Ethical Challenges in Compassionate Access to Investigational Medicines image

December 7, 2015 12:30 - 2:00 PM
Lectures and Panels
Harvard Medical School
641 Huntington Ave., Boston, MA


Bringing medicines to patients to address unmet medical needs is the goal of most physicians in pharmaceutical research. However, few situations are more difficult for physicians in research than deciding how to help patients with life threatening conditions who seek “compassionate access” to investigational medicines outside of clinical trials. Many factors need to be taken into consideration, including regulatory requirements, drug supply, evolving efficacy and safety risks, and numerous ethical questions. 

This event was free and open to the public.

About the Speaker

Joanne Waldstreicher, MD, is Chief Medical Officer, Johnson & Johnson. In this role, Joanne has oversight across pharmaceuticals, devices and consumer products for safety, epidemiology, clinical and regulatory operations, internal and external partnerships and collaborations, and development of the corporate science, technology, and R&D policies, including those related to clinical trial transparency and compassionate access. Joanne also chairs the Pharmaceuticals (Janssen) R&D Development Committee, which reviews all late stage development programs in the pharmaceutical pipeline. 

Among her prior roles in the pharmaceutical sector of Johnson & Johnson, Joanne was responsible for late-stage development spanning the areas of neuroscience, cardiovascular and metabolism including Invokana®, Xarelto®, Invega Sustenna®, and Invega Trinza®.  Before joining Johnson & Johnson in 2002, Joanne was head of the Endocrinology and Metabolism clinical research group at Merck Research Laboratories, and responsible for overseeing clinical development of Mevacor®, Zocor®, Proscar® and Propecia®, and for clinical development programs in atherosclerosis, obesity, diabetes, urology and dermatology. During that time, she received numerous distinctions, including the Merck Research Laboratory Key Innovator Award.

Joanne received both the Jonas Salk and Belle Zeller scholarships from the City University of New York and graduated Summa Cum Laude from Brooklyn College. She graduated Cum Laude from Harvard Medical School in 1987, and completed her internship and residency at Beth Israel Hospital, and her endocrinology fellowship at MGH. Joanne has done research with Dr. William F. Crowley, Jr., Chief of the Reproductive Endocrinology Unit at MGH, as well as Dr. Charles Czeisler, Chief of the Division of Sleep and Circadian Disorders at the Brigham. She has won numerous awards and scholarships, and has authored numerous papers and abstracts. Joanne combines broad experience in science and medicine along with a passion for advancing transparency and ethics.

Cosponsored by the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School; the Center for Bioethics at Harvard Medical School; Harvard Catalyst | The Harvard Clinical and Translational Science Center at Harvard Medical School; and the MRCT Center of Harvard and Brigham and Women's Hospital.