Speaker Biographies
Session 1: Setting the stage

Joseph M. Betz, Ph.D., is the acting director of the National Institutes of Health’s (NIH’s) Office of Dietary Supplements (ODS). Prior to joining the ODS, he was vice president for scientific and technical affairs at the American Herbal Products Association (AHPA). Before serving at the AHPA, he spent 12 years at the Food and Drug Administration’s (FDA’s) Center for Food Safety and Applied Nutrition (CFSAN). Dr. Betz is a member of the American Society of Pharmacognosy (ASP), a fellow of AOAC International, and a member of U.S. Pharmacopeia’s (USP’s) Expert Committee on Dietary Supplements. Co-author of more than 100 publications, he has received the American Botanical Council’s Farnsworth Award, the AHPA Herbal Insight Award, and the ASP Varro E. Tyler Prize. He received his Ph.D. in pharmacognosy from the University of the Sciences (formerly the Philadelphia College of Pharmacy and Science).

Barbara C. Sorkin, Ph.D., is the director of the Botanical Research Centers Program at the National Institutes of Health’s (NIH’s) Office of Dietary Supplements (ODS). Before moving to the ODS, Dr. Sorkin was responsible for extramural research in the areas of antioxidants, healthy aging, cancer, and sleep at NIH’s National Center for Complementary and Alternative Medicine (NCCAM, now the National Center for Complementary and Integrative Health [NCCIH]). She has authored research reviews and original research papers in areas ranging from cell adhesion molecule structure to health effects of dietary supplements. Prior to joining the NIH, Dr. Sorkin was on the faculty at the Forsyth Institute in Boston, Massachusetts, and at the Scripps Research Institute in La Jolla, California. She received her B.S. and M.S. in molecular biophysics and biochemistry from Yale University and her Ph.D. in developmental and molecular biology from the Rockefeller University, where she was an assistant professor prior to moving to Scripps and her research focused on the molecular structures, biological functions, and molecular biology of cell-cell adhesion molecules belonging to the immunoglobulin superfamily and the cadherin family.

Steven J. Casper, Ph.D., is an ethnobotanist in the Office of Dietary Supplement Programs in the Food and Drug Administration’s (FDA’s) Center for Food Safety and Applied Nutrition. His main role is to conduct botanical reviews on new dietary ingredients that are the subjects of 75-day premarket notifications. He also is the center expert in botany and the subject of botanical dietary supplement ingredients. During his graduate work he focused on anti-malarial plants from the Peruvian Amazon. Working with the Aguaruna people in the jungle and the Field Museum in Lima, Peru, he collected and curated hundreds of species used by the indigenous people and performed natural products chemistry and cell biology studies to isolate and identify active constituents. Prior to his graduate work, he was a plant molecular biologist/virologist at The Scripps Research Institute and the Plant Gene Expression Center. He received his Ph.D. in ethnobotany from Washington University in St. Louis.

D. Craig Hopp, Ph.D., is the deputy director of the Division of Extramural Research at the National Institutes of Health’s (NIH’s) National Center for Complementary and Integrative Health (NCCIH) where, in addition to serving as the deputy director, he oversees the administration of the product integrity policy. This involves evaluation of proposed study materials to ensure they are safe and properly characterized. His portfolio also includes research on drug-natural product interactions, the Innovation and Technology Research Center, and the Centers for Advancing Research on Botanical and Other Natural Products (CARBON) Program. Dr. Hopp uses his expertise in the field of natural products to help shape research priorities at NCCIH. Prior to joining NCCIH, Dr. Hopp was a senior research scientist for AMRI, where he was responsible for the isolation and identification of compounds from natural sources; an employee of Phyto-Technologies, where he was responsible for research and development on multiple herb formulas used in traditional Chinese medicine; and a postdoctoral researcher at Shaman Pharmaceuticals, where he used his knowledge of indigenous cultures from around the world regarding medicinal plants to aid in the discovery of new pharmaceutical agents and discovered and obtained multiple patents. He received his B.S. in chemistry from James Madison University and his Ph.D. in pharmacognosy from Purdue University.

Adam J. Kuszak, Ph.D., is the director of the Analytical Methods and Reference Materials (AMRM) Program at the National Institutes of Health’s (NIH’s) Office of Dietary Supplements (ODS). Through AMRM, he works with stakeholders involved in research, industry, and regulatory affairs to support scientific resource development and promote biomedical research on the mechanisms and health effects of dietary supplements and natural products. Dr. Kuszak’s primary research interests include elucidating the mechanisms of action and effects on cellular signaling networks of natural products and drugs and their chemical and biological characterization. He received his B.S. in pharmacology and toxicology from the University of Wisconsin-Madison and his Ph.D. in pharmacology from the University of Michigan. He completed his postdoctoral training at the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) and first joined the ODS as an American Association for the Advancement of Science (AAAS) Science and Technology Policy Fellow.

Session 2: Bioactivity assays

Hervé Tiriac, Ph.D. is a research investigator at Cold Spring Harbor Laboratory (CSHL). His primary research has focused on building a clinically translatable cell modeling and therapeutics facility at CSHL. Over the past 3 years, he developed and optimized the procedures for high efficiency generation and characterization of pancreatic cancer patient–derived organoids. Along with genotyping and expression analysis, he established a pharmacotyping platform to predict the efficacy of chemotherapeutic and targeted therapy. He recently published the findings in Cancer Discovery following analysis of the first cohort. In retrospective clinical studies, patient-derived organoid response to chemotherapy paralleled clinical outcome of treated patients and enabled identification of biomarkers of chemotherapy sensitivity. Importantly, Dr. Tiriac also incorporated a targeted agent pharmacotyping analysis that identified alternative treatment strategies for the patient-derived organoids that were pan-resistant to chemotherapy (approximately 33% of patients). He is now collaborating with multiple clinical centers to validate organoid-based precision medicine approaches in prospective clinical trials. In parallel he has partnered with SCRIPPS Florida professor Timothy Spicer to pioneer 3D high-throughput screening, potentially enabling individualized drug screening. He received his Ph.D. in molecular biology from the University of California, San Diego.

D. Lansing Taylor, Ph.D., is the director of the University of Pittsburgh Drug Discovery Unit. He began his academic career at Harvard University and then moved to Carnegie Mellon University (CMU) as a professor of biological sciences and the director of the Center for Fluorescence Research, developing and applying novel fluorescence-based technologies in biology and medicine. He co-founded Biological Detection Systems, which is now part of General Electric Life Sciences, in the early 1990s to commercialize research light microscope imaging systems and the multi-color cyanine dyes for fluorescence detection. He left CMU in 1996 to found and to lead a series of companies: Cellomics, high content screening, now part of ThermoFisher; Cellumen, early safety assessment, now part of Cyprotex; and Cernostics, cancer diagnostics based on tissue systems biology. Dr.Taylor returned to academia at the end of 2010 to apply quantitative systems pharmacology (QSP) to optimize drug discovery and companion diagnostics. He recently spun off SpIntellx, a computational and systems pathology company that predicts optimal therapeutic strategies. Human, biomimetic, microphysiology systems (MPS) are critical experimental models in QSP programs. The vascularized liver MPS (vLAMPS) is the most recent contribution that creates continuous oxygen zonation, allows immune cell infiltration,  limits the binding of hydrophobic molecules, and permits the physical coupling of multiple organ MPS. He received his Ph.D. in cell biology from the State University of New York at Albany.

Nisha S. Sipes, Ph.D.,  is a health science evaluator in the National Toxicology Program (NTP) Division of the National Institute of Environmental Health Sciences (NIEHS). Her role focuses on developing and using bioinformatics and computational toxicology approaches to translate high-throughput screening (HTS) data, such as Tox21 and transcriptomics data, to better estimate the in vivo likelihood of exposure. A main focus includes in silico approaches for in vitro-in vivo extrapolation (IVIVE). IVIVE approaches translate in vitro point-of-departure concentrations to estimated external dose levels anticipated to elicit biological effects in animal and human studies. IVIVE dose level translation is essential for integration of in vitro data into a risk assessment framework. These approaches have been used for the chemicals in the Tox21 library, including pharmaceuticals, pesticides, and industrial chemicals, as well as for targeted projects including botanicals, flame retardants, and potential developmental neurotoxicants. Prior to joining the NTP, Dr. Sipes had a similar role at the U.S. Environmental Protection Agency’s (EPA’s) National Center of Computational Toxicology, where she contributed to an in silico IVIVE tool (HTTK R-Package) that is freely available. She received her B.S. in mechanical engineering, her M.S. in biomedical engineering, and her Ph.D. in cell and cancer biology from the University of Cincinnati, Ohio.

Michael A. Walters, Ph.D., is a research associate professor in the Department of Medicinal Chemistry and the director of the Lead and Probe Discovery Group in the Institute for Therapeutics Discovery and Development at the University of Minnesota. As a National Institutes of Health (NIH) postdoctoral fellow at the University of Rochester he completed the total synthesis of lycorine. He then accepted a faculty position in the Department of Chemistry at Dartmouth College, where he specialized in synthetic methods development and computational chemistry. He joined the Chemistry Department at Parke-Davis in Ann Arbor, Michigan, in 1997. This site later became Pfizer Global Research and Development, Ann Arbor Laboratories. Dr. Walters was on the project team that in 2014 reported the screening of 150,000 natural product extracts against all 6 antiapoptotic Bcl-2 family proteins and the subsequent dereplication of the active extracts. His group collaborated with the Guido Pauli Laboratory on the 2017 publication, “The Essential Medicinal Chemistry of Curcumin.” This article currently has 60,000 views online and 121 citations. He received his B.S. in chemistry/physics from Hope College, Michigan, and his Ph.D. in organic chemistry from the University of Michigan.

Session 3: Product characterization

Kenneth D.R. Setchell, Ph.D., is a professor in the Department of Pediatrics at the University of Cincinnati College of Medicine and the director of Clinical Mass Spectrometry in the Division of Pathology and Laboratory Medicine at Cincinnati Children’s Hospital Medical Center. His expertise is in clinical and biomedical applications of mass spectrometry, primarily steroids, lipids, and related small molecules. He discovered 6 disease-causing genetic defects in the pathway for bile acid synthesis and developed a therapy approved by the European Medicines Agency and the U.S. Food and Drug Administration (FDA). He runs an international center for the diagnosis and treatment of liver disease caused by these genetic defects. Dr. Setchell discovered lignans and isoflavones in humans and their dietary association with flaxseed and soy foods, leading to a program in their relationship to hormone-dependent diseases. He received the Adolf Windaus Prize, the MSACL Distinguished Contributor Award for lifetime application of mass spectrometry in the clinic, the Roche/DSM International Award for Innovative Research in Human Nutrition, and awards from AOCS and the North American Menopause Society. He has published more than 360 peer-reviewed papers, is inventor on 10 patents, and co-founded 3 companies. He received his Ph.D. in steroid biochemistry from the University of London and performed postdoctoral studies at the Karolinska Institute in Stockholm.

Mario G. Ferruzzi, Ph.D., is a professor in the Plants for Human Health Institute and in the Department of Food, Bioprocessing and Nutrition Science at North Carolina State University.  His research focuses on the impact of food formulation and processing on bioavailability, metabolism, and biological activity of phytochemicals and micronutrients. He has received research support from the U.S. Department of Agriculture (USDA), National Institutes of Health (NIH), USAID, and the food industry. He serves as an advisor to food manufacturers, providing perspectives on the interface of food and nutrition sciences and guidance in development and assessment of foods. Dr. Ferruzzi is a member of the Institute of Food Technologists (IFT), the American Society for Nutrition (ASN), and the American Chemical Society (ACS) and is a Fellow of the Royal Society of Chemistry (RSC). He serves on the editorial board for Critical Reviews in Food Science and Nutrition, Nutrition Research, and Nutrition Today and as an associate editor for Food & Function. Previously he was a professor in the Department of Food Science at Purdue University and a research scientist with Nestlé Research & Development. He received his B.S. in chemistry from Duke University and his Ph.D. in food science and nutrition from The Ohio State University. 

Mahtab Jafari, Pharm.D., is a professor and the vice chair of Pharmaceutical Sciences at the University of California, Irvine (UCI). Using fruit flies as her main model system, her work focuses on evaluating (1) the impact of botanical extracts and dietary supplements on lifespan and healthspan through a science that she introduced as “Healthspan Pharmacology,” (2) the adverse effects of dietary supplements, and (3) the impact of natural products on the phenotypes of Drosophila models of human diseases such as Alzheimer’s disease. Dr. Jafari developed a new major in pharmaceutical sciences and helped develop the Department of Pharmaceutical Sciences at UCI. She also has served as the director of the Cholesterol Clinic and the co-director of the Cardiovascular Risk Reduction Program at UCI Medical Center. Previously she was on the faculty at the University of California, San Francisco, School of Pharmacy and a scientist in the Neuroscience Group at Abbott Laboratories, where she became a regional medical scientific manager and was involved in investigator-initiated clinical trials. She received her Pharm.D. and completed her residency at the University of California, San Francisco.

John B. MacMillan, Ph.D., is a professor in the Department of Chemistry and Biochemistry at the University of California, Santa Cruz. He also leads the Center for High Content Functional Annotation of Natural Products that is developing technologies to obtain a better mechanistic understanding of botanicals. His research focuses on the chemical and biological characterization of natural products. Over the last 10 years, the MacMillan Laboratory has been working on the development of platforms to study the mechanisms by which natural products engage with biological systems. His work in natural products spans the development of nuclear magnetic resonance (NMR) methods for structural elucidation, medicinal chemistry, and chemical biology. Prior to the University of California, Santa Cruz, Dr. MacMillan was on the faculty in the Department of Biochemistry at the University of Texas Southwestern Medical Center. He received his Ph.D. in chemistry from the University of California, Davis, where his interests in small molecule NMR began by studying the natural products chemistry of marine organisms. He performed his postdoctoral work at the Scripps Institution of Oceanography in San Diego with microbial natural products.

Guido F. Pauli, Ph.D., is the Norman R. Farnsworth Professor of Pharmacognosy, director of the Program for Collaborative Research in the Pharmaceutical Sciences (PCRPS), and associate director of the Institute for Tuberculosis Research (ITR) at the University of Illinois at Chicago College of Pharmacy. His basic and translational research projects involve bioactive natural products (NPs) from diverse sources, NP technologies, botanical dietary supplements, clinical intervention materials, drug discovery, the NAPRALERT database, and institutional training programs. His main research interests encompass the metabolomic analysis of natural health products, botanicals, anti-TB hit-to-lead development, dental biomodifiers, and pharmaceutical analysis. Contributing his expertise in the development of analytical methods and innovative approaches, Dr. Pauli seeks to address challenges posed by nature's metabolomic variation and enhance the understanding of natural products as health products and sources of new drugs. His academic record includes mentoring 18 doctoral students, 20 postdoctoral students, and 15 visiting scientists and international collaborations particularly in China and Europe. His approximately 200 peer-reviewed publications have an h-index of 43 in Scopus. He was trained as a pharmacist with specialization in pharmaceutical analysis and received his Ph.D. in pharmacognosy from the University of Düsseldorf.

Session 4: Foundation for translation, preclinical models

Harold Seifried, Ph.D., is the acting director of the Division of Cancer Prevention at the National Institutes of Health’s (NIH’s) National Cancer Institute (NCI). He is a member of the American Chemical Society Biological Chemistry Division, the American College of Toxicology Industrial Toxicology Subcommittee, the American Industrial Hygiene Association, the Society of Toxicology, and the International Society for the Study of Xenobiotics and has been a Diplomate of the American Board of Toxicology since 1980. He has served in an advisory capacity to the U.S. Department of Agriculture (USDA) Irradiated Foods Program, the National Institute of Environmental Health Sciences (NIEHS) National Toxicology Program Chemical Selection Committee, the Environmental Protection Agency (EPA) Interagency Test Committee, and Centers for Disease Control and Prevention (CDC) National Center for Chronic Disease Prevention and Health Promotion’s REACH 2010. Dr. Seifried served as ad hoc reviewer for The Lancet, Toxicology and Applied Pharmacology, the Food and Drug Administration (FDA), NCI Divisions, the National Science Foundation (NSF), and the American Cancer Society Maryland Chapter. He was selected Maryland Academy of Sciences Outstanding Young Scientist Quarter Finalist and was awarded the Naval Reserve Officer Training Course, New York State Regents undergraduate and graduate scholarships, and NSF and NIH summer fellowships. He has published more than 60 abstracts, book chapters, and journal articles. He received his B.S. in biology from the University of Rochester and his Ph.D. in biochemistry from Cornell University.

Jacqueline M. Stephens, Ph.D., is the Claude Pennington Endowed Chair in Biomedical Research and a tenured professor in the Department of Biological Sciences at Louisiana State University (LSU). She teaches endocrinology at LSU and has an active research lab of undergraduates and Ph.D. students from LSU as well as several postdoctoral fellows. In graduate school, she became interested in fat cell biology and the role of these cells in the pathogenesis of Type 2 diabetes. She has had sustained funding from the National Institutes of Health (NIH) to study signaling proteins involved in the molecular pathogenesis of Type 2 diabetes since 1997. Dr. Stephens serves on the editorial boards of several journals, including Diabetes. In 2011, she moved her research laboratory to the Pennington Biomedical Research Center to become more active in botanical-related research. Her interests include understanding adipocyte biology and how botanicals can act on fat cells to promote metabolic health. She received her Ph.D. in biochemistry from East Carolina University School of Medicine and her postdoctoral training from Boston University School of Medicine, where she had a fellowship from the Juvenile Diabetes Foundation.

Jeffrey Paul, Ph.D., is an adjunct faculty member at Drexel Medical College, Philadelphia, serving as the course director for Clinical Pharmacology (i.e., Pharmacotherapy) and a lecturer in graduate neuropharmacology and the Drug Discovery and Development Programs. He also is a clinical pharmacology consultant to the pharmaceutical industry, where he focuses on early clinical development of drugs for central nervous system (CNS) and pain. He is an active member of the American Society for Clinical Pharmacology and Therapeutics and the American Society for Pharmacology and Experimental Therapeutics. Dr. Paul is active on translation, clinical pharmacology, biomarkers, and mentoring/career development committees. He has more than 30 years of experience in early drug development, having worked at Berlex, Pfizer (formerly Wyeth), and Astellas at the executive director/assistant vice president level.  For the past 15 years his research interests have focused on applying pharmacokinetic/pharmacodynamic (PK/PD), translation, experimental medicine, and biomarker techniques to molecules transitioning to human trials. Many tools and learning from drug development can be applied to natural products. He received his M.S. in food science and nutrition from Cornell University and his Ph.D. in physiology from the University of Medicine and Dentistry of New Jersey.

Kathleen Pritchett-Corning, D.V.M., is a senior clinical veterinarian in the Harvard University Faculty of Arts and Sciences and has an affiliate appointment in the Department of Organismic and Evolutionary Biology. Since 2002, she has held affiliate faculty positions at the University of Washington, most recently in the Department of Comparative Medicine. She is a member of the Laboratory Animal Working Group of the American Veterinary Medical Association (AVMA) Panel on Euthanasia, the AVMA Panel on Depopulation, the Federation of European Laboratory Animal Science Associations (FELASA) Working Group on Health Monitoring, and the joint American Association for Laboratory Animal Science (AALAS)/FELASA Working Group on Health Monitoring of Rodents for Animal Transfer. She also has held positions at the University of Washington and the Jackson Laboratory. From 2011 to 2014 Dr. Pritchett-Corning served on the American College of Laboratory Animal Medicine’s (ACLAM’s) Board of Directors and currently is a Diplomate of ACLAM. She has more than 20 years of experience in laboratory animal science, with a focus on animal-based research. She has authored more than 60 peer-reviewed publications and book chapters, including chapters in Laboratory Animal Medicine, and 5 volumes of the Charles River Handbook series. She received the AALAS Pravin Bhatt Scientific Excellence Award in 2015. She received her B.S. and D.V.M. from Washington State University and completed postdoctoral training in laboratory animal medicine at the University of Washington.

Session 5: Lost in Translation (to human diversity)

Giovanna Zappalà, Ph.D., M.P.H., is a health scientist administrator in the Division of Geriatrics and Clinical Gerontology (DGCG) at the National Institute on Aging (NIA). She leads the NIA Nutrition Office and DGCG's research efforts on nutrition and aging with focus on clinical studies of different dietary interventions (e.g., whole food plant-based, caloric restriction, intermittent fasting, time-restricted feeding) that may affect a healthy life span. In the DGCG Dr. Zappalà cultivates a research portfolio that focuses on elucidating physiological mediators of molecular pathways involved in promoting health across the life span and in aging. Mechanistic targets under research include—but are not limited to—progenitor and stem cell populations, telomere length, epigenetic modifications, mitochondrial bioenergetics, adipokines and metabolic mediators, peptides, growth factors, hormones, and other biomolecular targets and biomarkers. She received her Ph.D. in experimental physiopathology from the University of Rome Tor Vergata School of Medicine through a trans-institutes collaboration with the National Institutes of Health (NIH), her degree in medicinal chemistry and pharmaceutics from the University of Catania School of Pharmacy, and her M.P.H. from the Milken Institute School of Public Health at the George Washington University.

Sara K. Quinney, Pharm.D., Ph.D., is an assistant professor in the Department of Obstetrics and Gynecology and Division of Clinical Pharmacology in the Department of Medicine at Indiana University School of Medicine and the associate director of the Indiana Clinical and Translational Sciences Institute (CTSI) Disease and Therapeutic Response Modeling Program. She utilizes quantitative systems pharmacology models to improve understanding of drug disposition and response in special populations, including pregnant women. She has expertise in pharmacokinetic drug-drug interactions and is funded by the National Institutes of Health (NIH) to evaluate complex drug interactions among polypharmacy patients. She leads a collaboration with the University of Illinois at Chicago NIH Center for Botanical Dietary Supplements Research to develop quantitative models to predict the risk of herb-drug interactions. Dr. Quinney also serves as the clinical pharmacology and pharmacokinetic/ pharmacodynamic modeling expert for the Model Organism Development and Evaluation for Late-onset Alzheimer’s Disease (MODEL-AD) Program’s Preclinical Trial Core, which has established a pipeline for rigorous preclinical testing in animal models of Alzheimer’s disease. She is an active member of the American Society for Clinical Pharmacology and International Society of Pharmacometrics. She received her Pharm.D. and Ph.D. in pharmacy practice from Purdue University and completed clinical pharmacology and bioinformatics fellowships at Indiana University. 

Frederic Bushman, Ph.D., is the W. M. Measey Professor and Chair of Microbiology at the Perelman School of Medicine at the University of Pennsylvania. His research centers on host/microbe interactions, with specific projects focusing on the human microbiome, HIV pathogenesis, and human genome modification. He served as a principal investigator (PI) for the Human Microbiome Project and is a founding PI of the PennCHOP Microbiome Program. Dr. Bushman has also been named a Pioneer in Human Gene Therapy. He has published more than 300 research papers (cited more than 35,000 times; Institute for Scientific Information [ISI] h factor of 88) and 2 books. He received his B.A. in biology and English from Amherst College and his Ph.D. in cellular and developmental biology from Harvard University.

Floyd (Ski) H. Chilton Ph.D., is a professor of nutritional sciences, the director of the Precision Wellness Initiative, and an associate director of the BIO5 Institute at the University of Arizona. He is a successful innovator in a wide range of areas including an academic professor, with more than 130 scientific publications; an entrepreneur, starting several for-profit and non-profit organizations; and an inventor, holding more than 25 patents. Dr. Chilton is widely recognized for his work on nutrition in the context of variation in the human genome. Specifically, his work examines how genetic/epigenetic variations associated with polyunsaturated fatty acid metabolism interact with human diets, especially the modern Western diet, to impact molecular (metabolomic) and clinical phenotypes associated with inflammatory and psychiatric/developmental disorders. These precision- and population-based research approaches have the capacity to provide a wide range of opportunities to enhance human wellness that include: (1) providing long-sought pathogenetic mechanism(s) that underscore the different biologic behavior of inflammatory diseases in diverse racial/ethnic populations, (2) discovering new metabolomic biomarker profiles of disease aggressiveness for early diagnostic and therapeutic intervention, and (3) revealing new therapeutic strategies to attenuate disease aggressiveness using precision gene-based dietary and/or pharmacologic interventions. He received his Ph.D. in biochemistry from Wake Forest University School of Medicine.

Marco Pahor, M.D., is the director of the University of Florida Institute on Aging and the founding chairman of the Department of Aging and Geriatric Research at the University of Florida College of Medicine. He is an internationally recognized expert on population-based studies, clinical trials, and multidisciplinary translational research in the fields of aging and disability. He has an excellent publication record, having authored or co-authored more than 450 papers in leading peer-reviewed journals (more than 43,800 citations; h-index of 107). He has an extensive portfolio of grants from the National Institutes of Health (NIH) and other agencies and is a leader in education, serving as the director of faculty mentoring programs at the Claude D. Pepper Older Americans Independence Center. Dr. Pahor served on the Physical Exercise Task Force and the Aging Clinical Trials Advisory Panel of the National Institute on Aging (NIA). He has served as an editor for a number of academic journals, including Aging; Clinical and Experimental Research; the Journal of the American Geriatrics Society; the Journal of Gerontology: Medical Sciences; and the Journal of Nutrition, Health and Aging. He has served on numerous NIH grant and program review panels. He received his M.D. from Catholic University in Rome.

Freddie Ann Hoffman, M.D., is the chief executive officer of HeteroGeneity, a DC-based consultancy specializing in development strategies for natural and complex products. She is an expert on complex drug development. HeteroGeneity has guided sponsors to achieve the first two botanical “new” drugs approved by the Food and Drug Administration (FDA), both as prescription drugs. She is a member of the American Society of Pharmacognosy and a past chair of the Drug Information Association’s Natural Health Products Track. Previously she was the director of the Nutrition and Supportive Care Section in the Division of Cancer Treatment and then the director of extramural clinical trials in the Biological Response Modifiers Program at the National Cancer Institute (NCI). She then served at the FDA as branch chief of Cytokines, Growth Factors, and Oncologic Products; deputy director of the medicine staff in the Office of the Commissioner; and in the FDA Office of Dietary Supplements. She started and chaired the internal agency botanical working group that drafted the FDA Guidance for Industry on Botanical Drug Products. Dr. Hoffman then became the senior medical director for new product development at Warner-Lambert Pfizer Consumer Healthcare. She was an invited speaker on dietary supplements at the 18th Presidential Commission on Bioethics (BRAIN initiative). She received her B.S. in chemistry from the University of California, Los Angeles, and her M.D. from the University of California, Davis. She performed her pediatric residency at the University of California, Davis, and completed a pediatric hematology-oncology fellowship at the NCI. 

Session 6: Optimizing the foundations, prior research

Laura Lee Johnson, Ph.D., is the patient-focused drug development liaison and an acting division director for the Office of Biostatistics at the U.S. Food and Drug Administration’s (FDA’s) Center for Drug Evaluation and Research (CDER). She specializes in design, logistics, implementation, and analysis of research studies ranging from clinical outcome assessment (COA) qualification to trials of all sizes. She works across the FDA on patient-focused drug development initiatives and rare disease trials. Prior to working at the FDA Dr. Johnson spent more than a decade at the National Institutes of Health (NIH) working on and overseeing clinical research and research support programs. She received her B.A. in mathematics from the University of Virginia and her M.S. and Ph.D. in biostatistics from the University of Washington.

Bruce Barrett, M.D., Ph.D., is a professor in the Department of Family Medicine and Community Health at the University of Wisconsin-Madison School of Medicine and Public Health. He is a family physician and tenured research professor and has contributed research on alternative/complementary/integrative medicine, herbal/botanical medicine, mind-body interactions, and placebo effects. He has directed clinical research including more than 1,280 participants in National Institutes of Health (NIH)-funded, randomized controlled trials (RCTs). The PEP trial enrolled and randomized 719 people, testing echinacea as a treatment for the common cold and for placebo effects related to receiving blinded versus open label echinacea, compared to blinded placebo or to no pills. He also looked at the effects of patient-centered interaction. In addition to directing the first and the largest echinacea trials conducted in the United States, he co-authored systematic reviews of echinacea and other herbals, including ginger. Two more recent trials tested the effects of mindfulness meditation and bodily exercise on immunity, inflammation, and susceptibility to acute respiratory infection. Dr. Barrett’s primary contribution to RCT theory and method has been “sufficiently important difference” defined “as the smallest amount of patient-valued benefit that an intervention would require justifying associated costs, risks, and other harms.” Related work helps to shift the conceptual framework away from “that-which-can-be-measured” (distribution-based assessment) towards “that-which-is-important” (outcomes anchored to patient values). He received his M.D. and Ph.D. in anthropology from the University of Wisconsin-Madison.

Mairead Kiely, Ph.D., is a professor of human nutrition at the School of Food and Nutritional Sciences at University College Cork, which is located in the South of Ireland. She is co-director of the Cork Centre for Vitamin D and Nutrition Research and leads the Maternal and Child Nutrition Research Platform at the Infant Centre for Perinatal Research. She has more than 25 years of experience in human nutrition research focused on clinical and epidemiological studies of micronutrients. Her research program integrates the main themes of vitamin D and human health and the role of maternal and child nutrition in growth and development. Dr. Kiely was joint coordinator of the European Commission-funded Integrated Project on Vitamin D (Food-based strategies for vitamin D deficiency prevention throughout life; ODIN). She is an honorary member of the U.K. Scientific Advisory Committee for Nutrition (SACN) subgroup on Maternal and Child Nutrition, a member of the Public Health Nutrition Committee of the Food Safety Authority of Ireland, and an editorial board member of two international journals in nutritional science and dietetics. She received her Ph.D. in nutritional sciences from University College Cork.

Daniel Lakens, Ph.D., is an experimental psychologist working at the Human-Technology Interaction Group at Eindhoven University of Technology. He works on how researchers can design informative studies, reward structures in science, and applied statistics. He is funded until 2022 by a Vidi grant from NWO on a project that aims to improve the reliability and efficiency of psychological science. He co-edited a special issue consisting of pre-registered replication studies with Brian Nosek and convinced the Dutch science funder NWO to start a pilot project with grants dedicated to replication research. He also teaches a popular online course, “Improving Your Statistical Inferences.” In his research he examines how scientists can improve their statistical inferences, given a biased scientific literature, and how they can work toward making the scientific literature a better reflection of reality. He aims to introduce best practices from other scientific disciplines into psychological science. In his work he explains how scientists can collect more reliable data as efficiently as possible without inflating their error rates, design well-powered studies based on a biased literature, and prevent publication bias through preregistration and by making statistical methods to interpret null-results more widely available. He received his Ph.D. from Utrecht University.

Session 7, Strategies for optimizing cost-effectiveness of NP clinical research investments

Gregory Bloss, M.A., M.P.P., is a program staff member at the National Institute on Alcohol Abuse and Alcoholism (NIAAA), where he manages a portfolio of research grants focused on analyzing public policies relating to alcoholic beverages and alcohol-related problems, prevention of impaired driving, systems-based dynamic modeling, and economic research on alcohol-related behaviors and outcomes. He conceived and led the development of the Alcohol Policy Information System (APIS), a major project to provide detailed and authoritative information on alcohol-related public policies to facilitate research on the effects and effectiveness of such policies. Mr. Bloss is a leading voice in the National Institutes of Health (NIH) Common Fund Health Economics Program, where he leads the Prevention and Personalized Health Care Project team in promoting health economics research to improve health and reduce health care costs. He serves as coordinator for the new NIH Health Economics Scientific Interest Group. Mr. Bloss received his master’s degrees in economics from the University of British Columbia and in public policy from the University of Maryland, Baltimore County.

Leonard Freedman, Ph.D., is the founding president of the Global Biological Standards Institute (GBSI). Prior to starting GBSI, he was vice dean for research at Thomas Jefferson University. Dr. Freedman also led discovery research efforts in the pharmaceutical industry as a vice president at Wyeth Pharmaceuticals and executive director at Merck Research Laboratories. Before moving to industry, Dr. Freedman was a member and professor of cell biology and genetics at Memorial Sloan-Kettering Cancer Center. He received his B.A. in biology from Kalamazoo College and his Ph.D. in molecular genetics from the University of Rochester. He performed his postdoctoral studies at the University of California, San Francisco.

Christopher S. Coffey, Ph.D., is a professor in the Department of Biostatistics and the director of the Clinical Trials Statistical and Data Management Center (CTSDMC) at the University of Iowa. He is the principal investigator (PI) of the Data Coordinating Center (DCC) for several large clinical studies and PI of the National Institute of Neurological Disorders and Stroke (NINDS)-funded Network for Excellence in Neuroscience Clinical Trials (NeuroNEXT). He also serves as the head of the statistics core for the Parkinson’s Progression Markers Initiative and has been the primary statistician for multi-site clinical trials in Fragile X syndrome, Huntington’s disease, hypertension, multiple sclerosis, myasthenia gravis, obesity, pediatric migraine, spinal muscular atrophy, stroke, and traumatic brain injury. Dr. Coffey has nearly 20 years of experience providing data management and statistical support to clinical trials. He is a past member of the NINDS NSD-K clinical trials study section, a fellow of both the Society for Clinical Trials and American Statistical Association, serves on a number of data and safety monitoring boards, and has published extensively in the areas of adaptive designs and general clinical trial design. He received his Ph.D. in biostatistics from the University of North Carolina at Chapel Hill.

 

David Meltzer, M.D., Ph.D., is the chief of the Section of Hospital Medicine, director of the Center for Health and the Social Sciences and the UChicago Urban Health Lab, and chair of the Committee on Clinical and Translational Science at the University of Chicago, where he also is The Fanny L. Pritzker Professor in the Department of Medicine, the Harris School of Public Policy Studies, and the Department of Economics. His research explores problems in health economics and public policy with a focus on the theoretical foundations of medical cost-effectiveness analysis and the cost and quality of hospital care. With initial funding from CMMI, he has studied the effects of improved continuity in the doctor-patient relationship between the inpatient and outpatient setting on the costs and outcomes of care for frequently hospitalized Medicare patients. Dr. Meltzer helped lead the Clinical and Translational Science Awards (CTSA)-funded Chicago Learning Effectiveness Advancement Research Network (Chicago LEARN) and the Patient-Centered Outcomes Research Institute (PCORI)-funded Chicago Area Patient-Centered Outcomes Research Network (CAPriCORN). He is a member of the National Academy of Medicine. His awards include the Garfield Award from Research America, the Agency for Healthcare Research and Quality (AHRQ) Eisenberg Excellence in Mentoring Award, and the Association of American Medical Colleges (AAMC) Learning Healthcare System Award. He received his M.D. and Ph.D. in economics from the University of Chicago and completed his residency in internal medicine at Brigham and Women’s Hospital.

Naomi K. Fukagawa, M.D., Ph.D., is the director of the U.S. Department of Agriculture (USDA) Beltsville Human Nutrition Research Center in Beltsville, Maryland. She is a board-certified pediatrician and expert in nutritional biochemistry and metabolism and the role of diet in aging and chronic diseases. She is a member of the American Society for Clinical Investigation, associate editor for the American Journal of Clinical Nutrition, and editor-in-chief of Nutrition Reviews. Her present work focuses on environmental stressors (specifically exposure to petrodiesel and biodiesel exhaust) and human health. Nutrition is not often viewed as an environmental factor that influences health, but all are aware of the concerns about obesity and related disorders, air pollution, and the search for alternative fuels that may divert crops to fuel production. Melding nutrition science with agricultural practices will support experiments to determine environmental factors that influence susceptibility to obesity and diabetes mellitus and whether diet can mitigate the adverse effects of environmental stressors while maintaining adequate and sustainable food production. Previously Dr. Fukagawa was a professor of medicine and acting director of the Gerontology Unit at the University of Vermont, vice-chair of the 2010 Dietary Guidelines Advisory Committee, and past president of the American Society for Clinical Nutrition (American Society for Nutrition). She received her M.D. from Northwestern University and her Ph.D. in nutritional biochemistry from the Massachusetts Institute of Technology. Her clinical training included residency at the Children’s Hospital of Philadelphia at the University of Pennsylvania, chief residency at the University of Vermont, and nutrition/gerontology fellowships at the Children’s Hospital and Beth Israel Hospital at Harvard Medical School.