Fellow, American Gynecological and Obstetrical Society; fellowship of the American College of Physicians; fellowship of the Royal College of Physicians of London; and fellowship of the Royal College of Physicians of Edinburgh. He was the 2005 recipient of the Rawls-Palmer Award and in 2008 received the honorary degree of Doctor of Laws, honoris causa, from the University of Dundee.

Dr. Wood is a past member of the Food and Drug Administration’s Cardio-Renal Advisory Committee and the Non-Prescription Drug Advisory Committee, which he also chaired. He is currently an advisor to the Tufts University spin-off Immediate Therapeutics. Dr. Wood has served on a number of editorial boards and his research has resulted in more than 300 articles, reviews, and editorials.

Mark C. Bicket, M.D., Ph.D., FASA, is an assistant professor and director pain and opioid research in the Department of Anesthesiology and the Institute for Healthcare Policy and Innovation at the University of Michigan Medical School. He is also the co-director of the Opioid Prescribing Engagement Network, whose mission is to change the trajectory of the opioid crisis. Dr. Bicket and his colleagues have published around 100 peer-reviewed articles on prescription opioid use, non-opioid treatments for acute and chronic pain, the quality and safety of pain treatment in diverse health care settings, and clinical trials and health services research. He previously served on the National Academies of Sciences, Engineering, and Medicine Committee on Evidence-Based Clinical Practice Guidelines for Prescribing Opioids for Acute Pain. Dr. Bicket has provided scientific guidance on health care, opioid, and pain policy to government departments and agencies at the federal, regional, and state levels, including the White House Office of Science and Technology Policy and the Centers for Medicare & Medicaid Services. He previously directed the Fellowship Program and Quality and Safety for Pain Medicine at Johns Hopkins University (JHU), where he trained and mentored fellows, residents, and medical students while treating patients in East Baltimore. He received his M.D. and Ph.D. from JHU. He completed his anesthesiology residency at Johns Hopkins Hospital, where he served as chief resident, and his pain medicine fellowship training at Massachusetts General Hospital.

Irene Z. Chan, Pharm.D., is the deputy director in the Office of Medication Error Prevention and Risk Management within the Center for Drug Evaluation and Research (CDER) at the Food and Drug Administration (FDA). Previously, Captain (CAPT) Chan served as the director in the Division of Medication Error Prevention and Analysis I in CDER. CAPT Chan has expertise in regulatory science, human factors, risk management, and pharmacovigilance. CAPT Chan is responsible for managing,

planning, and providing guidance for the premarket and postmarket operations, programs, functions, and activities of four Divisions in FDA that focus on minimizing use errors related to the naming, labeling, packaging, or design of drug products, and developing effective and efficient risk evaluation and mitigation strategies for certain drug products that ensure the benefits outweigh risks. She is also CDER’s representative on the Association for the Advancement of Medical Instrumentation Human Factors Committee. CAPT Chan received B.S. in pharmacy and Doctor of Pharmacy degrees from Rutgers University Ernest Mario School of Pharmacy.

Ruchi M. Fitzgerald, M.D., FAAFP, is assistant professor in the Departments of Family Medicine and Psychiatry/Behavioral Sciences at Rush University. She is also the associate program director of the Rush University Addiction Medicine Fellowship. She is the service chief of Inpatient Addiction Medicine at PCC Community Wellness Center, a Federally Qualified Health Center system that serves the West Side of Chicago. Dr. Fitzgerald is a National Academy of Medicine James C. Puffer/American Board of Family Medicine fellow.

Dr. Fitzgerald’s work has focused on promoting cross-sector collaboration to improve care for persons affected by substance use disorders, with an emphasis in the perinatal/child health arena. Her scholarly work has focused on addressing stigma, building capacity in primary care for treating opioid use disorder in special populations, and implementing evidence-based substance use disorder curricula in the next generation of clinicians.

Dr. Fitzgerald received her M.D. from the University of Michigan Medical School and completed her family medicine training with the Montana Family Medicine Residency and her Addiction Medicine Fellowship with Rush University.

Lewis Grossman, Ph.D., J.D., is the Ann Loeb Bronfman Professor of Law at the American University (AU) Washington College of Law, where he has taught since 1997 and where he served as associate dean for scholarship from 2008 to 2011. He teaches and writes in the areas of food and drug law, health law, American legal history, and civil procedure. He has also been a visiting professor of law at Cornell Law School and a Law and Public Affairs Fellow at Princeton University. Prior to joining the AU faculty, he was an associate at Covington & Burling LLP in Washington, DC. Before that, he clerked for Chief Judge Abner Mikva of the U.S. Court of Appeals for the DC Circuit. Professor Grossman’s scholarship has appeared in the Cornell Law Review; Law and History Review; Yale Journal of Health Policy, Law, & Ethics; and Administrative Law Review, among others.

He has made recent contributions to volumes published by Oxford University Press and Columbia University Press. He is the co-author of Food and Drug Law: Cases and Materials (with Peter Barton Hutt and Richard A. Merrill) and of a widely used supplement to the first year civil procedure course titled A Documentary Companion to A Civil Action (with Robert G. Vaughn). In 2021, Oxford University Press will publish Professor Grossman’s book titled Choose Your Medicine: Freedom of Therapeutic Choice in America. He has served as a member or legal consultant on three previous committees of the Health and Medicine Division (formerly the Institute of Medicine) of the National Academies of Sciences, Engineering, and Medicine. Professor Grossman earned his Ph.D. in history from Yale University, where he was awarded the George Washington Egleston Prize for Best Dissertation in the Field of American History. He received a J.D. magna cum laude from Harvard Law School and a B.A. summa cum laude from Yale University.

Stephen W. Hoag, Ph.D., is professor at the University of Maryland, Baltimore School of Pharmacy. He received a B.S. in biochemistry from the University of Wisconsin–Madison and a Ph.D. in pharmaceutical science from the University of Minnesota, Twin Cities. His primary research interests are in oral delivery systems, controlled release polymers, excipient functionality, stability testing, excipient functionality testing, abuse-deterrent formulations, pediatric formulations, and the use of Raman and near-infrared spectroscopy in process analytical technology applications. Dr. Hoag is the director of the School of Pharmacy Good Manufacturing Practices Facility, a member of the National Institute for Pharmaceutical Technology and Education Steering Committee for the Handbook of Pharmaceutical Excipients, a member of the editorial board of the journal called Pharmaceutical Development and Technology, and an American Association of Pharmaceutical Scientists Fellow.

Robert Morones, M.P.H., is the area injury prevention specialist for the Phoenix Area Indian Health Service (IHS). He is responsible for managing the Phoenix Area Injury Prevention Program, assisting more than 40 Arizona, California, Nevada, and Utah tribes and IHS professional staff in the development of community-based injury prevention programs and initiatives. Morones’s past positions include being assigned as a service unit environmental health officer at the Fort Yuma Service Unit in Winterhaven, California, and as an environmental health specialist at the Centers for Disease Control and Prevention in Atlanta, GA. His educational background includes a B.S. in environmental health sciences from Wright State University and an M.P.H. from the University of Massachusetts at Amherst.

Peter Barton Hutt, the late Richard A. Merrill, Lewis A. Grossman, Nathan Cortez, and Erika Lietzan). She currently serves on the Food and Drug Law Institute’s Board of Directors and as co-chair of the International Society of Cell & Gene Therapy’s Committee on the Ethics of Cell and Gene Therapy, also chairing its subcommittee on expanded access. Previously she served on the National Academies of Sciences, Engineering, and Medicine’s (the National Academies’) Committee on Reviewing the Public Health Emergency Medical Countermeasures Enterprise and as a consultant to the National Academies’ Committee on Pain Management and Regulatory Strategies to Address Prescription Opioid Abuse. Before entering academics, Zettler served as an associate chief counsel in the Office of the Chief Counsel at FDA. She received her undergraduate and law degrees from Stanford University, both with distinction.

SPEAKER AND PANELIST BIOSKETCHES

Anish K. Agarwal, M.D., M.P.H., M.S., is assistant professor and chief wellness officer of emergency medicine at the University of Pennsylvania. His research interests fall at the intersection of health care delivery, innovation, and digital health. Dr. Agarwal seeks to use advancements in mobile health to help create and build learning health systems. His work specifically has been applied to the opioid epidemic, health care workforce well-being, and remote patient engagement.

Dr. Agarwal’s work has been published in the New England Journal of Medicine, Journal of the American Medical Association, Annals of Emergency Medicine, Journal of General Internal Medicine, Circulation, Resuscitation, and Critical Care Medicine. His work has been featured throughout multiple media outlets. His work has been funded by the Food and Drug Administration, Agency for Healthcare Research and Quality, Patient-Centered Outcomes Research Institute, National Institutes of Health, and foundation grants. Dr. Agarwal completed his medical and public health training at the Tufts University School of Medicine and Public Health, followed by an emergency medicine residency at the University of Pennsylvania.

Hanz Atia, M.P.H., is an associate of policy and programs at the Product Stewardship Institute (PSI), a policy advocate and consulting non-profit that pioneered product stewardship in the United States. Atia completed an M.P.H. with a concentration in epidemiology and biostatistics from Tufts University, where they discovered how product stewardship blended their passion for public health and the environment. They joined PSI in 2022 to work on several product categories and now manage programs to expand take-back infrastructure for medical sharps and pharmaceuticals in Oklahoma and Missouri.

He is co-lead of the USGS Environmental Health Program, Drinking-Water and Wastewater Infrastructure Integrated Science Team. His research focuses on human exposures to and potential effects of inorganic, organic, and microbial contaminant mixtures in drinking water at the point of use and on exposures and adverse ecological health effects of stormwater and wastewater contaminant mixtures, including pharmaceuticals, on aquatic ecosystems. Dr. Bradley completed his master’s in applied biology at the Georgia Institute of Technology and his doctorate in physiological ecology at the University of South Carolina.

Kaitlyn Brown, Pharm.D., DABAT, is the clinical managing director for America’s Poison Centers. In this role, she promotes the use of poison center data by public health, industry, and non-government agencies to reduce poisoning. She serves on national committees that provide support for surveilling and responding to emerging hazards. As an adjunct assistant professor for the University of Utah and through her previous experience at the Utah Poison Control Center, she has contributed to clinical toxicology research and education. Dr. Brown holds a Doctor of Pharmacy degree from Wilkes University and completed a fellowship in clinical and applied toxicology at the Utah Poison Control Center. She is a Diplomate of the American Board of Applied Toxicology.

Chad M. Brummett, M.D., is professor at the University of Michigan Medical School where he serves as co-director of the Opioid Research Institute and as the senior associate chair for research. He has written or contributed to more than 270 publications, including articles in top journals such as Journal of the American Medical Association (JAMA), JAMA Surgery, Anesthesiology, and Annals of Surgery. He is also the co-director of the Opioid Prescribing Engagement Network (OPEN) at the University of Michigan, which aims to apply a preventative approach to the U.S. opioid epidemic through appropriate prescribing after surgery, dentistry, and emergency medicine, including opioid disposal. In addition, his research interests include predictors of acute and chronic postsurgical pain and failure to derive benefit from interventions and surgeries primarily to treat pain. He is the co-principal investigator of multiple National Institutes of Health grants studying these concepts. Dr. Brummett also receives funding from the Michigan Department of Health and Human Services, Substance Abuse and Mental Health Services Administration, Centers for Disease Control and Prevention, and multiple foundations. He completed his medical training at the Indiana University School of Medicine, a residency in anesthesiology at the University of Michigan Health System, and a fellowship in pain medicine at the Johns Hopkins Hospital.

drug-related issues. He completed his legal training at the University of California, Berkley School of Law.

Kathleen Egan, Ph.D., M.S., is assistant professor in the Department of Health Education and Promotion at East Carolina University. She completed a postdoctoral fellowship at the University of Florida Substance Abuse Training Center. She earned her Ph.D. in community health education from University of North Carolina at Greensboro and her M.S. in clinical and translational population science from Wake Forest University School of Medicine. Her overarching research agenda aims to reduce harms associated with substance use through the implementation of interventions and policies in medical, community, and academic settings. She has been funded by the National Institute on Drug Abuse (NIDA), Centers for Disease Control and Prevention (CDC), and Substance Abuse and Mental Health Services Administration to lead projects pertaining to secure storage and disposal of unused opioid medications.

Dr. Egan’s research is focused on preventing harms associated with opioid, cannabis, and polysubstance use among adolescents and young adults. Her research involves the development and assessment of substance use prevention strategies that are implemented in community, medical, and academic settings. Dr. Egan is currently the principal investigator on a National Institutes of Health–funded R34 (NIDA) research study that aims to develop and pilot test a text message intervention to facilitate secure storage and disposal of unused prescription opioids (1R34DA051710-01). Her work is also supported by CDC and the North Carolina Division of Health and Human Services. Dr. Egan teaches program evaluation at both the undergraduate and graduate levels.

Kristin Fitzgerald, M.S., has been with the Environmental Protection Agency since 2001, working primarily on sector-based rule makings for hazardous waste generators. Fitzgerald started working with the Resource Conservation and Recovery Act (RCRA) more than 30 years ago, answering questions on the RCRA/Superfund Hotline. She holds a B.A. in government from St. Lawrence University and an M.S. in environmental science and policy from George Mason University.

Christopher Gaw, M.D., M.P.H., M.B.E., is a pediatric emergency medicine fellow and an associate fellow at the Center for Injury Research and Prevention at Children’s Hospital of Philadelphia. Dr. Gaw’s research is primarily on the epidemiology and prevention of pediatric injury and poisoning. In the past decade, he has worked with several research groups to study a wide array of topics, including head traumas, unintentional poisonings, and consumer product-related injuries. Dr. Gaw has signifi-

cant experience leveraging large administrative databases to better characterize injury and poisoning hazards to children, with the goal of informing education, advocacy, and policy initiatives. His research also has used survey science and qualitative methods to understand provider views toward injury control. In addition to his injury prevention research, Dr. Gaw has academic interests in bioethics and medical education and has authored works on medical trainee wellness, shared decision making, and end-of-life care. He completed his doctoral training at the University of Pennsylvania Perelman School of Medicine, with a residency and fellowship at the Children’s Hospital of Philadelphia.

Robert Hoffman, M.D., completed a 3-year internship and residency in internal medicine followed by a fellowship in medical toxicology, all at New York University (NYU) School of Medicine. He achieved and maintains Board Certification in Internal Medicine, Medical Toxicology, and Emergency Medicine. In 1989 Dr. Hoffman became director of the Fellowship in Medical Toxicology at the New York City Poison Center, and in 1994 he became director of the New York City Poison Center. He was director of the Division of Medical Toxicology at NYU School of Medicine from 2014 through 2020. Dr. Hoffman has authored more than 500 publications in peer-reviewed journals covering various aspects of toxicology. He has been an editor of Goldfrank’s Toxicologic Emergencies for the past seven editions. Dr. Hoffman has held offices in all three American Toxicology Societies and is a recipient of the American College of Medical Toxicology Ellenhorn Award, the European Association of Poison Centres and Clinical Toxicologists Louis Roche Award, and the American Academy of Clinical Toxicology Career Achievement award. Dr. Hoffman’s current interests focus on the development and propagation of evidence-based recommendations in toxicology. He is a co-chair of the Extracorporeal Treatments in Poisoning (EXTRIP) workgroup and the co-chair of the International Clinical Toxicology Recommendations Collaborative. In December 2022 Dr. Hoffman became the co-editor-in-chief of Clinical Toxicology. He completed his medical training at New York University.

Jeff Horwitz, J.D., M.S., joined SAFE Project in 2018 as the chief executive officer. He has 30 years of administrative, management, and leadership experience. SAFE Project is a national 501(c)(3) non-profit committed to overcoming the addiction epidemic in the United States. Founded by Admiral James and Mary Winnefeld in 2017 following the loss of their 19-year-old son Jonathan to an opioid overdose, SAFE Project provides transformative programming, training, and technical assistance based on a collaborative, multipronged, and nonpartisan approach within each of

its key initiatives—SAFE Campuses, SAFE Communities, SAFE Workplaces, and SAFE Veterans.

Prior to arriving at SAFE Project, Horwitz served for 28 years in the U.S. Navy. He retired as a captain in 2014. In addition to his final assignment as the general counsel of the White House Military Office, Horwitz served in multiple assignments, including command judge advocate on board the USS Harry S. Truman (CVN 75); staff judge advocate, COMNAVAIRFOR; counsel for the commander, U.S. Naval Forces in Northern Europe and the United Kingdom; and director of the Navy’s Legislative Program for nearly 9 years. In his free time, Horwitz serves on the board of St. Joseph’s University’s Center for Addiction and Recovery Education (CARE) and Heartshine, a resilience and trauma support community program in Harrisburg, PA. Horwitz earned a J.D. from the University of Pittsburgh, an M.S. in homeland security from American Military University, and a B.S. in international affairs from Seton Hall University.

Lyen Huang, M.D., M.P.H., FACS, FASCRS, is assistant professor of surgery at the Spencer Fox Eccles School of Medicine and adjunct assistant professor of family and preventative medicine and population health sciences at the University of Utah. He is a board-certified general and colorectal surgeon and provides care to patients with colorectal cancer, inflammatory bowel disease, and other gastrointestinal tract diseases. His research spans the breadth of perioperative opioid stewardship, including patient education, screening, patient-centered prescribing, prescribing guided by machine learning, transitional pain services, naloxone co-prescribing, and opioid disposal. He was a University of Utah Clinical and Translational Science Institute K12 Mentored Career Development Scholar from 2020 to 2022. Dr. Huang completed his medical training at Stanford University.

Mary Kellington joined the Washington State Department of Health in 2000 and began managing Washington’s Safe Medication Return system in 2021. The impact of the environment on populations and of populations on the environment has intrigued Kellington throughout her public health career and informed her work developing and implementing public health programs. Her earlier work focused on maternal and infant health, adolescent health, and sexual and reproductive health. She enjoys working with a variety of stakeholders and facilitating collaboration among groups with conflicting priorities. She strives to make healthy choices easy choices.

Tamar Krishnamurti, Ph.D., is assistant professor of medicine at the University of Pittsburgh. Dr. Krishnamurti works on issues at the intersection

of health, risk, technology, and communication. Dr. Krishnamurti was the 2020 recipient of the Kuno Award for Applied Science to develop mobile health strategies to address maternal morbidity and mortality risks. She leads the FemTech Collaborative at the University of Pittsburgh and is a co-founder of Naima Health, whose flagship product, MyHealthyPregnancy, offers early risk assessment and intervention for adverse pregnancy outcomes. Dr. Krishnamurti earned her Ph.D. in behavioral decision research at Carnegie Mellon University.

Eleanor T. Lewis, Ph.D., is deputy director of the Program Evaluation and Resource Center (PERC) in the Office of Mental Health and Suicide Prevention in the Veterans Administration (VA). PERC’s mission is to use program evaluation and advanced informatics to promote more veteran-centered, effective, and cost-efficient care for veterans with mental health conditions and substance use disorders. In addition to supporting PERC’s operational mission broadly, Dr. Lewis has participated in multiple research projects on opioid use and misuse and helped implement opioid safety and risk mitigation initiatives in the Department of Veterans Affairs for more than a decade. She helps lead implementation of the VA Stratification Tool for Opioid Risk Mitigation (STORM), which shows promise for targeting prevention interventions to reduce mortality in patients who are prescribed opioids. STORM was profiled on the Agency for Healthcare Research and Quality Patient Safety Network. Dr. Lewis earned her Ph.D. in organization science and sociology at Carnegie Mellon University.

Lynn Mehler, J.D., is a partner at Hogan Lovells LLP. As practice area lead for pharmaceuticals and biotechnology, Mehler advises clients on a range of Food and Drug Administration (FDA) and Drug Enforcement Administration (DEA) regulatory matters. She has worked extensively on the approval processes for new drugs and biologics, on safety issues that include risk evaluation and mitigation strategy (REMS), and on unique regulatory issues raised during the development and marketing of controlled substances. Drawing on her 12 years with the FDA’s Office of the Chief Counsel, Mehler has a deep understanding of FDA. Her experience as the primary attorney handling all FDA issues related to controlled substances provides her with unique insights into both the FDA’s and DEA’s regulatory processes for controlled substances. She advised the agency on drug safety matters, including at approval and those leading to labeling changes, REMS, and even product withdrawal, and she applies that understanding to help clients create effective solutions for FDA regulatory matters.

India. She is the co-director of the Baltimore HIV Collaboratory and a part of the Executive Leadership Committee of the Johns Hopkins Center for AIDS Research. She co-leads the Addiction and Overdose workgroup of the Bloomberg American Health Initiative. She is the principal investigator of a study that examines the role of the police on the sexually transmitted infection/HIV risk environment of street-based sex workers and includes the first cohort of sex workers in the United States. She is also evaluating an innovative prebooking diversion program for low-level drug offenders. She has a new study that focuses on the effects of a structural-level intervention with sex workers in Baltimore and which will create a full service drop-in center for them in that city. She serves on several Baltimore City and state advisory commissions on syringe exchange and overdose prevention initiatives. She is the board secretary of the National Harm Reduction Coalition. Dr. Sherman earned her M.P.H. from the University of North Carolina at Chapel Hill and her Ph.D. from the Johns Hopkins Bloomberg School of Public Health.

Margaret Shield, Ph.D., is a public health and environmental health consultant based in Seattle. She combines a background as a health sciences researcher with more than 18 years of experience working on legislative and regulatory initiatives at the local, state, and national levels. Since 2008, Dr. Shield has been working on solutions for safe, convenient, and environmentally sound disposal of unwanted and expired medications from residents to reduce misuse, diversion, poisonings, and pollution. She has operational and policy experience with residential drug take-back programs, pharmaceutical waste regulation, and drug stewardship policies at the national, state, and local levels. She began this work as a policy staff member for King County, Washington’s Local Hazardous Waste Management Program as it worked with partners to develop a secure and convenient pharmacy-based medicine return program. These model protocols informed development of the Drug Enforcement Administration’s 2014 rule on controlled substances disposal. She led policy staff for the King County Board of Health’s process to pass a 2013 county-wide secure medicine return regulation and subsequently consulted for local health agencies in four other counties that also enacted local pharmaceutical stewardship ordinances. She was a leader in passing the WA Secure Drug Take-Back Act in 2018, the first law in the nation requiring the pharmaceutical industry to provide this critical service. She consulted for the Oregon Department of Environmental Quality on its similar 2019 safe drug disposal law. She researched two reports for the San Francisco Department of the Environment, examining medicine disposal products and whether available information supports their performance claims. Dr. Shield earned her Ph.D. at the University of Washington.