2024 Summer Immersion on Innovative Approaches in Science

Dr. Danilo Tagle is currently director of the Office of Special Initiatives at the National Center for Advancing Translational Sciences (NCATS) of the National Institutes of Health (NIH), where he coordinates efforts toward developing microphysiological systems or organs-on-chips. He also coordinates efforts on 3D bioprinting for drug discovery and development, on automated chemistry, on the use of electronic nose technology for disease diagnosis, and on the clinical utility of secreted RNA in exosomes for biomarker and therapy development. Prior to joining NCATS in 2012, Dan was a program director for neurogenetics at the National Institute of Neurological Disorders and Stroke (NINDS, NIH), where he was involved in developing programs concerning genomics-based approaches for basic and translational research in inherited brain disorders. Prior to joining NINDS in 2001, Dan was an investigator and section head of molecular neurogenetics at the National Human Genome Research Institute (NHGRI, NIH) and has been involved in the highly collaborative effort toward the positional cloning of genes for Huntington’s disease, ataxia-telangiectasia, and Niemann-Pick disease type C. He has served on numerous committees, advisory boards, and editorial boards. Dan obtained his doctorate in molecular biology and genetics from Wayne State University School of Medicine in 1990. He was an NIH National Research Service Award postdoctoral fellow in human genetics at the University of Michigan. Dan has authored many scientific publications and has garnered numerous awards, including the Roscoe O. Brady Award for Innovation and Accomplishment, the Henry J. Heimlich Award for Innovative Medicine, and the HHS Secretary's Award for Distinguished Service: Rapid Acceleration of Diagnostics (RADx) Initiative.

Dr. Nicole Kleinstreuer is the director of the NTP Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM) and the executive director of the congressionally mandated Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM). NICEATM is the U.S. federal resource for alternatives to animal testing and is part of the National Institute of Environmental Health Sciences (NIEHS). Her work is centered on domestic and international efforts to develop novel testing, modeling, and analysis strategies that provide more rapid, mechanistic, and human-relevant predictions of potential environmental chemical hazards. She has a doctorate in biomedical engineering and postdoctoral training in computational toxicology. Dr. Kleinstreuer has adjunct faculty positions in the Yale University School of Public Health and the University of North Carolina at Chapel Hill. She has published more than 140 peer-reviewed publications and won numerous awards, including the 2023 NIEHS Individual Merit Award, the 2022 NIH Director’s Award, and the 2019 Society of Toxicology Achievement Award.

Dr. Ellen Berg is chief scientific officer at Alto Predict, LLC. She was previously vice president of integrated assay science at Insitro and chief scientific officer of translational biology at Eurofins Discovery. Prior to Eurofins, Dr. Berg worked in the biopharmaceutical industry and was co-founder and chief scientific officer of BioSeek, where she led the development of the BioMAP® human primary cell-based assay platform, now commercially available through Eurofins. Dr. Berg holds a doctorate from Northwestern University and completed postdoctoral work at Stanford University. Her research interests include in vitro NAMs, mechanisms of drug action and disease biology, phenotypic drug discovery, and predictive methods for product safety and efficacy testing. Dr. Berg works with industry, academic, and government stakeholders to incorporate human-based alternatives to animals in drug discovery and product development. She has more than 100 publications and patents in diverse areas of disease biology (autoimmune, vascular, respiratory, fibrosis, etc.), phenotypic drug discovery, antibody development, drug mechanisms, and predictive toxicology.

Dr. Angela Hvitved is program director at the Alternatives Research and Development Foundation, where she manages grant programs aimed at developing nonanimal research methods. Previously, she was a contract merit review officer for the Patient-Centered Outcomes Research Institute, where she managed the review of clinical trial proposals. She has also worked as a public health adviser at the U.S. Department of Health and Human Services Office for Human Research Protections and, before that, was a health science policy analyst at the National Institutes of Health. Dr. Hvitved received a Bachelor of Science in biochemistry and biophysics and a Bachelor of Arts in philosophy from Iowa State University, a doctorate in biochemistry and cell biology from Rice University, and a Master of Arts in philosophy from Johns Hopkins University.

Dr. Thomas Hartung is the Doerenkamp-Zbinden Chair for Evidence-Based Toxicology in the department of environmental health and engineering at Johns Hopkins Bloomberg School of Public Health and the Whiting School of Engineering in Baltimore. He also holds a joint appointment for molecular microbiology and immunology at the Bloomberg School. He is adjunct affiliate professor at Georgetown University in Washington, D.C. In addition, he holds a joint appointment as professor for pharmacology and toxicology at University of Konstanz, Germany, and he also is director of Centers for Alternatives to Animal Testing (CAAT, CAAT.JHSPH.edu) of both universities. CAAT hosts the secretariat of the Evidence-Based Toxicology Collaboration (EBTox.org) and manages collaborative programs on good read-across practice, good cell culture practice, green toxicology, developmental neurotoxicity, developmental immunotoxicity, microphysiological systems, and refinement. As principal investigator, he headed the Human Toxome project funded as an NIH Transformative Research Grant and the series of annual Microphysiological Systems World Summits started in 2022 by more than 60 organizations. He is field chief editor of Frontiers in Artificial Intelligence. He is the former head of the European Commission’s Center for the Validation of Alternative Methods, in Ispra, Italy, and has authored more than 670 scientific publications with more than 46,000 citations (h-index 112). His toxicology classes on Coursera had more than 18,000 active learners.

Dr. Catharine E. Krebs is a medical research program manager at the Physicians Committee for Responsible Medicine, a United States-based organization that promotes nonanimal research and medical training. She received doctoral biomedical research training in human genetics with a focus on psychiatric disease genetics and genomics from the University of California Los Angeles. Her work in animal research policy involves advocating for the National Institutes of Health to shift away from its reliance on animals toward more ethical, equitable, and effective human-specific research approaches. She also advocates for policy changes to promote a more diverse and inclusive research workforce. Dr. Krebs has authored numerous U.S. congressional statements and public comments to the NIH and other federal agencies. She leads a collaborative international effort to characterize and address the bias toward animal-based methods within biomedical research. Dr. Krebs has been an invited speaker at national and international meetings to provide expertise on research policy and advancing nonanimal research approaches.

Emily Anderson is the policy advocate for the Physicians Committee for Responsible Medicine, a nationwide organization of physicians and laypersons that promotes preventive medicine, conducts clinical research, and advocates for ethical and effective medical research, product testing, and training.

At the Physicians Committee, Emily manages federal lobbying efforts to promote the development, use, and implementation of human-specific, nonanimal research and testing methods that are more relevant to humans and help reduce and replace animal experiments. Since 2017, Emily has led successful efforts that contributed to increased federal funding for nonanimal methods, and congressional directives to help agencies transition away from animal use and better integrate human-specific approaches.

With the help of her team, Emily develops effective strategies to overcome the many barriers to use of human-specific methods. To garner support for the Physicians Committee’s legislative and policy proposals, Emily builds and maintains relationships with legislators and frequently meets with congressional offices to discuss the scientific and ethical advantages of nonanimal approaches.

Emily organizes and hosts events on Capitol Hill, including congressional briefings and a Lobby Day to demonstrate the importance of prioritizing innovative nonanimal approaches in federal laws and policies. She consistently monitors legislation, hearings, and other activities for opportunities to further push for modernized research and testing policies and effectively engages with congressional staff, agency staff, industry representatives, nongovernmental organizations, and Physicians Committee members.

Emily earned her master’s degree in animals and public policy from Tufts University and her bachelor’s degree in biology from Smith College. She is a member of the American Society for Cellular and Computational Toxicology.

Dr. Lena Smirnova is an assistant professor at the environmental health and engineering department at Bloomberg School of Public Health and Center of Alternatives to Animal Testing, Johns Hopkins University, where she is leading the education program and microphysiological systems program. She has joint appointments at Johns Hopkins School of Engineering and Georgetown University. Her research focuses on the development of new approach methodologies for developmental neurotoxicity testing and understanding gene environmental interactions in autism. She promotes the idea of organoid intelligence as a new field to address cognition with an in vitro brain model—a brain microphysiological system. She is a co-organizer of a series of conferences on microphysiological systems (MPS) and is a president of the International MPS Society.

Dr. Matt Martin received his doctorate from the University of North Carolina at Chapel Hill in 2011 while working as a research biologist at the U.S. Environmental Protection Agency’s National Center for Computational Toxicology since 2005 and taking on ever-increasing responsibilities, including leading ToxCast/Tox21 data analysis efforts; mentoring/advising 10 postbaccalaureate, two master’s, one doctorate, and four postdoctoral fellows; publishing more than 60 peer-reviewed articles; and releasing numerous database and software tools.

In 2017, he joined Pfizer’s Drug Safety Research and Development (DSRD) organization as the computational toxicology lead with a nascent group of two direct reports focused on supporting computational needs of project teams and developing a strategy for computational toxicology. Over the following years, he has grown the group to 13 direct reports expanding DSRD capabilities in process and informatic automation, drug and target predictive toxicology, and an ever-increasing array of computational biology and chemistry solutions. Dr. Martin also spearheaded DSRD’s joining of the WRDM integrative (computational) biology (IB) discipline and serves on the IB leadership team, as well as having created the Computational Safety Science (CSS) community within DSRD aimed at strategically developing and growing DSRD’s computational culture and capacity. Dr. Martin is currently an executive director of the Global Computational Safety Science organization and serves on the DSRD executive team.

Dr. Martin has personal interests in further developing our ability to predict inherent target safety risk, applying molecular and computational approaches to assess safety and efficacy of novel modalities and platforms, and further developing a positive data and computational science culture. Externally, he serves on the SOT Scientific Program Committee, Lhasa Limited Science Advisory Board, and the NTP Board of Scientific Counselors.

Married with three kids, he enjoys spending time with the family in between trying to satisfy his itch for nearly anything active and competitive.

Dr. Anthony Reardon is currently a scientific evaluator at Health Canada within the Existing Substances Risk Assessment Bureau. He received his doctorate in medical sciences from the University of Alberta in Edmonton, Canada, in 2019, where he worked on analytical methods to quantify per- and polyfluoroalkyl substances (or PFAS) in humans to study their effects on neurological development during pregnancy. His current priorities involve providing research data and expertise that further the implementation of new approach methodologies (NAMs) in human health risk assessment strategies. This work includes developing case studies and creating reports that increase confidence in the use of NAMs to provide alternative approaches for regulatory activities. Prior to this, when he was a postdoctoral fellow within Health Canada, his research included implementing NAMs and next generation “omics”-based approaches to assess data-poor chemicals.

Dr. Maria Baltazar is currently a science leader at the Safety and Environmental Assurance Centre of Unilever, responsible for leading research teams developing new approach methodologies (NAMs) applied to next generation risk assessment for systemic toxicity. She joined Unilever in 2016 as a risk assessor in the skin allergy and immunology field, and from 2018 to 2022, she led the Inhalation Research Group, which developed new methods for assessing lung toxicity using 3D tissue models and computational tools. Dr. Baltazar received her Master of Science and doctorate in pharmaceutical sciences from the Faculty of Pharmacy from the University of Porto in Portugal. While in Portugal, she was an invited assistant professor at the Advanced Institute of Health Sciences (Gandra, Portugal), where she lectured on food toxicology analysis in the Bachelor of Science degree in forensic and criminal sciences for two years. After graduating in 2014, she joined the fast consumer goods company Imperial Brands as a risk assessor.

Dr. Baltazar is a frequent invited speaker at international conferences and webinars and recipient of two awards from the Society of Toxicology Risk Assessment Specialty Section. She has been appointed as industry representative in international consortia (e.g., Texas A&M Tissue Chip Validation Consortium) and in trade associations, both Cosmetics Europe and the International Consortium on Cosmetic Safety. Dr. Baltazar’s research passion is to advance the application of nonanimal methods for safety assessment and ultimate regulatory acceptance.

Dr. Tina Morrison is the director of the Office of Regulatory Science and Innovation in the Office of the Chief Scientist at the Food and Drug Administration. She joined the FDA in 2008 through the Medical Device Fellowship Program. For the first seven years, Dr. Morrison was a regulatory reviewer of cardiovascular devices, and she participated in several initiatives as part of the Center for Devices and Radiological Health (CDRH) Innovation Pathway: the early feasibility studies program, streamlining clinical trials, the medical device development tools program, and the Medical Device Innovation Consortium. Alongside the regulatory review work, she also worked to advance the role of computer modeling and simulation in medical device design and product evaluation. She founded and chaired two working groups: the Regulatory Review of Computational Modeling working group for CDRH, and the Modeling and Simulation working group for the FDA.

Dr. Morrison led the development of guidance and standards for enhancing modeling credibility and acceptance. She led the development of a verification and validation standard for the American Society of Mechanical Engineers (ASME), which culminated in 2018 with the first-ever set of evaluating procedures for computational modeling of medical devices, the ASME V&V 40 standard. Because of these efforts, Dr. Morrison was the FDA’s Federal Engineer of the Year in 2019, received ASME’s Dedicated Service Award in 2020, and was inducted into the University of Connecticut’s Academy of Distinguished Engineers.

Dr. Kathrin Herrmann is a veterinary expert in animal welfare science, ethics, and law. She studied veterinary medicine in Berlin, Germany, and Zurich, Switzerland. Dr. Herrmann worked as a clinical veterinarian for a few years before she specialized in animal welfare science, ethics, and law. For almost a decade, she worked at the competent authority in Berlin, where she assessed and inspected animal experiments and laboratory animal husbandries. In addition, she conducted a PhD thesis in biomedical sciences. Since 2017, she has worked at the Center for Alternatives to Animal Testing at Johns Hopkins University, where she directs the Beyond Classical Refinement Program. Her work addresses the reproducibility and translatability crises that science is facing. Taking into consideration insurmountable interspecies differences, solely refining animal studies will not be sufficient to advance human health care. Consequently, Dr. Herrmann’s program is critically appraising current animal use practices in science. To inform the public about animal use in science and its alternatives, Dr. Herrmann initiated and co-edited the open access book Animal Experimentation: Working Towards a Paradigm Change (Brill 2019). It features 51 authors who critically review current animal use in science, present new and innovative nonanimal approaches, and offer a roadmap toward science based on human biology. In November 2020, Dr. Herrmann took an additional position as the animal protection commissioner of Berlin, Germany, a role in which she advises the government of Berlin in various animal welfare and protection issues. 

Dr. Marc Teunis has a doctorate in medical biology and is associate professor of data science in life sciences and chemistry at the University of Applied Sciences in Utrecht, Netherlands, where he has a research team that focuses on the application of data science approaches in toxicology. Dr. Teunis also teaches in bachelor’s and master’s degree data science programs.

Dr. Teunis has a wide range of interests. For the past 15 years, he has been involved in research to new approach methodologies. He conducted research on the development and validation of methods for skin sensitization, mutagenicity, developmental toxicity, and metabolism. Dr. Teunis moved his attention in research from the wet lab to in silico modeling and has become a proficient programmer and machine learning model developer. His current research focuses on the application of artificial intelligence in chemical risk assessment, the development and application of large language models for synthesis of evidence and data extraction, and the implementation of open science and reproducible research principles in the toxicological research field.

For the development of the data science competences of the university, Dr. Teunis is a driving force behind the formation of an organization-wide data science group that is intended to support many research projects in the organization. Furthermore, Dr. Teunis frequently teaches data science workshops and trainings for postdoctoral researchers within the university and in large research collaborations such as ONTOX. In his capacity as data scientist, Dr. Teunis regularly provides statistical advice and develops visualizations and interactive data exploration tools.     

In his spare time, Dr. Teunis likes to cook and is a regular guest of the bouldering and climbing gyms around Utrecht. He always takes his climbing shoes along when visiting another country.

https://orcid.org/0000-0002-3496-6669

https://loop.frontiersin.org/people/111717

Dr. Mark Cronin is professor of predictive toxicology at the School of Pharmacy and Biomolecular Sciences, Liverpool John Moores University, UK. He has more than 30 years’ experience in the application of in silico approaches to predict the toxicity and fate of chemicals, in addition to development of strategies to advance alternatives to whole-animal testing for toxicity. His current research includes the application of chemical grouping and read-across to assess human health and environmental endpoints, particularly the quantification of adverse outcome pathways (qAOPs) to inform safety decisions. This research effort has resulted in four books and more than 300 publications in all areas of the use of quantitative structure-activity relationships, expert systems, read-across, and qAOPs to predict toxicity. He has worked in numerous projects in this area, including more than 15 European Union framework projects, as well as assisting in the uptake of in silico methods for regulatory purposes.

Dr. Warren Casey is an accomplished scientist and strategic thinker with a proven track record of building and leading teams that successfully solve highly complex problems. He holds a doctorate in microbiology and a Bachelor of Science in biochemistry from North Carolina State University and has served as a diplomate of the American Board of Toxicology since 2007. Currently, Dr. Casey is the director of strategic partnerships in the Division of Translational Toxicology (DTT) at the National Institute of Environmental Health Sciences (NIEHS), where he is responsible for identifying strategic opportunities, recruiting key partners, securing funding, and managing collaborative programs that support the mission of DTT and NIEHS.

Dr. Casey has held several key leadership positions over his career, including executive director of the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM), director of the NTP Interagency Center for the Evaluation of Toxicological Methods, and acting chief of predictive toxicology and biomolecular screening branches. As executive director of ICCVAM, he provided strategic and scientific leadership across the U.S. government in modernizing the safety assessment of drugs and chemicals.  He is widely credited for “reinventing ICCVAM,” serving as the architect and driving force behind the “Strategic Roadmap for Establishing New Approaches to Evaluate the Safety of Chemicals and Medical Products in the United States” (Roadmap), an effort that served as the impetus for the Food and Drug Administration’s Predictive Toxicology Roadmap and the Environmental Protection Agency's New Approach Methods Workplan. The framework outlined in the Roadmap has now been adopted by multiple organizations and agencies throughout the world. In his role as acting branch chief, he was responsible for the development, validation, and deployment of computational tools and systems toxicology models to predict human-relevant health effects. Dr. Casey continues to serve as the NIEHS representative and scientific adviser on national and international consortia, including Tox21 and ASPIS (Animal-free Safety assessment of chemicals: Project cluster for Implementation of novel Strategies).

In recognition of his accomplishments, Dr. Casey has received numerous awards, including the NIH Director’s Merit and Special Act awards, the Society of Toxicology’s Enhancement of Animal Welfare Award, a Special Certificate of Appreciation from the EPA Assistant Administrator, and GlaxoSmithKline’s highest award for research (Gold Award), and he was named as a Distinguished Alumnus by both the NCSU department of microbiology and the College of Agriculture and Life Sciences.

In addition to his career achievements, Dr. Casey was a captain in the U.S. Army (top secret security clearance) and participated in Operation Desert Shield/Storm in Saudi Arabia from 1990-1992. He received the National Defense Service Medal and Southwest Asia Service Medal for combat operations in Operation Desert Storm.

Dr. Anna B. Lowit received her doctorate in environmental toxicology from the University of Tennessee in 1998, where she was a graduate fellow in sustainable waste management. Dr. Lowit began her career with the Environmental Protection Agency in 1998. She is currently the senior science adviser in the Office of Pollution Prevention and Toxics. She advises senior managers and leads multidisciplinary teams on a variety of cross-cutting topics related to human health and ecological risk assessment. Some of these topics include new approach methods, physiologically based pharmacokinetic models, mode of action/adverse outcome pathways, and cumulative risk assessment. She served as the one of the co-chairs of the Interagency Coordinating Committee on the Validation of Alternative Methods from 2013 to 2024. She is the U.S. lead for the Organisation for Economic Co-operation and Development Working Party on Hazard Assessment.

Dr. Kambez H. Benam is a distinguished alumnus of Newcastle University, where he graduated with honors in 2007, and of the University of Oxford, where he was awarded a Doctor of Philosophy in 2012. His postdoctoral endeavors at Harvard University's Wyss Institute for Biologically Inspired Engineering, encompassing roles as a senior researcher and technology development fellow until 2017, significantly shaped his career trajectory. Currently, Dr. Benam holds the position of associate professor of medicine and bioengineering at the University of Pittsburgh. He is the founder of the Translational and Multidisciplinary Lung Microengineering Lab (BenamLab.net/). This innovative space unites a diverse array of experts and trainees from engineering, biological sciences, the bio-pharmaceutical sector, and clinical fields. Their collective focus is to develop groundbreaking technologies, including organs-on-chips and biomimetic robotic systems, that emulate complex human organ pathophysiology in vitro. These advancements are pivotal in the discovery of new therapeutics and the identification of personalized biomarkers. Dr. Benam's contributions to science have been recognized with prestigious accolades such as the Science and Innovation Center Rising Star Award, the American Thoracic Society's REAAch Award, and honors from the Society of Toxicology, including the IRSS Young Investigator Award, as well as Baxter and Lush Young Investigator Awards. His research enjoys widespread media attention, with features on platforms like BBC, STAT News, Sky News, and US News and World Report, as well as academic acclaim with publications in top-tier journals like Nature Methods, Cell Systems, iScience and Nature Protocols. As an innovator, Dr. Benam has more than 15 patents pending and issued as co-inventor, with several licensed, showcasing his commitment to advancing medical science and technology. His work not only garners attention but also translates into real-world applications that continue to impact the field of biomedicine and beyond.

Dr. Sophie Zaaijer is scientific consultant, founder, and entrepreneur-in-residence at AdAstral Labs. She works on the intersection of process optimization and innovation implementation. As an entrepreneur-in-residence, she translates cutting-edge technology into high-impact business opportunities. She founded FIND Genomics, which aims to accelerate biomedicine through high-accuracy cell-based science and is backed by the Jacobs Technion-Cornell Institute. Additionally, she is passionate about helping pharmaceutical industry and academia think about methods to support a shift to an inclusive preclinical workflow and mindset. Dr. Zaaijer did her postdoctoral research at the New York Genome Center and Columbia University after completing her doctorate in molecular biology and genetics at Cancer Research UK, UCL in London and her research studies at the National Institutes of Health and Harvard Medical School.

Dr. James J. Hickman is a founder and chief scientist at Hesperos, Inc., a biotechnology contract research organization leveraging its patented human-on-a-chip multiorgan platform to accelerate drug discovery by providing safety and efficacy testing for novel therapeutics. Hesperos has been constructing multiorgan human-on-a-chip or body-on-a-chip systems for toxicology and efficacy with up to six organs and has demonstrated long-term (more than 28 days) evaluation of drugs and compounds, which have shown similar response to results seen from clinical data or reports in the literature. Application of these systems are being used for amyotrophic lateral sclerosis; Alzheimer’s disease; rare diseases; diabetes; and cardiac, immune, and skeletal muscle mechanistic toxicity. He is also the founding director of the NanoScience Technology Center, a professor of nanoscience technology, and professor of electrical engineering at the University of Central Florida. Previously, he was the Hunter Endowed Chair in the bioengineering department at Clemson University. Dr. Hickman has a doctorate from Massachusetts Institute of Technology in chemistry. For the past 30 years, he has been studying the interaction of biological species with modified surfaces, first in industry and later in academia. He has worked at the National Science Foundation and the Defense Advanced Research Projects Agency in the area of biological computation. He has 164 publications and 20 book chapters, in addition to 31 issued patents out of 49 total patent applications. He is a fellow of the American Institute of Medical and Biomedical Engineers (2004), the American Vacuum Society (2007) International Academy of Nanobiotechnology (2019), and the National Academy of Inventors (2020).

Dr. Tom Luechtefeld is the founder and CEO of Insilica.co, a bioinformatics company focused on accelerating the adoption of informatics for public health through enhancing human learning, collaboration, and shared understanding through technology. He has been the CEO of Insilica since January 2017, where he has helped develop sysrev.com, an artificial intelligence-guided document review platform; biobricks.ai, a data registry for public health; and toxindex.com, a set of computational tools for toxicology. Tom received his doctorate in environmental health engineering at Johns Hopkins, where he did thesis work on computational models for toxicology. Besides Insilica, Tom also founded and serves as the lead scientist at ToxTrack, a company established in 2016. His career demonstrates a blend of executive leadership, scientific expertise, and a clear vision toward leveraging AI for practical and meaningful applications.

Dr. Joannella Morales is a program director in the Division of Genomic Medicine at the National Human Genome Research Institute. She serves as the project lead for the Multi-Omics for Health and Disease Consortium, a recently formed effort that aims to advance the application of multi-omic approaches to study human and disease. She is also a project scientist for the Clinical Genome Resource, a consortium that aims to define the clinical relevance of genes and variants for use in precision medicine and research. Dr. Morales also has a portfolio that includes investigator-initiated grants in her area of interests, including the role of human genetic variation in health and disease and in leveraging genomic findings to improve medical care.

Dr. Zoè Johnson is a process scientist at Pfizer Global Supply (PGS), where he plays a role in the startup of the Gene Therapy Manufacturing Sciences and Technology laboratories. He currently focuses on process transfers, continuous improvements, and analytical operations between research and development. Prior to joining PGS, Dr. Johnson was a scientific trainee at the U.S. Food and Drug Administration, Center for Drug Evaluation and Research’s Office of New Drugs, where he assisted in assessing the safety profile of pharmaceutical products and advocated for the use of new approach methodologies in nonclinical research studies. He earned his doctorate and Master of Science in toxicology at the University of Maryland Eastern Shore, where his research focused on exploring neuroprotective strategies for neurodegeneration. He serves as an ambassador to the U.S. Department of Education’s White House Initiative on Historically Black Colleges and Universities, where he leverages community-based organization relationships to promote the value of education networking with federal agencies and created a STEM student engagement and academic performance improvement program. Dr. Johnson is a recipient of numerous awards and recognition in academic scholarship, scientific research, leadership, and civic engagement. He is a recipient of the White House Presidential Award for Excellence in Innovation and Competitiveness by the White House Initiative on HBCUs, and the System of Maryland’s National Science Foundation Research Scholar Award.

Ms. Sullivan joined the Institute for In Vitro Sciences team in 2023 to lead its education and outreach programs designed to advance the IIVS mission. These programs include organizing workshops and trainings to advance acceptance and use of new approach methodologies (NAMs), engaging with toxicologists and stakeholders to develop educational materials and resources, and acting as an information resource to industry, government, and the animal protection community.

Prior to joining IIVS, Ms. Sullivan served as vice president for research policy at the Physicians Committee for Responsible Medicine, where she led a team charged with developing, promoting, and implementing NAMs for the testing of drugs, chemicals, and other products. She has 20 years’ experience advancing NAMs through scientific scholarship, validation, policy advocacy, and outreach. Ms. Sullivan has served on a number of Organisation for Economic Co-operation and Development committees related to specific animal testing and NAM issues and has provided advice and training to state and federal agencies, including as a past member of the Pesticide Program Dialog Committee and ad hoc FIFRA Science Advisory Panel and Board of Scientific Counselors reviews. She is currently a member of the executive boards of the Society for the Advancement of Adverse Outcome Pathways, the Society of Toxicology In Vitro and Alternative Methods Specialty Section, and the American Society for Cellular and Computational Toxicology, of which she is a founding member, and the editorial board of Computational Toxicology and Frontiers in In Vitro Toxicology.

Dr. Madhu Lal-Nag earned her Doctor of Philosophy in molecular and cellular oncology from the George Washington University in Washington, D.C., and her master’s in bioscience business from the Keck Graduate Institute of Applied Biosciences in Claremont, Calif.

Her main passion lies in being able to bridge the gap between the academic and the translational aspects of cutting-edge science in oncology, metabolic diseases, and investigative toxicology and in using the results of current therapeutic regimens to creatively translate cutting-edge research to immediately serve patient need. Her research interests include the development of predictive alternative models for safety and efficacy in drug development and evaluation. This is evidenced by her work at the NIH National Center for Advancing Translational Sciences as the director of the Trans NIH RNAi Facility, as well as at the U.S. Food and Drug Administration as program director. She currently serves as the chief scientific officer of InSphero AG, a company that is driven to reducing the preclinical disparities in drug discovery.

Dr. Eunan Hendron received his doctorate in biochemistry from Temple University and has spent the past five years driven by the mission of advancing human health and well-being through cutting-edge technology and research.

Microphysiological systems (MPS), commonly known as organ-chips, are setting a new standard for how we study biology and develop drugs, therapies, and cures for those who need them most. Emulate understands that animal studies and reductionist models are limited because they are not based on integrated human biology. By leveraging 21st-century technologies, such as MPS, these limitations can be overcome with living human in vitro models. Emulate organ-on-chip solutions unlock human-relevant insights above that of traditional tissue/disease models to reduce translational failure and improve human disease and therapeutic research with unparalleled in vitro complexity.

Within Emulate, Dr. Hendron leads the North American sales team to help drive broad adoption of our toolkit of human organ models, MPS instrumentation, and laboratory services.

Dr. Eryn Slankster-Schmierer is a regulatory testing specialist at the Physicians Committee for Responsible Medicine, where she promotes more effective, human-relevant toxicological assessment by replacing existing animal use with nonanimal methods.

To achieve this, Dr. Slankster-Schmierer coordinates the Physicians Committee’s NAM Use for Regulatory Application (NURA) program. NURA provides scientists and regulators from industry, government, and academia with free training on new approach methodologies (NAMs) to help facilitate the shift away from current animal-based approaches.

Dr. Slankster-Schmierer also coordinates the Physicians Committee's efforts as the secretariat of the International Council on Animal Protection in OECD Programmes (ICAPO), a nongovernmental coalition of international organizations with invited expert status at the Organisation for Economic Co-operation and Development (OECD). OECD chemical testing guidelines and recommendations seek harmonization of testing requirements among the 38 OECD member countries. As an ICAPO representative, Dr. Slankster-Schmierer works with OECD and other regulatory organizations to replace current animal-based chemical testing requirements with more effective in vitro and in silico models.

Prior to the Physicians Committee, Dr. Slankster-Schmierer attended Oakland University in Rochester, Mich. She obtained her Bachelor and Master of Science in biology with a focus on genetics where she developed genetic markers in a plant, Brassica rapa, to demonstrate genetic linkage and paternity testing in teaching laboratories. She continued her education at Oakland University, where her doctoral research focused on modeling the immune response resulting from atherosclerosis and limb ischemia, and the development of an anti-inflammatory, autologous, multicellular therapy to prevent the disease progression. She then performed postdoctoral training at the University of Nevada, Reno, where her work delved into the neurological mechanism of how internal state (gut microbiota, diet) modulates the olfactory response through GABA and insulin signaling, with a focus on behavior tracking and gene expression analysis.

Elizabeth Baker, Esq., is the director of research policy for the Physicians Committee for Responsible Medicine. She leads the organization’s impactful team of scientists and policy professionals that is dedicated to integrating human-specific approaches and strategies that improve medical research, product testing, and advanced education, while reducing and replacing animal use.

Ms. Baker develops strategies, builds relationships, and leads collaborations with scientists, lawyers, policymakers, and other professionals from a variety of sectors. As a licensed attorney, many of Ms. Baker’s efforts focus on supporting scientific innovation by changing the policies and practices that act as barriers to the use of nonanimal approaches.

Since joining the Physicians Committee in 2015, Ms. Baker has worked alongside drug development stakeholders—including federal agencies, pharmaceutical companies, academics, technology companies, and patient, research, and health organizations—to improve the human relevance of nonclinical drug testing to expedite the availability of safer, more effective, more affordable medicines that are developed with less animal testing. Ms. Baker has identified and led efforts that have resulted in funding, directives, and programs to integrate nonanimal approaches. Her diplomatic approach has secured a seat at many important tables.

In 2018, Ms. Baker lobbied with a small but effective team in California to pass the Cruelty-Free Cosmetic Act, marking the first state law to restrict the sale of cosmetics if the final cosmetic product or its ingredients were tested on animals. She continues her work toward a global end to cosmetic animal testing.

Ms. Baker frequently presents at domestic and international scientific and legal conferences. She is frequently interviewed by a variety of media and has authored numerous manuscripts, regulatory comments, science blogs, and op-eds, including publication in Drug Discovery Today, ALTEX, Regulatory Toxicology and Pharmacology, ATLA, The Hill, STAT, the Food and Drug Law Institute Policy Forum, the North Carolina Central University School of Law Biotechnology and Pharmaceutical Law Review, and the Physicians Committee’s Good Science Digest, regarding Food and Drug Administration policy and innovative human-based science for drug development.

Dr. Morgan Chandler is a scientist at MIMETAS, a company developing human organ-on-a-chip tissue models to drive novel drug development within a robust, screenable platform. She is part of a collaborative team currently working to develop a kidney-on-a-chip model for the discovery of chronic kidney disease therapies. Prior to joining MIMETAS, Dr. Chandler completed an Oak Ridge Institute for Science and Education postdoctoral fellowship at the Center for Biologics Evaluation and Research, U.S. Food and Drug Administration. She holds a Bachelor of Science with honors in biological sciences and doctorate in nanoscale science from the University of North Carolina at Charlotte, where her research focused on the design, delivery, and immunostimulatory properties of therapeutic nucleic acids.

Brad Olinger is a graduate student at the National Institute on Aging, pursuing a doctorate in cell, molecular, and developmental biology, and biophysics through Johns Hopkins University and the National Institutes of Health. He is co-chair of the Graduate Student Council that serves the graduate student community of approximately 500 students from many universities hosted at the NIH. He received a Master of Health Science in biochemistry and molecular biology from the Johns Hopkins School of Public Health, where he also completed their humane sciences program at the JHSPH Center for Alternatives to Animal Testing that emphasized the translational potential of human-derived models of research. His master’s thesis focused on stem cell regulation, aging, and therapeutic potential and reviewed mechanisms underlying mammalian aging. Prior to graduate school, he was a postbaccalaureate research fellow at the NIH/NIDCR, where he used confocal microscopy to investigate the role of pluripotency factors—stemness genes—in regulating stem cell potential in human-derived organoid models of embryogenesis. For his thesis project, Brad is using a proteomics approach to investigate cellular senescence and protein turnover in human cohorts, which in recent years has emerged as a novel hallmark of aging.

Dr. Melanie Ort is a biomedical researcher at Freie Universität and Charité Universitätsmedizin Berlin. She had the chance to work internationally at the University of Gothenburg, Sweden. She was a visiting researcher at Whitehead Institute of biomedical research at the Massachusetts Institute of Technology and at Harvard Medical School in Boston. She combines patient-centered studies with animal-free research to decipher the role of adaptive immunity in musculoskeletal regeneration. She develops and applies advanced human 2D and 3D in vitro methods, for which the animal welfare officer of the State of Berlin awarded her the young scientist prize. As part of her research, she works very closely with her colleagues in orthopedic and trauma surgery and actively promotes the use of patient tissues and cells in research to improve the translation of research results into clinical applications. She is also actively involved in teaching nonanimal methods and bioethics in regard to animal experiments to younger doctoral students.