As CEO of US Pharmacopeial Convention (USP) and chair of its Council of Experts, Ron Piervincenzi ’93 oversees the nonprofit organization and a group of expert-volunteers who develop quality standards for all medications and their generic counterparts marketed in the US (enforceable by the FDA), as well as for dietary supplements, herbal medicines and food ingredients. As one of Hofstra’s first Bioengineering students, Piervincenzi was mentored by a then-new professor, Dr. Sina Rabbany, and given opportunities to spend his summers working at the Naval Research Lab in Washington, DC. When Piervincenzi reflects on those years and speaks about the growth of Hofstra’s Engineering Department, it is clear he takes a lot of pride in his roots and in the program and professors who helped set him on his path to success. (Above photo: Piervincenzi -right- with Professor Rabbany at the 2014 Hofstra Gala)
As an incoming student, Piervincenzi was familiar with the campus because his mother worked as a secretary in the Athletics and the Mathematics Departments for many years (before graduating with him in 1993 with her own bachelor’s). The University, he says, “was something I grew up with. I knew the campus pretty well, even as a kid.”
When he enrolled at Hofstra, he was drawn to the burgeoning Bioengineering program. “I found bioengineering’s combination of the sciences and engineering very appealing, as well as being part of a new academic area. There was special attention to the students, and Sina was able to create special research opportunities. Those kinds of opportunities tend to snowball and create new contacts and projects.”
Working with Dr. Rabbany on biosensor-related research at the Naval Research Lab over two summers were just such experiences. They worked in the laboratory of Dr. Frances Ligler, a pioneer in the development of ultra-sensitive antibody-based systems for biological agent detection. “We were conducting various experiments that applied engineering principles to biologic science.”
“After the summer, coming back to the University, Sina organized poster presentations and other activities, usually reserved for graduate students. By the time I got to grad school, I was ahead of where many other students were in regard to research and research presentation and publication.”
After earning a master’s and PhD at Duke University, Piervincenzi spent 14 years at McKinsey & Company before joining USP. Piervincenzi explains USP’s essential role in healthcare: “If a doctor prescribes a brand medication – Pfizer’s Lipitor, for example – it’s pretty straightforward. There is a review and approval process followed by an agreement between Pfizer and the FDA which says the drug does what it claims to do and it is safe to use.
“But what happens when Lipitor goes generic? Then you have anywhere from 10-15 companies all around the world making that drug. It becomes incredibly complicated to ensure that all those generic medications are of the appropriate quality. That’s where USP comes in. USP creates a baseline quality standard that applies to the initial FDA-approved manufacturer, and can be used by any drug manufacturer anywhere in the world to ensure drug strength, quality and purity. USP quality standards promote consistency across manufacturers, which is important because up to 80 percent of today’s brand medications have gone generic and the majority of generic drugs are made in India and China. As a matter of public health, by US law, every one of those manufacturers has to adhere to our applicable standards. Otherwise they are not legally able to import or market their drugs in the US.”
Currently there are three industry-wide challenges USP faces. “First,” says Piervincenzi, “is the amazing complexity of the supply chain, including online pharmacies and global sourcing. Another piece is volume. Almost every medication developed over the last 30 years is now available as a generic, and each of these generics creates another 10 copies. There’s a multiplicative effect.
“The last category is economically-motivated adulteration – essentially criminals making and selling medications that are not what they say they are. While this is not new, it’s a problem that rising very rapidly. It’s an issue everywhere in the world, and there are countries where it’s more the rule than the exception. In some sub-Saharan African countries more than half the drugs on the shelves are fake and/or substandard.”
USP’s Council of Experts and their Expert Committees, of which Piervincenzi is chair, is made up of several hundred scientific experts from all over the world and walks of life – academia, industry and regulators – who meet on a regular basis to vote on standards. In his other role as CEO, Piervincenzi oversees a staff of more than 900 employees in six countries (U.S., India, China, Brazil, Ghana, Switzerland), seeing to the technical support and administrative side of the organization. One exciting new development for USP is its growing presence in the vitamin and supplement market. The dietary supplement industry is a booming business, but since it does not fall under the same stringent regulations as pharmaceuticals, it can be a confusing area for consumers. USP Verified is a program that works with dietary supplement manufacturers who choose to certify the identify, quality and purity of their products. Items that pass this review can then be marked with the USP Verified seal (not unlike the Good Housekeeping Seal of Approval created by Harvey Wiley M.D., who served as USP Convention President from 1910-1920).
When asked what advice he might have to offer current Hofstra students, specifically those pursuing studies in engineering and science, Piervincenzi says, “What I’ve learned from my own career path is that you’ll always be wrong if you think you know what you’re going to do next. Create options for the future. Broaden your horizons and take classes in areas that may lead you in other professional directions or graduate school. Plan to go beyond what you’re certain to do.”
Piervincenzi currently serves on the Industrial Advisory Group for Hofstra’s School of Engineering and Applied Science. “I feel like I owe it to give back as much as I can. I think it’s quite exciting and a unique opportunity to attract and train young engineers.” Piervincenzi and his wife, Laura, currently live in Potomac, MD, with their daughters Serena, 14, and Clara, 8.