On March 12, 2004 Brooklyn Law School hosted the symposium “Developing Innovative Therapies in a Complex Regulatory Environment.” Society benefits immeasurably from the development of new therapies, including drugs and vaccines. Other ongoing research possesses great potential, including gene therapy and stem cell research. Investigators in industry and academia who are devoted to this research increasingly find themselves constrained by a complex array of regulations. Compliance is required by a variety of sources, including the FDA, NIH, OHRP, and HIPAA. These limitations are justified by the need to protect our citizens as research subjects and patients. But does such protection unduly hinder the development of needed drugs and other therapies? And to what extent should health care cost concerns influence regulation bearing on development and dissemination of new tests and treatments?

Program participants included:

• Alan R. Fleishman, M.D., Senior Vice President, The New York Academy of Medicine
• Michael A. Carome, M.D., Associate Director of Regulatory Affairs, Office for Human Research Protections (OHRP)
• Joanne E. Pollak, Esq., Vice President and General Counsel, Johns Hopkins Medicine

View video from the event.

View the day’s schedule (PDF) (Adobe Acrobat Reader software required. Download free software.

Read about Brooklyn Law School’s Center for Health Law and Policy.