Speakers

Brahim Achour is an Assistant Professor at the College of Pharmacy, University of Rhode Island. His research focuses on the study of pharmacokinetics and pharmacodynamics in special and disease populations using clinical and translational modelling tools and the development of precision medicine approaches to enable individualized pharmacological therapy. Dr Achour has co-authored more than 50 articles (H-factor = 23), including several patents as co-inventor of a novel liquid biopsy test. Brahim has extensive experience in multi-’omics’ with specific expertise in quantitative proteomics and transcriptomics as applied to pharmacologically-relevant pathways involved in drug metabolism and transport. Along with experimental work, Brahim has teaching and consultancy responsibilities for external and affiliated companies and institutions in relation to the use of systems data in PBPK and liquid biopsy applications.

Dr. Fatemeh Akhlaghi has worked in academia and the pharmaceutical sector for more than 25 years. She is currently the clinical pharmacology lead for two Pfizer assets and a director within Pfizer Worldwide Research and Development in San Diego, California. She was a full professor and endowed chair at the University of Rhode Island's College of Pharmacy until transitioning to the pharmaceutical industry full-time in 2022. She has mentored more than 30 PhD students and postdocs and has received ongoing extramural funding from the NIH and various pharmaceutical companies. Areas of Dr. Akhlaghi’s research expertise include diabetes, fatty liver disease and immunomodulation as well as benign hematology. Dr. Akhlaghi has authored 120 peer-reviewed articles and presented at several events as an invited presenter.

Zubida Al-Majdoub is a senior research associate at the Centre for Applied Pharmacokinetic Research (CAPKR), her research focuses on investigating the expression profiles of drug-metabolizing enzymes, drug transporters and any other interesting proteins in different systems including tissue (liver, kidney, intestine, brain, placenta, skin etc.) and in vitro systems, for the purpose of enabling in vitro-in vivo extrapolation (IVIVE) and leveraging precision dosing strategies. Another focus of her research in recent years has been related to liquid biopsy test for model-informed precision dosing.

Bio coming soon.

Dr. Vivaswath Ayyar, PhD is Associate Scientific Director, Clinical Translational & Systems Modeling, within Clinical Pharmacology and Pharmacometrics (CPP) at Janssen R&D (Johnson & Johnson). Dr. Ayyar has experience investigating and developing small molecules, antibody-based therapeutics, siRNA, and cell therapies (CAR-T). His work focuses on using mechanism-based PK/PD and systems pharmacology modeling to drive the Janssen clinical portfolio across therapeutic areas, including the model-informed development of gene therapies - particularly siRNAs. Viva Ayyar received a Bachelor of Science degree in Biological Sciences from the University at Buffalo in 2014 followed by the Ph.D. in Pharmaceutical Sciences in 2019, also from UB, with Dr. William Jusko. He joined Janssen in 2019 and his research has focused on mechanism- and physiologically-based modeling since. Dr. Ayyar also serves as Adjunct Assistant Professor of Pharmaceutical Sciences at the University at Buffalo, and has authored over 20 peer-reviewed papers, reviews, and patents.

Dr. Balthasar is the David and Jane Chu Endowed Chair in Drug Discovery and Development and Professor of Pharmaceutical Sciences in the School of Pharmacy and Pharmaceutical Sciences at the State University of New York at Buffalo. Dr. Balthasar received a B.S. in Pharmacy (1991) and a Ph.D. in Pharmaceutics (1996) from the University at Buffalo. He served as a Clinical Assistant Professor of Pharmaceutics at the University at Buffalo from 1996-1997 and, from 1997-1999, as an Assistant Professor in the Department of Pharmaceutics and Pharmaceutical Chemistry at the University of Utah. Dr. Balthasar rejoined the University at Buffalo as an Assistant Professor in 1999, and was promoted to Associate Professor in 2003 and to Full Professor in 2008. Dr. Balthasar also serves as the Director of the Center for Protein Therapeutics and as UB’s Executive Director for Research Initiatives. Dr. Balthasar’s research utilizes pharmacokinetic and pharmacodynamic analyses to guide the development of new immunotherapies. Current research in the Balthasar Lab, which is funded by the National Cancer Institute and the Center for Protein Therapeutics, focuses on the development of new platform strategies to improve the safety and efficacy of antibody-based treatments for cancer. Balthasar’s Payload Binding Selectivity Enhancer (PBSE) platform is under development by Abceutics Inc., a UB start-up company, and the lab’s Anti-Idiotypic Distribution Enhancer (AIDE) platform is being pursued via the Empire Discovery Institute.

Dr. Joel Bercu PhD, MPH, DABT is an Exec. Director in the Nonclinical Safety and Pathobiology group at Gilead Science and has over 20 years of public health / toxicology experience in pharmaceuticals. His mission while at these positions is to protect the safety of staff, patients, and the environment. He leads the Environmental and Occupational Toxicology (EOT) group at Gilead. The EOT group provides expert toxicological documentation for occupational health categorizations / occupational exposure limits, permitted / acceptable daily exposures for cleaning validation, environmental risk assessments, pharmaceutical impurity assessments (including mutagenic / carcinogenic impurities), QSAR assessments of impurities for ICH M7 compliance, deviations, leachables and extractables and excipients. The EOT group is also responsible for monitoring and reviewing toxicology tests including ecotoxicology, mutagenicity testing for impurities, and worker safety testing. Prior to joining Gilead Sciences, he has worked at Eli Lilly and Amgen. He is a member of the Society of Toxicology and the Risk Assessment, Occupational and Public Health (where he served as President), and Medical Devices specialty sections. He has had several external committees such as chairing the IQ/Drusafe Impurities Working Group and on the board of directors for the Extractables Leachables Safety Information Exchange (ELSIE). He received his BS from Texas A&M University, MPH from University of Texas Houston School of Public Health, PhD from Indiana University, and is a Diplomate of the American Board of Toxicology (DABT).

Alison is currently the global lead of DMPK and modeling at Takeda, leading a team of DMPK and modeling and simulation scientists in Boston, San Diego and Shonan, Japan in support of the Oncology, GI & Neuroscience portfolios at Takeda. Prior to this Alison was VP of Scientific Collaborations & Fellow of Modeling and Simulation at Applied BioMath. Prior to this, Alison spent 25 years at Pfizer, in DMPK and modeling & simulation roles with increasing responsibilities. Alison holds a Ph.d. in Systems Pharmacology from the University of Leiden, The Netherlands, and a B.Sc. in Biochemistry form the University of St. Andrews in Scotland, UK.

Dr. Jayaprakasam (Prakash) Bolleddula is a Clinical Pharmacology Expert Team Lead (CPET) at EMD Serono, Billerica, MA. Dr. Bolleddula is an experienced scientific leader with 20+ years of experience at the intersections of drug metabolism, drug-drug interactions, PBPK modeling, and clinical pharmacology. Before joining EMD Serono, Dr. Bolleddula led drug metabolism groups at Agios Pharmaceuticals, Takeda-Boston, and Theravance Biopharma. He has published over 50 peer-reviewed research articles and is also a co-inventor of numerous patents. Dr. Bolleddula obtained Ph.D. in organic chemistry from Sri Venkateswara University, Tirupati, India, and completed a postdoctoral fellowship at Michigan State University.

Brandon M. Bordeau is a Research Assistant Professor in the Department of Pharmaceutical Sciences at the University at Buffalo (UB). He received his Ph.D. from UB in 2020 and remained at UB post-graduation to develop a technology to increase the therapeutic index of antibody-drug conjugates (ADCs). Brandon Bordeau is also a co-founder and CEO of Abceutics Inc., a biotechnology company that is working to commercialize payload binding selectivity enhancers as an adjuvant approach to increase the tolerability of ADCs.

Tjerk Bueters has a passion for integrative and predictive sciences and project leadership. He currently works as Executive Director at Merck & Co, Inc, leading a group that provides translational and quantitative pharmacological and pharmacometric support in preclinical and clinical studies across Merck’s immunology portfolio. In addition, he co-leads the MK-1942 early development team tasked to deliver clinical proof of concepts for symptomatic Alzheimer’s Disease and depression. Prior to his current role, Tjerk has among others been Director of the Cardiometabolic group in his current department, and ADME Predictive and Translational Science group. Tjerk has a Ph.D. degree in quantitative pharmacology obtained at Leiden University, The Netherlands and conducted Post-Doctoral research within neuroscience at the Karolinska Institute in Sweden.

Matthew A. Cerny is an Associate Research Fellow in the Pharmacokinetics, Dynamics and Metabolism Department, Pfizer Inc., Groton, CT Laboratories. He received his Ph.D. in Medicinal Chemistry from the University of Kansas (2005). After carrying out postdoctoral research on cytochromes P450 and flavin-containing monooxygenases at the Human BioMolecular Research Institute in San Diego, he began his industrial career at Arena Pharmaceuticals. In 2009, Matthew left Arena to work at Boehringer Ingelheim where he worked in DMPK groups in both Research and Development groups within the organization. In 2015, Matthew began work at Pfizer and currently works in the Biotransformation and Environmental Sciences Team. His main research interests include non-P450 enzymes, mechanistic enzymology of P450s and other drug-metabolizing enzymes, and mechanisms of P450 inactivation.

Javier worked for 8 years in the field of enzyme engineering and received his Ph.D. in 2003. After his postdoctoral training he joint Pfizer, where he is leading the BioTherapeutic Discovery department within Biomedicine Design. In this role, he is responsible for leading biotherapeutic discovery work, including lead generation and optimization, biophysical characterization, and non-GLP biotherapeutic production. Javier is interested in understanding the underlying biology of drug design and delivery and engineering solutions for challenges associated with developing the next generation of biotherapeutics.

Aditi Das received her Ph.D. in Chemistry from Princeton University and completed post-doctoral work with Prof. Steve Sligar. She is currently a tenured Professor (rank: associate) in the School of Chemistry and Biochemistry at Georgia Institute of Technology. Her research is in the area of enzymology of cytochrome P450 epoxygenases that are involved lipid metabolism and cannabinoid metabolism. Das is recipient of an American Heart Associate (AHA) career award and has been funded by National Institute of Health (NIH - NIGMS, NIDA and NCCIH), USDA, AHA and NMSS. Her research was recently recognized by three National awards: Young Investigator award From Eicosanoid Research Foundation, Mary Swartz Rose Young Investigator Award and E.L.R. Stokstad award from American Society for Nutrition (ASN) for outstanding research on bioactive compounds for human health. She is also the recipient of Zoetis Research Excellence Award from her college. Since 2018, her laboratory contributed several seminal papers on cannabinoid metabolism by human P450s. In recognition of this work, she was awarded El Sohly award from the ACS-Cannabis division for excellence in Cannabis research.

Dr. Ronilda D'Cunha is currently an Associate Director in the department of Clinical Pharmacology at AbbVie Inc. She obtained her PhD in Clinical Pharmaceutical Sciences from the University of Iowa, and her BS in Pharmacy from SNDT University, Mumbai, India. Since joining AbbVie in 2018, Ronilda has been the Clinical Pharmacology lead for several early-stage immunology assets including small molecules, biologics, and ADCs, and has contributed to the clinical development of late-stage immunology assets. She has published original research in this area and her work has been presented at various national meetings.

Dr. Li Di has over 25 years of experience in the pharmaceutical industry including Pfizer, Wyeth and Syntex. She is currently a research fellow at Pfizer Worldwide Research and Development, Groton, CT. Her research interests include the areas of drug metabolism, pharmacokinetics, drug-drug interactions, absorption, transporters, and blood–brain barrier. She has over 170 publications including two books and presented over 100 invited lectures. She is a recipient of the Thomas Alva Edison Patent Award, the New Jersey Association for Biomedical Research Outstanding Woman in Science Award, the Wyeth President’s Award and Peer Award for Excellence.

Krista holds a B.S. in Biology from Indiana University of Pennsylvania, and received her Ph. D. in Environmental Toxicology from the University of California, Riverside. During her graduate years she applied various in vitro genotoxicity assays to evaluate mechanisms of clastogenicity and mutagenicity. Krista joined Pfizer in the Genetic Toxicology department, where she contributed to the team as a study director, subject matter expert, supervisor and department head. During her time at Pfizer Krista has also developed expertise related to impurity qualification and risk assessments. She represents Drug Safety on a multidisciplinary council that provides advice to teams regarding impurity qualification matters. She currently leads Drug Safety’s Global Risk Assessment Services Team (GRAS). GRAS collaborates with Pfizer Global Supply manufacturing sites and contributes to the development of risk assessments to address potential safety issues that arise across Pfizer’s global marketed product supplies. External to Pfizer, Krista has served two terms as a member of the Genetic Toxicology Association (GTA) Board of Directors and also acted as Chair of the GTA. She is also a former Councilor of the Environmental Mutagenesis and Genomics Society (EMGS), and served as Co-Chair of the EMGS Applied Genetic Toxicology special interest group. She has been an active participant in PhRMA LDKIT efforts to revise the ICH Genetic Toxicology Testing Guidance (ICHS2R) and develop the ICH M7 Guideline and Addendum. Krista is currently PhRMA topic lead for the ICH M7 Expert Working Group, as well as member of a collaborative team (industry and QSAR vendors) working towards understanding the structure activity relationships of nitrosamines. She also serves on the Board of Trustees for Lhasa Limited and Editorial Board of Environmental and Molecular Mutagenesis.

Isabel Figueroa is a Preclinical Director at the Pharmacokinetics and Drug Metabolism Department at AMGEN. Isabel earned his PhD in Chemical Engineering from University of Pittsburgh, PA. There, she currently heads the Quantitative Pharmacology group at AMGEN in South San Francisco in support of the discovery and development of drug therapeutics for the treatment of oncology, cardiometabolic and inflammatory diseases. Prior joining AMGEN, Isabel worked in various roles related to the preclinical PK-PD aspects of the development of drug therapeutics in AbbVie, Genentech and Merck. Isabel has a keen interest in the topics related to the application of mathematical principles to inform, accelerate, and optimize the process of discovery and development of novel therapeutics to solve patients’ unmet needs.

Michael received his PhD from the prestigious Centre for Applied Pharmacokinetic Research, The University of Manchester, UK. For his postdoctoral work, he received the 2015 AAPS Meritorious Manuscript Award. For the last 10 years, Michael has been at Roche as DMPK Project Leader and Translational Modelling and Simulation scientist. He supports the development of both large and small molecules. His current research focusses on PK and drug-drug interaction predictions in pediatric populations and developing translational PK/PD models in ophthalmology.

Dr. Goldman is a Professor of Pediatrics at the University of Missouri-Kansas City and a member of the Divisions of Clinical Pharmacology, Toxicology and Therapeutic Innovation and Infectious Diseases at Children’s Mercy Kansas City. Both her research and clinical efforts are centered around working with people across disciplines to improve the lives of children. She has led a NIH-supported research program investigating the mechanisms associated with severe adverse drug reactions to a commonly prescribed antibiotic, trimethoprim-sulfamethoxazole (TMP-SMX). Her team's research has led to identification of a new pulmonology pathology finding associated with TMP-SMX respiratory failure, and associated HLA risk alleles. In 2021, a TMP-SMX drug label revision was approved by the Food and Drug Administration warning of the associated respiratory failure with TMP-SMX in response to these research discoveries.

Andrew L. Goodman, PhD, is the C. N. H. Long Professor and Interim Chair of the Department of Microbial Pathogenesis at Yale University School of Medicine and Director of the Yale Microbial Sciences Institute. Dr. Goodman received his undergraduate degree in Ecology and Evolutionary Biology from Princeton University, his PhD in Microbiology and Molecular Genetics from Harvard University, and completed postdoctoral training at Washington University. His lab uses microbial genetics, gnotobiotics, and mass spectrometry to understand the mechanisms of host-microbiome interaction and the role of the gut microbiome in drug metabolism. The lab’s contributions have been recognized by the NIH Director New Innovator Award, the Pew Foundation, the Dupont Young Professors Award, the Burroughs Wellcome Foundation, the Howard Hughes Medical Institute Faculty Scholars Program, the ASPET John J. Abel Award, and the Presidential Early Career Award in Science and Engineering.

Dr. Grillo is the Associate Director for Labeling and Health Communication for the Office of Clinical Pharmacology (OCP) in the Center for Drug Evaluation and Research of the United States Food and Drug Administration. Prior to this Dr. Grillo was a senior clinical pharmacologist in OCP focusing extensively on developing and implementing the Office’s physiologically based modeling (PBPK) program. Dr. Grillo received his Doctor of Pharmacy degree in 1993 from Virginia Commonwealth University followed by a two-year post-doctoral fellowship in critical care pharmacotherapy and emergency medicine. During this fellowship he developed and published one of the first PBPK models aimed at human dose optimization for lidocaine in cardiac arrest patients. Dr. Grillo was on faculty in the Departments of Pharmacy Practice at St. John's University and Shenandoah University and is currently an Affiliate Professor of Pharmaceutics at Virginia Commonwealth University. Dr. Grillo has conducted independent research while in academia and at FDA in the areas of pharmacy education, critical care, acute cardiac care, PBPK modeling, and regulatory science resulting in over 50 published articles and abstracts as well as four textbook chapters. Dr. Grillo has received two presidential citations from the Society of Critical Care Medicine for his work in the area of intensive care pharmacotherapy.

Prof. F. Peter Guengerich received his B.S. from the University of Illinois in 1970 and a Ph.D. (Biochemistry) from Vanderbilt University in 1973 (with Prof. H. P. Broquist). Following two years of postdoctoral training at the University of Michigan (with Prof. M. J. Coon), he joined the faculty at Vanderbilt as Assistant Professor of Biochemistry. He became (full) Professor in 1983 and was Director of the Vanderbilt Center in Molecular Toxicology from 1980-2011. Prof. Guengerich is an enzymologist and his interests have been in the characterization of cytochrome P450 enzymes and the metabolism and bioactivation of drugs and toxic chemicals. He has published 760 refereed papers, 318 invited reviews, and 138 published proceedings and is one of the most highly cited authors in the fields of biochemistry (13th) and toxicology (26th) (2022). Prof. Guengerich is a Fellow of the American Chemical Society, the American Society for Biochemistry and Molecular Biology, and the American Society for Pharmacology and Experimental Therapeutics and has received major awards from these and other scientific societies, including the ISSX North American Region Scientific Achievement Award (2003) and R. T. Williams Distinguished Scientific Achievement Award (2010). Prof. Guengerich served as an Associate Editor, Deputy Editor, and Interim Editor-in-Chief of The Journal of Biological Chemistry from 2006-2022 and has also served as an Associate Editor of Toxicology and Applied Pharmacology, Molecular Pharmacology, Cancer Research, and Chemical Research in Toxicology. He has directed the training of 22 graduate students and 141 postdoctoral fellows. In 2000 he received the first Vanderbilt School of Medicine Medal given for Mentoring Postdoctoral Fellows or Residents in the Research Setting, and subsequently this award was named for him.

Stephen S. Hecht, Ph.D. is Wallin Professor of Cancer Prevention at the University of Minnesota and an American Cancer Society Research Professor. He is an internationally recognized expert on carcinogens in tobacco products and their mechanisms. He is the co-discoverer of tobacco-specific nitrosamines, causative agents for tobacco-induced cancer. His current research focuses on the relationship of human carcinogen and toxicant metabolites and DNA adducts to cancer risk. He has a B.S.in chemistry (Duke University) and a Ph.D. in organic chemistry (MIT). Prior to moving to the University of Minnesota in 1996, he conducted research at the American Health Foundation cancer prevention research institute in Valhalla, NY, where he was Director of Research from 1987-1996. He received the AACR Award for Excellence in Cancer Prevention Research in 2006, and the Founders Award from the Division of Chemical Toxicology, American Chemical Society in 2009. He was elected an American Chemical Society Fellow in 2009, a Fellow of the American Association for the Advancement of Science in 2014, and was Editor-in-Chief of Chemical Research in Toxicology 2013-17. He has received a Merit Award and an Outstanding Investigator Grant from the National Cancer Institute. He has published over 900 papers in the scientific literature.

Matt Hoffmann has 20+ years experience in the pharmaceutical industry, primarily in the drug development ADME space. He earned his bachelor’s degree in Biology from Cornell University and a Ph.D. in Toxicology from Rutgers University. After completing his graduate work, Matt joined Wyeth as a Senior Research Scientist in the drug metabolism department, initially working as a bench scientist and eventually running a DMPK laboratory. In 2009, he moved to Celgene as a Senior Principal Scientist, working as a project representative and overseeing the biotransformation laboratories. Matt currently works as a Senior Director at Bristol Myers Squibb, and is responsible for coordinating all nonclinical drug metabolism activities for the developmental small molecule pipeline. Over the past several years, he has worked on multiple protein degrader programs and has been teaching continuing education classes discussing ADME related issues associated with these molecules. During his career, Matt has worked to achieve marketing approval for multiple programs including tigecycline, desvenlafaxine, apremilast and pomalidomide.

Dr. Cornelis “Marcel” Hop is Vice-President at Genentech and manages the Drug Metabolism and Pharmacokinetics department. He leads a team of about 85 scientists involved in acquisition and interpretation of ADME data in support of drug discovery and development ranging from early stage research to NDA and beyond. He is also a member of various strategic decision-making bodies at Genentech. Before that, he was a Senior Director at Pfizer and a Senior Research Fellow at Merck. He has extensive experience in ADME sciences with a particular focus on PK optimization, human PK and dose prediction, biotransformation, bioanalysis and the use of artificial intelligence and machine learning in drug discovery. He has authored more than 190 publications and made more than 90 external oral presentations. In addition, he co-authored two of the best-selling books in the ADME field: Drug Metabolism and Pharmacokinetics Quick Guide and Discovery DMPK Quick Guide. He has served on various committees for ISSX, the IQ Consortium, academic industrial advisory boards and the Tuberculosis Drug Accelerator.

Paulina Jakubiak is a Senior Scientist in the Preclinical and Translational PK/PD Department within Development Sciences at Genentech. She applies preclinical animal and in silico models to guide the design, delivery, and development of novel therapeutics in ophthalmology and oncology. In her role, she focuses on approaches to translate preclinical PK/PD to support first-in-human dose selection. She is actively contributing to the development of new long-acting ocular drug delivery systems and technologies with a patient-centric view.

Young Jeong is a Professor in the Departments of Industrial and Physical Pharmacy and Pharmacy Practice at the College of Pharmacy, Purdue University. Dr. Jeong received her Pharm.D. (2001) and Ph.D. (2004) from the University of Illinois at Chicago (UIC), followed by postdoctoral training in molecular pharmacology at UIC. She joined the UIC faculty in 2006 and established a research program in drug metabolism and pharmacokinetics, funded by multiple extramural grants. She moved to Purdue in 2021. Her current research, in collaboration with Dr. Hyunwoo Lee at Purdue University, focuses on determining how gut microbiota modulates drug efficacy and toxicity. Dr. Jeong received Early Career Achievement Award in Drug Metabolism and Disposition from the American Society of Pharmacology and Experimental Therapeutics. She currently serves on the editorial boards for Drug Metabolism and Disposition and Pharmacological Reviews.

William J. Jusko is SUNY Distinguished Professor of Pharmaceutical Sciences and received BS in Pharmacy (1965) and PhD (1970) degrees from the State University of New York at Buffalo. He then joined the Clinical Pharmacology Section of the Boston Veterans Administration Hospital and was Assistant Professor of Pharmacology at Boston University School of Medicine. He returned to Buffalo in 1972 as Director of the Clinical Pharmacokinetics Laboratory and Assistant Professor. He was a Fulbright Scholar at The Mario Negri Institute for Pharmacology in Italy in 1978/79, received the Doctor Honoris Causae from Jagellonian University in 1987 and University of Paris in 2015, the Oscar B Hunter Career Award in Therapeutics from ASCPT in 2018, and the AAPS Distinguished Pharmaceutical Scientist Award in 2020. He is a Fellow of several scientific societies and has served on many editorial boards and NIH review panels. His research covers clinical, basic, and theoretical pharmacokinetics and pharmacodynamics of diverse drugs and has produced over 650 publications.

Roger Kamm is the Green Distinguished Professor of Biological and Mechanical Engineering at MIT, where he has served on the faculty since 1978. His research activities lie at the interface of biology and mechanics, formerly in cell and molecular mechanics, and now in engineered living systems. Current interests are in developing models of healthy and diseased organ function using microfluidic technologies, with a focus on vascularization in the context of metastatic cance, neurological diseases and subcutaneous delivery of biologics. He is a fellow of the National Academy of Medicine and the National Academy of Engineering. Kamm is co-founder of two companies, Cardiovascular Technologies and AIM Biotech, a manufacturer of microfluidic systems for 3D culture.

I am an Associate Director of Pharmacometrics/Clinical Pharmacology at Novartis Pharmaceuticals leading multiple early and late phase Radioligand Therapies (RLTs) drug development projects by providing strategic leadership and execution of quantitative clinical pharmacology analyses.

Dr. Larissa Lachi Silva received a Bachelor in Pharmacy (2012) and a PhD in Pharmaceutical Sciences (2019) from State University of Maringa. She then completed postdoctoral fellowships at Indiana University School of Medicine (IUSM) in Clinical Pharmacology. Dr. Lachi Silva is the lead pharmacometrician for full development RLTs on prostate cancer at Novartis.

Julie Lade received a PhD in Pharmacology & Molecular Sciences in 2016 from Johns Hopkins University School of Medicine under the mentorship of Dr. Namandjé N. Bumpus with a focus on anti-HIV small molecule drug metabolism and transcriptional regulation of phase I and phase II drug metabolizing enzymes. Since graduating, Julie has worked at Amgen in the Pharmacokinetics & Drug Metabolism department and is currently a Senior Principal Scientist contributing to the preclinical and clinical development of small molecules and RNA therapeutics.

J. Steven Leeder, PharmD, PhD, is the Marion Merrell Dow Endowed Chair in Pediatric Precision Therapeutics at Children’s Mercy Kansas City (CMKC), Kansas City, Missouri. He is Deputy Director of the Children’s Research Institute at CMKC, and Associate Chair-Research, Department of Pediatrics after having served as Director of the Division of Clinical Pharmacology, Toxicology and Therapeutic Innovation at CMKC for 10 years (2008-2018). He holds faculty appointments as Professor of Pediatrics and Pharmacology at the University of Missouri-Kansas City; Courtesy Professor of Pharmaceutical Chemistry in the School of Pharmacy at the University of Kansas (Lawrence, KS); and Clinical Professor of Pediatrics at the University of Kansas Medical Center (Kansas City, KS), and serves as co-PI of the Frontiers Clinical and Translational Science Institute at the University of Kansas with Dr. Mario Castro. Within the Children’s Mercy Research Institute Dr. Leeder is responsible for the Precision Therapeutics Area of Emphasis. His research focuses on characterizing the relative contributions of ontogeny, genetic variation, and disease to observed variability in drug disposition and response in children- a program known as the GOLDILOKs initiative: Genomic- and Ontogeny-Linked Dose Individualization and clinical Optimization for Kids. Dr. Leeder is strongly committed to mentoring pediatric sub-specialists, clinical pharmacists with advanced training, and other healthcare practitioners embarking on careers as independent clinical and translational investigators in the field of pediatric clinical pharmacology and precision therapeutics.

Xiaomin Liang, Ph.D. is a Sr Scientist II in the Department of Drug Metabolism at Gilead Sciences Inc. Xiaomin earned her B.S. degree (2011) in molecular toxicology from University of California, Berkeley, and Ph.D. degree (2016) in pharmaceutical sciences focused on membrane transporters and transporter-mediated drug disposition and pharmacokinetics (PK) at University of California, San Francisco. After doing a short fellowship in the Office of Clinical Pharmacology at FDA, she joined Gilead in 2017. Her primary research interests are in the applications of transporter biology, in vitro methodologies, and mechanism-based PK/PBPK modeling to understand the ADME of compounds and translate preclinical data to predict human PK.

Robert Lyon received his PhD in Medicinal Chemistry at the University of Washington in 2002. Since 2005 he has been with Seagen (formerly Seattle Genetics) working on multiple aspects of antibody-drug conjugate technology, including linker chemistry, conjugation methodologies, payload design, alternatives to antibodies, and novel targets. He has coauthored more than two dozen papers in the field of ADCs and presented work at many conferences.

Dr MacLauchlin is a Director of DMPK at Alnylam Pharmaceuticals, Inc., a pharmaceutical company focused on developing innovative RNAi-based medicines. Chris has approximately 20 years of research and development experience and has had positions of increasing responsibility in diverse organizations in the pharmaceutical and biotechnology sector. He has a broad range of expertise in understanding drug disposition and has worked on numerous approved products. At Alnylam, Chris provides DMPK guidance to programs to support portfolio development. He had a central role in ensuring the DMPK components were complete and authored regulatory components in support of the NDA/MAA filing of Patisiran, Lumasiran and Vutrisiran. Chris obtained a Ph.D. in Medicinal Chemistry at the University of North Carolina at Chapel Hill. Chris began his career in industry at Magellan Laboratories/Cardinal Health (Raleigh, NC), in their Drug Metabolism group. In 2003 he joined GlaxoSmithKline (RTP, NC) in the DMPK Mechanism and Extrapolation Technology (MET) group where he remained for 12 years. He specialized in metabolism and disposition properties of development compounds to identify liabilities and provide guidance to manage those liabilities in the clinic. In addition, Chris provided DMPK representation on project teams in the development of numerous metabolic, oncology and anti-infective drug candidates from candidate selection through Phase IV. In 2015 Chris joined Cempra, Inc, a biotech focused on development of a new macrolide anti-biotic as a director of clinical programs. While there he used his experience in DMPK to provide interpretive guidance for strategic decision making critical for safety, marketability and regulatory requirements including the writing of key regulatory documents for NDA and MAA submission for Solithromycin.

Dr. Bridget Morse is currently a Director in Drug Disposition at Lilly Research Laboratories. She received her Pharm.D. from Butler University and her Ph.D. in Pharmaceutical Sciences from the University at Buffalo. Since 2014, Bridget has served in the pharmaceutical industry as a subject matter expert in pharmacokinetics, transporters, and drug-drug interactions, particularly in the use of pharmacokinetic modeling for substrates of hepatic transporters. She is actively involved in many cross-functional committees in these subject matter areas. She is currently Chair of the IQ OATP1B Biomarkers Working Group and Chair of the AAPS Drug Transporter Community. She serves as a peer reviewer for multiple publications sits on the Editorial Advisory Board for the AAPS Journal. She has over 30 published journal articles and book chapters.

Jamie Nosbisch is a Principal Scientist at Applied BioMath. Jamie earned her BS degrees in Biochemistry and Cell and Molecular Biology from the University of Minnesota-Duluth and her PhD in Biomathematics from North Carolina State University. Her interests and expertise lie in using mechanistic modeling to better understand human biology and improve human health, and as a graduate student, she built and analyzed models to study the signaling pathways involved in the wound healing process. During her time at Applied BioMath, she has worked with many pharmaceutical and biotech teams to build quantitative systems pharmacology (QSP) and mechanistic PK/PD models to help drive decisions in drug development for a variety of therapeutic modalities. Through analysis of these mechanistic models, she has helped teams better understand their drug’s mechanism of action, determine key drug design features to promote better efficacy, as well as guide human dose projections.

Following his university degree in Chemistry 1994, Dr. Pähler received a Ph.D. in toxicology at the Department of Toxicology, University of Würzburg in 1998. During a postdoctoral training as biochemical toxicologist at the Nestlé Research Center he broadened his experience in biomarker research, drug metabolism and mass spectrometry. Dr. Pähler joined the Non-Clinical Drug Safety Department of F. Hoffmann-La Roche in 2001 where he led the Drug Metabolism Group for both Drug Discovery and Development until 2012 when he moved to DMPK project leadership. His research interests include biochemical pathways in drug metabolism and disposition relevant to pharmacokinetics, pharmacodynamics and safety. Dr. Pähler currently holds a position as Distinguished Scientist and Translational DMPK/PD Leader at Roche in Basel, Switzerland and Head of the Translational DMPK/PD Leader group.

K. Sandy Pang Ph.D. is Professor of Pharmacy and Pharmacology, Faculties of Pharmacy and Medicine at the University of Toronto. She received her Ph.D. from UCSF and post-doctoral training at the National Institutes of Health. Dr. Pang’s work spans the fields of pharmacokinetics, enzymes and transporters, and their regulation, and metabolite kinetics. She uses mechanistic-based approaches to explain drugs and metabolite handling within the eliminating organs upon inclusion of transport and metabolic processes into physiologically-based pharmacokinetic models. Recent work focuses on targets for the vitamin D receptor, VDR, and processing of calcitriol, active VDR ligand, on the regulation of transporters and enzymes and dynamics in the brain and kidney. She has served on various committees for NIH ASPET, AAPS, ISSX, and AAAS and is presently the Treasurer of ISSX. She is the editor-in-chief of Biopharmaceutics and Drug Disposition and member of the editorial review boards of Drug Metabolism and Disposition and Xenobiotica. She was the recipient of various awards and was honored recently with the Gary Levy Lectureship at University of Buffalo.

David is a Principal Scientist at Lhasa Limited. He completed his undergraduate degree in Natural Sciences at the University of Cambridge, specialising in Chemistry, and stayed to study for a PhD under the supervision of Professor Jonathan Goodman, investigating computational - principally quantum-mechanical modelling - approaches to the prediction of skin sensitisation. After successfully defending his thesis, David moved to the University of Gothenburg for postdoctoral research with Professor Ann-Therese Karlberg, applying the principles for the prediction of covalent-reactivity mediated toxicity developed during his PhD to a series of diverse chemical classes, as well as briefly returning to the experimental side of the lab. Following this, David joined Lhasa Limited, where he has taken on a number of distinct roles utilising both aspects of his previous experience: David is a core member of the team continually improving the science in Derek Nexus, developing alerts for a wide variety of endpoints - including of course skin sensitisation, but also genetic toxicology endpoints from mutagenicity to carcinogenicity. David is applying his quantum-mechanics expertise to develop novel descriptors for aromaticity, reactivity, bond dissociation energy and photochemical parameters in order to improve predictions across Lhasa’s range of products. David is heavily involved in Lhasa’s response to the nitrosamine crisis where, as well as internal Lhasa Limited work, he has been co-leading a major cross-industry working group addressing, and publishing on, aspects of nitrosamine carcinogenic potency, structure-activity relationships and risk assessment.

Dr. Bhagwat Prasad’s primary research interest focuses on drug safety in populations that are underrepresented in clinical trials, such as children, pregnant women, and ethnic minorities. He leads several federal and industry-funded research programs on characterization of interindividual variability and in vitro to in vivo extrapolation (IVIVE) of drug transport and metabolism by utilizing quantitative proteomics and metabolomics. He serves as the director of proteomics-based research in non-cytochrome P450 enzymes (PRINCE), a consortium funded by multiple pharmaceutical companies. Prior to moving WSU, Dr. Prasad was an assistant professor at the University of Washington (UW), Seattle and was affiliated with the UW research affiliate program on transporters (UWRAPT). Dr. Prasad has published 110 peer-reviewed articles and delivered over 90 invited talks at various conferences, peer institutes, and FDA. Dr. Prasad is an elected member of Washington State Academy of Sciences and a recipient of ISSX North American New Investigator Award and ASPET Early Career Faculty Showcase award. Dr. Prasad has also served as the Secretary of Drug Metabolism and Disposition Division of ASPET. Dr. Prasad is a senior editor of Pharmacology Research and Perspectives and a member of the editorial boards of Drug Metabolism and Disposition, Clinical Pharmacology and Therapeutics, and Trends in Analytical Chemistry. Dr. Prasad obtained his MS and Ph.D. in Pharmaceutical Sciences from NIPER, Mohali, India (2010) and postdoc from UW, Seattle, WA (2012).

Will Proctor, PhD, DABT is a Senior Director in the Pre-Clinical Safety at Kymera Therapeutics, a clinical stage biotechnology company focusing on discovering and developing targeted protein degraders. Prior to joining Kymera in November of 2021, Will served as the Senior Director and Head of Predictive Toxicology at Genentech, where he led the Investigative Toxicology, Complex In Vitro Systems, and Discovery Toxicology functions. Prior to joining Genentech in 2013, Will earned his PhD in Pharmaceutical Sciences from the University of North Carolina at Chapel Hill in the laboratory of Dr. Dhiren Thakker with a focus on drug transport and pharmacokinetics. He then performed postdoctoral training at the National Institutes of Health in the laboratory of Dr. Lance Pohl, with research centered on immune mechanisms of drug-induced liver injury (DILI). Will is a board-certified toxicologist and organizational leader with extensive experience in investigative and discovery toxicology. In addition to these activities, Will has continued his research in mechanisms of DILI, including identifying and qualifying preclinical tools to better assess hepatotoxicity risk during drug discovery.

Diane Ramsden is a Director and ADME BA group leader within AstraZeneca Oncology. She has worked in the pharmaceutical industry for over 20 years and has a range of experience in project representation from early discovery stage to post marketing in multiple therapeutic and disease areas including Oncology, GI, NS, cardiometabolic, respiratory, immunology and rare diseases and across modalities including small molecule drugs, PROTACs, microbiome-based therapeutics, mAbs, ADCs and RNAi. She is an active member of several industry Consortia aimed to improve predictions of drug-drug interactions from in vitro data. She has authored over 50 peer reviewed articles, book chapters and abstracts and has given over 20 invited talks. She is an editorial board member for Drug Metabolism and Disposition and serves as a member of the scientific committee leadership team with PBSS Boston. Her other research interests include the application of in vitro and in vivo models towards developing a mechanistic understanding of the disposition of novel therapeutics.

Brooke Rock is an Executive Director in the Pharmacokinetics and Drug Metabolism department at Amgen. Prior to joining Amgen, Brooke worked at start-up biotechnology companies in Seattle area; after receiving her PhD degree from University of Washington, in medicinal chemistry. Brooke’s research interest focuses on translational pharmacology, specifically in the field of enzymology. At Amgen, she has applied that interest across the portfolio in developing novel analytical tools to aid in understanding drug disposition. Brooke has contributed to more than 40 peer-reviewed research papers, and multiple book chapters, as well as numerous presentations at international conferences.

Professor Amin Rostami-Hodjegan, PhD, FCP, FAAPS, FJSSX, FBPS Professor of Systems Pharmacology and Director of Centre for Applied Pharmacokinetic Research (CAPKR), University of Manchester, UK & Chief Scientific Officer at Certara, Princeton, USA The Institute of Scientific Information (ISI, Clativate) listed Amin as one of the world’s most highly cited researchers (under ‘Pharmacology & Toxicology’) in 2017. Amin is also at 0.05% top rank of the Highly Cited Researchers List by Elsevier for pharmacology (2021). He has published over 300 peer reviewed highly influential scientific articles (>21,000 citations, h-index = 78). The work of Professor Rostami covers wide areas of drug development over the last 30 years, ranging from pharmaceutics (e.g. bioequivalence) to clinical pharmacology (e.g. mixture pharmacology of drug/metabolites), translational and systems pharmacology (e.g. quantitative proteomics of enzymes and transporter for in vitro to in vivo (IVIVE) scaling). Amin was co-founder of two spin-off companies from the University of Sheffield (Simcyp Limited and Diurnal PLC). As a leader in the field of physiologically-based pharmacokinetics (PBPK) and quantitative systems pharmacology (QSP), he is internationally recognized for his expertise in IVIVE to predict the behaviour of drugs in human body and understanding the associated inter-individual variabilities. He was one of the founding editors of Pharmacometrics and System Pharmacology, and serves on the Editorial Boards of several other journals. As the Senior Vice President of Research & Development (SVP) and Chief Scientific Officer at Certara, he facilitates the incorporation and integration of the latest advances in translational modelling to biosimulation platforms offered by Certara to its clients, with the aim of accelerating the development and regulatory approval of safer drug products and bringing them to the patients.

Malcolm Rowland, Emeritus Ph.D. University of Manchester.

Dr. Sanchez started her career as an associate scientist providing DMPK laboratory support, including the discovery and development of drugs that are now commercial products. She obtained a Ph.D. in Toxicology and progressed into Principal Investigator roles, where she has been ADME lead in cross-functional discovery and development teams in various therapeutic areas, including metabolic disorders, neurosciences, oncology and infectious diseases. She is currently Executive Director in ADME & Discovery Toxicology at Merck & Co., where she leads an organization that provides ADME and PK/PD support in a variety of program from the lead identification stage through candidate selection. Her team also provides expert input during clinical development, filing and life-cycle management. Dr. Sanchez and her team have contributed support and scientific expertise to the selection and clinical development of multiple preclinical candidates and recently, to the approval of several products, including DELSTRIGOTM, LAGEVRIOTM and WELIREGTM. She has been a co-author in over 50 publications that highlight her contributions to drug discovery and development.

Prof. Dhaval K. Shah is an Associate Professor of Pharmaceutical Sciences at the State University of New York at Buffalo. Prior to becoming the faculty Prof. Shah served as a Principle Scientist in the ‘Translational Research-Modeling & Simulation’ group at Pfizer Inc. He received his PhD from the Department of Pharmaceutical Sciences at the State University of New York at Buffalo in 2010. His research focuses on understanding the determinants for the absorption, distribution, metabolism, and elimination (ADME) of protein therapeutics and novel biologics. His lab uses the principles of Pharmacokinetics-Pharmacodynamics (PK-PD) Modeling & Simulation to support the discovery, clinical translation, and late phase development of novel biologics like engineered antibodies, multi-specific proteins, immuno-oncology agents, engineered T cells, antibody-drug conjugates, and gene delivery vectors.

Bio coming soon.

As an assistant professor in the department of Pharmaceutical Sciences at the University at Buffalo, my research program involves studying the role of solute carriers (SLCs) as contributors to drug efficacy and toxicity. It is expected that expanding our knowledge of SLCs will aid in understanding biological systems required for homeostasis along with interpatient variability and treatment response. It is also anticipated that identification of SLCs responsible for drug uptake will provide therapeutic targets to improve patient outcome. My lab group has led the characterization of OCT2 as a regulator of platinum toxicity, the discovery of anion transporters as mediators of platinum-metabolite uptake and toxicity, and more recently, the discovery that tyrosine kinase activity regulates function of several transporters, including OCT2, OATP1B1, and OATP1B3. Our work has been funded by NIGMS, NIDCD, and the University at Buffalo Clinical and Translational Science Institute. I have also been highly involved in the academic community with societal leadership positions and service as a reviewer for numerous scientific journals and funding agencies. I was also the recipient of the 2019 AACP New Investigator award and the 2023 ASPET Translational and Clinical Pharmacology Division Early Investigator Award.

Mark Stroh is currently Vice President and Head of Clinical Pharmacology at Intellia Therapeutics. Mark has 20 years of experience both within quantitative clinical pharmacology and across multiple functions within the development sciences; he has supported small molecules, biologics, and novel formats across multiple therapeutic areas and stages of development. Before Intellia Mark held several previous positions of increasing responsibility across the industry after receiving his PhD in Chemical Engineering from Cornell University.

Yuichi Sugiyama started working as the Special Professor Emeritus in Josai International University as of April 1, 2021, and recently became Adjunct Professor at the iHuman Institute, Shanghai Tech University, China, as of Oct 1, 2022. Dr. Sugiyama was the Head of Sugiyama Laboratory, RIKEN, Yokohama between April 2012 until 2021, and Professor, Dept of Molecular Pharmacokinetics at the University of Tokyo from 1991 to 2012. Dr. Sugiyama is acknowledged as a world-leader in the fields of physiologically-based pharmacokinetic (PBPK) modeling and membrane transporters. His works on PBPK has been pivotal for quantitative in vitro – in vivo extrapolation, especially the development of models for the prediction of drug clearance and the magnitude of drug-drug interactions in humans. His studies on transporters, which encompass functional and kinetic characterization and the impact of genetic variation, have been fundamental to our understanding of the role of transporters in drug disposition. He was also the president of both “International Society for the Study of Xenobiotics (ISSX)” and JSSX in 2006-2007.

Shaji Theodore is a Senior Pharmacologist at the Center for Drug Evaluation and Research in the Division of Pharmacology and Toxicology at Office of Cardiology, Hematology, Endocrinology and Nephrology.

Greg M. Thurber is Associate Professor of Chemical Engineering and Biomedical Engineering at the University of Michigan and Associate Chair of Graduate Education in ChE. His work focuses on applying fundamental biotransport principles to design novel therapeutics and molecular imaging agents including antibody drug conjugates. Prof. Thurber has authored over 60 papers and book chapters and delivered 80 invited talks at major pharmaceutical companies, national and international conferences, and university departmental seminars. He also has consulting/research contract affiliations with more than 15 different companies. Prof. Thurber’s work has been featured in popular news outlets including NPR’s “All Things Considered” and Smithsonian Magazine, and he has received several awards including an NIH K01 award, the National Science Foundation CAREER award, and most recently the World ADC George R. Pettit Award for Individual Contribution to the Field of Antibody Drug Conjugates.

Mirjam N. Trame, PharmD, PhD is the Vice President for Integrated Drug Development, and the US Northeast Regional Lead Pharmacometrics.

Christine Wegler is a pharmacist by training. She carried out her dissertation thesis entitled “Proteomics-informed analysis of drug disposition in the human liver and small intestine” at the Department of Pharmacy, Uppsala University, Sweden, under the supervision of Professor Per Artursson. She continued her research at the research facility Uppsala Drug Optimization and Pharmaceutical Profiling (UDOPP), as part of the Drug Discovery and Development (DDD) platform of Science for Life Laboratory (SciLifeLab), Sweden. She currently does postdoctoral work in the lab of Professor Felipe Cava at the Department of Microbiology, Umeå University, Sweden, where her project involves mapping the cell wall composition of bacterial species.

Dane Wittrup is the Carbon P. Dubbs Professor of Chemical Engineering and Biological Engineering at the Koch Institute for Integrative Cancer Research at the Massachusetts Institute of Technology. He received his Ph.D. in Chemical Engineering from Caltech in 1988 under the direction of Jay Bailey. Following a year of postdoctoral research at Amgen, he joined the faculty at the University of Illinois, and in 1999 moved to MIT. Wittrup’s research program is focused on engineering of biopharmaceutical proteins by directed evolution, and development of pharmacological design principles for immunotherapies for cancer. His lab invented yeast display, and formulated a predictive PK theory for tumor targeting agents. He has trained approximately 20 individuals that hold faculty positions around the world. He recently coauthored a comprehensive textbook on kinetic analyses in biological systems, titled “Quantitative Fundamentals in Molecular and Cellular Bioengineering”. Among other entrepreneurial activities, in 2007, he co-founded Adimab, Inc. with Tillman Gerngross, and served in the Office of the CSO for ten years. Adimab is a global leader in human antibody drug discovery. Particular recognitions of Wittrup’s accomplishments include the AIChE Colburn Award and induction into the National Academy of Engineering.

Dr. Xinning Yang is a Policy Lead in Guidance & Policy team (GPT) under the Office of Clinical Pharmacology (OCP), CDER of FDA. He was graduated from the Dept. Pharmaceutical Sciences of State University of New York at Buffalo (SUNY-Buffalo), mentored by Dr. Marilyn Morris. He is the Chair of Transporter Focus Group of International Society of Studying Xenobiotics (ISSX), a committee member of the Regulatory Affairs of ISSX, Co-vice chair of the Membrane Transporter (MT) community of the American Society of Clinical Pharmacology and Therapeutics (ASCPT), a committee member of the PBPK community of ASCPT, and a member of International Transporter Consortium (ITC) committee. He is participating in the International Council Harmonization (ICH) M12 DDI guidance global harmonization working group and serves as the Deputy Topic Lead from FDA.

Michael A. Zientek (Mike) is a U.S. Citizen and received his B.S. from Purdue University and MPH from the University of Michigan. Mike has 29 years of experience in drug metabolism and pharmacokinetics working in industry for both Pfizer Worldwide Research and Development and Takeda Pharmaceuticals. Mike has served in many roles throughout his career including Head of DMPK Takeda San Diego, and a neuroscience research project leader. He is currently a senior director and global head of ADME sciences at Takeda where he and his group provide mechanistic ADME, biotransformation, isotope chemistry, biodistribution and DMPK guidance to advance molecules through design efforts in discovery, optimizing and predicting human pharmacokinetic properties, preparing molecules for regulatory submission, and progressing compounds through clinical proof of concept. Mike’s research activities have been and continue to be devoted to investigation of drug metabolizing enzymes, polymorphisms, drug-drug interactions, and human ADME of new and established xenobiotics. He has authored >40 publications and book chapters in this area ranging from new tools for ADME investigations to characterization of targeted therapies.