April 20, 2018; updated April 25, 208
Early Stage Regulatory Guidance on the Pathway to an IND discussed at April 19 CBCAN
CBC Associate Director Nancy Tyrrell hosted the April 19 CBCAN event which was focused on ‘Early Stage Regulatory Guidance on the Pathway to an IND.’ The event was held at Prentice Women’s Hospital in downtown Chicago. The CBC Accelerator Network (CBCAN) program regularly brings together industry experts, university tech transfer officers, researchers and others from the local and extended biomedical ecosystem. The main goal of the CBCAN forum is to provide early commercial guidance to universities and university-based researchers in order to move promising discoveries into and forward in the pipeline towards commercialization. Hence, the regulatory aspects of Investigational New Drug application (IND) were chosen as a topic for the April 19 CBCAN meeting.
The program consisted of a panel discussion featuring Chicago area regulatory experts followed by an informal networking session. Panel members included Diane Barnes-Glait, Director of Global Regulatory Affairs, Astellas Pharma; Kenneth Miller, New Business Development, Regulatory, Quality, Patient Safety, AbbVie; Teresa Raich, Senior Director of Regulatory Affairs, Abbott Diagnostics; and Michael Schlosser, President, MSR Pharma Services. The panelists represented a breadth of perspectives on the regulatory space, ranging from devices and diagnostics, to small molecules to biologics, including the latest in gene editing and cellular therapies. Each shared their own views on the changing regulatory environment, but all the panelists showed their passion and energy for the drug development process. A lively discussion ensued with numerous questions from the CBC leadership and the audience in attendance, carrying over into the networking session where it continued with good food and drink.
The panel discussion was recorded for those unable to attend and is posted below.
Photos and video: Corinna Kitcharoen, CBC.