Dr. Pai is an Associate Professor of Clinical Pharmacy with expertise in precision dosage regimen design. He has extensive training in clinical pharmacology and drug development, with specific expertise in clinical pharmacokinetics/pharmacodynamics (PK/PD). During his first academic appointment, he completed a general clinical research center scholars program and subsequently completed a 2-year clinical translational science center scholars program. Dr. Pai has hands-on training with biostatistics, population PK Modeling, physiology-based PK modeling, and technical writing that have supported my academic work and regulatory-level submissions. His research focus over the past decade has been on the design of optimal dosing regimens across the adult and pediatric body weight distribution (1-250 kg). He has served as the PI on six clinical trials dedicated to the evaluation of the PK/PD of antimicrobials in obesity and have developed PK models for 15 compounds in this special population. He has also performed preclinical studies to better inform the exposure-safety relationships of certain drugs. These works have propelled my understanding and passion for the design of safer and more effective treatment regimens in special populations, who are often excluded during drug development. He currently serves as the Deputy Director of the PK Core that is a shared resource for the University of Michigan. Information about the PK Core is detailed on our webpage (www.pkcore.org). The PK support includes: 1) LC-MS/MS assay of small molecules in biological matrices such as serum, plasma, and urine with full validation; 2) PK analyses through non-compartmental and compartmental methods that utilize parametric and non-parametric algorithms; 3) Support of all clinical trial phases that incorporate exposure-response designs including the derivation of optimal time-points for biological sampling; 4) Population PK modeling and simulation to enable dose regimen justification and optimization for clinical trials.
Dr. Leslie Satin is a Professor of Pharmacology in the University of Michigan Medical School. Dr. Satin’s research has combined several strands, involving studies of the electrophysiology of neurons and synaptic changes after traumatic brain injury, the production of oscillations in neurosecretory cells and their theoretical basis, and the regulation of intracellular free Calcium and ion channels by cell fuel metabolism. Dr. Satin is an expert on the cellular signaling mechanisms, ion channel biophysics, the application of theoretical models to biomedical systems, and synaptic mechanisms of plasticity in the brain. He received his graduate training at the University of Southern California, where he studied neuromuscular physiology and the regulation of membrane calcium fluxes (1975-1982). After obtaining his Ph.D. in biology from UCLA, Dr. Satin moved to SUNY Stony Brook where he was a postdoctoral fellow in the laboratory of P. R. Adams in the Department of Neurobiology and Behavior. Dr. Satin’s work with Adams focused on potassium channel biophysics, an area of study he continued to pursue after moving to D. Cook’s lab at the University of Washington School of Medicine in Seattle. Dr. Satin was promoted to the rank of Research Assistant Professor of Physiology and Biophysics at UW in 1988. In 1990, he left Seattle to establish his own laboratory in Pharmacology and Toxicology at Virginia Commonwealth University (1990-2008). Dr. Satin gained recognition at VCU for his teaching and research excellence by winning annual teaching and research excellence awards given by the VCU School of Medicine. Dr. Satin joined the Department of Pharmacology at UMMS in 2008. Dr. Satin has published over 100 peer reviewed papers that have appeared in journals such as Science, J. Neuroscience, J. Neurotrauma, J. Neurophysiology, Nature Genetics, J. Biol. Chemistry, and J. Physiology (London). He has served on the editorial boards of Neurochemistry International, Endocrinology, Endocrine, Diabetes, J. Biol. Chem., and American Journal of Physiology. He has served on many NIH study sections, including those devoted to TBI and stroke, and diabetes and metabolic diseases.
Dr. Schwendeman’s long-term research goal is to design highly potent and safe synthetic high-density lipoprotein (HDL) nanomedicines for treatment of atherosclerosis. Dr. Schwendeman spent 12 years in pharmaceutical industry at Cerenis Therapeutics, Pfizer, and Esperion Therapeutics. She was involved in discovery and translation of several HDL therapies to Phase II clinical trials. Her efforts led to development of a kilo-scale recombinant process for Apolipoprotein A-I (ApoA-I - main HDL protein) process and highly homogeneous HDL particles for the largest-to-date Phase II sHDL clinical trial (>500 patients). She successfully submitted FDA INDs for six different products including nanoparticles, liposome, proteins, peptides and small molecule. Her current research interests focus on understanding the mechanisms of how phospholipid composition of HDL affects its potency, and designing of ApoA-I mimic peptides. Her laboratory has several ongoing translational collaborative projects focused on assessing sHDL utility for treatment of Alzheimer's disease, sepsis, acute lung injury, lupus and diabetic nephropathy. Dr. Schwendeman also explores the utility of these “nature-made” nanoparticles for targeted delivery of chemotherapeutics, siRNA, miRNA and peptide antigens. Finally, her laboratory is active in developing science-based regulations for testing of complex parenteral products such as nanoparticles, recombinant proteins and microspheres. Research is currently supported by grants from the American Heart Association and the US Food and Drug Administration.
Dr. Steven P. Schwendeman is the Ara G. Paul Professor and Chair of Pharmaceutical Sciences, Professor of Biomedical Engineering, and the Biomaterials and Drug Delivery Thrust Leader of the Biointerfaces Institute, at the University of Michigan. He received a B.S.E. in Chemical Engineering (1986) and a Ph.D. in Pharmaceutics (1992) from the same university and was an NIH postdoctoral fellow (1992 - 1995) in the Department of Chemical Engineering at MIT. He has published 80 papers and book chapters and >100 conference abstracts, has delivered 75 invited lectures, and is co-inventor on number of patents. His research has appeared in Nat. Biotech., PNAS, Angew. Chem. Int. Ed., J. Am. Chem. Soc., J. Biol. Chem., Macromolecules, Biomaterials, J. Controlled Release, Pharm. Res., Vaccine, and may other prestigious journals. Prof. Schwendeman received the Young Investigator Award from the Controlled Release Society (CRS) in 2002 and an outstanding paper award in Consumer & Diversified Products from the CRS in 2010. He has served on the board of scientific advisors to the CRS, was a member of the Biomaterials and Biointerfaces NIH study section (2003 - 2008) and the NIH College of CSR Reviewers(2010 – present). After serving as Editor for Pharmaceutical Research (2004 - 2007), he joined the editorial team at the Journal of Controlled Release as Associate Editor of the Americas (2007 - present).
His research focus involves all aspects of the most commonly studied polymer for long-term controlled release of bioactive substances, poly(lactic-co-glycolic acid) PLGA and related copolymers, which includes: microencapsulation, stabilization and controlled release of PLGA-encapsulated small molecule, peptide and protein drugs, and vaccine antigens; mechanisms of microclimate pH development, drug instability, polymer self-healing, surface modification, and release kinetics; and site-specific delivery for treatment of cancer, and cardiovascular, bone, and ophthalmic diseases. Recently, his lab has begun to study mucoadhesive delivery systems for buccal and nasal applications. His research is currently funded by NIH, FDA, large pharmaceutical companies and private foundations.
Dr. Stringer is a Professor of Clinical Pharmacy in the Department of Clinical Sciences, College of Pharmacy at the University of Michigan. She received her PharmD degree from the University of Michigan, completed a residency in pharmacy practice at the University of Illinois Chicago, and a fellowship in cardiovascular pharmacotherapy at the State University of New York at Buffalo. She also completed a mid-career fellowship pulmonary research at the University of Colorado Health Sciences Center, Webb Waring Institute for Antioxidant Research. Dr. Stringer was a member of the School of Pharmacy faculty at the University of Colorado Health Sciences Center in Denver from 1988-2007; she joined the College of Pharmacy faculty at the University of Michigan in 2007. Since joining the University of Michigan faculty, Dr. Stringer has secured National Institutes of Health funding to support her work in pulmonary drug delivery and drug development. She also has developed an emerging program in clinical metabolomics and serves as a mentor on the NIH/NHLBI T32 Multidisciplinary Training Program in Lung Diseases.
Dr. Stringer’s research focuses on prognostic biomarker and drug target discovery using nuclear magnetic resonance (NMR) and liquid-chromatography-mass-spectroscopy (LC-MS)-based untargeted and targeted metabolomics. She is also using pharmacometabolomics to search for predictive biomarkers of drug response. Her effort is aimed at unraveling the complexity and characterizing the treatment responses of fibrin-inflammatory illnesses including acute respiratory distress syndrome, deep vein thrombosis and the rare, most often pediatric disease, plastic bronchitis.