May 2, 2019 8:30am-2:30pm
In partnership with EY and Scientific American, Bioethics International will hosts its 10th annual Forum on what it means to be a trustworthy, patient-centered & ethical pharma and healthcare innovation company.
Location: New York, NY
June 23, 2019 — June 27, 2019
Panelists will explore the pros and cons of the pathway from the patient perspective and learn about how regulators and sponsors may help facilitate the development of critically needed treatments. This discussion will introduce a streamlined approach to early-stage development of therapies to address severely debilitating or life-threatening diseases and consider the potential value of a global regulatory approach.
Location: San Diego, CA
The New York Times interviewed our founder, Jennifer Miller, on FDA Commissioner Dr. Scott Gottlieb's clinical trial transparency initiatives. She discussed his new pilot, launched last month, which selects 9 recently-approved drugs, whose sponsors (generally pharmaceutical companies) volunteer to participate, to post portions of Clinical Study Reports (CSRs) from their pivotal trials on FDA's website…
February 12, 2018
This week we focused on the ethics of Big Data, publishing an article titled, Big Data Probably Knows More About You Than Your Friends Do, in Leaps Mag. The article discusses the promises and perils of big data and concludes with a way to manage your data wealth. To read the full article click here.
February 7, 2018
Jeremy Puthumana, MS; Jennifer E. Miller, PhD; Jeanie Kim, JD; et al Joseph S. Ross, MD, MHS. JAMA Network Open. 2018;1(2):e180283. doi:10.1001/jamanetworkopen.2018.0283
The Right to Try Act of 2017 allows patients with life-threatening conditions to access investigational medicines outside clinical trials without oversight from the US Food and Drug Administration (FDA). A better understanding of existing expanded access programs can inform the consideration and implementation of both the federal Right to Try Act and state right-to-try laws.
Cross-sectional descriptive analysis of all clinical trials supporting 2014 Food and Drugs Administration (FDA)-approved new drug applications (NDAs) for novel drugs sponsored by large companies.