eLearning Seminar
Back to Basics: Why, When, and How to Conduct Specialty Toxicology Studies for Eyes, Skin, and Immune System

Speaker Bios

Daniel Bauer, PhD

Dr. Daniel Bauer is Director of Preclinical Safety at Novartis in Basel, Switzerland. He is a trained chemist and a board-certified toxicologist with over 20 years of experience in the pharmaceutical industry. Dr. Bauer began his career at Novartis as a lab head in molecular and cellular toxicology, later specializing in photosafety evaluation with a focus on tiered testing strategies from in vitro to in vivo to clinical translation.

As a study director and monitor, Dr. Bauer has contributed to numerous in vitro safety screening studies, including phototoxicity and genetic toxicity, during candidate selection. He has also supervised in vitro phototoxicity studies under GLP. Currently, he serves as Global Expert in Photosafety, overseeing all photosafety activities at Novartis.

For EFPIA, Dr. Bauer was a member of the ICH S10 Expert Working Group representing the European pharmaceutical industry. He is currently the chair of the EFPIA Photosafety Working Group, where he facilitates industry-wide knowledge exchange and new initiatives.

In addition, Dr. Bauer acts as a project toxicologist, working on topical and oral FIH projects in dermatology and oncology indications.

Florence G. Burleson, PhD

Dr. Florence Burleson received her PhD from the Department of Microbiology at the University of Notre Dame, and a Master of Science in Financial Management and Technology Commercialization from North Carolina State University (NCSU). She has 30 years of professional experience in government, pharmaceutical, and contract research. She is the co-founder of Burleson Research Technologies, Inc. (BRT), a CRO in North Carolina, specializing in immunotoxicology. Dr. Burleson has served as an immunotoxicology Study Director at BRT conducting GLP-compliant studies for immunological, functional, and host resistance immunotoxicity assessments. As Executive VP and Senior Director of Nonclinical Studies, she currently provides oversight and direction for nonclinical studies at BRT and is responsible for company budgets and financial management.

Dr. Burleson is a member of the American College of Toxicology (ACT) and SOT. She was elected to the ACT Outreach committee in 2013, ACT Council in 2016, and was ACT President in 2023. She has served on the SOT Finance Committee and was President of the Immunotoxicology Specialty Section. Dr. Burleson was Chair of the Scientific Liaison Coalition (SLC), a coalition of societies to increase the impact of the science of toxicology to improve public health. She currently serves on the Editorial Board of the International Journal of Toxicology, the official journal of ACT, and on the Editorial Board of Toxicology Research Application.

Jeffrey A. Klein, PhD, DABT

Dr. Jeff Klein is an Advisor in the Nonclinical Safety and Development group at SciLucent, Inc. In this role, he provides scientific and regulatory nonclinical consulting for drug development programs. He was previously a Senior Manager at Noven Pharmaceuticals leading nonclinical programs for transdermal drug development, Director of Preclinical Research at EP Technologies leading a team delivering large molecules through the skin using cold plasma, and Director of Toxicology and Dermatology at Sinclair Research, now Altasciences Preclinical Columbia. Dr. Klein is Past President of the Dermal Specialty Section of the Society of Toxicology and was certified by the American Board of Toxicology in 2012.

Vincent A. Murphy, PhD, DABT

Dr. Vincent A. Murphy has over 30 years of experience as a toxicologist while working at Procter & Gamble, Array BioPharma, Inc., and STILLMEADOW, Inc., and as the sole proprietor of a consulting firm, Pharma Toxicology Advisors, LLC. In these positions, he contributed to all developmental phases of drug and other product development from discovery to marketing.

While at Procter and Gamble and Array BioPharma, Inc., he gained extensive experience in drug discovery and early development of pharmaceuticals for oral, dermal and injectable routes. Dr. Murphy has designed and monitored studies internally and at contract laboratories that included dermal toxicity, irritation and sensitization studies in animals and cumulative irritation and sensitization studies in humans. In vitro assays for drug candidate optimization were utilized by Dr. Murphy to assess eye and skin irritation, cytotoxicity, metabolism, genotoxicity, phototoxicity, enzyme induction and safety pharmacology. He has used in silico programs, like Leadscope and Derek Nexus for identification of potential toxicities of parent, metabolite and impurities.

In his current position as Director of Toxicology, at STILLMEADOW, Inc., he also serves as study director for dozens of acute dermal irritation and toxicity studies and local lymph node and Buehler skin sensitization studies as well as occasional repeat dose dermal toxicity studies. The use of in vitro and in silico assays is currently being explored.

Dr. Murphy earned a BS in Pharmacy from the University of Washington in Seattle and a PhD in Biochemical Pharmacology and Toxicology at the University of Utah in Salt Lake City. He has been a councilor, vice-president and president of the In Vitro and Alternative Methods Specialty Section in the Society of Toxicology and has served the American College of Toxicology as member of the Program and Communications Committees and Newsletter Subcommittee and currently serves as a member of the Education Committee.

Marie-Soleil Piche, PhD

Dr. Marie-Soleil Piche is the Scientific Director of the Immunology group at Charles River Laboratories and specializes in nonclinical and clinical immune safety assessment of biotherapeutic drugs. She obtained her Bachelor’s degree in Immunology at McGill University and her Master of Science in Immunotoxicology at the Armand Frappier Institute. She completed a PhD in the field of autoimmune disease, studying the role of autoantibodies in the pathogenesis of lupus. Prior to joining Charles River, Dr. Piche worked at a small biotech company where she was responsible for developing cell-based assays to study the pharmacodynamics of various biotherapeutic drugs. She is an active member of the HELSI/ITC working group, where she co-leads the Education and Outreach group, and of the APPS, where she participates in the Immunogenicity and qPCR working groups. She is also the past president of the ITSS SOT. Dr. Piche is a co-author on several methods, best practices, and validation white papers.

Brian Short, DVM, PhD, DACVP

Dr. Brian Short is a board-certified pathologist with a focus on ocular toxicology, pathology and ocular drug development. Previously he was at Allergan (currently AbbVie) as Sr Director of Toxicology and then Pathology following his early career at GlaxoSmithKline (formerly SmithKline Beecham). As an independent consultant since 2016, Dr. Short has consulted over 160 projects involving ocular drug development of small molecules, biologics, oligonucleotides, and gene and cell therapies or ocular toxicity of systemic small molecules and biologics. He has authored several seminal publications on ocular toxicology and pathology, served as invited speaker for over 20 presentations on ocular drug development and was honored in 2021 with a Career Achievement Award by the Ocular Toxicology Specialty Section of SOT. Currently Dr. Short is Chair of the Ocular Adversity Working Group sponsored by STP Scientific and Regulatory Policy Committee. Dr. Short has a DVM from University of California, Davis, completed a Veterinary Pathology Residency from University of Florida, Gainesville, earned a PhD in Experimental Pathology from University of North Carolina, Chapel Hill, and was a Postdoctoral Trainee at Chemical Industry Institute of Toxicology in Research Triangle Park, NC.