|
Drug Development: Stuck in a State of Puberty? Regulatory Reform of Human Clinical Research to Raise Responsiveness to the Reality of Human Variability |
Monday, May 27, 2013 |
10:00 AM–10:50 AM |
Auditorium Room 3 (Convention Center) |
Area: TBA; Domain: Theory |
CE Instructor: Nicole Luke, Ph.D. |
Chair: Nicole Luke (Surrey Place Centre) |
MICHAEL MALINOWSKI (Louisiana State University Law Center) |
Professor Michael J. Malinowski is the Ernest R. and Iris M. Eldred Endowed Professor of Law at Louisiana State University's Paul Hebert Law Center. He is a member of Phi Beta Kappa and Oxford University's 21st Century Trust, and he is a past chair of the Health and Human Services Committee, Administrative Law Section, of the American Bar Association and member of the ABA President's Special Committee on Bioethics. He received a B.A. summa cum laude from Tufts University and a J.D. from Yale Law School, where he was articles editor for the Yale Law Journal. Upon graduating from Yale, Professor Malinowski clerked first for Judge Emilio M. Garza and then for Chief Judge Carolyn Dineen King, U.S. Court of Appeals for the Fifth Circuit. He has published extensively on the commercialization of biotechnology and related health care and bioethics issues, and frequently lectures on these topics throughout the United States and abroad. |
Abstract: This article questions how prescription medicines reach the market and proposes law-policy reforms to enhance the FDA's science standard for human clinical trials and new drug approvals. The core message is that relying too heavily on clinical research data generated through the global "gold standard" of group experimental design--reliance on statistical analysis to compile and compare group averages--risks predicting little about the actual impact of prescription medicines on individuals, including members of the groups under study. This article introduces a law-policy methodology based upon commercial incentives and intervention by Congress and the FDA to raise the science standard for human clinical research, and to make drug development more closely parallel the reality of drug delivery in the practice of medicine. The objectives of this proposal are to promote several pressing needs: maximize drug performance and minimize adverse events; end the pattern of putting new prescription medications on the market with too much dependence on the medical profession to introduce meaningful clinical understanding of drugs through patient use over time; improve biopharmaceutical R&D decision making; align the regulatory standard with the infusion of added precision associated with contemporary genetics-based R&D; and realize more sound scientific information directly through the regulatory process to support the integrity of science in an age of academia industry integration, aggressive commercialization, secrecy in science, and constantly, rapidly evolving technology. |
|
|
|
|
Brain Limbic Generators for Delight, Desire, and Dread |
Monday, May 27, 2013 |
11:00 AM–11:50 AM |
Main Auditorium (Convention Center) |
Area: SCI; Domain: Basic Research |
CE Instructor: M. Christopher Newland, Ph.D. |
Chair: M. Christopher Newland (Auburn University) |
KENT BERRIDGE (University of Michigan) |
Dr. Kent Berridge received his Ph.D. from the University of Pennsylvania and is currently the James Olds Collegiate Professor of Psychology and Neuroscience at the University of Michigan. He has been a Guggenheim Fellow, a Fulbright Senior Scholar and recipient of the Early Career Award from the American Psychological Association. Dr. Berridge's research focuses on the role of reinforcing and affective properties of rewards, addiction, and the brain mechanisms of pleasure and reward. He has contributed to behavioral and neurobiological distinctions between "wanting" and "liking" rewards. His research has been funded by the National Institute on Drug Abuse, National Institute on Alcohol Abuse and Alcoholism, and the National Institute of Neurological Disorders and Stroke. Dr. Berridge serves on several editorial boards, including the Journal of Neuroscience, Behavioral Neuroscience, and Cognitive Affective & Behavioral Neuroscience. |
Abstract: Take-home idea: Behavior analyses reveal surprising psychological features and neurobiological mechanisms underlying intense motivations of reward-related "liking" and "wanting," and relations to negative-valence motivations of fear and disgust. Abstract: Clinical disorders of addiction, binge eating, depression and schizophrenia often involve intense psychopathological mood or motivation states. So it is of interest to understand how limbic brain circuits (involving nucleus accumbens) generate intense motivational states of reward "wanting" and "liking," and also of fearful or aversive states. Behavioral analyses and affective neuroscience studies indicate that "wanting" a reward is generated by a different brain mechanism from "liking" the same reward. The difference between wanting versus liking has implications for understanding addiction and related disorders. Yet surprisingly, desire and fear can both can both be generated by an overlapping mechanism, which may have different modes for each. This lecture will address such dissociations and convergence in affective brain mechanisms. |
|
|
|
|
Do Animals Have "Willpower?" Comparative Investigations of Self-Control |
Monday, May 27, 2013 |
2:00 PM–2:50 PM |
Main Auditorium (Convention Center) |
Area: SCI; Domain: Basic Research |
CE Instructor: Michael J. Beran, Ph.D. |
Chair: John C. Borrero (University of Maryland, Baltimore County) |
MICHAEL J. BERAN (Language Research Center, Georgia State University) |
Michael J. Beran is a senior research scientist at Georgia State University and associate director of the Language Research Center. He received his B.A. in psychology from Oglethorpe University in 1997, his M.A. in 1997, and his Ph.D. in 2002, both from Georgia State University. His research is conducted with human and nonhuman primates, including chimpanzees, bonobos, orangutans, capuchin monkeys, and rhesus monkeys. His research interests include numerical cognition, metacognition, planning and prospective memory, self-control, and decision making. Dr. Beran is a fellow of Division 6 and Division 3 of the American Psychological Association. He was the inaugural Duane M. Rumbaugh Fellow at Georgia State University. He received the Brenda A. Milner award from the APA in 2005. He has published more than 100 peer-reviewed journal articles, written chapters in 20 edited books, and co-edited a book entitled Foundations of Metacognition published by Oxford University Press. His research has been featured on numerous television and radio programs and in magazines, including Animal Planet, the BBC, New Scientist, The Wall Street Journal, and Scientific American Mind. His research is supported by funding from the National Science Foundation, the National Institute of Child Health and Human Development, and the European Science Foundation. |
Abstract: Self-control is sometimes necessary for optimal choice behavior, and perhaps even for future-oriented decision-making. Humans sometimes show self-control by choosing better, but more delayed outcomes over more immediate outcomes. However, the failure of self-control (impulsivity) underlies many problematic human behaviors, and has led humans to train themselves to overcome their "animal impulses." But is it fair to assume that animals cannot do the same, and also exhibit self-control? The presentation will argue that it is not fair, and that many species do show some degree of self-control. Delaying gratification (or postponing a response to a present reward for the sake of a future bigger or better reward) is one of the hallmark aspects of self-control. It also is not a unique human capacity. The presentation will discuss recent studies with chimpanzees and other animals that examine the capacities of those animals to delay gratification and the behavioral strategies that they employ to cope with impulsivity. In some cases, there are close parallels between nonhuman animal performance and that of humans, but in other cases those similarities decrease. But, overall, comparative research suggests that humans are not alone in their capacity to demonstrate some degree of "willpower." |
|
|
|
|
Contextual Factors in the Reinforcing Effects of Drugs |
Monday, May 27, 2013 |
3:00 PM–3:50 PM |
Auditorium Room 1 (Convention Center) |
Area: BPH; Domain: Basic Research |
Instruction Level: Basic |
CE Instructor: Jack Bergman, Ph.D. |
Chair: Paul L. Soto (Johns Hopkins University) |
JACK BERGMAN (Harvard Medical School-McLean Hospital) |
Dr. Jack Bergman received his initial training in behavioral pharmacology in the laboratories of C. R. Schuster and C. E. Johanson at the University of Chicago (Ph.D. 1981). His dissertation research examined the reinforcing effects of the benzodiazepine diazepam in monkeys and, as well, the issue of tolerance to its anti-suppressant actions. Dr. Bergman continued research as a postdoctoral fellow with W. H. Morse in the Psychobiology Laboratory at Harvard Medical School, where he studied behavioral and physiological effects of novel opioids in monkeys and began long-term studies of dopaminergic mechanisms in the reinforcing and other behavioral effects of psychomotor stimulant drugs. Dr. Bergman moved to the New England Primate Research Center where, with Roger Spealman, he continued those studies and, as well, undertook work to delineate the behavioral effects of new, atypical antipsychotic drugs. After moving to McLean Hospital in 1996, Dr. Bergman continued studies of psychomotor stimulant abuse liability including the evaluation of candidate medications, and also began to examine the behavioral effects of THC and other CB1 agonists. He also refined procedures using concurrent schedules of reinforcement to better evaluate the reinforcing strength of self-administered drugs. Most recently, Dr. Bergman's interests in improving behavioral methodologies have included the development of novel operant-based means for studying analgesic drugs. |
Abstract: Early studies showing that drugs that people take illicitly can maintain IV self-administration in laboratory animals have led to a continuing role for such studies to measure abuse potential of existing and new drugs and, as well, continuing interest in understanding the multiple determinants of the reinforcing effects of drugs and how to measure them. Laboratory studies have shown that, in addition to subject-related and drug-related variables, contextual factors can qualitatively and/or quantitatively influence drug-maintained behavior. Among these factors are the schedule of availability, drug-taking history, and reinforcement options. Their influence will be reviewed with examples of differences in the dose-related effects of selected drugs under varying schedule conditions, the role pharmacological history can play in the expression of a drug's reinforcing effects, and the utility of using the availability of an alternative reinforcer under concurrent schedule conditions to study drug-maintained and drug-seeking behavior. |
Target Audience: The target audience is researchers and practitioners interested in substance abuse and current laboratory procedures for assessing abuse liability of drugs. |
Learning Objectives: 1. Identify procedures used for measuring the reinforcing strength of abused drugs 2. Identify different pharmacotherapeutic approaches to drug abuse (agonist substitution, antagonist, other) 3. Identify the major neurotransmitter system and its receptors involved in stimulant abuse |
|
|
|
|
Ape Language Studies |
Monday, May 27, 2013 |
4:00 PM–4:50 PM |
Ballroom B (Convention Center) |
Area: TPC; Domain: Theory |
Instruction Level: Basic |
CE Instructor: Marleen T. Adema, Ph.D. |
Chair: Marleen T. Adema (Dutch Association for Behavior Analysis) |
SUE SAVAGE-RUMBAUGH (Great Ape Trust) |
Sue Savage-Rumbaugh obtained her Ph.D. from the University of Oklahoma (1975). For 23 years, she was based at the Language Research Center of Georgia State University. Currently, she is executive director and senior scientist at Great Ape Trust, a world-class research center dedicated to studying the behavior and intelligence of great apes. Dr. Savage-Rumbaugh is the first scientist to conduct language research with bonobos. She helped pioneer the use of new technologies for working with primates, such as a keyboard providing for speech synthesis, allowing the animals to communicate using spoken English. Her work with Kanzi, the first ape to learn language in the same manner as children, was detailed in Language Comprehension in Ape and Child (1993), which is listed in the top 100 most influential works in cognitive science in the 20th century (University of Minnesota Center for Cognitive Sciences, 1999). Her work is also featured in Kanzi: The Ape at the Brink of the Human Mind (1996), and Apes, Language, and the Human Mind (2001). Savage-Rumbaugh received honorary doctorates from the University of Chicago (1997) and Missouri State University (2008), and was invited speaker to the Nobel Conference XXXII (1996). In 2011, she was recognized as one of TIME magazine’s 100 Most Influential People in the World. |
Abstract: Language has always been assumed to be uniquely human. And many linguists (for example, Chomsky and Pinker) still subscribe to this assumption. However, extensive research since the 1970s has shown that primates are capable of acquiring language skills. This presentation focuses on language studies with bonobos at the Language Research Center of Georgia State University and at Great Ape Trust, using a keyboard with lexigrams as a communication system. The language environment the bonobos were exposed to will be described, as well as their language acquisition process and the language skills they acquired. Theoretical and philosophical implications of these studies will be discussed along with methodological issues and criticism this research raised. The ape language studies have challenged traditional views on language and cognition: findings regarding the abilities of nonhuman primates to acquire symbols, comprehend spoken words, decode simple syntactical structures, learn concepts of number and quantity, and perform complex perceptual-motor tasks have helped change the way humans view other members of the primate order.
Photo: Russ RuBert, RuBert Studios 2012 |
Target Audience: General. |
Learning Objectives: Forthcoming. |
|
|