Medicine and Health Sciences Commons^™

An Independent Living Skills Training Guide For Direct Support Professionals Working With People With Intellectual Or Developmental Disabilities, Nigel Yeo, Steven Gerardi Phd, Otd, Mss, Otr

Spring 2025 OTD Capstone Symposium

Direct Support Professionals (DSPs) serve an important role in assisting people with intellectual and developmental disabilities (IDD) in many aspects of their lives through the provision of care and support. Despite lacking in knowledge and training to support the potentially complex and varied presentation of people with IDD, DSPs are in a position to help their clients address and improve on their independent living skills that are important for autonomy and overall well-being. The capstone project developed the Independent Living Skills Teaching Guide (ILSTG), as a tool for DSPs, containing activity plans related to independent living skills, activity modifications based …

Building Bridges: A Community Health Worker Training Course, Taylor A. Ramsey, Lesley Khan-Farooqi, Phd, Otd, Otr, Dr. Sharita Ambrose, Dhed., Mph, Ches, Chwi

Spring 2025 OTD Capstone Symposium

Building Bridges: A Community Health Worker Training Course is a comprehensive 20-hour continuing education course designed for community health workers (CHWS) who work with Black pregnant women. This training course was developed for and in collaboration with Allure Alliance Incorporated, a non-profit organization whose mission is to improve the lives of Black women through community programming, education, and advocacy. This training course reflects an interprofessional collaborative approach to addressing the racial disparities in the Black maternal health population in the U.S. The course includes evidence-based strategies and health management interventions derived from the Occupational Therapy Practice Framework, 4th Edition (OTPF-4), …

Enhancing Concussion Management: Addressing The Needs Of Student-Athletes, Coaches, And Occupational Therapy Practitioners, Anya Vernon, Lesley Khan-Farooqi, Tyra Lea

Spring 2025 OTD Capstone Symposium

There are limited educational resources available on concussion management for occupational therapy practitioners, coaches, and student-athletes which can limit access to comprehensive occupational therapy services for clients who have sustained a concussion, ultimately hindering participation in sport and overall wellbeing. The purpose of this capstone was to develop a comprehensive guidebook for coaches and student-athletes and a comprehensive handbook for occupational therapy practitioners to raise awareness in concussion education and clarify occupational therapy's role on a multidisciplinary concussion management team. This project addresses the growing need for concussion education among student-athletes and coaches, improves understanding of concussion signs and symptoms, …

The Role Of Occupational Therapy In The Care Of Informal Caregivers Of People With Dementia: A Concept Analysis, Ashley M. Taylor, Steven M. Gerardi, Elizabeth Deluca-Berg

Spring 2025 OTD Capstone Symposium

Informal caregivers (care partners) are people, such as family members, who provide care to those who cannot care for themselves, including people with dementia (PwD). Care partners assist PwD in their daily occupations, often without training. Caring for PwD can lead to emotional, physical, financial, and occupational challenges for care partners. Occupational therapy (OT) has a role to play in the care of PwD. However, if clinicians do not operate from a dyadic model, care partners’ needs may be overlooked. Problem: Although addressing the care partner dyad is important to the delivery of OT, the role of OT in the …

Enhancing Psychosocial Well-Being For Pediatric Oncology Clients: A Guidebook For Occupational Therapists, Marzia Khan, Lesley Khan-Farooqi, Brooke Weber

Spring 2025 OTD Capstone Symposium

This capstone project addressed the critical gap in psychosocial support for pediatric oncology clients by developing an evidence-based guidebook for occupational therapy (OT) practitioners. Grounded in the Model of Human Occupation (MOHO), the guidebook provides therapists with developmentally appropriate strategies to enhance emotional regulation, social participation, and engagement in meaningful activities for children aged 3 to 12 undergoing cancer treatment. The project identified key psychosocial challenges through qualitative interviews, needs assessments, and real-time clinical feedback and designed targeted interventions aligned with OT principles. The digital guidebook provides accessible, structured resources to support holistic, client-centered care and improve the quality of …

Optimizing Care For Heart Failure Patients With Reduced Ejection Fraction: A Quality Improvement Project On Guideline Directed Medical Therapy Adherence, Leonie Campbell-Williams

DNP Projects

Significance and Background: Heart failure with reduced ejection fraction (HFrEF) remains a major cause of hospital readmissions, increasing both healthcare utilization and patient morbidity. Guideline-Directed Medical Therapy (GDMT) has been proven to reduce mortality and hospitalizations; however, adherence to these evidence-based guidelines remains inconsistent (Yancy et al., 2022).

Purpose: This quality improvement project aimed to evaluate whether enhancing GDMT adherence in an outpatient heart failure clinic could reduce emergency room (ER) admissions among patients with HFrEF.

Methods: A structured intervention was implemented at a local healthcare system Cardiology Clinic, focusing on optimizing adherence to GDMT in 60 patients with HFrEF. …

Co-Designing A Web-Based And Tablet App To Evaluate Clinical Outcomes Of Early Psychosis Service Users In A Learning Health Care Network: User-Centered Design Workshop And Pilot Study, Kathleen E Burch, Adam B Wilcox, Et Al.

2020-Current year OA Pubs

BACKGROUND: The Early Psychosis Intervention Network of California project, a learning health care network of California early psychosis intervention (EPI) programs, prioritized incorporation of community partner feedback while designing its eHealth app, Beehive. Though eHealth apps can support learning health care network data collection aims, low user acceptance or adoption can pose barriers to successful implementation. Adopting user-centered design (UCD) approaches, such as incorporation of user feedback, prototyping, iterative design, and continuous evaluation, can mitigate these potential barriers.

OBJECTIVE: We aimed to use UCD during development of a data collection and data visualization web-based and tablet app, Beehive, to promote …

Activation Of Endoplasmic Reticulum-Localized Metabotropic Glutamate Receptor 5 (Mglu5) Triggers Calcium Release Distinct From Cell Surface Counterparts In Striatal Neurons, Yuh-Jiin I Jong, Steven K Harmon, Karen L O'Malley

2020-Current year OA Pubs

Metabotropic glutamate receptor 5 (mGlu

Investigation Of The Cyanothece Nitrogenase Cluster In Synechocystis: A Blueprint For Engineering Nitrogen-Fixing Photoautotrophs, Deng Liu, Anindita Bandyopadhyay, Michelle Liberton, Himadri B Pakrasi, Maitrayee Bhattacharyya-Pakrasi

2020-Current year OA Pubs

The nitrogenase gene cluster of unicellular diazotrophic cyanobacteria, such as

Impact Of Perioperative Organ Injury On Morbidity And Mortality In 28 Million Surgical Patients, Felix Kork, Yafen Liang, Adit A Ginde, Xiaoyi Yuan, Rolf Rossaint, Hongfang Liu, Alex S Evers, Holger K Eltzschig

2020-Current year OA Pubs

Perioperative organ injury contributes to morbidity and mortality of surgical patients. This cohort study included all elective and emergent surgeries in Germany over 4 years to address the impact of perioperative organ injuries on outcomes. We analyzed 28,350,953 cases. In-hospital mortality was 1.4% (n = 393,157), and 4.4% of cases (n = 1,245,898) experienced perioperative organ injury. Perioperative organ injury was associated with 9-fold higher odds of death and prolonged hospital stay by 11.2 days. Acute kidney injury had the highest incidence (2.0%) and was associated with 25.0% mortality. While delirium had the second highest incidence (1.5%), it was associated …

Gramd1b Is A Regulator Of Lipid Homeostasis, Autophagic Flux And Phosphorylated Tau, Diana Acosta Ingram, Jacob Marsh, Celeste M Karch, Et Al.

2020-Current year OA Pubs

Lipid dyshomeostasis and tau pathology are present in frontotemporal lobar degeneration (FTLD) and Alzheimer's disease (AD). However, the relationship between lipid dyshomeostasis and tau pathology remains unclear. We report that GRAM Domain Containing 1B (GRAMD1B), a nonvesicular cholesterol transporter, is increased in excitatory neurons of human neural organoids (HNOs) with the MAPT R406W mutation. Human FTLD, AD cases, and PS19 tau mice also have increased GRAMD1B expression. We show that overexpression of GRAMD1B increases levels of free cholesterol, lipid droplets, and impairs autophagy flux. Modulating GRAMD1B in iPSC-derived neurons also alters key autophagy-related components such as PI3K, phospho-AKT, and p62, …

Occupational Therapy In Upper Limb Loss, Prosthetics, And Rehabilitation: A Video Training Series For Entry-Level Occupational Therapy Practitioners, Bailey M. Brown, Lesley Khan-Farooqi

Spring 2025 OTD Capstone Symposium

The purpose of this capstone project was to deepen my understanding of upper limb prosthetics, observe patient care, and identify gaps in occupational therapy education related to upper limb loss, prosthetic use, and rehabilitation. A key objective was to support the Hanger Clinic by increasing the number of completed Upper Limb Prosthetic User Outcome Forms, as well as to capture photos and videos—separate from this video training series—to contribute to Hanger’s educational library. Additionally, the project aimed to develop practical resources for both patients and clinicians navigating upper limb loss. Insights gained throughout this experience informed the creation of a …

Sound Asleep: A Manual For Occupational Therapy Practitioners (Otp) Addressing Sleep-Related Challenges In Young Children, Lorie-Ann Love, Ellen M. Pope Otd, Otr/L, Angela L. Blackwell Phd, Otr

Spring 2025 OTD Capstone Symposium

This capstone project sought to address the limited competence and confidence of occupational therapy practitioners (OTP) in providing services for children and families facing sleep-related challenges. The objective was to enhance OTP knowledge and skills in delivering specialized sleep interventions through the development of an educational resource. The project was implemented across two settings: telehealth and an outpatient pediatric service, integrating both virtual and outdoor environments for occupational therapy (OT). Participants include OTP, OT students, and families of young children (ages 0-5) experiencing sleep disturbances.

The project followed a structured four-phase approach: strengths and needs assessment, development of an educational …

Learning What To Say Through Theater And Play: A Theater Arts Communication And Conflict Resolution Program For Neurodivergent Children, Elena Corsair, Steven M. Gerardi

Spring 2025 OTD Capstone Symposium

Joshua’s Stage is a theater-based enrichment program for children with special needs. Joshua’s Stage provides developmentally appropriate activities for their students, but they do not address clinical or functional problems. Problem: Joshua’s Stage does not provide specialized programming to meet the needs of neurodivergent children with communication problems and conflict resolution, making it difficult for these children to participate fully. Purpose: The purpose of this project was to create a theater arts communication and conflict resolution program for neurodivergent children to be integrated into Joshua’s Stage enrichment program. A four-week program, consisting of eight sessions, was developed over a 14-week …

The Role Of Occupational Therapy In Bladder And Bowel Management For Individuals With Spinal Cord Injuries: An Educational Video Series, Julia Ryan, Steven Gerardi, Heather Rennerfeldt

Spring 2025 OTD Capstone Symposium

Occupational therapy (OT) practitioners are uniquely positioned to support individuals with spinal cord injury (SCI) in developing effective bowel and bladder management (BBM) routines. However, most existing literature approaches BBM from a medical perspective, offering limited guidance on how to translate occupation-based strategies into OT practice. This lack of discipline-specific resources contributes to reduced confidence among generalist practitioners and hinders the consistent implementation of BBM interventions across inpatient and community settings. To address this gap, a nine-part educational video series was developed to enhance OT practitioners’ knowledge, clinical reasoning, and confidence in delivering BBM interventions for clients with SCI. The …

Graded Habilitation Activities For Direct Support Professionals: An Educational Video Series, Christi Cantu, Steven M. Gerardi, Daniel J. Burt

Spring 2025 OTD Capstone Symposium

This capstone project was created for direct support professionals (DSPs) to have a new resource for education and training on how to properly apply the concept of graded habilitation activities based on the Allen’s cognitive levels to the DSPs sessions. This capstone project was a need in the DSP community for DSPs provide direct care to people with intellectual or development disabilities (IDD). Therefore, this capstone project supports education and training DSPs need to optimally apply graded habilitation activities, based on participants’ cognitive level, to provide optimal services for people with IDD. Problem: DSPs lack knowledge of and education/training …

Bridges To Asd: Building Resilience, Self-Efficacy And Capacity In Belizean Caregivers Of Children With Autism Spectrum Disorder (Asd), Katherine B. Anderton, Amy Satterthwaite, Angela Labrie Blackwell

Spring 2025 OTD Capstone Symposium

The Bridges to ASD program was a capstone project that contributed to the nonprofit clinic in a developing country by providing resources and training sessions that potentially helped to unify the caregivers, the teachers and the therapists in their common goals to better support their children in the community with ASD.

Occupational Therapy For Participation In Spirituality For Individuals With Cancer: A Scoping Review, Natalie Fernandez, Lesley Khan-Farooqi, Steven Gerardi

Spring 2025 OTD Capstone Symposium

The incidence of cancer continues to rise. For many individuals with cancer, spirituality is an important part of life. Spirituality impacts the individual’s meaning, purpose, self-identity, occupational engagement, occupational performance, and quality of life. However, there are sometimes barriers to participation in religions activities. Occupational therapy (OT) is indicated when people have barriers to participation. However, spirituality is not consistently addressed in OT practice and OT practitioners may not feel comfortable in addressing barriers to participation in spiritual activities among their clients with cancer. Objective: Scoping review methodology was used to answer the research question, how are OT practitioners addressing …

A Training Toolkit For Introducing Stem Cell Transplantation To The Inpatient Oncology Nurse, Susan G. Berg Bsn, Rn, Cmsrn, Ocn, Jenna Ruggiero Bsn, Rn, Jordan Mellinger Kish Msn, Rn, Lisa Russo Msn, Rn, Gavin Bauer Bsn, Rn, Tammy Selby Rn

Hematology-Medical Oncology Division

No abstract provided.

Association Of Clonal Hematopoiesis Of Indeterminate Potential With Cardiovascular Events In Patients With Ckd, Yang Pan, Caitlyn Vlasschaert, Varun Rao, Elvis A Akwo, James E Hixson, Md Mesbah Uddin, Zhi Yu, Do-Kyun Kim, Alexander Bick, Bryan Kestenbaum, Michael Chong, Guillaume Paré, Michael Rauh, Adeera Levin, James P Lash, Manjula Kurella Tamura, Debbie L Cohen, Jiang He, Lee Hamm, Rajat Deo, Zeenat Bhat, Panduranga Rao, Dawei Xie, Pradeep Natarajan, Tanika N Kelly, Cassianne Robinson-Cohen, Matthew B Lanktree

Faculty, Staff and Student Publications

Key Points:

1. In patients with CKD, non-DNMT3A clonal hematopoiesis of indeterminate potential (CHIP) was associated with higher risk of cardiovascular events.

2. There was no significant difference in the CHIP–cardiovascular disease association based on baseline eGFR, diabetes status, or race.

3. The protective effect of IL6R p.Asp358Ala on non-DNMT3A CHIP cardiovascular risk was similar to the general population.

Background: Patients with CKD are at higher risk of cardiovascular disease. Clonal hematopoiesis of indeterminate potential (CHIP) has been associated with cardiovascular disease in the general population, with a causal role observed in animal models. In the general population, the effect of …

Can Endothelin-1 Help Address The Diagnostic And Prognostic Challenges In Multimorbid Acute Heart Failure Patients?, Bianca-Ana Dmour, Minerva Codruta Badescu, Cristina Tuchiluș, Corina Maria Cianga, Daniela Constantinescu, Nicoleta Dima, Ștefania Teodora Duca, Awad Dmour, Alexandru Dan Costache, Maria-Ruxandra Cepoi, Adrian Crișan, Sabina Andreea Leancă, Cătălin Loghin, Ionela-Lăcrămioara Șerban, Irina Iuliana Costache-Enache

Faculty, Staff and Student Publications

The management of acute heart failure (AHF) is becoming increasingly complex, especially in patients with multiple comorbidities. Endothelin-1 (ET-1), a vasoconstrictive peptide, is an important mediator of neurohormonal activation, endothelial dysfunction, and cardiac remodeling-key processes involved in the pathogenesis of AHF. The aim of our study was to evaluate the diagnostic and prognostic performance of ET-1 in multimorbid AHF patients, compared to established markers such as amino terminal pro B-type natriuretic peptide (NT-proBNP) and high-sensitivity cardiac troponin I (hs-cTnI). We conducted a single-center prospective study including 76 patients; 54 with AHF and 22 serving as controls. Upon admission, all patients …

Cell Type-Specific Multi-Omics Analysis Of Cocaine Use Disorder In The Human Caudate Nucleus, Lea Zillich, Annasara Artioli, Veronika Pohořalá, Eric Zillich, Laura Stertz, Hanna Belschner, Ammar Jabali, Josef Frank, Fabian Streit, Diana Avetyan, Maja P Völker, Svenja Müller, Anita C Hansson, Thomas D Meyer, Marcella Rietschel, Julia Ladewig, Rainer Spanagel, Ana M M Oliveira, Consuelo Walss-Bass, Rick E Bernardi, Philipp Koch, Stephanie H Witt

Faculty, Staff and Student Publications

Structural and functional alterations in the brain's reward circuitry are present in cocaine use disorder (CocUD), but their molecular underpinnings remain unclear. To investigate these mechanisms, we performed single-nuclei multiome profiling on postmortem caudate nucleus tissue from six individuals with CocUD and eight controls. We profiled 30,030 nuclei, identifying 13 cell types including D1- and D2-medium spiny neurons (MSNs) and glial cells. We observed 1485 differentially regulated genes and 10,342 differentially accessible peaks, with alterations in MSNs and astrocytes related to neurotransmitter activity and synapse organization. Gene regulatory network analysis identified transcription factors including ZEB1 as exhibiting distinct CocUD-specific subclusters, …

Impact Of Perioperative Organ Injury On Morbidity And Mortality In 28 Million Surgical Patients, Felix Kork, Yafen Liang, Adit A Ginde, Xiaoyi Yuan, Rolf Rossaint, Hongfang Liu, Alex S Evers, Holger K Eltzschig

Faculty, Staff and Student Publications

Perioperative organ injury contributes to morbidity and mortality of surgical patients. This cohort study included all elective and emergent surgeries in Germany over 4 years to address the impact of perioperative organ injuries on outcomes. We analyzed 28,350,953 cases. In-hospital mortality was 1.4% (n = 393,157), and 4.4% of cases (n = 1,245,898) experienced perioperative organ injury. Perioperative organ injury was associated with 9-fold higher odds of death and prolonged hospital stay by 11.2 days. Acute kidney injury had the highest incidence (2.0%) and was associated with 25.0% mortality. While delirium had the second highest incidence (1.5%), it was associated …

Geographic Divergence Of Methicillin-Resistant Staphylococcus Aureus St5-Scc Mec I In The Aftermath Of A Major Earthquake And Tsunami: Impact Of A Plasmid Harboring Heavy Metal Resistance Genes, Jose R W Martínez, Manuel Alcalde-Rico, Estefanía Jara-Videla, Jinnethe Reyes, Lina P Carvajal, Sandra Rincon, Rafael Ríos, Lorena Diaz, Ana Quesille-Villalobos, Roberto Riquelme-Neira, Lina Rivas, Ahmed M Moustafa, Blake Hanson, Eduardo A Undurraga, Jorge Olivares-Pacheco, Patricia García, Rafael Araos, Paul J Planet, César A Arias, Jose M Munita

Faculty, Staff and Student Publications

Methicillin-resistant Staphylococcus aureus (MRSA) is a major public health menace. The global spread of MRSA is characterized by successive waves of epidemic clones dominating specific geographical regions. The acquisition of genes encoding resistance to heavy metals (HMRGs) is thought to be a key feature in the geographic divergence of MRSA. However, the cause-effect relationship between the presence of HMRGs and the divergence of MRSA clones remains to be clarified. In this study, we assessed the role that HMRGs may have played in the evolutionary divergence of the MRSA ST5-SCCmecI lineage in Latin America. We conducted a genomic characterization …

An In Vivo Microscopy Dataset For The Characterization Of Leukocyte Death, Alain Pulfer, Diego Ulisse Pizzagalli, Miguel Palomino Segura, Nina Germic, Tommaso Virgilio, Mauro Di Pilato, Pau Carrillo Barbera, Elisa Palladino, Paola Antonello, Marcus Thelen, Hans-Uwe Simon, Rolf Krause, Santiago F Gonzalez

Faculty, Staff and Student Publications

Recent advancements in intravital microscopy have enabled the study of cell death in vivo under various experimental conditions, such as infection and cancer. However, the limited throughput of this technology, together with a lack of openly accessible datasets, affects the development of algorithms for the automatic detection and characterization of cell death, which in turn require the integration of extensive and curated datasets. To address these needs, we present a curated dataset of microscopy videos depicting the death of neutrophils, eosinophils, and dendritic cells, acquired in the spleen and in the lymph node of mice under inflammatory conditions. The dataset …

The Impact Of Digital Inequities On Oropharyngeal Cancer Disparities In The United States, David J. Fei-Zhang, Achilles A. Kanaris, Camaren M. Cuenca, Sydney A. Fleishman, Jill N. D'Souza, Anthony M. Sheyn, Daniel C. Chelius, Jeffrey C. Rastatter

School of Medicine Faculty Publications

Objective: To assess associations of digital inequity with oropharyngeal cancer (OPC) prognostic and care outcomes in the United States while adjusting for traditional social determinants/drivers of health (SDoH). Study Design: Retrospective cohort study. Setting: United States. Methods: In total, 70,604 patients from 2008 to 2017 were assessed for regression trends in long-term follow-up period, survival, prognosis, and treatment across increasing overall digital inequity, as measured by the Digital Inequity Index (DII). DII is based on 17 census-tract level variables derived from the American Community Survey and Federal Communications Commission. Variables were categorized as infrastructure-access (ie, digital-related variables) or sociodemographic (ie, …

The Medial Olivocochlear Efferent Pathway Potentiates Cochlear Amplification In Response To Hearing Loss, Patricia M Quiñones, Michelle Pei, Hemant Srivastava, Ariadna Cobo-Cuan, Marcela A Morán, Bong Jik Kim, Clayton B Walker, Michael J Serafino, Frank Macias-Escriva, Juemei Wang, James B Dewey, Brian E Applegate, Matthew J Mcginley, John S Oghalai

Faculty, Staff and Students Publications

The mammalian cochlea receives efferent feedback from the brain. Many functions for this feedback have been hypothesized, including on short timescales, such as mediating attentional states, and long timescales, such as buffering acoustic trauma. Testing these hypotheses has been impeded by an inability to make direct measurements of efferent effects in awake animals. Here, we assessed the role of the medial olivocochlear (MOC) efferent nerve fibers on cochlear amplification by measuring organ of Corti vibratory responses to sound in both sexes of awake and anesthetized mice. We studied long-term effects by genetically ablating the efferents and/or afferents. Cochlear amplification increased …

An Unsupervised Map Of Excitatory Neuron Dendritic Morphology In The Mouse Visual Cortex, Marissa A Weis, Stelios Papadopoulos, Laura Hansel, Timo Lüddecke, Brendan Celii, Paul G Fahey, Eric Y Wang, J Alexander Bae, Agnes L Bodor, Derrick Brittain, Joann Buchanan, Daniel J Bumbarger, Manuel A Castro, Forrest Collman, Nuno Maçarico Da Costa, Sven Dorkenwald, Leila Elabbady, Akhilesh Halageri, Zhen Jia, Chris Jordan, Dan Kapner, Nico Kemnitz, Sam Kinn, Kisuk Lee, Kai Li, Ran Lu, Thomas Macrina, Gayathri Mahalingam, Eric Mitchell, Shanka Subhra Mondal, Shang Mu, Barak Nehoran, Sergiy Popovych, R Clay Reid, Casey M Schneider-Mizell, H Sebastian Seung, William Silversmith, Marc Takeno, Russel Torres, Nicholas L Turner, William Wong, Jingpeng Wu, Wenjing Yin, Szi-Chieh Yu, Jacob Reimer, Philipp Berens, Andreas S Tolias, Alexander S Ecker

Faculty, Staff and Students Publications

Neurons in the neocortex exhibit astonishing morphological diversity, which is critical for properly wiring neural circuits and giving neurons their functional properties. However, the organizational principles underlying this morphological diversity remain an open question. Here, we took a data-driven approach using graph-based machine learning methods to obtain a low-dimensional morphological "bar code" describing more than 30,000 excitatory neurons in mouse visual areas V1, AL, and RL that were reconstructed from the millimeter scale MICrONS serial-section electron microscopy volume. Contrary to previous classifications into discrete morphological types (m-types), our data-driven approach suggests that the morphological landscape of cortical excitatory neurons is …

Bioseq: A Molecular Intelligence Platform Based On Organism-On-Chip Technology For Bridging Data Gaps Between C. Elegans And Humans, Hunter Edwards, Adnan Qureshi, Mizanur Rahman, Tyler Chiriboga, Amar Chittiboyina, Ikhlas Khan, Siva Vanapalli

Oxford ICSB

The FDA Modernization Act 2.0, emphasizes the urgent need for New Approach Methodologies (NAMs) to replace conventional animal testing in safety and efficacy assessments. NemaLife’s organism-on-chip platform, utilizing C. elegans, microfluidics and visual AI, provides a high throughput platform for in vivo screening. To enhance human relevance and reduce the inter-species gap between C. elegans and human, we developed BioSeq, a novel discovery workflow, based on high-throughput transcriptomics. Leveraging the 60-80% homology between C. elegans and human genomes, BioSeq translates worm gene expression data to human orthologs. This enables: (i) identification of differentially expressed human-relevant genes triggered by bioactive ingredients …

Current Regulatory And Enforcement Landscape Under Mocra, Diane Mcenroe

Oxford ICSB

The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) became effective December 29th, 2023 and is the most significant expansion of FDA’s authority to regulate cosmetics since the FD&C Act was enacted in 1938. MoCRA expands the FDA's authority over cosmetics and creates new compliance obligations for manufacturers. Diane McEnroe, an FDA regulatory lawyer at Sidley Austin, LLP, will provide an overview of the law and its implication for cosmetic manufacturers and marketers. The presentation will also provide an update on the current regulatory and enforcement landscape to date, including considerations about follow on litigation when there has been publicity …