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1. 508 A Multi-Institutional Look at Single-Patient Expanded Access Submissions

Author

Misty Gravelin, Laurie Rigan, Joan E Adamo, Sharon Ellison, Erika Segear, Amanda Parrish, Christine Deeter, Jennifer Hamill, Erik Soliz, Ahamed Idris, George A Mashour, and Kevin J Weatherwax

Subjects
Medicine
Abstract

OBJECTIVES/GOALS: Physicians can request the clinical use of investigational products for their patients through an FDA pathway called Expanded Access (EA). Most evaluations of EA focus on the FDA submission only. We sought to evaluate these requests through the full academic medical center process. METHODS/STUDY POPULATION: Through the Transforming Expanded Access to Maximize Support and Study grant, we reviewed regulatory records for single-patient EA requests at four institutions (Duke University, University of Rochester, University of Michigan, and University of Texas Southwestern) which occurred between June 1, 2021 and February 28, 2023. Key data was collected, including the investigational product requested, submission and approval dates, urgency of request, and indication for treatment. Descriptive statistics were performed with Microsoft Excel. RESULTS/ANTICIPATED RESULTS: A total of 405 EA requests were identified, of which 319 (78.8%) were for drugs, 59 (14.6%) for biologics, and 27 (6.7%) for medical devices. The majority were characterized as non-emergency (60.7%), but the proportion of emergency to non-emergency cases varied considerably when stratified by year, with a peak in emergency cases in 2020. The most common products included therapies for COVID-19 and Mpox. Median time to obtain all approvals for treatment was 7 days for emergency cases and 28 days for non-emergency. The FDA review took the least time, with a median of 1 day in non-emergency cases. Full board approval from an institutional review board in non-emergency cases was 7 days. DISCUSSION/SIGNIFICANCE: These results generally align with previous reports on EA submissions received by the FDA. The timelines for the EA process represent an important benchmark both for treatment planning and institutional improvement.

Published
2024
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2. 512 Understanding Expanded Access: Who are the Patients?

Author

Misty Gravelin, Joan E Adamo, Sharon Ellison, Erika Segear, Amanda Parrish, Christine Deeter, Jennifer Hamill, Erik Soliz, Ahamed Idris, George A Mashour, Kevin J Weatherwax, and Laurie Rigan

Subjects
Medicine
Abstract

OBJECTIVES/GOALS: The FDA allows physicians to request clinical use of investigational drugs, biologics, and devices for patients with no satisfactory treatment options through a pathway called Expanded Access (EA). TEAMSS (Transforming Expanded Access to Maximize Support and Study) sought to examine single-patient cases to better characterize these patients. METHODS/STUDY POPULATION: We prospectively collected data on requests for single-patient EA at any one of the four collaborating TEAMSS institutions (Duke University, University of Rochester, University of Michigan, and University of Texas Southwestern) between September 1, 2021 and February 28, 2023. Regulatory and health records were reviewed for past cases that occurred between June 1, 2018 and August 31, 2021. Descriptive statistics were performed on data from the submission process, the patient demographics, the indication for treatment, and patient health status over time. RESULTS/ANTICIPATED RESULTS: The patient population was representative with respect to the largest racial groups (69.3% White / 13.0% Black or African American) and legal sex (51.3% male / 48.7% female). All ages were represented, with overrepresentation of those 60-70 years old (16.8%) and under 10 (14.8%). Patients were most often treated for infectious diseases (44.2%) or oncologic conditions (39.0%). Those who received more than one dose stayed on treatment for 76 days (median) and up to 1427 days (maximum). At the end of study, 53.9% had completed treatment as planned, moved to commercial product, or continued treatment. Death, disease progression, or failure to respond occurred for 31.9% of patients. DISCUSSION/SIGNIFICANCE: The population that receives Expanded access treatments is heterogeneous in both demographics and medical conditions. Some successful treatments are continued for years. Many patients complete their treatment, and a minority experience death or disease progression during treatment.

Published
2024
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3. Proceedings from the 9th annual conference on the science of dissemination and implementation

Author

David Chambers, Lisa Simpson, Gila Neta, Ulrica von Thiele Schwarz, Antoinette Percy-Laurry, Gregory A. Aarons, Ross Brownson, Amanda Vogel, Shannon Wiltsey Stirman, Kenneth Sherr, Rachel Sturke, Wynne E. Norton, Allyson Varley, Cynthia Vinson, Lisa Klesges, Suzanne Heurtin-Roberts, M. Rashad Massoud, Leighann Kimble, Arne Beck, Claire Neely, Jennifer Boggs, Carmel Nichols, Wen Wan, Erin Staab, Neda Laiteerapong, Nathalie Moise, Ravi Shah, Susan Essock, Margaret Handley, Amy Jones, Jay Carruthers, Karina Davidson, Lauren Peccoralo, Lloyd Sederer, Todd Molfenter, Ashley Scudder, Sarah Taber-Thomas, Kristen Schaffner, Amy Herschell, Eva Woodward, Jeffery Pitcock, Mona Ritchie, JoAnn Kirchner, Julia E. Moore, Sobia Khan, Shusmita Rashid, Jamie Park, Melissa Courvoisier, Sharon Straus, Daniel Blonigen, Allison Rodriguez, Luisa Manfredi, Andrea Nevedal, Joel Rosenthal, David Smelson, Christine Timko, Nicole Stadnick, Jennifer Regan, Miya Barnett, Anna Lau, Lauren Brookman-Frazee, Erick Guerrero, Karissa Fenwick, Yinfei Kong, Gregory Aarons, Rebecca Lengnick-Hall, Benjamin Henwood, Nina Sayer, Craig Rosen, Robert Orazem, Brandy Smith, Lindsey Zimmerman, David Lounsbury, Rachel Kimerling, Jodie A. Trafton, Steven Lindley, Rahul Bhargava, Hal Roberts, Laura Gibson, Gabriel J. Escobar, Vincent Liu, Benjamin Turk, Arona Ragins, Patricia Kipnis, Ashley Ketterer Gruszkowski, Michael W. Kennedy, Emily Rentschler Drobek, Lior Turgeman, Aleksandra Sasha Milicevic, Terrence L. Hubert, Larissa Myaskovsky, Youxu C. Tjader, Robert J. Monte, Kathryn G. Sapnas, Edmond Ramly, Diane R Lauver, Christie M Bartels, Shereef Elnahal, Andrea Ippolito, Hillary Peabody, Carolyn Clancy, Randall Cebul, Thomas Love, Douglas Einstadter, Shari Bolen, Brook Watts, Vera Yakovchenko, Angela Park, William Lukesh, Donald R. Miller, David Thornton, Mari-Lynn Drainoni, Allen L. Gifford, Shawna Smith, Julia Kyle, Mark S Bauer, Daniel Eisenberg, Celeste Liebrecht, Michelle Barbaresso, Amy Kilbourne, Elyse Park, Giselle Perez, Jamie Ostroff, Sarah Greene, Michael Parchman, Brian Austin, Eric Larson, Stefanie Ferreri, Chris Shea, Megan Smith, Kea Turner, Jennifer Bacci, Kyle Bigham, Geoffrey Curran, Caity Frail, Cory Hamata, Terry Jankowski, Wendy Lantaff, Melissa Somma McGivney, Margie Snyder, Megan McCullough, Chris Gillespie, Beth Ann Petrakis, Ellen Jones, Carol VanDeusen Lukas, Adam Rose, Sarah J. Shoemaker, Jeremy Thomas, Benjamin Teeter, Holly Swan, Appathurai Balamurugan, Meghan Lane-Fall, Rinad Beidas, Laura Di Taranti, Sruthi Buddai, Enrique Torres Hernandez, Jerome Watts, Lee Fleisher, Frances Barg, Isomi Miake-Lye, Tanya Olmos, Emmeline Chuang, Hector Rodriguez, Gerald Kominski, Becky Yano, Stephen Shortell, Mary Hook, Linda Fleisher, Alexander Fiks, Katie Halkyard, Rachel Gruver, Emily Sykes, Kimberly Vesco, Kate Beadle, Joanna Bulkley, Ashley Stoneburner, Michael Leo, Amanda Clark, Joan Smith, Christopher Smyser, Maggie Wolf, Shamik Trivedi, Brian Hackett, Rakesh Rao, F. Sessions Cole, Rose McGonigle, Ann Donze, Enola Proctor, Amit Mathur, Emmanuela Gakidou, Stephen Gloyd, Carolyn Audet, Jose Salato, Sten Vermund, Rivet Amico, Stephanie Smith, Beatha Nyirandagijimana, Hildegarde Mukasakindi, Christian Rusangwa, Molly Franke, Giuseppe Raviola, Matthew Cummings, Elijah Goldberg, Savio Mwaka, Olive Kabajaasi, Adithya Cattamanchi, Achilles Katamba, Shevin Jacob, Nathan Kenya-Mugisha, J. Lucian Davis, Julie Reed, Rohit Ramaswamy, Gareth Parry, Sylvia Sax, Heather Kaplan, Keng-yen Huang, Sabrina Cheng, Susan Yee, Kimberly Hoagwood, Mary McKay, Donna Shelley, Gbenga Ogedegbe, Laurie Miller Brotman, Roman Kislov, John Humphreys, Gill Harvey, Paul Wilson, Robert Lieberthal, Colleen Payton, Mona Sarfaty, George Valko, Rendelle Bolton, Christine Hartmann, Nora Mueller, Sally K. Holmes, Barbara Bokhour, Sarah Ono, Benjamin Crabtree, Leah Gordon, William Miller, Bijal Balasubramanian, Leif Solberg, Deborah Cohen, Kate McGraw, Andrew Blatt, Demietrice Pittman, Helen Kales, Dan Berlowitz, Teresa Hudson, Christian Helfrich, Erin Finley, Ashley Garcia, Kristen Rosen, Claudina Tami, Don McGeary, Mary Jo Pugh, Jennifer Sharpe Potter, Krysttel Stryczek, David Au, Steven Zeliadt, George Sayre, Jennifer Leeman, Allison Myers, Jennifer Grant, Mary Wangen, Tara Queen, Alexandra Morshed, Elizabeth Dodson, Rachel Tabak, Ross C. Brownson, R. Chris Sheldrick, Thomas Mackie, Justeen Hyde, Laurel Leslie, Itzhak Yanovitzky, Matthew Weber, Nicole Gesualdo, Teis Kristensen, Cameo Stanick, Heather Halko, Caitlin Dorsey, Byron Powell, Bryan Weiner, Cara Lewis, Patricia Carreno, Kera Mallard, Tasoula Masina, Candice Monson, Taren Swindle, Zachary Patterson, Leanne Whiteside-Mansell, Rochelle Hanson, Benjamin Saunders, Sonja Schoenwald, Angela Moreland, Sarah Birken, Justin Presseau, David Ganz, Brian Mittman, Deborah Delevan, Jennifer N. Hill, Sara Locatelli, Gemmae Fix, Jeffrey Solomon, Sherri L. Lavela, Victoria Scott, Jonathan Scaccia, Kassy Alia, Brittany Skiles, Abraham Wandersman, Anne Sales, Megan Roberts, Amy Kennedy, Muin J. Khoury, Nina Sperber, Lori Orlando, Janet Carpenter, Larisa Cavallari, Joshua Denny, Amanda Elsey, Fern Fitzhenry, Yue Guan, Carol Horowitz, Julie Johnson, Ebony Madden, Toni Pollin, Victoria Pratt, Tejinder Rakhra-Burris, Marc Rosenman, Corrine Voils, Kristin Weitzel, Ryanne Wu, Laura Damschroder, Christine Lu, Rachel Ceccarelli, Kathleen M. Mazor, Ann Wu, Alanna Kulchak Rahm, Adam H. Buchanan, Marci Schwartz, Cara McCormick, Kandamurugu Manickam, Marc S. Williams, Michael F. Murray, Ngoc-Cam Escoffery, Erin Lebow-Skelley, Hallie Udelson, Elaine Böing, Maria E. Fernandez, Richard J. Wood, Patricia Dolan Mullen, Jenita Parekh, Valerie Caldas, Elizabeth A. Stuart, Shalynn Howard, Gilo Thomas, Jacky M. Jennings, Jennifer Torres, Christine Markham, Ross Shegog, Melissa Peskin, Stephanie Craig Rushing, Amanda Gaston, Gwenda Gorman, Cornelia Jessen, Jennifer Williamson, Dianne Ward, Amber Vaughn, Ellie Morris, Stephanie Mazzucca, Regan Burney, Shoba Ramanadhan, Sara Minsky, Vilma Martinez-Dominguez, Kasisomayajula Viswanath, Megan Barker, Myra Fahim, Arezoo Ebnahmady, Rosa Dragonetti, Peter Selby, Margaret Farrell, Jordan Tompkins, Wynne Norton, Kaelin Rapport, Margaret Hargreaves, Rebekka Lee, Gina Kruse, Charles Deutsch, Emily Lanier, Ashley Gray, Aaron Leppin, Lori Christiansen, Karen Schaepe, Jason Egginton, Megan Branda, Charlene Gaw, Sara Dick, Victor Montori, Nilay Shah, Ariella Korn, Peter Hovmand, Karen Fullerton, Nancy Zoellner, Erin Hennessy, Alison Tovar, Ross Hammond, Christina Economos, Christi Kay, Julie Gazmararian, Emily Vall, Patricia Cheung, Padra Franks, Shannon Barrett-Williams, Paul Weiss, Erica Hamilton, Luana Marques, Louise Dixon, Emily Ahles, Sarah Valentine, Derri Shtasel, Ruben Parra-Cardona, Mary Northridge, Rucha Kavathe, Jennifer Zanowiak, Laura Wyatt, Hardayal Singh, Nadia Islam, Madalena Monteban, Darcy Freedman, Kimberly Bess, Colleen Walsh, Kristen Matlack, Susan Flocke, Heather Baily, Samantha Harden, NithyaPriya Ramalingam, VCE Physical Activity Leadership Team, Rachel Gold, Erika Cottrell, Celine Hollombe, Katie Dambrun, Arwen Bunce, Mary Middendorf, Marla Dearing, Stuart Cowburn, Ned Mossman, Gerry Melgar, Suellen Hopfer, Michael Hecht, Anne Ray, Michelle Miller-Day, Rhonda BeLue, Greg Zimet, Eve-Lynn Nelson, Sandy Kuhlman, Gary Doolittle, Hope Krebill, Ashley Spaulding, Theodore Levin, Michael Sanchez, Molly Landau, Patricia Escobar, Nadia Minian, Aliya Noormohamed, Laurie Zawertailo, Dolly Baliunas, Norman Giesbrecht, Bernard Le Foll, Andriy Samokhvalov, Zachary Meisel, Daniel Polsky, Bruce Schackman, Julia Mitchell, Kaitlyn Sevarino, Sarah Gimbel, Moses Mwanza, Marie Paul Nisingizwe, Catherine Michel, Lisa Hirschhorn, Mahrukh Choudhary, Della Thonduparambil, Paul Meissner, Hilary Pinnock, Melanie Barwick, Christopher Carpenter, Sandra Eldridge, Gonzalo Grandes-Odriozola, Chris Griffiths, Jo Rycroft-Malone, Elizabeth Murray, Anita Patel, Aziz Sheikh, Stephanie J. C. Taylor, Martin Guilliford, Gemma Pearce, Diane Korngiebel, Kathleen West, Wylie Burke, Peggy Hannon, Jeffrey Harris, Kristen Hammerback, Marlana Kohn, Gary K. C. Chan, Riki Mafune, Amanda Parrish, Shirley Beresford, K. Joanne Pike, Rachel Shelton, Lina Jandorf, Deborah Erwin, Thana-Ashley Charles, Laura-Mae Baldwin, Brooke Ike, Jacqueline Fickel, Jason Lind, Diane Cowper, Marguerite Fleming, Amy Sadler, Melinda Dye, Judith Katzburg, Michael Ong, Sarah Tubbesing, Molly Simmons, Autumn Harnish, Sonya Gabrielian, Keith McInnes, Jeffrey Smith, John Ferrand, Elisa Torres, Amy Green, Angela R. Bradbury, Linda J. Patrick-Miller, Brian L. Egleston, Susan M. Domchek, Olufunmilayo I. Olopade, Michael J. Hall, Mary B. Daly, Generosa Grana, Pamela Ganschow, Dominique Fetzer, Amanda Brandt, Rachelle Chambers, Dana F. Clark, Andrea Forman, Rikki S. Gaber, Cassandra Gulden, Janice Horte, Jessica Long, Terra Lucas, Shreshtha Madaan, Kristin Mattie, Danielle McKenna, Susan Montgomery, Sarah Nielsen, Jacquelyn Powers, Kim Rainey, Christina Rybak, Christina Seelaus, Jessica Stoll, Jill Stopfer, Xinxin Shirley Yao, Michelle Savage, Edward Miech, Teresa Damush, Nicholas Rattray, Jennifer Myers, Barbara Homoya, Kate Winseck, Carrie Klabunde, Deb Langer, Avi Aggarwal, Elizabeth Neilson, Lara Gunderson, Marla Gardner, Liam O’Sulleabhain, and Candyce Kroenke

Subjects
Medicine (General), R5-920
Published
2017
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4. Workload Management Strategies to Promote Senior Physical Therapy Faculty Retention in the United States

Author

Amanda Parrish

Abstract

In recent years, several physical therapy programs have been launched at U.S. colleges and universities to respond to the need for trained practitioners to serve an aging population. However, there is a shortage of qualified physical therapy faculty to meet the needs of students and to adhere to accreditation requirements, and limited information exists regarding what resources might promote faculty job retention. The purpose of this basic qualitative study was to explore the perspectives of senior physical therapy faculty regarding how they had balanced their workloads throughout their career and what key resources they used that directly contributed to the longevity of their career. The conceptual framework for this basic qualitative study was grounded in Bandura's theory of self-efficacy and Herzberg's two-factor theory of motivation. The research question focused on the perceptions of senior physical therapy faculty regarding workload management and what resources contributed to the longevity of their career. A self-developed interview protocol was used to gather data from nine senior physical therapy faculty in the U.S. who were selected via purposeful sampling. Data from semistructured interviews were analyzed through open coding, followed by axial coding, and then the development of emergent themes. The primary themes encompass how participants used (a) organizational strategies, (b) support, and (c) self-advocacy to balance their workload. An implication for positive social change includes the identification of strategies that stakeholders might use to support the retention of physical therapy faculty to prepare students to meet the health care needs for the patients they serve. [The dissertation citations contained here are published with the permission of ProQuest LLC. Further reproduction is prohibited without permission. Copies of dissertations may be obtained by Telephone (800) 1-800-521-0600. Web page: http://www.proquest.com/en-US/products/dissertations/individuals.shtml.]

Published
2024

5. Why We Are Failing to Make the Grade: Covid-19 has contributed to a crisis in America's classrooms, but the problems predate the pandemic and are likely to outlast it

Author

Morgan, Amanda Parrish

Subjects
Epidemics -- Educational aspects -- United States, Grades (Scholastic marks) -- Evaluation, Academic achievement -- Evaluation, General interest, Political science
Abstract

When I was in high school in the late 1990s, my copy of The Princeton Review's 310 Best Colleges was more dog-eared than any of the beloved books on my [...]

Published
2022

6. Stroller

Author

Amanda Parrish Morgan

Published
2022

7. Application of the Rate Transient Analysis for Estimation of the Stimulated Reservoir Volume Associated with a Marcellus Shale Horizontal Well

Author

Amanda Parrish, Arya Sattari, Mohamed El Sgher, Kashy Aminian, and Samuel Ameri

Abstract

the Flowing Material Balance (FMB) has become popular in recent years because it does not require static (shut-in) pressure data that are needed for the traditional material balance application. This method is particularly useful for the shale reservoirs where shut-in pressure data are rarely available. The application FMB to the shale reservoirs is challenging because of the presence of the adsorbed gas, due to high organic content, and the long time that is required to establish boundary-dominated flow (BDF) due to ultra-low permeability. However, the interference between the fracture stages in a horizontal well with multiple hydraulic fracture stages leads to an early BDF period during the production. Therefore, the production data from this early BDF period can be utilized to determine the gas in place which can be attributed to the stimulated reservoir volume (SRV) and is of more economic significance. The objective of this study was to investigate the applicability of the FMB for estimation of the gas in the SRV associated with a Marcellus shale horizontal well with multiple hydraulic fracture stages. The available information from several existing horizontal wells at MSEEL site in West Virginia were utilized to develop a reservoir for model for a Marcellus shale horizontal well with multiple hydraulic fracture stages. To accurately simulate the production data, the adsorbed gas as wells as geomechanical factors, derived from the laboratory and published data, were incorporated in the model. The geomechanical factors account for the impairments in hydraulic fracture conductivity and the reduction in the formation (matrix and fissure) permeability caused by the reservoir depletion. The simulated production data were then analyzed by both conventional method and King method which accounts for gas desorption. The FMB method which accounts for gas desorption was found to provides reliable estimates of the gas in place in SRV. The analysis of the production data indicated the presence of two BDF. The analysis of the data from the early BDF provided the gas in place in SRV. The analysis of the data from the late BDF provided the total gas in the reservoir. The results were found to be comparable to the values determined from the model. Therefore, the reliability of the data analysis method was confirmed.

Published
2022

11. WHY WE ARE FAILING TO MAKE THE GRADE.

Author

MORGAN, AMANDA PARRISH

Subjects
*GOSSIP, *MENTAL health services, *PSYCHOLOGICAL distress, *MENTAL health of students, *YOUNG adults, *COVID-19 pandemic
Published
2023

13. Getting back on track after parenthood

Author

Morgan, Amanda Parrish

Subjects
Physical fitness -- Methods, Mothers -- Health aspects -- Social aspects, General interest, News, opinion and commentary
Abstract

Byline: Amanda Parrish Morgan When I got pregnant with my daughter at 33, I thought that I'd seen the last of my competitive running days. And I was okay with [...]

Published
2018

14. Parenthood doesn't have to mean the end of competitive running: 9 tips to get back on track

Author

Morgan , Amanda Parrish

Subjects
Running -- Methods, Parenthood, Runners (Sports) -- Training -- Social aspects, Business, Computers and office automation industries, Telecommunications industry
Abstract

Byline: Amanda Parrish Morgan When I got pregnant with my daughter at 33, I thought that I'd seen the last of my competitive running days. And I was okay with [...]

Published
2018

15. How instant access to grades and other data is contributing to helicopter parenting

Author

Morgan, Amanda Parrish

Subjects
Parenting -- Methods -- Social aspects -- Personal narratives, Grades (Scholastic marks) -- Social aspects, Educational assessment, Business, Computers and office automation industries, Telecommunications industry
Abstract

Byline: Amanda Parrish Morgan Before I had children, I taught high school English. My colleagues and I often expressed despair over the push to make data instantly and widely available [...]

Published
2018

17. The Bloody Unicorn.

Author

da Morgan, Amanda Parrish

Subjects
CHILDREN'S books, CHILD psychology
Abstract

Reading frightening stories with my children in turbulent times. [ABSTRACT FROM AUTHOR]

Published
2020

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