Event Calendar

Closing Plenary

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2019 Agenda


Sunday, September 29, 8:40 to 9:25

Applying the Principles of the Science of Safety to Improve Subject Safety in Clinical Research: Actionable Practices to Identify and Minimize Risk

Mr. Kessler will use case studies to illustrate and describe 1) selected practices in the management of investigational drugs and the consent process that are potentially unsafe and increase the risk to subjects, 2) enhanced reporting strategies to identify potential risks, and 3) enhanced ways to learn from deviations/mistakes that occur. 901
Presenter: John Kessler, PharmD, BS Pharm, Chief Clinical Officer, SecondStory Health, LLC

Dr. Kessler will use case studies to illustrate and describe 1) selected practices in the management of investigational drugs and the consent process that are potentially unsafe and increase the risk to subjects, 2) enhanced reporting strategies to identify potential risks, and 3) enhanced ways to learn from deviations/mistakes that occur. 901

Presenter: John Kessler, PharmD, BS Pharm, Chief Clinical Officer, SecondStory Health, LLC


Sunday, September 29, 9:25 to 10:10 

The Evolution of Vulnerability – The Ethics of Equitable Subject Selection

In April of 1979, the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research published the Belmont Report. The Report summarized ethical principles and guidelines for research involving human subjects. Three core principles were identified: respect for persons, beneficence, and justice. While all three principles consider the rights of the research subjects, the justice principle focused primarily on subject selection. The spirit of the justice principle describes the protection of subjects vulnerable to unethical research. However, vulnerability in 1979 is markedly different from vulnerability today.  This talk will chronicle the history of vulnerability in human subjects research and compare and contrast how this vulnerability is now manifested in today’s research environment. 903

Presenter: Quincy Byrdsong, EdD, CCRP, CIP, Executive Director for Research Administration, WellStar Research Institute


Sunday, September 29, 10:30 to 11:00

Including Vulnerable Subjects with Cognitive Impairment in Research

This talk will review the new common rule definition of vulnerable subjects including “individuals with impaired decision making ability.” It will discuss why inclusion of this vulnerable population is needed in research studies, especially for diseases such as Alzheimer’s research. Finally, it will review the ethical guidelines and discuss practical strategies for obtaining informed consent for subjects who may lack decision making capacity. 904

Presenter: Laura Holtz, MS, CCRP, Senior Research Manager, IU Center for Aging Research, Regenstrief Institute


Sunday, September 29, 11:00 to 11:30

Sharing De-Identified Data

Ms. Balch will discuss Count Me In, a nonprofit that allows researchers to work directly with patients and advocacy groups, along with software engineers and computational scientists, to collect, analyze, and share de-identified data in order to transform cancer care. 905

Presenter: Sara Balch, BS, Project Manager, Count Me In and the Broad Institute of MIT and Harvard


Sunday, September 30, 11:30 to 12:00

The Reality of Enrollment Expectations

Louis Lasagna was the founder of the Tufts Center for the Study of Drug Development at Tufts University where he became Dean of the Sackler School of Graduate Biomedical Sciences. Lasagna’s Law states “The incidence of patient availability sharply decreases when a clinical trial begins and returns to its original level as soon as the trial is completed.” Why is this true? Can it ever be changed? If not, why not? 906

Presenter: Harvey Arbit, PharmD, MBA, CCRP,  RAC, President, Arbit Consulting, LLC