Navigating the gray space – Bioethics in the Pharmaceutical Industry and Innovative Technology
The development of innovative new medicines and medical devices takes place in a highly regulated environment. If we look at the history of the development of those laws and regulations, we will see that they are strongly rooted in the principles of bioethics and have often arisen from crises or missteps in the historical conduct of research. And yet, even with a robust regulatory framework, we are routinely confronted with challenging questions that benefit from ethical analysis – allocation of scarce resources, appropriate use of new technology, access to investigational medicines, data stewardship. During this talk, we will take a look back at the history and the foundations of research ethics and how those principles are applied in the context of developing innovative medicines and medical technology. We will round out our discussion with a reflection on the application of bioethics to emerging technology and the importance of cultivating one’s personal values and application of moral principles in the context of considering potential unintended consequences of technology that we develop.
More about our speaker Karla Childers...
Karla Childers joined Johnson & Johnson (J&J) in October 2013 in the Office of the Chief Medical Officer where her primary responsibility has been leading and coordinating various ethics-based, science and technology policy projects. Ms. Childers is the Chair of the J&J Bioethics Committee, which serves as an internal forum providing advice on bioethical questions within J&J. She serves as a bioethics subject matter expert for various internal and external science and technology policy work and coordinates the internal bioethics educational program sponsored by the Office of the Chief Medical Officer.
Ms. Childers is actively engaged outside J&J in various R&D and ethics-based work. She co-founded the Drug Information Association (DIA) Bioethics Community and recently joined the board of directors of FASPE (Fellowships at Auschwitz for the Study of Professional Ethics). She also serves as a teaching assistant and lecturer in the Columbia University Master of Bioethics Program.
Before joining J&J, she managed cross functional drug development teams in various therapeutic areas and stages of development for Merck Research Labs. Prior to that, Ms. Childers began her career in industry as a bench chemist in MRL’s Process Chemistry group.
She received her Bachelor of Arts Degree in Chemistry from Indiana University-Purdue University in Indianapolis and a Master of Science in Jurisprudence with a concentration in Health Law from Seton Hall Law School. She is also a graduate of Columbia University with a Master of Science in Bioethics.
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