asian strategy for non-clinical safety assessment, “due diligence” for the acquisition of outside assets, and review and approval of toxicology studies, packages, processes, and capabilities in Lilly’s decision processes.
Dr. Hoover is currently a manager for V-Path Global, LLC, which is a consulting business founded to deliver expertise in preclinical safety assessments. He also serves as an Adjunct Associate Professor in the Department of Veterinary Medicine at Purdue University.
Dr. Hoover’s expertise in the pharmaceutical industry provides a valuable asset to clients seeking to develop products and services regulated by the FDA.
David McLaughlin, MD, FACOG, FACS-
Dr. David McLaughlin attended Indiana University, where he obtained his BS and MD. While completing his residency in Obstetrics and Gynecology in Dayton, Ohio, he was a member of the Ohio Army National Guard and received an honorable discharge after serving as his MASH unit's Company Commander.
Accredited with both OB-GYN and Laser Surgery board certifications, Dr. McLaughlin is a Fellow of the American College of OB-GYN and the American College of Surgeons. He has published two scientific textbooks, multiple scientific articles and has spoken at numerous national and international medical conferences. In the American Society of Reproductive Medicine, he is a Charter member of the Society of Reproductive Surgeons and a member of the Society of Assisted Reproductive Technologies, where he serves as a consultant to other programs wishing to improve their success rates.
Dr. McLaughlin’s expertise in the medical practice of infertility, reproductive surgery, and menopausal treatments make him a great resource for projects involving these specialties.
Mark E. Stobaugh, PhD, DABCC-
Dr. Mark E. Stobaugh earned his MT (ASCP) at the University of Indianapolis and his PhD in Biochemistry from Indiana University School of Medicine. Dr. Stobaugh is board certified in clinical chemistry (DABCC). Dr. Stobaugh worked at Follas Laboratories where he served as a technical supervisor. Dr. Stobaugh continued his career at Seradyn as a Manager in Research and Development, and was responsible for the development, validation, and manufacturing support of Therapeutic Drug Monitoring (TDM) and protein assays.
Dr. Stobaugh served at Roche Diagnostics as a Manager in Technical Affairs. In this position Dr. Stobaugh oversaw all aspects of the Clinical Chemistry product line production, from inspecting incoming raw materials, to testing the finished products. He also held the position of Principal Scientist for the development and manufacturing transfer of Drug Abuse Testing (DAT) immunoassays.
Dr. Stobaugh’s expertise in product development and manufacturing provide a valuable asset to those clients seeking to develop products in the IVD market.
Andrew M. Weston, PhD, HCLD, CC-
Dr. Weston earned his B.S. at the University of Georgia, his M.S. at the University of Arkansas, and his Ph.D. at Cornell University. He completed his post-doctoral fellowship at the Oregon Regional Primate Research Center, where he studied In Vitro fertilization, cryopreservation, non-surgical embryo transfer, and other reproductive sciences. During this time, he also had nine scholarly articles published in various reproductive medicine journals. Dr. Weston transferred many of these skills over to human patients when he began his clinical career in 1993. Since that time, Dr. Weston has served as the Laboratory Director for multiple Andrology and Embryology Programs, including the Follas Center for Reproductive Medicine. His clinical experience as an embryologist has given him a great knowledge base in cell biology, as well as a thorough understanding of the clinical applications of cell-based assays, especially in the field of reproductive medicine.
Daniel Wierda, MS, PhD, Fellow ATS-
Dr. Wierda’s career in academia, industry, and the private sector has spanned the areas of myelotoxicity, immunotoxicity, immunogenicity, and biopharmaceutical preclinical drug development. After receiving his MS and PhD degrees in 1979 in pharmacology and toxicology at the University of Kansas Medical Center, he conducted postgraduate research at the Chemical Industry Institute for Toxicology, Research Triangle Park, NC. He then continued his research career as a faculty member in the Department of Pharmacology and Toxicology at the University of West Virginia, Morgantown. He was awarded several federal grants for his research on environmental chemical toxicity to bone marrow B lymphocyte development and became a tenured associate professor prior to accepting a position as a research scientist and immuntoxicologist for Eli Lilly and Company in Indianapolis, IN.
For the next 20 years, he maintained a lab in Investigative Immunotoxicology that was involved in GLP studies and research support for a broad array of drugs and biopharmaceuticals, such as monoclonal antibodies and endocrine peptides. Prior to retiring from Lilly in 2010 as a Research Fellow, he was an internal consultant specializing in immunotoxicity and immunogenicity issues company-wide and involved in the early preclinical planning and development of Lilly’s candidate biopharmaceuticals. He is currently providing preclinical discovery and toxicology consulting support for contract research organizations and pharmaceutical firms, and is a cofounder of B2S Labs, LLC. Dan’s extensive experience in xenobiotic toxicology and drug development is a great asset for clients evaluating the safety and efficacy of their own test compounds.
Lin Xu, MD, PhD-
Dr. Lin Xu earned his PhD in Biochemistry and Molecular Biology from the Sun Yat-sen University School of Medicine in Guangzhou, China. Dr. Xu then completed his post-doctoral research fellowship at the Gazes Cardiac Research Institute at the Medical University of South Carolina. Lin continued at the Medical University of South Carolina as an assistant professor, specializing in the areas of DNA cloning, real-time PCR, bacteria culture, and protein analysis.
In 2006, Dr. Xu joined Pathologists Associated in Indianapolis, Indiana, as a Senior Scientist and Assistant Laboratory Director. Aside from performing and overseeing routine clinical molecular testing, Dr. Xu was instrumental in developing new molecular assays.
Dr. Xu currently provides consultative services for biochemical groups internationally. As a consultant, he has designed new clinical diagnostic kits, helped build a molecular diagnostic laboratory, and was placed in charge of routine quality control of that laboratory.
As an ASCP Certified Molecular Biologist, Dr. Xu continues his focus on molecular based technologies and quality control activities. Dr. Xu’s expertise in molecular diagnostics provides a valuable resource to clients seeking to develop products and services or molecular diagnostics for the clinical laboratory.