Ronald T. Piervincenzi, Ph.D., has served as Chief Executive Officer of the U.S. Pharmacopeia (USP) since February 2014. USP is an independent, nonprofit, scientific organization that sets quality standards for medicines, dietary supplements, and food ingredients worldwide. USP’s quality standards are legally recognized in the United States and elsewhere and are used in more than 150 countries.
Dr. Piervincenzi provides strategic leadership to USP’s global staff of over 1,400 across sites in Rockville/USA, Brazil, China, Ghana, and India. His transformative vision has launched key USP initiatives in bringing quality across the healthcare spectrum, upholding USP’s reputation as a quality leader since its founding in 1820.
In response to the pandemic, USP has actively worked with government organizations, other pharmacopeias, manufacturers of drugs and other health products, and healthcare professionals in the U.S. and around the world to help build the public’s trust and improve the supply of safe, trusted COVID-19 vaccines, treatments, and preventatives.
Most recently releasing the newest version of its COVID-19 Vaccine Handling Toolkit. The Toolkit brings to the front lines of the COVID-19 vaccination effort operational strategies assembled in a single resource to address potential efficiency gaps while maintaining safety and quality. The goal is to help build public trust, get more shots in arms and end the pandemic.
Dr. Piervincenzi also provides oversight and leadership of USP’s global public health initiatives, including sites in Ethiopia, Indonesia, Nigeria and the Philippines. Dr. Piervincenzi served as Chair of the Council of Experts, USP’s scientific standards-setting body of 24 Expert Committees and over 750 standards-setting experts until June 2015, when he transferred this responsibility to USP’s new Chief Science Officer. Under his leadership, USP has modernized its operations and launched innovative new science, including in the areas of digital medicine, cutting-edge manufacturing technologies and advanced biologics.
Dr. Piervincenzi brings more than 20 years of industry experience across pharmaceutical sciences, research and business strategy. Before joining USP, Dr. Piervincenzi served as Vice President of Development Sciences with Biogen Idec, Inc., where he designed and launched Biogen’s value-based medicine group focusing on applying tools and technologies of personalized medicine in the treatment and management of multiple sclerosis. Dr. Piervincenzi was a partner and leader in McKinsey & Company’s global pharmaceutical and medical products practice for over 12 years. In this capacity, Dr. Piervincenzi launched McKinsey’s global drug safety, medical and regulatory service line. With McKinsey, Dr. Piervincenzi also led the global research and information analytics team, managing staff in New Jersey, London, Brussels, and India.
Dr. Piervincenzi earned his M.S. and Ph.D. from Duke University in Biomedical Engineering, with research focused on protein engineering. He is the proud co-founder and chairman of the board for the Newark Mentoring Movement.
Below are excerpts from the interview, for the full interview please click on the video:
Introduction to USP | What is the mission and vision of U.S. Pharmacopeia? How is USP structured/funded?
USP was founded in 1820 in the U.S. Senate chamber for the simple purpose to improve the quality of medicine in the United States. Poor quality medicines were coming in from other countries so the notion was to create a set of rules of what should constitute the most basic medicines of the day.That humble beginning is now 201 years ago, and our mission remains the same.
USP Standards and Other Programs | The core aspect of your work is standards, but you also have other programs – can you tell us about them?
As the supply of medicine has gotten more plentiful and more varied so has USP as an organization. The programs we have to ensure quality are for all the different medicines – prescription, over the counter, dietary supplements, and food ingredients in some areas. It takes different kinds of science to make sure and measure that those medicines are what they say they are.
200th Anniversary | Last year, USP celebrated its 200th Anniversary. Can you summarize the origins of USP and its impact over two centuries?
Nine physician leaders from Philadelphia, New York, Boston and Washington DC, a U.S. senator and House members who were also physicians formed the national pharmacopoeia, with the vision that everyone in this whole country should have the same quality medicine. Today we apply that same vision globally, USP standards are used in 150 countries today and more than fifty of those countries adhere to our standards, including the U.S. as the official legal standard in that country.
Career |Prior to joining USP, your career path included stints at McKinsey & Company and Biogen. Please tell us about your career and the decision to join USP.
I was a laboratory scientist; my PhD was in biomedical engineering, and I wanted to learn more about the business sector. I was at McKinsey for twelve years working in the pharmaceutical and biotech industry and for the federal government including with the FDA. That work around R&D and all the issues gave me a broad view that was just amazing.
Milestones |You were appointed CEO of United States Pharmacopeia in 2014. Can you provide some milestones at USP during your stewardship?
Upon my arrival my focus was USP’s interaction with the world outside of USP. Our stakeholders, a complex mix of industry mostly pharmaceutical, government especially regulatory authorities in the U.S. and abroad, and practitioners. It is a big group, and the focus was to listen more. Next was to go global and digital. Going global is different from being international. Being global is a mindset shift.
Global Medicine Supply Chain | What vulnerabilities were exposed during the pandemic about the global medicine supply chain? What is USP’s role in strengthening the supply chain?
It guided us for over a year. The first part was the safety of our people, USP employees and expert volunteers. The second was maintaining operations, especially in a pandemic, it is a time you need quality medicine more than ever. The third is doing what we do – our mission, to ensure quality medicine. Around the vaccines, we partnered with the CDC and created a COVID-19 Handling Toolkit, a set of instructions sent all over the country, how to deliver the vaccine safely and how to get the most people vaccinated as quickly as possible.
Lessons Learned | What was USP’s response to the COVID-19 pandemic and what are some of the other lessons that have been learned?
Agility. Being able to move quickly, doing it well and adapting.
How to really think globally. We have staff in many countries where vaccine access is just starting or not started yet. The pandemic is not over. We need to keep working to get billions of doses around the world, that work is underway, and we are proud to be part of it.
Potential Solutions | Beyond the pandemic, what are some of the other current challenges and solutions to those critical issues?
I am not sure if this is a challenge or an opportunity, the digitization in healthcare. For USP not just delivery but medicines themselves. It’s a transformation that is coming faster than most people realize.
Future of Medicine |What does the future of medicine look like and what is USP doing to ensure quality and foster trust?
The future of medicine is personalization. One is a truly personalized therapy like gene therapy that exists only for you. Personalization can also apply to medicines we already have but will be used in different combinations, different dosages by measuring other biomarkers.
The attributes of how you think of good is much different, it becomes even more important because the personalized medicine of tomorrow is more like the medicine of the 1800’s then 1990. It requires monitoring and measuring of what good looks like from the beginning all the way through to the delivery to the patient and is unique for each patient.
To cover the medicine supply in the U.S. today, USP has well over 7000 standards. A standard is a scientific document, developed over many years and updated on a regular basis, that describes analytical tests and rules for what a medicine should and shouldn’t be. Good standards empower faster innovation because each new innovation does not need to reinvent all the processes. With the future of more complexity and specialization, a really solid standard base will enable that specialization to occur in a way that is safe and effective.
That is why I am so excited about what the next chapter is for USP.
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