Maryland Smith’s Rossi Selected for FDA Committee

Maryland Smith finance professor Clifford Rossi has been selected by the Food and Drug Administration to serve on its Pharmaceutical Science and Clinical Pharmacology Advisory Committee.

Rossi, an Executive-in-Residence and Professor of the Practice at the University of Maryland’s Robert H. Smith School of Business, will serve on the 16-member committee as a special government employee. Through his role, Rossi will utilize his risk expertise to provide recommendations on appropriate manufacturing practices and quality systems implementation, as well as assist in addressing scientific and technical issues concerning the safety and effectiveness of drug products.

Committee members were selected by the commissioner or designees from fields such as pharmaceutical sciences, clinical pharmacology and biostatistics among others. Members will gather once per year and serve overlapping terms of up to four years.

“I am honored that the FDA would think enough of me to ask to participate on a committee of this nature,” says Rossi. “We'll be making recommendations to the decision-makers on what they should do with these very important public policy topics that affect all of us in terms of access to drugs and the impact of those drugs on us.”

This committee position marks Rossi’s second collaboration with the FDA. In 2020, the FDA awarded Rossi with a cooperative agreement research grant to study the risks to industry and government of returning pharmaceutical manufacturing to the United States. The grant was allocated through the University of Maryland’s Center of Excellence in Regulatory Science and Innovation (CERSI), an FDA-funded grant between the University of Maryland College Park and the University of Maryland Baltimore campuses.

The research experience, which yielded “A Comparative Investment Analysis of Batch Versus Continuous Pharmaceutical Manufacturing Technologies,” Rossi says, emboldened him to take on this new role with the FDA.

“It underscores the importance of more focus on drug safety, efficacy and making sure that we have adequate manufacturing quality and technology to do that,” says Rossi. “Looking especially at how we finance and invest in that area is something that I’m thrilled to have a voice in now.”

Rossi’s other policy and research interests include GSE reform, housing finance reform, bank capital issues and implications of Dodd-Frank on banking. He most recently testified to the U.S. House of Representatives on current risk models being insufficient for regulators to mandate climate stress testing.

Prior to his career in academia, Rossi spent 25 years in banking and government. He was chief risk officer for Citigroup’s Consumer Lending Division during the financial crisis of 2008-2009, overseeing the risk of the bank’s $300-billion secured consumer asset portfolio. He has also held senior risk management positions at Freddie Mac and Fannie Mae.