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3. Microdystrophin Expression as a Surrogate Endpoint for Duchenne Muscular Dystrophy Clinical Trials

Author

Chamberlain, Jeffrey S, Robb, Melissa, Braun, Serge, Brown, Kristy J, Danos, Olivier, Ganot, Annie, Gonzalez-Alegre, Pedro, Hunter, Nina, McDonald, Craig, Morris, Carl, Tobolowsky, Mark, Wagner, Kathryn R, Ziolkowski, Olivia, and Duan, Dongsheng

Subjects
Medical Biotechnology, Biomedical and Clinical Sciences, Regenerative Medicine, Clinical Trials and Supportive Activities, Biotechnology, Intellectual and Developmental Disabilities (IDD), Gene Therapy, Orphan Drug, Duchenne/ Becker Muscular Dystrophy, Pediatric, Brain Disorders, Muscular Dystrophy, Rare Diseases, Genetics, Clinical Research, 5.2 Cellular and gene therapies, Development of treatments and therapeutic interventions, Musculoskeletal, Male, Humans, Muscular Dystrophy, Duchenne, Muscle, Skeletal, Genetic Therapy, Gene Transfer Techniques, Biomarkers, microdystrophin, Duchenne muscular dystrophy, gene therapy, AAV vector, Clinical Sciences, Medical biotechnology
Abstract

Duchenne muscular dystrophy (DMD) is a serious, rare genetic disease, affecting primarily boys. It is caused by mutations in the DMD gene and is characterized by progressive muscle degeneration that results in loss of function and early death due to respiratory and/or cardiac failure. Although limited treatment options are available, some for only small subsets of the patient population, DMD remains a disease with large unmet medical needs. The adeno-associated virus (AAV) vector is the leading gene delivery system for addressing genetic neuromuscular diseases. Since the gene encoding the full-length dystrophin protein exceeds the packaging capacity of a single AAV vector, gene replacement therapy based on AAV-delivery of shortened, yet, functional microdystrophin genes has emerged as a promising treatment. This article seeks to explain the rationale for use of the accelerated approval pathway to advance AAV microdystrophin gene therapy for DMD. Specifically, we provide support for the use of microdystrophin expression as a surrogate endpoint that could be used in clinical trials to support accelerated approval.

Published
2023

7. Are you effectively managing your managed care billing?

Author

Brown, Kristy

Subjects
Managed care plans (Medical care), Practical nurses, Nursing homes, Company business management, Business, Health, Health care industry, Seniors
Abstract

With the announcement of the nursing home minimum staffing rule, I asked myself the same question as operators nationwide: how on earth are we going to pay for this? Even [...]

Published
2024

13. Extracellular Vesicle and Particle Biomarkers Define Multiple Human Cancers

Author

Hoshino, Ayuko, Kim, Han Sang, Bojmar, Linda, Gyan, Kofi Ennu, Cioffi, Michele, Hernandez, Jonathan, Zambirinis, Constantinos P., Rodrigues, Gonçalo, Molina, Henrik, Heissel, Søren, Mark, Milica Tesic, Steiner, Loïc, Benito-Martin, Alberto, Lucotti, Serena, Di Giannatale, Angela, Offer, Katharine, Nakajima, Miho, Williams, Caitlin, Nogués, Laura, Pelissier Vatter, Fanny A., Hashimoto, Ayako, Davies, Alexander E., Freitas, Daniela, Kenific, Candia M., Ararso, Yonathan, Buehring, Weston, Lauritzen, Pernille, Ogitani, Yusuke, Sugiura, Kei, Takahashi, Naoko, Alečković, Maša, Bailey, Kayleen A., Jolissant, Joshua S., Wang, Huajuan, Harris, Ashton, Schaeffer, L. Miles, García-Santos, Guillermo, Posner, Zoe, Balachandran, Vinod P., Khakoo, Yasmin, Raju, G. Praveen, Scherz, Avigdor, Sagi, Irit, Scherz-Shouval, Ruth, Yarden, Yosef, Oren, Moshe, Malladi, Mahathi, Petriccione, Mary, De Braganca, Kevin C., Donzelli, Maria, Fischer, Cheryl, Vitolano, Stephanie, Wright, Geraldine P., Ganshaw, Lee, Marrano, Mariel, Ahmed, Amina, DeStefano, Joe, Danzer, Enrico, Roehrl, Michael H.A., Lacayo, Norman J., Vincent, Theresa C., Weiser, Martin R., Brady, Mary S., Meyers, Paul A., Wexler, Leonard H., Ambati, Srikanth R., Chou, Alexander J., Slotkin, Emily K., Modak, Shakeel, Roberts, Stephen S., Basu, Ellen M., Diolaiti, Daniel, Krantz, Benjamin A., Cardoso, Fatima, Simpson, Amber L., Berger, Michael, Rudin, Charles M., Simeone, Diane M., Jain, Maneesh, Ghajar, Cyrus M., Batra, Surinder K., Stanger, Ben Z., Bui, Jack, Brown, Kristy A., Rajasekhar, Vinagolu K., Healey, John H., de Sousa, Maria, Kramer, Kim, Sheth, Sujit, Baisch, Jeanine, Pascual, Virginia, Heaton, Todd E., La Quaglia, Michael P., Pisapia, David J., Schwartz, Robert, Zhang, Haiying, Liu, Yuan, Shukla, Arti, Blavier, Laurence, DeClerck, Yves A., LaBarge, Mark, Bissell, Mina J., Caffrey, Thomas C., Grandgenett, Paul M., Hollingsworth, Michael A., Bromberg, Jacqueline, Costa-Silva, Bruno, Peinado, Hector, Kang, Yibin, Garcia, Benjamin A., O’Reilly, Eileen M., Kelsen, David, Trippett, Tanya M., Jones, David R., Matei, Irina R., Jarnagin, William R., and Lyden, David

Published
2020
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14. Assessing Long-Term Volume Retention in Breast Fat Grafting

Author

Chen, Yunchan, primary, Arbuiso, Sophia, additional, Vernice, Nicholas A., additional, Black, Grant G., additional, Wang, Marcos Lu, additional, Liao, Matthew W., additional, Medina, Samuel J., additional, Brown, Kristy A., additional, and Otterburn, David, additional

Published
2024
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15. Serum pharmacodynamic biomarkers for chronic corticosteroid treatment of children.

Author

Hoffman, Eric, Hathout, Yetrib, Conklin, Laurie, Seol, Haeri, Gordish-Dressman, Heather, Brown, Kristy, Morgenroth, Lauren, Nagaraju, Kanneboyina, Heier, Christopher, Damsker, Jesse, van den Anker, John, Henricson, Erik, Clemens, Paula, Mah, Jean, and McDonald, Craig

Subjects
Adolescent, Adrenal Cortex Hormones, Anti-Inflammatory Agents, Biomarkers, Blood Proteins, Case-Control Studies, Child, Child, Preschool, Cross-Sectional Studies, Female, Humans, Inflammation Mediators, Inflammatory Bowel Diseases, Longitudinal Studies, Male, Muscular Dystrophy, Duchenne, Proteome
Abstract

Corticosteroids are extensively used in pediatrics, yet the burden of side effects is significant. Availability of a simple, fast, and reliable biochemical read out of steroidal drug pharmacodynamics could enable a rapid and objective assessment of safety and efficacy of corticosteroids and aid development of corticosteroid replacement drugs. To identify potential corticosteroid responsive biomarkers we performed proteome profiling of serum samples from DMD and IBD patients with and without corticosteroid treatment using SOMAscan aptamer panel testing 1,129 proteins in

Published
2016

22. Discovery of serum protein biomarkers in the mdx mouse model and cross-species comparison to Duchenne muscular dystrophy patients.

Author

Hathout, Yetrib, Marathi, Ramya, Rayavarapu, Sree, Zhang, Aiping, Brown, Kristy, Seol, Haeri, Gordish-Dressman, Heather, Cirak, Sebahattin, Bello, Luca, Nagaraju, Kanneboyina, Partridge, Terry, Hoffman, Eric, Takeda, Shinichi, Mah, Jean, Henricson, Erik, and McDonald, Craig

Subjects
Adolescent, Aging, Animals, Biomarkers, Blood Proteins, Child, Child, Preschool, Cluster Analysis, Dystrophin, Female, Gene Expression, Humans, Male, Mice, Mice, Inbred C57BL, Mice, Inbred mdx, Molecular Sequence Annotation, Muscular Dystrophy, Animal, Muscular Dystrophy, Duchenne, Species Specificity
Abstract

It is expected that serum protein biomarkers in Duchenne muscular dystrophy (DMD) will reflect disease pathogenesis, progression and aid future therapy developments. Here, we describe use of quantitative in vivo stable isotope labeling in mammals to accurately compare serum proteomes of wild-type and dystrophin-deficient mdx mice. Biomarkers identified in serum from two independent dystrophin-deficient mouse models (mdx-Δ52 and mdx-23) were concordant with those identified in sera samples of DMD patients. Of the 355 mouse sera proteins, 23 were significantly elevated and 4 significantly lower in mdx relative to wild-type mice (P-value < 0.001). Elevated proteins were mostly of muscle origin: including myofibrillar proteins (titin, myosin light chain 1/3, myomesin 3 and filamin-C), glycolytic enzymes (aldolase, phosphoglycerate mutase 2, beta enolase and glycogen phosphorylase), transport proteins (fatty acid-binding protein, myoglobin and somatic cytochrome-C) and others (creatine kinase M, malate dehydrogenase cytosolic, fibrinogen and parvalbumin). Decreased proteins, mostly of extracellular origin, included adiponectin, lumican, plasminogen and leukemia inhibitory factor receptor. Analysis of sera from 1 week to 7 months old mdx mice revealed age-dependent changes in the level of these biomarkers with most biomarkers acutely elevated at 3 weeks of age. Serum analysis of DMD patients, with ages ranging from 4 to 15 years old, confirmed elevation of 20 of the murine biomarkers in DMD, with similar age-related changes. This study provides a panel of biomarkers that reflect muscle activity and pathogenesis and should prove valuable tool to complement natural history studies and to monitor treatment efficacy in future clinical trials.

Published
2014

23. Breast adipose tissue‐derived extracellular vesicles from obese women alter tumor cell metabolism

Author

Liu, Shuchen, primary, Benito‐Martin, Alberto, additional, Pelissier Vatter, Fanny A, additional, Hanif, Sarah Z, additional, Liu, Catherine, additional, Bhardwaj, Priya, additional, Sethupathy, Praveen, additional, Farghli, Alaa R, additional, Piloco, Phoebe, additional, Paik, Paul, additional, Mushannen, Malik, additional, Dong, Xue, additional, Otterburn, David M, additional, Cohen, Leslie, additional, Bareja, Rohan, additional, Krumsiek, Jan, additional, Cohen‐Gould, Leona, additional, Calto, Samuel, additional, Spector, Jason A, additional, Elemento, Olivier, additional, Lyden, David C, additional, and Brown, Kristy A, additional

Published
2023
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25. Breast Cancer Macrophage Heterogeneity and Self-renewal are Determined by Spatial Localization

Author

Ben-Chetrit, Nir, primary, Niu, Xiang, additional, Sotelo, Jesus, additional, Swett, Ariel D., additional, Rajasekhar, Vinagolu K., additional, Jiao, Maria S., additional, Stewart, Caitlin M., additional, Bhardwaj, Priya, additional, Kottapalli, Sanjay, additional, Ganesan, Saravanan, additional, Loyher, Pierre-Louis, additional, Potenski, Catherine, additional, Hannuna, Assaf, additional, Brown, Kristy A., additional, Iyengar, Neil M., additional, Giri, Dilip D., additional, Lowe, Scott W., additional, Healey, John H., additional, Geissmann, Frederic, additional, Sagi, Irit, additional, Joyce, Johanna A., additional, and Landau, Dan A., additional

Published
2023
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26. Sex-steroid hormones and risk of postmenopausal estrogen receptor-positive breast cancer: a case-cohort analysis

Author

Albers, Frances EM, primary, Lou, Makayla WC, additional, Dashti, S Ghazaleh, additional, Swain, Christopher TV, additional, Rinaldi, Sabina, additional, Viallon, Vivian, additional, Karahalios, Amalia, additional, Brown, Kristy A, additional, Gunter, Marc J, additional, Milne, Roger L, additional, English, Dallas R, additional, and Lynch, Brigid M, additional

Published
2023
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37. Supplementary Tables 1-4; Supplementary Figures 1-4 from Linking Physical Activity to Breast Cancer Risk via the Insulin/Insulin-like Growth Factor Signaling System, Part 2: The Effect of Insulin/Insulin-like Growth Factor Signaling on Breast Cancer Risk

Author

Drummond, Ann E., primary, Swain, Christopher T.V., primary, Milne, Roger L., primary, English, Dallas R., primary, Brown, Kristy A., primary, Skinner, Tina L., primary, Lay, Jannelle, primary, van Roekel, Eline H., primary, Moore, Melissa M., primary, Gaunt, Tom R., primary, Martin, Richard M., primary, Lewis, Sarah J., primary, and Lynch, Brigid M., primary

Published
2023
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38. Data from Linking Physical Activity to Breast Cancer Risk via the Insulin/Insulin-like Growth Factor Signaling System, Part 2: The Effect of Insulin/Insulin-like Growth Factor Signaling on Breast Cancer Risk

Author

Drummond, Ann E., primary, Swain, Christopher T.V., primary, Milne, Roger L., primary, English, Dallas R., primary, Brown, Kristy A., primary, Skinner, Tina L., primary, Lay, Jannelle, primary, van Roekel, Eline H., primary, Moore, Melissa M., primary, Gaunt, Tom R., primary, Martin, Richard M., primary, Lewis, Sarah J., primary, and Lynch, Brigid M., primary

Published
2023
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39. Supplementary Figure from Linking Physical Activity to Breast Cancer Risk via the Insulin/Insulin-like Growth Factor Signaling System, Part 2: The Effect of Insulin/Insulin-like Growth Factor Signaling on Breast Cancer Risk

Author

Drummond, Ann E., primary, Swain, Christopher T.V., primary, Milne, Roger L., primary, English, Dallas R., primary, Brown, Kristy A., primary, Skinner, Tina L., primary, Lay, Jannelle, primary, van Roekel, Eline H., primary, Moore, Melissa M., primary, Gaunt, Tom R., primary, Martin, Richard M., primary, Lewis, Sarah J., primary, and Lynch, Brigid M., primary

Published
2023
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40. Data from Linking Physical Activity to Breast Cancer Risk via Insulin/Insulin-Like Growth Factor Signaling System, Part 1: The Effect of Physical Activity on the Insulin/Insulin-Like Growth Factor Signaling System

Author

Swain, Christopher T.V., primary, Drummond, Ann E., primary, Milne, Roger L., primary, English, Dallas R., primary, Brown, Kristy A., primary, Chong, Jamie E., primary, Skinner, Tina L., primary, van Roekel, Eline H., primary, Moore, Melissa M., primary, Gaunt, Tom R., primary, Martin, Richard M., primary, Lewis, Sarah J., primary, and Lynch, Brigid M., primary

Published
2023
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41. Supplementary Figure from Linking Physical Activity to Breast Cancer Risk via Insulin/Insulin-Like Growth Factor Signaling System, Part 1: The Effect of Physical Activity on the Insulin/Insulin-Like Growth Factor Signaling System

Author

Swain, Christopher T.V., primary, Drummond, Ann E., primary, Milne, Roger L., primary, English, Dallas R., primary, Brown, Kristy A., primary, Chong, Jamie E., primary, Skinner, Tina L., primary, van Roekel, Eline H., primary, Moore, Melissa M., primary, Gaunt, Tom R., primary, Martin, Richard M., primary, Lewis, Sarah J., primary, and Lynch, Brigid M., primary

Published
2023
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42. Figure S1A from Linking Physical Activity to Breast Cancer Risk via Inflammation, Part 1: The Effect of Physical Activity on Inflammation

Author

Swain, Christopher T.V., primary, Drummond, Ann E., primary, Milne, Roger L., primary, English, Dallas R., primary, Brown, Kristy A., primary, Lou, Makayla W.C., primary, Boing, Leonessa, primary, Bageley, Amy, primary, Skinner, Tina L., primary, van Roekel, Eline H., primary, Moore, Melissa M., primary, Gaunt, Tom R., primary, Martin, Richard M., primary, Lewis, Sarah J., primary, and Lynch, Brigid M., primary

Published
2023
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43. Table S6B from Linking Physical Activity to Breast Cancer Risk via Inflammation, Part 1: The Effect of Physical Activity on Inflammation

Author

Swain, Christopher T.V., primary, Drummond, Ann E., primary, Milne, Roger L., primary, English, Dallas R., primary, Brown, Kristy A., primary, Lou, Makayla W.C., primary, Boing, Leonessa, primary, Bageley, Amy, primary, Skinner, Tina L., primary, van Roekel, Eline H., primary, Moore, Melissa M., primary, Gaunt, Tom R., primary, Martin, Richard M., primary, Lewis, Sarah J., primary, and Lynch, Brigid M., primary

Published
2023
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44. Figure 1 from Linking Physical Activity to Breast Cancer Risk via Inflammation, Part 1: The Effect of Physical Activity on Inflammation

Author

Swain, Christopher T.V., primary, Drummond, Ann E., primary, Milne, Roger L., primary, English, Dallas R., primary, Brown, Kristy A., primary, Lou, Makayla W.C., primary, Boing, Leonessa, primary, Bageley, Amy, primary, Skinner, Tina L., primary, van Roekel, Eline H., primary, Moore, Melissa M., primary, Gaunt, Tom R., primary, Martin, Richard M., primary, Lewis, Sarah J., primary, and Lynch, Brigid M., primary

Published
2023
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45. Data from Linking Physical Activity to Breast Cancer via Inflammation, Part 2: The Effect of Inflammation on Breast Cancer Risk

Author

Lou, Makayla W.C., primary, Drummond, Ann E., primary, Swain, Christopher T.V., primary, Milne, Roger L., primary, English, Dallas R., primary, Brown, Kristy A., primary, van Roekel, Eline H., primary, Skinner, Tina L., primary, Moore, Melissa M., primary, Gaunt, Tom R., primary, Martin, Richard M., primary, Lewis, Sarah J., primary, and Lynch, Brigid M., primary

Published
2023
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46. Table S1 from Linking Physical Activity to Breast Cancer via Inflammation, Part 2: The Effect of Inflammation on Breast Cancer Risk

Author

Lou, Makayla W.C., primary, Drummond, Ann E., primary, Swain, Christopher T.V., primary, Milne, Roger L., primary, English, Dallas R., primary, Brown, Kristy A., primary, van Roekel, Eline H., primary, Skinner, Tina L., primary, Moore, Melissa M., primary, Gaunt, Tom R., primary, Martin, Richard M., primary, Lewis, Sarah J., primary, and Lynch, Brigid M., primary

Published
2023
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47. Figure S1E from Linking Physical Activity to Breast Cancer via Inflammation, Part 2: The Effect of Inflammation on Breast Cancer Risk

Author

Lou, Makayla W.C., primary, Drummond, Ann E., primary, Swain, Christopher T.V., primary, Milne, Roger L., primary, English, Dallas R., primary, Brown, Kristy A., primary, van Roekel, Eline H., primary, Skinner, Tina L., primary, Moore, Melissa M., primary, Gaunt, Tom R., primary, Martin, Richard M., primary, Lewis, Sarah J., primary, and Lynch, Brigid M., primary

Published
2023
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48. Table 1 from Linking Physical Activity to Breast Cancer Risk via Inflammation, Part 1: The Effect of Physical Activity on Inflammation

Author

Swain, Christopher T.V., primary, Drummond, Ann E., primary, Milne, Roger L., primary, English, Dallas R., primary, Brown, Kristy A., primary, Lou, Makayla W.C., primary, Boing, Leonessa, primary, Bageley, Amy, primary, Skinner, Tina L., primary, van Roekel, Eline H., primary, Moore, Melissa M., primary, Gaunt, Tom R., primary, Martin, Richard M., primary, Lewis, Sarah J., primary, and Lynch, Brigid M., primary

Published
2023
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49. Table 1 from Linking Physical Activity to Breast Cancer via Inflammation, Part 2: The Effect of Inflammation on Breast Cancer Risk

Author

Lou, Makayla W.C., primary, Drummond, Ann E., primary, Swain, Christopher T.V., primary, Milne, Roger L., primary, English, Dallas R., primary, Brown, Kristy A., primary, van Roekel, Eline H., primary, Skinner, Tina L., primary, Moore, Melissa M., primary, Gaunt, Tom R., primary, Martin, Richard M., primary, Lewis, Sarah J., primary, and Lynch, Brigid M., primary

Published
2023
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50. Figure 2 from Linking Physical Activity to Breast Cancer via Inflammation, Part 2: The Effect of Inflammation on Breast Cancer Risk

Author

Lou, Makayla W.C., primary, Drummond, Ann E., primary, Swain, Christopher T.V., primary, Milne, Roger L., primary, English, Dallas R., primary, Brown, Kristy A., primary, van Roekel, Eline H., primary, Skinner, Tina L., primary, Moore, Melissa M., primary, Gaunt, Tom R., primary, Martin, Richard M., primary, Lewis, Sarah J., primary, and Lynch, Brigid M., primary

Published
2023
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