USP CEO Discusses Quality and Partnership in Pharma

The CEO of the United States Pharmacoepia (USP) highlighted the importance of collaboration and component quality in pharmaceutical development during a presentation at the Eastern Analytical Symposium in Princeton, New Jersey last month. Ronald Piervincenzi’s lecture emphasized the development and goals of the USP, and how improving material quality and establishing worldwide standard progression can further the field as a whole.

Ronald Piervincenzi | Image Credit: © Eastern Analytical Symposium - https://eas.org/2024-special-lecture/

Piervincenzi, whose tenure as CEO of the USP began in 2014, leads more than 1300 staff members of USP, who are based in North America, Southeast Asia, and Europe, with global public health field offices being found across nine countries (2). Under his leadership, USP has launched key initiatives in increasing quality across the healthcare spectrum, modernizing its operations and creating innovative new science across various fields, including digital medicine, manufacturing technologies, and advanced biologics.

Piervincenzi discussed how for 205 years, the USP has been centered around improving medicine quality in the United States. During that time, USP has grown its partnerships with other organizations to “build the capacity and capability of others to use standards in regulatory authorities, governments, and industry” (1). Today, more than two-thirds of USP standard usage occurs outside of the United States; this growth is a net positive according to Piervincenzi, as it helps organizations in various low- and middle-income countries to “raise the bar on their own capacity to measure and improve the quality of medicines” (1).

Future-Proofing

The USP is focused on strengthening the international manufacturing capacities for various pharmaceuticals. Current supply of many essential health products rely on limited producers from limited major manufacturing hubs. This over consolidation of the market heightens the risk of disruption and prevents millions of patients, especially in low- and middle-income countries, from getting the care they need. The organization works to improve production on regional and local levels in various communities. This ranges from where production takes places to the ingredients used in production, which is vital to the entire process.

“We have to start with creating a trusted supply of active pharmaceutical ingredients (APIs) to have good quality products,” Piervincenzi said. This ensures that the products created and distributed are of acceptable quality. Overall quality control expectations must be raised to ensure that no medicines of poor quality enter the market, he said.

“Once you can establish a new foundation, you move the baseline from substandard to an expectation of quality, the economic development starts,” he said.

The USP’s Work on Medicine Quality

In October 2019, the USP received a 5-year, $160 million cooperative agreement with the U.S. Agency for International Development (USAID) to further efforts to sustainably strengthen medical product quality (3). This was meant to address the proliferation of poor-quality medical products, which waste health system resources while putting millions of people at increased risk of illness or death. This reflects the organization’s goals, which involve strengthening regional and local manufacturing capacities on a global scale. This allows health products, such as medicines, vaccines, and personal protective equipment, to be more easily accessed across international communities, regardless of their financial status (4).

This system, referred to as Promoting the Quality of Medicines Plus (PQM+), will help the USP and its partners strengthen governance and regulatory structures, optimize resource allocation and use, and more. This program helps show how the USP helps its partners mature to become direct providers of technical assistance.

All countries have the power to push the worldwide scientific community further, though it takes collaboration and negotiations to make this possible. Piervincenzi believes in the importance of working together.

“Let's not forget the lessons we learned and how we're improving to help build the people around the world,” he said. “Let’s not forget that in other places where we've already achieved that level of high-quality medicine, that it can be at risk if we don't take care of the thing that got us there in the first place, focusing on the quality on the science.”

References

(1) Piervincenzi, R. “Role of Quality and Analytical in Supporting Industry Growth in LMICs,” lecture held at the 2024 Eastern Analytical Symposium, Plainsboro, New Jersey, 2024.

(2) 2024 Keynote Lecture. Eastern Analytical Symposium 2024. https://eas.org/2024-special-lecture/ (accessed 2024-12-9)

(3) Bell, A. USP Selected by USAID to Strengthen Systems that Improve the Quality of Medical Products in Low- and Middle-Income Countries. USP 2024. https://www.usp.org/news/usp-selected-by-usaid (accessed 2024-12-10)

(4) Expanding Manufacturing Capacity. USP 2024. https://www.usp.org/global-public-health/technical-areas/building-manufacturing-capacity (accessed 2024-12-10)