Tina Kiang, Ph.D. currently serves as the Director of the Division of Regulation and Guidance in OPQ/OPPQ. She has 20 years of combined regulatory and leadership experience at the FDA. Tina has led and supervised the development and finalization of guidance and regulations on a variety of topics within pharmaceutical and manufacturing quality, including for novel areas such as advanced manufacturing and platform technologies. She received her Bachelor of Engineering in chemical engineering from The Cooper Union in New York and her Ph.D. in Biomedical Engineering from The Johns Hopkins University School of Medicine.

Alexander Gaffney is the Executive Director of Regulatory Policy and Intelligence for POLITICO's AgencyIQ, where he leads a team of more than a dozen regulatory intelligence professionals. Alexander has worked in regulatory for more than a decade, including at the Regulatory Affairs Professionals Society (RAPS) and PricewaterhouseCoopers (PwC). At AgencyIQ, his research, insights and analysis is relied upon by the regulatory teams of many of the world's leading companies. He is also the author of AgencyIQ's flagship daily newsletter, "FDA Today."

Rumi Young is the Director of Regulatory Policy at Novo Nordisk, ensuring future growth and innovation by promoting effective biopharmaceutical policies. Previously, she led BD’s Global Regulatory Policy team to shape future policies for medical devices, diagnostics, and combination products. As Assistant Director – Injection Devices at FDA, she managed reviewers and set technical and regulatory expectations for combination products and drug delivery devices. Before FDA, Rumi worked in R&D for a number of years at Genentech and AstraZeneca. She holds a Bachelor’s in Chemistry and Chemical Biology and a Masters in Material Science Engineering from Cornell University.