Jan 25 2019
Barbara Binzak Blumenfeld, shareholder in the firm's FDA & Biotechnology section, will chair two sessions and speak at the upcoming Phacilitate Leaders World and World Stem Cell Summit in Miami, Florida from Jan. 22-25. The first session, “Bringing Order to the Wild West: Regulatory Enforcement, Lawsuits and Ethical Considerations for Stem Cells in Clinical Practice,” will discuss the role of and limitations on physicians practicing “regenerative medicine.” Barbara’s presentation, “Walking the Line Between Practice of Medicine and Unauthorized Product Manufacturing: Enforcement Lessons,” will address recent FDA, DOJ, and FTC enforcement actions against companies and physicians in the regenerative medicine arena.
The second session that Barbara is chairing, “Need to Know! Legal and Regulatory Issues Impacting Clinicians,” will also discuss regenerative medicine clinical trials and physicians’ ethical and professional obligations.