20 results on '"Judith Arcidiacono"'
Number of results to display per page
Search Results
2. FDA and NIST collaboration on standards development activities supporting innovation and translation of regenerative medicine products
- Author
-
Steven R. Bauer, David S. Kaplan, Sheng Lin-Gibson, Judith Arcidiacono, Sumona Sarkar, and Clare M. Allocca
- Subjects
0301 basic medicine ,Cancer Research ,Process (engineering) ,media_common.quotation_subject ,Immunology ,Regenerative Medicine ,Regenerative medicine ,Translational Research, Biomedical ,Food and drug administration ,03 medical and health sciences ,Consistency (negotiation) ,Inventions ,Humans ,Immunology and Allergy ,Quality (business) ,Cooperative Behavior ,Drug Approval ,Intersectoral Collaboration ,Genetics (clinical) ,media_common ,Biological Products ,Transplantation ,United States Food and Drug Administration ,business.industry ,Therapies, Investigational ,Genetic Therapy ,Cell Biology ,Reference Standards ,United States ,030104 developmental biology ,Oncology ,New product development ,NIST ,Engineering ethics ,Business - Abstract
The development of standards for the field of regenerative medicine has been noted as a high priority by several road-mapping activities. Additionally, the U.S. Congress recognizes the importance of standards in the 21st Century Cure Act. Standards will help to accelerate and streamline cell and gene therapy product development, ensure the quality and consistency of processes and products, and facilitate their regulatory approval. Although there is general agreement for the need of additional standards for regenerative medicine products, a shared understanding of standards is required for real progress toward the development of standards to advance regenerative medicine. Here, we describe the roles of standards in regenerative medicine as well as the process for standards development and the interactions of different entities in the standards development process. Highlighted are recent coordinated efforts between the U.S. Food and Drug Administration and the National Institute of Standards and Technology to facilitate standards development and foster science that underpins standards development.
- Published
- 2018
- Full Text
- View/download PDF
3. List of contributors
- Author
-
Masashi Abe, Jon D. Ahlstrom, Julie Albon, Julie Allickson, Graça Almeida-Porada, Richard A. Altschuler, Daniel G. Anderson, Nasim Annabi, Judith Arcidiacono, Nureddin Ashammakhi, Anthony Atala, Kyriacos A. Athanasiou, Hani A. Awad, Stephen F Badylak, Gowri Balachander, Wayne Balkan, Jennifer J. Bara, Michael P. Barry, Harihara Baskaran, Matthew L. Bedell, Donald Andrew Belcher, David B. Berry, Hina Bhat, Zuhaib F. Bhat, Sangeeta N. Bhatia, Catherine Clare Blackburn, Anna Blocki, Kevin M. Blum, Matthew A. Bochenek, Lawrence J. Bonassar, Joseph V. Bonventre, Mimi R. Borrelli, Robby D. Bowles, Amy D. Bradshaw, Andres M. Bratt-Leal, Christopher K. Breuer, Luke Brewster, Eric M. Brey, Priscilla S. Briquez, J.A. Buckwalter, Karen J.L. Burg, Timothy C. Burg, Batzaya Byambaa, Prafulla K. Chandra, Amanda X. Chen, Fa-Ming Chen, Shaochen Chen, Julian Chesterman, Arnav Chhabra, Seow Khoon Chong, Richard A.F. Clark, Muriel A. Cleary, M. Coleman, George Cotsarelis, Ronald G. Crystal, Gislin Dagnelie, Mohammad Ali Darabi, Jeffrey M. Davidson, Joseph Davidson, Paolo De Coppi, Derfogail Delcassian, Paul de Vos, Anthony Dominijanni, Ryan Donahue, Allison P. Drain, Craig L. Duvall, Jenna L. Dziki, Abdelmotagaly Elgalad, George Eng, Vincent Falanga, Niloofar Farhang, Lino Ferreira, Donald W. Fink, Heather E. Fleming, Peter Fong, Mark R. Frey, Denise Gay, Sharon Gerecht, Charles A. Gersbach, D.M.R. Gibbs, Simran Gidwani, Shaimar R. González Morales, Ritu Goyal, Maria B. Grant, Andrea Gray, Howard P. Greisler, Tracy C. Grikscheit, Karl Grosh, Farshid Guilak, Jason L. Guo, Yingli Han, Joshua M. Hare, Ammar Mansoor Hassanbhai, Konstantinos Hatzistergos, David C. Hay, Xiao-Tao He, Timothy Henderson, Darren Hickerson, Darren H.M. Hickerson, Abdelkrim Hmadcha, Camila Hochman-Mendez, Chao Huang, Jeffrey A. Hubbell, Joern Huelsmann, Jun Tae Huh, Joshua G. Hunsberger, Leanne E. Iannucci, Haruhisa Inoue, John Jackson, Yangzi Jiang, Vladimir V. Kalinichenko, J.M. Kanczler, Jeffrey M. Karp, F. Kurtis Kasper, Ali Khademhosseini, Ji Hyun Kim, Erin A. Kimbrel, Irina Klimanskaya, Joachim Kohn, Sunil Kumar, Themis R. Kyriakides, Spencer P. Lake, Johnny Lam, Robert Langer, Robert Lanza, Timothy S. Leach, Benjamin W. Lee, Iris Lee, Sang Jin Lee, David Li, Linheng Li, Qian Liu, Alexander V. Ljubimov, Chi Lo, Michael T. Longaker, Javier López-Beas, Jeanne F. Loring, Ying Luo, Ben D. MacArthur, Nicolas N. Madigan, Henning Madry, Renata S. Magalhaes, Nancy Ruth Manley, Jonathan Mansbridge, Jeremy J. Mao, K.M. Marshall, J.A. Martin, M. Martins-Green, Kathryn M. Maselli, Mark W. Maxfield, Kyle W. McCracken, James Melville, Antonios G. Mikos, José del R. Millán, Maria Mirotsou, Daniel T. Montoro, Matthew P. Murphy, Sean V. Murphy, Michael Musillo, Padmalosini Muthukumaran, Adam M. Navara, Christopher E. Nelson, Laura E. Niklason, Craig Scott Nowell, Regis J. O’Keefe, Kathy E. O’Neill, Richard O.C. Oreffo, Ophir Ortiz, Andre Francis Palmer, Serafeim Perdikis, M. Petreaca, Maksim V. Plikus, Christopher D. Porada, Mark Post, Aleš Prokop, Raj K. Puri, Pengxu Qian, Milica Radisic, Micha Sam Brickman Raredon, Ellen Rothman Richie, Paul Rouse, Hooman Sadri-Ardekani, W. Mark Saltzman, Luiz C. Sampaio, Christopher R. Schlieve, Su-Hua Sha, Paul T. Sharpe, V. Prasad Shastri, Yanhong Shi, Thomas Shupe, Dario Sirabella, Aleksander Skardal, J.M.W. Slack, Stephen R. Sloan, Shay Soker, Bernat Soria, Bárbara Soria-Juan, Frank E. Stockdale, Josh Stover, Thomas Stransky, H. Christiaan Stronks, Patrick S. Stumpf, Kyung Eun Sung, Daniel Swarr, Dagmara Szkolnicka, Jun Takahashi, D.K.O. Tang, Winson Tang, Doris A. Taylor, Yao Teng, Swee Hin Teoh, Anthony J. Smith, Elsa Treffeisen, Rocky S. Tuan, Joseph P. Vacanti, Cor van der Weele, Matthew Vincent, Gordana Vunjak-Novakovic, Lars U. Wahlberg, Derrick C. Wan, Anne Wang, Dan Wang, Qiwei Wang, Yanling Wang, Yu-li Wang, Zhanwen Wang, Valerie M. Weaver, J.A. Wells, Jean F. Welter, Feng Wen, Jake Weston, Jeffrey A. Whitsett, James K. Williams, Anthony J. Windebank, Mark Eu-Kien Wong, Stefan Worgall, Iwen Wu, Rui-Xin Wu, Virginia Y. Xie, Malcolm Xing, Kenneth M. Yamada, Shinya Yamanaka, James J. Yoo, Simon Young, Claire Yu, Hanry Yu, Yifan Yuan, William Zacharias, Jason Zakko, Ai Zhang, Yuanyuan Zhang, Zheng Zhang, Chunfeng Zhao, Yimu Zhao, and Laurie Zoloth
- Published
- 2020
- Full Text
- View/download PDF
4. The regulatory process from concept to market
- Author
-
Kyung Eun Sung, Judith Arcidiacono, Donald W. Fink, Andrea Gray, Johnny Lam, Winson Tang, Iwen Wu, and Raj K. Puri
- Published
- 2020
- Full Text
- View/download PDF
5. Xenotransplantation: The FDA Perspective
- Author
-
Judith Arcidiacono and Winson W. Tang
- Subjects
Clinical trial ,medicine.medical_specialty ,Development plan ,Animal health ,business.industry ,Xenotransplantation ,medicine.medical_treatment ,Clinical study design ,Public health ,medicine ,business ,Intensive care medicine - Abstract
To advance xenotransplantation into the clinic relies on (i) an appropriate clinical development plan that includes a robust preclinical program, (ii) the development of suitable animal herds, and (iii) a clinical trial design with built-in protections for the xenograft recipient and the public. The potential public health risks can be mitigated by appropriate animal husbandry that includes (i) animals bred from closed herds of known origin, (ii) maintenance of animal health, and (iii) facility maintenance. Potential physiologic incompatibilities between pig and human need to be investigated as soon as possible before the trial is initiated. When possible, first-in-human studies should be conducted in individuals who can understand and consent to the study procedures and risks and thus should exclude children. For those planning a clinical trial, early consultation with the FDA is recommended.
- Published
- 2020
- Full Text
- View/download PDF
6. Cyt-Geist: Current and Future Challenges in Cytometry: Reports of the CYTO 2018 Conference Workshops
- Author
-
Kamila Czechowska, Giacomo Vacca, Cherie Green, Ruth M Barnard, Jaroslav Icha, Michael Nathan Hedrick, Gelo Victoriano Dela Cruz, Nicole E. Paul, Judith Arcidiacono, Andrew Filby, Jakob Zimmermann, Jonni S. Moore, Steven R. Bauer, Ruben Props, Jakub Nedbal, Yongliang Sun, Soren Ulrik Sonder, Christopher Hall, Caryn van Vreden, Cláudia Bispo, Paul K. Wallace, Rachel J. Errington, Jenny Molloy, Joanne Lannigan, Frederik Hammes, Johanna Ivaska, Thomas M. Ashhurst, Frederiek-Maarten Kerckhof, Michael Lee, Hyun-Dong Chang, Christian Kukat, Attila Tárnok, Nao Nitta, Robert S. Hoffman, Gert Van Isterdael, Lina Chakrabarti, John Sharpe, Michael Weber, Raluca Niesner, Christopher Groves, Peter Rubbens, Samson Rogers, Yanli Liu, Dominic Gagnon, Alessandra Vitaliti, Radhika Rayanki, Matthias Schiemann, Lili Wang, Robert Salomon, Grace Chojnowski, Rui Gardner, Bunny Cotleur, Derek H. Jones, John T. Elliott, Betsy Ohlsson-Wilhelm, Stefan Radtke, Maciej Cabanski, Ryan R. Brinkman, Michael Gregory, Henning Ulrich, Jennifer J. Stewart, Sheng Lin-Gibson, Dominic C. Jenner, Heba A. Degheidy, Virginia Litwin, Ziv Portat, Silas J. Leavesley, David Lanham, Susann Müller, Stephen P. Perfetto, Steven Eck, Aja M. Rieger, and Diana L. Bonilla
- Subjects
Histology ,Drug development ,Geist ,Immunology ,570 Life sciences ,biology ,Cell Biology ,Computational biology ,Biomarker discovery ,Biology ,500 Science ,Cytometry ,Pathology and Forensic Medicine - Published
- 2019
- Full Text
- View/download PDF
7. Overview of the US Food and Drug Administration Regulatory Process
- Author
-
Rebecca Robinson, Andrea Gray, Judith Arcidiacono, Laura Ricles, Carolyn Yong, Scott A. Brubaker, Lei Xu, Cynthia J. Chang, David S. Kaplan, Richard McFarland, and Anna Kwilas
- Subjects
Food and drug administration ,Process management ,Process (engineering) ,Organizational structure ,Product (category theory) ,Business ,Regenerative medicine ,health care economics and organizations - Abstract
This chapter provides a brief historical review of the US Food and Drug Administration (FDA) and its organizational structure and discusses the regulation of regenerative medicine products, possible regulatory pathways for combination products, and relevant jurisdictional issues. Sources of information concerning FDA regulatory policies important to regenerative medicine product developers are also discussed. Suggestions are provided regarding how to engage the FDA effectively during the development of a novel regenerative medicine product.
- Published
- 2019
- Full Text
- View/download PDF
8. Contributors
- Author
-
Rachit Agarwal, Jon D. Ahlstrom, Rafiq Ahmad, Emilio I. Alarcon, Alejandro J. Almarza, Graça Almeida-Porada, Manuel Almeida, Melissa Alvarado-Velez, James M. Anderson, Judith Arcidiacono, Anthony Atala, Stephen F. Badylak, Wayne Balkan, Brian G. Ballios, Pedro M. Baptista, M. Douglas Baumann, Supinder S. Bedi, Ravi V. Bellamkonda, Nicole M. Bergmann, Helen M. Blau, Joel D. Boerckel, Andres M. Bratt-Leal, James C. Brown, Scott Brubaker, Isabelle Brunette, Gisele A. Calderon, Arnold I. Caplan, David G. Castner, Cynthia Chang, Aditya Chawla, Xuguang Chen, Paul Cohen, Michael J. Cooke, Joshua S. Copus, Vitor M. Correlo, Charles S. Cox, Abritee Dahl, Richard M. Day, Paolo De Coppi, Mahesh C. Dodla, Jennifer H. Elisseeff, Juliet A. Emamaullee, Adam Esa, Yunlan Fang, Heather J. Faust, John P. Fisher, Matthew B. Fisher, Elvis L. Francois, Andrés J. García, Svetlana Gavrilov, Dan Gazit, Zulma Gazit, Christopher V. Gemmiti, Gregory J. Gillispie, Sarah E. Gilpin, W.T. Godbey, Andrea Gray, Ronald M. Green, May Griffith, Robert E. Guldberg, Qiongyu Guo, Geoffrey C. Gurtner, Michael C. Hacker, Issa A. Hanna, Joshua M. Hare, Konstantinos E. Hatzistergos, Ralf-Peter Herber, Jöns Hilborn, H. David Humes, Joshua G. Hunsberger, Kenjiro Iwasa, John D. Jackson, Margaret L. Jackson, Hae Lin Jang, John A. Jansen, Josephine Johnston, Carl Jorns, Huijun Kang, David L. Kaplan, David S. Kaplan, Adam J. Katz, Matthew W. Kelley, Kelsey Kennedy, Ali Khademhosseini, Gilson Khang, Jinho Kim, Rachel H. Klein, Irina Klimanskaya, Paul S. Knoepfler, In Kap Ko, Yash M. Kolambkar, Jan Krieghoff, Nathan W. Kucko, Manoj Kumar, Joanne Kurtzberg, Anna Kwilas, Donald W. Landry, Mark T. Langhans, Robert Lanza, Giacomo Lanzoni, Sang Jin Lee, Sander C.G. Leeuwenburgh, Kam W. Leong, Rui Liang, Volha Liaudanskaya, Hang Lin, Michael T. Longaker, Hermann P. Lorenz, Jeanne F. Loring, Shi-Jiang Lu, Alberto Lue, Peter X. Ma, Renata S. Magalhaes, Serena Mandla, Clement D. Marshall, Manuela Martins-Green, Devon E. Mason, Jonquil R. Mau, Richard McFarland, Melissa K. McHale, James C. Melville, Jason R. Meyers, Antonios G. Mikos, Jordan S. Miller, Paul A. Mittermiller, Hideki Miyachi, Shinka Miyamoto, Nelson Monteiro, Alessandra L. Moore, Sara Morini, Philipp T. Moser, Vivek J. Mukhatyar, Mark Murdock, Aaron Nagiel, Gail K. Naughton, Allison Nauta, Javier Navarro, Jared M. Newton, Aparna Nori, Teruo Okano, Joaquim M. Oliveira, Harald C. Ott, Jagannath Padmanabhan, Kristin M. Page, Anil Kumar Pallickaveedu Rajan Asari, Virginia E. Papaioannou, Jihoon Park, Samantha L. Payne, Gadi Pelled, Andrew Pepper, Elumalai Perumal, Melissa Petreaca, Christopher J. Pino, Alessandro Pirosa, Iris Pla-Palacín, Marta Pokrywczynska, Christopher D. Porada, Blaise D. Porter, Milica Radisic, Kunal J. Rambhia, F. Raquel Maia, Buddy D. Ratner, A.H. Reddi, Rui L. Reis, Laura Ricles, Camillo Ricordi, Muhammad Rizwan, Rebecca Robinson, Melanie Rodrigues, Benjamin B. Rothrauff, Hooman Sadri-Ardekani, Pilar Sainz-Arnal, Rangarajan Sambathkumar, Natalia Sánchez-Romero, Michelle Scarritt, Christopher M. Schneider, Steven D. Schwartz, Sarah Selem, Trinidad Serrano-Aulló, A.M. James Shapiro, Dmitriy Sheyn, Tatsuya Shimizu, Toshiharu Shinoka, Molly S. Shoichet, Toshihiro Shoji, Thomas Shupe, Andrew G. Sikora, Fiona Simpson, Aleksander Skardal, Daniel Skuk, Brandon T. Smith, Jihee Sohn, Shay Soker, Estela Solanas, Jeong Eun Song, Disha Sood, David L. Stocum, Stephen C. Strom, Jessica M. Sun, Hironobu Takahashi, Jacques P. Tremblay, Nirmalya Tripathy, John W. Tse, Rocky S. Tuan, Catherine M. Verfaillie, Gordana Vunjak-Novakovic, William R. Wagner, Yanling Wang, Emma Watson, Jennifer L. West, David F. Williams, James K. Williams, Mark E. Wong, Savio L-Y. Woo, Fiona M. Wood, Lei Xu, Doron C. Yakubovich, Yafeng Yang, Michael J. Yaszemski, Pamela C. Yelick, Evelyn K.F. Yim, Carolyn Yong, James J. Yoo, Simon Young, Nora Yucel, Rachel L. Zacharias, Yuanyuan Zhang, Ai Zhang, Jin Zhang, and Yang Zhu
- Published
- 2018
- Full Text
- View/download PDF
9. Regulation of xenogeneic porcine pancreatic islets
- Author
-
Bruce S. Schneider, Evgenij Evdokimov, Larisa Rudenko, Cheng-Hong Wei, Phillip J. Snoy, Allen K. Wensky, Jeff Jones, Judith Arcidiacono, Mark H. Lee, and Keith Wonnacott
- Subjects
endocrine system ,Transplantation ,Type 1 diabetes ,geography ,geography.geographical_feature_category ,endocrine system diseases ,business.industry ,Pancreatic islets ,Immunology ,medicine.disease ,Bioinformatics ,Islet ,Genetically modified organism ,Clinical trial ,medicine.anatomical_structure ,Diabetes mellitus ,medicine ,business - Abstract
The use of xenogeneic porcine pancreatic islets has been shown to be a potentially promising alternative to using human allogeneic islets to treat insulin-dependent type 1 diabetes (T1D). This article provides an overview of the existing FDA regulatory framework that would be applied to the regulation of clinical trials utilizing xenogeneic porcine pancreatic islets to treat T1D.
- Published
- 2010
- Full Text
- View/download PDF
10. Considerations for Tissue-Engineered and Regenerative Medicine Product Development Prior to Clinical Trials in the United States
- Author
-
Keith Wonnacott, Caitilin A. Hamill, Judith Arcidiacono, Steven S. Oh, Martha A. Wells, Anastacia M. Bilek, Mark H. Lee, and Jeremiah J. Wille
- Subjects
Clinical Trials as Topic ,Tissue engineered ,Tissue Engineering ,United States Food and Drug Administration ,Process (engineering) ,business.industry ,Biomedical Engineering ,Bioengineering ,Regenerative Medicine ,Biochemistry ,Regenerative medicine ,United States ,Biotechnology ,Biomaterials ,Food and drug administration ,Clinical trial ,Innovative Therapies ,Risk analysis (engineering) ,New product development ,Drug and Narcotic Control ,Humans ,Medicine ,Product (category theory) ,business - Abstract
Tissue-engineered and regenerative medicine products are promising innovative therapies that can address unmet clinical needs. These products are often combinations of cells, scaffolds, and other factors and are complex in both structure and function. Their complexity introduces challenges for product developers to establish novel manufacturing and characterization techniques to ensure that these products are safe and effective prior to clinical trials in humans. Although there are only a few commercial products that are currently in the market, many more tissue-engineered and regenerative medicine products are under development. Therefore, it is the purpose of this article to help product developers in the early stages of product development by providing insight into the Food and Drug Administration (FDA) process and by highlighting some of the key scientific considerations that may be applicable to their products. We provide resources that are publically available from the FDA and others that are of potential interest. As the provided information is general in content, product developers should contact the FDA for feedback regarding their specific products. Also described are ways through which product developers can informally and formally interact with the FDA early in the development process to help in the efficient progression of products toward clinical trials.
- Published
- 2010
- Full Text
- View/download PDF
11. Translation of Regenerative Medicine Products Into the Clinic in the United States
- Author
-
Donald Fink, Michael Mendicino, Mohammad Heidaran, Lynne Boxer, Celia Witten, Charles N. Durfor, Brent McCright, John Hyde, Richard McFarland, Carmen Gacchina Johnson, Diana Yoon, Judith Arcidiacono, Lori Tull, Mark H. Lee, David S. Kaplan, Patrick Au, and Safa Karandish
- Subjects
medicine.medical_specialty ,Process (engineering) ,business.industry ,Alternative medicine ,Regenerative medicine ,Product (business) ,Clinical trial ,New product development ,medicine ,Relevance (law) ,Engineering ethics ,Regulatory science ,business ,health care economics and organizations - Abstract
The field of regenerative medicine encompasses a breathtaking array of interdisciplinary scientific approaches with the promise of delivering future therapies to meet current unmet medical needs for patients. Increasingly more of these innovative products are being translated into human clinical trials in the United States, and general familiarity of the FDA is important to efficiently navigate the process. The basics of FDA history, organization, and processes are described herein for those new to clinical translation, with more detailed content added regarding approval pathways, regulations, guidances, and select special topics of relevance to regenerative medicine. In addition to the cumulative experience of previous products, the FDA regulatory approach to medical products evaluation includes an ongoing assessment of how the science of those products informs regulatory policy. FDA engages in ongoing dialogue with the scientific community and product sponsors to continue to develop science-based regulatory review policies that are robust and predictable in order to meet the needs of the challenging array of products that are on the horizon.
- Published
- 2015
- Full Text
- View/download PDF
12. United States Food and Drug Administration Regulation of Gene and Cell Therapies
- Author
-
Zenobia Taraporewala, Steve Winitsky, Judith Arcidiacono, Alexander M. Bailey, and Kimberly A Benton
- Subjects
Statute ,Food and drug administration ,Flexibility (engineering) ,Patient safety ,business.industry ,Medicine ,Guidance documents ,Accounting ,Regulatory agency ,business ,health care economics and organizations ,Genetic therapy ,Biotechnology - Abstract
The United States (US) Food and Drug Administration (FDA) is a regulatory agency that has oversight for a wide range of products entering the US market, including gene and cell therapies. The regulatory approach for these products is similar to other medical products within the United States and consists of a multitiered framework of statutes, regulations, and guidance documents. Within this framework, there is considerable flexibility which is necessary due to the biological and technical complexity of these products in general. This chapter provides an overview of the US FDA regulatory oversight of gene and cell therapy products.
- Published
- 2015
- Full Text
- View/download PDF
13. Contributors
- Author
-
Mehran Abolbashari, Jaimo Ahn, Salem Akel, Julie G. Allickson, Graça Almeida-Porada, Judith Arcidiacono, Anthony Atala, Patrick Au, Danielle Aufiero, Pedro M. Baptista, Ronnda L. Bartel, Amelia Bartholomew, Elona Baum, Angie Botto-van Bemden, Khalil N. Bitar, Lynne Boxer, Matthew P. Brown, Heather L. Brown, Stephanie J. Bryant, Pedro P. Carvalho, Prafulla Chandra, John R. Chapman, Shreyasi Das, Daniel B. Deegan, Abritee Dhal, Albert D. Donnenberg, Matthew B. Durdy, Charles N. Durfor, Elazer R. Edelman, Donald Fink, Steven Fischkoff, Joyce L. Frey-Vasconcells, Tobias Führmann, Carmen Gacchina Johnson, Or Gadish, Sanjiv S. Gambhir, Adrian P. Gee, Manuela E. Gomes, Kurt D. Hankenson, Robert J. Hariri, Heather C. Hatcher, Mohammad Heidaran, Ralf Huss, John Hyde, Yoshito Ikada, Deepak Jain, Paul A. Jain, Jesse V. Jokerst, Philipp Jungebluth, Eve Kandyba, David S. Kaplan, Safa Karandish, F. Kurtis Kasper, Sneha S. Kelkar, Norma Kenyon, Krzysztof Kobielak, Jesse Kramer, Sang Jin Lee, Mark H. Lee, Yvonne Leung, Mei Ling Lim, Neil J. Littman, Paolo Macchiarini, Nafees N. Malik, Brenda K. Mann, Kacey G. Marra, Robert E. Marx, Lina Mastrangelo, Brent McCright, Richard McFarland, Michael Mendicino, Antonios G. Mikos, Nikolaos Mitrousis, Aaron M. Mohs, Thomas Moore, Emma C. Moran, Walter Niles, Guoguang Niu, Masashi Nomi, Tamara Nunez, Robert Perry, Robert P. Pfotenhauer, Christopher D. Porada, Kavitha Premenand, Glenn D. Prestwich, Shreya Raghavan, Mahendra Rao, Anthony Ratcliffe, Stephen Rego, Rui L. Reis, Ivan N. Rich, Márcia T. Rodrigues, J. Peter Rubin, Steven Sampson, Etai Sapoznik, John G. Sharp, Molly S. Shoichet, Daniel Skuk, Evan Y. Snyder, Shay Soker, Sita Somara, Tom Spencer, Suzanne Stewart, Premenand Sundivakkam, Erszebet Szilagyi, Alexander M. Tatara, Brian Tobe, Jacques P. Tremblay, Alan O. Trounson, Anup Tuladhar, Lori Tull, Jolene E. Valentin, Dipen Vyas, Zhan Wang, Alicia Winquist, Celia Witten, Mark E.K. Wong, James J. Yoo, Diana Yoon, Elie Zakhem, and Joao Paulo Zambon
- Published
- 2015
- Full Text
- View/download PDF
14. List of Contributors
- Author
-
Russell C. Addis, Piero Anversa, Judith Arcidiacono, Anthony Atala, Joyce Axelman, Ashok Batra, Helen M. Blau, Susan Bonner-Weir, Mairi Brittan, Hal E. Broxmeyer, Mara Cananzi, Constance Cepko, Tao Cheng, Susana M. Chuva de Sousa Lopes, Gregory O. Clark, Maegen Colehour, Paolo de Coppi, Giulio Cossu, George Q. Daley, Jiyoung M. Dang, Natalie Direkze, Yuval Dor, Gregory R. Dressler, Charles N. Durfor, Ewa C.S. Ellis, Martin Evans, Donna M. Fekete, Donald Fink, Elaine Fuchs, Margaret T. Fuller, Richard L. Gardner, Zulma Gazit, Dan Gazit, John D. Gearhart, Victor M. Goldberg, Rodolfo Gonzalez, Deborah Lavoie Grayeski, Ronald M. Green, Markus Grompe, Stephen L. Hilbert, Marko E. Horb, Jerry I. Huang, Jaimie Imitola, D. Leanne Jones, Jan Kajstura, David S. Kaplan, Pritinder Kaur, Kathleen C. Kent, Candace L. Kerr, Ali Khademhosseini, Nadav Kimelman, Irina Klimanskaya, Jennifer N. Kraszewski, Mark A. LaBarge, Robert Langer, Robert Lanza, Ellen Lazarus, Jean Pyo Lee, Mark H. Lee, Annarosa Leri, Shulamit Levenberg, S. Robert Levine, John W. Littlefield, Richard McFarland, Jill McMahon, Douglas A. Melton, Mary Tyler Moore, Franz-Josef Mueller, Christine L. Mummery, Bernardo Nadal-Ginard, Hitoshi Niwa, Keisuke Okita, Jitka Ourednik, Vaclav Ourednik, Kook I. Park, Ethan S. Patterson, Gadi Pelled, Christopher S. Potten, Sean Preston, Philip R. Roelandt, Valerie D. Roobrouck, Nadia Rosenthal, Janet Rossant, Maurilio Sampaolesi, Maria Paola Santini, David T. Scadden, Holger Schlüter, Gunter Schuch, Michael J. Shamblott, Dima Sheyn, Richard L. Sidman, Evan Y. Snyder, Shay Soker, Stephen C. Strom, Lorenz Studer, M. Azim Surani, Francesco Saverio Tedesco, Yang D. Teng, David Tosh, Alan Trounson, Tudorita Tumbar, Edward Upjohn, George Varigos, Catherine M. Verfaillie, Zhan Wang, Gordon C. Weir, Kevin J. Whittlesey, J. Koudy Williams, James W. Wilson, Celia Witten, Nicholas A. Wright, Shinya Yamanaka, and Jung U. Yoo
- Published
- 2014
- Full Text
- View/download PDF
15. The Regulatory Process from Concept to Market
- Author
-
Celia Witten, Donald Fink, Charles N. Durfor, Judith Arcidiacono, Alexander M. Bailey, Becky Robinson, Richard McFarland, Patricia Holobaugh, Rachael Anatol, Steve Winitsky, and Mark H. Lee
- Subjects
Process (engineering) ,business.industry ,Investigational New Drug Application ,Pharmacology ,Key issues ,humanities ,Food and drug administration ,Product (business) ,Clinical research ,Late phase ,Clinical investigation ,Medicine ,Engineering ethics ,business ,health care economics and organizations - Abstract
The US Food and Drug Administration (FDA) is responsible for the regulatory oversight of a wide range of products, including cell-based products regulated by the Office of Tissues and Advanced Therapies (OTAT) in the Center for Biologics Evaluation and Research. This chapter focuses on several key issues relevant to the development of cell-based products, including early and late phase considerations for chemistry, manufacturing, and controls; pharmacology/toxicology; and clinical testing. This chapter introduces the following topics: the regulatory process, sponsor meetings with OTAT, the requirements for submitting an investigational new drug application (IND), and FDA review of an original IND submission. Also discussed are combination products, tissue-engineered/regenerative medicine products, medical devices, special regulatory considerations such as clinical research involving children, responsibilities of sponsors and investigators, and the use of standards. Knowledge and consideration of the topics discussed in this chapter may aid in the development of cell-based product.
- Published
- 2014
- Full Text
- View/download PDF
16. List of Contributors
- Author
-
Robby D. Bowles, Anthony J. (Tony) Smith, Jon D. Ahlstrom, Julie Albon, Peter G. Alexander, Richard A. Altschuler, Pedro Alvarez, A. Amendola, Rachael Anatol, Nasim Annabi, Piero Anversa, Judith Arcidiacono, Anthony Atala, Kyriacos A. Athanasiou, François A. Auger, Debra T. Auguste, Hani A. Awad, Stephen F. Badylak, Alexander M. Bailey, Michael P. Barry, Daniel Becker, Visar Belegu, Jonathan Bernhard, Timothy Bertram, Valérie Besnard, Z.F. Bhat, Hina Bhat, Sangeeta N. Bhatia, Sarindr Bhumiratana, Paolo Bianco, Catherine Clare Blackburn, Thomas Bollenbach, Lawrence A. Bonassar, Mike Boulton, Amy D. Bradshaw, Christopher K. Breuer, Luke Brewster, Eric M. Brey, Mairi Brittan, Bryan N. Brown, T. Brown, J.A. Buckwalter, Deborah Buffington, Karen J.L. Burg, Timothy C. Burg, Stéphane Chabaud, Thomas Ming Swi Chang, Yunchao Chang, Robert G. Chapman, Fa-Ming Chen, Una Chen, Elisa Cimetta, Richard A.F. Clark, Karen L. Clark, Muriel A. Cleary, Réjean Cloutier, Clark K. Colton, George Cotsarelis, Ronald G. Crystal, Gislin Dagnelie, Lino da Silva Ferreira, Jeffrey M. Davidson, Thomas F. Deuel, Natalie Direkze, Gregory R. Dressler, Charles N. Durfor, Craig L. Duvall, George Eng, George Engelmayr, Thomas Eschenhagen, Mark Eu-Kien Wong, Vincent Falanga, Katie Faria, Denise L. Faustman, Dario O. Fauza, Qiang Feng, Lino Ferreira, Donald W. Fink, William Fissell, Lisa E. Freed, Mark E. Furth, Denise Gay, Sharon Gerecht-Nir, Lucie Germain, Charles A. Gersbach, Francine Goulet, Ritu Goyal, Maria B. Grant, Howard P. Greisler, Farshid Guilak, Brendan A.C. Harley, David A. Hart, Abdelkrim Hmadcha, Steve J. Hodges, Heidi R. Hofer, Jeffrey O. Hollinger, Patricia Holobaugh, Jeffrey A. Hubbell, H. David Humes, Donald E. Ingber, Beau Inskeep, Xingyu Jiang, Jan Kajstura, Ravi S. Kane, Jeffrey M. Karp, F. Kurtis Kasper, Ali Khademhosseini, Sven Kili, Erin A. Kimbrel, Irina Klimanskaya, Joachim Kohn, Shaun M. Kunisaki, Themis R. Kyriakides, Eric Lagasse, Jean Lamontagne, Robert Langer, Robert Lanza, Shimon Lecht, Benjamin W. Lee, Chang H. Lee, Mark H. Lee, Peter I. Lelkes, Annarosa Leri, David W. Levine, Feng Li, Michael T. Longaker, Javier López, Shi-Jiang Lu, Ying Luo, Ben D. MacArthur, Nancy Ruth Manley, Rohan Manohar, Jonathan Mansbridge, Athanasios Mantalaris, Jeremy J. Mao, J.L. Marsh, David C. Martin, J.A. Martin, M. Martins-Green, Koichi Masuda, Mark W. Maxfield, Kathryn L. McCabe, John W. McDonald, Richard McFarland, Antonios G. Mikos, José del R. Millán, Josef M. Miller, Shari Mills, Kristen L. Moffat, Mark J. Mondrinos, Daniel T. Montoro, Malcolm A.S. Moore, Rebekah A. Neal, Robert M. Nerem, Shengyong Ng, Craig Scott Nowell, Haruko Obokata, Bjorn Reino Olsen, Richard O.C. Oreffo, Regis J. O’Keefe, Kathy O’Neill, Ophir Ortiz, Carolyn K. Pan, Vikas Pathak, M. Petreaca, Daniela Pezzolla, Maksim V. Plikus, Julia M. Polak, Mark Post, Sean Preston, Aleš Prokop, Milica Radisic, Egon Ranghini, Yehoash Raphael, A.H. Reddi, Herrmann Reichenspurner, Ellen Richie, Pamela Gehron Robey, Becky Robinson, Anabel Rojas, Shuvo Roy, Alan J. Russell, Rajiv Saigal, W. Mark Saltzman, Ali Samadikuchaksaraei, Athanassios Sambanis, Jochen Schacht, Stacey C. Schutte, Lyndsey Schutte, Steven D. Schwartz, Robert E. Schwartz, Lori A. Setton, Su-Hua Sha, Jing Shan, Paul T. Sharpe, Songtao Shi, Arun R. Shrivats, Franck Simon, Dario Sirabella, J.M.W. Slack, Bernat Soria, Patrick Spicer, Kelly R. Stevens, Frank E. Stockdale, H. Christiaan Stronks, Lorenz Studer, Shuichi Takayama, James A. Thomson, Jordan E. Trachtenberg, Elsa Treffeisen, Rocky S. Tuan, Charles A. Vacanti, Joseph P. Vacanti, Cor van der Weele, Matthew Vincent, Gordana Vunjak-Novakovic, Lars U. Wahlberg, Derrick C. Wan, Anne Wang, Angela J. Westover, George M. Whitesides, Jeffrey A. Whitsett, Steve Winitsky, Celia Witten, Stefan Worgall, Nicholas A. Wright, Ioannis V. Yannas, Simon Young, Junying Yu, Zheng Zhang, Wenfu Zheng, Wolfram Hubertus Zimmermann, and Laurie Zoloth
- Published
- 2014
- Full Text
- View/download PDF
17. Contributors
- Author
-
Piero Anversa, Judith Arcidiacono, Anthony Atala, Yann Barrandon, Ashok Batra, Daniel Becker, Nicole M. Bergmann, Paolo Bianco, Helen M. Blau, Susan Bonner-Weir, Mairi Brittan, Hal E. Broxmeyer, Mara Cananzi, Arnold I. Caplan, Constance Cepko, Maegen Colehour, Giulio Cossu, George Q. Daley, Jiyoung M. Dang, Ayelet Dar, Brian R. Davis, Paolo de Coppi, Natalie Direkze, Juan Domínguez-Bendala, Yuval Dor, Gregory R. Dressler, Charles N. Durfor, Rita B. Effros, Ewa C.S. Ellis, Margaret A. Farley, Donna M. Fekete, Qiang Feng, Donald Fink, Elaine Fuchs, Dan Gazit, Zulma Gazit, Sharon Gerecht, Victor M. Goldberg, Rodolfo Gonzalez, François Gorostidi, Elizabeth Gould, Nicolas Grasset, Deborah Lavoie Grayeski, Ronald M. Green, Markus Grompe, Joshua M. Hare, Konstantinos E. Hatzistergos, Kevin E. Healy, Stephen L. Hilbert, Jerry I. Huang, James Huettner, Jaimie Imitola, Elizabeth F. Irwin, Joseph Itskovitz-Eldor, Josephine Johnston, Jan Kajstura, David S. Kaplan, Adam J. Katz, Pritinder Kaur, Erin A. Kimbrel, Nadav Kimelman, Chris Kintner, Naoko Koyano-Nakagawa, Tilo Kunath, Mark A. LaBarge, Robert Lanza, Stéphanie Lathion, Ellen Lazarus, Jean Pyo Lee, Mark H. Lee, Annarosa Leri, S. Robert Levine, Feng Li, Shi-Jiang Lu, John W. McDonald, Richard McFarland, Melissa K. McHale, Douglas A. Melton, Alexander F. Mericli, Christian Mirescu, Malcolm A.S. Moore, Mary Tyler Moore, Franz-Josef Mueller, Bernardo Nadal-Ginard, Jitka Ourednik, Vaclav Ourednik, Kook I. Park, Gadi Pelled, Antonello Pileggi, Jacob F. Pollock, Christopher S. Potten, Sean Preston, Nicole L. Prokopishyn, Camillo Ricordi, Pamela Gehron Robey, Ariane Rochat, Philip R. Roelandt, Valerie D. Roobrouck, Nadia Rosenthal, Janet Rossant, Maurilio Sampaolesi, Maria Paola Santini, David V. Schaffer, Holger Schlüter, Gunter Schuch, Sarah Selem, Dima Sheyn, Richard L. Sidman, Daniel Skuk, Evan Y. Snyder, Shay Soker, Stephen C. Strom, Lorenz Studer, Francesco Saverio Tedesco, Yang D. Teng, Jacques P. Tremblay, Tudorita Tumbar, Edward Upjohn, George Varigos, Catherine M. Verfaillie, Zhan Wang, Gordon C. Weir, Jennifer L. West, Kevin J. Whittlesey, J. Koudy Williams, J.W. Wilson, Celia Witten, Nicholas A. Wright, and Jung U. Yoo
- Published
- 2013
- Full Text
- View/download PDF
18. US Food and Drug Administration international collaborations for cellular therapy product regulation
- Author
-
Joan W Blair, Kimberly A Benton, and Judith Arcidiacono
- Subjects
business.industry ,United States Food and Drug Administration ,International Cooperation ,Cell- and Tissue-Based Therapy ,Medicine (miscellaneous) ,Cell Biology ,Review ,Public relations ,Biochemistry, Genetics and Molecular Biology (miscellaneous) ,United States ,Biotechnology ,Underdevelopment ,Food and drug administration ,Medical product ,Molecular Medicine ,Medicine ,Humans ,Product (category theory) ,business - Abstract
Cellular therapy products are an emerging medical product class undergoing rapid scientific and clinical innovation worldwide. These products pose unique regulatory challenges both for countries with existing regulatory frameworks and for countries where regulatory frameworks for cellular therapy products are under development. The United States Food and Drug Administration (US FDA) has a history of productive working relationships with international regulatory authorities, and seeks to extend this to the cellular therapy field. The US FDA and its global regulatory counterparts are engaged in collaborations focused on the convergence of scientific and regulatory approaches, and the education of scientists, clinicians, regulators, and the public at large on the development of cellular therapies.
- Published
- 2012
19. Contributors
- Author
-
Tamer Aboushwareb, Jon D. Ahlstrom, Alejandro J. Almarza, James M. Anderson, Judith Arcidiacono, Anthony Atala, Stephen F. Badylak, Jae Hyun Bae, Brian G. Ballios, Ashok Batra, M. Douglas Baumann, Ravi V. Bellamkonda, Nicole M. Bergmann, Mickie Bhatia, Martin A. Birchall, Helen M. Blau, Joel D. Boerckel, Ali H. Brivanlou, Mara Cananzi, Arnold I. Caplan, Joseph W. Carnwath, Grant A. Challen, George J. Christ, Hyun Jung Chung, Maegen Colehour, Michael J. Cooke, V.M. Correlo, Benjamin D. Cosgrove, Stefano Da Sacco, Jiyoung M. Dang, Richard M. Day, Paolo De Coppi, Roger E. De Filippo, Mahesh C. Dodla, Juan Domínguez-Bendala, Ryan P. Dorin, Charles N. Durfor, Rita B. Effros, Jennifer H. Elisseeff, Ewa C.S. Ellis, Juliet A. Emamaullee, Per Fagerholm, Qiang Feng, Donald Fink, Matthew B. Fisher, Andrés J. García, Svetlana Gavrilov, Dan Gazit, Zulma Gazit, Christopher V. Gemmiti, Charles A. Gersbach, Margaret A. Goodell, Deborah Lavoie Grayeski, Ronald M. Green, May Griffith, Robert E. Guldberg, Qiongyu Guo, M.C. Hacker, Joanne Hackett, Joshua M. Hare, Benjamin S. Harrison, Konstantinos E. Hatzistergos, Kevin E. Healy, Stephen L. Hilbert, Jiang Hu, Alexander Huber, H. David Humes, Elizabeth F. Irwin, Brett C. Isenberg, Takanori Iwata, Sam Janes, Lily Jeng, Junfeng Ji, Josephine Johnston, Kimberly A. Johnston, David L. Kaplan, David S. Kaplan, Sinan Karaoglu, Adam J. Katz, Jaehyun Kim, Erin A. Kimbrel, Nadav Kimelman, Jonathan A. Kluge, Chester J. Koh, Yash M. Kolambkar, Makoto Komura, Wilfried A. Kues, Francois Ng kee Kwong, Neil Lagali, Deepak A. Lamba, Donald W. Landry, Robert Lanza, Barrett Larson, Malcolm A. Latorre, Ellen Lazarus, Hyukjin Lee, Mark H. Lee, Sang Jin Lee, Gary G. Leisk, Feng Li, Rui Liang, Kuanyin K. Lin, Xiaohua Liu, Michael T. Longaker, H. Peter Lorenz, Shi-Jiang Lu, Andrea Lucas-Hahn, Peter X. Ma, Paolo Macchiarini, Masood A. Machingal, J.F. Mano, M. Martins-Green, Michael McCall, Richard McFarland, Melissa K. McHale, Alexander F. Mericli, A.G. Mikos, Vivek J. Mukhatyar, Allison Nauta, N.M. Neves, Heiner Niemann, Teruo Okano, Keisuke Okita, J.M. Oliveira, Virginia E. Papaioannou, Tae Gwan Park, Gadi Pelled, Laura Perin, M. Petreaca, Antonello Pileggi, Jacob F. Pollock, Blaise D. Porter, Milica Radisic, Nandini Rao, A.H. Reddi, Thomas A. Reh, R.L. Reis, Camillo Ricordi, Philip Roelandt, Caroline Beth Sangan, Justin M. Saul, David V. Schaffer, Gunter Schuch, Michael V. Sefton, Sarah Selem, A.M. James Shapiro, Heather Sheardown, Dima Sheyn, Molly S. Shoichet, Harvir Singh, Sirinrath Sirivisoot, Daniel Skuk, Shay Soker, Myron Spector, David L. Stocum, Stephen C. Strom, James A. Thomson, David Tosh, Robert T. Tranquillo, Jacques P. Tremblay, Catherine M. Verfaillie, Zhan Wang, Jennifer L. West, Kevin J. Whittlesey, Chrysanthi Williams, David F. Williams, J. Koudy Williams, Celia Witten, Savio L.-Y. Woo, Fiona Wood, Shinya Yamanaka, Masayuki Yamato, Saami K. Yazdani, James J. Yoo, Junying Yu, and Bonan Zhong
- Published
- 2011
- Full Text
- View/download PDF
20. Overview of the FDA Regulatory Process
- Author
-
David S. Kaplan, Donald Fink, Ashok Batra, Judith Arcidiacono, Richard McFarland, Celia Witten, Charles N. Durfor, Jiyoung M. Dang, Mark H. Lee, Maegen Colehour, Deborah Lavoie Grayeski, Stephen L. Hilbert, Kevin J. Whittlesey, and Ellen Lazarus
- Subjects
Engineering ,Sociology of scientific knowledge ,Process (engineering) ,business.industry ,Investigational New Drug ,Guidance documents ,Accounting ,Guideline ,Regenerative medicine ,Public health service ,Clinical research ,Knowledge base ,Code of Federal Regulations ,Infectious disease (medical specialty) ,Cardiac valve ,Medicine ,Operations management ,Regulatory science ,Engineering ethics ,Organizational structure ,Business ,Eligibility Determination ,Enforcement - Abstract
Publisher Summary This chapter provides a brief historical review of the Food and Drug Administration (FDA) and its organizational structure and discusses topics pertaining to the regulation of regenerative medicine products including possible regulatory pathways for combination products and relevant jurisdictional issues. FDA regulations are contained in the Code of Federal Regulations (CFR). Regulations for drugs, biologics, devices, and tissues, along with related regulations, may be found in various parts of Title 21 of the CFR. Guidance documents are nonbinding publications that describe the FDA's interpretation of policy pertaining to a regulatory issue or set of issues related to the design, production, labeling, promotion, manufacturing, and testing of regulated products, the processing, content, and evaluation, or approval of submissions inspection, and enforcement policies. Guidance documents, which are developed in accordance with Good Guidance Practices found at 21 CFR §10.115, are intended to clarify the FDA's current thinking related to regulatory issues and procedures. The FDA has issued “Guidance for Industry: Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products to assist establishments making donor eligibility determinations with complying with the Donor Eligibility rule (21 CFR 1271 Subpart C).” This guidance also incorporates and finalizes the content of “Guidance for Industry, Preventive Measures to Reduce the Possible Risk of Transmission of Creutzfeldt–Jakob Disease (CJD) and Variant Creutzfeldt–Jakob Disease (vCJD) by Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps).” The US Public Health Service (PHS) agencies including the FDA, National Institutes of Health (NIH), Centers for Disease Control and Prevention (CDC), and Health Resources and Services Administration (HRSA) have worked together to address the risk of infectious disease transmission, publishing the “PHS Guideline on Infectious Disease Issues in Xenotransplantation.”
- Published
- 2011
- Full Text
- View/download PDF
Catalog
Books, media, physical & digital resources
Discovery Service for Jio Institute Digital Library
For full access to our library's resources, please sign in.