Lyceum Society November 2015 Meeting
Monday, November 2, 2015
The Lyceum Society comprises the Academy's retired and semi-retired members.
Talks cover various scientific fields. All Academy members are welcome.
All Lyceum meetings (except December) are Brown Bag lunches.
Brown Bag: 11:30 AM
Brief-Brief: 12:45-1:15 PM
Lecture & Discussion: 1:15–3:00 PM
Speaker: Ralph Kaslick
Can Genetic Testing Forecast the Level of Personalized Responsiveness to a Placebo?
Recent evidence indicates that lacebo and nocebo responders may soon be able to be detected in advance of enrollment in clinical trials by certain genetic test results. Genetic variations in opioid and dopamine neurotransmitter pathways may also be able to predict which patients may benefit most from placebo enhancement or even replacement of routine drug or other medical therapies
Speaker: Clifton Hotvedt
The Drug Approval Process
The Food and Drug Administration traces its roots back to the Import Drugs Act of 1848, passed as a result of the United States at that time being, "the world's dumping ground for counterfeit, contaminated, diluted, and decomposed drug materials."
While it was at first only mandated that manufacturers demonstrate that drugs were safe, regulation over time required that proof of effectiveness was also important. Many new regulations were passed in response to public health disasters. More recent changes to the FDA review process allow for getting drugs to the market sooner.
The FDA's mantra is that no drug is entirely safe and no drug is entirely effective. The balance between these two needs is constantly being challenged.
This presentation will review how the FDA's approach to drug regulation has evolved from crises such as thalidomide through current issues such as personalized medicine, generic drugs and biosimilars.
Ralph S. Kaslick, DDS, graduated from Columbia University in 1956, receiving his DDS from Columbia's medical campus. He was active for 23 years at Fairleigh Dickinson U, serving as Professor of Periodontics and Oral Medicine, Dean of the College of Dental Medicine, and Campus Provost. During the following 15 years, he was Chief of Dentistry and Medical Consultative Services and President of the Medical Staff at Goldwater Memorial Hospital, while holding the position of Professor of Periodontics and Hospital Dentistry at NYU's College of Dentistry. For the past 9 years, he has been Chair of the Visiting Professor Program dedicated to Contemporary Issues in Dentistry at Columbia University's College of Dental Medicine.
Dr. Kaslick has presented three lectures to the Lyceum Society on the placebo response, covering such issues as the influence of biological mechanisms, the role of the non-conscious mind and the effect of open-labelling. In two other talks, he has examined the biological basis of our subjective perception of free will and addressed new evidence of changes in epigenetic markers retained during the inheritance of acquired characteristics.
Clif Hotvedt's diverse scientific background reflects his experience in the pharmaceutical industry, as a medical writer at Ives Laboratories and at leading public relations firms including Robert Marston & Associates, Manning Selvage & Lee and Ketchum, where he was vice president and global director of medical & scientific affairs. For 40 years, he has counseled companies on over 100 small molecule drugs, biological and devices for indications including cardiovascular disease, rheumatology, metabolic disease, dermatology, central nervous system disease, vaccines, infectious disease and cancer. A New Mexico State University graduate in secondary education and journalism, Clif has used his teaching background to develop and present courses on the FDA approval process, pharmacokinetics, pharmacodynamics and biostatistics among other topics for coworkers and clients.
|Member (Student / Postdoc / Resident / Fellow)||$0|
|Nonmember (Student / Postdoc / Resident / Fellow)||$10|
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