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51. Thermoregulatory plasticity in free-ranging vervet monkeys, Chlorocebus pygerythrus

Author

Richard McFarland, Shane K. Maloney, Alwyn Lubbe, Robyn S. Hetem, Leith C. R. Meyer, Andrea Fuller, Louise Barrett, Duncan Mitchell, and Peter Henzi

Subjects
Physiology, Wet-bulb globe temperature, Acclimatization, Photoperiod, Rain, Cercopithecinae, Nocturnal, Biochemistry, Statistics, Nonparametric, Body Temperature, South Africa, Endocrinology, Animal science, biology.animal, Heterothermy, Animals, Telemetry, Primate, Circadian rhythm, Ecology, Evolution, Behavior and Systematics, biology, Ecology, Torpor, biology.organism_classification, Circadian Rhythm, Linear Models, Animal Science and Zoology, Seasons, Body Temperature Regulation
Abstract

We used implanted miniature data loggers to obtain the first measurements of body temperature from a free-ranging anthropoid primate. Vervet monkeys (Chlorocebus pygerythrus) living in a highly seasonal, semi-arid environment maintained a lower mean 24-h body temperature in winter (34.6 ± 0.5 °C) than in summer (36.2 ± 0.1 °C), and demonstrated increased heterothermy (as indexed by the 24-h amplitude of their body temperature rhythm) in response to proximal environmental stressors. The mean 24-h amplitude of the body temperature rhythm in summer (2.5 ± 0.1 °C) was lower than that in winter (3.2 ± 0.4 °C), with the highest amplitude for an individual monkey (5.6 °C) recorded in winter. The higher amplitude of the body temperature rhythm in winter was a consequence primarily of lower 24-h minimum body temperatures during the nocturnal phase, when monkeys were inactive. These low minimum body temperatures were associated with low black globe temperature (GLMM, β = 0.046, P < 0.001), short photoperiod (β = 0.010, P < 0.001) and low rainfall over the previous 2 months, which we used as a proxy for food availability (β = 0.001, P < 0.001). Despite the lower average winter minimum body temperatures, there was no change in the lower modal body temperature between winter and summer. Therefore, unlike the regulated physiological adjustments proposed for torpor or hibernation, these minimum winter body temperatures did not appear to reflect a regulated reduction in body temperature. The thermoregulatory plasticity nevertheless may have fitness benefits for vervet monkeys.

Published
2014

52. 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

53. 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

54. 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

55. Recently identified measures of human thymic function

Author

Louis J. Picker, Richard A. Koup, Daniel C. Douek, and Richard McFarland

Subjects
education.field_of_study, Immunology, T-cell receptor, Population, Recent Thymic Emigrant, Disease, Biology, Microbiology, Immunodeficiency Syndrome, Transplantation, Infectious Diseases, Immunophenotyping, Immune system, Immunology and Allergy, education
Abstract

The increase in the number of patients with iatrogenic and disease-induced T-cell depletion over the last generation has heightened the sense of urgency for improved diagnostic modalities for immune reconstitution. A full understanding of immune reconstitution requires quantification of every important immune cell population. A cell population that is essential for full reconstitution of a robust immune system is the naive T cells that have recently emigrated from the thymus, the so-called recent thymic emigrants. In this article, we review the emerging methodologies, rationale and indications for monitoring human thymus function. These technologies (T-cell receptor excision circles, thymic index by computed topography analysis and multiparameter flow cytometric analysis of immunophenotype) are potentially useful in clinical laboratory monitoring of human immunodeficiency virus (HIV) disease, transplantation and congenital T-cell immunodeficiency syndromes.

Published
2001

56. Brief communication: Self-suckling in Barbary macaque (Macaca sylvanus) mothers before and after the death of their infant

Author

Bonaventura Majolo and Richard McFarland

Subjects
Behavior, Animal, biology, Macaca sylvanus, Physiology, Gender studies, Cercopithecidae, biology.organism_classification, Macaque, Prolactin, Animals, Suckling, Predation, medicine.anatomical_structure, Anthropology, biology.animal, Lactation, medicine, Animals, Macaca, Female, Milk flow, Anatomy, Maternal Behavior, Short duration, Stress, Psychological
Abstract

We report here self-suckling in four wild female Barbary macaques (Macaca sylvanus), living in two troops (i.e. ‘‘Flat face’’ and ‘‘Large’’ troop) in the middle-Atlas Mountains, Morocco. The four females lost their infants due to predation or for unknown causes. Self-suckling was observed before and after the infants died in the four females living in the ‘‘Flat face’’ troop. When the infants were still alive, self-suckling was of short duration and it was probably a method to improve milk flow when the infant switched from one nipple to the other. After the infants died, self-suckling lasted significantly longer and the females were apparently drinking their own milk. Self-suckling was never observed among the four lactating females in the ‘‘Large’’ troop (including one monkey who lost her infant) and it could thus represent a cultural difference. Moreover, self-suckling after the death of an infant may be explained by the energetic and immunological benefits that a monkey may gain from drinking their own milk. Finally, selfsuckling may have a stress-releasing effect on the mothers who have lost their infants.

Published
2009

58. Behavioral flexibility of vervet monkeys in response to climatic and social variability

Author

Richard, McFarland, Louise, Barrett, Ria, Boner, Natalie J, Freeman, and S Peter, Henzi

Subjects
Male, Sexual Behavior, Animal, Behavior, Animal, Climate, Rest, Chlorocebus aethiops, Temperature, Animals, Female, Feeding Behavior, Seasons, Anthropology, Physical
Abstract

Responses to environmental variability sheds light on how individuals are able to survive in a particular habitat and provides an indication of the scope and limits of its niche. To understand whether climate has a direct impact on activity, and determine whether vervet monkeys have the behavioral flexibility to respond to environmental change, we examined whether the amount of time spent resting and feeding in the nonmating and mating seasons were predicted by the thermal and energetic constraints of ambient temperature. Our results show that high temperatures during the nonmating season were associated with an increase in time spent resting, at the expense of feeding. Cold temperatures during the nonmating season were associated with an increase in time spent feeding, at the expense of resting. In contrast, both feeding and resting time during the mating season were independent of temperature, suggesting that animals were not adjusting their activity in relation to temperature during this period. Our data indicate that climate has a direct effect on animal activity, and that animals may be thermally and energetically compromised in the mating season. Our study animals appear to have the behavioral flexibility to tolerate current environmental variability. However, future climate change scenarios predict that the time an animal has available for behaviors critical for survival will be constrained by temperature. Further investigations, aimed at determining the degree of behavioral and physiological flexibility displayed by primates, are needed if we are to fully understand the consequences of environmental change on their distribution and survival.

Published
2013

59. Coping with the cold: predictors of survival in wild Barbary macaques, Macaca sylvanus

Author

Richard McFarland and Bonaventura Majolo

Subjects
Male, Coping (psychology), media_common.quotation_subject, Longevity, Hierarchy, Social, Biology, Feeding behavior, Dogs, Adaptation, Psychological, Animals, Social Behavior, Sociality, media_common, Sex Characteristics, Natural selection, Ecology, Macaca sylvanus, Feeding Behavior, biology.organism_classification, Agricultural and Biological Sciences (miscellaneous), Cold Temperature, Morocco, Social relationship, Macaca, Animal Behaviour, Female, Seasons, General Agricultural and Biological Sciences, Sex characteristics, Demography
Abstract

We report the death of 30 wild Barbary macaques, living in two groups, during an exceptionally cold and snowy winter in the Middle Atlas Mountains, Morocco. We examined whether an individual's time spent feeding, the quality and number of its social relationships, sex and rank predicted whether it survived the winter or not. The time an individual spent feeding and the number of social relationships that an individual had in the group were positive and significant predictors of survival. This is the first study to show that the degree of sociality affects an individual's chance of survival following extreme environmental conditions. Our findings support the view that sociality is directly related to an individual's fitness, and that factors promoting the establishment and maintenance of social relationships are favoured by natural selection.

Published
2013

60. Report on the international workshop on alternative methods for Leptospira vaccine potency testing: state of the science and the way forward

Author

Karen Brown, Vivian W. Doelling, Hajime Kojima, Hans Draayer, William S. Stokes, Suman Mukhopadhyay, Catrina Stirling, Angela Walker, Brett Jones, Byron E. Rippke, Richard McFarland, Lori Rinckel, Kevin Ruby, David P. Alt, Geetha Srinivas, Nelson W Johnson, Jodie Kulpa-Eddy, Richard Hill, Elisabeth Balks, Randy Sebring, Eric Klaasen, and Warren Casey

Subjects
Bioengineering, Applied Microbiology and Biotechnology, Education, Leptospira, Cricetinae, Medicine, Potency, Animals, Humans, Leptospirosis, International harmonization, State of the science, Vaccine Potency, Animal use, Pharmacology, Alternative methods, General Immunology and Microbiology, biology, business.industry, In vitro toxicology, General Medicine, biology.organism_classification, Biotechnology, Bacterial Vaccines, business
Abstract

Routine potency testing of Leptospira vaccines is mostly conducted using a vaccination-challenge test that involves large numbers of hamsters and unrelieved pain and distress. NICEATM, ICCVAM, and their international partners organized a workshop to review the state of the science of alternative methods that might replace, reduce, and refine the use of animals for veterinary Leptospira vaccine potency testing and to identify ways to advance improved alternative methods. Vaccine manufacturers were encouraged to initiate or continue product-specific validation using in vitro enzyme-linked immunosorbent assays as replacements for potency testing of four common Leptospira serogroups. Participants discussed the potential for eliminating the back-titration procedure in the hamster challenge assay, which could reduce animal use by 50% for each individual potency test. Further animal reduction may also be possible by using cryopreserved Leptospira stock to replace continual passaging through hamsters. Serology assays were identified as a way to further reduce and refine animal use but should be considered only after attempting in vitro assays. Workshop participants encouraged consideration of analgesics and use of earlier humane endpoints when the hamster vaccination-challenge potency assay is used. International harmonization of alternative potency methods was recommended to avoid duplicative potency testing to meet regionally different requirements.

Published
2013

61. 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

62. What is the greatest regulatory challenge in the translation of biomaterials to the clinic?

Author

Sangeeta N. Bhatia, Alan O Trounson, Jonathan Sackner-Bernstein, Glenn D. Prestwich, Richard McFarland, Shannon L. M. Dahl, Jefrey Schox, William E. Tente, Chris Mason, Christopher K. Breuer, and David J. McQuillan

Subjects
Tissue Engineering, business.industry, United States Food and Drug Administration, Biocompatible Materials, General Medicine, Biocompatible material, United States, Translational Research, Biomedical, Medicine, Animals, Humans, Engineering ethics, business, Biotechnology
Abstract

Leaders in the field comment on what they perceive to be the greatest barriers to biomaterial translation.

Published
2012

63. Exploring the components, asymmetry and distribution of relationship quality in wild Barbary macaques (Macaca sylvanus)

Author

Bonaventura Majolo and Richard McFarland

Subjects
Male, Aging, Animal Types, Population Dynamics, Social Anthropology, lcsh:Medicine, Animals, Wild, Social behaviour, Biology, Wildlife, Social and Behavioral Sciences, Macaque, Interpersonal relationship, Sociology, biology.animal, Social partners, medicine, Animals, Social Behavior, lcsh:Science, Animal Management, Evolutionary Biology, Principal Component Analysis, C300 Zoology, Multidisciplinary, Social Research, Animal Behavior, Population Biology, Behavior, Animal, Aggression, Macaca sylvanus, lcsh:R, biology.organism_classification, C800 Psychology, Morocco, Social Dominance, Anthropology, Social relationship, Macaca, Veterinary Science, Female, lcsh:Q, medicine.symptom, Social psychology, Dyad, Research Article
Abstract

Social relationships between group members are a key feature of many animal societies. The quality of social relationships has been described by three main components: value, compatibility and security, based on the benefits, tenure and stability of social exchanges. We aimed to analyse whether this three component structure could be used to describe the quality of social relationships in wild Barbary macaques (Macaca sylvanus). Moreover, we examined whether relationship quality was affected by the sex, age and rank differences between social partners, and investigated the asymmetric nature of social relationships. We collected over 1,900 hours of focal data on seven behavioural variables measuring relationship quality, and used principal component analysis to investigate how these variables clustered together. We found that relationship quality in wild Barbary macaques can be described by a three component structure that represents the value, compatibility and security of a relationship. Female-female dyads had more valuable relationships and same-age dyads more compatible relationships than any other dyad. Rank difference had no effect on the quality of a social relationship. Finally, we found a high degree of asymmetry in how members of a dyad exchange social behaviour. We argue that the asymmetry of social relationships should be taken into account when exploring the pattern and function of social behaviour in animal societies.

Published
2011

64. 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

65. 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

66. Overview of FDA Regulatory Process

Author

Donald Fink, Charles N. Durfor, Stephen L. Hilbert, David S. Kaplan, Deborah Lavoie, Ashok Batra, Celia Witten, Ellen Maher, and Richard McFarland

Subjects
Process management, Process (engineering), business.industry, Medicine, business
Published
2008

67. List of Contributors

Author

Jon D. Ahlstrom, Taby Ahsan, Julie Allickson, Alejandro J. Almarza, James M. Anderson, Peter Andrews, Hadi Aslan, Anthony Atala, Stephen F. Badylak, Ashok Batra, M. Douglas Baumann, Ravi V. Bellamkonda, Nicole M. Bergman, Z. Beyhan, Mickie Bhatia, Sangeeta N. Bhatia, Peter M. Black, Helen Blau, Scott D. Boden, Eric M. Brey, Ali H. Brivanlou, Chris R. Brown, Scott P. Bruder, S.M. Chambers, Christopher S. Chen, LiHow Chen, Mike Chen, Sulin Chen, N. Cheng, George J. Christ, Seyung Chung, J.B. Cibelli, Massimo Cimini, Paolo De Coppi, Mahesh C. Dodla, Juan Dominguez-Bendala, AM Doyle, Charles N. Durfor, Yann Echelard, Rita B. Effros, Jennifer Elisseeff, Ewa C.S. Ellis, Juliet A. Emamaullee, Carol A. Erickson, Roger De Filippo, Donald Fink, William H. Fissell, Gary E. Friedlaender, Mark E. Furth, Yossi Gafni, Keneth Gage, Andres Garcia, William Gavin, Daniel Gazit, Zulma Gazit, Christopher S. Gemmiti, Jörg C. Gerlach, Paul J. Gokhale, M.A. Goodell, May Griffith, Louis M. Guenin, Stefano Giuliani, Robert E. Guldberg, M.C. Hacker, Benjamin S. Harrison, Bernd Hartmann, Stephen H. Hilbert, Alexander Hillel, Jason Hipp, Col. J.B. Holcomb, Jeffrey O. Hollinger, Chantal E. Holy, Mariah Hout, Jiang Hu, George T.-J. Huang, Johnny Huard, Elliot E. Hui, H. David Humes, Marcos Intaglietta, Junfeng Ji, Yueha Jiang, Christa Johnen, Josephine Johnston, Akira Joraku, David L. Kaplan, David S. Kaplan, Gilson Khang, Rehan N. Khanzada, Soon Hee Kim, Moon Suk Kim, Nadav Kimelman, Irina Klimanskaya, Jonathan A. Kluge, Yash Kolambkar, Chester J. Koh, Makoto Komura, Douglas Kondziolka, Deniz Konya, Wilfried A. Kues, Francois Ng kee Kwong, Deepak Lamba, Hai Bang Lee, Hyukjin Lee, Gary G. Leisk, Kam W. Leong, Ariel J. Levine, Ren Ke Li, Wan-Ju Li, Grace J. Lim, Yan Lin, William J. Lindblad, Wendy F. Liu, Xiaohua Liu, Andrea Lucas-Hahn, Aernout Luttun, Samuel Lynch, Peter X. Ma, Ellen Maher, Manuela Martins-Green, Randall E. McClelland, Richard McFarland, Larry V. McIntire, Harry Meade, David L. Melican, A.G. Mikos, Fernando Ulloa Montoya, Robert M. Nerem, Heiner Niemann, Aparna Nori, Patrea L. Pabst, Kook In Park, Tae Gwan Park, David P. Patterson, Karen Pauwelyn, Gadi Pelled, Laura Perin, M. Petreaca, Antonello Pileggi, Jason H. Pomerantz, Blaise Porter, Milica Radisic, Buddy D. Ratner, A. Hari Reddi, Thomas A. Reh, Lola M. Reid, Camillo Ricordi, Jeff Ross, Alan J. Russell, Filipe N.C. Santos, John P. Schmitz, Gunter Schuch, Sargis Sedrakyan, Michael V. Sefton, Marta Serafini, Paulesh Shah, A.M. James Shapiro, Heather Sheardown, Molly S. Shoichet, M. Minhaj Siddiqui, Richard L. Sidman, Ronald Silverman, Daniel Skuk, Evan Snyder, Shay Soker, Myron Spector, David L. Stocum, Stephen C. Strom, Doris A. Taylor, Yang D. Teng, James Thomson, Robert T. Tranquillo, Jacques P. Tremblay, Amy Tsai, Rocky S. Tuan, Ross S. Tubo, Mark Van Dyke, Deborah Vavoie, Catherine Verfaillie, F. Jerry Volenec, Sara Wargo, Joseph W. Warnwath, Lawrence Wechsler, Shen Wei, Richard D. Weisel, Jennifer L. West, Chrysanthi Williams, J. Koudy Williams, Celia Witten, Steven E. Wolf, Savio L.-Y. Woo, Jordan H. Wosnick, Christine Wrenzycki, Munira Xaymardan, Hsin-Lei Yao, Saami K. Yazdani, Pamela C. Yelick, James J. Yoo, Junying Yu, Katrin Zeilinger, Lepeng Zeng, Andrey G. Zenovich, Bonan Zhong, Carol A. Ziomek, and Laurie Zoloth

Published
2008

68. Regulatory Considerations in Manufacturing, Product Testing, and Preclinical Development of Cellular Products for Cardiac Repair

Author

Ellen Areman, Kim Benton, and Richard Mcfarland

Subjects
Clinical trial, Engineering, Risk analysis (engineering), Process (engineering), business.industry, Clinical study design, Cardiac repair, New product development, Product testing, Systems engineering, business, health care economics and organizations, Design characteristics
Abstract

This chapter outlined the authors’ current perspective on the complexities of general product testing requirements and design characteristics for preclinical studies involved in investigational use of cellular products for cardiac repair. The IND process is intended to balance the potential benefit of novel therapies to society with the need to generate data for prudent product development, to increase scientific knowledge, to protect subject safety, and to benefit the public health. This chapter represents an introduction to the regulation of these cellular products and investigator/sponsors are encouraged to contact FDA CBER OCTGT for more specific information on the conduct of clinical trials.

Published
2006

69. Social Interactions through the Eyes of Macaques and Humans

Author

Wu Li, Richard McFarland, Kun Guo, Bonaventura Majolo, Yin Yan, and Hettie Roebuck

Subjects
Male, Visual perception, Visual System, Emotions, lcsh:Medicine, Eye, Social and Behavioral Sciences, Macaque, Behavioral Neuroscience, Cognition, Human Performance, Psychology, lcsh:Science, Phylogeny, Multidisciplinary, Animal Behavior, biology, Experimental Psychology, Animal Models, Sensory Systems, Visual Perception, Female, Sensory Perception, Body region, Cues, medicine.symptom, Research Article, Cognitive psychology, C850 Cognitive Psychology, Cognitive Neuroscience, Young Adult, Interpersonal relationship, Model Organisms, Species Specificity, biology.animal, medicine, Animals, Humans, Interpersonal Relations, Set (psychology), Biology, Behavior, Aggression, lcsh:R, C830 Experimental Psychology, Grooming, Macaca mulatta, Animal Cognition, Gaze, lcsh:Q, Attention (Behavior), Zoology, Neuroscience
Abstract

Group-living primates frequently interact with each other to maintain social bonds as well as to compete for valuable resources. Observing such social interactions between group members provides individuals with essential information (e.g. on the fighting ability or altruistic attitude of group companions) to guide their social tactics and choice of social partners. This process requires individuals to selectively attend to the most informative content within a social scene. It is unclear how non-human primates allocate attention to social interactions in different contexts, and whether they share similar patterns of social attention to humans. Here we compared the gaze behaviour of rhesus macaques and humans when free-viewing the same set of naturalistic images. The images contained positive or negative social interactions between two conspecifics of different phylogenetic distance from the observer; i.e. affiliation or aggression exchanged by two humans, rhesus macaques, Barbary macaques, baboons or lions. Monkeys directed a variable amount of gaze at the two conspecific individuals in the images according to their roles in the interaction (i.e. giver or receiver of affiliation/aggression). Their gaze distribution to non-conspecific individuals was systematically varied according to the viewed species and the nature of interactions, suggesting a contribution of both prior experience and innate bias in guiding social attention. Furthermore, the monkeys' gaze behavior was qualitatively similar to that of humans, especially when viewing negative interactions. Detailed analysis revealed that both species directed more gaze at the face than the body region when inspecting individuals, and attended more to the body region in negative than in positive social interactions. Our study suggests that monkeys and humans share a similar pattern of role-sensitive, species- and context-dependent social attention, implying a homologous cognitive mechanism of social attention between rhesus macaques and humans.

Published
2013

72. Degos' disease

Author

H. Richard McFarland

Subjects
Neurology (clinical)
Published
1997

75. Addison's disease and related psychoses

Author

H. Richard McFarland

Subjects
Psychiatry and Mental health, Clinical Psychology, Pediatrics, medicine.medical_specialty, business.industry, Addison's disease, Medicine, business, medicine.disease
Published
1963

76. Incidence of rebleeding after aneurysm resection

Author

H. Richard McFarland

Subjects
medicine.medical_specialty, Subarachnoid hemorrhage, business.industry, Incidence (epidemiology), Follow up studies, Intracranial Aneurysm, Subarachnoid Hemorrhage, medicine.disease, Surgery, Resection, Postoperative Complications, Aneurysm, Text mining, Neurology, medicine, Humans, Neurology (clinical), business, Follow-Up Studies
Published
1977

77. Myelopathy After Duck Embryo Vaccine

Author

H. Richard McFarland

Subjects
medicine.medical_specialty, Weakness, Respiratory distress, business.industry, Polyradiculoneuropathy, General Medicine, Spinal cord, medicine.disease, Dysphagia, Surgery, Myelopathy, medicine.anatomical_structure, medicine, Sphincter, medicine.symptom, business, Duck embryo vaccine
Abstract

To the Editor.— According to Dorland , myelopathy in this case refers to a disease of the spinal cord. The case presented by Dr. Mozar, in addition to marked weakness of the back, arm, and leg muscles, had marked weakness of the neck, dysphagia, and minimal respiratory distress. There was also a loss of reflexes without sensory deficit. These neurologic signs are not typical of a myelopathic process that often includes a sensory level and sphincter disturbance. The spinal fluids showed a persistent elevation of protein content without cells (an albuminocytologic dissociation). The patient apparently responded to treatment with glucocorticoids. These findings are consistent with the GuillaineBarre complex, a polyradiculoneuropathy, that has occurred after a variety of inoculations, including duck embryo rabies vaccine ( Arch Neurol 14:196, 1966).

Published
1973

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