Qnovia, Inc., a pharma company developing inhaled therapeutics across a variety of indication areas, announced today Mitch Zeller has joined the company as an advisor to focus on policy and regulatory strategy. Qnovia’s lead asset, QN-01, is an application to FDA’s Center for Drug Evaluation and Research (CDER), with the potential to be the first prescription inhaled smoking cessation therapy.
Mr. Zeller has 40 years of experience working on FDA issues. In his advisory role, he will advise Qnovia on the optimal policy and regulatory strategy that will advance a framework for the development and advancement of new smoking cessation therapies to support the company’s strategy as it advances through the drug approval process in the U.S. and in other global markets.
“I am excited to serve as an advisor to Qnovia at this pivotal stage in the company’s lifecycle,” said Mitch Zeller. “There have been no new therapies approved for smoking cessation in over a decade. Although most smokers are concerned about their health and want to quit, existing products simply don’t work all that well in the real world. Qnovia is taking a unique approach and is committed to developing a safe and effective medical therapy that can help more smokers successfully quit. An inhalable smoking cessation therapy is a potential game-changer, and I look forward to helping the company achieve its goal of ending the death and disease caused by smoking.”
“Mitch brings a wealth of regulatory experience and an unparalleled perspective to our team as we work to advance our lead smoking cessation asset through FDA’s 505 (b)(2) pathway and ultimately to those patients in need,” said Brian Quigley, CEO of Qnovia. “The successful development of QN-01 not only represents a potential breakthrough in smoking cessation treatment but also can validate Qnovia’s platform technology as we expand development in additional therapeutic areas including asthma, COPD, pain management, depression and anxiety.”
Mr. Zeller is an important addition to Qnovia, given his leadership and understanding of the public health, policy, product and regulatory environment around smoking cessation. He was the Director of FDA’s Center for Tobacco Products from March 2013 to April 2022, where he shaped regulatory policy and participated in intra-agency planning for comprehensive nicotine policy. He continues to remain dedicated to advancing the development of new medicinal cessation therapies for patients…
