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2. Continued improvement in disease manifestations of acid sphingomyelinase deficiency for adults with up to 2 years of olipudase alfa treatment: open-label extension of the ASCEND trial.

Author

Giugliani, Roberto, Guelbert, Norberto, Hennermann, Julia, Ikezoe, Takayuki, Lidove, Olivier, Mabe, Paulina, Mengel, Eugen, Scarpa, Maurizio, Senates, Ebubekir, Tchan, Michel, Villarrubia, Jesus, Thurberg, Beth, Yarramaneni, Abhimanyu, Armstrong, Nicole, Kim, Yong, Kumar, Monica, Wasserstein, Melissa, Lachmann, Robin, Hollak, Carla, Barbato, Antonio, and Gallagher, Renata

Subjects
Acid sphingomyelinase deficiency, Dose escalation, Lung diffusing capacity, Niemann–Pick type A/B, Niemann–Pick type B, Organomegaly, Recombinant human acid sphingomyelinase, Adult, Humans, Sphingomyelin Phosphodiesterase, Niemann-Pick Disease, Type A, Niemann-Pick Diseases, Recombinant Proteins
Abstract

BACKGROUND: Olipudase alfa is a recombinant human acid sphingomyelinase enzyme replacement therapy for non-central-nervous-system manifestations of acid sphingomyelinase deficiency (ASMD). The ASCEND randomized placebo-controlled trial in adults with ASMD demonstrated reductions in sphingomyelin storage, organomegaly, interstitial lung disease and impaired diffusion capacity of the lung (DLCO), during the first year of olipudase alfa treatment. In an ongoing open-label extension of the ASCEND trial, individuals in the placebo group crossed over to olipudase alfa, and those in the olipudase alfa group continued treatment. RESULTS: Thirty-five of 36 participants continued in the extension trial, and 33 completed year 2. Change-from-baseline results are presented as least-square mean percent change ± SEM. Improvements in the cross-over group after 1 year of treatment paralleled those of the olipudase alfa group from the primary analysis, while clinical improvement continued for those receiving olipudase alfa for 2 years. In the cross-over group, percent-predicted DLCO increased by 28.0 ± 6.2%, spleen volume decreased by 36.0 ± 3.0% and liver volume decreased by 30.7 ± 2.5%. For those with 2 years of olipudase alfa treatment, the percent predicted DLCO increased by 28.5 ± 6.2%, spleen volume decreased by 47.0 ± 2.7%, and liver volume decreased by 33.4 ± 2.2%. Lipid profiles and elevated liver transaminase levels improved or normalized by 1 year and remained stable through 2 years of treatment. Overall, 99% of treatment-emergent adverse events were mild or moderate, with one treatment-related serious adverse event (extrasystoles; previously documented cardiomyopathy). No individual discontinued due to an adverse event. CONCLUSION: Treatment with olipudase alfa is well tolerated and reduces manifestations of chronic ASMD with sustained efficacy. Trial registration NCT02004691 registered 9 December 2013, https://clinicaltrials.gov/ct2/show/NCT02004691.

Published
2023

5. Contributors

Author

Albokhari, Daniah, primary, Ayoubieh, Houriya, additional, Balwani, Manisha, additional, Barry, Jessica C., additional, Blagowidow, Natalie, additional, Bodurtha, Joann, additional, Bottini, Alexander, additional, Brewer, Takae M., additional, Brodie, Scott, additional, Brown, Emily E., additional, Bush, Lynn Wein, additional, Butterfield, Russell J., additional, Campbell, Kirk, additional, Clemens, Douglas K., additional, Corson, Virginia L., additional, Cytrynbaum, Cheryl, additional, Dedania, Vaidehi, additional, Diaz, George A., additional, Dietz, Harry C., additional, Dinulos, Mary Beth Palko, additional, Eng, Christine M., additional, Eng, Charis, additional, Fan, Audrey L., additional, Francomano, Clair A., additional, Frucht, Steven J., additional, Ganesh, Jaya, additional, Gelb, Bruce D., additional, Goduni, Lediana, additional, Gu, Shen, additional, Gupta, Isha, additional, Hagerman, Randi J., additional, Hall, Judith G., additional, Hoover-Fong, Julie, additional, Hudgins, Louanne, additional, Iverson, Ayuko, additional, Jabs, Ethylin Wang, additional, James, Cynthia A., additional, Jari, Shama, additional, Keppler-Noreuil, Kim M., additional, Kerr, Lynne M., additional, Kimball, Amy, additional, Kline, Antonie D., additional, Kline, Joel N., additional, Kritzer, Amy, additional, Lambert, Michele P., additional, Lew, Cheryl D., additional, Li, Shao-Tzu, additional, MacCarrick, Gretchen, additional, Matalon, Dena R., additional, McDonald-McGinn, Donna M., additional, McMahon, Francis J., additional, Meliambro, Kristin, additional, Moore, Rebekah A., additional, Murray, Brittney, additional, Newcomb, Tara, additional, Ngeow, Joanne, additional, Ogawa, Jessica, additional, Patel, Dhruv K., additional, Pollin, Toni I., additional, Prasun, Pankaj, additional, Puliaiev, Maksym, additional, Pyeritz, Reed E., additional, Rasmussen, Sonja A., additional, Riboldi, Giulietta Maria, additional, Schecter, Scott M., additional, Scheuerle, Angela E., additional, Scott, Stuart A., additional, Shankar, Suma, additional, Slavotinek, Anne, additional, Smith-Hicks, Constance L., additional, Stewart, Rosalyn W., additional, Trandafir, Cristina, additional, Triano, Vivian Narcisa, additional, Vernon, Hilary J., additional, Wasserstein, Melissa P., additional, Webb, Bryn D., additional, Weksberg, Rosanna, additional, and Yuan, Bo, additional

Published
2024
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7. Evaluating parental personal utility of pediatric genetic and genomic testing in a diverse, multilingual population

Author

Marathe, Priya N., Suckiel, Sabrina A., Bonini, Katherine E., Kelly, Nicole R., Scarimbolo, Laura, Insel, Beverly J., Odgis, Jacqueline A., Sebastin, Monisha, Ramos, Michelle A., Di Biase, Miranda, Gallagher, Katie M., Brown, Kaitlyn, Rodriguez, Jessica E., Yelton, Nicole, Aguiñiga, Karla Lopez, Rodriguez, Michelle A., Maria, Estefany, Lopez, Jessenia, Zinberg, Randi E., Diaz, George A., Greally, John M., Abul-Husn, Noura S., Bauman, Laurie J., Gelb, Bruce D., Wasserstein, Melissa P., Kenny, Eimear E., and Horowitz, Carol R.

Published
2024
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8. Consensus guidelines for the monitoring and management of metachromatic leukodystrophy in the United States

Author

Adang, Laura A., Bonkowsky, Joshua L., Boelens, Jaap Jan, Mallack, Eric, Ahrens-Nicklas, Rebecca, Bernat, John A., Bley, Annette, Burton, Barbara, Darling, Alejandra, Eichler, Florian, Eklund, Erik, Emrick, Lisa, Escolar, Maria, Fatemi, Ali, Fraser, Jamie L., Gaviglio, Amy, Keller, Stephanie, Patterson, Marc C., Orchard, Paul, Orthmann-Murphy, Jennifer, Santoro, Jonathan D., Schöls, Ludger, Sevin, Caroline, Srivastava, Isha N., Rajan, Deepa, Rubin, Jennifer P., Van Haren, Keith, Wasserstein, Melissa, Zerem, Ayelet, Fumagalli, Francesca, Laugwitz, Lucia, and Vanderver, Adeline

Published
2024
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9. Continued improvement in disease manifestations of acid sphingomyelinase deficiency for adults with up to 2 years of olipudase alfa treatment: open-label extension of the ASCEND trial

Author

Wasserstein, Melissa P., Lachmann, Robin, Hollak, Carla, Barbato, Antonio, Gallagher, Renata C., Giugliani, Roberto, Guelbert, Norberto Bernardo, Hennermann, Julia B., Ikezoe, Takayuki, Lidove, Olivier, Mabe, Paulina, Mengel, Eugen, Scarpa, Maurizio, Senates, Ebubekir, Tchan, Michel, Villarrubia, Jesus, Thurberg, Beth L., Yarramaneni, Abhimanyu, Armstrong, Nicole M., Kim, Yong, and Kumar, Monica

Published
2023
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10. The TeleKidSeq pilot study: incorporating telehealth into clinical care of children from diverse backgrounds undergoing whole genome sequencing

Author

Sebastin, Monisha, Odgis, Jacqueline A., Suckiel, Sabrina A., Bonini, Katherine E., Di Biase, Miranda, Brown, Kaitlyn, Marathe, Priya, Kelly, Nicole R., Ramos, Michelle A., Rodriguez, Jessica E., Aguiñiga, Karla López, Lopez, Jessenia, Maria, Estefany, Rodriguez, Michelle A., Yelton, Nicole M., Cunningham-Rundles, Charlotte, Gallagher, Katie, McDonald, Thomas V., McGoldrick, Patricia E., Robinson, Mimsie, Rubinstein, Arye, Shulman, Lisa H., Wolf, Steven M., Yozawitz, Elissa, Zinberg, Randi E., Abul-Husn, Noura S., Bauman, Laurie J., Diaz, George A., Ferket, Bart S., Greally, John M., Jobanputra, Vaidehi, Gelb, Bruce D., Horowitz, Carol R., Kenny, Eimear E., and Wasserstein, Melissa P.

Published
2023
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11. Consensus clinical management guidelines for acid sphingomyelinase deficiency (Niemann–Pick disease types A, B and A/B)

Author

Geberhiwot, Tarekegn, Wasserstein, Melissa, Wanninayake, Subadra, Bolton, Shaun Christopher, Dardis, Andrea, Lehman, Anna, Lidove, Olivier, Dawson, Charlotte, Giugliani, Roberto, Imrie, Jackie, Hopkin, Justin, Green, James, de Vicente Corbeira, Daniel, Madathil, Shyam, Mengel, Eugen, Ezgü, Fatih, Pettazzoni, Magali, Sjouke, Barbara, Hollak, Carla, Vanier, Marie T., McGovern, Margaret, and Schuchman, Edward

Published
2023
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13. ScreenPlus: A comprehensive, multi-disorder newborn screening program

Author

Kelly, Nicole R., Orsini, Joseph J., Goldenberg, Aaron J., Mulrooney, Niamh S., Boychuk, Natalie A., Clarke, Megan J., Paleologos, Katrina, Martin, Monica M., McNeight, Hannah, Caggana, Michele, Bailey, Sean M., Eiland, Lisa R., Ganesh, Jaya, Kupchik, Gabriel, Lumba, Rishi, Nafday, Suhas, Stroustrup, Annemarie, Gelb, Michael H., and Wasserstein, Melissa P.

Published
2024
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14. Physician services and costs after disclosure of diagnostic sequencing results in the NYCKidSeq program

Author

Berkalieva, Asem, Kelly, Nicole R., Fisher, Ashley, Hohmann, Samuel F., Sebastin, Monisha, Di Biase, Miranda, Bonini, Katherine E., Marathe, Priya, Odgis, Jacqueline A., Suckiel, Sabrina A., Ramos, Michelle A., Rhodes, Rosamond, Abul-Husn, Noura S., Greally, John M., Horowitz, Carol R., Wasserstein, Melissa P., Kenny, Eimear E., Gelb, Bruce D., and Ferket, Bart S.

Published
2024
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15. Free sialic acid storage disorder: Progress and promise

Author

Huizing, Marjan, Hackbarth, Mary E, Adams, David R, Wasserstein, Melissa, Patterson, Marc C, Walkley, Steven U, Gahl, William A, Dobrenis, Kostantin, Foglio, Jessica, Gasnier, Bruno, Hackbarth, Mary, Lek, Monkol, Malicdan, May CV, Paavola, Liisa E, Reimer, Richard, Wang, Raymond Y, and Zoncu, Roberto

Subjects
Biochemistry and Cell Biology, Biomedical and Clinical Sciences, Biological Sciences, Rare Diseases, Pediatric, Clinical Research, Neurodegenerative, Brain Disorders, Intellectual and Developmental Disabilities (IDD), Neurosciences, 2.1 Biological and endogenous factors, Aetiology, Neurological, Animals, Genetic Therapy, Humans, N-Acetylneuraminic Acid, Organic Anion Transporters, Sialic Acid Storage Disease, Stem Cell Transplantation, Symporters, Hypomyelination, Infantile sialic acid storage disorder, Lysosomal membrane transporter, N-acetylneuraminic acid, Salla disease, Sialic acid, SLC17A5, FSASD Consortium, Psychology, Cognitive Sciences, Biochemistry and cell biology, Biological psychology
Abstract

Lysosomal free sialic acid storage disorder (FSASD) is an extremely rare, autosomal recessive, neurodegenerative, multisystemic disorder caused by defects in the lysosomal sialic acid membrane exporter SLC17A5 (sialin). SLC17A5 defects cause free sialic acid and some other acidic hexoses to accumulate in lysosomes, resulting in enlarged lysosomes in some cell types and 10-100-fold increased urinary excretion of free sialic acid. Clinical features of FSASD include coarse facial features, organomegaly, and progressive neurodegenerative symptoms with cognitive impairment, cerebellar ataxia and muscular hypotonia. Central hypomyelination with cerebellar atrophy and thinning of the corpus callosum are also prominent disease features. Around 200 FSASD cases are reported worldwide, with the clinical spectrum ranging from a severe infantile onset form, often lethal in early childhood, to a mild, less severe form with subjects living into adulthood, also called Salla disease. The pathobiology of FSASD remains poorly understood and FSASD is likely underdiagnosed. Known patients have experienced a diagnostic delay due to the rarity of the disorder, absence of routine urine sialic acid testing, and non-specific clinical symptoms, including developmental delay, ataxia and infantile hypomyelination. There is no approved therapy for FSASD. We initiated a multidisciplinary collaborative effort involving worldwide academic clinical and scientific FSASD experts, the National Institutes of Health (USA), and the FSASD patient advocacy group (Salla Treatment and Research [S.T.A.R.] Foundation) to overcome the scientific, clinical and financial challenges facing the development of new treatments for FSASD. We aim to collect data that incentivize industry to further develop, obtain approval for, and commercialize FSASD treatments. This review summarizes current aspects of FSASD diagnosis, prevalence, etiology, and disease models, as well as challenges on the path to therapeutic approaches for FSASD.

Published
2021

16. The NYCKidSeq randomized controlled trial: Impact of GUÍA digitally enhanced genetic results disclosure in diverse families

Author

Suckiel, Sabrina A., Kelly, Nicole R., Odgis, Jacqueline A., Gallagher, Katie M., Sebastin, Monisha, Bonini, Katherine E., Marathe, Priya N., Brown, Kaitlyn, Di Biase, Miranda, Ramos, Michelle A., Rodriguez, Jessica E., Scarimbolo, Laura, Insel, Beverly J., Ferar, Kathleen D.M., Zinberg, Randi E., Diaz, George A., Greally, John M., Abul-Husn, Noura S., Bauman, Laurie J., Gelb, Bruce D., Horowitz, Carol R., Wasserstein, Melissa P., and Kenny, Eimear E.

Published
2023
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17. Molecular diagnostic yield of genome sequencing versus targeted gene panel testing in racially and ethnically diverse pediatric patients

Author

Abul-Husn, Noura S., Marathe, Priya N., Kelly, Nicole R., Bonini, Katherine E., Sebastin, Monisha, Odgis, Jacqueline A., Abhyankar, Avinash, Brown, Kaitlyn, Di Biase, Miranda, Gallagher, Katie M., Guha, Saurav, Ioele, Nicolette, Okur, Volkan, Ramos, Michelle A., Rodriguez, Jessica E., Rehman, Atteeq U., Thomas-Wilson, Amanda, Edelmann, Lisa, Zinberg, Randi E., Diaz, George A., Greally, John M., Jobanputra, Vaidehi, Suckiel, Sabrina A., Horowitz, Carol R., Wasserstein, Melissa P., Kenny, Eimear E., and Gelb, Bruce D.

Published
2023
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18. The Genomic Medicine Integrative Research Framework: A Conceptual Framework for Conducting Genomic Medicine Research

Author

Horowitz, Carol R, Orlando, Lori A, Slavotinek, Anne M, Peterson, Josh, Angelo, Frank, Biesecker, Barbara, Bonham, Vence L, Cameron, Linda D, Fullerton, Stephanie M, Gelb, Bruce D, Goddard, Katrina AB, Hailu, Benyam, Hart, Ragan, Hindorff, Lucia A, Jarvik, Gail P, Kaufman, Dave, Kenny, Eimear E, Knight, Sara J, Koenig, Barbara A, Korf, Bruce R, Madden, Ebony, McGuire, Amy L, Ou, Jeffrey, Wasserstein, Melissa P, Robinson, Mimsie, Leventhal, Howard, and Sanderson, Saskia C

Subjects
Health Services and Systems, Health Sciences, Genetics, Biological Sciences, Prevention, Human Genome, Clinical Research, Biotechnology, Good Health and Well Being, Biomedical Research, Delivery of Health Care, Integrated, Genetics, Medical, Genomics, Humans, Models, Theoretical, Precision Medicine, Rare Diseases, Research Design, conceptual, diversity, framework, genomics, implementation, model, translational research, Medical and Health Sciences, Genetics & Heredity, Biological sciences, Biomedical and clinical sciences, Health sciences
Abstract

Conceptual frameworks are useful in research because they can highlight priority research domains, inform decisions about interventions, identify outcomes and factors to measure, and display how factors might relate to each other to generate and test hypotheses. Discovery, translational, and implementation research are all critical to the overall mission of genomic medicine and prevention, but they have yet to be organized into a unified conceptual framework. To fill this gap, our diverse team collaborated to develop the Genomic Medicine Integrative Research (GMIR) Framework, a simple but comprehensive tool to aid the genomics community in developing research questions, strategies, and measures and in integrating genomic medicine and prevention into clinical practice. Here we present the GMIR Framework and its development, along with examples of its use for research development, demonstrating how we applied it to select and harmonize measures for use across diverse genomic medicine implementation projects. Researchers can utilize the GMIR Framework for their own research, collaborative investigations, and clinical implementation efforts; clinicians can use it to establish and evaluate programs; and all stakeholders can use it to help allocate resources and make sure that the full complexity of etiology is included in research and program design, development, and evaluation.

Published
2019

19. The Clinical Sequencing Evidence-Generating Research Consortium: Integrating Genomic Sequencing in Diverse and Medically Underserved Populations

Author

Amendola, Laura M, Berg, Jonathan S, Horowitz, Carol R, Angelo, Frank, Bensen, Jeannette T, Biesecker, Barbara B, Biesecker, Leslie G, Cooper, Gregory M, East, Kelly, Filipski, Kelly, Fullerton, Stephanie M, Gelb, Bruce D, Goddard, Katrina AB, Hailu, Benyam, Hart, Ragan, Hassmiller-Lich, Kristen, Joseph, Galen, Kenny, Eimear E, Koenig, Barbara A, Knight, Sara, Kwok, Pui-Yan, Lewis, Katie L, McGuire, Amy L, Norton, Mary E, Ou, Jeffrey, Parsons, Donald W, Powell, Bradford C, Risch, Neil, Robinson, Mimsie, Rini, Christine, Scollon, Sarah, Slavotinek, Anne M, Veenstra, David L, Wasserstein, Melissa P, Wilfond, Benjamin S, Hindorff, Lucia A, consortium, CSER, Plon, Sharon E, and Jarvik, Gail P

Subjects
Biological Sciences, Biomedical and Clinical Sciences, Genetics, Health Services and Systems, Health Sciences, Clinical Sciences, Clinical Research, Human Genome, Health Services, Biotechnology, Aetiology, 2.1 Biological and endogenous factors, Generic health relevance, Good Health and Well Being, Adult, Cost-Benefit Analysis, Delivery of Health Care, Europe, Exome, Genome, Human, Genomics, Humans, National Human Genome Research Institute (U.S.), Phenotype, United States, Whole Genome Sequencing, CSER consortium, Medical and Health Sciences, Genetics & Heredity, Biological sciences, Biomedical and clinical sciences, Health sciences
Abstract

The Clinical Sequencing Evidence-Generating Research (CSER) consortium, now in its second funding cycle, is investigating the effectiveness of integrating genomic (exome or genome) sequencing into the clinical care of diverse and medically underserved individuals in a variety of healthcare settings and disease states. The consortium comprises a coordinating center, six funded extramural clinical projects, and an ongoing National Human Genome Research Institute (NHGRI) intramural project. Collectively, these projects aim to enroll and sequence over 6,100 participants in four years. At least 60% of participants will be of non-European ancestry or from underserved settings, with the goal of diversifying the populations that are providing an evidence base for genomic medicine. Five of the six clinical projects are enrolling pediatric patients with various phenotypes. One of these five projects is also enrolling couples whose fetus has a structural anomaly, and the sixth project is enrolling adults at risk for hereditary cancer. The ongoing NHGRI intramural project has enrolled primarily healthy adults. Goals of the consortium include assessing the clinical utility of genomic sequencing, exploring medical follow up and cascade testing of relatives, and evaluating patient-provider-laboratory level interactions that influence the use of this technology. The findings from the CSER consortium will offer patients, healthcare systems, and policymakers a clearer understanding of the opportunities and challenges of providing genomic medicine in diverse populations and settings, and contribute evidence toward developing best practices for the delivery of clinically useful and cost-effective genomic sequencing in diverse healthcare settings.

Published
2018

20. GenomeDiver: a platform for phenotype-guided medical genomic diagnosis

Author

Pearson, Nathaniel M., Stolte, Christian, Shi, Kevin, Beren, Faygel, Abul-Husn, Noura S., Bertier, Gabrielle, Brown, Kaitlyn, Diaz, George A., Odgis, Jacqueline A., Suckiel, Sabrina A., Horowitz, Carol R., Wasserstein, Melissa, Gelb, Bruce D., Kenny, Eimear E., Gagnon, Charles, Jobanputra, Vaidehi, Bloom, Toby, and Greally, John M.

Published
2021
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22. GUÍA: a digital platform to facilitate result disclosure in genetic counseling

Author

Suckiel, Sabrina A., Odgis, Jaqueline A., Gallagher, Katie M., Rodriguez, Jessica E., Watnick, Dana, Bertier, Gabrielle, Sebastin, Monisha, Yelton, Nicole, Maria, Estefany, Lopez, Jessenia, Ramos, Michelle, Kelly, Nicole, Teitelman, Nehama, Beren, Faygel, Kaszemacher, Tom, Davis, Kojo, Laguerre, Irma, Richardson, Lynne D., Diaz, George A., Pearson, Nathaniel M., Ellis, Stephen B., Stolte, Christian, Robinson, Mimsie, Kovatch, Patricia, Horowitz, Carol R., Gelb, Bruce D., Greally, John M., Bauman, Laurie J., Zinberg, Randi E., Abul-Husn, Noura S., Wasserstein, Melissa P., and Kenny, Eimear E.

Published
2021
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25. Olipudase alfa enzyme replacement therapy reverses interstitial lung disease in adults with acid sphingomyelinase deficiency: Long-term pulmonary outcomes of the ASCEND trial

Author

Wasserstein, Melissa, primary, Bonella, Francesco, additional, Giugliani, Roberto, additional, Lachmann, Robin, additional, Noth, Imre, additional, Scarpa, Maurizio, additional, Wuyts, Wim A., additional, Aguiar, Mario, additional, Armstrong, Nicole, additional, Kumar, Monica, additional, and Berger, Kenneth, additional

Published
2024
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26. Improvements in liver and lipid outcomes continue in children and adults with chronic acid sphingomyelinase deficiency treated for 2 to 6.5 years with olipudase alfa in long-term clinical trials

Author

Lachmann, Robin, primary, Ganesh, Jaya, additional, Giugliani, Roberto, additional, Guffon, Nathalie, additional, Mengel, Eugen, additional, Scarpa, Maurizio, additional, Wasserstein, Melissa, additional, Aguiar, Mario, additional, Armstrong, Nicole, additional, Thurberg, Beth L., additional, and Kumar, Monica, additional

Published
2024
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27. Collaborative research efforts drive therapeutic advancements for free sialic acid storage disorder (FSASD)

Author

Malicdan, May Christine, primary, Adams, David R., additional, Brooks, P.J., additional, Dobrenis, Konstantin, additional, Gahl, William A., additional, Gasnier, Bruno, additional, Hackbarth, Mary E., additional, Hossain, Mahin, additional, Leoyklang, Petcharat, additional, Anne-Longin, Christine, additional, Paavola, Liisa, additional, Platt, Frances, additional, Pollard, Laura, additional, Reimer, Richard, additional, Sabir, Marya S., additional, Wang, Raymond Y., additional, Walkley, Steven, additional, Wasserstein, Melissa, additional, and Huizing, Marjan, additional

Published
2024
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28. The motivation and process for developing a consortium‐wide time and motion study to estimate resource implications of innovations in the use of genome sequencing to inform patient care

Author

Hoban, Hannah G., primary, Yip, Tiffany A., additional, Chau, Joanna C., additional, Bensen, Jeannette T., additional, Desrosiers, Lauren R., additional, Finnila, Candice R., additional, Hindorff, Lucia A., additional, Kelly, Nicole R., additional, Lynch, Frances L., additional, Rolf, Bradley A., additional, Smith, Hadley S., additional, Wasserstein, Melissa P., additional, and Hassmiller Lich, Kristen, additional

Published
2023
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30. Correction to: The NYCKidSeq project: study protocol for a randomized controlled trial incorporating genomics into the clinical care of diverse New York City children

Author

Odgis, Jacqueline A., Gallagher, Katie M., Suckiel, Sabrina A., Donohue, Katherine E., Ramos, Michelle A., Kelly, Nicole R., Bertier, Gabrielle, Blackburn, Christina, Brown, Kaitlyn, Fielding, Lena, Lopez, Jessenia, Aguiniga, Karla Lopez, Maria, Estefany, Rodriguez, Jessica E., Sebastin, Monisha, Teitelman, Nehama, Watnick, Dana, Yelton, Nicole M., Abhyankar, Avinash, Abul-Husn, Noura S., Baum, Aaron, Bauman, Laurie J., Beal, Jules C., Bloom, Toby, Cunningham-Rundles, Charlotte, Diaz, George A., Dolan, Siobhan, Ferket, Bart S., Jobanputra, Vaidehi, Kovatch, Patricia, McDonald, Thomas V., McGoldrick, Patricia E., Rhodes, Rosamond, Rinke, Michael L., Robinson, Mimsie, Rubinstein, Arye, Shulman, Lisa H., Stolte, Christian, Wolf, Steven M., Yozawitz, Elissa, Zinberg, Randi E., Greally, John M., Gelb, Bruce D., Horowitz, Carol R., Wasserstein, Melissa P., and Kenny, Eimear E.

Published
2021
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31. Aberrant Function of the C-Terminal Tail of HIST1H1E Accelerates Cellular Senescence and Causes Premature Aging

Author

Flex, Elisabetta, Martinelli, Simone, Van Dijck, Anke, Ciolfi, Andrea, Cecchetti, Serena, Coluzzi, Elisa, Pannone, Luca, Andreoli, Cristina, Radio, Francesca Clementina, Pizzi, Simone, Carpentieri, Giovanna, Bruselles, Alessandro, Catanzaro, Giuseppina, Pedace, Lucia, Miele, Evelina, Carcarino, Elena, Ge, Xiaoyan, Chijiwa, Chieko, Lewis, M.E. Suzanne, Meuwissen, Marije, Kenis, Sandra, Van der Aa, Nathalie, Larson, Austin, Brown, Kathleen, Wasserstein, Melissa P., Skotko, Brian G., Begtrup, Amber, Person, Richard, Karayiorgou, Maria, Roos, J. Louw, Van Gassen, Koen L., Koopmans, Marije, Bijlsma, Emilia K., Santen, Gijs W.E., Barge-Schaapveld, Daniela Q.C.M., Ruivenkamp, Claudia A.L., Hoffer, Mariette J.V., Lalani, Seema R., Streff, Haley, Craigen, William J., Graham, Brett H., van den Elzen, Annette P.M., Kamphuis, Daan J., Õunap, Katrin, Reinson, Karit, Pajusalu, Sander, Wojcik, Monica H., Viberti, Clara, Di Gaetano, Cornelia, Bertini, Enrico, Petrucci, Simona, De Luca, Alessandro, Rota, Rossella, Ferretti, Elisabetta, Matullo, Giuseppe, Dallapiccola, Bruno, Sgura, Antonella, Walkiewicz, Magdalena, Kooy, R. Frank, and Tartaglia, Marco

Published
2019
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32. The Brain Gene Registry: a data snapshot.

Author

Baldridge, Dustin, Kaster, Levi, Sancimino, Catherine, Srivastava, Siddharth, Molholm, Sophie, Gupta, Aditi, Oh, Inez, Lanzotti, Virginia, Grewal, Daleep, Riggs, Erin Rooney, Savatt, Juliann M., Hauck, Rachel, Sveden, Abigail, Wasserstein, Melissa, Sahin, Mustafa, Wangler, Michael F., Schultz, Robert, Gropman, Andrea, Smith-Hicks, Constance, and Abbeduto, Len

Subjects
ETHNIC differences, ATTENTION-deficit hyperactivity disorder, ELECTRONIC health records, AUTISM spectrum disorders, GENETIC variation, DEVELOPMENTAL delay
Abstract

Monogenic disorders account for a large proportion of population-attributable risk for neurodevelopmental disabilities. However, the data necessary to infer a causal relationship between a given genetic variant and a particular neurodevelopmental disorder is often lacking. Recognizing this scientific roadblock, 13 Intellectual and Developmental Disabilities Research Centers (IDDRCs) formed a consortium to create the Brain Gene Registry (BGR), a repository pairing clinical genetic data with phenotypic data from participants with variants in putative brain genes. Phenotypic profiles are assembled from the electronic health record (EHR) and a battery of remotely administered standardized assessments collectively referred to as the Rapid Neurobehavioral Assessment Protocol (RNAP), which include cognitive, neurologic, and neuropsychiatric assessments, as well as assessments for attention deficit hyperactivity disorder (ADHD) and autism spectrum disorder (ASD). Co-enrollment of BGR participants in the Clinical Genome Resource's (ClinGen's) GenomeConnect enables display of variant information in ClinVar. The BGR currently contains data on 479 participants who are 55% male, 6% Asian, 6% Black or African American, 76% white, and 12% Hispanic/Latine. Over 200 genes are represented in the BGR, with 12 or more participants harboring variants in each of these genes: CACNA1A, DNMT3A, SLC6A1, SETD5, and MYT1L. More than 30% of variants are de novo and 43% are classified as variants of uncertain significance (VUSs). Mean standard scores on cognitive or developmental screens are below average for the BGR cohort. EHR data reveal developmental delay as the earliest and most common diagnosis in this sample, followed by speech and language disorders, ASD, and ADHD. BGR data has already been used to accelerate gene-disease validity curation of 36 genes evaluated by ClinGen's BGR Intellectual Disability (ID)-Autism (ASD) Gene Curation Expert Panel. In summary, the BGR is a resource for use by stakeholders interested in advancing translational research for brain genes and continues to recruit participants with clinically reported variants to establish a rich and well-characterized national resource to promote research on neurodevelopmental disorders. [ABSTRACT FROM AUTHOR]

Published
2024
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33. Physician services and costs after disclosure of diagnostic sequencing results in the NYCKidSeq program

Author

Berkalieva, Asem, primary, Kelly, Nicole R., additional, Fisher, Ashley, additional, Hohmann, Samuel F., additional, Sebastin, Monisha, additional, Di Biase, Miranda, additional, Bonini, Katherine E., additional, Marathe, Priya, additional, Odgis, Jacqueline A., additional, Suckiel, Sabrina A., additional, Ramos, Michelle A., additional, Rhodes, Rosamond, additional, Abul-Husn, Noura S., additional, Greally, John M., additional, Horowitz, Carol R., additional, Wasserstein, Melissa P., additional, Kenny, Eimear E., additional, Gelb, Bruce D., additional, and Ferket, Bart S., additional

Published
2023
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34. Reversal of interstitial lung disease after olipudase alfa enzyme replacement therapy in adults with acid sphingomyelinase deficiency

Author

Bonella, Francesco, primary, Wasserstein, Melissa, additional, Giugliani, Roberto, additional, Lachmann, Robin, additional, Noth, Imre, additional, Scarpa, Maurizio, additional, Wuyts, Wim A, additional, Aguiar, Mario, additional, Armstrong, Nicole M, additional, Jessel, Andreas, additional, Kumar, Monica, additional, Waters, Sara, additional, and Berger, Kenneth I, additional

Published
2023
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36. P1483: LONG-TERM IMPACT OF OLIPUDASE ALFA ENZYME REPLACEMENT THERAPY ON SPLEEN VOLUME AND HEMATOLOGIC MANIFESTATIONS IN CHILDREN AND ADULTS WITH CHRONIC ACID SPHINGOMYELINASE DEFICIENCY

Author

Villarrubia, Jesus, primary, Ganesh, Jaya, additional, Giugliani, Roberto, additional, Guffon, Nathalie, additional, Mengel, Eugen, additional, Scarpa, Maurizio, additional, Wasserstein, Melissa, additional, Armstrong, Nicole, additional, Maja, Gasparic, additional, Kim, Yong, additional, Wong, Holly, additional, and Yarramaneni, Abhimanyu, additional

Published
2023
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37. The NYCKidSeq randomized controlled trial: Impact of GUÍA digitally enhanced genetic counseling in racially and ethnically diverse families

Author

Suckiel, Sabrina A., primary, Kelly, Nicole R., additional, Odgis, Jacqueline A., additional, Gallagher, Katie M., additional, Sebastin, Monisha, additional, Bonini, Katherine E., additional, Marathe, Priya N., additional, Brown, Kaitlyn, additional, Biase, Miranda Di, additional, Ramos, Michelle A., additional, Rodriguez, Jessica E., additional, Scarimbolo, Laura, additional, Insel, Beverly J., additional, Ferar, Kathleen D.M., additional, Zinberg, Randi E., additional, Diaz, George A., additional, Greally, John M., additional, Abul-Husn, Noura S., additional, Bauman, Laurie J., additional, Gelb, Bruce D., additional, Horowitz, Carol R., additional, Wasserstein, Melissa P., additional, and Kenny, Eimear E., additional

Published
2023
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38. The motivation and process for developing a consortium‐wide time and motion study to estimate resource implications of innovations in the use of genome sequencing to inform patient care.

Author

Hoban, Hannah G., Yip, Tiffany A., Chau, Joanna C., Bensen, Jeannette T., Desrosiers, Lauren R., Finnila, Candice R., Hindorff, Lucia A., Kelly, Nicole R., Lynch, Frances L., Rolf, Bradley A., Smith, Hadley S., Wasserstein, Melissa P., and Hassmiller Lich, Kristen

Subjects
PATIENT care, GENETIC testing, CONSORTIA, ACQUISITION of data, FLOW charts, NUCLEOTIDE sequencing
Abstract

Costs of implementing genomic testing innovations extend beyond the cost of sequencing, affecting personnel and infrastructure for which little data are available. We developed a time and motion (T&M) study within the Clinical Sequencing Evidence‐Generating Research (CSER) consortium to address this gap, and herein describe challenges of conducting T&M studies within a research consortium and the approaches we developed to overcome them. CSER investigators created a subgroup to carry out the T&M study (authors). We describe logistical and administrative challenges associated with resource use data collection across heterogeneous projects conducted in real‐world clinical settings, and our solutions for completing this study and harmonizing data across projects. We delineate processes for feasible data collection on workflow, personnel, and resources required to deliver genetic testing innovations in each CSER project. A critical early step involved developing detailed project‐specific process flow diagrams of innovation implementation in projects' clinical settings. Analyzing diagrams across sites, we identified common process‐step themes, used to organize project‐specific data collection and cross‐project analysis. Given the heterogeneity of innovations, study design, and workflows, which affect resources required to deliver genetic testing innovations, flexibility was necessary to harmonize data collection. Despite its challenges, this heterogeneity provides rich insights about variation in clinical processes and resource implications for implementing genetic testing innovations. [ABSTRACT FROM AUTHOR]

Published
2024
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43. Contributors

Author

Abdel-Wahab, Omar, primary, Abrahm, Janet L., additional, Adams, Sharon, additional, Adewoye, Adeboye H., additional, Allen, Carl, additional, Ambinder, Richard F., additional, Anasetti, Claudio, additional, Anastasi, John, additional, Anderson, Julia A., additional, Antin, Joseph H., additional, Antony, Aśok C., additional, Araten, David J., additional, Armand, Philippe, additional, Armstrong, Gillian, additional, Armstrong, Scott A., additional, Arnold, Donald M., additional, Artz, Andrew S., additional, Awan, Farrukh T., additional, Baglin, Trevor P., additional, Benson, Don M., additional, Benz, Edward J., additional, Berliner, Nancy, additional, Bhagat, Govind, additional, Bhardwaj, Nina, additional, Bhatia, Ravi, additional, Bhatia, Smita, additional, Bhatt, Mihir D., additional, Bhatt, Vijaya Raj, additional, Bitan, Menachem, additional, Blinderman, Craig D., additional, Bollard, Catherine M., additional, Braun, Benjamin S., additional, Brenner, Malcolm K., additional, Brittenham, Gary M., additional, Brodsky, Robert A., additional, Brown, Myles, additional, Broxmeyer, Hal E., additional, Brummel-Ziedins, Kathleen, additional, Brunner, Andrew M., additional, Buadi, Francis K., additional, Burkhardt, Birgit, additional, Burns, Melissa, additional, Byrd, John C., additional, Caimi, Paolo F., additional, Caligiuri, Michael A., additional, Canavan, Michelle, additional, Cantor, Alan B., additional, Carcao, Manuel, additional, Carroll, Michael C., additional, Carty, Shannon A., additional, Castillo, Jorge J., additional, Chan, Anthony K.C., additional, Chapin, John, additional, Chiu, April, additional, Chute, John P., additional, Clark, David B., additional, Coates, Thomas D., additional, Cogle, Christopher R., additional, Connell, Nathan T., additional, Cooke, Elizabeth, additional, Cooley, Sarah, additional, Corradini, Paolo, additional, Creager, Mark A., additional, Creger, Richard J., additional, Cromwell, Caroline, additional, Crowther, Mark A., additional, Cushing, Melissa M., additional, Cutler, Corey, additional, Dang, Chi V., additional, Danial, Nika N., additional, Dave, Sandeep S., additional, DeCaprio, James A., additional, Dinauer, Mary C., additional, Dinner, Shira, additional, Diz-Küçükkaya, Reyhan, additional, Dodd, Roger Y., additional, Donato, Michele L., additional, Dorshkind, Kenneth, additional, Dotti, Gianpietro, additional, Dror, Yigal, additional, Dunleavy, Kieron, additional, Dvorak, Christopher C., additional, Ebert, Benjamin L., additional, Eck, Michael J., additional, Eikelboom, John W., additional, Epperla, Narendranath, additional, Ershler, William B., additional, Evans, William E., additional, Faderl, Stefan, additional, Ferrara, James L.M., additional, Filipovich, Alexandra Hult, additional, Fischer, Martin, additional, Fredenburgh, James C., additional, Friedman, Kenneth D., additional, Fuchs, Ephraim, additional, Fuller, Stephen J., additional, Gailani, David, additional, Galipeau, Jacques, additional, Gallagher, Patrick G., additional, Ganapathi, Karthik A., additional, Gardner, Lawrence B., additional, Gee, Adrian P., additional, Gerson, Stanton L., additional, Gertz, Morie A., additional, Giardina, Patricia J., additional, Gibson, Christopher J., additional, Golan, Karin, additional, Golub, Todd R., additional, Gonzales, Matthew J., additional, Gotlib, Jason, additional, Gottschalk, Stephen, additional, Grant, Marianne A., additional, Graubert, Timothy A., additional, Gregg, Xylina T., additional, Gribben, John G., additional, Gross, Dawn M., additional, Gruber, Tanja A., additional, Guitart, Joan, additional, Gurbuxani, Sandeep, additional, Gur-Cohen, Shiri, additional, Gutierrez, Alejandro, additional, Hamadani, Mehdi, additional, Hari, Parameswaran N., additional, Hartwig, John H., additional, Hayman, Suzanne R., additional, Hayward, Catherine P.M., additional, Hebbel, Robert P., additional, Heslop, Helen E., additional, Hillis, Christopher, additional, Hillyer, Christopher D., additional, Ho, Karin, additional, Hockenbery, David M., additional, Hoffman, Ronald, additional, Hogg, Kerstin E., additional, Holtan, Shernan G., additional, Horny, Hans-Peter, additional, Hsu, Yen-Michael S., additional, Hunter, Zachary R., additional, Huntington, James A., additional, Iancu-Rubin, Camelia, additional, Iqbal, Ali, additional, Isenman, David E., additional, Israels, Sara J., additional, Italiano, Joseph E., additional, Jaffe, Elaine S., additional, Jaffer, Iqbal H., additional, Jagannath, Sundar, additional, Jäger, Ulrich, additional, Jain, Nitin, additional, James, Paula, additional, Jeha, Sima, additional, Jordan, Michael B., additional, Josephson, Cassandra D., additional, Jung, Moonjung, additional, Kager, Leo, additional, Kambayashi, Taku, additional, Kanakry, Jennifer A., additional, Kantarjian, Hagop M., additional, Kaplan, Jason, additional, Karafin, Matthew S., additional, Karsan, Aly, additional, Kaufman, Randal J., additional, Kaufman, Richard M., additional, Keller, Frank G., additional, Kelly, Kara M., additional, Kessler, Craig M., additional, Key, Nigel S., additional, Keyzner, Alla, additional, Khandoga, Alexander G., additional, Khanna-Gupta, Arati, additional, Khatib-Massalha, Eman, additional, Klein, Harvey G., additional, Knoechel, Birgit, additional, Kollet, Orit, additional, Konkle, Barbara A., additional, Kontoyiannis, Dimitrios P., additional, Koreth, John, additional, Koretzky, Gary A., additional, Kotecha, Dipak, additional, Kremyanskaya, Marina, additional, Kumari, Anju, additional, Kuzel, Timothy M., additional, Küppers, Ralf, additional, Lacy, Martha Q., additional, Ladas, Elana, additional, Landier, Wendy, additional, Lapid, Kfir, additional, Lapidot, Tsvee, additional, Larson, Peter J., additional, Levi, Marcel, additional, Lewis, Russell E., additional, Liebman, Howard A., additional, Lillicrap, David, additional, Lim, Wendy, additional, Lin, Judith C., additional, Lindblad, Robert, additional, Lip, Gregory Y.H., additional, Little, Jane A., additional, Lohr, Jens G., additional, López, José A., additional, Luscinskas, Francis W., additional, Maciejewski, Jaroslaw P., additional, Majhail, Navneet S., additional, Manches, Olivier, additional, Mandle, Robert J., additional, Mann, Kenneth G., additional, Manno, Catherine S., additional, Marcogliese, Andrea N., additional, Mariani, Guglielmo, additional, Marincola, Francesco M., additional, Mascarenhas, John, additional, Massberg, Steffen, additional, McEver, Rodger P., additional, McGrath, Emer, additional, McKinney, Matthew S., additional, Mehta, Rohtesh S., additional, Mentzer, William C., additional, Merlini, Giampaolo, additional, Merryman, Reid, additional, Michel, Marc, additional, Migliaccio, Anna Rita, additional, Miller, Jeffrey S., additional, Mims, Martha P., additional, Mondoro, Traci Heath, additional, Moorehead, Paul, additional, Muniz, Luciana R., additional, Munshi, Nikhil C., additional, Najfeld, Vesna, additional, Nayak, Lalitha, additional, Nazy, Ishac, additional, Neff, Anne T., additional, Ness, Paul M., additional, Notarangelo, Luigi D., additional, O'Brien, Sarah H., additional, O'Connor, Owen A., additional, O'Donnell, Martin, additional, Olson, Amanda, additional, Orkin, Stuart H., additional, Pai, Menaka, additional, Pai, Sung-Yun, additional, Paidas, Michael, additional, Panch, Sandhya R., additional, Pande, Reena L., additional, Papayannopoulou, Thalia, additional, Parikh, Rahul, additional, Petersdorf, Effie W., additional, Peterson, Shane E., additional, Pittaluga, Stefania, additional, Ponce, Doris M., additional, Popolo, Laura, additional, Prchal, Josef T., additional, Pui, Ching-Hon, additional, Puigserver, Pere, additional, Rak, Janusz, additional, Ramos, Carlos A., additional, Rand, Jacob H., additional, Rand, Margaret L., additional, Rao, Dinesh S., additional, Ravandi, Farhad, additional, Rawlings, David J., additional, Reddy, Pavan, additional, Reding, Mark T., additional, Reiter, Andreas, additional, Rice, Lawrence, additional, Riese, Matthew J., additional, Ritchey, Arthur Kim, additional, Roberts, David J., additional, Roman, Elizabeth, additional, Rooney, Cliona M., additional, Rosen, Steven T., additional, Rosenthal, David S., additional, Rossmann, Marlies P., additional, Rot, Antal, additional, Rowley, Scott D., additional, Rubnitz, Jeffrey E., additional, Rydz, Natalia, additional, Salama, Mohamed E., additional, Sauk, Steven, additional, Saunthararajah, Yogen, additional, Savage, William, additional, Scadden, David, additional, Schaefer, Kristen G., additional, Schiffman, Fred, additional, Schneidewend, Robert, additional, Schrier, Stanley L., additional, Schuchman, Edward H., additional, Scullion, Bridget Fowler, additional, Selvaggi, Kathy J., additional, Senoo, Keitaro, additional, Shaheen, Montaser, additional, Shaz, Beth H., additional, Shelburne, Samuel A., additional, Shpall, Elizabeth J., additional, Shurin, Susan B., additional, Siegal, Deborah, additional, Silberstein, Leslie E., additional, Silberstein, Lev, additional, Silverstein, Roy L., additional, Sloan, Steven R., additional, Smith, Franklin O., additional, Smith, James W., additional, Smith, Katy, additional, Steensma, David P., additional, Steinberg, Martin H., additional, Stock, Wendy, additional, Storry, Jill R., additional, Stramer, Susan L., additional, Strauss, Ronald G., additional, Stroncek, David F., additional, Taylor, Justin, additional, Thota, Swapna, additional, Treon, Steven P., additional, Tulpule, Anil, additional, Valdes, Roberto Ferro, additional, Valent, Peter, additional, Vedantham, Suresh, additional, Vercellotti, Gregory M., additional, Verneris, Michael R., additional, Vichinsky, Elliott P., additional, von Andrian, Ulrich H., additional, Vose, Julie M., additional, Wagner, Andrew J., additional, Wang, Ena, additional, Wang, Jia-huai, additional, Warkentin, Theodore E., additional, Wasserstein, Melissa P., additional, Webster, Ann, additional, Weisdorf, Daniel J., additional, Weitz, Jeffrey I., additional, Westhoff, Connie M., additional, Wheeler, Allison P., additional, Widick, Page, additional, Wiley, James S., additional, William, Basem M., additional, Williams, David A., additional, Wilson, Wyndham H., additional, Wolfe, Joanne, additional, Wolgast, Lucia R., additional, Wood, Deborah, additional, Wu, Jennifer, additional, Yahalom, Joachim, additional, Yee, Donald L., additional, Younes, Anas, additional, Young, Neal S., additional, and Zeller, Michelle P., additional

Published
2018
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46. A concerted action to explore therapies for free sialic acid storage disease

Author

Huizing, Marjan, primary, Walkley, Steven U., additional, Wasserstein, Melissa, additional, Anne-Longin, Christine, additional, Wang, Raymond Y., additional, Reimer, Richard, additional, Pollard, Laura, additional, Paavola, Liisa, additional, Malicdan, May Christine, additional, Sabir, Marya S., additional, Leoyklang, Petcharat, additional, Adams, David R., additional, and Gahl, William A., additional

Published
2023
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48. Are we prepared to deliver gene‐targeted therapies for rare diseases?

Author

Yu, Timothy W., primary, Kingsmore, Stephen F., additional, Green, Robert C., additional, MacKenzie, Tippi, additional, Wasserstein, Melissa, additional, Caggana, Michele, additional, Gold, Nina B., additional, Kennedy, Annie, additional, Kishnani, Priya S., additional, Might, Matthew, additional, Brooks, Phillip J., additional, Morris, Jill A., additional, Parisi, Melissa A., additional, and Urv, Tiina K., additional

Published
2023
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49. P245: GUÍA application: Effectiveness in enhancing communication of genomic results in diverse, multilingual populations*

Author

Marathe, Priya, primary, Suckiel, Sabrina, additional, Odgis, Jacqueline, additional, Gallagher, Katie, additional, Sebastin, Monisha, additional, Bonini, Katherine, additional, Brown, Kaitlyn, additional, Di Biase, Miranda, additional, Kelly, Nicole, additional, Ramos, Michelle, additional, Rodriguez, Jessica, additional, Scarimbolo, Laura, additional, Insel, Beverly, additional, Zinberg, Randi, additional, Diaz, George, additional, Greally, John, additional, Abul-Husn, Noura, additional, Bauman, Laurie, additional, Horowitz, Carol, additional, Gelb, Bruce, additional, Wasserstein, Melissa, additional, and Kenny, Eimear, additional

Published
2023
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